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Wed, Nov 12
Thu, Nov 13
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Wednesday, November 12, 2025
7:00 AM - 8:00 PM
East Coast USA Time
Breakfast
7:45 AM - 8:45 AM
East Coast USA Time
Breakfast
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
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
– 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
11:30 AM - 12:30 PM
East Coast USA Time
LUNCH
11:30 AM - 12:30 PM
East Coast USA Time
LUNCH
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
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
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
3:15 PM - 5:15 PM
East Coast USA Time
EDDO
3:15 PM - 5:15 PM
East Coast USA Time
Workshop: Essential Drug Delivery Output
Moderator:
Susan Neadle (she/her/hers)
– Combination Products Consulting Services, LLC
Moderator:
Fran DeGrazio
– Strategic Parenteral Solutions
Speaker:
Kristin Benokraitis
– Merck
Speaker:
John McMichael
– AstraZeneca
