[
Webinar
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August 15, 2022
]

Why Knowledge Management is Important for Virtual Companies

Why Knowledge Management is Important for Virtual Companies

A 60-minute panel discussion of cross-industry experts will share their unique perspectives on WHY and HOW virtual companies need to understand and manage the details of their product and process development, even when outsourcing the development activities to a CDMO/CMO.

Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of the activities you need to manage as the sponsor, what information is important to capture and manage, and how to manage the overall "data" relationship with your CDMO/CMO.

Speakers

Watch the webinar

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Vice President, Product & Process Development
]

Adam Lambert

Dr. Adam Lambert has more than 20 years of experience in drug and device development, spanning device and drug combination products, vaccines, monoclonal antibodies, recombinant proteins, peptides, and small molecules across parenteral, pulmonary, solid oral, topical, and transdermal dosage forms. He specializes in Quality by Design, with particular emphasis on designing and leading risk-based QbD activities for ANDA, NDA, BLA, PMA, and MDD applications, and brings CMC strategy experience across small, large, and complex large-molecule modalities, from formulation and upstream and downstream process development through analytical methods at every phase of the product lifecycle.

[
CEO
]

Bikash Chatterjee

Bikash Chatterjee has worked in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products in the U.S. and Europe. He has developed and transferred products and processes to satellite operations and CMOs, designing and implementing systems to satisfy ICH Q8, Q9, and Q10, e-pedigree, and risk-based validation, and developing a Six Sigma-based methodology to support the PAT initiative. He serves on the USP National Advisory Board, is past chairman of the Golden Gate Chapter of the American Society of Quality, and is the author of Applying Lean Six Sigma in the Pharmaceutical Industry. He holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California, San Diego.

[
President & CEO
]

Yash Sabharwal

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.