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Mon, Nov 16
Tue, Nov 17
Wed, Nov 18
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Monday, November 16, 2026
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 5:00pm
East Coast USA Time
Registration
7:00am - 5:00pm
East Coast USA Time
Registration
8:00am - 9:30am
East Coast USA Time
Integrated Combination Product Shelf Life Strategy
8:00am - 9:30am
East Coast USA Time
Integrated Combination Product Shelf Life Strategy
Moderator:
Andrea Redd
– Eli Lilly
Moderator:
Chin-Wei Soo
– Genentech/Roche
9:30am - 9:50am
East Coast USA Time
BREAK
9:30am - 9:50am
East Coast USA Time
BREAK
9:55am - 11:25am
East Coast USA Time
Hot Topics For Combination Products
9:55am - 11:25am
East Coast USA Time
Hot Topics For Combination Products
Moderator:
Jason Lipman
– Sanofi
Speaker:
Willy Liou
– Amgen
Speaker:
Ana Gomez Bent
– Novo Nordisk
Speaker:
Amanda Matthews
– Pfizer
Speaker:
John McMichael
– AstraZeneca
Speaker:
Hemal Mehta
– Johnson & Johnson
Speaker:
Andrea Redd
– Eli Lilly
Speaker:
Porsche Sanders
– Genentech/Roche
Speaker:
Alexander Valenca
– Sanofi
11:25am - 12:25pm
East Coast USA Time
LUNCH
11:25am - 12:25pm
East Coast USA Time
LUNCH
12:30pm - 2:00pm
East Coast USA Time
Hot Topics For Combination Products
12:30pm - 2:00pm
East Coast USA Time
Hot Topics For Combination Products (continued)
Moderator:
Jason Lipman
– Sanofi
Speaker:
Ana Gomez Bent
– Novo Nordisk
Speaker:
Willy Liou
– Amgen
Speaker:
Amanda Matthews
– Pfizer
Speaker:
John McMichael
– AstraZeneca
Speaker:
Hemal Mehta
– Johnson & Johnson
Speaker:
Andrea Redd
– Eli Lilly
Speaker:
Porsche Sanders
– Genentech/Roche
Speaker:
Alexander Valenca
– Sanofi
2:05pm - 2:25pm
East Coast USA Time
BREAK
2:05pm - 2:25pm
East Coast USA Time
BREAK
2:30pm - 5:00pm
East Coast USA Time
Building a Platform Combination Product
2:30pm - 5:00pm
East Coast USA Time
Building a Platform Combination Product
Moderator:
Rumi Young
– Novo Nordisk
Moderator:
James Bertram
– FDA
Moderator:
Fran DeGrazio
– Strategic Parenteral Solutions
Speaker:
Tina Kiang
– FDA
Speaker:
Patricia Love
– FDA (Virtual)
Speaker:
Sarah Mollo
– Suttons Creek
Speaker:
Alan Stevens
– AbbVie, Inc.
Speaker:
Lisa Wright
– Novo Nordisk
Tuesday, November 17, 2026
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 5:00pm
East Coast USA Time
Registration
7:00am - 5:00pm
East Coast USA Time
Registration
8:00am - 8:20am
East Coast USA Time
Let's Make A Difference
8:00am - 8:20am
East Coast USA Time
Let's Make A Difference
8:20am - 9:05am
East Coast USA Time
The Solutions Exchange
8:20am - 9:05am
East Coast USA Time
The Solutions Exchange
Moderator:
Ryan McGowan
– AstraZeneca
Moderator:
Tine Albeck
– ALK A/S
Moderator:
Khaudeja Bano
– Genentech/Roche
9:10am - 9:40am
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
9:10am - 9:40am
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
Moderator:
Tricia Young
– AFDO/RAPS Healthcare Products Collaborative
Speaker:
James Bertram
– FDA
9:40am - 10:05am
East Coast USA Time
Break
9:40am - 10:05am
East Coast USA Time
Break
10:05am - 10:20am
East Coast USA Time
Workshop Readout
10:05am - 10:20am
East Coast USA Time
Workshop Readout
10:25am - 11:25am
East Coast USA Time
Evolving European Union Legislation, Regulation, and Policy for Integral Drug-Device Combinations
10:25am - 11:25am
East Coast USA Time
Evolving European Union Legislation, Regulation, and Policy for Integral Drug-Device Combinations
Moderator:
Tine Albeck
– ALK A/S
Moderator:
Amanda Matthews
– Pfizer
Speaker:
Andreas Emmendoerffe
– Roche Diagnostics (Virtual)
Speaker:
Thomas Moller Wejs
– Novo Nordisk
11:25am - 12:55pm
East Coast USA Time
LUNCH
11:25am - 12:55pm
East Coast USA Time
LUNCH
12:55pm - 1:55pm
East Coast USA Time
Clinical Investigations for Combined Use Systems (2026 update)
12:55pm - 1:55pm
East Coast USA Time
Clinical Investigations for Combined Use Systems (2026 update)
Moderator:
Jason Lipman
– Sanofi
Speaker:
Luke Kirsch
– Genentech/Roche
Speaker:
Aditya Sukthankar
– Sanofi
2:00pm - 3:00pm
East Coast USA Time
The New Frontier: Evolving Pharma Capabilities for Standalone Devices
2:00pm - 3:00pm
East Coast USA Time
The New Frontier: Evolving Pharma Capabilities for Standalone Devices
Moderator:
Chin-Wei Soo
– Genentech/Roche
Speaker:
James Bertram
– FDA
Speaker:
Andrea Gray
– FDA
Speaker:
Shruti Mistry
– FDA (Invited)
Speaker:
Alan Stevens
– AbbVie, Inc.
