Full Schedule

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

Breakfast

Location: Narragansett Foyer

7:00 AM - 12:00 PM East Coast USA Time

Registration

Location: Narragansett Coatroom

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

Day 2 Opening

Location: Narragansett Ballroom

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

Location: Narragansett Ballroom

Moderator: – Novo Nordisk

Speaker: – Novo Nordisk

Speaker: – Regeneron

Speaker: – Merck

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

BREAK

Location: Narragansett Foyer

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

Challenges of Supplier & Partner Relationships

Location: Narragansett Ballroom

Moderator: – Sanofi

Speaker: – Sanofi

Speaker: – Becton Dickinson & Co

Speaker: – Enable Injections

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

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

Location: Narragansett Ballroom

Moderator: – Genentech/Roche

Speaker: – Genentech

Speaker: – FDA (Virtual)

Speaker: – Eli Lilly

Speaker: – Novo Nordisk

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

LUNCH

Location: Providence Ballroom Foyer

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

Navigating Clinical Strategies for Combination Products with Investigational Devices

Location: Narragansett Ballroom

Moderator: – Eli Lilly

Moderator: – AbbVie, Inc.

Speaker: – Suttons Creek

Speaker: – FDA (Virtual)

Speaker: – AbbVie, Inc.

Speaker: – EdgeOne Medical

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

Fireside Chat and Summit Recap

Location: Narragansett Ballroom

Moderator: – Sanofi

Moderator: – AstraZeneca

Speaker: – FDA (Virtual)

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

Summit Close-Out

Location: Narragansett Ballroom

Speaker: – AFDO/RAPS Healthcare Products Collaborative