The Syneos Health Podcast

Conversations on Commercialization: Navigating Dermatology’s New Access Landscape with Paul Rittman of Almirall US

Thu, 19 Feb 2026 18:00:00 -0500

In this episode of The Syneos Health Podcast, Conversations on Commercialization, Tyler Cowan, VP, Commercial speaks with Paul Rittman, President and General Manager of Almirall US, about how payer consolidation and PBM influence are reshaping dermatology commercialization.

They discuss how pharmaceutical companies must adapt launch strategy, market access planning and clinical differentiation to succeed in today’s competitive specialty landscape. The conversation explores the growing role of digital engagement, direct-to-consumer (DTC) strategy, telehealth and cash-pay models in improving patient access.

Listeners will gain practical insights into how innovation, payer strategy and patient-centric commercialization drive success in dermatology and specialty pharma.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Functionally Speaking Series: Regulatory Intelligence, Medical Writing and the AI Inflection Point

Fri, 30 Jan 2026 11:00:00 -0500

In this episode, Lynn Hamilton speaks with Stuart Goodall, Senior Vice President at Syneos Health, about how regulatory functions are evolving in response to growing complexity, accelerating timelines and emerging technologies. With more than 35 years of global experience, Stuart offers an unfiltered perspective on what regulatory and medical writing teams need to succeed today—and how to scale smartly for what’s next.

Topics explored include:

· The shift from information advantage to decision advantage in regulatory intelligence

· How AI is changing—not replacing—medical writing and regulatory operations

· What sponsors need to consider when building scalable, tech-enabled models

· Why FSP is no longer just transactional and how strategic partnerships are redefining value

· Why storytelling and judgment remain irreplaceable in an automated world

Whether you're exploring your next medical writing solution or rethinking regulatory infrastructure, this conversation offers grounded insights with a forward-looking lens.

Functionally Speaking Series: Reimagining Site Experience: CRAs, AI and the Future of Functional Models

Thu, 22 Jan 2026 11:00:00 -0500

In this forward-looking episode, Lynn Hamilton sits down with Bret Couturier, Executive Director, FSP 360 at Syneos Health, to explore how sponsors can shift from incremental improvements to intentional design when it comes to site experience. With a career spanning frontline monitoring to strategic FSP leadership, Bret offers practical insights into what's working, and what’s holding teams back.

Key themes include:

Why the CRA role isn’t disappearing, but rather evolving with AI and data-driven tools
The importance of designing from the site’s perspective, not just for internal efficiency
How functional service provider (FSP) models can go beyond staffing to drive systemic improvement
Simple but powerful steps sponsors can take now to reduce burden and build stronger site relationships
What it means to move from reactive fixes to strategic collaboration, and why the time is now

If you’re rethinking site engagement, functional models or the next phase of FSP delivery, this conversation offers both strategic clarity and real-world takeaways.

Functionally Speaking Series: Modernizing Safety and Pharmacovigilance, The Human in the Loop

Thu, 15 Jan 2026 14:00:00 -0500

In this episode of the Functionally Speaking series, host Lynn Hamilton speaks with Carol Aliyar, Executive Vice President and Global Head of Safety and Pharmacovigilance (PV) at Syneos Health, about the transformation of PV from a highly regulated, task-oriented function into a more strategic and technology-enabled discipline. With over 30 years in the industry and a career that spans commercial, clinical and safety roles, Carol brings a rare full-spectrum perspective.

Listeners will gain insight into:

How PV is shifting from transactional taskwork to strategic lifecycle integration
What AI and automation really mean for safety operations and talent needs
The enduring importance of human judgment, especially in the age of AI agents
Why functional service provider (FSP) models are now resonating in PV
How consistency, flexibility and subject matter depth strengthen long-term partnerships

Whether you're expanding your PV model, exploring AI adoption or rethinking how functional teams deliver value, this conversation offers real-world perspective and practical foresight.

Functionally Speaking Series: Clinical Operations for Large Pharma, Navigating Model Evolution With Agility

Thu, 08 Jan 2026 12:00:00 -0500

What does it take to run a truly effective Functional Service Provider (FSP) model in today’s biopharma landscape? From harmonizing global teams to embedding innovation into daily delivery, FSP engagement is more than a resourcing solution — it’s about strategic collaboration and approaches that accelerate delivery. The Syneos Health Podcast: Functionally Speaking series explores the nuances that make these models work.

In this episode of the Functionally Speaking series, host Lynn Hamilton sits down with Wayne Wise, Vice President of Clinical Operations at Syneos Health, to explore the real-world shifts happening in large pharma partnerships. With nearly two decades at the company and deep cross-functional experience, Wayne shares how agility, strategic governance and trust-based team leadership are reshaping FSP delivery models.

From evolving CRA roles and co-created governance to the increasing use of AI, Wayne offers a firsthand look at how functional teams are adapting in real time to operational and strategic shifts across the industry.

You will walk away with insights on:

Moving beyond transactional models to strategic, insight-driven partnerships
Building agile teams that thrive amid complexity
Transforming governance to focus on action, not just KPIs
How the CRA role is evolving with tech-enabled site engagement
What sponsors can do to unlock value through co-creation

Functionally Speaking Series: FSP for SMID Sponsors, Navigating Complexity with Flexibility and Trust

Thu, 08 Jan 2026 12:00:00 -0500

In this episode of Functionally Speaking, host Lynn Hamilton welcomes Matt Lawton, Executive Director of FSP Delivery at Syneos Health, to explore the unique challenges and opportunities facing small-to-mid-size (SMID) biopharma sponsors. Often operating with leaner resources and evolving pipelines, these companies require partners who can flex with their journey—not just deliver headcount.

With over 15 years of experience guiding functional partnerships, Matt offers grounded insights on how to build trust-based FSP models tailored to each sponsor’s origin, stage and future goals.

Listeners will gain a practical understanding of:

What truly defines the SMID segment—and why it’s a space of rapid innovation
How functional support needs vary widely across early- to mid-stage sponsors
The critical role of adaptability in both delivery teams and partnership models
Why strong cultural fit and team integration matter more in SMID engagements
When to start considering FSP—and how a conversation, not a contract, is often the best first step

If you're working in or with an emerging biopharma organization, this episode offers a valuable look into how functional partnerships can evolve to meet you where you are—and grow with you.

2025 CNS Summit Series: Scaling Psychedelic Medicines Responsibly, A Conversation with Dr. Dan Karlin, CSO, MindMed

Thu, 08 Jan 2026 09:00:00 -0500

What does it take to redefine psychiatric care with psychedelic therapies? In this episode, Dr. Dan Karlin of MindMed joins host Dr. Talar Hopyan to discuss the clinical, regulatory and cultural shifts underway in mental health.

They explore the momentum behind MindMed’s LSD program for anxiety and depression, how the team is preparing for NDA filing and commercialization and why purposeful growth—not hype—is key to long-term success in psychedelics.

What you’ll learn:

Why MindMed’s MM120 program could reshape the treatment landscape for anxiety
How collaboration with regulators is enabling more responsible innovation
What intentional scaling means for the future of psychedelic biotech

2025 CNS Summit Series: Revolutionizing Clinical Trials with Virtual Patients, A Conversation with Anzar Abbas, CEO, Brooklyn Health

Thu, 18 Dec 2025 16:00:00 -0500

What’s the path to better measurement in psychiatry?

In this episode, Dr. Alexandria Wise speaks with Dr. Anzar Abbas—neuroscientist, innovator and CNS Summit 2025 Innovation Showcase winner—about how Brooklyn Health is using AI to standardize rater training and improve data quality in psychiatric trials.

They discuss why subjective interviews still dominate, where today’s models fall short and how multimodal digital tools could reshape how we evaluate treatments.

2025 CNS Summit Series: Rewriting the Rules of Neurodegeneration, A Conversation with Arvinas CSO Angela Cacace, PhD

Thu, 11 Dec 2025 12:00:00 -0500

What if protein degradation could address neurodegenerative diseases, not just cancer?

In this episode, Dr. Angela Cacace, CSO at Arvinas, speaks with Dr. Talar Hopyan, Global Head of CST at Syneos Health, about how the company is advancing a degrader targeting LRRK2 in Parkinson’s disease and why early-stage signals in healthy volunteers are raising new possibilities for CNS care.

They discuss how Arvinas is engineering blood-brain barrier-penetrant molecules, the translational challenges in neurodegeneration and what’s required to move from platform to patient.

What you’ll learn:

How Arvinas is expanding targeted protein degradation into neurology
Why LRRK2 degradation is a promising approach for Parkinson’s disease
What it takes to translate platform innovation into measurable clinical outcomes

CNS Summit Series: Balanced Disruption in Neurology, A Conversation with Merz Therapeutics CEO Stefan König

Thu, 13 Nov 2025 16:00:00 -0500

Now in its second season, this exclusive CNS Summit podcast series features biopharma leaders sharing bold ideas, breakthrough innovations and what it takes to move smarter and faster for patients.

How is a mid-sized, family-owned company scaling with impact in specialty neurology? Stefan König, CEO of Merz Therapeutics, joins guest host Andy Moniz, VP of Therapeutic Strategy and Innovation at Syneos Health at the 2025 CNS Summit. Together, they explore what it takes to lead through volatility, invest globally and grow with intention, all while upholding culture and delivering with purpose.

In this episode:

How Merz is leveraging global capital to expand its neurology pipeline
What today’s market volatility reveals about opportunity
Why “balanced disruption” matters for scaling innovation

Conversations on Commercialization: Changing the Name Game with Addison Whitney’s Ari™

Wed, 12 Nov 2025 15:00:00 -0500

A new limited series of the Syneos Health Podcast, Conversations on Commercialization unpacks how biopharma leaders are rewriting the commercial playbook, redefining what it takes to succeed.

What if drug naming could be faster, smarter and more aligned to brand strategy?

In this episode, Addison Whitney’s Joe Daley, President, and Bill Purdy, SVP and Managing Director of Global Brand Development & Strategy, break down how Ari™, a purpose-built AI platform, is solving long-standing naming and branding challenges in biopharma.

Listen and you’ll learn:

How Ari™ integrates strategic input, trademark search and POCA screening
Ways AI reduces attrition and regulatory risk in naming
Why naming is now a strategic process and not just a creative one

CNS Summit Series: Can Psychedelics Reshape Psychiatry? A Conversation with Kabir Nath, CEO, Compass Pathways

Thu, 06 Nov 2025 14:00:00 -0500

Now in its second season, this exclusive CNS Summit podcast series features biopharma leaders sharing bold ideas, breakthrough innovations and what it takes to move smarter and faster for patients.

Compass Pathways CEO Kabir Nath joins host, Dr. Alex Wise, Global Head of Neuroscience at Syneos Health, to discuss the clinical promise of psychedelics and what’s next for psychiatric innovation.

What you’ll learn:

What’s driving the momentum behind psilocybin therapy
Why investor confidence is growing in mental health biotech
How biopharma can better communicate the value of innovation
Kabir’s message to next-gen leaders in science and strategy

Conversations on Commercialization: GLP-1 Gold Rush — Who’s Really Winning in the New Obesity Market?

Thu, 23 Oct 2025 12:00:00 -0400

A new limited series of the Syneos Health Podcast, Conversations on Commercialization unpacks how biopharma leaders are rewriting the commercial playbook, redefining what it takes to succeed.

In this episode, recorded at Fierce Pharma Week 2025, Tyler Cowan, VP Commercial at Syneos Health, joins Hruta Shah, Senior Engagement Manager for Syneos Health Consulting, to break down the high-stakes race in obesity treatment and the commercial boom around GLP-1 therapies.

You’ll hear:

What emerging launch strategies look like in a crowded, competitive pipeline and how success is being redefined
How GLP-1s are accelerating a shift in stakeholder dynamics, including telehealth, large employers and direct-to-patient platforms
Why traditional DTC advertising is evolving and how informed patients are influencing brand messaging

Conversations on Commercialization: DTP, AI and the Future of Pharma Access

Thu, 16 Oct 2025 10:00:00 -0400

A new limited series of the Syneos Health Podcast, Conversations on Commercialization unpacks how biopharma leaders are rewriting the commercial playbook, redefining what it takes to succeed.

Recorded at Fierce Pharma Week 2025, the series continues with part two of our conversation with Mark Bard, co-founder of the Digital Health Coalition.

In this episode, Bard and host Tyler Cowan turn the lens to patients, exploring how direct-to-patient models are disrupting traditional care and the implications of reduced physician involvement. They also tackle the rise of agentic AI, what it could enable and what commercial teams should be thinking about now.

Conversations on Commercialization: The New Rules of HCP Engagement

Thu, 16 Oct 2025 10:00:00 -0400

A new limited series of the Syneos Health Podcast, Conversations on Commercialization unpacks how biopharma leaders are rewriting the commercial playbook, redefining what it takes to succeed.

Recorded at Fierce Pharma Week 2025, the series begins with a two-part conversation with Mark Bard, co-founder of the Digital Health Coalition.

In this episode, Bard joins host Tyler Cowan, VP, Commercial at Syneos Health to unpack how the pandemic reshaped provider expectations and the continued impact on commercial teams. From feedback loops to content fatigue, to the myth of multichannel mastery, they break down what it takes to engage HCPs on their terms.

2025 Health Trends | Getting Real About Omnichannel: A View from the Leading Edge

Tue, 29 Jul 2025 15:00:00 -0400

Yes, omnichannel is still trending—but it’s also evolving fast. Helen Green, Head of Patient Recruitment and Retention Strategy and AJ Triano, EVP, Customer Experience Practice, with host Drew Beck, unpack how forward-thinking strategies are transforming patient engagement and accelerating clinical development. Discover how AI and data intelligence are enabling smarter, more connected experiences across the healthcare and life sciences ecosystem. Tune in for actionable insights and a strategic lens on what’s next in omnichannel innovation.

Asembia AXS25 Series: Redefining Access for Enhanced Retail Therapies, with Cheryl Allen of Curatio Advisors

Mon, 07 Jul 2025 10:00:00 -0400

In this episode, host Sara Rubin is joined by Cheryl Allen, RPh, founding partner at Curatio Advisors, to explore how manufacturers can evolve their access strategies in response to the growing complexity of specialty-like therapies. With a career spanning specialty pharmacy, digital health innovation and commercialization strategy, Cheryl shares how reframing these products as “enhanced retail” can unlock smarter, patient-centered support models.

The conversation highlights how patient voices are shaping the next generation of hub services, starter kits and adherence programs, and why a product’s clinical and administrative profile should inform infrastructure decisions from day one. Cheryl offers actionable guidance on building programs that not only help patients start therapy, but support long-term persistence in a fragmented and demanding access environment.

Asembia AXS25 Series: Reimagining Patient Support: Scaling Access, Affordability and AI Integration with Kelly Carter of Amgen

Thu, 05 Jun 2025 15:00:00 -0400

In this special edition of the Syneos Health Podcast recorded from the floor of Asembia’s AXS25 Summit, host Michael Sarshad sits down with Kim Plesnarski, SVP of Market Access and Patient Support Services at Syneos Health and Kelly Carter, AVP of Patient Support at Amgen, to unpack the evolving landscape of patient support.

The discussion explores the blurring lines between general and specialty medicine, the growing administrative burden on providers and the need to embed seamless, tech-enabled support into the healthcare journey. The trio dives into the role of Field Reimbursement Managers (FRMs), payer challenges, affordability barriers and how AI and automation are beginning to transform operations—from personalized patient education to proactive intervention.

If you're interested in how manufacturers can shift from reactive to proactive models and scale personalized support in an increasingly complex environment, this episode is a must-listen.

Asembia AXS25 Series: Redefining Market Access: Patient Support, Technology and Pharma Strategy with Rob Truckenmiller of PharmaCord

Thu, 29 May 2025 16:00:00 -0400

In this episode of our Navigating Modern Market Access series, recorded from the floor of Asembia's AXS25 Summit, host Sara Rubin sits down with Rob Truckenmiller, the newly appointed CEO of PharmaCord.

Drawing from his deep experience across small, mid-sized and large pharmaceutical companies, Rob explores how market access strategies must evolve to meet today’s healthcare challenges. From the integration of patient services and payer strategies to the role of technology and data in shaping outcomes, Rob shares his perspective on how pharma companies can empower patients, optimize gross-to-net and navigate the complex US healthcare landscape.

Tune in for actionable insights on building a smarter, more patient-centric access model.

Asembia AXS25 Series: Holistic Patient Support with Tiara Green of Accessia Health

Thu, 22 May 2025 08:00:00 -0400

In this special episode recorded from the floor at Asembia’s AXS25 Summit, host Michael Sarshad sits down with Tiara Green, President of Accessia Health, to explore the evolving landscape of patient support.

They discuss how Accessia Health is addressing the growing needs of individuals with rare and chronic conditions—not just through copay assistance, but by tackling social determinants of health like transportation, food insecurity and mental health services. Tiara shares insights on the expanding role of technology, from streamlined eligibility systems to telehealth and AI, and emphasizes the importance of personalized, community-based care. They also dive into provider education, the power of partnerships and how pharma can promote health equity by engaging diverse populations earlier in the care continuum.

Tune in for an inspiring conversation about improving access and outcomes through innovation and collaboration.

Asembia AXS25 Series: Modernizing Patient Services: AI, Hybrid Models and Innovation Strategy with Greg Morris of CareMetx

Tue, 20 May 2025 12:00:00 -0400

In this special edition of the Syneos Health Podcast recorded from the floor of Asembia’s AXS25 Summit, host Michael Sarshad speaks with Kim Plesnarski, SVP of Market Access and Patient Support Services at Syneos Health and Greg Morris, Chief Strategy Officer at CareMetx.

They explore the latest trends shaping patient support services—from the surge of AI-powered solutions to the shift toward hybrid hub models. The conversation dives into the challenges of reactive support programs, the need for continual innovation and the nuanced debate between insourcing and outsourcing.

With practical insights and real-world examples, Kim and Greg share strategies for building scalable, tech-forward patient service models that meet the evolving demands of both patients and providers.

Project Optimus Series: Clinical Pharmacology and Project Optimus

Wed, 14 May 2025 14:00:00 -0400

We continue our Project Optimus series with a focus on clinical pharmacology—a foundational element in redefining dose optimization in oncology drug development.

Dr. Wael Harb is joined by Pierre-Olivier Tremblay, Vice President of Clinical Pharmacology at Syneos Health, to discuss how model-informed strategies, exposure-response analysis and biomarkers are transforming early phase trials. They examine how tools like PK/PD modeling and tumor dynamics simulations enable a shift from traditional maximum tolerated dose approaches to more patient-centric dosing strategies, and explore how AI, data sharing and regulatory innovation are shaping the future of precision oncology.

2025 Health Trends | Strategy, Agility and Innovation in Launch Excellence

Thu, 08 May 2025 14:00:00 -0400

Hosted by Drew Beck, Head of Strategy, Growth and Innovation for Syneos Health Learning Solutions, this limited series dives into the breakthrough trends redefining health in 2025 and beyond. From bold moves in R&D and medical affairs to next-gen trial design, product launch strategies and the future of healthcare communications, each episode connects you with the minds driving real change. Big ideas. Real-world impact.

In this episode, Drew dives into launch excellence in 2025 with Syneos Health experts Larry Dollar, VP of Medical Affairs, and Michael Sarshad, Managing Director, Consulting. Together, they unpack how strategic spending, agile planning and early investment in medical resources are driving launch success. They explore the rise of new medical affairs roles using the transformative impact of AI on clinical trials, and the evolving needs of field teams. The discussion also highlights how innovations like machine learning–driven physician segmentation are helping companies identify new clinical trial sites faster and more precisely. Whether you're with an emerging biotech or a large pharma company, you'll get key insights on collaboration, creativity and why the year leading up to launch is more critical than ever.

2025 Health Trends | AI as an R&D Investment

Thu, 24 Apr 2025 13:00:00 -0400

2025 Health Trends meets The Syneos Health Podcast for a limited series exploring how Trends come alive in the life sciences industry with host Drew Beck, Head of Strategy, Growth and Innovation for Syneos Health Learning Solutions.

Syneos Health experts Brian Carver, Executive Director of Therapeutic Strategy and Innovation, Rare Disease Consortium, Vik Chawla, Managing Director, Syneos Health Consulting and Katya Magonova, Managing Director, Syneos Health Consulting explore the role of AI in rare disease drug development, diagnosis and treatment. They share how AI is accelerating R&D, improving patient identification and enhancing clinical trials. The discussion also highlights investment trends in AI within the healthcare sector, the emergence of AI-first companies and the ongoing challenges and opportunities of integrating AI into life sciences, underpinned with data from our 2025 Dealmakers’ Intentions Survey. Emphasizing the importance of understanding AI's applications and implications, host Drew Beck has a special call to action for the industry to harness AI’s power in drug development and commercializ

Asembia AXS25 Series: Navigating Modern Market Access

Wed, 23 Apr 2025 17:00:00 -0400

The biopharma market is booming—but not without turbulence. In this kickoff episode of our special podcast series in collaboration with Asembia, hosts Michael Sarshad, Managing Director, Commercial Advisory, Syneos Health and Sara Rubin, Senior Vice President, Market Access Strategy at Spherico, a Syneos Health company, unpack the dynamic forces reshaping how therapies reach patients. Recorded ahead of Asembia’s AXS25 Specialty Pharmacy Summit, they dive into the impact of tariffs, the power of AI in streamlining patient support, the ripple effects of the Inflation Reduction Act and how digital transformation is changing the way manufacturers engage population health decision-makers. Tune in for expert insights, preview topics for this year’s summit, and discover how the industry is responding to rising complexity with strategic innovation.