3:00pm - 3:25pm
East Coast USA Time
BREAK
3:00pm - 3:25pm
East Coast USA Time
BREAK
3:25pm - 4:25pm
East Coast USA Time
10 Years Since US Combination Product cGMP Regulations: Reflections on Requirements, Expectations, and Enforcement.
3:25pm - 4:25pm
East Coast USA Time
10 Years Since US Combination Product cGMP Regulations: Reflections on Requirements, Expectations, and Enforcement.
Moderator:
Ryan McGowan
– AstraZeneca
Speaker:
James Bertram
– FDA
Speaker:
Steven Hertz
– FDA (Invited)
Speaker:
John Weiner
– Barr Consulting LLC
4:30pm - 5:15pm
East Coast USA Time
Right Dose, Real Impact: Strategies to Ensure Consistent Dose for Every Patient
4:30pm - 5:15pm
East Coast USA Time
Right Dose, Real Impact: Strategies to Ensure Consistent Dose for Every Patient
Moderator:
Chin-Wei Soo
– Genentech/Roche
Moderator:
Andrea Redd
– Eli Lilly
Speaker:
Ashley Boam
– FDA
5:20pm - 5:30pm
East Coast USA Time
Day 1 Close-Out
5:20pm - 5:30pm
East Coast USA Time
Day 1 Close-Out
Moderator:
Tricia Young
– AFDO/RAPS Healthcare Products Collaborative
5:30pm - 6:30pm
East Coast USA Time
Networking Reception
5:30pm - 6:30pm
East Coast USA Time
Networking Reception
Wednesday, November 18, 2026
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 3:00pm
East Coast USA Time
Registration
7:00am - 3:00pm
East Coast USA Time
Registration
8:00am - 8:10am
East Coast USA Time
Day 2 Opening
8:00am - 8:10am
East Coast USA Time
Day 2 Opening
Moderator:
Tricia Young
– AFDO/RAPS Healthcare Products Collaborative
8:10am - 9:10am
East Coast USA Time
Global Updates for Drug Delivery
8:10am - 9:10am
East Coast USA Time
Global Updates for Drug Delivery
Moderator:
Rumi Young
– Novo Nordisk
Moderator:
Ryan Hoshi
– AbbVie, Inc.
Speaker:
Mohammad Alkudsi
– Saudi Food and Drug Authority (SFDA) (Invited)
Speaker:
Ashley Boam
– FDA
Speaker:
Erin Cutts
– FDA
Speaker:
Augusto Geyer
– Anvisa
9:15am - 10:15am
East Coast USA Time
Digital Innovation Integrated with Advanced On-Body Drug Delivery Systems (OBDS)
9:15am - 10:15am
East Coast USA Time
Digital Innovation Integrated with Advanced On-Body Drug Delivery Systems (OBDS)
Moderator:
James Wabby
– AbbVie, Inc.
Speaker:
Carolyn Dorgan
– Suttons Creek
Speaker:
Alan Stevens
– AbbVie, Inc.
10:15am - 10:40am
East Coast USA Time
BREAK
10:15am - 10:40am
East Coast USA Time
BREAK
10:40am - 12:10pm
East Coast USA Time
FDA and Industry Insights: QMSR Impacts on Combination Product Design, Development & Risk and How to Prepare for Compliance
10:40am - 12:10pm
East Coast USA Time
FDA and Industry Insights: QMSR Impacts on Combination Product Design, Development & Risk and How to Prepare for Compliance
Moderator:
Jiaying Shen
– Merck
Speaker:
Khaudeja Bano
– Genentech/Roche
Speaker:
Fady Khalla
– Merck
Speaker:
Karen Masley-Joseph
– FDA (Invited)
Speaker:
Keisha Thomas
– FDA (Invited)
12:10pm - 1:10pm
East Coast USA Time
LUNCH
12:10pm - 1:10pm
East Coast USA Time
LUNCH
1:10pm - 2:10pm
East Coast USA Time
Timely Changes: FDA Expectations and Industry Strategies for Combination Products
1:10pm - 2:10pm
East Coast USA Time
Timely Changes: FDA Expectations and Industry Strategies for Combination Products
Moderator:
Rumi Young
– Novo Nordisk
Speaker:
ChiaYee Ang
– Lilly
Speaker:
Melissa Burns
– FDA (Invited)
Speaker:
Tina Kiang
– FDA
Speaker:
Alan Stevens
– AbbVie, Inc.
2:10pm - 3:10pm
East Coast USA Time
Fireside Chat
2:10pm - 3:10pm
East Coast USA Time
Fireside Chat
Speaker:
James Bertram
– FDA
3:10pm - 3:20pm
East Coast USA Time
Close-Out
3:10pm - 3:20pm
East Coast USA Time
Close-Out
Moderator:
Tricia Young
– AFDO/RAPS Healthcare Products Collaborative
