Veristat Podcasts
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Reasons For Setting Up Natural History Studies & Their Challenges
10/20/2022
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.
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The Current Landscape Of Cell And Gene Therapies And Where We Are Headed
5/5/2022
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.
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Use Of PRO In Cell And Gene Therapy Studies
4/14/2022
Listen to several key considerations for the deployment in cell and gene therapy studies including the appropriate execution of PROs.
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Real-World Considerations When Administering Advanced Therapy Products
4/4/2022
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.
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Podcast: Planning The Way Forward In Neurodegenerative Disease Studies
3/17/2022
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.
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Pitfalls To Avoid In Marketing Applications For Cell & Gene Therapies
2/17/2022
Identify some of the key components of a cell & gene therapy marketing application with an industry expert who outlines the most common pitfalls and gaps he has encountered with sponsor applications.
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Are Autologous Therapies Here To Stay? Are Allogeneic Therapies The Future?
2/17/2022
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.
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EU Post Marketing Requirements For Cell And Gene Therapy Studies
2/17/2022
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.
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Long-Term Follow-Up Studies In Gene Therapy
2/17/2022
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.
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The Logistics Of A Clinical Study Scale-Up
2/17/2022
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.