University of Wisconsin–Madison

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

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

Register

Refund Policy

Course date:Apr 14, 2022 - May 19, 2022
Location:
Course fee:

$1400
$1150 two or more from same company

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

Live webinar dates: April 14, 21, 28 May 5, 12, 19, 2022
(This course will also be available in-person Oct 3-6, 2022 in Madison, WI).
Please contact Eric Buxton to qualify for an academic and graduate student rate.

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:

  1. The role of the CMC team and project manager in the broader context of the entire product development program
  2. Essentials of project team management, including team dynamics, managing meetings, decision making, communication, negotiation and conflict resolution
  3. Project planning and timing of CMC-related events leading to regulatory filings
  4. Practical approaches for addressing typical tasks carried out by the project team
  5. Key drug substance, drug product, and analytical method development activities as they pertain to regulatory filings
  6. Content of Drug Substance and Drug Product sections of regulatory filings and the level of detail recommended by relevant FDA guidance documents

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, IMP and CTX filings; breakdown of DS and DP sections; key content; typical level of detail expected; Exploratory-IND filing process and addressing FDA questions.

 

3: Technical Overview: Drug Substance Synthesis and Process Development

Speaker: Ashok Bhatia, PhD, Director, 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

 

4: Analytical Challenges with Testing Drug Substance

Speaker: James Bernstein, PhD, Pharmaceutical Consultant, Live Oak Pharmaceutical Consulting, Inc.

Overview of analytical chemistry role in DS development; analytical methods used for raw material, intermediates and final DS; analysis of DS; associated release tests, the C of A; method validation requirements; specifications; stability assessment and protocol example; initial retest period and extension; typical level of detail provided in an IND or IMPD for DS

April 14, 2022

Session 1: Opening Live Webinar - Tuesday, April 14, 2022 (approximately 2.0 hours)
10:00 AM - 12:00 PM CST

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

 

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 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: Biotechnology Talk-Large Molecules and CMC
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 21, 2022

Session 2: Live Webinar - Tuesday, April 21, 2022 (approximately 2.0 hours)
10:00 AM - 12:00 PM CST

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: Physical & Chemical Factors in Candidate Selection and Optimization

Speaker: Rick Pyter, PhD

The key physicochemical factors that distinguish "lead compounds" from "development candidates" will be addressed.

 

10: 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.

 

11: 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.

 

12: CMC Project Management of Life Cycle Management and Drug Device Programs/ Drug/Device Combination Products - CMC Considerations

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.

April 28, 2022

Session 3: Live Webinar - Tuesday, April 28, 2022 (approximately 2.0 hours)
10:00 AM - 12:00 PM CST

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: 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.

 

14: FDA-Sponsor Interactions

Speaker: Sharon Graham

General types of meetings, EOP2, pre-NDA, Pre-approval Inspections, preparation of questions and briefing documents, meeting conduct.

 

15: Assessing CMC Changes During Phase 3 and after Primary Stability Batches

Speaker: Sharon Graham

Post Approval Change Guidance

May 5, 2022

Session 4: Live Webinar - Tuesday, May 5, 2022 (approximately 2.0 hours)
10:00 AM - 12:00 PM CST

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

Rick Pyter and faculty

 

Asynchronous presentations
Teams work offline and watch following videos

 

16: Challenges with An 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. 

 

17: 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 12, 2022

Session 5: Tuesday, May 12, 2022 (approximately 2.0 hours)
10:00 AM - 12:00 PM CST

Team Exercise #4: Sub-Group Reports to Entire Group

Sub-groups present their constructed project plans, highlighting key features, assumptions, and critical success factors

Discuss Lecture 16-17 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 19, 2022

Session 6: Tuesday, May 19, 2022 (approximately 2.0 hours)
10:00 AM - 12:00 PM CST

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: Challenges of Emerging Drug Therapies

James Bernstein and Gene McNally lead

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, 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