Podcast: Pharma – The Last Word

Welcome to the podcast series, "Pharma: The last word," hosted by Partner Phil Katz. This series aims to dive into the intricate world of pharmaceuticals and biotech regulatory and legal landscapes, exploring new innovations, trends, and their practical impacts. Each episode will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them. Subscribe and listen to the podcast.

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In this episode of “Pharma – The last word,” host Phil Katz, discusses regulatory and legal trends in the pharma and biotech industries with Komal Karnik Nigam. They delve into the FDA’s evolving approach to data packages required for drug approval, highlighting the increased flexibility in accepting alternative forms of evidence. Komal explains how FDA’s guidance has shifted from demanding large, multicenter trials to considering confirmatory evidence such as natural history studies, mechanistic data, and data from other products in the same class. The episode emphasizes the importance of strategic planning and early consideration of data presentation in regulatory interactions.


Join Phil and his first guest, Lynn Mehler, co-head of the Life Sciences and Health Care industry sector, and Lead of the Pharmaceuticals and Biotech Regulatory Practice, as they discuss the unique insights and deep expertise their team brings to the table, the largest of its kind outside the FDA. They will share the inner workings of their practice, how they stay ahead of industry trends, and their passion for the field.


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