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Xtalks, Online
2024-10-07
The chemistry, manufacturing and controls (CMC) path to a successful investigational new drug (IND) submission and biologics license application (BLA) for therapeutic biologics is both an exercise in strategy deployment and a race against the clock. Drug developers and consultants that facilitate their path to regulatory filing must execute robust CMC development strategies while simultaneously assembling documentation that will hold up to the scrutiny of jurisdictional regulatory authorities.
As most CMC consultants are fully aware, consultants and service providers alike should jointly operate in the client’s best interest. Rarely, the three-way relationship between the contract development and manufacturing organization (CDMO), the client organization is as complementary as it should be.
Read more...
Register for this webinar today to gain critical insights into optimizing CMC development for biologics programs and ensuring successful IND and BLA submissions.
Keywords: Antibodies, Drug Development, Biologics, CRO, Investigational New Drug, Regulatory, Contract Manufacturing, CMC, Commercial Manufacturing, CDMO, CDMO/CMO
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Organized by:
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Xtalks |
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Invited Speakers:
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Brian R. Berquist, PhD, Chief Development Officer, Wheeler Bio
Stewart McNaull, PhD, Chief Business Officer, Wheeler Bio
Aaron Pilling, PhD, Director of Business Development, Wheeler Bio
Ali Siahpush, President & Owner, Pharmefex Consulting
Libby Russell, PhD, Vice President, Syner-G
Stephen Monks, Principal, GSL CMC Consulting
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Deadline for Abstracts:
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2024-10-07
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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