Appendix C
Workshop Agendas
Envisioning a Transformed Clinical Trials Enterprise for 2030: A Virtual Workshop
January 26, February 9, March 24, and May 11, 2021
Workshop Part 1: January 26, 2021
11:00 a.m.–3:30 p.m. ET
11:00 a.m. | Welcome and Opening Remarks STEVEN GALSON, Workshop Co-Chair Senior Vice President, Global Regulatory Affairs and Safety Amgen Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
SESSION I
A MORE PERSON-CENTERED AND INCLUSIVE CLINICAL TRIALS ENTERPRISE
Session Objective:
- Discuss key priority challenges and opportunities when it comes to person-centeredness and inclusivity in the 2030 clinical trials enterprise
11:10 a.m. | A Story in Action: Person-Centeredness and Inclusivity TERRIS KING Former Director, Office of Minority Health Centers for Medicare & Medicaid Services |
11:25 a.m. | Facilitated Breakout Groups (30 min) |
Discussion Questions:
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Goals to Consider for Enhancing Person-Centeredness and Inclusivity
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11:55 a.m. | Breakout Group Report-Outs (10 min) |
12:10 p.m. | BREAK (30 min) |
SESSION II
A MORE RESILIENT, SUSTAINABLE, AND TRANSPARENT CLINICAL TRIALS ENTERPRISE
Session Objective:
- Discuss key priority challenges and opportunities when it comes to building a more resilient, sustainable, and transparent clinical trials enterprise
12:45 p.m. | The State of Clinical Trials in 2021: A Perspective from Industry ELLIOTT LEVY Senior Vice President, R&D Strategy and Operations Amgen Inc. |
1:00 p.m. | A Story in Action: Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise JANET WOODCOCK Acting Commissioner of Food and Drugs U.S. Food and Drug Administration |
1:15 p.m. | Facilitated Breakout Groups (30 min) |
Discussion Questions:
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Goals to Consider for Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
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1:45 p.m. | Breakout Group Report-Outs (10 min) |
2:00 p.m. | BREAK (30 min) |
SESSION III
MORE APPROPRIATE USE OF TECHNOLOGIES TO OPTIMIZE THE CLINICAL TRIALS ENTERPRISE
Session Objective:
- Discuss key priority challenges and opportunities when it comes to appropriately using new technologies to optimize the 2030 clinical trials enterprise
2:30 p.m. | A Story in Action: Optimizing with New Technologies ROBERT CALIFF Head of Clinical Policy and Strategy Verily Life Sciences and Google Health |
2:45 p.m. | Facilitated Breakout Groups (30 min) |
Discussion Questions:
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Goals to Consider for More Appropriately Using Technology to Optimize the Clinical Trials Enterprise
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3:15 p.m. | Breakout Group Report-Outs (10 min) |
WRAP-UP
3:30 p.m. | Wrap-Up Discussion and Closing Remarks STEVEN GALSON, Workshop Co-Chair Senior Vice President, Global Regulatory Affairs and Safety Amgen Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
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3:35 p.m. | ADJOURN |
Workshop Part 2: February 9, 2021
Enhancing Outcomes in a More Person-Centered and Inclusive Clinical Trials Enterprise
11:00 a.m.–3:00 p.m. ET
11:00 a.m. | Welcome and Opening Remarks STEVEN GALSON, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
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LUTHER CLARK, Moderator Deputy Chief Patient Officer and Global Director, Scientific, Medical, and Patient Perspective Merck & Co., Inc. |
SESSION I
THE ROAD TO 2030: AN ATLAS FOR CHANGE
11:10 a.m. | Frontline Experience: A Fireside Chat ESTHER KROFAH, Moderator Executive Director FasterCures, Milken Institute |
ELISEO PÉREZ-STABLE Director National Institute on Minority Health and Health Disparities National Institutes of Health |
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RICHARDAE ARAOJO Associate Commissioner for Minority Health Director, Office of Minority Health and Health Equity U.S. Food and Drug Administration |
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MEGAN O’BOYLE Principal Investigator Phelan-McDermid Syndrome Registry |
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11:45 a.m. | Charge to the Breakout Groups |
11:50 a.m. | “Lightning Round” Breakout Discussion Groups (30 min) |
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12:30 p.m. | Session I Wrap-Up (10 min) |
12:45 p.m. | BREAK (30 min) |
SESSION II THE ROAD TO 2030: A CALL TO ACTION
1:15 p.m. | “North-Star” Visions of What Is Possible (10 min each) SILAS BUCHANAN Chief Executive Officer Institute for eHealth Equity |
MARILYN A. METCALF Senior Director, Patient Engagement GlaxoSmithKline |
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1:40 p.m. | Frontline Experience: A Road Already Traveled MARGARET ANDERSON Consulting Managing Director, Strategy and Analytics Deloitte |
1:50 p.m. | Charge to the Breakout Groups |
2:00 p.m. | “Lightning Round” Breakout Discussion Groups (30 min) |
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2:30 p.m. | Session II Wrap-Up (10 min) |
WRAP-UP
2:45 p.m. | Wrap-Up Discussion and Closing Remarks LUTHER CLARK, Moderator Deputy Chief Patient Officer and Global Director, Scientific, Medical, and Patient Perspective Merck & Co., Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
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STEVEN GALSON, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. |
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3:00 p.m. | ADJOURN |
Workshop Part 3: March 24, 2021
Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
11:00 a.m.–3:00 p.m. Eastern Time
11:00 a.m. | Welcome and Opening Remarks STEVEN GALSON, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
SESSION I
THE ROAD TO 2030: AN ATLAS FOR CHANGE
CHRISTOPHER AUSTIN, Moderator Director National Center for Translational Sciences National Institutes of Health |
