Mon, 06 Apr 2026 14:49:27 -0400 https://www.buzzsprout.com/1869856 en-us © 2026 Advancing Revolutionary Therapies yes 5ac18cdf-2c07-50d1-9dd0-827483e40d3c ART episodic false Buzzsprout (https://www.buzzsprout.com) ART https://storage.buzzsprout.com/7bvibok2yqphuewm0fcjavivz1zh?.jpg The influence of MDR’s Article 117 in the Marketing of Combination Products MDR’s Article 117 brings improved patient safety measures with implications for manufacturers, as they must fulfill a significant set of additional requirements. Listen as Andrea Larrañaga, Associate Manager, Regulatory Affairs at Veristat and her colleagues, Laura Ocaña and Gemma Dorrego, discuss the Article and its influence in the marketing of combination products. 

]]> MDR’s Article 117 brings improved patient safety measures with implications for manufacturers, as they must fulfill a significant set of additional requirements. Listen as Andrea Larrañaga, Associate Manager, Regulatory Affairs at Veristat and her colleagues, Laura Ocaña and Gemma Dorrego, discuss the Article and its influence in the marketing of combination products. 

]]> ART Buzzsprout-12208590 Wed, 08 Feb 2023 03:00:00 -0500 630 3 9 full false Apples to Apples: Playing the Comparability Game in Biotherapeutics Development Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk. Listen as Kevin Hennegan, Lisa Erickson and Sarah Roemer take us through several considerations when Playing the Comparability Game in Biotherapeutics Development.  

]]> Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk. Listen as Kevin Hennegan, Lisa Erickson and Sarah Roemer take us through several considerations when Playing the Comparability Game in Biotherapeutics Development.  

]]> ART Buzzsprout-12110403 Tue, 24 Jan 2023 13:00:00 -0500 1002 3 8 full false Considerations for Developing Rare Disease Treatments When developing a new therapy for a rare disease, a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities. Listen to our podcast as Veristat experts share important considerations to reduce your regulatory risk along the way.

]]> When developing a new therapy for a rare disease, a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities. Listen to our podcast as Veristat experts share important considerations to reduce your regulatory risk along the way.

]]> ART Buzzsprout-11878687 Thu, 15 Dec 2022 10:00:00 -0500 663 3 7 full false Regulatory Considerations for Biosimilars Development in the U.S. The development of biosimilar products in the US has been progressing since the regulatory pathway was established as part of the Affordable Care Act. Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.  

]]> The development of biosimilar products in the US has been progressing since the regulatory pathway was established as part of the Affordable Care Act. Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.  

]]> ART Buzzsprout-11802129 Tue, 06 Dec 2022 02:00:00 -0500 911 3 6 full false The Importance of Regulatory Project Management Sponsors are familiar with the role of a Regulatory Strategist on the core team but have less familiarity with the responsibilities of a Project Manager. Listen as members of Veristat’s regulatory team bring to light the invaluable contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.

]]> Sponsors are familiar with the role of a Regulatory Strategist on the core team but have less familiarity with the responsibilities of a Project Manager. Listen as members of Veristat’s regulatory team bring to light the invaluable contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.

]]> ART Buzzsprout-11686710 Tue, 15 Nov 2022 03:00:00 -0500 490 3 5 full false CMC Pitfalls: From Benchtop to IND Listen as members of Veristat’s regulatory team outline the fundamentals— and the pitfalls— as you determine your readiness to file an Investigational New Drug (IND) from a manufacturing perspective.

]]> Listen as members of Veristat’s regulatory team outline the fundamentals— and the pitfalls— as you determine your readiness to file an Investigational New Drug (IND) from a manufacturing perspective.

]]> ART Buzzsprout-11598706 Mon, 31 Oct 2022 02:00:00 -0400 758 3 4 full false Marketing Application Best Practices for Publishing Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application. Get a jump start by learning the key steps that go into making documents “submission ready”.   

]]> Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application. Get a jump start by learning the key steps that go into making documents “submission ready”.   

]]> ART Buzzsprout-11519553 Mon, 17 Oct 2022 22:00:00 -0400 619 3 3 full false Emergency Use Authorizations In this ART podcast, Kevin Hennegan, Veristat’s Director of North American Regulatory Affairs, takes us through the many nuances key to the success of an Emergency Use Authorization application. 

]]> In this ART podcast, Kevin Hennegan, Veristat’s Director of North American Regulatory Affairs, takes us through the many nuances key to the success of an Emergency Use Authorization application. 

