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Defining, building, and implementing in the next wave of biopharma R&D
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In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with two PharmaLex experts about navigating complex R&D processes to unleash the next wave of biopharma breakthroughs.
PharmaLex’s Dr Christian Schneider, VP & Chief Medical Officer, Clinical Development Services, together with Dr Christelle Boileau, Director of Regulatory Development Strategy and IPD solution lead at PharmaLex, which is part of Cencora, explore the many challenges faced across the clinical trial landscape when it comes to new therapies, including ATMP development.
From preclinical to market access and regulatory considerations, Dr Boileau warns that development is not a linear process, and for both an early-as-possible strategy is paramount. Comparing classical paradigms with the new, traditional endpoints need to be reassessed – for example, when defining dosage – says Dr Schneider.
You can listen to episode 165a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, Amazon Music, Podbean, and pretty much wherever you get your other podcasts!
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