Get there Faster - Therapeutics Development to CMC IND Submission

Presenter: Carmella S. Moody, PhD
Regulatory Program Director
RTI International www.rti.org
Presenter Carmella S. Moody, Ph.D. is a Regulatory Program Director at RTI; she has more than 33 years of experience developing small molecules, large molecules (biologic), and combination products with emphasis in product development and regulatory affairs.
This presentation focusses on developing therapeutics from a Chemistry, Manufacturing, and Controls (CMC) perspective. Information is provided regarding important considerations to keep in mind during development and an overview of data included in the CMC section (Quality Section) for early phase IND submissions.
Seminar presented on July 21, 2021 to an invited audience.
Seminar #2 of NHLBI Catalyze Seminar Series.
This video is provided for educational purposes only.
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.
Presentation Bookmarks
2:19 - Purpose of CMC
3:00 - CMC Relative and to Overall Product Development
3:57 - When and Why is CMC considered
4:35 - Critical elements of CMC
5:35 - CMC is Specific to the Product
6:10 - Plan for Success with the right team
7:28 - Key Considerations: Analytical Testing
9:40 - Key Considerations: Control of Raw Materials
12:50 - Key Consideration : Manufacturing
15:55 - Drug Master Files (DMF)
19.50 - Key Considerations: Quality Assurance (QA)
22:00 - Key Considerations: CGMPs
26:00 - Drug Substance CMC Information in CTD Format
29:28 - Description of Manufacturing Process and Process Controls
32:11 - Impurities
36:45 - Specifications
40:40 - Analytical Procedures
43:00 - Justification of Specification
44:00 - Reference Standard of Materials
50:55 - Drug Product CMC Information in CTD Format
51:20 - Description of Manufacturing Process and Process Controls
52:05 - Controls
55:50 - Specifications
56:55 - Stability Summary and Conclusion
Helpful Links
cGMPs for Phase 1 Invetigational Drugs
www.fda.gov/media/70975/download
Content and Format of INDs for Phase 1
www.fda.gov/media/72057/download
ICH Q6B Specifications
www.fda.gov/media/71510/download
ICH M4Q(R1)
www.gmp-compliance.org/files/...