Veristat Podcasts
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Considerations For Developing Rare Disease Treatments
1/17/2023
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.
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The Importance Of Regulatory Project Management
12/8/2022
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.
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Regulatory Considerations For Biosimilars Development In The U.S.
12/8/2022
Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.
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Emergency Use Authorizations
11/11/2022
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.
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Marketing Application Best Practices For Publishing
11/11/2022
Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application.
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CMC Pitfalls: From Benchtop To IND
11/11/2022
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.
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Orphan Drug Designations And Orphan Subsets
10/21/2022
Listen as members of Veristat’s regulatory team shed light on orphan drug designation classifications and the strategic use of subsets in study design.
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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 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.