In this free webinar, gain critical insights into optimizing chemistry, manufacturing and controls (CMC) development for biologics programs and ensuring successful investigational new drug and biologics license application submissions. Attendees will learn about the fundamental misalignment between legacy contract development and manufacturing organizations (CDMO), CMC consultants and drug developers. The featured speakers will discuss the methods CDMOs can use to ease the CMC development pathway. The speakers will also share key considerations for CDMO selection to ensure a seamless integration of service provider and consultant.
TORONTO, Sept. 19, 2024 /PRNewswire-PRWeb/ -- 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 CMC consultant and the client organization is as complementary as it should be.
CMC consultants play a critical role in successfully advancing lifesaving biologics medicines and guiding biologics programs through critical milestones. Therefore, an optimal biologics program outcome requires a CDMO that is purposefully built to work effectively and in concert with clients and CMC consultants.
In this webinar, the expert panel will discuss key considerations for CDMO selection to ensure a seamless integration of service provider and consultant, including process and data transparency, facility design and person-in-plant accommodations. They will also discuss how the Portable CMC® platform provides a focused, streamlined approach to CMC development and clinical manufacturing through modular work packages, structured documentation support and flexible workflows that align priorities in favor of client success.
Register for this webinar today to gain critical insights into optimizing CMC development for biologics programs and ensuring successful IND and BLA submissions.
Join Ali Siahpush, President & Owner, Pharmefex Consulting; Libby Russell, PhD, Vice President, Syner-G; and Stephen Monks, Principal, GSL CMC Consulting; and experts from Wheeler Bio, Brian R. Berquist, PhD, Chief Development Officer; Stewart McNaull, PhD, Chief Business Officer; and Aaron Pilling, PhD, Director of Business Development, for the live webinar on Monday, October 7, 2024, at 1pm EDT (6pm BST/UK).
For more information, or to register for this event, visit Modular CMC Development for Antibodies: Deploying a Purpose-Designed Path to Clinic.
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