C2: Drug Quality Lifecycle: Current Regulatory Concerns

Moderator(s)

• 

  Patricia Hughes, PhD

  Senior Scientific Advisor, CDER
  U.S. FDA
  Silver spring, Maryland, United States

Panelist(s)

• 

  Gang Chen, PhD

  Vice President
  Regeneron Pharmaceuticals, Inc.
  Tarrytown, New York, United States
• 

  Pamela De Moor, MS, PhD

  Senior Director, Formulations and Drug Product Development
  Vir Biotechnology, Inc
  Palo Alto, California, United States
• 

  Michele Lastro, MS, PhD

  Executive Director
  Regeneron Pharmaceuticals, Inc.
  Fonda, New York, United States

Presenter(s)

• 

  Pamela De Moor, MS, PhD

  Senior Director, Formulations and Drug Product Development
  Vir Biotechnology, Inc
  Palo Alto, California, United States

  Presentation Handout
• 

  Michele Lastro, MS, PhD

  Executive Director
  Regeneron Pharmaceuticals, Inc.
  Fonda, New York, United States

  Presentation Handout

Regulatory Panelist(s)

• 

  Maria Gutierrez Lugo, PhD

  Supervisory Chemist, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Presentations:

• 13:30 – 13:54 EDT

  Regulatory Approaches to Accelerated SARS-CoV-2 Neutralizing Antibody Development
  

  Regulatory Presenter: Maria T. Gutierrez Lugo, PhD – U.S. FDA
• 13:54 – 14:17 EDT

  Delivering Therapeutic mAbs for COVID-19: What Can Be Done in Just One Year
  

  Presenter: Pamela C. De Moor, MS, PhD – Vir Biotechnology, Inc
• 14:17 – 14:37 EDT

  From Benchtop to BLA in Record Time: A Case Study
  

  Presenter: Michele Lastro, MS, PhD – Regeneron Pharmaceuticals, Inc.
• 14:37 – 15:00 EDT

  Live Q&A (C2)
  

  Moderator: Patricia F. Hughes, PhD – U.S. FDA

  Panelist: Gang Chen, PhD – Regeneron Pharmaceuticals, Inc.

  Panelist: Pamela C. De Moor, MS, PhD – Vir Biotechnology, Inc

  Panelist: Michele Lastro, MS, PhD – Regeneron Pharmaceuticals, Inc.

  Regulatory Panelist: Maria T. Gutierrez Lugo, PhD – U.S. FDA