Project Optimus Series: The Role of Biostatistics

Fri, 11 Apr 2025 10:00:00 -0400

As regulatory expectations evolve under the FDA’s Project Optimus oncology dosing initiative, biostatistics is emerging as a central pillar in designing and executing trials that move beyond the traditional maximum tolerated dose (MTD) approach.

In this fourth episode of our Project Optimus series, host Dr. Wael Harb is joined by biostatistics expert X.Q Xue, PhD, Vice President and Global Head, Biostatistics at Syneos Health to explore how statistical science is transforming dose optimization in oncology drug development. Dr. Xue discusses the limitations of legacy 3+3 dose-escalation designs and introduces innovative alternatives, including Bayesian modeling, adaptive trial strategies and randomized parallel dose-response studies, which support more precise dose selection and can ultimately improve patient outcomes and trial efficiency.

Together, Drs. Harb and Xue examine how smaller biotech companies can overcome barriers to implementation, the role of simulation and AI in trial planning and how a biostatistics-driven approach may increase the likelihood of late-phase success, reduce post-marketing adjustments and support faster regulatory approvals.

Project Optimus Series: Operationalizing Dose Optimization

Wed, 19 Mar 2025 13:00:00 -0400

In this episode of The Syneos Health Podcast, we continue our exploration of Project Optimus and the evolution of dose optimization in oncology drug development. Following our discussion on regulatory expectations in the previous episode, we now turn to the operational challenges and strategies required to implement optimized dosing in real-world settings.

Host Dr. Wael Harb is joined by Patrick Melvin, Vice President, Oncology & Hematology and Global Head, Novel and Emerging Therapies at Syneos Health, to discuss the complexities of operationalizing Project Optimus. Together, they examine how drug developers, investigator sites and patients are affected by these changes, the role of adaptive study designs, and how AI-driven technologies and digital health innovations are helping to streamline dose optimization.

Tune in to gain valuable insights into the future of precision dosing and the long-term benefits of this industry shift, from improving patient outcomes to enhancing drug development efficiency.

Opportunities Abound for PDTs, with Click Therapeutics

Wed, 12 Feb 2025 11:00:00 -0500

Unlike general health and wellness apps, Prescription Digital Therapeutics (PDTs) are FDA-authorized, prescribed by healthcare professionals, and rigorously studied in clinical trials. With the global PDT market projected to reach $43 billion by 2032, new regulatory pathways, including CMS billing codes in 2025, are set to enhance adoption and accessibility.

In his final episode hosting the Syneos Health Podcast, Nick Kenny is joined by Dr. Shaheen Lakhan, Chief Medical Officer, and Laura Taraboanta, Director of Medical Operations and Strategy, both from Click Therapeutics, to explore the evolving landscape of PDTs.

Together, they discuss how PDTs work and for which conditions, the opportunities driven by the FDA’s Prescription Drug Use-Related Software (PDURS) guidance—which now enables PDTs to be integrated into drug labels, where PDTs are making inroads to expand access to care, and a future that will include “software enhanced” (SE) drugs that improve adherence, personalization and treatment outcomes.

The discussion underscores how PDTs are redefining personalized medicine, transforming healthcare delivery, and expanding into new therapeutic areas beyond mental health.

For more from Click Therapeutics and our experts on Digital Therapeutics, check out:

Syneos Health Podcast | Digital Therapeutic Commercialization

Syneos Health Podcast | Digital Therapeutic Development and Approval

10 Ways to Optimize and Accelerate Brand Performance using Prescription DTx

How Digital Therapeutics Developers Can Satisfy Diverse Stakeholder Needs

About Click SE™

Unlocking the Black Box of Psychiatric Clinical Research, with Dr. Rishi Kakar of Segal Trials

Fri, 24 Jan 2025 10:00:00 -0500

In this episode, we welcome Dr. Rishi Kakar, Chief Scientific Officer and Medical Director at Segal Trials. Host Andy Moniz, Vice President, Therapeutic Strategy & Innovation at Syneos Health, sits down with Dr. Kakar to explore his inspiring journey from a 15-year-old immigrant discovering neuroscience in a Queens library to becoming a leader in clinical research and innovation.

Dr. Kakar shares the personal moments that shaped his passion for psychiatry, the pivotal experiences that drove his commitment to understanding the drug development process, and how Segal Trials has remained at the forefront of clinical research. From pioneering psychedelic trials to building innovative quality dashboards, Dr. Kakar offers insights into the future of patient-centric clinical trials, workforce transformation, and the integration of emerging technologies.

Project Optimus Series: The Regulatory Implications of Project Optimus

Fri, 17 Jan 2025 13:00:00 -0500

In this episode of the Syneos Health Podcast, series host Dr. Wael Harb, Vice President of Medical Management at Syneos Health, continues the exploration of FDA's groundbreaking Project Optimus and its profound implications for oncology drug development. He is joined by Zohra Lomri, Executive Director, Regulatory Affairs at Syneos Health, to discuss how this initiative is transforming dose optimization strategies and reshaping the clinical trial landscape.

The conversation delves into the FDA’s emphasis on balancing efficacy and tolerability, the shift away from maximum tolerated doses, and the integration of patient-reported outcomes. Zohra provides valuable insights on the regulatory expectations for dose-ranging studies, the importance of leveraging non-clinical data, and the role of pharmacokinetics (PK) and pharmacodynamics (PD) modeling in optimizing trial designs.

Whether you’re in oncology drug development or interested in regulatory innovation, this episode offers actionable advice and a glimpse into the future of patient-focused drug development.

CNS Summit Series: Pioneering Patient Advocacy, with Ryan Brooks from CenExel

Thu, 16 Jan 2025 08:00:00 -0500

For our special series celebrating 15 years of innovation with CNS Summit, host Dr. Alexandria Wise sits down with Ryan Brooks, Executive Chairman and CEO of CenExel, a leading specialty site network. In this discussion, recorded from the floor of CNS Summit 2024, Ryan shares his journey from a farm in Idaho to leading a network of Centers of Excellence, driven by personal health challenges and a passion for advancing healthcare. The conversation explores CenExel's mission to advocate for patients, innovate in CNS clinical trials, and embrace the promise of personalized medicine. Ryan's insights into balancing patient needs with evolving study designs and his reflections on the future of life sciences offer a thought-provoking look at the industry’s path forward.

CNS Summit Series: Future-Proofing Clinical Trials

Tue, 14 Jan 2025 08:00:00 -0500

In this episode, Dr. Alexandria Wise speaks with Steve Rosenberg, CEO of uMotif, recorded from the CNS Summit 2024 exhibit floor. With over four decades of experience in software development and two decades in clinical research, Steve shares his journey from early tech innovations to his current mission of revolutionizing patient engagement and site support in clinical trials.

Steve discusses the pivotal role of patient-centric tools in modernizing clinical research, emphasizing the need to recognize and support patients as key contributors to advancements in medicine. He also delves into the growing challenges faced by clinical sites, the potential of AI and computer modeling to streamline trials, and his vision for a future where the industry prioritizes patient and site experiences over protocol complexity.

CNS Summit Series: Pioneering Psychiatry - Behind the Breakthrough KarXT with Dr. Stephen Brannan

Thu, 09 Jan 2025 09:00:00 -0500

In this inspiring look at the progress and potential in psychiatry research, Dr. Alexandria Wise sits down with Dr. Stephen Brannan, former Chief Medical Officer of Karuna Therapeutics, to discuss the groundbreaking approval of KarXT—the first muscarinic mechanism antipsychotic in decades. Dr. Brannan reflects on his journey in psychiatry, the challenges of clinical trials, and the transformative impact of KarXT on treating schizophrenia's positive, negative, and cognitive symptoms.

The conversation dives into the critical role of clinical trials and the altruism that drives their success, overcoming unprecedented obstacles while developing KarXT, and the importance of pushing boundaries in neuroscience to address unmet needs.

CNS Summit Series: Decoding Biology to Radically Change the Lives of Patients, with Dr. Najat Khan of Recursion Pharma

Tue, 07 Jan 2025 08:00:00 -0500

In this episode, host Dr. Alexandria Wise sits down with Dr. Najat Khan, Chief R&D Officer and Chief Commercial Officer at Recursion Pharma, live from the floor of CNS Summit 2024. Together, they explore how cutting-edge technologies like AI and machine learning are transforming drug discovery and development, shortening timelines, and driving precision medicine.

Dr. Khan shares her inspiring journey, from her upbringing surrounded by medicine to leading innovations at the intersection of biology, chemistry, and technology. She emphasizes the importance of connecting the "first mile" of biological insight to the "last mile" of patient access and discusses Recursion’s mission to decode biology and radically improve lives.

CNS Summit Series: Schizophrenia, Clinical Trials and Hope, with Dr. David Walling of Cenexel CNS

Thu, 19 Dec 2024 08:00:00 -0500

In this special edition of The Syneos Health Podcast, host Dr. Alexandria Wise celebrates 15 years of innovation with CNS Summit by interviewing Dr. David Walling, Chief Clinical Officer at CenExel CNS. Recorded from the floor of CNS Summit 2024, the conversation dives into Dr. Walling’s career journey, his passion for advancing care for individuals with schizophrenia, and the evolution of clinical trials over the past two decades.

Dr. Walling shares insights into CenExel’s mission as a “Center of Excellence” for clinical research and reflects on his early work with schizophrenia patients, from the development of atypical antipsychotics in the 1990s to today’s cutting-edge therapies like KarXT, a newly FDA-approved medication with a novel mechanism of action. The discussion highlights the increasing importance of patient-centered approaches, the integration of patient voices in clinical trial design, and the promise of innovative treatments that address not only positive symptoms but also negative symptoms and cognitive deficits in schizophrenia.

Tune in for an engaging and hopeful exploration of advancements in CNS disorders, the challenges of drug development, and the strides being made toward improving patient quality of life.

CNS Summit Series: The Future of Immunology and Personalized Health,with Jane Metcalfe of The Human Immunome Project

Tue, 17 Dec 2024 08:00:00 -0500

Recorded from the 15th annual CNS Summit, Andy Moniz, Vice President of Therapeutic Strategy Innovation at Syneos Health, sits down with Jane Metcalfe, Board Chair of the Human Immunome Project, to discuss the transformative potential of immunology in medicine. Jane shares her inspiring journey into this groundbreaking field, highlighting how advanced biological measurements, machine learning, and personalized immune profiling are reshaping drug development, clinical practice, and medical education.

From the immune system’s role in diseases like Alzheimer’s and cancer to the need for diverse clinical trials, this conversation explores the dynamic intersection of science, technology, and humanity.

CNS Summit Series: Psychedelics and Beyond, with Kevin Craig of atai Life Sciences

Thu, 12 Dec 2024 08:00:00 -0500

In this episode, Dr. Alexandria Wise celebrates 15 years of innovation at CNS Summit 2024 by sitting down with Kevin Craig, Senior Vice President of Clinical Development at atai Life Sciences. Recorded from the floor of the conference, Kevin shares his journey from research and medicine to leading drug development in mental health, with a focus on the company's pioneering work in psychedelics.

This episode delves into the complexities of drug development in the psychedelic space, the importance of global accessibility, and the profound impact of patient involvement in clinical trial design. Kevin also shares his perspective on the future of the life sciences industry, emphasizing the role of big data, biomarkers, and efficient trial models in advancing mental health care.

CNS Summit Series: Redefining Psychiatry with Science and Compassion, with Dr. David Brown of Community Clinical Research

Tue, 10 Dec 2024 07:00:00 -0500

Join host Andy Moniz, Vice President of Therapeutic Strategy Innovation at Syneos Health, as he sits down with Dr. David Brown from Community Clinical Research in Austin, Texas, for a compelling conversation recorded from the floor of CNS Summit. In this episode, Dr. Brown shares his journey into psychiatry, inspired by his experiences in medical school and his personal connection to mental health.

The discussion delves into the transformative impact of clinical trials, the advancements in schizophrenia research, and the potential for a new era in personalized psychiatry driven by genetic insights and AI. Dr. Brown reflects on the challenges of stigma, the progress in neuroscience, and his hopes for the industry in the next five years, including bridging gaps between academia and pharma and inspiring the next generation of researchers.

CNS Summit Series: Patient-Centric Innovation at Scale, with Cristina Duran of Evinova

Thu, 05 Dec 2024 08:00:00 -0500

In this episode, recorded from the floor of the CNS Summit, host Andy Moniz, Vice President of Therapeutic Strategy and Innovation at Syneos Health, sits down with Cristina Duran, CEO of Evinova, to discuss her transformative journey in life sciences and the future of patient-centric innovation in healthcare.

Cristina shares insights from her experience leading R&D transformation at AstraZeneca, where she pioneered patient-centric approaches to clinical trials. She discusses how Evinova is driving industry-wide change by creating integrated, scalable solutions that prioritize patient needs while delivering faster, more efficient outcomes for life sciences—emphasizing the importance of collaboration, learning from failures, and connecting across the sector to accelerate progress.

CNS Summit Series: Celebrating 15 Years of Innovation with Dr. Amir Kalali of CNS Summit

Tue, 03 Dec 2024 08:00:00 -0500

In this special series of the Syneos Health Podcast, we celebrate 15 years of innovation in collaboration with CNS Summit, a community of innovators and life science industry leaders devoted to discovering better, more efficient ways to advance the industry through innovation, collaboration, and technology. Over the course of the series, we will feature conversations with key experts and members of the community on how the life sciences industry is continuing to reinvent itself in the pursuit of better outcomes for more patients.

In this episode, guest host Dr. Alexandria Wise, SVP and Global Neuroscience Head at Syneos Health, is joined by physician-scientist Dr. Amir Kalali, Chairman and Chief Curator of CNS Summit. Dr. Kalali shares the origins of CNS Summit, the unique vision that set it apart, and the milestones achieved along the way—and offers insights on the future of collaboration in clinical development and advice for the next generation of industry leaders.

Project Optimus Series: Navigating the Realities of Project Optimus

Tue, 26 Nov 2024 09:00:00 -0500

Launched in 2021 by the FDA's Oncology Center of Excellence, Project Optimus seeks to reshape traditional oncology trial designs and dosing paradigms, shifting from maximum tolerated doses to precision dosing strategies. While the FDA's hope was that the added time and cost of collecting comprehensive dose and exposure response data would benefit both patients and sponsors, there is also concern and debate in the biotech community that, if the Optimus formula is closely followed, the additional time, cost, and patient needs may, in fact, be crippling to cash-strapped emerging companies.

So what is the reality around Project Optimus? And how best can it be implemented and navigated?

Kicking off a new special series on Project Optimus, in this episode Nick Kenny, Chief Scientific Officer at Syneos Health, is joined by Dr. Wael Harb, Vice President on the Syneos Health Medical Oncology Team, to explore this transformative initiative, diving into the implications for biotech companies and discussing the balance between upfront investment and long-term benefits, the operational challenges of implementation, and the critical role of early planning.

Stay tuned for upcoming episodes in this series, which will dive deeper into the regulatory, statistical, clinical, and operational implications of this evolving regulatory framework.

For more insights from our oncology experts:

Syneos Health Podcast | A Site-Specific Approach to Optimizing Diversity in Oncology Trials

WEBINAR | Transforming Oncology Drug Development: Insights from Healthcare Providers on the Frontlines of Cancer Care

Syneos Health Podcast | Circulating Tumor DNA: Transforming Oncology Clinical Trials

Navigating Tumor-Agnostic Drug Development: Value, Challenges and Strategic Insights for Sponsors

Psychedelics 3.0: Challenges and Opportunities in an Evolving Field

Wed, 30 Oct 2024 12:00:00 -0400

There is a significant unmet need for medicines to treat neuropsychiatric and neurological conditions in underserved patient populations. Recently, there has been renewed interest in psychedelic, hallucinogenic and dissociative compounds to meet those needs. In clinical trials, a wide array of these compounds are showing efficacy across a variety of indications.

Syneos Health experts Andy Moniz, Dr. Leslie Moldauer, Zelma Gandy Don Sing and Lindsay Crampton—along with Dr. Aaron Koenig, CMO of Delix Therapeutics—convened in a roundtable discussion to provide their own unique perspectives about the current and future state of psychedelic drug development and how to actively navigate the rapidly evolving field of clinical trials for these revolutionary treatments.

Listen in to hear how psychedelics have progressed from their origins as a spiritual aid, their acceptance as a treatment for neuropsychiatric conditions, and the development of next-generation compounds.

For more from our neuroscience experts, check out these insights:

Syneos Health Podcast | Can AI Help Get the Right Patients Into Alzheimer's Clinical Trials?

Artificial Intelligence and Alzheimer’s: Transforming Patient Screening with Predictive Models

WEBINAR | Psychedelics 3.0: Challenges and Opportunities

Syneos Health Podcast | World Mental Health Day: The State of Mental Health Clinical Development

BLOG | The Reimbursement Case for Psychedelic Therapies Must Incorporate the Patient’s Voice

A Site-Specific Approach to Optimizing Diversity in Oncology Trials

Wed, 23 Oct 2024 16:00:00 -0400

As the biopharma industry strives to ensure that clinical trials reflect the rich diversity of the patient populations they aim to serve, the challenges to make this possible have fallen on the trial sites.

In a recent webinar, Syneos Health experts Jane Bentley and Juliette Roberts from our Oncology Therapeutic Strategy & Innovation team, and Kelli Defenbaugh from Patient Recruitment and Retention Management, offered robust strategies and actionable insights tailored to overcome obstacles sites are facing.

Listen in to learn more about how sites can contribute to enhanced diversity in oncology trials, with specific actions that sites can take to make each clinical trial better represent the population it seeks to serve.

Visit here for more oncology insights from our experts.

Circulating Tumor DNA: Transforming Oncology Clinical Trials

Wed, 02 Oct 2024 11:00:00 -0400

Use of circulating tumor DNA (ctDNA) – small fragments of DNA that are released into the bloodstream by cancer cells – as a diagnostic tool represents a significant shift toward more precise, personalized cancer care, enhancing both trial efficiency and patient experience. Unlike traditional tissue biopsies, which sample a single tumor site, ctDNA offers a real-time, comprehensive view of the genetic mutations present in the tumor throughout the body. By offering faster, more detailed insights than traditional imaging, ctDNA can identify tumor mutations earlier and help clinicians adjust treatments sooner – a crucial advantage in particular for early phase oncology trials.

In this episode of the Syneos Health Podcast, Chief Scientific Officer Nick Kenny is joined by oncology experts Dr. Patrick Kelly and Dr. Wael Harb to discuss how circulating tumor DNA (ctDNA) is transforming cancer treatment and clinical trial design, and its potential to drive more patient-centric, adaptive clinical trials.

Find all of our oncology-related insights on our Insights Hub here.

Cashing in on the Currency of Information

Tue, 24 Sep 2024 10:00:00 -0400

Medical science liaisons—or MSLs—within pharmaceutical companies deal in a special currency: scientific exchange and real-world insights gathering. Only they can share certain types of information with a growing number of medical stakeholders. And only they can bring back medical insights to guide strategic development and brand decisions. Yet, can anyone be certain that this highly valuable currency is being spent wisely?

Recently, some of our Medical Affairs experts led an engaging webinar on maximizing the value of your MSL team and driving better outcomes in pharmaceutical development.

Listen in as they unravel the challenges in quantifying MSLs’ value, explore how these teams are enhancing impact through strategic engagement, unpack new ways of measuring value beyond output and illustrate how companies can further empower MSLs with data-driven AI/tech-enabled solutions.

Be sure to check out these other insights from our Medical Affairs experts:

WEBINAR | From Insight to Impact: Leveraging Early Medical Affairs Engagement for Future Commercial Success

Driving Impact: Key Themes for Advancing Medical Affairs in the Evolving Pharma Landscape

Webinar | Driving Patient-Powered Medicine: Scientific Communication with Patient Communities

It’s Time We Got the Most Out of Medical Affairs Data

Decoding Gen AI’s Potential to Drive More Effective Clinical Trials

Wed, 21 Aug 2024 08:00:00 -0400

AI is seemingly everywhere now in our lives, including healthcare and drug discovery and development. AI certainly has the potential to enable major advances than development of more effective and safe medical products. And in fact, GenAI has already been successfully used in drug discovery.

But are we fully leveraging the current AI yet in practical ways? Are our trial designs informed appropriately by AI and data? From the mundane document generation and handling to the complex patient engagement, what is the here and now of how we can and should apply AI to support more informed, more effective drug development?

