PODCASTS

• Apples To Apples: Playing The Comparability Game In Biotherapeutics Development

  Comparability studies are a significant issue for those working in biotherapeutics development. Consider these factors when playing the comparability game in biotherapeutics development.

• The Influence Of MDR’s Article 117 In The Marketing Of Combination Products

  While improving patient safety measures, learn how MDR’s Article 117 is causing implications for manufacturers, as they must fulfill a significant set of additional requirements.

• Considerations For Developing Rare Disease Treatments

  When developing a new therapy for a rare disease, learn why a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities.

• The Importance Of Regulatory Project Management

  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.

• Regulatory Considerations For Biosimilars Development In The U.S.

  Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.  

• Emergency Use Authorizations

  In this 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.

• 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. 

• 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.

• Orphan Drug Designations And Orphan Subsets

  Listen as members of Veristat’s regulatory team shed light on orphan drug designation classifications and the strategic use of subsets in study design.

• 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.

• The Current Landscape Of Cell And Gene Therapies And Where We Are Headed

  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.

• Use Of PRO In Cell And Gene Therapy Studies

  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. 

• 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.

• Podcast: Planning The Way Forward In Neurodegenerative Disease Studies

  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.

• Pitfalls To Avoid In Marketing Applications For Cell & Gene Therapies

  Listen as Kevin, North American Regulatory Affairs Director for Veristat, 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. 

• 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.

• EU Post Marketing Requirements For Cell And Gene Therapy Studies

  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.

• Selecting Endpoints For An Early Phase Cell Or Gene Study

  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.

• 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.

• The Logistics Of A Clinical Study Scale-Up

  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.

• Common Pitfalls In Gene Therapy Studies

  Rachel Smith, Portfolio Director for Veristat, takes us through a number of pitfalls to avoid when planning 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.

• 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.