Expertise: Consulting 38 results
Madelyn “Mimi” Huang, Ph.D.
CMC Considerations for Pre-IND Meetings
The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics. In general, such meetings are multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical plans for…
Will Bainbridge
Nicole Sativtsky
Suzanne Courtney
MORRISVILLE, N.C., October 9, 2023 — Premier Consulting, a business unit of Premier Research whose mission is to help the most innovative companies take their best ideas from concept to commercialization, is pleased to announce the appointment of William Bainbridge as Senior Director, Head of Commercial Strategy Solutions. Mr. Bainbridge has a range of therapeutic…