Course

Fast Track pre-IND CMC Projects

06 June 2024
Zoom
6 hours
English

16:00-22:00 Brussels
15:00-21:00 UK
10:00am-04:00pm New York

$700 Until 01 May 2023

$780 Until 30 May 2024

$900 Until 06 Jun 2024

About the Course

Lecturer: Joseph Tyler

Mr. Tyler has had over 50 years of experience in the areas of pharmaceutical process development, manufacturing, and CMC drug development management with both large pharmaceutical and smaller biotechnology companies. He received his B.S in Chemical Engineering from Carnegie Mellon University and an M.S. in Biochemical Engineering from Cornell University. Previously he was Vice President CMC for Shattuck Labs and has worked for GelTex Pharmaceuticals, Salix Pharmaceuticals, Momenta Pharmaceuticals, Proteon Therapeutics, KBI BioPharma, and Aeglea Biotherapeutics. Mr. Tyler has managed the chemistry, manufacturing, and controls development programs and ultimate approval of six new drugs.

Speed to the initiation of human clinical trials is a critical step for many emerging companies. In most situations the Chemistry, Manufacturing, and Controls (CMC) program will be the rate limiting aspect of the project. This course will provide guidance on developing fast track CMC programs to shorten the overall development time to an Investigational New Drug application (or IMPD/CTX) by identifying important project inter-dependencies, efficient scheduling of activities, and timely execution of the project tasks. The course will consist of the following topics:

CMC IND requirements for both biologics and small molecules
> Requirements
> Scope definition
CMC program scheduling for drug substance and drug product
> Schedule development
> Critical milestones and dependencies
Project management and executional best practices
Resource requirements and allocation
Short cuts that can reduce the overall timeline
Risk identification
Coping with changes and delays
IND preparation