]]> ART Buzzsprout-11370278 Thu, 22 Sep 2022 03:00:00 -0400 537 3 2 full false Orphan Drug Designations and Orphan Subsets FDA’s Orphan Drug Designation provides incentives to encourage the development of treatments for rare diseases. Listen as Mara Holinger, SVP of Regulatory Affairs at Veristat and members of the regulatory team shed light on ODD classification and the strategic use of subsets in study design. 

]]> FDA’s Orphan Drug Designation provides incentives to encourage the development of treatments for rare diseases. Listen as Mara Holinger, SVP of Regulatory Affairs at Veristat and members of the regulatory team shed light on ODD classification and the strategic use of subsets in study design. 

]]> ART Buzzsprout-11299153 Sun, 11 Sep 2022 15:00:00 -0400 551 3 1 full false Season 3 Trailer Our Regulatory experts kick off Season 3 of the ART Podcast series in just a few weeks! Listen to the trailer to learn more about some of the topics we’ll be covering.

]]> Our Regulatory experts kick off Season 3 of the ART Podcast series in just a few weeks! Listen to the trailer to learn more about some of the topics we’ll be covering.

]]> ART Buzzsprout-11209728 Fri, 26 Aug 2022 14:00:00 -0400 63 3 trailer false Reasons for Setting Up Natural History Studies & Their Challenges Listen as Rachel Smith, Portfolio Director at Veristat, reviews considerations for setting up Natural History studies and the value they bring to rare and ultra-rare clinical research, despite the challenges in their design. 

]]> Listen as Rachel Smith, Portfolio Director at Veristat, reviews considerations for setting up Natural History studies and the value they bring to rare and ultra-rare clinical research, despite the challenges in their design. 

]]> ART Buzzsprout-10633990 Wed, 18 May 2022 03:00:00 -0400 324 2 8 full false The Current Landscape of Cell and Gene Therapies and Where We are Headed Cell and gene therapy innovations continue to progress despite their clinical trial complexities. Listen as we replay some of Ewan Campbell’s insights from a recent webinar where Ewan provides a historical recap of the approved cell and gene therapy treatments over the past decade along with insights on where we are headed.

]]> Cell and gene therapy innovations continue to progress despite their clinical trial complexities. Listen as we replay some of Ewan Campbell’s insights from a recent webinar where Ewan provides a historical recap of the approved cell and gene therapy treatments over the past decade along with insights on where we are headed.

]]> ART Buzzsprout-10512261 Wed, 27 Apr 2022 03:00:00 -0400 475 2 7 full false Use of PRO In Cell and Gene Therapy Studies Patient reported outcomes provide an important dimension to assessing the overall patient impact from a novel treatment. Listen as Robin Bliss describes the appropriate execution of PROs using clearly defined endpoints, measurable changes within context to the indication and disease progression, and several other key considerations for deployment in cell and gene therapy studies. 

]]> Patient reported outcomes provide an important dimension to assessing the overall patient impact from a novel treatment. Listen as Robin Bliss describes the appropriate execution of PROs using clearly defined endpoints, measurable changes within context to the indication and disease progression, and several other key considerations for deployment in cell and gene therapy studies. 

]]> ART Buzzsprout-10428092 Wed, 13 Apr 2022 03:00:00 -0400 1042 2 6 full false Real-world Considerations When Administering Advanced Therapy Products Administering advanced therapy products during a clinical trial can bring about many unique circumstances. Listen as Rachel Smith discusses Convection Enhanced Delivery (CED) which delivers medicines directly into the brain. Learn how to prepare for its challenges and what it can mean for patients, clinical teams, and sponsors.

]]> Administering advanced therapy products during a clinical trial can bring about many unique circumstances. Listen as Rachel Smith discusses Convection Enhanced Delivery (CED) which delivers medicines directly into the brain. Learn how to prepare for its challenges and what it can mean for patients, clinical teams, and sponsors.

]]> ART Buzzsprout-10346330 Wed, 30 Mar 2022 09:00:00 -0400 560 2 5 full false Planning the Way Forward in Neurodegenerative Disease Studies Clinical trials involving advanced therapies for the treatment of Central Nervous System (CNS) do not follow a classic road map to market. Listen as Ewan Campbell, Advanced Therapy and Biotech Director for Veristat outlines some of the unique challenges faced when developing advanced therapies and shares some of his experience gained in neurodegenerative disease studies over the past 20 years.

