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Presenter: Dr. Mark Levi This is the final webinar in a 3-part series dedicated to effective partnerships with external research/manufacturing organizations. The Catalyze team receives many questions around approaching Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMO), or Contract Development and Manufacturing Organizations (CDMO) to perform necessary studies. This webinar focuses on preparing for and managing partnerships to carry out chemistry, manufacturing, and controls (CMC) activities. This webinar is presented by Dr. Mark Levi, an expert in regulatory affairs with other 20 years of experience. Dr. Levi will answer common questions about required CMC activities by providing real-world examples. This presentation is meant to give academic and small business investigators a better understanding of the regulatory process and tools to set their product up for regulatory success through partnership. This seminar was presented on February 29, 2024 to an invited audience. This video is for educational purposes only. Presentation Bookmarks 0:00 Objectives and Disclaimers 2:04 Background 4:07 Purpose of CMC 5:45 Chemistry, Manufacturing and Controls Legal Basis 21 CFR 312.23(a)(7) 9:45 Plan for Success with the Right Expertise on the CMC Team 11:16 Critical Elements of CMC 12:18 Key Considerations: Control of Raw Materials 16:46 Key Considerations: Analytical Testing (QC) 17:55 Additional CMC Testing Is Specific to the Product 19:10 Phase Appropriate cGMPs for CMC (Generic) 23:33 Key Considerations: Manufacturing 25:46 Key Considerations: Quality Assurance (QA) 27:01 CMC Contract Organizations 29:56 CMO Vendor Selection Criteria 30:48 How to Choose a Contract Organization 35:17 cGMP Requirements for Vendor Qualification 36:03 CMO Audit Process 37:48 Types of Contract Manufacturing Agreements 39:01 Benefits of Contract Manufacturing Organization 41:32 Top 10 Contract Manufacturing Mistakes 42:53 Helpful Links 43:25 Top 10 Contract Manufacturing Mistakes (continued) 45:01 Q&A The Catalyze program utilizes a new approach to translational research by supporting both the technical needs of an innovation and the management, commercialization, regulatory, and training requirements of the innovators developing them. Projects supported by Catalyze receive funding and advisory support through the National Heart, Lung, and Blood Institute (NHLBI), as well as project management assistance, access to technical services and expertise, and training opportunities through the Catalyze Coordinating Center. This research was funded, in part, by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions of the presenters are their own and should not be interpreted as representing the official policies, either expressed or implied, of the NIH. NHLBI Catalyze Public Site: https://nhlbicatalyze.org