This course covers practical CMC aspects for large molecule development programs and associated regulatory filings. Presentations will cover key technical activities carried out in drug substance, drug product, analytical method development leading to the initial IND and subsequently to a BLA/CTD. Other important activities typically conducted by the CMC team covered include the preparation, testing, packaging, and labeling of clinical trial supplies and the associated elements of quality assurance and regulatory compliance. In addition, the course covers basic project planning for regulatory filings, including timing of events and interdependencies of the many tasks required to advance a candidate to Phase 1 and beyond. Filing documents are examined, section by section, with a description of the content of each section and the typical level of detail consistent with FDA guidance documents.
The course is structured to provide background information in an informal setting designed to offer many question and answer opportunities. Additionally, attendees will work in small groups to conduct a number of exercises related to leading the construction and execution of CMC project plans and addressing specific tasks typically encountered by the project team. Each group will create a team structure and project plans to advance real-life development programs through the various stages of drug substance, drug product, analytical method and clinical development. All small group members will have the opportunity to lead their teams through a planning exercise and present their team’s results back to the course attendees and faculty.
The overall objective of the course is to provide current and prospective CMC project leaders and others engaged in chemistry, formulation and manufacturing activities a sufficient depth of knowledge and management skill to immediately and positively impact their organization’s CMC development activities and regulatory filings, the key deliverables of the team. Concepts and lessons are equally applicable to all stages of drug candidate and life cycle management development programs. As noted in the course title, and per the requests by many past attendees in the CMC small molecule focused course, the focus of this course is large molecules.
This course is part of the Drug Product Development Certificate. It fulfills one elective. Take the course ‘as-is’ or as part of the certificate.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.