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.
Upon completion of the course, the attendees should be able to describe:
- The role of the CMC team and project manager in the broader context of the entire product development program
- Essentials of project team management, including team dynamics, managing meetings, decision making, communication, negotiation and conflict resolution
- Project planning and timing of CMC-related events leading to regulatory filings
- Practical approaches for addressing typical tasks carried out by the project team
- Key large molecule drug substance, drug product, and analytical method development activities as they pertain to regulatory filings
- Content of Drug Substance and Drug Product sections of regulatory filings and the level of detail recommended by relevant FDA guidance documents
Who should attend:
Scientists, technical managers and directors who work in large molecule development as part of CMC teams, particularly those already managing or motivated to assume leadership responsibilities for large molecules, or life cycle management programs. Given this is the large molecule version of the very popular CMC Project Team Leadership course. Attendees include PhD graduates with typically 3+ years and MS graduates with 5+ years of experience in product development.
The scientists, technical managers and directors who would benefit from the course include those working in process chemistry, analytical chemistry, preformulation and formulation development for large molecules, also known as biologics. Other individuals who would be well-suited to attend this short course are those who have previously completed other core Applied Drug Development short courses: 1) Principles and Experimental Strategies in Physicochemical Characterization, Solubilization, and Solid Form Screening for Candidate Selection, and/or 2) Practical Strategies for Developing Preclinical and Phase 1 Oral Drug Formulations. This course integrates the most critical scientific elements presented in the above-mentioned courses into coherent project plans created and executed by optimally led CMC development teams, as pertains to large molecules.
This course is part of the Drug Product Development Certificate. It fulfills one of three required courses. We encourage scientists who wish to advance into leadership to take this course.