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Wednesday, March 15 • 11:30am - 12:00pm
CMC: Optimize & Protect the Value of Your Asset

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  • As a rule, good even great CMC package will not increase the value of an asset but a poor package can rapidly erode value
  • The key aspects of any great CMC package
    • DS Availability
    • Well documented development history and manufacturing batch records
    • Using reputable CMO’s / CRO’s
    • Analytical methods that are phase appropriate and aligned with current regulatory guidance
    • Well thought out plan for delivery of the molecule throughout the development lifecycle
    • Asking the right questions of regulatory bodies and understanding expectations
  • Invest in Quality systems and personnel
    • Having DS and DP that is not usable destroys value

Speakers
avatar for James M. Koers

James M. Koers

Sr. Director: CMC and Clinical Capabilities Business Development, Eli Lilly and Company
Jim Koers is currently the Sr. Director for CMC Business Development at Eli Lilly and Company based in Indianapolis, IN. Jim has 20 year’s experience in the Pharma industry with roles in analytical chemistry, CMC Project management and Business Development. Prior to the past 12... Read More →

Wednesday March 15, 2023 11:30am - 12:00pm PDT
Hyatt Centric Fisherman's Wharf San Francisco
  Due Diligence

Attendees (11)