In this episode of the Syneos Health Podcast, Nick Kenny, Chief Scientific Officer at Syneos Health is joined by industry experts Nataraj Dasgupta, Vice President of Advanced Analytics at RxDataScience and Greg Christie, Chief Product Officer at StudyKIK to dive deep into the transformative potential of Artificial Intelligence (AI) in the realm of drug development and clinical trials. The discussion explores the practical applications of AI—from improving patient recruitment and engagement to revolutionizing document generation and protocol design—and touches on the exciting promise of Generative AI (GenAI) in streamlining processes, enhancing patient experiences, and democratizing access to clinical trials. The panel also confronts the challenges, including data accuracy, regulatory concerns, and the ethical implications of AI-driven decisions.

Tune in to understand how AI is reshaping the future of healthcare and what lies ahead in this rapidly evolving field.

For more AI insights from our experts:

Syneos Health Podcast | Can AI Help Get the Right Patients Into Alzheimer's Clinical Trials?

Artificial Intelligence and Alzheimer’s: Transforming Patient Screening with Predictive Models

Syneos Health Podcast | Turbo-Charging Clinical Trials

WEBINAR | How AI is Supercharging Clinical Trials

Connecting the Global Dots on Carbon Footprint in Biopharma

Tue, 09 Jul 2024 10:00:00 -0400

The World Economic Forum projects that by 2050, climate change could cause 14 million additional deaths and $12 trillion in global healthcare costs. And this will exacerbate global health inequities with our most vulnerable populations, including women, youth, elderly, lower-income groups, and hard-to-reach communities bearing the brunt of this change. We think we know the culprits…but do we really?

The fact is, the healthcare sector is responsible for almost 5% of global greenhouse gas emissions and has a carbon footprint equivalent to 514 coal-fired power plants. And if the healthcare sector was a country, it would be the 5th largest polluter on Earth. (Source)

In this episode of the Syneos Health Podcast, Nick Kenny is joined by Syneos Health colleagues Sharon Gordon, leader of our Social Impact practice and Beth Anne McPheeters, head of ESG programming, to discuss the intersection of climate change, ESG (Environmental, Social, and Governance), and healthcare.

The conversation delves into the responsibilities of big industries versus collective action, the role of ESG in driving meaningful change, and the importance of integrating ESG into business goals to mitigate risks and create value, ultimately benefiting both business and patient outcomes—reinforcing that addressing climate change and promoting ESG is not just corporate responsibility but also essential for improving global health and equity.

For more on how Syneos Health is committed to making purposeful actions upholding our responsibility to create a more sustainable world for each other, read our 2023 ESG Report.

Check out more of our insights on the role of ESG in the healthcare industry:

BLOG | Pharma Reputation Slipping, Leaving Fewer Allies in Intense Environment

BLOG | 4 Reasons ESG Priorities are Becoming More Important in the Life Sciences Industry

Clinical Trials and Environmental, Social and Governance: Plans for Operations Leaders

Can AI Help Get the Right Patients Into Alzheimer's Clinical Trials?

Fri, 31 May 2024 09:00:00 -0400

Alzheimer's disease is a challenging and devastating diagnosis that affects memory and cognitive skills, with no known way to predict, track, treat, or cure it effectively. In 2024, around 90 million people over the age of 65 will be living with Alzheimer's. Clinical trials for new treatments have faced high failure rates, partly because it's difficult to identify the right patients at the right stage of the disease. The potential solution to this dilemma might lie in AI, which could help analyze vast amounts of clinical data and provide a practical prognostic tool.

Our host Nick Kenny, Chief Scientific Officer at Syneos Health, is joined by Dr. Claudine Brisard, Senior Vice President of Neurosciences at Syneos Health and Dr. Christian Dansereau, CEO of Perceiv AI, to explore how AI and prognostic models might solve the challenges of selecting the right patients for Alzheimer's clinical trials.

Check out these insights for more from our experts on Alzheimer’s Disease or the use of AI to accelerate clinical trials:

BLOG: Artificial Intelligence and Alzheimer’s: Transforming Patient Screening with Predictive Models

Syneos Health Podcast | Turbo-Charging Clinical Trials

Webinar | How AI is Supercharging Clinical Trials

Artificial Intelligence, Machine Learning and a New Epoch for Clinical Trials

Unpacking the Role of Adjuvant Therapies in Breast Cancer

Thu, 23 May 2024 08:00:00 -0400

Breast cancer is the most common type of cancer among women worldwide, and it can be treated with different modalities, such as surgery, chemotherapy, radiation, hormone therapy and targeted therapy. However, even after the primary treatment, some cancer cells may remain in the body and cause recurrence or metastasis. This is where adjuvant therapies come in: they are additional treatments that aim to reduce the risk of cancer coming back or spreading to other parts of the body.

In this episode, Syneos Health colleagues Dr. Juan Manuel Carrera, Senior Medical Director and Lisamarie Burgio, Executive Director, Therapeutic Strategy and Innovation join the podcast to explore the role of adjuvant therapies in breast cancer, with a focus on the latest developments and challenges in this field. They share their extensive experiences and insights from both clinical and operational perspectives, emphasizing the importance of personalized treatment approaches based on the latest genomic information and the evolving landscape of clinical trials, offering a comprehensive view of the strides being made and the challenges that remain.

For the latest oncology insights from our experts, check out:

Bridging the Gap in Male Breast Cancer Research Through Inclusive Clinical Trial Strategy

Oncology and the Evolution of Master Clinical Trials | Lessons from the Beat AML Master Trial

Readiness Assessment: What Strategies Can You Deploy to Improve Diversity in Your Oncology Trials?

Syneos Health Podcast | The Case for Genetic Medicine

Is Your NSCLC Asset Ready to Create Value Post-FDA Approval? | 2024 Update

Site and Study Execution for Ophthalmology Trials

Wed, 08 May 2024 08:00:00 -0400

This is an exciting time in the development of new medicines to treat both rare and age-related eye diseases. But what is it like in the trenches to develop and deliver clinical trials that evaluate both the safety and efficacy of these potential new medicines for diseases of the eye?

In this episode, Nick Kenny, Syneos Health CSO and interim podcast host, is joined by Eileen Schramm, Senior Clinical Trial Manager, and Nicole Curry, Senior Project Manager, both in the Syneos Health Ophthalmology team, to discuss the challenges and realities of developing and delivering clinical trials for ophthalmology studies. They highlight the importance of finding and engaging clinical investigators who have the necessary equipment, training, and patient stream to conduct these complex trials; the need for proper site staffing, minimizing staff turnover, and investing in training for study coordinators; and the critical role of patient engagement and providing trial participants with clear expectations and tools to navigate the study journey.

For more from our ophthalmology experts, check out these insights:

Navigating Biometrics Challenges in Ophthalmology Clinical Trials: Lessons Learned
Syneos Health Podcast | Ophthalmology Clinical Trials: Low Vision and AMD Awareness Month

The Case for Genetic Medicines

Mon, 29 Apr 2024 07:00:00 -0400

In March 2024, the FDA approved a groundbreaking gene therapy for children with a specific form of leukodystrophy, offering hope to those with no current care options. However, the approval came with a hefty price tag, making headlines as the most expensive medicine in the world at $3,500,000 per patient. With the cost of innovation so high, what can we do to de-risk development, ensure affordability and achieve equitable access to these potentially life-changing therapies for the long term?

Nick Kenny, CSO for Syneos Health and host for this episode, is joined by colleagues Abhi Gupta, Head of Genetic Medicine, and Dr. Prateet Minhas, Managing Director, Value & Access Consulting, to explore the evolution of genetic medicines, from the early days of clinical trials fraught with challenges to the recent surge in approvals and the promise of curative potential. Abhi and Prateet discuss the landscape for genetic medicines today, touching on topics such as manufacturing challenges, regulatory considerations, and the importance of demonstrating durability of response in clinical development.

As they navigate the complexities of the field, they address key questions surrounding the value proposition of genetic medicines, including their potential to transform patient outcomes and the challenges of reimbursement and access. They also examine the role of collaboration and innovation in driving progress in the field, highlighting the need for a balanced approach that prioritizes both scientific advancement and real-world impact.

For more from our cell & gene therapy experts, check out these insights:

BLOG: Three Lessons Learned in Adoptive Cell Therapy Trials: A Look at the Road Ahead for Immunology

BLOG: A Holistic Approach to Genetic Medicines is Next for the Life Science Industry

Exploring an Expedited Regulatory Pathway for Cell and Gene Therapies

BLOG: Cell and Gene Therapy Sponsors Must Overcome Unique Hurdles to Realize Promise to Patients

Jeff Stewart Says Goodbye

Tue, 23 Apr 2024 10:00:00 -0400

After 7 years as the Syneos Health Podcast's founding and flagship host, Jeff Stewart is stepping down. Here, he reflects on his experience and bids farewell.

It doesn't end here - stay tuned for new episodes with new host(s), coming soon!

(Jeopardy! clip courtesy of Ken Jennings.)

Patient Assistance: The Best Deal in Pharma

Tue, 23 Apr 2024 07:00:00 -0400

Patient assistance programs can make a huge difference for patients who need expensive medicines but can't afford them.

In this episode, Jeff Stewart talks with Dave MacLeod, Managing Director, Value & Access at Syneos Health about the benefits and challenges of patient assistance programs, which provide free or low-cost medicines to eligible patients. They discuss how these programs can improve access, adherence, and outcomes, as well as the operational and regulatory issues involved in running them. Covering key topics such as the Inflation Reduction Act (IRA), the impact of technology and AI in patient services, and the challenges posed by copay accumulators and maximizers, Dave sheds light on the complexities of navigating copay assistance optimization and the strategies employed to mitigate the effects on patients and manufacturers alike.

For more from our Value & Access experts, check out these topics:

Syneos Health Podcast | Real Talk About the Inflation Reduction Act

BLOG: Industry Cheers “Co-Pay Accumulator” Ruling, Should Prep for What’s Next

Potential Impact of European Pharma Legislation on Commercialization and Access of New Therapies

BLOG: What Can We Learn From ICER's New Value Framework

Syneos Health Podcast | Market Access for Weight Loss Drugs

MM+M Podcast | Gaining Access and Delivering Pull-Through in IDNs and Key Accounts

Real Talk About the Inflation Reduction Act

Wed, 17 Apr 2024 11:00:00 -0400

The Inflation Reduction Act (IRA), signed into law by President Joe Biden in August 2022, brings significant changes to the U.S. pharmaceutical market as it rolls out over the next 10 years.

Today we dive deep into the IRA with Tiffany McCaslin, Managing Director, Value, Access and Health Outcomes at Syneos Health. Drawing from her extensive background in healthcare policy and industry strategy, Tiffany offers invaluable insights into the practical implications of this landmark legislation for the pharmaceutical industry.

From dissecting the intricacies of price negotiation to unraveling the complexities of data collection requirements, this episode provides a clear roadmap for pharmaceutical companies and life sciences firms navigating the post-IRA era.

For more from our Value & Access experts, check out these insights:

BLOG: Industry Cheers “Co-Pay Accumulator” Ruling, Should Prep for What’s Next

Potential Impact of European Pharma Legislation on Commercialization and Access of New Therapies

BLOG: What Can We Learn From ICER's New Value Framework

Syneos Health Podcast | Market Access for Weight Loss Drugs

MM+M Podcast | Gaining Access and Delivering Pull-Through in IDNs and Key Accounts

BLOG: What ICER’s Draft Sickle Cell Disease Report Means for CGT Pricing

Turbo-Charging Clinical Trials

Tue, 02 Apr 2024 08:00:00 -0400

For the first time, the technology behind Wall Street and Formula One racing is being used in pharmaceuticals—and it’s offering unparalleled potential for innovation in clinical trial execution and healthcare delivery.

In this episode, host Jeff Stewart is joined by Darren Coleman, the general manager of RxDataScience, a Syneos Health company, who discusses KX technology, the world’s fastest time series database and analytics engine, and how it is now being applied to improve clinical trial efficiency, reduce costs and speed time to market for life-changing therapies for patients. From current applications to optimize site selection, predict enrollment rates, and identify trial risks months in advance, to future use cases including patient selection and predicting drug efficacy, Coleman outlines exciting possibilities for the future of clinical trials and healthcare.

For more from Syneos Health on AI applications in biopharma, check out these insights:

WEBINAR | How AI is Supercharging Clinical Trials

Syneos Health Podcast | 2024 Health Trends: Managing the Healthcare Revolution

It’s Time We Got the Most Out of Medical Affairs Data

Artificial Intelligence, Machine Learning and a New Epoch for Clinical Trials

Investing for Commercial Success as an Emerging Company

Wed, 06 Mar 2024 08:00:00 -0500

When it comes to launching a pharmaceutical product in today’s market—especially as an emerging company—strategic investment can make all the difference.

Drawing from a recent study on investing for commercial success, Michael Sarshad, Managing Director in the Commercial Advisory Group at Syneos Health, discusses the key factors for successfully launching a drug in today's market; the importance of strategic investment, timing and team experience in exceeding launch forecasts; and the diverse areas where this investment is crucial, from medical affairs and market access to clinical strategy and supply chain logistics.

Tune in for expert insights into the intricacies of launching pharmaceutical products and how strategic investment can make all the difference.

For more of our insights on launch and commercialization, check out this content on our Insights Hub:

Investing for Launch Success: The “Goldilocks” Ratio

Investing for Launch Success: Tailoring Your Strategy for Europe

Good Science Is Not Good Enough: For Emerging Companies, Differentiation Requires a Commercial Value Creation Story

Supporting the Launch of Biosimilars

WEBINAR | The Three Perils of Cross-Functional Commercialization: Time, Insight and Integration

Ophthalmology Clinical Trials: Low Vision and AMD Awareness Month

Fri, 16 Feb 2024 16:00:00 -0500

Age-related vision loss is a rising concern for our growing aging population. According to the most recent data published by the CDC, nearly 20 million Americans aged 40+ have been diagnosed with some form of age-related macular degeneration (AMD). By the age of 75, roughly 1 in 3 people living in the United States will have some form of AMD, and about 1 in 4 of those will have a vision-threatening, late-stage form of AMD. These statistics underscore the need for heightened public awareness and increased accessibility to innovative treatments.

February is Low Vision and Age-Related Macular Degeneration (AMD) Awareness Month. In this episode, Laszlo Bekesi, MD, Vice President of Strategy and Innovation, and Jonathan Angelastro, Executive Director of Project Delivery at Syneos Health provide valuable insights into the evolving field of ophthalmology and the efforts to address the growing burden of age-related vision impairment—with a focus on understanding both wet and dry AMD types, the complexities of AMD, its impact on vision and the urgency for early detection and treatment. They also discuss the current landscape of research and development in the space and highlight the opportunities for—and inherent operational challenges of—conducting clinical trials in ophthalmology.

For more insights and information on our ophthalmology expertise, check out:

Ophthalmology: Collaborating to Restore Vision and Improve Lives

Navigating Biometrics Challenges in Ophthalmology Clinical Trials: Lessons Learned

FDA Rules for Radio & TV Advertising

Tue, 30 Jan 2024 10:00:00 -0500

The FDA has finalized a rule that addresses how drug ads must be presented in TV and radio commercials. The rule, proposed in 2010 and now effective from May of this year, aims to provide clarity and guidelines for pharmaceutical companies in presenting side effects and contraindications in a balanced manner. But it’s still a 27-page document.

Here, we’ll boil it down for you.

Matthew Snodgrass, head of US Digital and Social Strategy at Syneos Health, sheds light on the 13-year journey from proposal to finalization, exploring key aspects of the rule, restrictions on distracting visuals during side effect discussions, and the use of quantitative terminology to convey information more precisely. The conversation delves into the challenges faced by regulatory teams in interpreting and implementing these rules and highlights the importance of understanding and following FDA guidelines in pharmaceutical advertising.

For a more detailed exploration of the FDA rule, check out our highlighted version of the full document in a downloadable PDF format.

2024 Health Trends: Managing the Healthcare Revolution

Tue, 30 Jan 2024 09:00:00 -0500

Nervousness and uncertainty surround the question of what Artificial Intelligence (AI) may mean for the future of work. How can we deploy AI transformation—thoughtfully—across an organization and help workforces see what the new models will signify and require of us?

In the first episode in this series related to our 2024 Health Trends, host Jeff Stewart is joined by Celeste Mosby, Senior Vice President and General Manager of Syneos Health Learning Solutions, to discuss the challenges of managing this healthcare revolution, especially in terms of training and adapting to the rapidly evolving landscape.

The conversation highlights the shift in the industry over the past five years, where technology, data and AI are now shaping the healthcare landscape—requiring professionals to keep up with the dynamic changes—and explores the impact of AI on human-to-human interactions, workforce training and the importance of thought leaders staying ahead of evolving trends.

For additional insights into Revolution Management, Learning and Change in the New World of Work—as well as the year(s) of reinvention ahead for the life sciences sector—download our 2024 Health Trends report.

World Mental Health Day: The State of Mental Health Clinical Development

Tue, 10 Oct 2023 06:00:00 -0400

October is National Depression and Mental Health Screening Month, with October 10th specifically recognized as World Mental Health Day. A recent study co-led by Harvard Medical School and the University of Queensland established that one out of every two people in the world will develop a mental health disorder in their lifetime. This staggering number underscores the critical need to reduce the stigma of mental health, and to make sure that people who are suffering understand the diverse help and treatment options that are available to them.

Dr. Alexandria Wise, Global Head of Therapeutic Strategy and Innovation and Andy Moniz, VP, Therapeutic Strategy and Innovation at Syneos Health, join the podcast to help raise mental health awareness, discussing the evolution in mental health treatment over the past 30 years and where it stands today; the challenges of mental healthcare access for certain patient groups and what is being done to ease this; and the unique aspects of psychedelics in mental health clinical trials and their potential for promising results.

For more content on neuroscience topics, check out these insights:

Understanding the Role of the Placebo Response in Clinical Trials

Digital Flexibility and the Digital Divide: Meeting Patients Where They're At With Mental Health Services

WEBINAR | Psychedelics 3.0: Drug Development Challenges and Opportunities in a Rapidly Evolving Field

Radiosensitizers in Head and Neck Cancer

Mon, 02 Oct 2023 09:00:00 -0400

Radiosensitizers have emerged as potential game-changers in head and neck cancer therapy. A diverse group of compounds, radiosensitizers enhance radiation therapy's impact on tumor cells. Ongoing research seeks radiosensitizers that augment radiotherapy's efficacy without increasing toxicity, offering exciting prospects for the APAC region and beyond.

Our new APAC Edition host Lance Eminger, Executive Director of Business Development is joined by Dr. Juan Manuel Carrera, Senior Medical Director at Syneos Health to discuss what radiosensitizers are and how they work—highlighting the potential of new radiosensitizers to redefine cancer treatment, fostering better results with fewer side effects.

Market Access for Weight Loss Drugs

Thu, 21 Sep 2023 10:00:00 -0400

One of the biggest trends making headlines and impacting the healthcare industry to date is the rising popularity of GLP-1 drugs. Initially developed for diabetes management, these products have recently gained traction for weight loss indications. But with promising efficacy and growing popularity, is the healthcare industry truly prepared for the challenges posed by these drugs becoming such a hot commodity in the market?

Tom Albers, Vice President of Strategy at Syneos Health company Spherico, joins the podcast to discuss his insights on the future of weight loss drugs – payer challenges, the transformative potential of these drugs, and the need for smart investments in data and evidence.

For more content on value and access, check out these insights:

MM+M Podcast | Gaining Access and Delivering Pull-Through in IDNs and Key Accounts

Syneos Health Podcast: The Inflation Reduction Act

Building a Market Access Case for Real World Evidence in Oncology

Training MSLs in the Metaverse

Wed, 13 Sep 2023 08:00:00 -0400

In this episode of the Syneos Health Podcast, we embark on a journey into the metaverse – a revolutionary concept that's transforming the way we approach training and learning.

As we delve into the world of the metaverse and its implications for healthcare training, Michael Shim, PharmD, National Director, Field Medical Affairs and Marie Latsa, PharmD, Community Medical Director at Syneos Health, will share their firsthand experiences with metaverse-based training for Medical Science Liaisons (MSLs), and provide valuable insights into the current state and future potential of this cutting-edge technology that offers an immersive and efficient training alternative.

Join us on this exciting journey into the metaverse and discover its role in shaping the future of education and training in healthcare.

For more of our insights on MSLs and Medical Affairs, check out these pieces on our Insights Hub:

A Field MSL Perspective on Tech-Enablement Using the Metaverse

Leveraging Metaverse Capabilities for Medical Affairs

Medical Science Liaisons: Your Role in Creating a Culture of Excellence

Early Adoption of Metaverse Technology in Medical Affairs

Using Omnichannel to Drive Integration between Medical and Commercial

Engaging Patient Communities: The Changing Role of Medical Affairs

Biopharma and the Emergency Department

Tue, 01 Aug 2023 15:00:00 -0400

The emergency department (ER) can be a place of chaos, panic and infinite amounts of unpredictability. Not knowing what can come through the doors at any given time makes this environment impossible to foresee and prepare for. Because of this uncertainty, the ER (and its patients) can be a particularly challenging target for clinical trials.

