Track: SUPPLY CHAIN & MANUFACTURING CHALLENGES

B1: Supply Chain Collaboration and Product Approvals during a Pandemic

Moderator(s)

• 

  Paul Balcer

  Program Manager, CDER
  U.S. FDA
  Arvada, Colorado, United States

Panelist(s)

• 

  Pat O'Sullivan, MBA

  Vice President Supply Chain for Sanofi Genzyme
  Sanofi
  Cobh , Cork, Ireland

Regulatory Panelist(s)

• 

  Mahesh Ramanadham, PharmD, MBA

  Associate Director Scientific Operations, CDER
  U.S. FDA
  Highland, Maryland, United States

As treatments for COVID-19 infections were deployed during the pandemic, we were faced with challenges in drug supply of life saving medicines. Some countries enacted export bans of certain drugs, and other factors including plant staffing caused strains on the existing supply chains of APIs, raw materials, and finished drug products. Pandemic travel bans limited inspections of drug manufacturing facilities. We will examine the effect of the pandemic on drug supply chain and drug applications. The session will include regulatory experiences with EUAs and how use of tools such as remote assessments provided insight into facilities named in drug applications.

Presentations:

• 13:30 – 14:03 EDT

  Supply Chain and Inspections during the Public Health Emergency (PHE)
  

  Regulatory Presenter: Mahesh R. Ramanadham, PharmD, MBA – U.S. FDA
• 14:03 – 14:17 EDT

  Supply Chain Collaboration during a Pandemic
  

  Presenter: Pat C. O'Sullivan, MBA – Sanofi
• 14:17 – 15:00 EDT

  Live Q&A (B1)
  

  Moderator: Paul Z. Balcer – U.S. FDA

  Panelist: Pat C. O'Sullivan, MBA – Sanofi

  Regulatory Panelist: Mahesh R. Ramanadham, PharmD, MBA – U.S. FDA