CMC Project Team Leadership

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.

The Science, Principles, and Practices for Successful Teams – Virtual

Effective CMC Project Team Leadership is essential for successful drug development projects. This course provides project management and leadership training for aspiring project team leaders. It is also suitable for current project team leaders who wish to enhance their team success.

This course covers effective leadership skills in the context of CMC development. You will learn team dynamics to improve performance. You will also develop project management skills and decision-making skills.

Three adults in attending a the CMC Project Team Leadership course at UW-Madison

In addition to leadership skills, the course also covers regulatory compliance and quality assurance. You will learn to plan candidate advancement to Phase I and beyond. You will anticipate FDA requirements and other considerations in testing, packaging, and labeling.

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.

This program has been developed and will be presented in cooperation with the Zeeh Pharmaceutical Experiment Station in the School of Pharmacy at the University of Wisconsin-Madison.

Registration Information

Refund Policy

Course date:

Apr 17, 2025 - May 22, 2025

Location:

Course fee:

$1750 (please contact us for group rates)
$875 Academic and non-profit (contact us for registration code)
$435 Graduate student (contact us for registration code)

This course will be held via weekly webinar as well as asynchronous presentations.

Live webinar dates: April 17, 24, May 1, 8, 15, 22, 2025
10:00 AM– 12:30 PM CENTRAL TIME

Refund Policy: All requests for refunds, less a $75 administrative fee, will be honored if received prior to April 7, 2025. No refunds will be provided after that date.

(This course is also available in-person October 6-9, 2024 in Madison, WI).

Overview

Course Objectives

This course covers practical aspects of CMC project management for development programs and associated regulatory filings for oral and parenteral dosage forms and drug-device combination products. Presentations will cover key technical activities carried out in drug substance, drug product, analytical method development leading to the initial IND and subsequently to an NDA/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 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 managers and others engaged in chemistry and pharmacy 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.

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 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 preclinical and clinical drug development as part of CMC teams, particularly those already managing or motivated to assume leadership responsibilities for NCE, NBE, or life cycle management programs. Attendees include PhD graduates with typically 3+ years and MS graduates with 5+ years of experience in product development.

The scientists, managers and directors who would benefit from the course include those working in process chemistry, analytical chemistry, preformulation and formulation development. 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.