In this episode, Dr. Ruth Henrice-Desrosiers, Medical Director, Syneos Health joins the podcast to discuss critical aspects to be considered by biopharma companies when choosing to bring a clinical trial to the ER—from location and cost implications to informed consent challenges, and everything in between.

Biotech Value Creation

Thu, 20 Jul 2023 10:00:00 -0400

The game continues to change in biotech as continued macroeconomic uncertainty has far reaching implications for the future of the biopharma ecosystem. Biotechs can no longer operate toward the single goal of being acquired by, or of licensing their assets to, large pharma—and players may need to develop products further than in the past, and therefore strategic pathway optionality needs to be weaved into and maintained throughout product and corporate development.

But with a multitude of new challenges facing this industry come multifold new opportunities for value creation and chances to reach new heights.

In this episode, Lee Taurman, Global Head of Syneos One and Keith Ruark, SVP Strategic Business Development, Syneos Health are joined by Ali Pashazadeh and Max Baumann, Co-Founders of Treehill Partners, to discuss strategic and operational implications for the biotech C-suite and share perspectives on how companies can succeed in an increasingly competitive environment. learn strategic and operational implications for the biotech C-suite and share perspectives on how companies can succeed in an increasingly competitive environment.

2023 Health Trends: Improved Sophistication in Retention

Mon, 10 Jul 2023 15:00:00 -0400

What is the healthcare industry up against in terms of recruiting, hiring, and retention, in the increasingly competitive job markets of China, Korea and Japan?

Leigh Householder and Sam Wilson, commercial solutions lead for APAC, Syneos Health, discuss how changing customer needs, evolving market dynamics and shifts in customer engagement continue to be challenges when recruiting top talent in the region.

Learn more about 2023 Health Trends here.

More Episodes in the 2023 Health Trends Series:
Syneos Health Podcast: 2023 Health Trends: Personally, Purposefully Building What's Next
Trend Talks: AgeTech with Musician, Actor & Patient Advocate, James Ian
Trend Talks: AI: Finally fit for Purpose
Trend Talks: A New Field for the Field Force
Trend Talks: The Data Effect

Digital Therapeutic Development and Approval

Thu, 15 Jun 2023 10:00:00 -0400

In our previous episode, we covered how companies can harness the power of digital therapeutics to improve their brand’s value proposition. But what does it really take to get a clinically validated prescription digital product to market?

Dr. Shaheen Lakhan, Chief Medical Officer, Click Therapeutics joins us on the second episode of our two-part series on digital therapeutics to discuss the diligence required to help regulators, health plans and payers, clinicians, and patients understand the potential of these digital solutions outside of entertainment—and how to apply the principles of traditional, biopharmaceutical types of drug development, validation and regulatory exercises to get them into the hands of patients.

Listen to part one of our conversation on digital therapeutics with Austin Speier, Chief Strategy Officer of Click Therapeutics, here.

And for a deeper dive into how companies can implement DTx to expand or augment the potential of their pharmaceutical and biologic therapeutic assets, read our article 10 Ways to Optimize and Accelerate Brand Performance using Prescription DTx.

Digital Therapeutic Commercialization

Tue, 06 Jun 2023 08:00:00 -0400

Digital therapeutics (DTx) are projected to be $50 billion industry by 2025. While many minds may immediately jump to unregulated companion apps when they hear “digital,” there are also clinically validated prescription digital products that act complementary to or in combination with traditional biopharmaceutical therapies. As these prescription DTx gain traction, how can companies harness their power to improve their brand’s value proposition?

In this first of two episodes on DTx, Michael Sarshad, Managing Director, Commercial Advisory at Syneos Health and Austin Speier, Chief Strategy Officer, Click Therapeutics, join the podcast to discuss the growing market and opportunities for DTx across the product lifecycle, where DTx can add value and ways to think about how to integrate them into a brand strategy.

For a deeper dive into how companies can implement DTx to expand or augment the potential of their pharmaceutical and biologic therapeutic assets, read our article 10 Ways to Optimize and Accelerate Brand Performance using Prescription DTx.

Cancer: The Patient Perspective

Wed, 31 May 2023 10:00:00 -0400

"It's July 2022. This morning I tried to donate my kidney, this afternoon the transplant team told me that I can't, I have cancer." Words no one wants to hear. Even for a former Jeopardy! champion with degrees in molecular biology and two decades of experience in the biopharma industry, the implications of the phrase are overwhelming.

Nearly a year later, our flagship podcast host Jeff Stewart is telling his story.

Today, Nick Kenny, Chief Scientific Officer at Syneos Health, turns the tables on Jeff, interviewing him on his recent experience being diagnosed and undergoing treatment for two separate cancers. They discuss the realities today for patients like Jeff who are dealing with complex cancer diagnoses—including information overload both fake and real, and the importance of “pre-bunking”—and his newly released book, Living: Inspiration from a Father with Cancer.

At a time when regulators in our industry at large are increasingly and rightly focused on patient perspectives in drug development, and with ASCO, the single largest global gathering of about 50,000 clinical cancer experts right around the corner in early June, this is a very timely discussion.

Read excerpts of the book on NPR.

Check out our other content on the patient experience:

Webinar: Patient Perspectives as Essential in Next-Generation Clinical Trials

Exploring the Value and Impact of Patient-Reported Outcomes in Patient-Centric CAR-T Clinical Trials

3 Ways Patient Voice is Impacting Rare Disease Research, According to Advocates

2023 Health Trends: The Data Effect

Thu, 25 May 2023 11:00:00 -0400

How can we use technology and increasing volumes of data to change the future of human health and healthcare as we move forward into 2023 and beyond?

In this episode of the limited Trend Talks series, Leigh Householder, Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with Bob Zambon, VP, Solution Architecture Group, Syneos Health, to discuss how increasing numbers of varying health data − medical data, clinical data, interaction data, program data – will affect a vastly privacy forward industry.

Listen to the podcast to find out how data will impact the future of healthcare.

Learn more about 2023 Health Trends here.

More Episodes in the 2023 Health Trends Series:
Syneos Health Podcast: 2023 Health Trends: Personally, Purposefully Building What's Next
Trend Talks: AgeTech with Musician, Actor & Patient Advocate, James Ian
Trend Talks: AI: Finally fit for Purpose
Trend Talks: A New Field for the Field Force

Find more of our content on Digital Medicine and MedTech topics.

2023 Health Trends: A New Field for the Field Force

Thu, 04 May 2023 12:00:00 -0400

How will a new field for the field force keep the doors open for customer communication while considering differences in culture, therapy, product lifecycle stage and healthcare professional preference?

In this episode of the limited Trend Talks series, Leigh Householder, Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with Ewan Cuthbertson, SVP, European Deployment Solutions, Syneos Health, to discuss how the field force is reemerging after a global pandemic and how it will impact the healthcare industry.

Listen to the podcast to find out what a new field for the field force means for the future of healthcare.

Learn more about 2023 Health Trends here.

More Episodes in the 2023 Health Trends Series:
Syneos Health Podcast: 2023 Health Trends: Personally, Purposefully Building What's Next
Trend Talks: AgeTech with Musician, Actor & Patient Advocate, James Ian
Trend Talks: AI: Finally fit for Purpose

Find more of our content on Digital Medicine and MedTech topics.

2023 Health Trends: Digital Transformation: Start, Stall, Restart

Tue, 04 Apr 2023 10:00:00 -0400

How will Digital transformation continue to impact the healthcare industry and help drive automation, efficiencies, quality and other changes to how we engage and operate in the future?

In this episode of the limited Trend Talks series, Leigh Householder, Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with Skye Hodson, PhD, Senior Director, Product Solutions & Asset Team, Syneos One, to discuss how various aspects of digital transformation continue to impact the healthcare industry.

Listen to the podcast to find out what the future holds for healthcare and digital transformation.

Learn more about 2023 Health Trends here.

More Episodes int he 2023 Health Trends Series:
Syneos Health Podcast: 2023 Health Trends: Personally, Purposefully Building What's Next
Trend Talks: AgeTech with Musician, Actor & Patient Advocate, James Ian
Trend Talks: AI: Finally fit for Purpose

Find more of our content on Digital Medicine and MedTech topics.

Gene Therapy for Hemophilia

Thu, 30 Mar 2023 08:00:00 -0400

Last year the FDA approved the first gene therapy for hemophilia B. This year, the first gene therapy may be approved in the US for hemophilia A. What does the gene therapy revolution mean for patients, payers, and pharma?

Ankita Chowdhury, Senior Engagement Manager, Commercial Advisory at Syneos Health®, joins the podcast to discuss the landscape of recent hemophilia gene therapy approvals, the state of upcoming additional therapies to market, and key considerations for developers to address in order to optimize access, pricing and reimbursement for patients impacted by this rare disease.

For more of our insights on rare disease and gene therapies, check out:

The Importance of the Right Go-to-Market in Cell Therapy Commercialization

WEBINAR: Early Integrated Evidence Strategy for Cell & Gene Therapies

Exploring an Expedited Regulatory Pathway for Cell and Gene Therapies

Success Factors for Commercializing Cell and Gene Therapies

Syneos Health Podcast: The Value of Registries

NOTE: At the time of recording, Biomarin’s hemophilia A product was expected to receive FDA approval in March of this year. Since then, news broke that FDA review will be delayed until June.

The Inflation Reduction Act

Tue, 21 Mar 2023 09:00:00 -0400

The Inflation Reduction Act of 2022 is a landmark United States federal law which aims to curb inflation by, among other things, lowering prescription drug prices. What can this mean for biopharmaceutical companies?

Dennis Kim, Senior Engagement Manager and Em Coriale, Director in the Value & Access team at Syneos Health, dive into the details of this piece of legislation, the true meaning of “unjustified price increases,” what negotiation might look like and how companies can prepare for the new reality.

For additional insights on the Inflation Reduction Act from our Reputation & Risk Management team, visit our blog.

2023 Health Trends: AI: Finally Fit for Purpose

Tue, 14 Mar 2023 21:00:00 -0400

How will Artificial Intelligence continue to impact the healthcare industry and its potential to introduce new technologies, enabling a shift from promise to performance?

In this episode of the limited Trend Talks series, Leigh Householder Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with Andrew Barron, SVP of Global Site Start Up & Regulatory, to discuss.
Listen to the podcast here or watch the video to find out what they are thinking about ChatGPT, the next industrial revolution and more.

Learn more about 2023 Health Trends here. And be sure to check out Leigh’s kick-off episode of the podcast series, as well as her recent interview with patient advocate James Ian.

Find more of our content on site and patient engagement and regulatory topics.

2023 Health Trends: AgeTech with Musician, Actor and Patient Advocate James Ian

Mon, 27 Feb 2023 15:00:00 -0500

In this episode of the limited Trend Talks series, Leigh Householder Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, sits down with James Ian , a Musician and Actor who lives with Spinal Muscular Atrophy Type Three—a rare neuromuscular disease that attacks the neurons that control all the voluntary muscles in the body. James is a passionate advocate for disability inclusion, particularly in the arts and entertainment industry, and here they discuss representation of disabilities through authentic, intentional and purpose-driven advocacy in media and technology.

Listen to the podcast here or watch the video to learn what’s changed, what’s changing and what matters most right now.

Learn more about 2023 Health Trends here. And be sure to check out Leigh’s kick-off episode of the podcast series (November 29—2023 Health Trends: Personally, Purposefully Building What’s Next).

Find more of our content on rare disease and patient voice topics.

Follow James Ian on Instagram @jamesianmusic

Leigh Householder is the EVP/Managing Director, Technology & Data at Syneos Health.

Reg Ops Edition: Attracting and Retaining Talent

Mon, 20 Feb 2023 00:00:00 -0500

This new podcast mini-series features interviews with industry leaders, focusing on hot topics within Regulatory Operations (Reg Ops).

Reg Ops is evolving in response to a rapidly changing regulatory landscape as well as the industry’s focus on achieving operational efficiency and excellence. Technological innovations such as advancements in Regulatory Information Management (RIM) capabilities are accelerating Reg Ops in their transition from traditional operational roles to more strategically focused roles, including a shift toward Delivery Excellence. Organizations must adapt to the evolution of Reg Ops, including rethinking their approach to attracting and retaining talent, to remain competitive and at the forefront of innovation.

In this episode, Reg Ops Edition host Caroline Masterman-Smith is joined by Matt Neal, Senior Director, Global Regulatory Affairs Operations at Atara Biotherapeutics; Stuart Goodall, Vice President of Regulatory Services Delivery at Syneos Health; and Hannah Riley, Engagement Manager within R&D Advisory at Syneos Health to discuss how the regulatory world has moved from truckloads of paper to electronic processes; how that, in turn, has changed the skillsets required for the Reg Ops function; and how companies need to think and act differently in order to attract and retain the talent they need.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

Be sure to read the white paper discussed in this episode: Attracting and Retaining Talent in the Age of Evolution for Regulatory Operations

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Life Sciences Dealmaking: Dealmakers' Intentions 2023

Wed, 15 Feb 2023 13:00:00 -0500

It’s a volatile time for biopharma, and a unique juncture in our industry’s history. War in Ukraine, a bearish market and supply chain chaos are just a few of the factors that kept much of the industry away from the table. Entering 2023, the investment and dealmaking panorama remains a puzzle. Despite worries and uncertainties, there are hints that dealmaking intensity may be poised for a rebound after a year of inertia that mirrored the slump in major biotech stock indexes. What lies ahead for dealmaking in the biopharmaceutical industry in 2023?

Our 13th Dealmakers’ Intentions Survey attempts to answer this question, based on responses from more than 100 members of the biopharma community, most of them with executive-level influence on decision-making. This report, released recently at Biotech Showcase—an event co-located with the famous J.P. Morgan Healthcare Conference in San Francisco—captures their expectations for deal activity, supply and demand for specific assets and different development stages, pitfalls leading to failure and other factors affecting dealmaking.

Neel Patel, Executive Managing Director, Commercial Advisory Group at Syneos Health and lead author of the report, joins the podcast to discuss the industry’s first time back in person at J.P. Morgan in three years, as well as key findings from the survey.

Read the latest Dealmakers’ Intentions report here.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

2023 Health Trends: Personally, Purposefully Building What’s Next

Tue, 29 Nov 2022 11:00:00 -0500

What’s Changed, What’s Changing and What Matters Most Right Now

In this inaugural episode of the limited podcast series on 2023 Health Trends, we’re setting the stage with Host & Author, 2023 Health Trends: Personally, Purposefully Building What’s Next, Leigh Householder.

Leigh provides a high-level look at what will be different this year. First, she discusses urgent optimism and the personal, purposeful commitments we have; to take our industry and our world to next. She goes through 12 Health Trends spanning technology, healthcare advancement and human engagement. These trends help us imagine what could be; our next – the future. Listen and learn what’s changed, what’s changing and what matters most right now.

Learn more about 2023 Health Trends here.

Leigh Householder is the EVP/Managing Director, Technology & Data Science at Syneos Health.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Real World Evidence and Rare Diseases, Part 3: The Value of Registries

Thu, 03 Nov 2022 11:00:00 -0400

When it comes to the generation and use of real-world data (RWD), there are variable and evolving stakeholder needs. Put it in the context of a rare disease, where patient samples are decreasing as diseases splinter with increasing specificity in diagnosis, and the prospect of meeting these stakeholder needs becomes more daunting. Layer on special circumstances—like a required 15 years of post-approval follow-up data for cell and gene therapies (CGT)—and the cards seem to be stacked against you. One way companies can alleviate the burden of RWD generation is through patient registries.

Mike D’Ambrosio, VP, Head of Real World Evidence Solutions, Susan Goodlow, VP, RWE and Late Phase Operations and Ray Huml, Head of the Rare Disease Consortium at Syneos Health, discuss the importance of registries for clinical research—particularly for rare disease and CGT, the evolution of rare disease registries and opportunities for the future, and how we can unlock the value of RWD generated from rare disease registries, for all stakeholders.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

Visit our Insights Hub for other content on RWE, rare diseases, and cell and gene therapy.

For more episodes on these topics, try:

Opportunities and Challenges in Cell and Gene Therapy

Navigating the Rare Disease Landscape

Real World Evidence and Rare Diseases, Part 1

Real World Evidence and Rare Diseases, Part 2

Like what you’re hearing? Be sure to rate and review u

Decentralized Clinical Trials: Implications for Biotech

Wed, 05 Oct 2022 15:00:00 -0400

Common misconceptions surrounding decentralized research often deter sponsors from attaining its key benefits—and this is especially true for small or emerging biotechs with limited shots on goal. But by separating fact from fiction and understanding how to identify fit for purpose solutions, these companies can lay the roadmap for successful implementation of a decentralized clinical trial (DCT) strategy.

Stephanie Gonzalez, Senior Vice President and Head of Global Biotech Solutions at Syneos Health and Alison Holland, Executive General Manager for Decentralized Clinical Trials at Medable debunk some common myths and provide an overview of the benefits decentralization can bring to biotechs.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

For more on DCT strategy, check out these insights:

3 Capabilities to Achieve Optimal Blend of On-Site and Virtual Patient Engagement in DCTs

Not All Decentralized Clinical Trial Capabilities Are Created Equal

4 Ways Decentralized Clinical Trials Can Be Game Changers for Better Patient Outcomes

Hybrid Decentralized Trials in Oncology: A Path to Diversity

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Full-Service Commercial

Wed, 21 Sep 2022 14:00:00 -0400

Early stage biotech companies have traditionally had limited options to get their first asset to market: in most cases, they pursue deals with larger partners, losing control of their intellectual property and limiting their future financial returns, or become a fully integrated company through heavy investment and a great deal of risk.

Opportunities for outsourcing some—or all—of a company’s commercial operations can be an option, but many companies have misconceptions about the highly viable “third option” of commercializing with a proven outsourced partner.

Lee Taurman, Executive Vice President and Head, Full-Service Commercial and Carl Sailer, Vice President and Global Go-to-Market Lead, both from Syneos Health, discuss the wide range of outsourcing options companies can consider that reduce risk, manage costs and optimize performance while maintaining control of their asset—while debunking some of the myths associated with this alternative path to market.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

For more on commercial options for biotech companies on the verge of market entry, check out these insights:

ON-DEMAND WEBINAR: Preparing and Aligning Your Biotech Organization for Commercial Success

PRESENTATION: Investing for Commercial Success as an Emerging Company

Five Considerations for Choosing an Agency Partner for a Successful Biopharma Launch

How Clarity Can Be a Differentiator for Biotechs in Uncertain Times

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com

MAPS Edition: Value Demonstration - A View From the Top

Mon, 08 Aug 2022 13:00:00 -0400

This podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.

In this continuation from our previous episode, Colin Oliver, PhD, MBA, Managing Director, Medical Affairs Consulting at Syneos Health, steps in as guest host to dig in more deeply with Eisai’s Dr. Kirk Shepard on a critical question: How do we make the case to our cross-functional partners that Medical Affairs deserves a seat at the leadership table? And how can we demonstrate the value that Medical Affairs can bring to that table?

Be sure to listen to the other episodes in this series here.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

MAPS Edition: Bringing Medical Affairs Into the C-Suite

Mon, 08 Aug 2022 13:00:00 -0400

This podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.

Today we are speaking with Dr. Kirk Shepard, co-founder of the Medical Affairs Professional Society (MAPS) and Chief Medical Officer and Head of Global Medical Affairs at Eisai. Dr. Shepard has effectively brought Medical Affairs into the C-Suite, and in this episode we discuss the importance of education, communication, collaboration – and what needs to change as the function continues to advance as a value-based strategic leader.

Be sure to listen to the other episodes in this series here.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Opportunities and Challenges in Cell and Gene Therapy

Thu, 14 Jul 2022 15:00:00 -0400

Cell and gene therapies have come a long way in the past 20 years. And more recent advances and successes with CRISPR and CAR-T technologies have left the field of opportunity wide open for treatments that can potentially move the needle, particularly for patients with oncologic or rare diseases. But with great advancements come significant challenges.

Pete Robinson, Vice President, Medical and Scientific Strategy and Head of the Cell & Gene Therapy Consortium and James Barwick-Silk, Director, Scientific Strategy, Cell & Gene Therapy at Syneos Health discuss the latest exciting developments, as well as hurdles the biopharmaceutical industry must overcome – from R&D, to manufacturing, to access and reimbursement – in order to successfully bring these therapies to market.

For more from our experts in rare disease, be sure to check out:

Innovation Perspectives in Rare Disease Drug Development

The Syneos Health Podcast: Navigating the Rare Disease Landscape

The Syneos Health Podcast: Mental Health in Rare Disease

The Syneos Health Podcast: Epilepsy, the Central Nervous System and Rare Disease

Incorporating the Patient Voice Into the Rare Disease Drug Development Paradigm

Prioritizing Mental Health Services for Those Living With Rare Disease

Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at

MAPS Edition: Recruiting for the New Profile of Medical Affairs

Fri, 01 Jul 2022 11:00:00 -0400

Reporting from the floor of the Medical Affairs Professionals Society (MAPS) Global Annual Meeting, this podcast series features interviews with industry leaders, focusing in on the impact and value of Medical Affairs today, where the function is heading and how we are going to get there.

