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 (PRO) Outcome Consortium, Critical Path Institute

8:50 – 10:20 am

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

Moderator: Michelle Campbell, PhD – Reviewer and Scientific Coordinator, COA Qualification Program, COA Staff, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Presenters:

Elektra Papadopoulos, MD, MPH – Acting Associate Director, COA Staff, OND, CDER, FDA
Virginia Kwitkowski, MS, ACNP-BC – Associate Director for Labeling, Division of Hematology Products, Office of Hematology and Oncology Products (OHOP), OND, CDER, FDA

Q & A

10:20 – 10:45 am

10:45 – 12:15 pm

Session 2: Assessing the Content Validity of Performance Outcome (PerfO) Measures

Moderator: Elizabeth (Nicki) Bush, MHS – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company

Presenters:

Rachel Ballinger, PhD – Lead Outcomes Researcher, Clinical Outcome Assessment, ICON Clinical Research
J. Scott Andrews, PharmD – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
Richard S.E. Keefe, PhD – Professor of Psychiatry, Psychology, and Neuroscience, Duke University Medical Center and CEO, NeuroCog Trials, Inc.

Panelists:

Michelle Campbell, PhD – Reviewer and Scientific Coordinator, COA Qualification Program, COA Staff, OND, CDER, FDA
Stephen Joel Coons, PhD – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute
Billy Dunn, MD – Director, Division of Neurology Products, OND, CDER, FDA

Q & A

12:15 – 1:15 pm

1:15 – 2:45 pm

Session 3: Addressing Key Challenges in Developing, Testing and Implementing Clinical Outcome Assessments in Pediatric Trials

Moderator: Linda Abetz-Webb – Paediatric PRO Expert, CEO/Senior Research Director, Patient-Centered Outcome Assessments, Ltd. (P-COA)

Presenters:

Linda Lowes, PT, PhD – Clinical Therapies Research Director, Nationwide Children’s Hospital
Rob Arbuckle – Vice President and UK Managing Director, Patient-Centered Outcomes, Adelphi Values
Valdo Arnera, MD – Scientific Advisor and General Manager ERT Geneva, ERT

Panelists:

Laura Lee Johnson, PhD – Associate Director, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences (OTS), CDER, FDA
Andrew E. Mulberg, MD, FAAP, CPI – Division Deputy Director, Gastroenterology and Inborn Errors Products, OND, CDER, FDA
Josephine Norquist, MS – Patient-Reported Outcome (PRO) & Study Endpoint Group Lead, Center for Observational and Real-world Evidence (CORE), Merck Sharp & Dohme, Corp.
Anna Rydén, PhD – Director, Patient Reported Outcomes, AstraZeneca

Q & A

2:45 – 3:10 pm

3:10 – 4:40 pm

Session 4: NCI’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE): Selecting Items and Assessment Frequency for Cancer Trials

Moderator: Sandra A. Mitchell, PhD, CRNP – Research Scientist and Program Director, Outcomes Research Branch, National Cancer Institute (NCI)

Presenters:

Paul G. Kluetz, MD – Associate Director of Clinical Science, OHOP, OND, CDER, FDA
Lori Minasian, MD, FACP – Deputy Director, Division of Cancer Prevention, NCI
Ethan Basch, MD, MSc – Director, Cancer Outcomes Research Program, University of North Carolina
Katarina Halling, MSc – Global Head Patient Reported Outcomes, AstraZeneca and Industry Co-Director, PRO Consortium

Panelist:

Selena R. Daniels, PharmD, MS – Reviewer and Acting Team Lead, COA Staff, OND, CDER, FDA

Q & A

4:40 – 4:55 pm

A Review of FDA PRO Labeling (2011 – 2015)

Ari Gnanasakthy, MSc, MBA – Head, Patient Reported Outcomes, RTI Health Solutions

4:55 – 5:00 pm

5:30 – 7:00 pm

7:30 – 8:30 am

8:30 – 10:00 am

Session 5: Developing the Symptoms of Major Depressive Disorder Scale (SMDDS): From Patient Input to Final Instrument

Moderator: Elizabeth (Nicki) Bush, MHS – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company

Presenters:

Elizabeth (Nicki) Bush, MHS – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
Kelly P. McCarrier, PhD, MPH – Senior Research Scientist, Health Research Associates, Inc.
Donald Bushnell, MA – Associate Director, Health Research Associates, Inc.
Valdo Arnera, MD – Scientific Advisor and General Manager ERT Geneva, ERT

Panelists:

Stephen Joel Coons, PhD – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute
Tiffany R. Farchione, MD – Deputy Director, Division of Psychiatry Products (DPP), CDER, FDA

Q & A

10:00 – 10:25 am

10:25 – 11:55 am

Session 6: Expanding Our Understanding of Meaningful Change from a Patient Perspective

Moderator: Cheryl D. Coon, PhD – Principal, Outcometrix

Presenters:

Mona Martin, RN, MPA – Executive Director, Health Research Associates, Inc.
Allison Martin Nguyen, MS – Senior Principal Scientist, Patient-Reported Outcomes & Study Endpoints, Merck Research Laboratories, Merck & Co., Inc.
Katarina Halling, MSc – Global Head Patient Reported Outcomes, AstraZeneca and Industry Co-Director, PRO Consortium
Karon F. Cook, PhD – Research Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University

Panelists:

Wen-Hung Chen, PhD – Reviewer, COA Staff, OND, CDER, FDA
Tara Symonds, PhD – Strategic Lead, Clinical Outcomes Assessments, Clinical Outcomes Solutions
Kathleen (Kathy) Wywrich, PhD – Vice President, Outcomes Research, Evidera

Q & A

11:55 – 12:15 pm