Outline

Course Outline

Precourse Lectures
	Asynchronous presentations Students provide bios to facilitate sub-team formation and are instructed to watch following videos before first meeting
	1: Introduction to CMC course Speaker: Rick Pyter, PhD, Development Consultant and Adjunct Professor School of Pharmacy, University of Wisconsin – Madison
	2: Anatomy of the Common Technical Dossier ("CTD"): The Key Deliverable Speaker: Sharon Graham, Regulatory Affairs, Chemistry Manufacturing and Controls (RA CMC) AbbVie IND, IMPD and CTA submissions; breakdown of DS and DP sections; key content; typical level of detail expected; Exploratory-IND submission process and addressing FDA questions.
	3: Physical & Chemical Factors in Candidate Selection and Optimization Speaker: Rick Pyter, PhD
	4: Technical Overview: Drug Substance Synthesis and Process Development Speaker: Ashok Bhatia, PhD, Director, Retired, Pharmaceutical Development, Associate Research Fellow, Process Chemistry, AbbVie Synthesis/process chemistry challenges; starting materials, intermediates, reagents, solvents, catalysts; particle isolation step; salts, crystal forms and polymorphs; impurity profiles of toxicological and clinical batches including: chirality; genotoxic impurity assessment; working with contractors; elucidation of structure and physical-chemical properties; reference standard; level of detail provided in an IND
April 17, 2025	Session 1: Opening Live Webinar - Thursday, April 17, 2025 (approximately 2.5 hours) 10:00 AM - 12:30 PM CDT Introductions/Organization/Sub-group formation Discuss recorded lectures 1-4 and introduce: Team Exercise #1: Calculation of drug requirements thru FIM-introduction and working session Moderators: Ashok Bhatia and other faculty create teams with work time
	Asynchronous presentations Teams work offline and watch following lectures.
	5: Technical Overview: Oral & Parenteral Drug Delivery and Dosage Form Development Speaker: Ed Elder, PhD, Director, Zeeh Pharmaceutical Experiment Station School of Pharmacy, University of Wisconsin – Madison Overview of major oral and parenteral dosage forms; formulation development stages (excipient compatibility, selection and level optimization, prototype formulation development); DS requirements and development time requirements for different dosage forms; technical considerations with placebos and packaging (container and closure) selection
	6: Analytical Challenges with Testing Drug Substance and Drug Product Speaker: James Bernstein, PhD Overview of the role of analytical chemistry in DP development; analytical methods used for raw materials, intermediates, and DP; support of DP development; analysis of DP (content, impurities, etc.), associated release tests, the C of A; method validation requirements; specifications; stability assessment and protocol example including packaging; assignment of DP expiration dating; typical level of detail provided in an IND or IMPD for DP
	7: What's Different About Project Planning for NBEs and NCEs? Speaker: Eugene McNally, PhD, PPD General types of meetings, EOP2, pre-NDA, pre-approval inspections, preparation of questions and briefing documents, meeting conduct.
	8: CMC Project Management Tools Speaker: James Bernstein, PhD Elements of project planning; timing and interdependencies of DS and DP tasks; critical path identification, determining DS and staffing requirements for development, clinical trial supply manufacture & scaleup; project reviews, strategy documents, progress reports and other communication vehicles; CMC team meeting management ( agendas, minutes, decision making approaches, conflict management and other aspects of project team meetings)
April 24, 2025	Session 2: Live Webinar - Thursday, April 24, 2025 (approximately 2.5 hours) 10:00 AM - 12:30 PM CDT Team Exercise 1: Sub-Group reports to entire group Discuss recorded lectures 5-8 and introduce: Team Exercise #2 - Creation of a CMC Project Plan for product development through the first filing for an NCE/NBE-Introduction & working session Moderators: Rick Pyter & faculty Small teams will create a project plan for development of either an NBE or NCE; teams review compound information; One team member will be elected by the team to present the plan to the entire group.
	Asynchronous presentations Teams work offline and watch following videos
	9: Technical Overview: Preparation of Toxicology and Clinical Trial Supplies Speaker: Ed Elder, PhD Overview of the strategies and other factors associated with design and production of supplies for GLP toxicology and human clinical trails.
	10: Quality Assurance and Quality Control for GLP and GMP Materials Speaker: James Bernstein, PhD Overview of the regulatory aspects of release and testing of supplies for GLP toxicology and GMP clinical trails.
	11: FDA-Sponsor Interactions Speaker: Sharon Graham General types of meetings, EOP2, pre-NDA, Pre-approval Inspections, preparation of questions and briefing documents, meeting conduct.