As Medical Affairs has evolved, so have the acumen required for Medical Affairs professionals and leaders to succeed. In this episode we sit down with Jackie Tisch, Managing Director, Taylor Strategy Partners, to discuss the new profile of Medical Affairs, how recruiting for these roles has changed and challenges in finding the right fit.

Be sure to listen to the other episodes in this series here.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

MAPS Edition: Stakeholder Engagement in a Data-Driven Environment

Mon, 27 Jun 2022 09:00:00 -0400

There’s been an overall shift in the healthcare ecosystem toward more proactive and cross-functional engagement, altering the fundamental nature of conversations from the perspective of Medical Affairs. In this episode, Anita Holz, Executive Director and Therapeutic Area Head, Cardiometabolism, Clinical Development and Medical Affairs at Boehringer Ingelheim, discusses the evolving interface with healthcare professionals and the power of omnichannel engagement in an increasingly data-driven environment.

Be sure to listen to the other episodes in this series here.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

MAPS Edition: Measuring the Immeasurable: Value and Impact of Medical Affairs

Wed, 08 Jun 2022 12:00:00 -0400

It’s no question that Medical Affairs has historically struggled to show value and impact within its organization. In this second episode of the series, Arshi Gupta, Managing Director, Medical Affairs at Syneos Health and Deb Crawford, Director, MSL Team at Teva Pharmaceuticals discuss the intricacies involved in measuring what seems, well, immeasurable.

Be sure to listen to the other episodes in this series here.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

MAPS Edition: Be Bold - Preparing Medical Affairs for 2030 and Beyond

Fri, 20 May 2022 08:00:00 -0400

As a function uniquely positioned to address evolving market dynamics, how can Medical Affairs prepare for 2030 and beyond? In this first episode, hear from Josh Ziel, Executive Vice President, Scientific Services at Syneos Health as he unpacks how we can get beyond incremental improvements to really be bold and think forward as we bring Medical Affairs into the future.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Training the Next Generation of Pharma

Fri, 13 May 2022 09:00:00 -0400

The clinical research enterprise faces a clear and present personnel shortage, creating inefficiencies for clinical trial sponsors and contract research organizations, many of whom find themselves in a constant recruitment cycle for qualified clinical research associates (CRAs) in a hyper-competitive job market.

While industry has traditionally recruited for these roles from healthcare and scientific programs or settings, we are now seeing a shift from requiring that specific, role-based experience to a more foundational competency-based model. This means potentially looking outside of those traditional sources. But how to we find, recruit and train this next generation?

Jennifer Sozio, Senior Vice President, Clinical Operations and Audra Holleman, Vice President, Clinical Development at Syneos Health discuss the new profile of CRA candidates, challenges and opportunities for recruitment in the current market, and how to train and prepare a growing pool of new CRA resources focused on quality, project delivery and commitment to advancement.

Learn more about the Syneos Health Clinical Training Institute here.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Getting Access

Wed, 27 Apr 2022 08:00:00 -0400

The medicine may be “transformational,” but doctors won’t write the script if payers don’t reimburse.

And there’s a veritable alphabet soup of players – everything from KAMs to NAMs, MSLs to MSOLs, PBMs to IDNs, and more – involved in negotiating the path to reimbursement and, ultimately, access for innovative therapies when they hit the market.

Jon Haas, Senior Director, Market Access at Syneos Health, discusses the complex process, how companies can best position their product for access and what really matters to payers in the long run.

For more on value and access in biopharma, check out:

How Competition Affects Market Access for Rare Disease Therapeutics, Part 1

How Competition Affects Market Access for Rare Disease Therapeutics, Part 2

Future-Forward Planning: What Drug and Device Manufacturers Need to Know About Preventive Drug Lists

2021 Update: Non-Personal Promotion: What Do Payers Want?

The Other Path to Access: Strategies for Direct Employer Engagement

The Syneos Health Podcast: Trade and Distribution in Pharma: It's Complicated

What to Expect on Drug Pricing in the Democratic Trifecta

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Epilepsy, the Central Nervous System and Rare Disease

Wed, 13 Apr 2022 08:00:00 -0400

Nobody thinks about epilepsy as a rare disease. But epilepsy syndromes actually make up a large portion of CNS rare diseases. And while progress has been made in developing therapies that treat the symptoms of epilepsy, the true underlying causes can be difficult to pinpoint and treat.

But progress is being made, and Nermina Nakas, MD, MPH and Jane Williams, MD, MPH, Executive Medical Directors in CNS at Syneos Health – and contributors to the book Rare Disease Drug Development: Clinical, Scientific, Patient and Caregiver Perspectives – join Jeff Stewart to discuss recent developments in rare disease epilepsy clinical trials, what they have learned and what drug developers need to know about treating young patients with neurological rare diseases.

For more on the topics covered in this episode, be sure to check out:

Innovation Perspectives in Rare Disease Drug Development

The Syneos Health Podcast: Navigating the Rare Disease Landscape

The Syneos Health Podcast: Mental Health in Rare Disease

Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

The Placebo Effect

Wed, 23 Mar 2022 13:00:00 -0400

Did you know that over half of doctors leverage the placebo effect in treating patients? Placebo can be a powerful tool in medical practice—and in clinical research.

Veeru Goli, MD, Vice President, Medical and Scientific Management, Syneos Health, unpacks the case for use of placebo in clinical treatment, and if applied properly, how the placebo effect can help in clinical trials.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Mental Health in Rare Disease

Wed, 09 Feb 2022 12:00:00 -0500

Life with a rare disease can have infinite milestones, setbacks, traumas and triumphs—all likely to be interlaced with a variety of factors that can influence mental health and quality of life.

In fact, according to Dr. Raymond A. Huml in the February 2020 Journal for Clinical Studies, psychological symptoms are estimated to affect 75% of rare disease patients. Whether the cause is from the physical disease or dynamics surrounding it, it is time to remove the stigma around talking about mental health, understand the unique challenges of this community, and drive support and solutions to address them.

In advance of Rare Disease Day 2022, Keri McDonough, VP, Head of the Patient Voice Consortium and Michelle Bailey, MD, Senior Medical Director at Syneos Health, sit down with host Jeff Stewart to discuss the impact of mental health on the rare disease community.

To find the resources discussed on the podcast:

Our Odyssey

New York Times: I’m Haunted by Sisters With Sickle Cell: Two Thrived. Two Suffered

Rare Disease Day 2022: Collaborating to Make Mental Health in Rare Disease Stigma-Free

For more on the topics covered in this episode, be sure to check out:

Innovation Perspectives in Rare Disease Drug Development

The Syneos Health Pocast: Navigating the Rare Disease Landscape

Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Navigating the Rare Disease Landscape

Wed, 02 Feb 2022 09:00:00 -0500

Patients with rare diseases and their caregivers face many unique challenges along the road to diagnosis, treatment and—ultimately—optimized quality of life. With all of the complex information and systems out there, the landscape can be difficult to navigate. Where can they go for guidance?

Ray Huml, Vice President, Medical & Scientific Strategy and Head of the Rare Disease Consortium at Syneos Health—and editor of the recently published book Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives—returns to the podcast to discuss his dual experience as a scientist and caregiver, what drove him to create two informative books, and insights on cracking the code to reimbursement in rare disease.

For more on the topics covered in this episode, be sure to check out:

How Competition Affects Market Access for Rare Disease Therapeutics – Part I

How Competition Affects Market Access for Rare Disease Therapeutics — Part II

The Syneos Health Podcast: Real World Evidence and Rare Diseases

Innovation Perspectives in Rare Disease Drug Development

Find the books discussed in this episode:

Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives

Muscular Dystrophy: A Concise Guide

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Business Continuity Through Strategic Outsourcing

Wed, 05 Jan 2022 08:00:00 -0500

The COVID-19 pandemic had had a considerable impact on biotech and pharma services outsourcing, as companies struggled to overcome supply chain issues in production, manufacturing and talent. This held true not only from an R&D perspective, but throughout the product lifecycle as biopharma continued to bring therapies to an evolving market.

Michael Jimmink, Vice President, FSP 360 and Jim Reidy, Vice President, Deployment Solutions from Syneos Health discuss ways to navigate business continuity through strategic outsourcing, including why, how and when to consider outsourcing solutions, as well as ways to utilize fit-for-purpose resourcing while maintaining strategic oversight.

For more on the topics covered in this episode, be sure to check out:

2022 Health Trends: Insights for Industry Change Agents

Are You Assembling the Right Team for Commercial Success?

FSP 360: A Flexible, Customizable Solution for Your Outsourcing Needs

Outsourcing R&D in Today’s Market

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

The Virtual Sales Organization

Wed, 03 Nov 2021 09:00:00 -0400

COVID-19 has accelerated adoption of virtual engagement across pharma – but many of these strategies have already been proven over and over again long before the pandemic. The key difference is, what started as a complement to traditional commercialization tactics is now an established best practice and has been core to an inevitable transformation in the pharmaceutical industry. Out of this, the Virtual Sales Organization was born.

Mike Minschwaner, Senior Director and Amy Jamison, Senior Vice President of the Syneos Health Engagement Center discuss the evolution and rationale behind the Virtual Sales Organization, where, when and how it is appropriate to incorporate into sales strategy and the non-traditional skillset required for reps to succeed.

For more on the Virtual Sales Organization, check out our on-demand webinar and white paper.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Thirty Years of Physician Answers

Thu, 16 Sep 2021 06:00:00 -0400

What if you had 30 years of longitudinal data, from thousands of HCPs across 30 specialties, on how and why health care practitioners prescribe therapies, and where and how they prefer to receive information on those therapies – or even how a major event, like a pandemic, impacted those behaviors? You would have powerful insights that point the way to new opportunities to engage customers, seize white space in the market and understand where your competitors are engaging.

In this episode of the Syneos Health Podcast, Cameron Thompson, Executive Vice President of AnswerSuite, a Syneos Health® company, discusses the value of longitudinal data, the impact COVID-19 has had on physician preferences and how companies can leverage this information to right-size their promotional efforts with agility in an ever-changing market.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Syneos Short: Talking to Our Families About COVID-19 Vaccines

Wed, 25 Aug 2021 10:00:00 -0400

This week, the US Food and Drug administration approved the first COVID-19 vaccine. But will this help accelerate the vaccination effort? The US Surgeon General gave a public warning recently: "Health misinformation is an urgent threat to public health. It can cause confusion, sow mistrust, and undermine public health efforts, including our ongoing work to end the COVID-19 pandemic.” Also this week, the Kaiser Family Foundation released a report saying the number one reason for those who changed their minds and got vaccinated, the single thing that worked best, was talking with family.

In this Syneos Short, host Jeff Stewart debunks the most common myths circulating about COVID-19 vaccines and provides tips for guiding friends and family as they wade through a sea of information.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

EPISODE REFERENCES:

AP News (SM-102)

YouGov.com poll - why won't Americans get vaccinated

CDC VAERS and vaccine risks

Nature hydroxychloroquine

The Guardian Ivermectin paper

NEJM COVID-19 vaccines reduce transmission

Gizmodo, Medium COVID-19 vaccine death claims retracted

2021 HEALTH TRENDS EDITION: Leading Change in China

Wed, 11 Aug 2021 16:00:00 -0400

In this episode of the Syneos Health Podcast: 2021 Health Trends Edition, we welcome Dr. George Li, Vice President, and General Manager in clinical solutions for mainland China, Hong Kong and Taiwan. Together with podcast host and Managing Director, Omnichannel Strategy, Leigh Householder, he discusses the rapid and dramatic growth occurring in the Chinese pharmaceutical and biotech market.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

RELATED CONTENT

China: The Pace Car of Change

Syneos Health Podcast: China vs. Cancer

2021 Health Trends: Field Force of the Future

2021 HEALTH TRENDS EDITION: Field Force of the Future

Wed, 28 Jul 2021 17:00:00 -0400

In this episode of the Syneos Health Podcast: 2021 Health Trends Edition, we discuss how to empower and amplify critical field teams as access and engagement evolve and change with the ‘new normal’ of a post-pandemic world.

Listen and learn as Ryan Maglione, SVP, Global Commercial Talent at Syneos Health shares his latest thinking with trends expert, podcast host and Managing Director, Omnichannel Strategy, Leigh Householder.

Learn More About Commercial Recruiting Solutions from Syneos Health.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

RELATED CONTENT

Forming the Future Field

Omnichannel Experience

Virtual Pharma

2021 HEALTH TRENDS EDITION: Omnichannel Experience

Thu, 15 Jul 2021 07:00:00 -0400

In this episode of the Syneos Health Podcast: 2021 Health Trends Edition, we share the latest thinking on the potential for our industry to make healthcare interactions and communications more personal and useful.

Many life sciences organizations are quickly moving into that world of right person, right message, right moment messaging and scaling internal expertise and external partnership to move from one-to-one messaging to synchronized personal/nonpersonal communications to truly optimized engagement.

Listen and learn from Syneos Health experts, Leigh Householder, Managing Director, Omnichannel Strategy, Howard Brock, Senior Managing Director, Customer Engagement/Consulting, Alex Brock, Managing Director, Omnichannel (EU) and Dr. Annah Sclafani, Data Scientist.

Curious where your organization sits on the omnichannel maturity curve? Click here.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Omnichannel Maturity

2021 Health Trend Edition: Remote Care in 2021 and Beyond

Storytelling in Pharma

Wed, 07 Jul 2021 08:00:00 -0400

A great story creates a connection, elicits feelings of compassion and empathy and can ultimately influence behavior. The rise of digital platforms have enabled richer, deeper storytelling, driving a greater desire for sharing and connection. How can biopharma companies better leverage their own stories to build trust and engagement with their audiences?

John Reid, Executive Creative Director and Jeanine O’Kane, President, Public Relations at Syneos Health Communications discuss the evolution of storytelling, the impact of COVID-19 on how we communicate – and the critical importance of transparency and authenticity in the biopharma industry.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

2021 HEALTH TRENDS EDITION: Remote Care in 2021 and Beyond

Wed, 30 Jun 2021 13:00:00 -0400

When the pandemic took hold, practices and research sites limited physical access to protect people while health systems and industry partners moved to rapidly scale digital and voice channels to maximize patient connectivity. Regulators and payers joined the cause to reduce friction and fuel reimbursement.

As that immediacy and urgency fade, there are changed expectations among healthcare providers and patients alike that pivot off a connection, not an office or site.

In this episode of the 2021 Health Trends Podcast Miniseries, Leigh Householder, Syneos Health resident trends expert and Managing Director, Omnichannel Strategy, discusses how the rise, fall and reset of remote monitoring and commercial telemedicine will largely shape the future of care and drive how life sciences leaders engage and support patients and prescribers. Guests include Syneos Health experts AJ Triano, SVP, Customer Experience Strategy and Jodi Scarbrough, VP, Strategy and Innovation.

Learn more about our 2021 Health Trends here.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Virtual Pharma

Wed, 30 Jun 2021 08:00:00 -0400

At the beginning of the COVID-19 pandemic and in direct response to government advisories limiting nonessential travel, healthcare practitioners (HCPs) were quick to adopt digital platforms for engaging with pharma sales reps. And interestingly, it appears that these virtual engagements are actually increasing the amount of time HCPs spend with these reps. Now, as we move past this transformative time, the future that is emerging is neither fully face-to-face nor solely digital-dedicated.

Bryan Roman, Executive Vice President of Creative Technology and Stephan Saba, Senior Vice President of Customer Experience at Syneos Health talk about innovations in technology that can better enable interactions between sales reps and their customers in a post-pandemic world.

For more on the impact COVID-19 has had on physicians’ engagement with telemedicine platforms and field force teams, check out our recent report.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Pharmacovigilance in the COVID-19 Era and Beyond

Tue, 18 May 2021 11:00:00 -0400

Right now, millions of patients are being dosed with vaccines for COVID-19, which have had accelerated development timelines in order to provide emergency use. This is a first in our industry, and it presents safety monitoring challenges for pharmaceutical companies managing an unprecedented volume of data to ensure that the benefits to patients outweigh the risks. How can they keep up – now, and in the future?

Carol Aliyar, Executive Vice President, Global Head of Safety and Pharmacovigilance at Syneos Health, discusses the impact the COVID-19 vaccine rollout on current safety monitoring processes, how biopharma needs to adjust going forward, and why the human element remains a critically important part of the solution.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Lifecycle Management

Wed, 05 May 2021 08:00:00 -0400

It is a common misconception in the biopharmaceutical industry that lifecycle management is really meant for the end of a product’s life, generally at the point where exclusivity is lost and generic competition erodes sales and, ultimately, the value of the brand.

According to Tim Arendt, Managing Director in the Commercial Advisory Group of Syneos Health Consulting, if done right, a lifecycle management plan developed early will actually pay off in spades in the end. Here, he discusses the importance of lifecycle management in biopharma and how companies can – and should – leverage this tool to ensure their products will reach their full potential, throughout their lifecycle.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Source Document Review in the Modern World

Thu, 01 Apr 2021 09:00:00 -0400

Source Document Review and Source Data Verification have been the gold standard for ensuring data quality and patient safety for more than 30 years. This review and verification process covers a wide range of material related to study subjects including anything from consent forms and medical histories to lab results and personal diary entries and beyond, consuming a significant amount of time and budget. In recent years, we’ve seen a drive to find ways to make clinical trial monitoring more effective and cost efficient, especially with the growing use of technologies such as Electronic Data Capture (EDC) systems.

Audra Holleman, Vice President, Clinical Monitoring and Nicole Stansbury, Vice President, Global Monitoring at Syneos Health, discuss the evolution of what once was a manual and time consuming process of sifting through potentially thousands of pieces of material to a far more efficient and strategic approach driven by advancements of the digital age.

Listen to Nicole Stansbury discuss the importance of risk-based monitoring previously on the podcast in our CORONAVIRUS SPECIAL EDITION, Episode 7: Continuity in Clinical Trials.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Learning Agility in Medical Affairs

Tue, 16 Mar 2021 14:00:00 -0400

Being prepared for what you know is going to happen is hard enough, but how can you get ready for the unexpected? The answer: learning agility.

Learning agility is a set of skills, competencies and mindsets that support an organization’s ability to respond in unforeseen situations. In fact, higher levels of learning agility could help to “future proof” organizations against challenges of turbulent times, and as such will likely become a differentiator for life science companies. Best of all, learning agility is a skillset that can be developed.

In this interview with Hasini Jayatilaka, PhD, Consultant and Data and Analytics Specialist, Scientific and Medical Affairs at Syneos Health, we discuss why learning agility is particularly beneficial in Medical Affairs, six tangible ways of cultivating learning agility and a diagnostic tool that can score, analyze, benchmark and provide recommendations for improvement on an individual, functional and organizational level.

Listen to our first podcast on Learning Agility here.

Read our white paper on Learning Agility on our Insights Hub here.

To learn more about Medical Affairs at Syneos Health, click here.

For more podcast episodes on Medical Affairs:

Medical Affairs from Zero

MA “Squared”: Medical Affairs Meets Market Access

Medical Affairs Series, Part One – A Foundation for Medical Affairs

Medical Affairs Series, Part Two – Measuring the Unmeasurable: Medical Affairs Metrics

Medical Affairs Series, Part Three – Moving to the Left

Medical Affairs Series, Part Four – Medical Affairs in the Field

Medical Affairs Series, Part Five – Medical Affairs in the Early Stage

Medical Affairs Series, Part Six – Commercial Plus Medi

Trade and Distribution in Pharma: It's Complicated

Wed, 24 Feb 2021 14:00:00 -0500

Getting a drug product into the hands of patients is not a simple task. What was once a straightforward “back office” operation has, with the advent of oncology, rare disease and other kinds of specialty therapeutics, risen to a level of complexity that requires greater strategy, planning and logistics acumen than ever before.

Tony Lanzone, Managing Director, Value, Access and HEOR at Syneos Health provides a deep dive into the art and science of getting therapies from the manufacturer to the patient, and how the right trade and distribution strategy can provide a true competitive advantage.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Peter Kolchinsky and Investing in Biopharma

Wed, 10 Feb 2021 13:00:00 -0500

Investing with confidence, and with a conscience – yes, it is possible to do both.

In our second interview with scientist-turned-investor Peter Kolchinsky, co-founder and Managing Partner at RA Capital Management, LP and author of The Great American Drug Deal: A New Prescription for Innovative and Affordable Medicines, we discuss his transition into biotech portfolio management, the art of unearthing potential investment opportunities through competitive mapping, and what it means to make a difference through his affiliation with nonprofit No Patient Left Behind.

Check out some of his firm’s fascinating, detailed landscape maps for COVID-19 diagnostics, therapeutics and vaccines here.

Listen to our first interview with Peter Kolchinsky here.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Peter Kolchinsky and The Great American Drug Deal

Wed, 03 Feb 2021 15:00:00 -0500

Biopharmaceutical innovation requires a hefty investment: A recent study published in The Journal of the American Medical Association (JAMA) reported an average cost of $1.3 billion to bring a new drug to market, from drug discovery through clinical trials to approval. And it is often the biopharma company that comes under fire when cost burden to patients is in question.