]]> Clinical trials involving advanced therapies for the treatment of Central Nervous System (CNS) do not follow a classic road map to market. Listen as Ewan Campbell, Advanced Therapy and Biotech Director for Veristat outlines some of the unique challenges faced when developing advanced therapies and shares some of his experience gained in neurodegenerative disease studies over the past 20 years.

]]> ART Buzzsprout-10265819 Wed, 16 Mar 2022 03:00:00 -0400 780 2 4 full false Opportunities for Virtual and Central Site Models in Cell and Gene Therapy Trials The roadmap to market for a cell or gene therapy is undoubtedly challenging, but also filled with great promise. Listen as we replay some of Rachel Smith’s insights from our recent webinar where Rachel reviews virtual and central site models in cell and gene trials and the logistics involved in planning and execution.

]]> The roadmap to market for a cell or gene therapy is undoubtedly challenging, but also filled with great promise. Listen as we replay some of Rachel Smith’s insights from our recent webinar where Rachel reviews virtual and central site models in cell and gene trials and the logistics involved in planning and execution.

]]> ART Buzzsprout-10182171 Thu, 03 Mar 2022 12:00:00 -0500 451 2 3 full false An Introduction to Natural History Studies If you are wondering how natural history studies are relevant to cell and gene therapy development, listen as Chris Kenwood, Principal Statistician with Veristat, takes us through an introduction. Learn how natural history studies provide evidence for identifying patient subgroups that may benefit from therapy, help in identifying or developing biomarkers, assist in establishing clinical outcome assessments, and more. 

]]> If you are wondering how natural history studies are relevant to cell and gene therapy development, listen as Chris Kenwood, Principal Statistician with Veristat, takes us through an introduction. Learn how natural history studies provide evidence for identifying patient subgroups that may benefit from therapy, help in identifying or developing biomarkers, assist in establishing clinical outcome assessments, and more. 

]]> ART Buzzsprout-10091018 Thu, 17 Feb 2022 03:00:00 -0500 885 2 2 full false Common pitfalls to avoid when planning a marketing application for cell and gene therapies Developing a successful marketing application involves several strategic steps, as described by Kevin Hennegan, Senior Regulatory Strategist for Veristat. Listen as Kevin identifies some of the key components of a cell & gene therapy marketing application in the US and EU, and outlines several of the most common pitfalls and gaps that he has encountered with sponsor applications. Listen now. 

]]> Developing a successful marketing application involves several strategic steps, as described by Kevin Hennegan, Senior Regulatory Strategist for Veristat. Listen as Kevin identifies some of the key components of a cell & gene therapy marketing application in the US and EU, and outlines several of the most common pitfalls and gaps that he has encountered with sponsor applications. Listen now. 

]]> ART Buzzsprout-9998284 Wed, 02 Feb 2022 08:00:00 -0500 623 2 1 full false Season 2 Trailer Our cell and gene experts are back for season two of ART Podcast starting next week! Listen to the trailer to learn more about some of the topics we’ll be covering.

]]> Our cell and gene experts are back for season two of ART Podcast starting next week! Listen to the trailer to learn more about some of the topics we’ll be covering.

]]> ART Buzzsprout-9943523 Tue, 25 Jan 2022 03:00:00 -0500 66 2 trailer false Are Autologous Therapies Here to Stay? Are Allogeneic Therapies the Future? The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for Veristat, shares her observations on the impact of these techniques on advanced cell-based therapies and what the next decade may hold. Factors spanning patient safety, manufacturing, costs and regulations are considered as Rachel responds to the question whether an autologous approach for rare disease therapies is sustainable long-term.

]]> The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for Veristat, shares her observations on the impact of these techniques on advanced cell-based therapies and what the next decade may hold. Factors spanning patient safety, manufacturing, costs and regulations are considered as Rachel responds to the question whether an autologous approach for rare disease therapies is sustainable long-term.

]]> ART Buzzsprout-9726664 Thu, 16 Dec 2021 03:00:00 -0500 529 full false EU Post Marketing Requirements for Cell and Gene Therapy Studies Post-marketing requirements within the European submission process offer conditional approval more flexible than FDA. Rachel Smith, Portfolio Director for Veristat, discusses the three types of post-marketing requirements that can be requested by the EMA and draws upon the recently approved therapies – Tecartus, Zolgensma and Libmeldy, Skysona and Abecma– for real-world context. 

