Agenda – 5th Human Abuse Liability Testing & Market Access

  • Day One
  • Day Two

Day One

 Monday, November 5

8:45AM – 9:00AM

Introduction From Chairperson
Dan Cohen, Chair, ABUSE DETERRENT COALITION; former Executive Vice President, Government and Public Relations, KEMPHARM

 WITHSTAND LEGAL CHANGES AND CHALLENGES

9:00AM – 9:45AM

Washington Report: The State of Federal Opioid Policymaking
Andrea Maresca, Policy Director, INNOVATIVE PAIN MEDICINES ALLIANCE; Senior Vice President for Health Policy, THORN RUN PARTNERS

9:45AM – 10:30AM

Understand the Impact of CDC Guidelines on Pain Patients and the Physicians who Try to Treat Them
Gary Jay, Clinical Professor, Dept. of Neurology, Division: Headache/Pain at UNC, UNIVERSITY OF NORTH CAROLINA – CHAPEL HILL

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Rethink the Approach for Understanding Opioids With Low Market Share
Elizabeth Nugent, Director, Clinical Research and Pharmacovigilance, RADARS SYSTEM

11:45AM – 12:30PM

Modify Opioid Prescriptions While Retaining Patient Empathy
Steven Passik, Vice President, Scientific Affairs, Education, and Policy, COLLEGIUM PHARMACEUTICALS

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Transfer Lessons Learned on Abuse Deterrence From Opioids to Stimulants
Andy Barrett, Vice President, Scientific Affairs, KEMPHARM

2:15PM – 3:00PM

CASE STUDY: Can ADFs Enable a Product to Return to the OTC Market?
Eric Galia, International Project Leader , GRUNENTHAL
Sebastian Schwier, International Technical Project Leader, GRUNENTHAL

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Prepare for Ever-Increasing Scrutiny from FDA and Advisory Committees
Christopher Altomare, Director of Pharmaceutical Services, DRUGSCAN

4:15PM – 5:00PM

Statistical Considerations in HAP Studies
Denise Milovan, Research Scientist, Neuropsychologist, SYNEOS HEALTH

5:00PM – 5:45PM

Gain Better Preparation Methods and Confidence for HAP Studies
Richard Mannion, Owner, MANNION CONSULTING; former Executive Director, Pharmaceutical and Analytical Development, PURDUE PHARMA


Day Two

 Tuesday, November 6

8:45AM – 9:00AM

Chairperson’s Recap of Day One
Dan Cohen, Chair, ABUSE DETERRENT COALITION; former Executive Vice President, Government and Public Relations, KEMPHARM

 OVERCOME OBSTACLES TO MARKET ACCESS

9:00AM – 9:45AM

Assess and Incentivize Innovation in Abuse Deterrence
Dan Cohen, Chair, ABUSE DETERRENT COALITION; former Executive Vice President, Government and Public Relations, KEMPHARM

9:45AM – 10:30AM

Take a New Approach to the Pharmacoeconomics of Abuse Deterrence
Bob Jones, CEO, ACURA PHARMACEUTICALS

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

A Systematic Approach to Meeting Regulatory Requirements for Evaluating Potentially Abuse-Related Events in Clinical Trials
Ryan Lanier, Senior Consultant, Drug Development, ANALGESIC SOLUTIONS

11:45AM – 12:30PM

Cross Technical Obstacles on Clinical Development of ADFs
Graham Wood, Chief R&D Officer, ALTASCIENCES CLINICAL RESEARCH

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Manage the Risk Profile of HCP-Administered Opioids
Karen DiDonato, Executive Director, Medical Affairs, ACELRX PHARMACEUTICALS

2:15PM – 3:00PM

Correct for Gender-Based Disparities in Drug R&D and Law Enforcement
Shruti Kulkarni, Director, FORCE FOUNDATION