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:Oct 5, 2020 - Oct 8, 2020
Location:

Pyle Center - University of Wisconsin-Madison Campus
702 Langdon Street
Madison, WI

Course fee:

$1625

($1300 each-two or more from same company)

Tuition includes breaks Monday through Thursday, lunch Monday, Tuesday and Wednesday, and reception on Monday evening.

Refund Policy: All requests for refunds, less a $75 administrative fee, will be honored if received prior to September 16, 2020. No refunds will be provided after that date.

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

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.

Course Outline

Monday, October 5, 2020
7:45 am

Continental Breakfast

8:15 am

Welcome

Eric Buxton, PhD
Clinical Associate Professor, School of Pharmacy, University of Wisconsin-Madison

8:30 am

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 CTX filings; breakdown of DS and DP sections; key content; typical level of detail expected; Exploratory-IND; IND filing process and addressing FDA questions.
9:15 am

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

10:25 am Break
10:40 am

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

11:40 am

Team Exercise #1: Calculation of drug requirements thru FIM

Moderators: Ashok Bhatia & other faculty
11:45 am Lunch
12:45 pm Team Exercise #1: Small groups work
1:15 pm Facilitated review of output
1:30 pm

FDA-Sponsor Interactions

Speaker: Sharon Graham
2:30 pm Break
2:45 pm

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

3:45 pm

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 for Phase 1; 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

4:30 pm

Team Exercise #2 - Assembly of tasks associated with development through the first filing for an NCE/NBE

Moderators: Rick Pyter & faculty
Sub-groups are formed to begin defining the elements of a CMC Project Plan that includes development of DS, DP and Toxicology and Clinical Supply Materials included in an IND filing for an assigned molecule

5:30 pm Adjournment
5:30 pm Reception
Tuesday, October 6, 2020
7:45 am

Continental Breakfast

8:30 am

Team Exercise #2 Sub-Groups Report to Entire Group

Sub-groups will present, compare and discuss their list of key tasks with a goal of developing an agreed list for use in Exercise # 3
9:15 am

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)

10:00 am Break
10:15 am

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.
10:45 am

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 trials
11:30am

ANDA and 505(b)(2) filings - CMC Considerations

Speaker: Sharon Graham

Differences between ANDA and NDA filings; FDA guidance, submissions for question-based review; 505(b)(2) filings from the CMC perspective, use of drug master files (DMF).
12:15pm

Lunch

1:00pm

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.
2:00 pm

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 trials
2:45 pm Break
3:00 pm

Team Exercise #3 - Creation of a CMC Project Plan for Development through the First Filing for an NCE/NBE

Moderators: Rick Pyter & other faculty

Small teams will be assigned to create a project plan for development of either an NBE or NCE; teams review compound information; teams assemble the appropriate tasks from Exercise #1 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.
5:15 pm

Adjournment

Evening free to explore Madison

Wednesday, October 7, 2020
7:45 am

Continental Breakfast

8:30 am Team Exercise #3: Sub-Group Reports to Entire Group
Sub-groups present their constructed project plans, highlighting key features, assumptions, and critical success factors
9:15 am

CMC Project Manager's Responsibilities: Deliverables and Optimization of Team Performance

Speaker: Rick Pyter, PhD

Key deliverables and leadership responsibilities will be defined; reporting responsibilities will be discussed; important attributes of an effective leader will be described. The composition of Global Project and CMC teams will be discussed as a function of project stage. The pros and cons of various team structures will be addressed. Teams will conduct a self-assessment of their overall effectiveness.
10:00 am Break
10:15 am

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.
11:00 am

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
12:00 pm Lunch
1:00 pm

Team Exercise #4 - Working Session: Creation of a CMC Project Plan for a Drug/Device Combination

Moderator: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
2:45 pm Break
3:00 pm

Team Exercise #4: Sub-Groups Report to Entire Group

Sub-groups present their constructed project plans, highlighting key features, assumptions, and critical success factors
3:45 pm

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.
4:30 pm

Discussion: Challenges of Emerging Drug Therapies

James Bernstein, PhD, Gene McNally, PhD
Synopsis

5:15 pm Adjournment - Evening free to explore Madison
Thursday, October 8, 2020
7:45 am

Continental Breakfast

8:30 am CMC Team Exercise #5 - Working Session: Creation of a CMC Project Plan for A Line Extension
Moderators: Rick Pyter,PhD, & other faculty

Assemble the appropriate tasks from Exercise #2 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

10:00 am

Team Exercise #5: Sub-Group Reports to Entire Group

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

10:45 am

CMC Project Manager's Responsibilities, Skills, and Key Attributes

Speaker: Rick Pyter, PhD
Key deliverables and leadership responsibilities will be defined;important skills and attributes of an effective leader will be described.

11:30 am

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

11:35 am Adjournment

 

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

Accommodations

Hotel accommodations are the responsibility of the registrant

Room blocks have been arranged at:

The Graduate
601 Langdon Street
Madison, WI  53703
Price: $139 per night
Room block release: 9/4/2020
Event Name: CMC Team Leadership
Booking Link

 

Lowell Center
610 Langdon St Madison, WI 53703
608-256-2621 Ext 1133

Event Title:  CMC Project Team Leadership (Event#103124)
Group Code: CMC

Price: $130 per night
Booking link
Room release: 9/4/2020

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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