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Full Agenda
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Sun, Sep 7
Mon, Sep 8
Tue, Sep 9
Wed, Sep 10
Thu, Sep 11
Fri, Sep 12
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Sunday, September 7, 2025
11:30 - 13:00
ET
Advisory Board Luncheon (River Birch A) (Invite Only)
11:30 - 13:00
ET
Advisory Board Luncheon (River Birch A) (Invite Only)
Location: River Birch A
13:00 - 17:00
ET
Advanced Therapy Medicinal Products Advisory Board (MR 14) (Invite Only)
AB Chair:
Friedrich von Wintzingerode, PhD (he/him/his)
– Genentech, a Member of the Roche Group
AB Vice-Chair:
Monica Markovski Commerford, PhD
– Thermo Fisher Scientific
13:00 - 17:00
ET
Advanced Therapy Medicinal Products Advisory Board (MR 14) (Invite Only)
Location: MR 14
AB Chair:
Friedrich von Wintzingerode, PhD (he/him/his)
– Genentech, a Member of the Roche Group
AB Vice-Chair:
Monica Markovski Commerford, PhD
– Thermo Fisher Scientific
13:00 - 17:00
ET
Biopharmaceutical Advisory Board (MR 15) (Invite Only)
AB Chair:
Maxwell De Long, MS, MechE (he/him/his)
– Genentech
AB Vice-Chair:
Peter J. Makowenskyj, MEng
– G-CON
13:00 - 17:00
ET
Biopharmaceutical Advisory Board (MR 15) (Invite Only)
Location: MR15
AB Chair:
Maxwell De Long, MS, MechE (he/him/his)
– Genentech
AB Vice-Chair:
Peter J. Makowenskyj, MEng
– G-CON
13:00 - 17:00
ET
Regulatory Affairs and Quality Advisory Board (MR 16) (Invite Only)
AB Chair:
Eva M. Urban, MSc (she/her/hers)
– Bristol Myers Squibb
AB Vice-Chair:
Vinny Browning, MS
– Amgen
13:00 - 17:00
ET
Regulatory Affairs and Quality Advisory Board (MR 16) (Invite Only)
Location: MR16
AB Chair:
Eva M. Urban, MSc (she/her/hers)
– Bristol Myers Squibb
AB Vice-Chair:
Vinny Browning, MS
– Amgen
13:00 - 17:00
ET
Science Advisory Board (MR 13) (Invite Only)
AB Chair:
Ivy Louis, MPharm, MBA(HRM)
– Vienni Training & Consulting LLP
AB Vice-Chair:
Ken Paddock
– Merz Aesthetics
13:00 - 17:00
ET
Science Advisory Board (MR 13) (Invite Only)
Location: MR 13
AB Chair:
Ivy Louis, MPharm, MBA(HRM)
– Vienni Training & Consulting LLP
AB Vice-Chair:
Ken Paddock
– Merz Aesthetics
14:00 - 19:00
ET
Registration Open (Rock Creek Ballroom Registration Desk)
14:00 - 19:00
ET
Registration Open (Rock Creek Ballroom Registration Desk)
Location: Rock Creek Ballroom Registration Desk
15:00 - 18:00
ET
Presenter Ready Room Open (Meeting Planner Office B)
15:00 - 18:00
ET
Presenter Ready Room Open (Meeting Planner Office B)
Location: Meeting Planner Office B
16:00 - 17:30
ET
PDA Capital Area Chapter Roundtable: FDA Complete Response Letters: A Growing Industry Challenge with Big Impacts (Rock Creek B)
Moderator:
Glenn E. Wright, MA
– PDA
16:00 - 17:30
ET
PDA Capital Area Chapter Roundtable: FDA Complete Response Letters: A Growing Industry Challenge with Big Impacts (Rock Creek B)
Location: Rock Creek B
Moderator:
Glenn E. Wright, MA
– PDA
16:00 - 16:05
ET
Chapter Welcome and Introductory Remarks
Location: Rock Creek B
Presenter:
Martin S. Jenkins, Jr., PMP (he/him/his)
– Circle MJ Consulting
16:05 - 16:20
ET
CRL Recap
Location: Rock Creek B
Presenter:
Glenn E. Wright, MA
– PDA
16:20 - 16:50
ET
CRL Impacts and Current Issues
Location: Rock Creek B
Presenter:
Thomas J. Cosgrove, JD
– Covington & Burling LLP
16:50 - 17:20
ET
Q&A with Additional Panelists
Location: Rock Creek B
Panelist:
Ghada N. Haddad, PhD
– Kite Pharma
Panelist:
Anil D. Sawant, PhD
– Merck & Co., Inc.
Panelist:
Stelios C. Tsinontides, PhD, FAIChE
– Merck & Co., Inc.
17:20 - 17:30
ET
Closing Remarks
Location: Rock Creek B
Presenter:
Glenn E. Wright, MA
– PDA
