DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.
Run time: 37:54mins
CMC002 - Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel
Video Credit: DSI, a PLG Company
Takeaways:
00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing regulatory starting materials
07:34 – James provides best practices for working with clients who don’t want to approach the FDA proactively and curating fallback plans
11:45 – James speaks to strategies for establishing ideal regulatory starting materials
16:44 – James shares his thoughts on ICH Q11
20:39 – James expounds on the idea behind Quality by Design (QBD)
28:53 – James provides some final thoughts on the process of establishing regulatory starting materials
34:10 – Ed and Miranda thank James for joining the show
About CMC Live
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.