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A Public Meeting Agendas COMMITTEE ON STRATEGIES TO BETTER ALIGN INVESTMENTS IN INNOVATIONS FOR THERAPEUTIC DEVELOPMENT WITH DISEASE BURDEN AND UNMET NEEDS MARCH 18, 2024 VIRTUAL CLOSED SESSION 12:00â2:00 Closed SessionâBias and Conflict of Interest Discussion 2:00 Adjourn APRIL 26, 2024 VIRTUAL CLOSED SESSION 12:00â2:00 Closed SessionâBias and Conflict of Interest Discussion OPEN SESSION 2:00â2:05 Welcome Study Sponsors and Introductory Remarks Ellen MacKenzie and Don Berwick, Committee Cochairs 2:05â2:35 Sponsor Presentations Relevant to the Committeeâs Task Goutham Kandru, Gates Ventures Hannah Menelas, Peterson Center on Healthcare Mairin Mancino, Peterson Center on Healthcare 197
198 ALIGNING INVESTMENTS IN THERAPEUTIC DEVELOPMENT 2:35â3:00 Discussion and Q&A with Sponsors Ellen MacKenzie and Don Berwick, Committee Cochairs CLOSED SESSION 3:00â5:00 Closed Session 5:00 Closing Comments Ellen MacKenzie and Don Berwick, Committee Cochairs Adjourn JUNE 17, 2024 The Keck Center, 500 Fifth Street, NW Washington, DC 20001 Room 201 CLOSED SESSION 8:30â7:30 Closed Session JUNE 18, 2024 The Keck Center, 500 Fifth Street, NW Washington, DC 20001 Room 206 CLOSED SESSION 8:30â11:00 Closed Session OPEN SESSION 11:00â12:30 Panel on Decision Making for Therapeutic Innovation Investment CLOSED SESSION 12:30â1:00 Closed Session 1:00 Adjourn JULY 23, 2024 VIRTUAL CLOSED SESSION 12:00â2:00 Closed Session
APPENDIX A 199 OPEN SESSION 2:00â3:10 Guest Speaker: Peter Kolchinsky, Managing Partner and Founder, RA Capital Q&A Session with Committee Members Moderator: David Scheer, Committee Member 3:10â3:15 Break 3:15â4:25 Guest Speaker: Aaron Kesselheim, Professor of Medicine, Harvard Medical School; Faculty Member, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Womenâs Hospital; Physician, Phyllis Jen Center for Primary Care, Brigham and Womenâs Hospital Q & A Session with Committee Members Moderator: Holly Fernandez Lynch, Committee Member 4:25â4:30 Break CLOSED SESSION 4:30-5:00 Closed Session 5:00 Adjourn JULY 24, 2024 VIRTUAL CLOSED SESSION 12:00â2:30 Closed Session OPEN SESSION 2:30â3:30 Guest Speaker: Jamie Robinson, Professor of Health Economics and Director of the Berkeley Center for Health Technology, University of California, Berkeley Q&A Session with Committee Members Moderator: Scott Howell, Committee Member 3:30â3:45 Break CLOSED SESSION 3:45â5:00 Closed Session 5:00 Adjourn
200 ALIGNING INVESTMENTS IN THERAPEUTIC DEVELOPMENT SEPTEMBER 30, 2024 The Keck Center, 500 Fifth Street, NW Washington, DC 20001 Room 105 CLOSED SESSION 8:30â1:00 Closed Session OPEN SESSION 1:00 Welcome and Introduction to the Study Ellen MacKenzie, Committee Cochair 1:05 Presentation Reshma Ramachandran, Yale School of Medicine Discussion 1:25 Inma Hernandez, NAM Fellow and Moderator 2:10 Closing Remarks 2:30â5:15 Closed Session 5:15 Adjourn OCTOBER 1, 2024 The Keck Center, 500 Fifth Street, NW Washington, DC 20001 Room 105 CLOSED SESSION 8:30â1:00 Closed Session OPEN SESSION 1:00â1:05 Welcome and Introduction to the Study Don Berwick, Committee Co-Chair 1:05â1:25 Presentation Patrizia Cavazzoni, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 1:25â1:55 Discussion Stacey Adam, Committee Member and Moderator 1:55â2:00 Closing Remarks CLOSED SESSION 2:00â3:00 Closed Session 3:00 Adjourn
APPENDIX A 201 NOVEMBER 21, 2024 VIRTUAL CLOSED SESSION 12:00â1:00 Closed Session OPEN SESSION 1:00â2:00 Guest Speaker: Rob Califf, Commissioner, Food and Drug Administration Q&A Session with Committee Members Moderator: Don Berwick, Committee Cochair 2:00â2:15 Break CLOSED SESSION 2:15â5:00 Closed Session 5:00 Adjourn NOVEMBER 22, 2024 VIRTUAL CLOSED SESSION 12:00â2:00 Closed Session OPEN SESSION 2:00â3:15 Guest Speaker: Monica Bertagnolli, Director, National Institutes of Health Q&A Session with Committee Members Moderator: Ellen MacKenzie, Committee Cochair CLOSED SESSION 3:15â5:00 Closed Session 5:00 Adjourn
202 ALIGNING INVESTMENTS IN THERAPEUTIC DEVELOPMENT DECEMBER 16, 2024 2101 Constitution Avenue Washington, DC 20418 National Academy of Sciences Members Room CLOSED SESSION 9:00â1:00 Closed Session OPEN SESSION 1:00â2:15 Virtual PanelâPatient Engagement in Therapeutic Development Pamela Gavin, Chief Executive Officer, National ÂOrganization for Rare Diseases Yasmin Ibrahim, Public Health Program Director, Hepatitis B Foundation Marc Boutin, Global Head of Patient Engagement, Novartis Q&A Session with Committee Members Moderator: Joshua Salomon, Committee Member CLOSED SESSION 2:15â5:00 Closed Session DECEMBER 17, 2024 2101 Constitution Avenue Washington, DC 20418 National Academy of Sciences Members Room CLOSED SESSION 8:00â1:00 Closed Session FEBRUARY 3, 2025 The Keck Center, 500 Fifth Street, NW Washington, DC 20001 Room 105 CLOSED SESSION 9:00â5:00 Closed Session
APPENDIX A 203 FEBRUARY 4, 2025 The Keck Center, 500 Fifth Street, NW Washington, DC 20001 Room 105 CLOSED SESSION 8:30â1:00 Closed Session