Full Schedule

7:00 AM - 8:00 AM East Coast USA Time

Breakfast

8:00 AM - 8:10 AM East Coast USA Time

Day 2 Opening

Speaker: – AFDO/RAPS Healthcare Products Collaborative

8:10 AM - 9:25 AM East Coast USA Time

Navigating Human Factors for Combination Products, Including Generic: URRA, Threshold Analysis and Post Market

Moderator: – Novo Nordisk

Speaker: – Novo Nordisk

Speaker: – Regeneron

Speaker: – Merck

Speaker: – FDA (Virtual)

9:25 AM - 9:50 AM East Coast USA Time

BREAK

9:50 AM - 10:50 AM East Coast USA Time

Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management

Moderator: – Merck

Speaker: – Lilly

Speaker: – Genentech/Roche

Speaker: – Combination Products Consulting Services, LLC

10:55 AM - 12:10 PM East Coast USA Time

Drug-Delivery Device Clinical Bridging: Leveraging Platform Approach and Prior Knowledge

Moderator: – Genentech/Roche

Speaker: – Genentech

Speaker: – Eli Lilly

Speaker: – Novo Nordisk

12:10 PM - 1:10 PM East Coast USA Time

LUNCH

1:15 PM - 2:30 PM East Coast USA Time

Navigating Clinical Strategies for Combination Products with Investigational Devices

Moderator: – Eli Lilly

Moderator: – AbbVie, Inc.

Speaker: – Suttons Creek

Speaker: – FDA

Speaker: – AbbVie, Inc.

Speaker: – Edgeone Medical

2:35 PM - 3:35 PM East Coast USA Time

FDA Fireside Chat

Moderator: – Sanofi

Moderator: – AstraZeneca

Speaker: – FDA (Invited)

3:35 PM - 3:45 PM East Coast USA Time

Summit Close-Out

Speaker: – AFDO/RAPS Healthcare Products Collaborative