CMC Essentials for Team Leaders in Biologics Product Development

Attendees view introductory lecture prior to the start of the course

Continental Breakfast/Networking

Welcome and Introductions

Introductions & Questions on Pre-Course Introduction
Robert Hagan, PhD, Outreach Program Manager, School of Pharmacy, University of Wisconsin-Madison (with pre-course input from Satish Singh, PhD, Vice President, Drug Product Development, Astria Therapeutics, Boston, MA).

Differences:  Small molecule vs. Large molecules
Speaker: Satish Singh, PhD, Vice President, Drug Product Development, Astria Therapeutics, Boston, MA

Compare and contrast of key properties between small and large molecules, including Structure, Manufacture, Delivery, Toxicology, and Immunogenicity.

Design and Selection of Monoclonal Antibodies (mAbs): Computational and Complementary Experimental Approaches
Speaker: Sandeep Kumar, PhD, Distinguished Fellow, Head of Computational Protein Design and Modeling, Modema Therapeutics, Cambridge, MA

  Coverage of current trends in Industrialization of antibody-based biotherapeutics, the   stages in antibody discovery Considerations of Developability and pre-formulation during antibody discovery, pointing out opportunities for the use of computation at different stages of antibody discovery and early development.  Finally, paradigm shifts related to discovering developable antibodies via computation, antibody developability in the age of mRNA delivery and developability screening assays.

Biologics Drug Substance Development-Part 1
Speaker: Adekunle Onadipe, PhD, Associate Research Fellow (retired), Pfizer, Inc., Chesterfield, MO

Discussion of the key aspects of drug substance development, to include cell line development, cell banking, cell culture process development and purification process development.

 Lunch

Biologics Drug Substance Development-Part 2
Speaker: Adekunle Onadipe, PhD 

A continuation of the Biologics Drug Substance topics from Part 1

Team Exercise #1: Drug Development
Moderator: Adekunle Onadipe, PhD 

Continental Breakfast/Networking

Summary of Day One
Students and instructors provide their perspectives and questions on the first day of the course

Team Exercise #3 Introduction and Working Session

Lunch

Team Exercise #3 - Sub-groups report to entire group

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

Comparability: Basic Concepts - Part 1
Speaker: Satish Singh, PhD

Comparability for large molecules vs the approach used for small molecules (SUPAC).  The various approaches for process comparability and analytical comparability are discussed leading to a phase appropriate comparability package with meaningful acceptance criteria.

Comparability: Strategy

Speaker: Satish Singh, PhD

Comparability from a Regulatory Perspective with Specific Relevance to Biologics
Speaker: Karen Sitney, PhD

Discussion of regulatory aspects of comparability, health authority expectations, and considerations for life cycle management, including some regulatory perspectives for Biosimilars.

Comparability - Case Studies with Discussions

Adjournment

Evening free to explore Madison

Continental Breakfast/Networking

Project Management in the World of CMC Biologics-Part 1

Speaker: Ardala Katzfuss, PhD, Applied Drug Development, University of WI-Madison, School of Pharmacy, Madison, WI

Project Management in the World of CMC Biologics-Part 2

Speaker: Ardala Katzfuss, PhD

Team Exercise #4

Moderator: Faculty

Team Exercise #4: Sub-groups report to entire group

Sub-groups present their assessments for drug substance and drug product changes

Team Exercise #5: Introduction and Working Session

Moderator: Rick Pyter faculty

Continental Breakfast/Networking

Tales of CMC Product Development
Instructors, staff and students are invited to share experiences on their real-life project successes, failures and 'what if' scenarios.

Team Exercise #5 - Sub-groups Report to Entire Group

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

Course summary

Instructors, staff and students  are invited to share experiences on their real-life project successes, “failures” and “what if” scenarios. 

Course Assessments

Rob Hagen, 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.