	12: CMC Considerations for Product Life Cycle Management and Drug/Device Combination Products Speaker: Rick Pyter, PhD Differences in the science, associated project planning and tasks for life cycle management programs, including drug device development and line extensions will be highlighted.
May 1, 2025	Session 3: Live Webinar - Thursday, May 1, 2025 (approximately 2.5 hours) 10:00 AM - 12:30 PM CDT Team Exercise #2: Sub-Group Reports to Entire Group Sub-groups present their constructed key tasks and project plans, highlighting key features, assumptions, and critical success factors. Discuss Lectures 9-12 and introduce Team Exercise #3: Creation of a CMC Project Plan for a Drug/Device Combination - Introduction and working session Moderators: Rick Pyter & other faculty Assemble the appropriate tasks into a coherent CMC project plan that includes timing, key dependencies, responsibilities, etc. One team member will be elected by the team to present the plan to the entire group.
	Asynchronous presentations Teams work offline and watch following videos
	13: CMC Development in the Outsourcing Model Speaker: James Bernstein, PhD Out-sourcing of various CMC activities creates new challenges for CMC team leaders, with additional differentiation occurring between large integrated pharmaceutical organizations and small or virtual pharmaceutical organizations. The different requirements of CMC leaders in these situations will be explored; participant experiences will be of particular value to the discussion. Physical & Chemical Factors in Candidate Selection and Optimization Speaker: Rick Pyter The key physicochemical factors that distinguish "lead compounds" from "development candidates" will be addressed.
	14: Phase Appropriate Strategies for CMC Development Speaker: James Bernstein, PhD A regulatory and strategic framework for phase-appropriate CMC development will be discussed; value drivers for early development identified; impact of drug properties on development activities will be considered.
	15: Assessing CMC Changes During Phase 3 and after Primary Stability Batches Speaker: Sharon Graham Post Approval Change Guidance
May 8, 2025	Session 4: Live Webinar - Thursday, May 8, 2025 (approximately 2.5 hours) 10:00 AM - 12:30 PM CDT Exercise #3: Sub-Groups Report to Entire Group Sub-groups present their constructed project plans, highlighting key features, assumptions, and critical success factors. Discuss lectures 13-15 Introduce Team Exercise #4 - Assessing changes to drug substance and drug product - introduction and working session Sharon Graham Discussion: Challenges Associated with Emerging Drug Therapies James Bernstein and Eugene McNally
	Asynchronous presentations Teams work offline and watch following videos
	16:CMC Project Manager's Responsibilities: Deliverables and Optimization of Team Performance Speaker: Rick Pyter, PhD Key deliverables and leadership responsibilities will be defined; important skills and attributes of an effective leader will be described.
May 15, 2025	Session 5: Thursday, May 11, 2025 (approximately 2.5 hours) 10:00 AM - 12:30 PM CDT Team Exercise #4: Sub-Group Reports to Entire Group Sub-groups present their regulatory assessments for changes to drug substance and drug product. Discuss Lecture 16 and introduce: Team Exercise #5: Creation of a CMC Project Plan for A Line Extension - introduction and working session Rick Pyter and faculty Assemble the appropriate tasks into a coherent CMC project plan that includes timing, key dependencies, responsibilities, etc. One team member will be elected by the team to present the plan to the entire group
May 22, 2025	Session 6: Thursday, May 22, 2025 (approximately 2.5 hours) 10:00 AM - 12:30 PM CDT Team Exercise #5: Sub-Group Reports to Entire Group Sub-groups present their constructed project plans, highlighting key features, assumptions, and critical success factors Discussion: Alternative Emerging Approaches - CMC Considerations Ashok Bhatia Course Summary and Assessments Rick Pyter, PhD, & Eric Buxton, PhD Key concepts will be summarized and integrated in closing comments. Attendees will be asked to fill out a course assessment form to help the faculty improve future offerings

Instructors

James Bernstein, PhD
Pharmaceutical Consultant
Live Oak Pharmaceutical Consulting, Inc.
Research Triangle Park, NC

Ashok V. Bhatia, PhD
Director, Retired, Pharmaceutical Development
Associate Research Fellow
Process Chemistry
AbbVie Inc., North Chicago, IL

Edmund (Ed) Elder, Jr., RPh, PhD
Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin – Madison, WI

Sharon Graham
Regulatory Affairs, Chemistry Manufacturing and Controls (RA CMC)
AbbVie
Chicago, IL

Eugene McNally, PhD
Executive Director, CMC, Global Regulatory Affairs
PPD
Madison, WI

Rick Pyter, PhD
Development Consultant and Adjunct Professor
School of Pharmacy, University of Wisconsin – Madison, WI

Program Coordinator

Eric Buxton, PhD

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 265-2259
eric.buxton@wisc.edu

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