[Webinar] Digitalize the CMC Path to Regulatory Submission and Technical Transfer
Having a complete and accurate development history is of paramount importance to address any CMC queries from regulatory agencies in a satisfactory and timely manner. Understanding what decisions were made, when they were made and why they were made, all form part of a unique CMC story for every medicine.
Digitalization, when done correctly, enables this story to be told accurately and in full.
In this webinar entitled “Digitalize the CMC Path to Regulatory Submission and Technical Transfer” we will explore:
The problems associated with the current dependence on human interactions to create context, curate data and create the development history
Existing digital solutions
The future for CMC digitalization
Our presenter, Dr. Bret Huff received his B.S. degree in chemistry in 1984 from CSU, Chico. He received his Ph.D. from University of California Santa Barbara in 1989. Following, he was a National Institutes of Health postdoctoral fellow at Harvard University. In 1991, he joined Eli Lilly and Company as a senior organic chemist where he worked on many early-phase drug candidates in process development. In the following years he held several scientific and management roles across the company. In 2019, Dr. Huff retired from Eli Lilly as Vice President of Small Molecule Discovery and Development. He serves now with APC as Digital Products Lead.