Discover/Develop, but how will you Manufacturing your therapeutic?

4:15 PM - 5:15 PM, Wednesday, June 10, 2020 ・ Room 8
How many CRL's are issued because of manufacturing challenges? This aspect of biopharmaceutical R&D is just as important as everything that came before it. The explosive growth in cell therapies, and even gene therapies present a new world of technical difficulties in validating reproducible methods of manufacturing
Moderator
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Institute Director
NIIMBL
Speakers
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EVP, Pharmaceutical Development & Operations
Celgene
Peter Marks
Director, Centers for Biologics Evaluation & Research
US Food & Drug Administration
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Associate Vice President, BPD & Clinical Manufacturing
Merck
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Sr. Dir Large Molecule API Development at Johnso
Janssen (J&J)