Episode 13 – A Discussion on CMC Strategy and Submissions with Ed, Brian & Meranda скачать в хорошем качестве

Episode 13 – A Discussion on CMC Strategy and Submissions with Ed, Brian & Meranda

🎙️ Full audio, including show notes & full transcription: https://dsinpharmatics.com/ep13 🍏 Subscribe on Apple Podcasts: https://dsinpharmatics.com/apple 🎧 Subscribe on Spotify: https://dsinpharmatics.com/spotify 🎤 Subscribe on Google Podcasts: https://dsinpharmatics.com/google ▶️ Twitter:   / dsinpharmatics   ▶️ LinkedIn:   / 238776   ▶️ Instagram:   / dsinpharmatics   ————————— SUMMARY: ————————— Edward Narke is a Principal and Regulatory Managing Director, Brian Lihou is the Head of Operations and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed, Brian and Meranda join the show to discuss CMC marketing application strategies and submissions. Specifically, they speak to the important role regulatory reviewers play in deciphering data and ensuring all authors are following one cohesive story. They break down other CMC issues they’ve encountered with projects they’ve worked on and provide insights and protocols clients can follow to yield a successful program. ————————— TAKEAWAYS: ————————— 01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions 11:26 – Ed, Brian and Meranda discuss resources required for compiling CMC dossiers and the importance of understanding roles and responsibilities within this process 20:09 – Essential aspects of putting together an effective authoring team 25:25 – Brian speaks to the importance of respecting the experience of those that have been working on projects from the jump 28:28 – Ed, Brian and Meranda discuss what sponsors should know about CMC regulations to prepare for a marketing application ————————— 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.