11:10 a.m. | Keynote Address MARTIN LANDRAY Professor of Medicine and Epidemiology Nuffield Department of Population Health University of Oxford |
11:25 a.m. | Frontline Experience: A Panel Discussion Physician’s perspective on a true “Learning Health Care System” ELIZABETH OFILI Contact Principal Investigator Research Centers at Minority Institutions Coordinating Center |
Patient’s perspective on sustainability BÁRBARA SEGARRA-VÁZQUEZ Dean School of Health Professions, Medical Sciences Campus University of Puerto Rico |
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Industry perspective on building community-based research infrastructure FREDA LEWIS-HALL Retired Senior Medical Advisor Pfizer Inc. |
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12:00 p.m. | Charge to the Breakout Groups |
12:05 p.m. | “Lightning Round” Breakout Discussion Groups (40 min) |
Discussion Questions:
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12:45 p.m. | Breakout Group Wrap-Up CHRISTOPHER AUSTIN, Moderator Director National Center for Translational Sciences National Institutes of Health |
12:55 p.m. | BREAK (30 min) |
SESSION II
THE ROAD TO 2030: A CALL TO ACTION
KHAIR ELZARRAD, Moderator Deputy Director Office of Medical Policy U.S. Food and Drug Administration |
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1:30 p.m. | “North-Star” Vision of What Is Possible BRIAN SOUTHWELL Senior Director, Science in the Public Sphere Program RTI International |
1:45 p.m. | Frontline Experience: A Road Already Traveled DYAN BRYSON Founder, Patient Engagement Strategist Inspired Health Strategies |
PAMELA TENAERTS Former Executive Director Clinical Trials Transformation Initiative |
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2:10 p.m. | Charge to the Breakout Groups |
2:15 p.m. | “Lightning Round” Breakout Discussion Groups (30 min) |
Discussion Questions:
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2:45 p.m. | Breakout Group Wrap-Up and Closing Remarks KHAIR ELZARRAD, Moderator Deputy Director Office of Medical Policy U.S. Food and Drug Administration |
STEVEN GALSON, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. |
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ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
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3:00 p.m. | ADJOURN |
Workshop Part 4: May 11, 2021
Practical Applications for Technology to Enhance the Clinical Trials Enterprise
11:00 a.m.–3:00 p.m. ET
11:00 a.m. | Welcome and Opening Remarks STEVEN GALSON, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
SESSION I
THE ROAD TO 2030: AN ATLAS FOR CHANGE
JENNIFER GOLDSACK, Moderator Executive Director Digital Medicine Society |
11:10 a.m. | Keynote Address AMY ABERNETHY Former Principal Deputy Commissioner of Food and Drugs U.S. Food and Drug Administration |
11:25 a.m. | Frontline Experience: A Panel Discussion A perspective on patient burden and accessibility TARA HASTINGS Senior Associate Director of Patient Engagement The Michael J. Fox Foundation for Parkinson’s Research |
A perspective on digital law JAN BENEDIKT BRÖNNEKE Director, Law & Economics Health Technologies health innovation hub |
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A perspective on improving software and experience for clinical trial sites BRADFORD HIRSCH Chief Executive Officer SignalPath Research |
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11:55 a.m. | Charge to the Breakout Groups |
12:00 p.m. | “Lightning Round” Breakout Discussion Groups (25 min) |
The breakout groups will be assigned one of the two following goals and asked to discuss practical applications and partnerships with new technologies that can address key priority challenges, and opportunities aligned with this goal that will move us toward the clinical trials enterprise envisioned for 2030. See associated breakout discussion guides for more detail.
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12:25 p.m. | Breakout Group Wrap-Up |
FIRESIDE CHAT
12:30 p.m. | Fireside Chat MARK MCCLELLAN Director Duke–Margolis Center for Health Policy |
AMY ABERNETHY, Moderator Former Principal Deputy Commissioner of Food and Drugs U.S. Food and Drug Administration |
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1:00 p.m. | BREAK (30 min) |
SESSION II
THE ROAD TO 2030: A CALL TO ACTION
ANITA ALLEN, Moderator Henry R. Silverman Professor of Law, Professor of Philosophy University of Pennsylvania Carey Law School |
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1:30 p.m. | Frontline Experience: A Road Already Traveled JANICE CHANG Chief Operating Officer TransCelerate BioPharma Inc. |
PAMELA TENAERTS Chief Scientific Officer Medable |
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1:50 p.m. | Charge to the Breakout Groups |
2:00 p.m. | “Lightning Round” Breakout Discussion Groups (25 min) |
The breakout groups will be assigned one of the two following goals and asked to discuss practical applications and partnerships with new technologies that can address key priority challenges, and opportunities aligned with this goal that will move us toward the clinical trials enterprise envisioned for 2030.
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2:25 p.m. | Breakout Group Wrap-Up |
CLOSING PANEL
2:35 p.m. | A “North-Star” Vision of What Is Possible ANDY CORAVOS Chief Executive Officer and Co-Founder Elektra Labs |
ERIC PERAKSLIS Chief Science and Digital Officer Duke Clinical Research Institute |
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SAM ROOSZ Co-Founder and Chief Executive Officer Crescendo Health |
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2:55 p.m. | Workshop Wrap-Up STEVEN GALSON, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. |
ESTHER KROFAH, Workshop Co-Chair Executive Director FasterCures, Milken Institute |
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3:00 p.m. | ADJOURN |