]]> Post-marketing requirements within the European submission process offer conditional approval more flexible than FDA. Rachel Smith, Portfolio Director for Veristat, discusses the three types of post-marketing requirements that can be requested by the EMA and draws upon the recently approved therapies – Tecartus, Zolgensma and Libmeldy, Skysona and Abecma– for real-world context. 

]]> ART Buzzsprout-9557657 Wed, 17 Nov 2021 03:00:00 -0500 534 1 6 full false Selecting Endpoints for an Early Phase Cell or Gene Study​ The selection of endpoints for a clinical trial relies on clinical relevance combined with statistical reasoning. Robin Bliss, PhD, and VP of Strategic Consulting for Veristat, takes us through the how-to’s of selecting appropriate endpoints for an early phase study, the importance of considering endpoints in the context of clinical meaning, and the value of ensuring that endpoints are measurable within a reasonable amount of time for continued progression of the clinical development plan.

]]> The selection of endpoints for a clinical trial relies on clinical relevance combined with statistical reasoning. Robin Bliss, PhD, and VP of Strategic Consulting for Veristat, takes us through the how-to’s of selecting appropriate endpoints for an early phase study, the importance of considering endpoints in the context of clinical meaning, and the value of ensuring that endpoints are measurable within a reasonable amount of time for continued progression of the clinical development plan.

]]> ART Buzzsprout-9483193 Thu, 04 Nov 2021 03:00:00 -0400 609 1 5 full false The Logistics of a Clinical Study Scale-up Scaling up from phase 1 to global phase II/III trials to beyond marketing approval has several implications on a sponsor’s commercial strategy. Hear from Rachel Smith, Portfolio Director for Veristat, as she uses our recent work with a biotech company to illustrate the importance of a comprehensive shipping and traceability strategy, tight management of the patient journey, and adoption of a well-conceived protocol and process documentation to support the commercialization strategy.

]]> Scaling up from phase 1 to global phase II/III trials to beyond marketing approval has several implications on a sponsor’s commercial strategy. Hear from Rachel Smith, Portfolio Director for Veristat, as she uses our recent work with a biotech company to illustrate the importance of a comprehensive shipping and traceability strategy, tight management of the patient journey, and adoption of a well-conceived protocol and process documentation to support the commercialization strategy.

]]> ART Buzzsprout-9396764 Tue, 19 Oct 2021 14:00:00 -0400 580 full false Common Pitfalls in Gene Therapy Studies Rachel Smith, Portfolio Director for Veristat, takes us through a number of pitfalls to avoid when planning for a gene therapy study. With the stakes high and having conducted trials for the first gene therapy approved in Europe, put Rachel’s lessons learned to work when determining your regulatory pathway, logistics strategies and donor screening requirements.

]]> Rachel Smith, Portfolio Director for Veristat, takes us through a number of pitfalls to avoid when planning for a gene therapy study. With the stakes high and having conducted trials for the first gene therapy approved in Europe, put Rachel’s lessons learned to work when determining your regulatory pathway, logistics strategies and donor screening requirements.

]]> ART Buzzsprout-9396659 Tue, 19 Oct 2021 14:00:00 -0400 637 1 2 full false Long-Term Follow-Up Studies in Gene Therapy Mariana Oviedo, Project Manager for Veristat, provides an overview of the key items that must be taken into consideration when designing and running a long-term follow-up study for a gene therapy product, sharing experiences from both a scientific and operational perspective. It is never too early to start thinking about the long-term follow up with so much on the line.

]]> Mariana Oviedo, Project Manager for Veristat, provides an overview of the key items that must be taken into consideration when designing and running a long-term follow-up study for a gene therapy product, sharing experiences from both a scientific and operational perspective. It is never too early to start thinking about the long-term follow up with so much on the line.

]]> ART Buzzsprout-9396657 Tue, 19 Oct 2021 14:00:00 -0400 691 1 3 full false Common Pitfalls in Cell Therapy Studies Listen as Kevin Hennegan, Senior Regulatory Strategist for Veristat, shares some of the common hurdles drug developers face when bringing cell therapies to market including international regulatory variability, patient safety assurance, planning for long term follow up and more.

]]> Listen as Kevin Hennegan, Senior Regulatory Strategist for Veristat, shares some of the common hurdles drug developers face when bringing cell therapies to market including international regulatory variability, patient safety assurance, planning for long term follow up and more.

]]> ART Buzzsprout-9356693 Tue, 12 Oct 2021 15:00:00 -0400 542 1 1 full false