The Syneos Health Podcast: Early Signals

Early Signals at ASCO 2026 | Can Real-World Evidence Bring Research Closer to Patients?

Thu, 27 Aug 2026 10:00:00 -0400

Can real-world evidence do more than support regulatory decisions? Could it fundamentally change how clinical research is designed, delivered and connected to patient care?

In this episode of The Syneos Health Podcast: Early Signals, Wael Harb, MD, sits down with Justin Spencer, Chief Executive Officer of Azimuth Research Group, to explore how real-world evidence is reshaping oncology drug development. Together, they discuss why bridging the gap between healthcare delivery and clinical research has become one of the industry's greatest opportunities—and what it will take to generate higher-quality evidence while improving patient access to innovative therapies.

The conversation examines the growing importance of integrated health system data, patient-centered research models and real-world evidence in supporting protocol design, trial recruitment and oncology development. Spencer also shares his perspective on how aligning healthcare providers, sponsors and patients around a common goal could accelerate drug development while improving access to new treatments.

In this episode, you'll learn:

Why high-quality real-world evidence depends on understanding the clinical context behind the data.
How closer integration between healthcare systems and research may improve trial design and patient recruitment.
The growing role of real-world evidence in oncology drug development and regulatory decision-making.
Why patient-centered research models could help accelerate access to innovative cancer therapies.
What the future of oncology development may look like as healthcare, data and research become more connected.

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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Early Signals at ASCO 2026 | Beyond Digitization: How AI Is Transforming Clinical Trial Operations

Thu, 20 Aug 2026 06:00:00 -0400

If clinical trials are already digitized, why do clinical operations remain so complex, manual and resource-intensive?

In this episode of Early Signals, Wael Harb, MD, speaks with Ram Yalamanchili, Founder and CEO of Tilda Research, about the next frontier for AI in clinical trials: moving beyond digitization to tackle the operational complexity that can slow clinical development.

They explore how agentic AI and “AI teammates” can support clinical operations teams across complex workflows, from site startup and trial oversight to data management and regulatory activities. Rather than replacing clinical research professionals, these technologies are designed to take on repetitive coordination and operational tasks, creating greater capacity for teams to focus on work that requires human expertise.

The conversation also examines what successful AI adoption requires beyond the technology itself, including AI fluency, governance and human oversight. Ram shares examples of how AI-enabled clinical operations can potentially improve productivity, quality and timeliness and discusses where CROs and biopharma organizations may see the greatest near-term opportunities.

In this episode, you’ll hear about:

Why digitization alone hasn’t eliminated clinical trial operational bottlenecks
How agentic AI and AI teammates differ from traditional copilots
Opportunities to use AI in site startup and other complex clinical trial workflows
The importance of human-in-the-loop AI governance and workforce AI fluency
How AI can help clinical operations teams increase capacity without simply reducing headcount
Potential applications across trial master file management, data management and monitoring, finance and trial oversight
What AI-enabled operating models could mean for the future of CROs, biopharma sponsors and clinical development

Listen to the full episode to explore how AI could help clinical research teams move beyond digitization toward more intelligent, scalable and efficient clinical trial execution.

Early Signals at ASCO 2026 | Can TIL Therapy Reach More Patients?

Thu, 13 Aug 2026 10:00:00 -0400

Can the next generation of tumor-infiltrating lymphocyte (TIL) therapies overcome the barriers that have limited broader adoption of cell therapy in solid tumors?

In this episode of Early Signals, recorded live at ASCO 2026, Wael Harb, MD sits down with Parameswaran Hari, MD, Chief Medical Officer at Obsidian Therapeutics, to discuss how engineered TIL therapies are evolving beyond first-generation approaches. Drawing on his experience leading the clinical development of lifileucel and now advancing OBX-115, Dr. Hari explores how controllable cytokine expression, streamlined manufacturing and patient-centric trial design may help make cell therapies safer, more accessible and easier to deliver across a broader range of treatment centers.

Together, they examine preliminary clinical data from an ongoing study of OBX-115, an investigational therapy that has not been approved by regulatory authorities. The conversation also explores where TIL therapy fits within an increasingly complex immuno-oncology landscape and why continued innovation in manufacturing, accessibility and global drug development will be essential to bringing these therapies to more patients.

