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Wed, Nov 12
Thu, Nov 13
Fri, Nov 14
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Wednesday, November 12, 2025
7:00 AM - 5:00 PM
East Coast USA Time
Registration
7:30 AM - 5:00 PM
East Coast USA Time
Registration
Location: Narragansett Coatroom
7:00 AM - 8:00 PM
East Coast USA Time
Breakfast
7:45 AM - 8:45 AM
East Coast USA Time
Breakfast
Location: Narragansett Foyer
8:00 AM - 11:35 AM
East Coast USA Time
FDA Office Hours
8:00 AM - 11:35 AM
East Coast USA Time
FDA Office Hours
Location: Blackstone
8:45 AM - 11:30 AM
East Coast USA Time
Workshop: Hot Topics for Combination Products
8:45 AM - 11:30 AM
East Coast USA Time
Workshop: Hot Topics for Combination Products
Location: Narragansett Ballroom
Moderator:
Jason Lipman
– Sanofi
Moderator:
Hemal Mehta
– Johnson & Johnson
Speaker:
Tanner Barnes
– Novo Nordisk
Speaker:
Nish Gupta
– Genentech
Speaker:
Willy Liou
– Amgen
Speaker:
Amanda Matthews
– Pfizer
Speaker:
John McMichael (he/him/his)
– AstraZeneca
Speaker:
Andrea Redd
– Eli Lilly
Speaker:
Alexander Valenca
– Sanofi
10:00 AM - 10:15 AM
East Coast USA Time
BREAK
10:00 AM - 10:15 AM
East Coast USA Time
BREAK
Location: Narragansett Foyer
11:30 AM - 12:30 PM
East Coast USA Time
LUNCH
11:30 AM - 12:30 PM
East Coast USA Time
LUNCH
Location: Providence Ballroom
12:30 PM - 3:00 PM
East Coast USA Time
Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions
12:30 PM - 3:00 PM
East Coast USA Time
Workshop: Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions
Location: Narragansett Ballroom
Moderator:
Rumi Young
– Novo Nordisk
Moderator:
Tine Schroder-Albeck
– ALK A/S
Moderator:
Ryan Hoshi
– AbbVie, Inc.
Speaker:
Alexis Boaz
– Epstein Becker Green
Speaker:
Katie Chowdhury
– AbbVie, Inc
Speaker:
Margaret Kober
– FDA (Virtual)
Speaker:
Patricia Love
– FDA (Virtual)
Speaker:
Harshit Thakkar
– DEKRA Certification B.V.
3:00 PM - 3:15 PM
East Coast USA Time
BREAK
3:00 PM - 3:15 PM
East Coast USA Time
BREAK
Location: Narragansett Foyer
3:15 PM - 5:15 PM
East Coast USA Time
EDDO
3:15 PM - 5:15 PM
East Coast USA Time
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products – Understanding Requirements and Opportunities to Refine Implementation
Location: Narragansett Ballroom
Moderator:
Ryan McGowan
– AstraZeneca
Moderator:
Andrea Redd
– Eli Lilly
Speaker:
Kristin Benokraitis
– Merck
Speaker:
Fran DeGrazio
– Strategic Parenteral Solutions
Speaker:
John McMichael (he/him/his)
– AstraZeneca
Speaker:
Susan Neadle (she/her/hers)
– Combination Products Consulting Services, LLC
Speaker:
Suzette Roan
– Sanofi
Thursday, November 13, 2025
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
Location: Narragansett Foyer
7:00 AM - 5:00 PM
East Coast USA Time
Registration
7:00 AM - 5:00 PM
East Coast USA Time
Registration
Location: Narragansett Coatroom
8:00 AM - 8:20 AM
East Coast USA Time
Let's Make a Difference
8:00 AM - 8:20 AM
East Coast USA Time
Let's Make a Difference
Location: Narragansett Ballroom
Speaker:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
Speaker:
Steven Mandernach
– Association of Food and Drug Officials (AFDO)
Speaker:
Brian Savoie
– Regulatory Affairs Professionals Society (RAPS)
8:20 AM - 9:20 AM
East Coast USA Time
The Solutions Exchange
8:20 AM - 9:20 AM
East Coast USA Time
The Solutions Exchange
Location: Narragansett Ballroom
Moderator:
Tine Schroder-Albeck
– ALK A/S
Moderator:
Khaudeja Bano
– Genentech/Roche
9:10 AM - 9:55 AM
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
9:25 AM - 9:55 AM
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
Location: Narragansett Ballroom
Moderator:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
Speaker:
James Bertram
– FDA (Virtual)
9:55 AM - 10:20 AM
East Coast USA Time
BREAK
9:55 AM - 10:20 AM
East Coast USA Time
BREAK
Location: Narragansett Foyer
10:20 AM - 11:20 AM
East Coast USA Time
Global Harmonization in the Diverging Combination Products Space
10:20 AM - 11:20 AM
East Coast USA Time
Global Harmonization in the Diverging Combination Products Space
Location: Narragansett Ballroom
Moderator:
Susan Neadle (she/her/hers)
– Combination Products Consulting Services, LLC
Speaker:
Ashley Boam (she/her/hers)
– FDA (Virtual)
Speaker:
Katie Duncan (she/her/hers)
– GSK
Speaker:
Subhi Saadeh
– Gilead Sciences
Speaker:
John Weiner
– Barr Consulting LLC
Speaker:
Mohammad Alkudsi
– Saudi Food and Drug Authority (SFDA) (Virtual)
11:25 AM - 12:25 AM
East Coast USA Time
Clinical Investigations for Combined Use Systems
11:25 AM - 12:25 PM
East Coast USA Time
Clinical Investigations for Combined Use Systems
Location: Narragansett Ballroom
Moderator:
Tine Schroder-Albeck
– ALK A/S
Moderator:
Ryan McGowan
– AstraZeneca
Speaker:
Tim Chesworth (he/him/his)
– Novartis
Speaker:
Ditte Zerlang Andersen (Virtual)
– Danish Medicines Agency
12:25 PM - 1:40 PM
East Coast USA Time
LUNCH
12:25 PM - 1:40 PM
East Coast USA Time
LUNCH (Click to see information on table topics)
Location: Providence Ballroom Foyer
1:40 PM - 2:25 PM
East Coast USA Time
Challenges and Opportunities in Advancing the Use of AI Technologies Across the Combination Product and Combined Use Lifecycle
1:40 PM - 2:25 PM
East Coast USA Time
Challenges and Opportunities in Advancing the Use of AI Technologies Across the Combination Product and Combined Use Lifecycle
Location: Narragansett Ballroom
Moderator:
Ryan Hoshi
– AbbVie, Inc.
