Overview: Provide a high-level summary of the recent accomplishments and ongoing activities within the Patient-Reported Outcome Consortium

Presenter:

Sonya Eremenco, MA– Director, Patient-Reported Outcome (PRO) Consortium, Critical Path Institute (C-Path)

Overview: Provide an update on FDA’s Clinical Outcome Assessment Qualification Program and other FDA initiatives

Moderator:

Michelle Campbell, PhD – Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience (ON), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Presenters:

Robyn Bent, RN, MS – Director, Patient Focused Drug Development Program, CDER, FDA

Selena Daniels, PharmD, PhD – Clinical Outcome Assessment Team Leader, Division of Clinical Outcome Assessment, FDA

Laura Lee Johnson, PhD – Director, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, CDER, FDA

David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, ODES, OND, CDER, FDA

Q & A

Overview: Examine three examples that advance the use of meaningful within-person change thresholds

Moderator:

Rebecca M. Speck, PhD, MPH – Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, C-Path

Presenters:

Carla Mamolo, PhD – Director, Health Economics & Outcomes Research, Pfizer, Inc.

Johannes Giesinger, PhD – Assistant Professor, Medical University of Innsbruck

Margaret Vernon, PhD – Senior Vice President, General Manager, Evidera, Inc.

Josephine Norquist, MS – Executive Director, Patient-Centered Endpoints & Strategy Lead, Merck & Co., Inc.

Panelists:

Selena Daniels, PharmD, PhD – Clinical Outcome Assessment Team Leader, Division of Clinical Outcome Assessment, FDA

Lili Garrard, PhD – Lead Mathematical Statistician, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, CDER, FDA

Q & A

Overview: Provide a brief update on the eCOA: Getting Better Together Initiative, an ongoing collaboration between the PRO Consortium and eCOA Consortium

Presenter:

Scottie Kern, BSc (Hons) – Executive Director, Electronic Clinical Outcome Assessment (eCOA) Consortium, C-Path

Overview: Discuss how digital health technology can be used to measure what is important

Moderator:

Maria Mattera, MPH – Scientific Director, PRO Consortium, C-Path

Presenters:

Maria Mattera, MPH – Scientific Director, PRO Consortium, C-Path

Rebecca M. Speck, PhD, MPH – Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, C-Path

Kai Langel – Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen

Jessie P. Bakker, PhD, MS – Executive Vice President of Medical Affairs, Signifier Medical Technologies (presenting on behalf of the Digital Medicine Society)

Panelists:

Michelle Campbell, PhD – Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA

Anindita Saha, BSE – Assistant Director, Digital Center of Excellence, Center for Devices and Radiological Health, FDA

Q & A