Plenary 1: Opening Plenary

Chairperson(s)

• 

  Jette Christensen, MSc

  Scientific Director
  Novo Nordisk A/S
  Gentofte, Hovedstaden, Denmark

Co-Chair(s)

• 

  Francis Godwin, MBA

  Office Director, OC, CDER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Valerie Whelan

  Vice President, Quality
  Thermo Fisher Scientific
  Ballycoolin, Dublin, Ireland

Moderator(s)

• 

  Francis Godwin, MBA

  Office Director, OC, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Panelist(s)

• 

  Darrin Cowley, PhD

  Vice President Head of Developmental Quality, Biologics
  AstraZeneca
  Longmont, Colorado, United States

President(s)

• 

  Richard Johnson, MSc

  President and CEO
  PDA
  Bethesda, Maryland, United States

Regulatory Panelist(s)

• 

  Patrizia Cavazzoni, MD

  Director, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Presentations:

• 09:15 – 09:23 EDT

  Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
  

  Chairperson: Jette Christensen, MSc – Novo Nordisk A/S

  President: Richard M. Johnson, MSc – PDA

  Co-Chair: Francis RW Godwin, MBA – U.S. FDA

  Co-Chair: Valerie Whelan – Thermo Fisher Scientific
• 09:23 – 09:46 EDT

  Updates from CDER
  

  Regulatory Presenter: Patrizia Cavazzoni, MD – U.S. FDA
• 09:46 – 10:06 EDT

  Live Q&A (P1-Cavazzoni)
  

  Moderator: Francis RW Godwin, MBA – U.S. FDA

  Regulatory Panelist: Patrizia Cavazzoni, MD – U.S. FDA
• 10:06 – 10:40 EDT

  Operating during a Global Pandemic Lessons Learned: Development through Production
  

  Presenter: Darrin J. Cowley, PhD – AstraZeneca
• 10:40 – 11:00 EDT

  Live Q&A (P1-Cowley)
  

  Moderator: Francis RW Godwin, MBA – U.S. FDA

  Panelist: Darrin J. Cowley, PhD – AstraZeneca