In this episode, you'll learn:

Why next-generation TIL therapies are being engineered to improve safety, scalability and patient access.
What preliminary ASCO 2026 findings from the ongoing OBX-115 study show to date, and the limitations of interpreting early efficacy and safety data from a small patient population.
What early ASCO 2026 clinical data suggest about efficacy, durability and safety in checkpoint inhibitor-resistant melanoma.
How innovations in manufacturing and trial design may expand the future role of cell therapy across solid tumors.
Why Dr. Hari believes accessibility, affordability and global collaboration will define the next era of oncology drug development.

Early Signals at ASCO 2026 | Is MRD Ready to Guide Drug Development?

Thu, 06 Aug 2026 14:00:00 -0400

Can minimal residual disease (MRD) do more than measure response? Could it redefine how multiple myeloma therapies are developed, approved and ultimately used to guide patient care?

In this episode of Early Signals, recorded live at ASCO 2026, Dr. Wael Harb sits down with Dr. Samer Al Hadidi, Associate Professor and Clinical Director of the Amyloidosis Program at Univestity of Texas Southwestern, to explore why MRD has become one of the most important conversations in multiple myeloma.

Together, they discuss how increasingly sensitive MRD testing is changing the definition of remission, supporting time-limited treatment strategies and emerging as a potential surrogate endpoint for drug development. They also examine what recent ASCO data—including the MajesTEC studies—may signal for the future of treatment sequencing, combination strategies and the long-term goal of curing multiple myeloma.

In this episode, you'll learn:

Why MRD has become central to defining remission—and potentially cure—in multiple myeloma.
How MRD is influencing treatment duration, escalation and de-escalation strategies.
What the FDA's acceptance of MRD as a surrogate endpoint could mean for oncology drug development.
Why sustained MRD negativity may be more meaningful than a single negative result.

Early Signals at ASCO 2026 | Can AI Predict Cancer's Next Move? Rethinking Drug Resistance in Oncology

Mon, 03 Aug 2026 15:00:00 -0400

Can AI predict cancer's next move before drug resistance develops?

Drug resistance remains one of the greatest challenges in oncology drug development. Most targeted therapies are designed to treat today's tumor biology, leaving researchers to react only after resistance mutations emerge. But what if artificial intelligence (AI) could help predict how cancer evolves before treatment begins?

In this episode of Early Signals, recorded live at ASCO 2026, Syneos Wael Harb, MD, Head of R&D and Scientific Strategy in Oncology, speaks with Violet Zahedi, MD, Founder and CEO of Synamics Therapeutics, about how AI, computational biology and protein modeling are being used to anticipate resistance mutations and design more durable cancer therapies.

Drawing on her experience as both a physician and biotechnology founder, Dr. Zahedi explains why oncology has traditionally taken a reactive approach to drug resistance, and how predictive AI platforms could fundamentally change the way targeted therapies are discovered, optimized and commercialized. Rather than redesigning drugs after resistance develops, her team is using machine learning, structural biology and protein modeling to predict cancer's next evolutionary move before it occurs.

The discussion explores the growing role of AI in oncology drug discovery, including its potential to accelerate lead optimization, improve compound prioritization, support biomarker-driven patient stratification and reduce the time and cost associated with developing next-generation cancer therapies. Dr. Zahedi also shares how her team validated its predictive platform using EGFR inhibitors and Aurora A kinase inhibitors, highlighting collaborations with the Mayo Clinic and presenting new findings at ASCO 2026.

Whether you're involved in oncology clinical development, precision medicine, AI-driven drug discovery or biopharmaceutical R&D, this episode explores how predictive resistance intelligence may reshape the future of cancer drug development.

In this episode, you'll learn:

· Why drug resistance remains one of oncology's greatest unmet challenges

· How AI can predict resistance mutations before they emerge

· The role of AlphaFold, computational biology and protein structure prediction in drug discovery

· How predictive resistance modeling may accelerate oncology drug development

· Opportunities to improve compound prioritization and patient stratification

· What AI could mean for the future of precision oncology and targeted therapies

Early Signals at ASCO 2026 | AI, Multimodal Data and the Next Era of Precision Oncology

Mon, 13 Jul 2026 17:00:00 -0400

What if artificial intelligence could help remove the uncertainty from cancer treatment decisions?