But affordability of these innovations is not the biopharma industry’s cross to bear alone, according to Peter Kolchinsky, co-founder and Managing Partner at RA Capital Management, LP and author of The Great American Drug Deal: A New Prescription for Innovative and Affordable Medicines. In this first of two interviews, Kolchinsky sits down with host Jeff Stewart to discuss the current healthcare landscape and how government, society, the insurance industry and biopharma must work together in order to fulfill what he calls the “biotech social contract” – where patients will be able to afford their treatments and society will continue to reap the benefits of medical innovation.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Real World Evidence and Rare Diseases

Wed, 13 Jan 2021 08:00:00 -0500

How rare is a rare disease? On their own they can be quite scarce, but did you know that one in ten people in the U.S. is afflicted with a rare disease? That’s over 30 million people. And that’s a big problem. But how do you study treatments when it’s so difficult to find patients for each rare disease? That’s when it is time to leave the lab and take a look at the real world.

In this episode, we are joined by Syneos Health experts Dr. Raymond Huml, Vice President, Medical and Scientific Strategy, Head of the Rare Disease Consortium and Dr. Javier Jimenez, Executive Vice President, Real World Evidence and Late Phase. They draw on their history working with rare diseases and the challenge of developing treatments for these conditions. For diseases that are so scarce you cannot just use clinical trials, you need to incorporate real world data. The challenge becomes combining these sources of information to create the treatments that patients desperately need. Drs. Hummel and Jimenez discuss their experience navigating this difficult field and how to get the information that everyone, from regulators to biopharma companies, needs to treat rare diseases.

For more content on rare disease drug development, check out:

Our webinar on the role of patient advocacy groups in rare disease drug development;
This report on accelerating rare disease drug development – lessons learned from muscular dystrophy; and
This paper on creating an integrated development plan in orphan and rare diseases.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Global Pharma

Wed, 21 Oct 2020 08:00:00 -0400

It may sound obvious that pharmaceutical companies operate according to the unique set of regulations, healthcare environments, market conditions, and cultures of the regions in which they operate, but what do such differences reveal about the industry as a whole?

In this episode, Sabine Dettwiler, Managing Director, Commercial Advisory Group at Syneos Health Consulting, shares some learnings from her experience in the U.S., Asia, and Europe – comparing and contrasting the pharmaceutical landscape across all three, including the challenges of clinical trial diversity, cultural barriers, and the differing values and priorities of healthcare providers.

For a deeper dive into our perspective on trends in the oncology landscape in China, listen to this podcast episode.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

APAC EDITION: Clinical Development in Japan

Wed, 09 Sep 2020 09:00:00 -0400

In the past decade, Japan’s biotech and pharmaceutical industries have expanded into global markets, and continue to evolve in light of recent regulatory changes and challenges.

Stephane Gouteux, Vice President and General Manager of Japan Clinical Solutions at Syneos Health, discusses overall healthcare trends and pharmaceutical trends in Japan, and also explores the opportunities available for major market players, including contract research organizations (CROs).

For a deeper dive into our perspective on the changing immune-oncology landscape in APAC, read this report.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Learning Agility

Wed, 02 Sep 2020 16:00:00 -0400

The COVID-19 pandemic has forced companies to adapt in unprecedented ways. More than ever, learning agility – the desire, capability, and skillset that allow people to navigate change and uncertainty – has become critical to organizational success and can lead to new opportunities.

In this episode, Syneos Health® experts, Karen White, Vice President of Human Resources and Kiely Flanigan, Director of Global Medical Affairs from our consulting team, discuss why learning agility matters and how it can add value to business areas across the pharmaceutical industry, from global drug launches to the increasing number of rare disease therapies.

For a deeper dive into our perspective on how businesses have adapted during COVID-19, read this report. Be sure to check out our recent article on learning agility and listen to the rest of our Medical Affairs podcast series episodes:

Medical Affairs from Zero

MA “Squared”: Medical Affairs Meets Market Access

Medical Affairs Series, Part One – A Foundation for Medical Affairs

Medical Affairs Series, Part Two – Measuring the Unmeasurable: Medical Affairs Metrics

Medical Affairs Series, Part Three – Moving to the Left

Medical Affairs Series, Part Four – Medical Affairs in the Field

Medical Affairs Series, Part Five – Medical Affairs in the Early Stage

Medical Affairs Part 6: Commercial + Medical Affairs

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision

China vs. Cancer

Wed, 26 Aug 2020 08:00:00 -0400

Within the last two years, the regulatory environment has evolved dramatically in China, allowing clinical trials to get off the ground faster and providing greater opportunity for drug development in the region.

Syneos Health® experts Patrick Nealon, Executive Vice President and Head of the Oncology Business Unit, and Nick Kenny, Chief Scientific Officer, discuss the extraordinary pace of investment and innovation in cancer drug development in China, the risks and challenges that arise from scaling clinical operations in the country’s untapped market, and the impact that such changes will have on U.S. pharma.

For a deeper dive into our perspective on the changing immune-oncology landscape in APAC, read this report.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Rapid Early Phase Clinical Trials

Thu, 06 Aug 2020 10:00:00 -0400

In an industry where time is money, rapid startup in early phase clinical trials – where patients receive a drug for the first time – is critical. But what does rapid mean, exactly, and why is it so important?

David Wyatt, MD, Vice President, Medical Affairs at Syneos Health discusses rapid early phase startup, explaining the advantages and complications that can arise, as well as the requirements for its success.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Payer Power, Part 3

Wed, 15 Jul 2020 09:00:00 -0400

The entirety of the US healthcare system was reformed with the advent of Obamacare in 2009 – and we’re still feeling the aftershocks over a decade later.

So says Keith Kelly, Senior Managing Director, Value, Access and HEOR at Syneos Health Consulting, who returns to the Syneos Health Podcast to continue the discussion on the trajectory of payer influence in the healthcare marketplace.

Listen to our previous episodes in the series, Payer Power and Payer Power, Part 2, to get the full story. And for additional market access-focused content, check out these recent publications:

The Great Benefits Migration of 2020

Demonstrating Value in the Real World

Non-Personal Promotion: What Do Payers Want?

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

CORONAVIRUS SPECIAL EDITION, Episode 12: COVID-19 and Children

Fri, 19 Jun 2020 10:00:00 -0400

Over the course of the COVID-19 pandemic, information has varied around whether or not – and how severely – children are affected by the virus.

In this episode for our Coronavirus Special Edition Series, Pierre Omnes, Executive Director, SSU and Regulatory and Alex Cvetkovich Muntañola, MD, Executive Director, Clinical Development at Syneos Health, share what we’ve learned so far about the impact of COVID-19 on children’s health, and how approaches to clinical trials for this specific population have been altered.

Stay tuned for more installments of the Coronavirus Special Edition Series, which explores, from an operational standpoint, the impact of COVID-19 on the biopharma industry, the challenges for rapid R&D in an outbreak environment, and the opportunities to leverage technology and innovation to address these critical issues. Additional materials and insights can also be found in our COVID-19 Resource Center.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 5/18/2020.

CORONAVIRUS SPECIAL EDITION, Episode 11: Rare Disease Clinical Trials and COVID-19

Tue, 02 Jun 2020 11:00:00 -0400

The COVID-19 pandemic has impacted drug development, and rare disease drug development in particular – and the industry in general grapples with challenges in this new clinical trial environment.

In this episode for our Coronavirus Special Edition Series, Zizi Imatorbhebhe, Global Lead of Rare Disease Clinical Development at Syneos Health, discusses the numerous challenges involved in rare disease drug development and how the pandemic has heightened the need to adapt innovations and strategic considerations to accelerate development.

To read more about rare disease clinical trials in the age of COVID-19, download our white paper.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 5/6/2020.

NEWYORKBIO BIOPHARMA INNOVATORS SERIES: Yelp Ratings for Clinical Trials

Wed, 27 May 2020 14:00:00 -0400

In this episode of our Biopharma Innovators Series in partnership with NewYorkBIO, we feature an influencer who is passionate about community engagement, and patient education and empowerment.

Irfan Khan, MD, CEO of Circuit Clinical, discusses the challenges for patients and physicians in navigating the current clinical trial system and how consumer-related technology platforms could potentially bring clinical trials more easily to the masses.

Stay tuned for more of our weekly Biopharma Innovators Series, where you’ll hear New York-based industry experts on a wide range of important issues, from helping patients navigate clinical trials, to real world evidence and value for innovation, to bringing lower priced drugs to market, and more. And to catch some of these experts live and in person, be sure to register for the rescheduled 2020 Annual Meeting on September 14th!

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

NEWYORKBIO BIOPHARMA INNOVATORS SERIES: Taming the Healthcare Data Explosion

Fri, 15 May 2020 15:00:00 -0400

In this episode in our Biopharma Innovators Series in partnership with NewYorkBIO, we feature a leader in the field of real world data and outcomes research.

Marc Berger, MD, Head of the Real World Evidence Product Advisory Board for SHYFT Analytics and former Vice President of Real World Data and Analytics at Pfizer, discusses the double-edged sword inherent in the veritable mountain of data available to us, from issues of privacy and accessibility of data to how companies can query this data in order to efficiently and effectively glean the insights they need.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

NEWYORKBIO BIOPHARMA INNOVATORS SERIES: Real World Data for Clinical Innovation

Fri, 08 May 2020 14:00:00 -0400

Continuing our Biopharma Innovators Series in partnership with NewYorkBIO, we welcome a recognized leader at the forefront of innovation in clinical research and medicine development.

Craig Lipset, former Head of Clinical Innovation at Pfizer, discusses where real world data (RWD) fits within the context of the clinical trial continuum, and innovative ways RWD can be used to drive better planned and executed studies as well as to drive greater efficiency.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

CORONAVIRUS SPECIAL EDITION, Episode 10: Ventilating the COVID-19 Patient

Tue, 05 May 2020 10:00:00 -0400

As the COVID-19 pandemic continues, clinicians are learning more about the impact of the disease on the body, particularly in the lungs, and it’s shaping the way hospitals need to think about treating these patients – specifically with regard to what type of breath support to use.

In this episode in our Coronavirus Special Edition Series, Dr. Bill Croft, Ed.D, Ph.D., RRT, RCP, Executive Director of the North Carolina Respiratory Care Board, discusses the unique physiology of the COVID-19 lung, the pros and cons of BiPAP versus mechanical ventilators, and a more refined, incremental treatment path for breath support in COVID-19 patients.

For more on the use of invasive BiPAP as a potential alternative to mechanical ventilation, listen to our previous episode, Surviving the Ventilator Shortage. And to learn more about the Syneos Health Ventilator Initiative, visit www.COVID-biPAPinfo.com.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 4/23/2020.

CORONAVIRUS SPECIAL EDITION, Episode 9: Telemedicine in the Age of COVID-19

Thu, 23 Apr 2020 16:00:00 -0400

In the midst of a pandemic situation that requires social distancing measures to minimize personal contact, how are non-emergency physicians continuing to engage with their patients? Further, what are their expectations around pharmaceutical field representatives and how they need to receive important information on potential products for treating their patients? A recent survey of 263 US clinicians provides a glimpse into their perspective.

In this episode in our Coronavirus Special Edition Series, Jodi Scarbrough, Director of Custom Research at Syneos Health, discusses the impact of the COVID-19 pandemic on the adoption of telemedicine and teledetailing, and how these platforms might play out in a post-pandemic environment.

For more information, download the full report, COVID-19 Pandemic Fuels Surge in Telemedicine and Virtual Field Force Engagements.

Stay tuned for more installments of the Coronavirus Special Edition Series, which will explore, from an operational standpoint, the impact of COVID-19 on the biopharma industry, the challenges for rapid R&D in an outbreak environment, and the opportunities to leverage technology and innovation to address these critical issues. Additional materials and insights can also be found in our COVID-19 Resource Center.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 4/10/2020.

CORONAVIRUS SPECIAL EDITION, Episode 8: Payers and COVID-19

Thu, 16 Apr 2020 10:00:00 -0400

In this Coronavirus Special Edition Series, we’ve talked a lot about the clinical implications of the COVID-19 pandemic. But what is the impact on the commercial side? Specifically, how are payers – key players in getting patients access to therapies – continuing to conduct business, and how are current conditions affecting priorities, if at all? Syneos Health advertising firm GSW conducted a survey to find out.

In this episode in our Coronavirus Special Edition Series, Adrian Garcia, Senior Vice President, Head of Payer & Integrated Health and Katherine Seay, Executive Vice President, Managing Director, Managed Markets at GSW, discuss the impact of the pandemic on payers, important considerations for manufacturers in engaging with these organizations in this environment, and the potential impact on formulary decision-making going into 2021.

For more information, download the full report, Payer Perspectives on Managing COVID-19.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 4/7/2020.

CORONAVIRUS SPECIAL EDITION, Episode 7: Continuity in Clinical Trials

Thu, 02 Apr 2020 08:00:00 -0400

The COVID-19 pandemic is impacting clinical trials in many ways, not the least of which being the ability for sponsors to continue traditional oversight activities such as on-site clinical trial monitoring. The Association of Clinical Research Organizations (ACRO) has issued recommendations for clinical trial monitoring that will help maintain continuity in clinical trials wherever possible.

In this episode in our Coronavirus Special Edition Series, Paul Colvin, President, Clinical Solutions and Nicole Stansbury, Vice President, Global Clinical Monitoring at Syneos Health, discuss the role of risk-based monitoring and opportunities for remote options that can potentially ensure continuity, trial viability and data preservation through this pandemic and beyond.

Read more about remote risk-based monitoring in action in this Clinical Leader article, and be sure to watch our webinar on implementing remote clinical trial monitoring.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/26/2020.

CORONAVIRUS SPECIAL EDITION, Episode 6: The Leader's Experience

Mon, 30 Mar 2020 08:00:00 -0400

Ensuring the health and safety of the workforce – while maintaining business as usual – is a delicate balance in the face of the COVID-19 pandemic.

In this episode of our Coronavirus Special Edition Series, Syneos Health CEO Alistair Macdonald discusses the unique decisions to be made as a pharmaceutical organization practicing corporate responsibility in the name of public health.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/13/2020.

CORONAVIRUS SPECIAL EDITION, Episode 5: Surviving the Ventilator Shortage

Tue, 24 Mar 2020 13:00:00 -0400

A critical shortage of mechanical ventilators is anticipated in many countries, including the United States, because of the ongoing COVID-19 pandemic. A potential emergency solution would be the use of bi-level positive airway pressure (BiPAP). BiPAP may be used in the hospital setting with appropriate precautions for intubated COVID-19 patients experiencing Acute Respiratory Distress Syndrome (ARDS). Use of invasive BiPAP on an emergency basis may delay or obviate the need for mechanical ventilation in appropriate COVID-19 patients.

In this episode for physicians on the front lines treating patients with COVID-19, Keith Robinson, MD, a critical care pulmonologist at Syneos Health, discusses how, when, and in which patients, the use of BiPAP can potentially be used in place of mechanical ventilators.

For more information on this solution, download the full white paper. And to learn more about the Syneos Health Ventilator Initiative, visit www.COVID-BiPAPinfo.com.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/22/2020.

CORONAVIRUS SPECIAL EDITION, Episode 4: Clinical Trials Through Pandemics

Tue, 24 Mar 2020 07:00:00 -0400

In the midst of the COVID-19 pandemic, late stage clinical trials are at risk of disruption as shelter-in-place and more restrictive lockdown requirements roll out across the globe. How can these trials continue if patients can’t get to the clinic?

In this episode in our Coronavirus Special Edition Series, Lou Boccumini, head of the infectious disease team at Syneos Health, discusses ways that developers can maintain continuity of their clinical trials during a pandemic – and how to create resiliency in their clinical trials for the future.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/19/2020.

CORONAVIRUS SPECIAL EDITION, Episode 3: Virtual Clinical Trials

Fri, 20 Mar 2020 12:00:00 -0400

In the midst of a pandemic, industry is looking for ways to ensure continuity of clinical trials while keeping patients safe. Virtual approaches to clinical research leverage digital technologies to bring the study to the patient, and may be – in time – a viable option for limiting personal contact and possible spread of disease during outbreak situations.

In the third episode in our Coronavirus Special Edition Series, David Thompson, Senior Vice President, Real World Evidence at Syneos Health discusses potential applications for virtual research in the real world, and the pros and cons of going virtual, offering a glimpse into the future of clinical research.

For more detail on the promise of virtual trials, read our latest paper “Virtual Research: What It Is and What It’s Doing in the Real-World Setting.”

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/16/2020.

CORONAVIRUS SPECIAL EDITION, Episode 2: The Clinical Experience

Tue, 17 Mar 2020 10:00:00 -0400

As COVID-19 continues to spread worldwide, increasingly strict measures are being put into place in an attempt to slow it down while the scientific community pushes to identify effective antiviral options.

In the second episode of our Coronavirus Special Edition series, Syneos Health infectious disease experts Gino Girardi, MD and Jaime E. Hernandez, MD dig into the epidemiology of COVID-19, the experience gained from past pandemics (such as H1N1 or “swine flu”), impact on health systems, and the race to find a treatment.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/13/2020.

CORONAVIRUS SPECIAL EDITION, Episode 1: The Personal Experience

Fri, 13 Mar 2020 08:00:00 -0400

The COVID-19 (coronavirus) outbreak continues to grow worldwide – recently declared by the World Health Organization as a global pandemic – with widespread personal, medical, and business implications.

In this first episode of our Coronavirus Special Edition Series, we hear the personal experience of Dr. Siying Zou, a cell biologist on the Syneos Health Consulting team in the United States. Dr. Zou is from Wuhan, China – the epicenter of the COVID-19 outbreak – and her mother and other family members have been diagnosed with the disease. This is her family’s story from the front lines, from lockdown, to hospitalization, to hope.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

* This episode was recorded on 3/11/2020.

Recruiting Patients for Clinical Trials

Fri, 06 Mar 2020 11:00:00 -0500

Recruiting patients into clinical trials is arguably one of the most, if not the most, important aspects of bringing a new therapy to market – and it can be the most difficult, time consuming part of the entire process.

Clare Grace, Vice President, Site and Patient Access at Syneos Health discusses the challenges for patients when it comes to clinical trials, the complexities for industry in recruiting these patients – and how enhancing communication to, through, and among physicians could be the key to boosting overall engagement and improving the clinical trial recruitment experience.

For a deeper dive into our perspectives on patient engagement in clinical trials, check out this pharmaphorum article, and our “Content that Clicks” report and related podcast Episode 024.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Medical Affairs Series, Part Six: Commercial Plus Medical Affairs

Wed, 19 Feb 2020 09:00:00 -0500

It may seem counter-intuitive to use the words “Commercial” and “Medical Affairs” in the same sentence. But with the evolution of Medical Affairs from a tactical support function to a strategy driving organization, it’s become clear that by partnering, the collective and complementary strengths of Medical Affairs and Commercial organizations will drive greater success than ever before.

In part six of our Medical Affairs Series, Suma Ramadas from our Medical Affairs team at Syneos Health Consulting, and Andy Hurley, who leads the Commercial Integration team at Syneos Health, discuss the intersection and alignment of Commercial and Medical Affairs functions and how they can work together to bring the full value story of a product to the customer.

For more episodes on Medical Affairs:

Medical Affairs from Zero

MA “Squared”: Medical Affairs Meets Market Access

Medical Affairs Series, Part One – A Foundation for Medical Affairs

Medical Affairs Series, Part Two – Measuring the Unmeasurable: Medical Affairs Metrics

Medical Affairs Series, Part Three – Moving to the Left

Medical Affairs Series, Part Four – Medical Affairs in the Field

Medical Affairs Series, Part Five – Medical Affairs in the Early Stage

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evo

2020 Health Trends: Box Store Healthcare

Wed, 05 Feb 2020 10:00:00 -0500

Radical changes in the interface of health are rapidly changing where people find care. Where is that, exactly? Quick answer: everywhere. The point of care has been steadily shifting away from where the clinic exists to wherever the patient goes. Advances in digital care connections and the growth of new customer segments have opened up entirely new ways to make healthcare more scalable and accommodating to both baby boomer demands and millennial disruption.

A.J. Triano, Senior Vice President, Engagement Strategy at GSW Advertising and Aaron Davis, Managing Director, Value, Access and HEOR at Syneos Health Consulting, discuss the factors impacting this shift, what the new ecosystem is looking like, and what it all means for developers, health care providers, and patients in the longer term.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Denials, Delays and Deep Discounts in Pharmaceutical Launch

Fri, 24 Jan 2020 09:00:00 -0500

FDA approval is no longer the finish line in the race to product launch success. Access and adoption have risen to the forefront as a major post-approval hurdle: recent research from Syneos Health Consulting’s Value and Access team shows that less than half of newly approved drugs appeared on formulary in their launch year. So what’s a drug developer to do?

Co-authors of the report on insurance coverage of new drugs at launch Jeff Stewart, Brian Cotten and Heather Martin discuss the results of their analysis, what developers can expect from payers in launch year, and how they can prepare the best possible access outcome for their new drug.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Medical Affairs Series, Part Five: Medical Affairs in the Early Stage

Fri, 10 Jan 2020 16:00:00 -0500

As we’ve hammered home over the last several episodes of this series, Medical Affairs can bring great value to any moment in an asset’s life cycle. But there is one area where developers may be missing out on an opportunity to gain real traction in their efforts.

