7:30 – 8:30 am

8:30 – 8:50 am

Welcome and Patient-Reported Outcome Consortium Update

Stephen Joel Coons, PhD – Executive Director, Patient-Reported Outcome (PRO) Consortium, Critical Path Institute (C-Path)

8:50 – 10:20 am

Session 1: Update from FDA Regarding the Clinical Outcome Assessment Qualification Program

Moderator: Michelle Campbell, PhD – Reviewer and Scientific Coordinator, COA
Qualification Program, COA Staff, OND, CDER, FDAPresenters:

Paul G. Kluetz, MD – Acting Associate Director of Patient Outcomes, Oncology Center of Excellence (OCE), FDA
Theresa M. Mullin, PhD – Director of Office of Strategic Programs, CDER, FDA
Elektra Papadopoulos, MD, MPH – Associate Director, COA Staff, OND, CDER, FDA

Q & A

10:20 – 10:45 am

10:45 – 12:15 pm

Session 2: Case Study: The Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

Moderator: Kendra DeBusk, PhD – Principal Outcomes Research Scientist, Genentech, Inc.

Presenters:

Astra Liepa, BS, PharmD – Principal Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
Kelly McCarrier, PhD, MPH – Senior Research Scientist, Health Research Associates, Inc.
Thomas Atkinson, PhD – Assistant Attending Behavioral Scientist, Memorial Sloan Kettering Cancer Center
Donald Bushnell, MA – Associate Director, Health Research Associates, Inc.

Panelists:

Paul G. Kluetz, MD – Acting Associate Director of Patient Outcomes, OCE, FDA
Stephen Joel Coons, PhD – Executive Director, PRO Consortium, C-Path

Q & A

12:15 – 1:15 pm

1:15 – 2:45 pm

Session 3: Barriers to Adoption of Electronic Collection of COA-based Endpoint Data in Clinical Trials

Moderator: David S. Reasner, PhD – Vice-President, Data Science and Head, Study Endpoints, Ironwood Pharmaceuticals

Presenters:

Bill Byrom, PhD – Senior Director, Product Innovation, ICON Clinical Research
Alexandra I. Barsdorf, PhD – Director, Rare Disease, Patient & Health Impact, Pfizer, Inc.
Kelly McQuarrie, BSN – Director, PRO Team, Janssen Pharmaceuticals
Sue Vallow, RPh, MBA, MA – Vice President, Patient eSolutions, MedAvante, Inc.
Marieke Manders, MSc – GCDO Trial Leader, Immunology, Janssen Research & Development

Panelists:

Serge Bodart, MS – eCOA Subject Matter Expert, Biomedical Systems

Q & A

2:45 – 3:10 pm

3:10 – 4:40 pm

Session 4: Clinical Outcome Assessments in Pediatric Trials: Measurement Gaps, Challenges, and Potential Solutions

Moderator: Sonya Eremenco, MA – Associate Director, PRO Consortium, C-Path

Presenters:

Mira Patel, MS – Graduate Research Associate, PRO Consortium, C-Path
Sonya Eremenco, MA – Associate Director, PRO Consortium, C-Path
Linda Nelsen, MHS – Senior Director and Head, Patient Centered Outcomes, GlaxoSmithKline

Panelist:

Linda Abetz-Webb – Paediatric PRO Expert, CEO/Senior Research Director Patient-Centred Outcome Assessments, Ltd (P-COA)
Tonya Winders – President and CEO, Allergy & Asthma Network
Susan McCune, MD – Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA

Q & A

4:40 – 4:55 pm

COMPASS Update

Stacie Hudgens, MA – CEO and Strategic Lead, Quantitative Science, Clinical Outcomes Solutions

4:55 – 5:00 pm

5:30 – 7:00 pm

7:30 – 8:30 am

8:30 – 10:00 am

Session 5: What’s the Score? Moving from Items to Scores – Methods, Considerations, and Case Examples

Moderator: Steve Blum, MBA, MA – Director, Patient-Reported Outcomes, GlaxoSmithKline

Presenters:

Kathleen (Kathy) W. Wyrwich, PhD – Senior Research Advisor, Eli Lilly and Company
Bryce B. Reeve, PhD – Professor, University of North Carolina
Cheryl D. Coon, PhD – Principal, Outcometrix

Panelists:

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

Q & A

10:00 – 10:25 am

10:25 – 11:55 am

Session 6: From Clinical Outcome Assessment to Clinical Trial Endpoint to Medical Product Labeling

Moderator: Michelle Campbell, PhD – Reviewer and Scientific Coordinator, COA Qualification Program, COA Staff, OND, CDER, FDA

Presenters:

Ashley F. Slagle, MS, PhD – Principal, Regulatory and Scientific Consulting, Aspen Consulting, LLC
David S. Reasner, PhD – Vice President, Data Science and Head, Study Endpoints, Ironwood Pharmaceuticals
Emily Edson Heredia, MPH – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
Ari Gnanasakthy, MSc, MBA – Principal Scientist, Patient-Centered Outcomes Assessments, RTI Health Solutions

Panelists:

Wen-Hung Chen, PhD – Reviewer COA Staff, OND, CDER, FDA
Ann Marie Trentacosti, MD – Medical Lead, Labeling Development Team, CDER, FDA

Q & A

11:55 – 12:15 pm