Precision oncology has already transformed cancer care by matching therapies to actionable biomarkers, but today's advances are moving beyond genomics alone. By integrating molecular, clinical and pathology data at scale, AI is helping researchers and clinicians better predict treatment response, identify the right patients for therapies and accelerate the development of more personalized cancer care.

In this episode of The Syneos Health Podcast: Early Signals, Wael Harb, MD, Head of R&D and Scientific Strategy in Oncology at Syneos Health, sits down with Ezra Cohen, MD, Chief Medical Officer at Tempus AI, to discuss how multimodal data and artificial intelligence are reshaping precision oncology. Together, they explore the evolution of biomarker discovery, the growing role of AI in clinical decision-making and what it will take to bring truly individualized cancer care into routine practice.

The conversation also explores how digital pathology, real-world data and AI-enabled clinical workflows are improving patient selection, supporting guideline-directed care and laying the foundation for earlier detection and more precise treatment strategies.

Topics include:

Why precision oncology extends beyond targeted therapies to reducing uncertainty throughout the patient journey
How multimodal data and AI are improving biomarker discovery and treatment selection
The promise of digital pathology and AI-powered clinical decision support
Using real-world data to improve immunotherapy response prediction
Closing care gaps through AI-enabled clinical workflows
The future of minimal residual disease, early detection and personalized cancer treatment
Why collaboration and data sharing will be essential to unlocking AI's full potential in oncology

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

Early Signals at ASCO 2026 | Can AI Finally Rebuild Clinical Research?

Mon, 06 Jul 2026 14:00:00 -0400

Less than 5% of patients participate in clinical trials today; a statistic that has remained virtually unchanged for more than two decades despite massive advances in science and technology.

In this episode of Early Signals, Dr. Wael Harb sits down with Kent Thoelke, Founder and CEO of Paradigm Health, to explore why clinical research still relies on outdated workflows and how AI, electronic health records and real-time data are creating an opportunity to fundamentally redesign the clinical trial ecosystem.

Drawing on more than 30 years in clinical research, Kent explains why simply digitizing existing processes isn't enough. Instead, he argues the future lies in embedding research directly into routine patient care, using AI to identify eligible patients before they're missed, automate manual data collection and accelerate decision-making across sponsors, investigators and regulators.

The conversation also explores Paradigm's collaboration with the FDA to pilot real-time clinical trials, where AI-generated clinical signals are transmitted directly from electronic health records to support faster regulatory review and more efficient trial execution.

Whether you're leading oncology development, clinical operations or regulatory strategy, this episode offers a practical look at how AI may reshape the future of clinical research—not by replacing people, but by removing the operational barriers that keep patients from accessing clinical trials.

In This Episode, You'll Learn:

Why clinical trial participation has remained below 5% despite decades of innovation
How AI and large language models are transforming patient identification and trial matching
Why community health systems may hold the key to expanding oncology research access
How AI-powered electronic health record integration can automate clinical trial data collection and reduce manual workload
What the FDA's real-time clinical trial initiative could mean for sponsors, regulators and patients
Why the future of clinical research depends on redesigning workflows rather than simply digitizing existing processes
How AI could reshape drug development over the next five years—from smarter trial execution to more predictive development strategies

Early Signals at ASCO 2026 | How Do You Turn Next-Generation ADC Science Into Global Clinical Success?

Tue, 30 Jun 2026 08:00:00 -0400

Antibody-drug conjugates (ADCs) are transforming oncology, but scientific innovation alone isn't enough. As platforms become more sophisticated—with novel linker technologies, diversified payloads and increasingly targeted approaches—the challenge shifts from discovery to execution. How do sponsors successfully translate next-generation ADC science into global clinical development programs?

In this episode of Early Signals, Wael Harb, MD, sits down with Diana Chen, Vice President of Global Clinical Operations at MediLink Therapeutics, to discuss what it takes to operationalize innovation at scale. From building a rapidly growing ADC pipeline and managing global partnerships with leading biopharma companies to navigating cross-cultural clinical operations, Diana shares practical insights into the strategies shaping the next generation of oncology drug development.

Together, they explore how platform technologies like MediLink's TMALIN® linker are expanding the potential of ADCs, why global collaboration is becoming a competitive advantage and what operational excellence looks like in an increasingly complex development landscape.

