C1: Holistic Capacity Planning: Best Practices and Lessons Learned from New Therapeutic Modalities

Moderator(s)

• 

  Ingrid Markovic, PhD

  Senior Science Advisor, Office of the Center Director, CBER
  U.S. FDA
  Silver Spring, Maryland, United States

Panelist(s)

• 

  Alicia Collins

  Senior Director, Cell Therapy Global Product Supply Planning and Management
  Bristol Myers Squibb
  Seattle, Washington, United States
• 

  Roger Nosal, MA

  Vice President, GCMC
  Pfizer
  Groton, Connecticut, United States

Presenter(s)

• 

  Alicia Collins

  Senior Director, Cell Therapy Global Product Supply Planning and Management
  Bristol Myers Squibb
  Seattle, Washington, United States

  Presentation Handout
• 

  Roger Nosal, MA

  Vice President, GCMC
  Pfizer
  Groton, Connecticut, United States

Regulatory Panelist(s)

• 

  Lily Koo, PhD

  Biomedical Engineer, CBER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Sau (Larry) Lee, PhD

  Deputy Director of Science, OPQ, CDER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Kimberly Schultz, PhD

  GTB CMC Reviewer, CBER
  U.S. FDA
  Silver Spring, Maryland, United States

Sudden onset of market and public health demands during in the face of global pandemic could lead to major capacity crunches causing production delays and/or unintended product quality outcomes. Holistic evaluation of process, facility, and operational requirements to identify potential bottlenecks is critical when planning for projected commercial manufacturing expansion (scale-up or scale-out) to ensure timely delivery of transformative therapies to patients with consistent product quality. Rapid advancement of C>s products and COVID-19 vaccines necessitated implementation of flexible and sustainable operational and facility designs. These could offer valuable learnings with operational aspects of individualized therapies possibly as challenging as those for the off-the-shelf products.

Presentations:

• 13:30 – 13:51 EDT

  Capacity Considerations for Cell & Gene Therapy Products
  

  Regulatory Presenter: Kimberly LW Schultz, PhD – U.S. FDA
• 13:51 – 14:10 EDT

  Capacity Planning for Individualized Therapies
  

  Presenter: Alicia D. Collins – Bristol Myers Squibb
• 14:10 – 14:33 EDT

  mRNA Vaccines: A Paradigm Shift for Product Development & Manufacturing Capacity
  

  Presenter: Roger Nosal, MA – Pfizer
• 14:33 – 15:00 EDT

  Live Q&A (C1)
  

  Moderator: Ingrid Markovic, PhD – U.S. FDA

  Panelist: Alicia D. Collins – Bristol Myers Squibb

  Panelist: Roger Nosal, MA – Pfizer

  Regulatory Panelist: Lily Y. Koo, PhD – U.S. FDA

  Regulatory Panelist: Sau (Larry) L. Lee, PhD – U.S. FDA

  Regulatory Panelist: Kimberly LW Schultz, PhD – U.S. FDA