FDA White Oak Campus Registration Form

Please complete the form below to register for the in-person meeting on June 21, 2023.

This event has concluded. A recording of the day’s sessions will be posted on the event page in the coming days.

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(Draft Agenda, changes possible)

8:00 am
Registration Open
8:30 am
Welcome and Introductions
Isabelle Lousada, Rosalyn Adigun, & Mat Maurer
8:40 am
Overview of ATTR Amyloidosis and Treatment Advances
Moderator: Mat Maurer
Presenter: Julian Gillmore
Discussants: Michael Polydefkis, Prem Soman
9:10 am
How Will Shifts in the Stage of Patients with ATTR-CA Affect Ongoing and Future Clinical Trials?
Moderator: Prem Soman
Presenter: Mazen Hanna
Discussants: Clemens Mittmann, Cynthia Welsh, Emmanouil Zouridakis, Franca Angeli, Jean-Michele Race, Jonathan Fox, Martha Grogan, Michael Polydefkis, Pablo Garcia-Pavia, Sam Tsimikas
9:50 am
Moderated Discussion: What can we collectively do for non-cardiac ATTR drug development?
Moderators: Rosalyn Adigun, Preston Dunnmon
Discussants: Andrew Slugg, Benjamin Booth, Jeff Kelly, Jie (Jenni) Li, John Berk, Ken Sakushima, Laura Jawidzik, Michael Polydefkis, Michael Roberts, Michelle Campbell, Motiur Rahman, Norman Stockbridge, Pablo Garcia-Pavia, Rhea Lloyd, Sylvia Kuehn, Wiley Chambers
10:20 am
10:30 am
Racial and Ethnic Disparities in ATTR
Moderator: Frederick Ruberg
Presenter: Michelle Kittleson
Discussants: Keith Ferdinand, Keyur Shah, Victoria Sanjurjo
11:00 am
Patient Perspectives: Today’s Unmet Need
Moderator: Isabelle Lousada
Presenters: Amy Feinberg, George “Hoss” Christensen, Kristen Hsu, Michael Lane, Robert “Bob” Gibson
Discussants: Kristen McCausland, Robyn Bent
12:20 pm
Moderated Discussion: What Aspect of this Disease Have We Heard from Patients that are Not Being Measured?
Moderator: Mat Maurer
Discussants: Julian Gillmore, Martha Grogan, Mazen Hanna, Michael Polydefkis

12:40 pm
1:30 pm
Approaches to Future Clinical Trial Design
Moderator: Prem Soman
Presenters: Adrian Hernandez, James Signorovitch, LJ Wei, & Pablo Garcia-Pavia
Discussants: Ahmad Masri, Charu Gandotra, Clemens Mittmann, Dalia Dawoud, Emmanouil Zouridakis, Fran Cunningham, Jean-Michele Race, Julian Gillmore, Laura Jawidzik, Mat Maurer, Matt Meldorf, Michael Maitland, Michael Polydefkis, Michele Mercuri, Michelle Campbell, Sylvia Kuehn
3:00 pm
3:10 pm
Moderated Discussion: Diversity in Research
Moderator: Frederick L. Ruberg
Presenter: Isabelle Lousada
Discussants: Alanna Morris, Keyur Shah, Mona Fiuzat, Renée Bullock-Palmer, Victoria Sanjurjo
3:40 pm
Clinical Trials, Drug Development, and Access
Moderator: Mathew S. Maurer
Presenters: Sharmila Dorbala & Dhruv Kazi
Discussants: Ahmad Masri, Dalia Dawoud, Fran Cunningham, Lynnette Henshaw, Megan Azzarone, Martin Cowie
4:20 pm
Closing Remarks
Isabelle Lousada & Rosalyn Adigun
4:25 pm