Early Signals at ASCO 2026 | Reigniting Response: How Oncolytic Viruses May Reshape Ovarian Cancer Treatment

Thu, 25 Jun 2026 11:00:00 -0400

What happens when an established treatment regains its effectiveness against resistant disease?

In this episode of the Syneos Health Podcast: Early Signals, Wael Harb, MD, Head of R&D and Scientific Strategy in Oncology at Syneos Health, sits down with Jason Litten, MD, Chief Medical Officer of Genelux, to discuss the evolving role of oncolytic virus therapy in oncology and its potential to reshape treatment strategies for patients with difficult-to-treat cancers.

Together, they explore the science behind Olvi-Vec, a modified vaccinia oncolytic virus designed to directly attack tumors, remodel the tumor microenvironment and potentially restore sensitivity to platinum-based chemotherapy. The conversation examines emerging approaches to immuno-oncology, the future of combination therapies and the opportunities and challenges of advancing innovative oncology programs from early development through pivotal clinical trials.

Topics include:

Why oncolytic viruses are gaining renewed attention in oncology drug development
The science behind Olvi-Vec and its potential role in platinum-resistant ovarian cancer
How tumor microenvironment remodeling may help restore sensitivity to platinum-based chemotherapy
Combining oncolytic virus therapy with chemotherapy, immunotherapy and future treatment modalities
Opportunities and challenges in developing novel oncology therapies for solid tumors
Expanding oncolytic virus approaches beyond ovarian cancer into additional tumor types
Emerging trends shaping the future of immuno-oncology and precision medicine
Lessons from clinical development across targeted therapies, cell therapies and oncolytic viruses

Early Signals at ASCO 2026 | Creating a New Therapeutic Class: The Promise of Direct MYC Inhibition

Tue, 23 Jun 2026 14:00:00 -0400

Can MYC finally be drugged? Learn how MycRx is advancing a direct MYC inhibitor and navigating the science and business of oncology innovation.

What if one of cancer's most important drivers was no longer considered "undruggable"?

For decades, MYC has remained one of oncology's most elusive targets—a transcription factor implicated in the majority of human cancers yet notoriously difficult to inhibit with small molecules. Today, advances in structural biology, medicinal chemistry and translational science are challenging that assumption.

In this episode of Early Signals, Wael Harb, MD, Head of R&D and Scientific Strategy in oncology at Syneos Health sits down with Nick Glover, CEO of MycRx, to discuss the company's efforts to develop a direct small-molecule MYC inhibitor. Together, they explore the science behind MYC biology, the challenges of targeting transcription factors, how real-world data is helping identify MYC-driven tumors and what it takes to advance a first-in-class oncology program from discovery toward the clinic.

The conversation also examines the realities of modern biotech leadership—from designing efficient global development strategies to balancing scientific innovation with the business of drug development.

Topics include:

· Why MYC has long been considered "undruggable"

· The scientific breakthroughs enabling direct MYC inhibition

· Identifying patient populations most likely to benefit

· Balancing efficacy and tolerability when targeting MYC

· Global strategies for accelerating early-phase oncology development

· Lessons for biotech leaders developing novel mechanisms of action

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

Welcome to Early Signals!

Fri, 19 Jun 2026 16:00:00 -0400

What are the signals today that will define the future of oncology treatment tomorrow?

The Syneos Health Podcast: Early Signals brings together leaders across biopharma, healthcare, academia and technology to explore the innovations reshaping drug development in oncology. Hosted by experts across Syneos Health, including Wael Harb, MD, Head of Research and Development and Scientific Strategy in oncology, each episode captures candid conversations about emerging science, evolving market dynamics and the trends poised to influence the future of patient care.

Tune in for timely perspectives on what's next—and what it means for the oncology industry, its stakeholders and most importantly its patients.

Subscribe to The Syneos Health Podcast: Early Signals for new episodes.

Project Optimus Series | Clinical Pharmacology and Project Optimus

Tue, 09 Jun 2026 00:00:00 -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.

Project Optimus Series | The Role of Biostatistics

Tue, 02 Jun 2026 00:00:00 -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

Tue, 26 May 2026 16:00:00 -0400

In this episode, 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.

Project Optimus Series | The Regulatory Implications of Project Optimus

Tue, 19 May 2026 00:00:00 -0400

In this episode, 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.

Project Optimus Series | Navigating the Realities of Project Optimus

Tue, 12 May 2026 00:00:00 -0400

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.