SOBRE ESTE EPISÓDIO
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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Estados Unidos da América
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OUTROS EPISÓDIOS NESTE PODCAST
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.
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 insigh…
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.
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.
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, an…
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EDITAR
Obrigado por ajudar a manter a base de dados dos podcasts atualizada.