Today we dive deeper into a Medical Affairs sweet spot with Steve Gomez, Senior Engagement Manager on the Scientific and Medical Affairs team at Syneos Health Consulting, discussing the ways that today’s Medical Affairs organization can be a shepherd, strategic partner, and even the leader for an organization in the earliest stages of development.

For more episodes on Medical Affairs:

Medical Affairs from Zero

MA “Squared”: Medical Affairs Meets Market Access

Medical Affairs Series, Part One – A Foundation for Medical Affairs

Medical Affairs Series, Part Two – Measuring the Unmeasurable: Medical Affairs Metrics

Medical Affairs Series, Part Three – Moving to the Left

Medical Affairs Series, Part Four – Medical Affairs in the Field

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Real World Evidence and Rare Diseases

Fri, 20 Dec 2019 11:00:00 -0500

A striking life sciences trend has come into focus the past 12 months. Global regulators—often viewed as taking a conservative approach to transformative technology—have moved into the vanguard in discussions and guidance around real world data (RWD) and real world evidence (RWE).

It is not so much the case with payers. According to new research by Syneos Health on payer perceptions of RWE in rare diseases, many payers are not entirely receptive to RWE-based representations or health economic forecasts in sponsors’ dossiers or related conversations.

What accounts for payers’ hesitation? Michelle Leeds, Vice President, Risk and Reputation Management and Alastair MacDonald, Senior Vice President, Real World Late Phase, join the podcast to examine the issues from several perspectives based on conversations with payers, drug developers, regulatory experts and patient organizations.

For more detail on the Syneos Health research into payer perceptions, download the full report “Real World Value: Advancing Payer Understanding of RWE in Rare Disease.”

To hear more from Alastair MacDonald, check out Episode 031, “Real World Evidence in Europe.”

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

The Digital Therapeutics Alliance: A European Perspective

Wed, 11 Dec 2019 09:00:00 -0500

Earlier this year on Episode 040, we discussed the relatively new digital therapeutics landscape and the opportunities and challenges for both biopharma and tech companies.

Today, we’ll take a deeper dive from the industry side – and specifically with a European perspective – with Jessica Shull, European Lead for the Digital Therapeutics Alliance, an international non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics.

For more, be sure to check out our previous episode on digital therapeutics, and download our report, How Digital Therapeutics Developers Can Satisfy Diverse Stakeholder Needs.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision making and investment. You can find it all at insightshub.health.

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Medical Affairs Series, Part Four: Medical Affairs in the Field

Wed, 20 Nov 2019 09:00:00 -0500

The Medical Science Liaison (MSL) has gone through a bit of an identity overhaul. A role that used to lean almost exclusively on scientific acumen must now more than ever also rely on business chops and people skills. A shift akin to moving from Geek Squad…to Apple Genius Bar.

Keith Morris, Executive Managing Director, Medical Affairs at Syneos Health Consulting, and Ric Phipps, Senior Vice President, Global Field Medical Affairs for Syneos Health Deployment Solutions discuss the increased complexity of the role of as the needs of today’s customer groups are evolving and how, as a result, the required competencies and skillsets of these field teams have changed.

For more episodes on Medical Affairs:

Medical Affairs from Zero

MA “Squared”: Medical Affairs Meets Market Access

Medical Affairs Series, Part One – A Foundation for Medical Affairs

Medical Affairs Series, Part Two – Measuring the Unmeasurable: Medical Affairs Metrics

Medical Affairs Series, Part Three – Moving to the Left

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Medical Affairs Series, Part Three: Moving to the Left

Wed, 06 Nov 2019 09:00:00 -0500

Traditionally, Medical Affairs has served as a support function in later phases of product development, but they now need to play a more strategic and value-based role within the organization – and that means earlier and deeper engagement.

In part three of our Medical Affairs Series, Suma Ramadas, Senior Managing Director and Colin Oliver, Director in Medical Affairs at Syneos Health Consulting, discuss how and why Medical Affairs organizations need to be involved earlier in the development life cycle.

Be sure to check out our other Medical Affairs-related episodes:

Medical Affairs from Zero

MA “Squared”: Medical Affairs Meets Market Access

Medical Affairs Series, Part One – A Foundation for Medical Affairs

Medical Affairs Series, Part Two – Measuring the Unmeasurable: Medical Affairs Metrics

Like what you’re hearing? Be sure to rate and review us!

We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Advocacy Archetypes

Thu, 24 Oct 2019 10:00:00 -0400

Patients have been at the forefront of many of healthcare’s most historic moments—not just as subjects, but also as catalysts for change. Some of today’s advocates look to the early ACT UP years for inspiration; others turn to blueprints established by pioneers like Abbey Meyers or Kathy Guisti.

In this episode, Keri McDonough, Lead, Advocacy and Patient Relations at Syneos Health, explores how certain patient advocate archetypes – the Caregiver, the Creator, the Citizen, the Magician, and the Rebel – have emerged over time and dig into how social determinants of health, politics of representation and even climate change will influence the advocates of the future.

For more on advocacy, check out the following publications:

How Patient Advocacy Connectivity Fuels Launch Success

The Changing Role of Patient Advocacy

Navigating Your Local Advocacy Community

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Medical Affairs Series, Part Two - Measuring the Unmeasurable: Medical Affairs Metrics

Wed, 09 Oct 2019 09:00:00 -0400

No industry standard currently exists to measure value and impact of medical affairs, and the traditional metrics that companies often use to determine return on investment (ROI) simply don’t apply.

In this second episode in our Medical Affairs series, Josh Samon, Managing Director and Colin Oliver, Director in Medical Affairs at Syneos Health Consulting, discuss the unique challenges around defining value, and define a path forward toward creating an industry standard that truly reflects the contributions of the Medical Affairs function.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Why We Resist

Wed, 25 Sep 2019 00:00:00 -0400

Why do people make good (and bad) decisions about their health? How can we help motivate them to change and give them the resilience to try and try again? Our industry and our world are obsessed with those questions right now.

Kathleen Starr, PhD, Managing Director, Behavioral Insights and Leigh Householder, Executive Vice President and Managing Director, Insights and Innovation at Syneos Health, tackle these tough questions in their new book, Why We Resist. In this episode, they talk about key principles of influence on behavior (things we all have in common), the behavioral science of segmentation (what makes us different), and how healthcare communicators can apply this knowledge to move their customers from a position of resistance to one of activation.

For a deeper dive into new ways to design communications, interventions and programs to help people make better, more confident decisions about their health, check out Why We Resist, available at Amazon and other retailers. All proceeds will benefit the STARR Coalition, a nonprofit organization dedicated to creating meaningful change in the field of mental health.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Medical Affairs Series, Part One: A Foundation for Medical Affairs

Wed, 11 Sep 2019 09:00:00 -0400

Medical Affairs, once considered a support function, now has a seat at the table as one of the major pillars of biopharmaceutical organizations. So now what? Our new Medical Affairs series, which will unfold over the next several months, will explore what’s next and provide insights and best practices for “Next Gen” Medical Affairs.

In this first episode of the series, Suma Ramadas, Senior Managing Director in the Scientific and Medical Affairs Advisory Group for Syneos Health Consulting, sets the foundation for discussion around the Medical Affairs function, how it can continue to communicate its worth, work effectively with Clinical and Commercial functions, and develop efficient processes – beginning earlier in development – that propel commercial planning and drive greater asset value.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

A Regulatory Roadmap for Real World Evidence

Wed, 28 Aug 2019 09:00:00 -0400

The need for real world evidence is growing beyond its original footprint of post-market intelligence, with uses now including regulatory approval, proof of value, maximized access and more. However, without a true understanding of the regulatory requirements around real world evidence, there is a risk of a “Goldilocks effect”— gathering either not enough information, the wrong information, or far more information than they need.

Stuart McCully, PhD, Vice President and Tara Isherwood, Senior Director, Real World Clinical Consulting, discuss the key information developers need in order to plan studies that will get them the intel that they need, the right way.

For more on real world evidence from across Syneos Health, check out our interviews with Alastair MacDonald in Episode 31, and Dave Thompson in Episode 1.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Talented Teams

Wed, 14 Aug 2019 09:00:00 -0400

Creating and supporting productive, motivated and happy teams is an ongoing challenge in today’s global workplace – and particularly in the fast-paced biopharmaceutical marketplace. Incentives can differ based on region, culture, or individual. Approaches can hinge on countless variables beyond compensation – although in some cases, cash is king. So what’s the key to success?

Based on 25 years of experience developing clinical teams, Tara Fitzgerald, President, Clinical Development Services at Syneos Health, shares her philosophy on attracting, building and retaining top talent – and what it truly takes to lead.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Digital Therapeutics

Wed, 31 Jul 2019 09:00:00 -0400

There are dozens of software-driven products under regulatory review for diagnosing, treating, or preventing medical conditions, defining an entirely new sector for the life sciences industry.

Today we are joined by Allison Murphy, Vice President, Business Development, Selling Solutions at Syneos Health and Skye Hodson, PhD, Engagement Manager, Commercial Advisory Group at Syneos Health Consulting, to discuss the digital therapeutics landscape, the opportunities for both biopharma and tech companies, regulatory and payer hurdles, and more.

For a deeper dive, download our report, How Digital Therapeutics Developers Can Satisfy Diverse Stakeholder Needs.

To become part of the broader conversation, check out these organizations mentioned in this episode: Digital Therapeutics Alliance and Digital Medicine Society (DiMe).

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Talking About PIE

Wed, 17 Jul 2019 09:00:00 -0400

Not that kind of pie. In this case, PIE – or Preapproval Information Exchange – refers to the communication of clinical and health care economic information on therapies in development between U.S. population health decision makers and drug manufacturers prior to regulatory approval.

John Seay, Vice President and Content Expert, Managed Markets Communications at Syneos Health, discusses the benefits of PIE, best practices for entering into these discussions, and the importance of building advocacy with payer organizations as a means of maximizing access.

For more information, check out the Food and Drug Administration guidance for PIE published in June 2018.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

MOAs in ONC: The Latest and Greatest in the Oncology Pipeline

Wed, 03 Jul 2019 09:00:00 -0400

Oncology continues to be one of the hottest therapeutic areas in the biopharmaceutical industry, but one that also poses some of the greatest challenges to developers.

Jessica Lee, Ph.D., Managing Director in the Commercial Advisory Group at Syneos Health Consulting, discusses the most recent and promising innovations in oncology therapeutics, the opportunities and challenges for combination therapies, and what could be the next great breakthrough.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Episode 037: Psychology in Clinical Trials

Wed, 19 Jun 2019 09:00:00 -0400

When it comes to clinical trials, what do clinical psychologists bring to the table?

Quite a lot, says Alexandria Wise-Rankovic, Ph.D., a clinical psychologist and Senior Vice President, Clinical Development in the CNS Business Unit at Syneos Health. In this episode, Dr. Wise-Rankovic discusses the important role of the clinical psychologist in clinical trials beyond recruitment, even beyond trials for psychiatric therapies – and how this role could be the key to developing and implementing trials that account for the true patient experience.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Episode 036: Commercialization for Emerging Companies

Wed, 05 Jun 2019 09:00:00 -0400

The biopharmaceutical market has evolved quite a bit over the last five to 10 years. As more emerging companies are opting to commercialize on their own, they can no longer look to the “tried and true,” traditional strategies for bringing a therapy to market – those rules no longer apply. So what’s the new normal, and what does it mean for this new generation of developers?

Nick Marasco, Executive Vice President for Global Business Development and Commercial Solutions at Syneos Health, discusses some of the biggest changes in the commercialization landscape and how they might impact how companies go to market, as well as some best practices to keep in mind along the path to launch (hint: preparation should start earlier than you think!).

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Episode 035: How Translational Science Can Solve Pharma's Productivity Puzzle

Wed, 15 May 2019 09:00:00 -0400

The infrastructure we rely on to create new medicines is in sore need of an upgrade. More and more investigational drugs are streaming into the pipeline. But most of them fail in clinical trials, draining corporate resources, disappointing investors, and shattering the hopes of patients. Financially speaking, return on investment (ROI) for R&D in biopharma is at an all-time low of 1.9%.

In a recent article, Riaz Bandali, President, Early Phase Clinical Services and George Scott, Senior Vice President, Early Phase Operations for Syneos Health, posit that translational science – the evidence-based process of converting research findings into tangible health improvements – offers companies an opportunity to make better decisions about the clinical path for an investigational drug.

Listen in to hear more from Bandali and Scott about how companies can use translational science as a toolkit for determining very early on which drug candidates will have the best chance of breaking through to clinical – and ultimately – commercial success.

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Episode 034: Can the Gut Microbiome Revolutionize Medical Care?

Wed, 01 May 2019 08:00:00 -0400

Research in the area of live biotherapeutics has exploded in the last seven years. There is still much to learn about whether a dysregulated gut microbiome (dysbiosis) causes disease, or whether disease leads to dysbiosis – but the potential for significant contribution to healthcare is there.

Erin Mistry, Senior Managing Director, and Thunicia Moodley, Senior Engagement Manager for Syneos Health Consulting, talk about the prospects for microbiome research, implications for future medical care, and the challenges inherent in bringing a new therapeutic area to the forefront.

For a deeper dive, check out our new white paper here.

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APAC Edition: Medical Affairs in China

Fri, 26 Apr 2019 00:00:00 -0400

The role of Medical Affairs has changed dramatically in China over the last 10-15 years, moving from what was once considered a secondary support function to one now at the forefront of a more patient-centric paradigm.

Sam Ying, Vice President and General Manager for Syneos Health Commercial in China, discusses the evolution of the Medical Affairs function in China, the rise of the Medical Science Liaison (MSL) and other customer-facing roles, and the importance of digital transformation in the region.

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Episode 033: From DTC to DT"Me" - The Future of Communications in Pharmaceuticals

Wed, 17 Apr 2019 07:00:00 -0400

The art of communications in the pharmaceutical industry is becoming more complex.

According to Amy Hutnik, Chief Growth and Transformation Officer for Syneos Health Communications, we’ve evolved from the point of DTC (Direct to Consumer) to the extremely individualized opportunity of DT“Me” (Direct to Me). The landscape has changed dramatically in terms of not only the sheer number of channels available to us for communicating with our audience, but also in the data available to provide the insights we need to make decisions about how, when and how much we spend on our promotional activities.

Listen in for a discussion on the way the space has changed in terms of decision-making and spend/budget planning, the necessity for breaking down the silos in large companies, why (despite popular belief) personal promotion is not dead – and a look at what lies ahead in the future of communications in pharmaceuticals.

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Episode 032: Navigating the New EU Medical Device Regulations

Wed, 03 Apr 2019 07:00:00 -0400

New regulations, which were adopted on May 26, 2017, will affect all device and diagnostics manufacturers looking to sell products in the EU, with stricter requirements being introduced in order for these products to be approved. We are just over a year out from implementation of some of these European Union Medical Device Regulations (EUMDR), set for May 2020. With the deadline looming, how prepared should manufacturers be at this point – and how prepared are they?

Adam Steadman, Vice President, Clinical Development, Medical Devices & Diagnostics at Syneos Health, discusses the importance of these regulatory changes, highlights some of the key steps manufacturers need to take and examines the challenges inherent in gathering the data required for re-certification and ultimately, renewed market approval, in the EU.

If you want to see more on this topic, check out our white paper and webinar.

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APAC Edition: Acceleration in Asia

Fri, 29 Mar 2019 00:00:00 -0400

In this first episode of the Syneos Health Podcast: APAC Edition, host Robbie Chana speaks with Sebastian Bather, President of APAC in Japan for Syneos Health, about key trends in Asia Pacific with potentially high impact on the biopharmaceutical industry in the region, including significant growth and change in regulation in China, great interest in digital, and the increasing talent war, among others, and what companies need from their partners in order to adapt to and leverage this rapid evolution of the market.

For more on the changing APAC landscape, tune in to Episode 030 – Land of Opportunity: R&D in Asia Pacific, and stay tuned for more coming up on the APAC Edition.

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Episode 031: Real World Evidence in Europe

Wed, 20 Mar 2019 00:00:00 -0400

According to the Syneos Health 2019 Health Trend Ten, perhaps the biggest shift for 2019 and beyond is global focus on understanding what product differentiation looks like in real-world environments. In Europe in particular, countries are implementing more stringent measures that will impact how value is assigned in the future – and real world evidence (RWE) will play a key role.

Alastair MacDonald, Senior Vice President, Real World and Late Phase at Syneos Health, discusses the complex landscape in Europe, why “real world” and “late phase” are no longer synonymous, the four key stakeholders driving the need for RWE, and more.

For more content related to real world evidence, check out our interview with David Thompson in Episode 001: The Real World Evidence Revolution, our Syneos Short in Episode 020: 21st Century Cures and our recent white paper on determining Which Real-World Research Design is Best.

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Episode 030: Land of Opportunity: R&D in Asia Pacific

Wed, 06 Mar 2019 00:00:00 -0500

Big changes are happening in Asia, opening up a world of possibilities for biopharmaceutical companies to accelerate clinical development of innovative medicines.

Robbie Chana, Vice President, Business Development, Asia Pacific talks about the unique opportunity for biopharma in the region, such as regulatory and financial incentives for innovation – but also the unique challenges that come with being a large, diverse and still developing market.

We will soon be kicking off a series of episodes focused on the Asia Pacific region, hosted by Robbie and featuring interviews with experts from that region. Stay tuned!

Do you like what you’re hearing? Be sure to subscribe and review us on iTunes, Stitcher, or wherever you get your podcasts.

Episode 029: Commercial Models of the (Very Near) Future

Wed, 20 Feb 2019 00:00:00 -0500

A commercial model built to deliver blockbuster drugs to the market is no longer effective – particularly for delivering therapies for complex disease states to smaller, more targeted patient populations and specialty providers. But what will the new, “commercial model of the future” look like?

There’s no one clear answer, but Howard Brock, Senior Managing Director and head of customer and digital engagement in the Commercial Advisory Group at Syneos Health Consulting, believes the key will lie in how we use data to better engage with the customer. Pharma wants to take a page from the playbooks of Amazon, Google and Facebook – but we need to figure out how to adapt those models to work within the complex regulatory and privacy limitations of the biopharma marketplace. Here he discusses the challenges biopharma CEOs are facing, the role of technology in the process, and how approaches like dynamic assembly will get us closer to a successful, targeted customer engagement model.

For more information, check out our recent paper, Biopharmaceutical Commercial Models of the (Very Near) Future, which outlines the path to a well-integrated model that considers key trends, specific influencers and their needs, and adoptable to address the specific needs of each disease state, and discusses the new ways that people will start to behave and operate within more integrated organizations, and how data will be generated and utilized to generate actionable insights and demonstrate value.

Do you like what you’re hearing? Be sure to subscribe, rate and review this podcast on iTunes, Stitcher, or whatever platform you’re using!

Episode 028: World Cancer Day

Fri, 01 Feb 2019 00:00:00 -0500

The treatment of cancer has undergone a sea change in the span of a generation. In this two-part episode for World Cancer Day, we discuss the increasingly complex oncology landscape, from both a clinical and clinician perspective.

First, Bob Millham, Executive Vice President of Clinical Development and head of our Oncology Center of Excellence, addresses the potential of clinical research in driving toward a world where cancer is treated more like a chronic condition than a death sentence – and the ongoing, critical importance of engaging patients in the process.

We then hear from Dave Querry, President of The Navicor Group, on the evolving role of the oncologist and how manufacturers need to think about engaging differently with this increasingly specialized practitioner.

Interested in reading more? Follow these links for a deeper dive into a broad range of oncology topics from these and other Syneos Health experts:

Trends In Oncology Trial Terminations Due To Toxicity

ESMO 2018 Congress: Some Good Answers and Quite a Few New Questions

Pursuing Accelerated Approval in Oncology Indications

The Importance of Real World Evidence in Oncology

BIO18: Oncology Surplus Could Drive Down Values

A New Reality for Small Oncology Trial Sites: A Need to Adopt a Federated Approach?

Episode 027: Caregivers

Tue, 11 Dec 2018 00:00:00 -0500

It’s just one word. But it carries the weight of over 43 million people, about a quarter which spends 41 hours or more per week providing care for loved ones with medical conditions.

Caregivers are not just influencers for healthcare decision-making; many are the decision makers, according to Carolyn Stephenson, SVP, Director of Insights, and Ilya Vedrashko, Managing Director, Communications Research at Syneos Health. Together, they’ll tease out key findings from their recent survey of over 1,000 caregivers to truly understand these individuals and what lies beneath the surface in their experiences and perception.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. Syneos Health reserves the right to make alterations or deletions to the content at any time without notice to you.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any Syneos Health clients, customers or other contacts.

