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Patients as Partners in Clinical Research

Date: Mar 17, 2025 - Mar 19, 2025

Location: Boston, MA

Day Three: Wednesday, March 19, 2025
Showing Events in 1 Track from 08:30am to 09:00am
Morning Remarks
8:30AM - 8:45AM
Morning Tea / Coffee
8:45AM - 9:00AM
Day Three Co-Chairs’ Welcome
Co-Chair:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Angi Gillen, MS, Senior Director, Head of Patient Experience, Global Development | Clinical Operations, Gilead Sciences
Showing Events in 1 Track from 09:00am to 10:15am
Morning Sessions
9:00AM - 9:25AM
Annual Keynote: How The implementation of Patient Engagement Practices and Solutions is Essential to Ensuring Drug Development Long-Term Economic Viability
Keynote Speaker:
Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
9:25AM - 9:55AM
Engaging Patients in Payer and CMS Decisions: Shaping Access to Innovative Therapies
Panelists:
June Cha, PhD, MPH, Policy Director, Milken Institute
Lee Fleisher, MD, ML, Senior Advisor / Former CMO and Former Director of the Center for Clinical Standards and Quality, FasterCures Milken Institute / CMS
Campbell Hutton, SVP, Global Advocacy, Breakthrough T1D
9:55AM - 10:15AM
Practical Approaches for Incorporating Patient Preferences into Clinical, Regulatory, and Market Decision-Making
Speaker:
Barry Liden, JD, Director, Public Policy, USC Schaeffer Center for Health Policy & Economics
Showing Events in 1 Track from 10:15am to 10:55am
Morning Networking Break
10:15AM - 10:55AM
Morning Break and Networking
Showing Events in 1 Track from 10:15am to 12:40pm
Morning Sessions Continued
10:15AM - 11:15AM
Evaluating Diversity in Clinical Trials: ICER’s New Framework for Accountability and Improvement
Speaker:
Foluso Agboola, MBBS, MPH, VP, Research, Institute for Clinical and Economic Review (ICER)
11:15AM - 12:40PM
FDA Guidance Updates and New Patient Engagement Initiatives
Speakers:
Robyn Bent, RN, Director, Patient-Focused Drug Development (PFDD) Program, Center for Drug Evaluation and Research (CDER), FDA
Kathryn Capanna, MBA, Deputy Division Director, Division of All Hazards Response, Science & Strategic Partnerships, Office of Strategic Partnerships Technology Innovation, Center for Devices and Radiological Health (CDRH), FDA
Cynthia (Cyndi) Grossman, PhD, Director, Division of Patient-Centered Development, Office of Equity and Innovative Development (OEID), Office of Strategic Partnerships and Technology Innovation (OST) & Center for Devices and Radiological Health (CDRH), FDA
Karen Jackler, MPH, Patient Engagement Program Manager, Center for Biologics Evaluation and Research (CBER), FDA
Christine Lee, PhD, PharmD, Deputy Director, Office of Minority Health and Health Equity, FDA
Bray Patrick-Lake, MFS, Senior Digital Health Specialist, Center for Devices and Radiological Health (CDRH), FDA
Showing Events in 1 Track from 12:40pm to 12:45pm
End of Conference
12:40PM - 12:45PM
End of Conference
Showing Events in 1 Track from 08:30am to 09:00am
Morning Remarks
8:30AM - 8:45AM
Morning Tea / Coffee
8:45AM - 9:00AM
Day Three Co-Chairs’ Welcome
Co-Chair:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Angi Gillen, MS, Senior Director, Head of Patient Experience, Global Development | Clinical Operations, Gilead Sciences
Showing Events in 1 Track from 09:00am to 10:15am
Morning Sessions
9:00AM - 9:25AM
Annual Keynote: How The implementation of Patient Engagement Practices and Solutions is Essential to Ensuring Drug Development Long-Term Economic Viability
Keynote Speaker:
Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
9:25AM - 9:55AM
Engaging Patients in Payer and CMS Decisions: Shaping Access to Innovative Therapies
Panelists:
June Cha, PhD, MPH, Policy Director, Milken Institute
Lee Fleisher, MD, ML, Senior Advisor / Former CMO and Former Director of the Center for Clinical Standards and Quality, FasterCures Milken Institute / CMS
Campbell Hutton, SVP, Global Advocacy, Breakthrough T1D
9:55AM - 10:15AM
Practical Approaches for Incorporating Patient Preferences into Clinical, Regulatory, and Market Decision-Making
Speaker:
Barry Liden, JD, Director, Public Policy, USC Schaeffer Center for Health Policy & Economics
Showing Events in 1 Track from 10:15am to 10:55am
Morning Networking Break
10:15AM - 10:55AM
Morning Break and Networking
Showing Events in 1 Track from 10:15am to 12:40pm
Morning Sessions Continued
10:15AM - 11:15AM
Evaluating Diversity in Clinical Trials: ICER’s New Framework for Accountability and Improvement
Speaker:
Foluso Agboola, MBBS, MPH, VP, Research, Institute for Clinical and Economic Review (ICER)
11:15AM - 12:40PM
FDA Guidance Updates and New Patient Engagement Initiatives
Speakers:
Robyn Bent, RN, Director, Patient-Focused Drug Development (PFDD) Program, Center for Drug Evaluation and Research (CDER), FDA
Kathryn Capanna, MBA, Deputy Division Director, Division of All Hazards Response, Science & Strategic Partnerships, Office of Strategic Partnerships Technology Innovation, Center for Devices and Radiological Health (CDRH), FDA
Cynthia (Cyndi) Grossman, PhD, Director, Division of Patient-Centered Development, Office of Equity and Innovative Development (OEID), Office of Strategic Partnerships and Technology Innovation (OST) & Center for Devices and Radiological Health (CDRH), FDA
Karen Jackler, MPH, Patient Engagement Program Manager, Center for Biologics Evaluation and Research (CBER), FDA
Christine Lee, PhD, PharmD, Deputy Director, Office of Minority Health and Health Equity, FDA
Bray Patrick-Lake, MFS, Senior Digital Health Specialist, Center for Devices and Radiological Health (CDRH), FDA
Showing Events in 1 Track from 12:40pm to 12:45pm
End of Conference
12:40PM - 12:45PM
End of Conference
Next
Day Three
Wednesday, March 19, 2025

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