Speaker:
Kathryn Drzewiecki
– FDA (Virtual)
Speaker:
Xia Huang (he/him/his)
– DEKRA
Speaker:
Christina Kuhn
– Covington & Burling
2:30 PM - 3:30 PM
East Coast USA Time
Under Control: Combination Products Control Strategies and Best Practices
2:30 PM - 3:30 PM
East Coast USA Time
EDDO Combination Product Control Strategies and Best Practices
Location: Narragansett Ballroom
Moderator:
Rumi Young
– Novo Nordisk
Speaker:
Anna Karina Busch
– Novo Nordisk
Speaker:
Ashley Boam (she/her/hers)
– FDA (Virtual)
Speaker:
Susan Clemmons
– GSK
Speaker:
Willy Liou
– Amgen
Speaker:
Shruti Mistry
– FDA (Virtual)
3:30 PM - 3:55 PM
East Coast USA Time
BREAK
3:30 PM - 3:55 PM
East Coast USA Time
BREAK
Location: Narragansett Foyer
3:55 PM - 4:55 PM
East Coast USA Time
Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management
3:55 PM - 4:55 PM
East Coast USA Time
Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management
Location: Narragansett Ballroom
Moderator:
Jiaying Shen
– Merck
Speaker:
ChiaYee Ang
– Lilly
Speaker:
Khaudeja Bano
– Genentech/Roche
Speaker:
Susan Neadle (she/her/hers)
– Combination Products Consulting Services, LLC
4:55 PM - 5:05 PM
East Coast USA Time
Close Out
4:55 PM - 5:05 PM
East Coast USA Time
Close Out
Location: Narragansett Ballroom
Moderator:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
5:30 PM - 7:00 PM
East Coast USA Time
Networking Reception
5:30 PM - 7:00 PM
East Coast USA Time
Networking Reception
Location: Providence Ballroom
Friday, November 14, 2025
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
Location: Narragansett Foyer
7:00 AM - 5:00 PM
East Coast USA Time
Registration
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
8:00 AM - 8:10 AM
East Coast USA Time
Day 2 Opening
Location: Narragansett Ballroom
Speaker:
Kimberly Belsky
– 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
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:
Rumi Young
– Novo Nordisk
Speaker:
Matt Marber
– Novo Nordisk
Speaker:
Tina Rees
– Regeneron
Speaker:
Jiaying Shen
– Merck
9:25 AM - 9:50 AM
East Coast USA Time
BREAK
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
9:50 AM - 10:50 AM
East Coast USA Time
Challenges of Supplier & Partner Relationships
Location: Narragansett Ballroom
Moderator:
Jason Lipman
– Sanofi
Speaker:
Jennifer Brennan
– Sanofi
Speaker:
Meenakshi Gupta
– Sanofi
Speaker:
Hrishikesh Khatav
– Becton Dickinson & Co
Speaker:
Gwendolyn Payne
– Enable Injections
10:55 AM - 12:10 PM
East Coast USA Time
Drug-Delivery Device Clinical Bridging: Leverage Platform Approach and Prior Knowledge
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:
Chin-Wei Soo (he/him/his)
– Genentech/Roche
Speaker:
Dez Crisolo
– Genentech
Speaker:
Patricia Love
– FDA (Virtual)
Speaker:
Andrea Redd
– Eli Lilly
Speaker:
Lisa Wright
– Novo Nordisk
12:10 PM - 1:10 PM
East Coast USA Time
LUNCH
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
1:15 PM - 2:30 PM
East Coast USA Time
Navigating Clinical Strategies for Combination Products with Investigational Devices
Location: Narragansett Ballroom
Moderator:
Andrea Redd
– Eli Lilly
Moderator:
James Wabby
– AbbVie, Inc.
Speaker:
Carolyn Dorgan (she/her/hers)
– Suttons Creek
Speaker:
Andrea Gray
– FDA (Virtual)
Speaker:
Alan Stevens
– AbbVie, Inc.
Speaker:
Amy Wise
– AbbVie, Inc.
Speaker:
Jerzy Wojcik
– EdgeOne Medical
2:35 PM - 3:35 PM
East Coast USA Time
FDA Fireside Chat
2:35 PM - 3:35 PM
East Coast USA Time
Fireside Chat and Summit Recap
Location: Narragansett Ballroom
Moderator:
Jason Lipman
– Sanofi
Moderator:
Ryan McGowan
– AstraZeneca
Speaker:
James Bertram
– FDA (Virtual)
3:35 PM - 3:45 PM
East Coast USA Time
Summit Close-Out
3:35 PM - 3:45 PM
East Coast USA Time
Summit Close-Out
Location: Narragansett Ballroom
Speaker:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