Episode 026: The Health Trend Ten - Clinical Perspective

Tue, 27 Nov 2018 07:00:00 -0500

As we head toward the close of the year, we are already looking to see what 2019 has in store. Drawing on the knowledge and experience of more than 200 leaders and experts who work on the front lines of healthcare, we identified 10 critical shifts that will change how we test and commercialize novel new therapies and innovations in the years ahead.

In our last episode, we heard about some of the commercial insights from the Health Trend Ten. Today, Leigh Householder, EVP / Managing Director, Insights and Innovation, and Nick Kenny, Chief Scientific Officer at Syneos Health, discuss key clinical trends that will impact the industry going into 2019 – including the “trials everywhere” model, the power of digital innovation, China’s disruptive impact and the penultimate importance of data.

Listen to part one of our Health Trend Ten series – the commercial perspective – here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 025: The Health Trend Ten - Commercial Perspective

Tue, 27 Nov 2018 07:00:00 -0500

In this first of two episodes on the Health Trend Ten, Leigh Householder, EVP / Managing Director, Insights and Innovation, and Bryan Distefano, EVP, Sales, Selling Solutions at Syneos Health, discuss key commercial trends that will impact the industry going into 2019 – including the precarious state of the healthcare practitioner, a rewiring of launch (and how we invest), the sales force of the future, and the potential (inevitable?) shift of the “M” in CMO.

Listen to part two of our Health Trend Ten series – the clinical perspective – here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 024: Content that Clicks

Wed, 31 Oct 2018 00:00:00 -0400

In our increasingly digital world, it was only a matter of time before search and social marketing would start to take on an important role in clinical trial patient recruitment. But with shaken trust in data security combined with sensitivities around medical data privacy, will potential patients click?

Matthew Snodgrass and Michael Pearlman from the Syneos Health Digital & Social Strategy team discuss the results of a survey of potential clinical trial participants on their perceptions and opinions of online channels as a means for receiving clinical trial information - and the many opportunities this channel offers for patients and sponsors alike.

See our full list of podcast episodes here.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. Syneos Health reserves the right to make alterations or deletions to the content at any time without notice to you.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any Syneos Health clients, customers or other contacts.

Episode 023: The Clinical Trial Marathon, at a Sprint

Wed, 03 Oct 2018 00:00:00 -0400

Clinical trials are arguably the largest investment a biopharma company makes in bringing a product to market - in dollars, and time. Driving the stakes higher: the patient is waiting. How can we improve the process, realize shorter and more efficient trials, and ultimately get the therapy to that patient faster?

Syneos Health Clinical Solutions experts Kellie Malloy, Executive Vice President and General Manager and Eleanore Doyle, Senior Vice President, Strategic Resourcing, share their thoughts on the current state of and future opportunities for clinical trials – including the impact and potential of technology, improvements in recruitment and enrollment… and keeping the human element in mind throughout.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 022: Spending for Launch Success

Wed, 19 Sep 2018 00:00:00 -0400

When it comes to investing in the launch of your biopharma product, how much is too much? Is there such a thing as too little? Director Sachin Purwar and his colleagues from the Commercial Strategy & Planning practice of Syneos Health Consulting set out to answer these questions - and found the "sweet spot" for launch spending that could mean the difference between success and failure.

The team's review of 19 emerging biopharma company launches was recently published in IN VIVO. In this episode, Sachin discusses with host Jeff Stewart special considerations, pitfalls to avoid, and the implications of spend on the potential for a new product to fly - or flop - in its first year out of the gate.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 021: The Sales Force Training (R)evolution

Wed, 05 Sep 2018 00:00:00 -0400

Biopharmaceutical sales forces have changed dramatically over the past decade. And not just the sales forces - the industry, customers, technology and more have all undergone tremendous evolution. As a result, the way we train sales forces and other customer-facing roles has and will have to adapt accordingly.

Celeste Mosby, Vice President of Learning Design in the Syneos Health Learning Solutions group, has seen a lot of this change and describes what can be considered a revolution in the development of training approaches that are efficient and effective, intuitive and immersive. In this episode, Mosby discusses some of the newer learning methods being implemented, what selling skills are key in the new paradigm, the growing importance of clinical knowledge and more.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 020: A Syneos Health Short - 21st Century Cures

Mon, 09 Jul 2018 00:00:00 -0400

The 21^st Century Cures Act was passed at the end of 2016 in an effort to accelerate the discovery, development and delivery of new therapies. But what's in it? And what does it mean for biopharma companies?

In this first "Syneos Health Short" episode, Jeff Stewart reviews the top ten things you need to know about 21^st Century Cures - and how one word changed everything.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 019: A Decade of Dealmakers' Intentions

Fri, 08 Jun 2018 00:00:00 -0400

The last decade has seen both depressing lows and astounding highs in biopharmaceutical dealmaking activity. Different therapeutic areas have fallen in and out of favor along with the pace of innovation and there has been a sustained focus on the next "hot spot" with high commercial value and the potential to provide solid returns for stakeholders. But certain trends have been persistent. What has changed? What has remained the same?

Neel Patel, Managing Director and Sachin Purwar, Director at Syneos Health Consulting discuss the last ten years of dealmaking and take a look forward based on the results of our 10th annual Dealmakers' Intentions Study - a report that takes the pulse of pharmaceutical executives around their expectations for licensing and acquisitions in the upcoming year.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 018: Partnering with a CRO

Wed, 23 May 2018 00:00:00 -0400

A relationship with a Contract Research Organization (CRO) is just like any other - to succeed, it requires communication, alignment on goals, respect, and ultimately, trust between two partners.

In this episode, Judy Swilley, Executive Vice President and Head of Strategic Alliance Management at Syneos Health, talks about the value a CRO brings to the table, the importance of an engaged executive team on the sponsor side, and best practices for working together.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 016: Payer Power, Part 2

Wed, 25 Apr 2018 00:00:00 -0400

Eighteen months is an eternity in the payer world.

Previously on The Syneos Health Podcast (Episode 003: Payer Power), we discussed the payer's rise in influence in the pharmaceutical industry. Today, we're seeing the impact of strategies payers were starting to bring to the marketplace 18-months-to-two-years ago, particularly on the pharmacy benefit side.

Keith Kelly, Managing Director, Global Access Solutions for Syneos Health Consulting, discusses key themes from the Express Scripts Drug Trend Report 2016, impact of payer controls on pharmacy benefit versus medical benefit products, how this plays out based on therapeutic area and ultimately, the challenges inherent in "bending the cost curve" for the average patient.

The information, data and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

Would you like to add to the discussion? Write to us at podcast@syneoshealth.com.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data, and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any Syneos Health clients, customers or other contacts.

Episode 015: ICER - Friend or Foe?

Wed, 14 Mar 2018 00:00:00 -0400

ICER - the Institute for Clinical and Economic Review - was established as an independent organization to examine the value of pharmaceuticals across disease categories. "But value is in the eye of the beholder," says Leslie Isenegger, principal strategist for Syneos Health Communications Reputation and Risk Management Practice, and ICER's analysis is only one piece of a very complicated puzzle. How should it fit within the broader conversation?

To try and answer this question, Isenegger provides a primer of sorts on ICER, exploring how the organization works to determine cost effectiveness and comparative effectiveness of therapies, the nature of its relationships with payers and pharma companies, the unique challenge of assessing value of orphan drugs, the growing role of the patient in value discussions and more.

Would you like to add to the discussion? Write to us at podcast@syneoshealth.com.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 014: MA-"Squared": Medical Affairs Meets Market Access

Wed, 07 Mar 2018 00:00:00 -0500

In Episode 012: Medical Affairs from Zero, Suma Ramadas talked about the inception and growing value of the Medical Affairs function. Today, in part two of our Medical Affairs Transformation series, Suma is joined by Susan Suponcic, Managing Director and head of the Pricing & Market Access practice of Syneos Health Consulting to discuss the importance of collaboration between the Medical Affairs and Market Access functions in developing a consistent and clear medical narrative.

For a deeper dive into maximizing the impact of Medical Affairs through strategic alignment and collaboration, check out our white paper and recent Pharmaceutical Executive webinar.

Would you like to add to the discussion? Write to us at podcast@syneoshealth.com.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 009: Rare Diseases

Mon, 26 Feb 2018 00:00:00 -0500

While regulatory changes have made the path to approval easier for rare disease therapies, it is by no means easy - and Judith Ng-Cashin, MD, Chief Scientific Officer of Syneos Health, warns developers getting into the market to do so with eyes wide open.

Host Jeff Stewart caught up with Dr. Ng-Cashin at a recent conference to discuss her perspective on the opportunities and challenges inherent in bringing a rare disease therapy to market, how the definition of value varies across stakeholders and why true patient engagement is critical to success.

Be sure to check out the pieces below for more on rare disease and implications for drug development:

Know Your Rare Disease Market explores the unique aspects of the rare disease market and how these will drive the commercialization process.

How payers and manufacturers can find common ground in rare diseases highlights the key findings from recent research with Payer organizations regarding factors driving coverage decisions in the rare disease market, including their view of the patient voice.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover,

Episode 013: Artificial Intelligence for Authentic Engagement

Tue, 13 Feb 2018 00:00:00 -0500

Since Stanley Kubrick's 2001: A Space Odyssey introduced the prospect of Artificial Intelligence (AI) with the spaceship computer system HAL, the world has had a rollercoaster relationship with the idea - from hope to hype, and everywhere in between. Have we "unleashed the demon" with AI, or does the potential of deep learning and machine learning for improving health outcomes far outweigh the fear factor? Duncan Arbour, Senior Vice President, Innovation with Syneos Health Communications, takes us on a fascinating journey through the progression of AI, its application in healthcare and touching on its potential impact on biopharma companies, healthcare providers, investors and the industry as a whole.

But what about the perspective of the patient - up till now, the missing component in healthcare's AI conversation? To answer this question, Arbour shares the findings from a new Syneos Health report, Artificial Intelligence for Authentic Engagement: Patient Perspectives on Healthcare's Evolving AI Conversation, based on a survey of 800 patients regarding their expectations and concerns around the potential role of AI in diagnosis, treatment and support in their day-to-day lives.

Also referenced in this episode:

The Gartner Hype Cycle
Google alum Sebastian Thrun's paper on melanoma diagnosis through machine learning in the journal Nature
Geoffrey Hinton's comparison of radiologists to Wile E. Coyote
IBM supercomputer Watson versus cancer
The General Data Protection Regulation in the EU
Investment opportunity for AI in the healthcare sector
The "Speak Easy" study on the potential for voice assistance to build relationships

Episode 012: Medical Affairs from Zero

Tue, 06 Feb 2018 00:00:00 -0500

Imagine two products that are very similar. One became one of the most successful launches the organization ever had; the other one was a flop. The main difference between the two? Medical Affairs.

There was a time - not all that long ago - when the Medical Affairs function did not exist. Today, the Medical Affairs organization is critical to a successful product launch, providing foresight into understanding who all of the stakeholders are and all of their evidentiary needs: getting the right evidence at the right time, communicated in the right way, to the right audience.

Suma Ramadas, Managing Director in the Medical Practice Area at Syneos Health Consulting, discusses with host Jeff Stewart the inception of what we know today as Medical Affairs, its evolution to current state - and what needs to happen now in order for Medical Affairs to transform into the powerhouse function of tomorrow.

For a deeper dive into maximizing the impact of Medical Affairs through strategic alignment and collaboration, check out our Pharmaceutical Executive webinar

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 011: Naming, Part 2 - The Drug

Mon, 08 Jan 2018 00:00:00 -0500

As we learned in our previous episode, naming a company is not something you can do by just “winging it.” The same holds true when it comes to naming a drug – especially in a podcast episode under 30 minutes.

In Part 2 of our naming series, Addison Whitney Creative Director Brittany Scott explains the ins and outs of drug naming, addresses a possible conspiracy theory and runs host Jeff Stewart through the process in a quick (and frustrating) game of “Name That Drug.”

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 010: Naming, Part 1 - The Pharma Company

Mon, 08 Jan 2018 00:00:00 -0500

What’s in a name? Quite a lot, actually, despite what Shakespeare says.

When it comes to a merger, this can be even more important. With research showing that up to 80% of mergers fail – and one major reason being clashing corporate cultures during post-merger integration – choosing a name and brand that the entire organization can get behind is critical to success.

In this episode, listen to Kristen Spensieri of Syneos Health and Joe Daley of Syneos Health branding firm Addison Whitney discuss how the company is walking the talk – rebranding its own organization after the 2017 merger of INC Research and inVentiv Health, and how these principles can be applied to any company going through a rebrand.

Listen to Part 2 of our Naming series here.

See our full list of podcast episodes here.

Syneos Health and its subsidiaries expressly disclaim all liabil

Episode 008: Social Centricity

Fri, 20 Oct 2017 00:00:00 -0400

Everything we know about what a patient decides to do could be wrong.

Kathleen Starr, Managing Director of the Behavioral Insights group at INC Research/inVentiv Health, has been studying patient behavior for her entire career – and she has found that we need to broaden our thinking beyond just the patient’s actions and really think about all of the different things that are really impacting their decisions and their ability to act on those decisions. This social centricity is made up of people's day-to-day lives and the social context in which they live: the family they live with, how they work, that really helps drive a lot of their decisions, how they think about their disease, how do they think about their treatment and then ultimately their real ability to be able to be adherent to therapy.

Host Jeff Stewart talks with Kathleen about what she found in a two-year ethnographic study of 30 American families, how that is changing the way we think about patient behavior and what pharma companies need to consider in order to evolve the way in which they interact with these patients.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. INC Research/inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

Episode 007: Medicine in 140 Characters: Digital KOLs

Wed, 16 Aug 2017 00:00:00 -0400

Channels of influence in pharma have expanded from the traditional offline sphere of publications, trials, conference activities and others to include a vast new digital landscape that is shaping the way we need to interact with a new generation of key opinion leaders -- so-called "digital" KOLs.

Digital KOLs have an "omnipresent" digital footprint that can include social media, independent websites, healthcare professional discussion platforms like SERMO and Doximity and a seemingly endless number of other potential channels. So what does this mean for those trying to find and reach out to these key influencers?

Nick Lapolla, Manager, KOL Market Research at inVentiv Health Research and Insights and Madeline Rounds, Consultant on the inVentiv Health Medical Communications team, discuss how KOL mapping in this new age is both easier and harder than it used to be, highlight best practices and tactics and explain why it's still necessary to keep a human element in the mix.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be c

Episode 006: Crossing the Finish Line: Factors Driving Patient Adherence to Drug Therapy

Mon, 10 Jul 2017 00:00:00 -0400

The patient standing at the pharmacy to fill a prescription represents the "final mile" that started in the laboratory. All the science and commercial investment comes down to this one decision point. Will the patient walk away? What will get them to stay?

In a survey of 200,000 retail prescriptions for the top 100 branded oral drugs, two inVentiv companies - Adheris Health and inVentiv Health Consulting - set out to understand the most influential factors to driving patient adherence or non-adherence.

Jeff Stewart sits down with Linda Morini, Senior Director, Analytic Services and Mike Occhipinti, Vice President, Analytics at Adheris Health, to discuss what they found.

Interested in learning more about the complex issue of adherence? Check out the inVentiv Health Communications white paper on social centricity, which discusses social forces that shape patient decisions.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

inVentiv Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

Episode 005: The Room Where it Happens: Dealmakers' Intentions 2017

Tue, 20 Jun 2017 00:00:00 -0400

At the BIO International Convention, arguably the largest and most important biopharma partnering event of the year with over 16,000 participants, it's all about getting the deal done. While the industry will very likely not see the extremely high level of licensing and M&A activity it did back in 2015, the year is shaping up to reach a respectable level closer to historical norms, according to Sachin Purwar, Senior Engagement Manager in the Commercial Strategy & Planning practice of inVentiv Health Consulting and one of the authors of the 2017 Dealmakers' Intentions Study -- the ninth in a series and a forward-looking measure of dealmaking activity in the pharmaceutical and biotech industries.

What are buyers interested in this year, and what do sellers have to offer? Where is there a buyers' market, and where a sellers' market? What are the hot therapeutic areas and technologies to watch? What is the discount rate spread, and what does that mean for getting deals done? Why is the deal success rate so low -- and why is this good news?

Host Jeff Stewart sits down with Sachin to answer these questions -- and discuss the year ahead for dealmaking in the biopharma industry.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements, or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

inVentiv Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data, and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any of inVentiv Health’s clients, customers or other contacts.

Episode 004: Innovation in Pharma Communications

Wed, 14 Jun 2017 00:00:00 -0400

According to Leigh Householder, Managing Director of Innovation for inVentiv Health Communications, in an industry where the appetite for innovation and change is strong, but the tolerance for risk is not, the answer lies in an accountable, data-driven marketing approach that allows for "targeted innovation” and leads to measurable impact.

inVentiv Health Podcast host Jeff Stewart talks with Leigh about the value of predictive analytics in endlessly experimenting with channels and messages without spending a single dollar on in-market pilots. They’ll also discuss why the 70/20/10 approach to planning is important -- including how it worked for the BBC -- and the potential impact of the millennial physician on pharma’s marketing decisions. Have a listen to hear the latest in truly innovative customer and physician engagement tools and technologies that hint at the future of pharma communications.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements, or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

inVentiv Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data, and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any of inVentiv Health’s clients, customers or other contacts.

Episode 003: Payer Power

Mon, 03 Apr 2017 00:00:00 -0400

The power of the payer in the biopharmaceutical industry has increased dramatically over the past several years, according to Keith Kelly, Managing Director and Head of the Pricing and Market Access Practice of inVentiv Health Consulting. Market access was once a dull topic. Today, price and if a drug will be covered is discussed on earnings calls and in the board room. What payers do can make or break the stock price of a company overnight.

In this episode, Kelly and host Jeff Stewart discuss what factors have contributed to the payer’s rise in influence; how payers are wielding this power; why drug price negotiation is similar to discount suit shopping; and the “prisoner’s dilemma” of acquiring access for products entering the market at the same or similar time. The pair also explores the nirvana concept of “sustainable market access” – is it even possible? – and the value creation equation for a pharmaceutical company looking to achieve it for their products.

Data from this episode originated from the following sources:
Gross to net pricing from Credit Suisse; manufacturing cost analysis published in the Journal of Pharmaceutical Innovation and Nature Biotechnology; and Hepatitic C drug costs covered in Reuters.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements, or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

inVentiv Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data, and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any of inVentiv Health’s clients, customers or other contacts.

Episode 002: The Impact of AHCA on Pharma

Tue, 21 Mar 2017 00:00:00 -0400

Introduced on March 6, 2017, if passed the American Health Care Act of 2017 (AHCA) is expected to have an enormous impact on Pharma. The Congressional Budget Office (CBO) on March 13 released its estimate of the budgetary effects of the AHCA, stating that under the new law, we could see 14 million more uninsured by 2018 than would have been under the current law – rising to 24 million more uninsured by 2026.

Our host Jeff Stewart sat down with inVentiv Health Consulting Pricing & Market Access Director Nicolle Hamilton, PhD and Meg Alexander, Head of the Reputation and Risk Management Practice for inVentiv Health Communications, to discuss key components of the AHCA, their potential implications and what it means for pharmaceutical companies.

*As documented in this podcast, the effects are both direct and perceptual. Financially, $592B in revenues will no longer be spent on healthcare over the next 10 years, according to the CBO. Of that, an estimated $59B would have been spent on pharma. Perceptually, there is the potential that the public and politicians will blame the pharmaceutical industry and high drug prices for erosion of healthcare coverage.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements, or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

inVentiv Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data, and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any of inVentiv Health’s clients, customers or other contacts.

Episode 001: The Real-World Evidence Revolution

Fri, 03 Mar 2017 00:00:00 -0500

The passage of the 21st Century Cures Act earlier this year catapulted the concept of “real-world evidence” into the spotlight, with many biopharmaceutical companies wondering whether this could be the panacea the industry has been looking for to attain product success. We reflected on this topic with David Thompson, PhD, Senior Vice President, Real-World Evidence Consulting at inVentiv Health, after he moderated a keynote panel at the Biotech Showcase event alongside the popular JP Morgan Healthcare Conference in San Francisco this January. Bottom line, according to Thompson, is that it’s complicated – but the fact of the matter is that approval alone no longer gets you to the end zone; more likely, it will get you to the 50-yard line. Appropriate use of real-world evidence can provide some degree of advantage for products entering the marketplace. Listen in to learn more from this discussion on real-world evidence, including why it’s so complicated, where the FDA fits in, what it means to payers and how it can impact commercial success.

The information, data, and other content contained in this podcast and any associated articles, sponsorships, advertisements, announcements, or other communications are provided for informational purposes only and should not be construed as professional advice of any kind, on any subject matter.

The content of the podcast contains general information and may not reflect current legal developments, verdicts or settlements. Moreover, the content is not guaranteed to be complete, correct, timely, current or otherwise up-to-date. inVentiv Health reserves the right to make alterations or deletions to the content at any time without notice to you.

inVentiv Health and its subsidiaries expressly disclaim all liability in respect to actions taken or not taken based on any or all of the podcast content.

The information, data, and other content contained in this podcast is not a reflection of, endorsed by or otherwise affiliated with, nor should it be attributed to, any of inVentiv Health’s clients, customers or other contacts.