DATE/TIME
September 22, 9:30 – 10:00 AM EST
TITLE
Best Practices for Concurrent Compilation of Module 3 CMC Data in Collaboration With the CMO
SPEAKER
Melissa Joseph, PhD
Principal Consultant and Owner
Chymesis, LLC
ABSTRACT
When preparing for an IND/IMPD, it’s inevitable that there will be gaps in understanding on both the client and CMO side. For example, sometimes it can be a challenge obtaining data from development, formulation, and analytical in a way that it needs to be presented within an IND. This is particularly true for earlier phase work. Unless you work with the CMO proactively it can be a struggle to get the information needed in the way it’s needed at the time it’s needed. In addition, it can also be a challenge getting CMOs to understand the criticality in the timing of reporting stability data, especially when extending expiries or if there is an OOS. This session will explore best practices for how to communicate these types of needs with CMOs ahead of time so you’re not scrambling at submission.
BIO
Dr. Joseph is a consultant working with various pharmaceutical development companies to support their development and manufacturing activities. She has over 25 years of industry chemistry and manufacturing experience producing drug substance and drug product to support studies ranging from preclinical through Phase 3 as well as commercial manufacture. This includes the manufacture, release, packaging and distribution of both drug substance and drug product in the US as well as Canada, Europe, and Asia. She also has experience providing technical input to Module 3 manufacturing sections for INDs, IMPDs and NDAs. Dr. Joseph worked for several contract research and manufacturing organizations as well as drug development companies prior to moving into consulting in 2015. She obtained her PhD in Analytical Chemistry from Duke University in 1991 and a BA in Chemistry from Duke University in 1995.
