7:30-8:30 am

8:30-8:50 am

8:50-8:55 am

8:55-9:30 am

Workshop Kickoff and FDA Update on DDT Qualification Program

ShaAvhrée Buckman, MD, PhD, FAAP — Director, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

9:35-10:25 am

Session 1 – Patient Participation in Drug Development

Patient Representation at FDA
Richard Klein — Director, Patient Liaison Program, Office of Health and Constituent Affairs, FDA

10:25-10:45 am

10:45-11:10am

Session 2 – Target Product Profile (TPP) Process

Michele L. Sharp, PharmD — Senior Director, Global Regulatory Affairs – US Advertising, Promotion and Policy, Eli Lilly and Company

11:15-12:45 pm

Panel Discussion 1 – Mixed Methods in Assuring Content Validity

Mixed Methods – FDA Perspective: Incorporating Mixed Methods to Enhance Content Validity in Drug-Development Tools
Moderator:
Ashley F. Slagle, PhD, MS — ORISE Fellow, Study Endpoints and Labeling Development (SEALD), Office of New Drugs (OND), CDER, FDA

Presenter/Panelist:
James P. Stansbury, PhD, MPH — Consumer Safety Officer, SEALD, OND, CDER, FDA

Panelists:
Laurie B. Burke, RPh, MPH — Associate Director, OND, SEALD, CDER, FDA;
Lisa Kammerman, PhD — Master Reviewer, Office of Biostatistics, CDER, FDA;
Scott Komo, DrPH — Senior Statistical Reviewer, Office of Biostatistics, CDER, FDA;
Päivi Miskala, MSPH, PhD — Study Endpoints Reviewer/Senior Clinical Analyst, SEALD, OND, CDER, FDA

Mixed Methods – Industry and Academic Experience
Moderator:
Josephine M. Norquist, MS — Patient-Reported Outcomes Specialist, Department of Epidemiology, Merck Sharp & Dohme Corporation

Presenters and Panelists:
Joseph C. Cappelleri, PhD, MPH — Senior Director, Biostatistics, Pfizer Inc.;
Ron D. Hays, PhD – Professor, Department of Medicine, David Geffen School of Medicine, UCLA

12:45-1:45 pm

1:45-1:55 pm

1:55-2:55 pm

Panel Discussion 2 – Selection of Appropriate Recall Period

Moderator:
Steven I. Blum, MBA — Director of Health Economics, Forest Research Institute

Presenter:
Sheri E. Fehnel, PhD — Vice President of Patient-Reported Outcomes, RTI-Health Solutions

Panelists:
Robyn T. Carson, MPH — Associate Director, Health Economics and Outcomes Research, Forest Research Institute;
Nicholas Greco IV, MS, BCETS, CATSM — Clinical Research Manager – Psychometrics and Assessment, AbbVie, Inc.;
William Lenderking, PhD — Senior Research Leader, United BioSource Corporation;
Linda Nelsen, MHS — Senior Principal Scientist, Epidemiology, Merck Sharp & Dohme Corporation

2:55-3:15 pm

3:15-4:45 pm

Panel Discussion 3 – Challenges in the Implementation of ePROs in Clinical Trials

Moderator:
Risa Hayes, PhD — Lead Scientist for Patient-Reported Outcomes, Eli Lilly and Company

Presenters:
Stephen Joel Coons, PhD — C-Path;
Sonya L. Eremenco, MA — Principal, ePRO Scientific Solutions, Bracket, a subsidiary of United BioSource Corporation;
Cindy Howry, MS— Principal, ePRO Solutions, Bracket, a subsidiary of United BioSource Corporation

Panelists:
Heather Blaudow — Associate Consultant Research, Global Health Outcomes, Eli Lilly and Company;
Tim Davis — CEO and Co-Founder, Exco InTouch;
Sarah Fleming, MPH — Analyst, Patient Reported Outcomes, Janssen Global Services;
Alison Greene, MPH — Senior Scientist, Patient Reported Outcomes, Genentech, a member of the Roche Group;
Cindy Howry, MS — Bracket;
Wilhelm Muehlhausen, DVM — Vice President, eCOA and Innovation, ICON and Vice-Director, ePRO Consortium;
Paul O’Donohoe — Manager of Health Outcomes, CRF Health;
Jean Paty, PhD — Chief Scientist and Regulatory Advisor, Outcomes, ERT Inc.;
Sheila Rocchio, MBA — Vice President of Marketing & Product Management, PHT Corporation;
Eric Ross — Associate Product Manager, Patient Management & ePRO, Almac Clinical Technologies;
Tara Symonds, PhD — Senior Director, Global Head PRO Center of Excellence, Pfizer Ltd.

4:45-5:00 pm

Day 1 Closing Remarks

Day 2 Preview

5:30-7:30 pm

Reception and Working Group Update Poster Session – Magnolia Room

Asthma
Cognition
Depression
Functional Dyspepsia
Irritable Bowel Syndrome (IBS)
Non-Small Cell Lung Cancer (NSCLC)
Rheumatoid Arthritis

7:30-8:30 am

8:30-8:40 am

8:40-10:10 am

Panel Discussion 4 – Decision-making to Include PRO Endpoints in Oncology Trials

Moderator:
Ari Gnanasakthy, MSc, MBA — Novartis

Presenters/Panelists:
Tom Simon — FDA Patient Representative;
Virginia Kwitkowski, MS, RN, ACNP-BC — Lead Clinical Analyst, Clinical Team Leader, Division of Hematology Products, CDER, FDA;
Patrick Marquis, MD — Independent Consultant;
Margaret Rothman, PhD — Senior Director, PRO Group, Janssen Pharmaceutical Companies of Johnson and Johnson

Panelists:
Ethan Basch, MD, MSc — Director, Cancer Outcomes Research Program, University of North Carolina at Chapel Hill;
Laurie B. Burke, RPh, MPH — FDA;
Alicyn Campbell, MPH — Global Head, Patient Reported Outcomes – Oncology, Genentech, a member of the Roche Group and co-chair of NSCLC WG;

10:10-10:30 am

10:30-11:50 am

Panel Discussion 5 – Considerations for the Implementation of Clinical Outcome Assessments in Pediatric Drug Development Programs

Moderator/Presenter:
Melissa S. Tassinari, PhD, DABT — Senior Clinical Analyst, Pediatric and Maternal Health Staff, OND, CDER, FDA

Presenters/Panelists:
Omar Khwaja, MD, PhD — Translational Medicine Leader, Neurosciences, F. Hoffmann-LaRoche AG;
Tiina Urv, PhD — Health Scientist Administrator, Intellectual and Developmental Disabilities Branch, National Institute of Child Health & Human Development

Panelists:
Nicholas Kozauer, MD — Acting Clinical Team Leader, Division of Neurology Products (DNP), CDER, FDA;
Ranjit Mani, MD — Medical Reviewer, DNP, CDER, FDA;
Elektra Papadopoulos, MD, MPH — Endpoint Reviewer, SEALD, OND, CDER, FDA;
Diana Rofail, PhD, CPsychol — Global Head of Patient-Reported Outcomes, CNS & Metabolism, Product Development, Biometrics, EpiPRO, Roche Products, Ltd.;
Juliana Setyawan, PharmD, MS — Director in Global Health Economics and Outcomes Research/Epidemiology, Shire Development, LLC;

11:50-12:00 pm

12:00 Noon