This document provides an introduction and overview for a course on CMC Project Management Principles and Practices for Successful Technical Leadership. The outline introduces the faculty, sponsors, planning committee, and applied drug development curriculum. It discusses attendee introductions, course goals and objectives, definitions, content and flow. The content will include overviews of drug substance synthesis, drug product development, analytical challenges, and preparation of clinical supplies. Related topics will include phase-appropriate strategies, outsourcing challenges, and life cycle management. Responsibilities and skills covered include anatomy of an IND, project manager deliverables and team optimization, and tools. Team exercises will include API needs calculation, task lists, and CMC project plans for early studies, combination

1. CMC Project Management
Principles and Practices for Successful
Technical Leadership
Introduction and Course Overview
Rick Pyter, Ph.D.
Pharmaceutical Consultant and Adjunct Professor
University of Wisconsin ‐ Madison

2. Outline
• Welcome and faculty introductions
• Applied Drug Development Curriculum
• Attendee introductions
• Goals and objectives. Who can benefit?
• Definitions
• Course content and flow
– Baseline information about CMC activities
– Small group exercises on NCE/NBEs and and LCM programs
– Technical, regulatory, and soft subjects
• 1st speaker is….
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and Course Overview

3. Brought to You By:
• Sponsors
– University of Wisconsin Extension Services in
Pharmacy (ESP) and the Zeeh Pharmaceutical
Experimental Station
• Planning Committee
– Rick Pyter (Adjunct Professor), Ed Elder (Zeeh
Director), James Bernstein (Pharmaceutical
Consultant), Eric Buxton (ESP)
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CMC Project Management ‐ Introduction
and Course Overview

4. Delivered to You By:
Faculty
• Ashok V. Bhatia, Ph.D., Project Leader and Associate Research Fellow, Process
R&D, Abbott Labs, North Chicago, IL (32 years)
• Edmund (Ed) Elder, Jr., R.Ph., Ph.D., Director, Zeeh Pharmaceutical Experiment
Station, School of Pharmacy, University of Wisconsin–Madison (23 years)
• Eugene McNally, Ph.D., Executive Director, Global CMC and Regulatory Affairs,
PPD Inc., Middleton, WI (23 years)
• James Bernstein, Ph.D., Owner, Live Oak Pharmaceutical Consulting Inc. ,
Research Triangle, NC (29 years)
• Richard (Rick) Pyter, Ph.D., Development Consultant, Adjunct Professor (32
years)
• Yeshwant Sanzgiri, Ph.D., CMC Scientific Director, Abbott Labs, Abbott Park, IL
(21 years)
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5. Applied Drug Development
Curriculuum
Short Courses
1. Principles and Experimental Strategies in Physicochemical
Characterization, Solubilization, and Solid Form Screening for
Candidate Selection
2. Practical Strategies for Developing Preclinical and Phase 1
Oral Drug Formulations.
3. CMC Project Team Management – Principles and Practices
for Successful Technical Leadership
Integrates the most critical scientific elements discussed
in the other core courses into coherent project plans
executed by optimally led CMC development teams
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CMC Project Management ‐ Introduction
and Course Overview

6. Certificate Program
A focused collection of courses, that, when
completed, afford the student a record of
coherent academic accomplishment in a given
discipline or set of related disciplines.
Students will be awarded certificates from the
UW School of Pharmacy to designate
completion of this well‐defined program of
coursework.
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and Course Overview
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7. Introductions of Attendees
• Name?
• Company or other affiliation? Virtual?
• Formal training in which disciplines?
• Current role?
• Why are you here and what would you like to
learn?
• How many working with small molecules, how
many working with biotech products? Both?
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and Course Overview
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8. Course Goals and Objectives
• 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 to immediately impact their organization’s CMC development activities and
regulatory filings, the key deliverables of the team. Although the emphasis is on the
early preclinical to Phase 1 stage of development of NCEs and NBEs, the concepts and
lessons are equally applicable to later stages of a candidate development program.
• 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 drug
development program
– Essentials of project team management, including leadership skills, team dynamics, managing
meetings, decision making, communication, etc.
– Project planning and timing of CMC‐related events leading to a regulatory filing
– Key drug substance, drug product, and analytical method development activities as they
pertain to regulatory filings and program development
– Content of Drug Substance and Drug Product sections of global regulatory filings at a level of
detail consistent with available guidance documents
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9. What is a “Project”?
A project is a unique venture, with a
beginning, and an end, carried out
by people to meet a specific
objective within parameters of
schedule, cost and quality
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10. What is “Project Management”?
Project management is a set of
processes, systems, and techniques
for effective planning and control of
projects and programs.
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and Course Overview
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11. Who Can Benefit and How?
• Current and prospective CMC project
managers and others engaged in chemistry
and pharmacy activities
By…..
getting a greater appreciation of what the
disciplines other than ours are responsible for,
how CMC activities intersect with each other,
and how the tasks are interrelated within a
project plan
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and Course Overview

12. How are we going to accomplish
our mission?
• Interactive presentations
• Interactive meals
• Interactive small group sessions
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and Course Overview

13. Course Connectivity
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Scientific/Technical
Overviews
Related
Development
Topics
Responsibilities
and Skills
Team Exercises

14. Short Course Content and Flow ‐ 1
I. Scientific/Technical Overviews
1) Drug Substance synthesis and process
development
2) Drug Product Development
3) Physical and Chemical Factors in candidate
selection
4) Analytical challenges with drug substance,
product, and supplies for tox. and clinical studies
5) Preparation of toxicology and clinical trial supplies
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and Course Overview

15. Short Course Content and Flow ‐ 2
II. Related Development Topics
1) Phase appropriate stategies for CMC Development
2) Challenges associated with an outsourcing model
3) CMC Project Management of Life Cycle
Management and Drug Device Programs
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and Course Overview

16. Short Course Content and Flow ‐ 3
III. Project Management Responsibilities & Skills
1) Anatomy of an IND Document – The Key
Deliverable
2) CMC Project Manager’s Responsibilities:
Deliverables and Optimization of Team
Performance
3) CMC Project Manager’s Responsibilities: Skills and
Key Attributes
4) CMC Project Management Tools
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17. Short Course Content and Flow ‐ 4
IV. Team Exercises
1) Calculation of API needs up to a FIH study.
2) Task list for CMC activities leading to a FIH study
3) Creation of a CMC Project Plan leading to a FIH
study
4) Creation of a CMC Project Plan for a Drug/Device
Combination Product
5) Creation of a CMC Project Plan for a Product Line
Extension
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and Course Overview

18. Responsibility Timescale
18
Discover Develop Register
Receive
Approval
Market
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Deliverables and Optimization of Team
Performance

19. What are the key tasks captured
by a CMC development plan for
NCE/NBEs and Line Extensions?
Key elements of a plan?

20. How are these key tasks
assembled into CMC
development plans?
Timing and dependencies?

21. What are the most important
leadership characteristics &
skills that make a CMC Project
Team Leader Effective?

22. 1st Speaker…..