CMC Project Management
- 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 ā Madison
- 2. Outline ā¢ Welcome and faculty introductions ā¢ Applied Drug Development Curriculum ā¢ Attendee introductions ā¢ Goals and objectives. Who can benefit? ā¢ Definitions ā¢ Course content and flow ā Baseline information about CMC activities ā Small group exercises on NCE/NBEs and and LCM programs ā Technical, regulatory, and soft subjects ā¢ 1st speaker isā¦. 10/8/2012 2 CMC Project Management ā Introduction and Course Overview
- 3. Brought to You By: ā¢ Sponsors ā University of Wisconsin Extension Services in Pharmacy (ESP) and the Zeeh Pharmaceutical Experimental Station ā¢ Planning Committee ā Rick Pyter (Adjunct Professor), Ed Elder (Zeeh Director), James Bernstein (Pharmaceutical Consultant), Eric Buxton (ESP) 10/8/2012 3 CMC Project Management ā Introduction and Course Overview
- 4. Delivered to You By: Faculty ā¢ Ashok V. Bhatia, Ph.D., Project Leader and Associate Research Fellow, Process R&D, Abbott Labs, North Chicago, IL (32 years) ā¢ Edmund (Ed) Elder, Jr., R.Ph., Ph.D., Director, Zeeh Pharmaceutical Experiment Station, School of Pharmacy, University of WisconsināMadison (23 years) ā¢ Eugene McNally, Ph.D., Executive Director, Global CMC and Regulatory Affairs, PPD Inc., Middleton, WI (23 years) ā¢ James Bernstein, Ph.D., Owner, Live Oak Pharmaceutical Consulting Inc. , Research Triangle, NC (29 years) ā¢ Richard (Rick) Pyter, Ph.D., Development Consultant, Adjunct Professor (32 years) ā¢ Yeshwant Sanzgiri, Ph.D., CMC Scientific Director, Abbott Labs, Abbott Park, IL (21 years) 10/8/2012 4 CMC Project Management ā Introduction and Course Overview
- 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 ā 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 10/8/2012 5 CMC Project Management ā 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 wellādefined program of coursework. 10/8/2012 CMC Project Management ā Introduction and Course Overview 6
- 7. Introductions of Attendees ā¢ Name? ā¢ Company or other affiliation? Virtual? ā¢ Formal training in which disciplines? ā¢ Current role? ā¢ Why are you here and what would you like to learn? ā¢ How many working with small molecules, how many working with biotech products? Both? 10/8/2012 CMC Project Management ā Introduction and Course Overview 7
- 8. Course Goals and Objectives ā¢ 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 organizationās 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. ā¢ Upon completion of the course, the attendees should be able to describe: ā The role of the CMC team and project manager in the broader context of the entire drug development program ā Essentials of project team management, including leadership skills, team dynamics, managing meetings, decision making, communication, etc. ā Project planning and timing of CMCārelated events leading to a regulatory filing ā Key drug substance, drug product, and analytical method development activities as they pertain to regulatory filings and program development ā Content of Drug Substance and Drug Product sections of global regulatory filings at a level of detail consistent with available guidance documents 10/8/2012 8 CMC Project Management ā Introduction and Course Overview
- 9. What is a āProjectā? 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 10/8/2012 CMC Project Management ā Introduction and Course Overview 9
- 10. What is āProject Managementā? Project management is a set of processes, systems, and techniques for effective planning and control of projects and programs. 10/8/2012 CMC Project Management ā Introduction and Course Overview 10
- 11. Who Can Benefit and How? ā¢ Current and prospective CMC project managers and others engaged in chemistry and pharmacy activities Byā¦.. 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 10/8/2012 11 CMC Project Management ā Introduction and Course Overview
- 12. How are we going to accomplish our mission? ā¢ Interactive presentations ā¢ Interactive meals ā¢ Interactive small group sessions 10/8/2012 12 CMC Project Management ā Introduction and Course Overview
- 13. Course Connectivity 10/8/2012 CMC Project Management ā Introduction and Course Overview 13 Scientific/Technical Overviews Related Development Topics Responsibilities and Skills Team Exercises
- 14. Short Course Content and Flow ā 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 10/8/2012 14 CMC Project Management ā Introduction and Course Overview
- 15. Short Course Content and Flow ā 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 10/8/2012 15 CMC Project Management ā Introduction and Course Overview
- 16. Short Course Content and Flow ā 3 III. Project Management Responsibilities & Skills 1) Anatomy of an IND Document ā The Key Deliverable 2) CMC Project Managerās Responsibilities: Deliverables and Optimization of Team Performance 3) CMC Project Managerās Responsibilities: Skills and Key Attributes 4) CMC Project Management Tools 10/8/2012 16 CMC Project Management ā Introduction and Course Overview
- 17. Short Course Content and Flow ā 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 10/8/2012 17 CMC Project Management ā Introduction and Course Overview
- 18. Responsibility Timescale 18 Discover Develop Register Receive Approval Market 10/08/2012 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 Speakerā¦..