7:30 – 8:00


8:00 – 8:05

Opening Remarks

Tamás Terlaky, PhD

George N. and Soteria Kledaras ’87 Endowed Chair Professor

Chair, Department of Industrial and Systems Engineering

P.C. Rossin College of Engineering and Applied Science

Lehigh University

8:05 – 9:05

Assessing REMS Program Impact: Historical Approaches, Current Catalysts for Improvement and Future Considerations

Mary Willy, PhD, Associate Director, Division of Risk Management, FDA

Terry Toigo, RPH, Associate Director, Drug Safety Operations, Center for Drug Evaluation

Gary Slatko, MD, MBA, Director, Office of Medication Error Prevention and Risk Management, FDA

9:05 – 9:35

Emerging Recommendations for Evaluating the Effectiveness of Risk Minimization Activities:  Highlights of CIOMS IX Working Group and EMA’s GVP Module XVI (as available)

Meredith Smith, PhD, MPA, Senior Scientific Director, Risk Management, Global & Research Development, AbbVie

9:35 – 10:05

Evaluating REMS and Behavioral Change Strategies from an Implementation Science Perspective

Russell Glasgow, PhD, Deputy Director, Implementation Science, Division of Cancer Control and Population Sciences, National Cancer Institute, NIH

10:05 – 10:30

Cross-Stakeholder Panel Discussion; Q&A


10:30 – 11:00



11:00 – 11:30

Case Study: A Brief History and Current Plan of Action for Measuring the Performance of Long-acting Opioid Risk Minimization

Paul Coplan, MS, DSc, MBA, Executive Director Risk Management & Epidemiology, Purdue Pharma

11:30 – 12:00

Quantifying REMS Program Burden on the Healthcare System Using Simulation Modeling

Robert H. Storer, PhD, Co-Director of the Integrated Business and Engineering Honors Program, Lehigh University

M. Kris Srinivasan, MD, MBA, MHSE, Clinical Consulting Director, ParagonRx International

Marc Deluca, MHSE candidate, Client Services Manager, ParagonRx International

12:00 – 12:30

Cross Stakeholder Panel Discussion; Q&A


12:30 – 1:30



1:30 – 1:50

Conjoint Analysis of Physician Preferences as a Measure of Burden

Christene Song, Director, Quantitative Market Research, Campbell Alliance

1:50 – 2:20

Using Novel Data Sources to Assess the Patient Perspective on REMS Burden

David Blaser, PharmD, Health Data and Drug Information Clinical Specialist, PatientsLikeMe

Meredith Smith, PhD, MPA, Senior Scientific Director, Risk Management, Global & Research Development, AbbVie

2:20 – 2:50

Health Literacy Measures of Patient Burden

Michael Wolf, PhD, MPH, Associate Professor of Medicine and Learning Sciences and Associate Division Chief for General Internal Medicine, Northwestern University

2:50 – 3:20

Cross-Stakeholder Panel Discussion; Q&A

3:20 – 3:50

Stakeholder Breakouts and Break

Break by stakeholder group; one FDA member per stakeholder group to act as a viewer

3:50 – 4:20

Reports from Stakeholder Breakouts to define research agenda (most important insights from the day and remaining gaps that should be included in research agenda)

Panel member from each breakout and regulatory representative to present findings of breakout

4:20 – 4:30

Closing Remarks

Jeff Fetterman, Co-Founder TERM; Adjunct Faculty, Lehigh University; President, ParagonRx International LLC