Patients as Partners in Clinical Research

Day 3: Friday, March 22, 2024

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Showing Events in 1 Track from 08:30am to 10:20am

Day 3 Morning General Session

8:30AM - 8:45AM

Morning Tea/Coffee

8:45AM - 9:00AM

Day Three Co-Chair’s Welcome

Co-Chairs:

Rebecca Vermeulen, RPh, Head, Global Patient Partnership, Product Development Medical Affairs, Genentech, A member of the Roche Group

Barry Nelson, Patient, Advocate

9:00AM - 9:25AM

VIP Session: New Findings from Tufts CSDD Research Study on Amplifying and Applying Patient Voices in Protocol Design and Execution

Speakers:

Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development

9:25AM - 9:45AM

ZeitGeist: Capacity Building for Patient Advocacy Groups - Developing Next Generation Leaders

Speaker:

Michael Zincone, Sr Director, Patient Advocacy, Pfizer

9:45AM - 10:20AM

BMS Case Study on Self-Identified Sexual Orientation and Gender Identity (SOGI)

Speakers:

Lorena Kuri, MSMHC, Head, Diversity Strategy for R&D, BMS

Donna Sattler, Director, Head of Standards Operational Management, BMS

Jessica Brescher, MPH, Senior Clinical Scientist, BMS

Showing Events in 1 Track from 10:20am to 11:00am

Morning Networking and Breakfast Break

10:20AM - 11:00AM

Morning Patients as Partners Networking and Breakfast Break

Showing Events in 1 Track from 11:00am to 12:40pm

Day 3 Morning General Session Continued

11:00AM - 11:20AM

HTA Initiatives for Inclusion of Patient Perspectives in Medicine Reviews

Speakers:

Catherine Koola Fischer, MPH, Director, Patient Engagement, Institute for Clinical and Economic Review (ICER)

11:20AM - 11:40AM

Optimizing “How" Patient Advocacy and Biopharma can Best Collaborate to Transform the Pace of Medicines Development

Speakers:

Victoria DiBiaso, MPH, VP, Head of Patient Informed Development & Health Value Translation, Sanofi

Trish Davidson, MPA, PALADIN Consortium Director, Tufts Center for the Study of Drug Development

Eda Baykal-Caglar, PhD, Director, Clinical Research Patient Engagement, The Michael J Fox Foundation

11:40AM - 12:40PM

FDA Guidance Updates and New Patient Engagement Initiatives

FDA agencies present guidance updates and new patient engagement initiatives. Following the presentations, the FDA representatives will be available in a panel setting for open Q&A.

Speakers:

Robyn Bent, RN, Director, Patient-Focused Drug Development (PFDD) Program, Center for Drug Evaluation and Research (CDER), FDA

Bray Patrick-Lake, MFS, Senior Digital Health Specialist, Center for Devices and Radiological Health (CDRH), 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

Karen Jackler, MPH, Patient Engagement Program Manager, Center for Biologics Evaluation and Research (CBER), FDA

Wendy Slavit, MPH, CHES, Senior Health Scientist, Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner (OC), FDA

12:40PM - 12:40PM

End of Conference

Showing Events in 1 Track from 08:30am to 10:20am

Day 3 Morning General Session

8:30AM - 8:45AM

Morning Tea/Coffee

8:45AM - 9:00AM

Day Three Co-Chair’s Welcome

Co-Chairs:

Rebecca Vermeulen, RPh, Head, Global Patient Partnership, Product Development Medical Affairs, Genentech, A member of the Roche Group

Barry Nelson, Patient, Advocate

9:00AM - 9:25AM

VIP Session: New Findings from Tufts CSDD Research Study on Amplifying and Applying Patient Voices in Protocol Design and Execution

Speakers:

Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development

9:25AM - 9:45AM

ZeitGeist: Capacity Building for Patient Advocacy Groups - Developing Next Generation Leaders

Speaker:

Michael Zincone, Sr Director, Patient Advocacy, Pfizer

9:45AM - 10:20AM

BMS Case Study on Self-Identified Sexual Orientation and Gender Identity (SOGI)

Speakers:

Lorena Kuri, MSMHC, Head, Diversity Strategy for R&D, BMS

Donna Sattler, Director, Head of Standards Operational Management, BMS

Jessica Brescher, MPH, Senior Clinical Scientist, BMS

Showing Events in 1 Track from 10:20am to 11:00am

Morning Networking and Breakfast Break

10:20AM - 11:00AM

Morning Patients as Partners Networking and Breakfast Break

Showing Events in 1 Track from 11:00am to 12:40pm

Day 3 Morning General Session Continued

11:00AM - 11:20AM

HTA Initiatives for Inclusion of Patient Perspectives in Medicine Reviews

Speakers:

Catherine Koola Fischer, MPH, Director, Patient Engagement, Institute for Clinical and Economic Review (ICER)

11:20AM - 11:40AM

Optimizing “How" Patient Advocacy and Biopharma can Best Collaborate to Transform the Pace of Medicines Development

Speakers:

Victoria DiBiaso, MPH, VP, Head of Patient Informed Development & Health Value Translation, Sanofi

Trish Davidson, MPA, PALADIN Consortium Director, Tufts Center for the Study of Drug Development

Eda Baykal-Caglar, PhD, Director, Clinical Research Patient Engagement, The Michael J Fox Foundation

11:40AM - 12:40PM

FDA Guidance Updates and New Patient Engagement Initiatives

FDA agencies present guidance updates and new patient engagement initiatives. Following the presentations, the FDA representatives will be available in a panel setting for open Q&A.

Speakers:

Robyn Bent, RN, Director, Patient-Focused Drug Development (PFDD) Program, Center for Drug Evaluation and Research (CDER), FDA

Bray Patrick-Lake, MFS, Senior Digital Health Specialist, Center for Devices and Radiological Health (CDRH), FDA

Karen Jackler, MPH, Patient Engagement Program Manager, Center for Biologics Evaluation and Research (CBER), FDA

Wendy Slavit, MPH, CHES, Senior Health Scientist, Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner (OC), FDA

12:40PM - 12:40PM

End of Conference

Day 2

Thursday, March 21, 2024

Day 3

Friday, March 22, 2024

Day 2

Day 3

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