Agenda – 4th Human Abuse Liability & Abuse-Deterrent Formulations

  • Day One
  • Day Two

Day One

 

 ADAPTING TO REGULATORY CHANGE

9:00AM – 9:45AM

Work With Regulators so New Guidelines Can Handle New Abuse Deterrence Techniques
Peter Pitts, President, CENTER FOR MEDICINE IN THE PUBLIC INTEREST

9:45AM – 10:30AM

Track the Development of State Legislation on Opioids
Michael Barnes, Executive Director, CENTER FOR LAWFUL ACCESS AND ABUSE DETERRENCE

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Tampering Methods and Routes of Administration – Perspectives From Recreational Drug Users
Beatrice Setnik, Vice President, Clinical Pharmacology, INC RESEARCH

11:45AM – 12:30PM

Identify the Right Questions (and the Wrong Ones) for Improving Standardization in ADF Development
Karsten Lindhardt, Senior Vice President, Head of R&D, EGALET

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Spotlight New Drugs of Abuse and Their Opioid Interaction Risks
Richard Dart, Executive Director, RADARS SYSTEM

2:15PM – 3:00PM

Effectiveness of ADFs: A Law Enforcement Perspective
Aaron Graham, Director, Brand Safety and Security, BOEHRINGER INGELHEIM
John Burke, President, INTERNATIONAL HEALTH FACILITY DIVERSION ASSOCIATION

3:00PM – 3:30PM

Networking Break

Sponsored by Grünenthal Group

3:30PM – 4:15PM

PRESENTATION BY ALCAMI

4:15PM – 5:00PM

Use the Totality of Evidence to Gain Abuse Deterrence Label Claims During an ANDA Registration
Torben Elhauge, Director, Analytical Development, EGALET

5:00PM – 6:15PM

Cocktail Networking Reception

Sponsored by Vince & Associates Clinical Research

6:15PM – 8:15PM

ADD-ON DINNER WORKSHOP
Anticipate the Greatest Challenges when Facing FDA Advisory Committee Meetings

Dan Cohen, Forum Chair, ABUSE DETERRENT COALITION; Executive Vice President, Government Relations, KEMPHARM


Day Two

 

8:00AM – 8:45AM

Continental Breakfast

 

R&D INNOVATIONS

9:00AM – 9:45AM

Overcome Challenges in the Clinical Evaluation of Abuse Deterrent Formulations: A CRO Perspective

Graham Wood, Executive Vice President, Phase I Clinical Development, ALTASCIENCES CLINICAL RESEARCH

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Configure Studies for Opioid Interactions with Benzos

Lynn Webster, Vice President, Scientific Affairs, PRA HEALTH SCIENCES

12:30PM – 1:30PM

Luncheon

MARKETPLACE PROGRESS

9:00AM – 9:45AM

Assign a Market Value to Real-World Evidence for Opioids

Marta Sokolowska, Vice President, Medical and External Affairs, DEPOMED

9:45AM – 10:30AM

Navigate the Data and Regulatory Requirements on Real-World Evidence for ADFs

Angela DeVeaugh-Geiss, Director, Epidemiology, PURDUE PHARMA

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Convey the Importance of ADFs to Payers

Charles Argoff, Professor of Neurology, ALBANY MEDICAL CENTER

11:45AM – 12:30PM

Craft the Correct Messaging for Clinicians About Abuse-Deterrent Formulations

Gene Levinstein, CMO, LEHIGH VALLEY TECHNOLOGIES

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Work With KOLs to Educate Clinicians and Forecast Developments in Pain Management

Colville Brown, Medical Director, EGALET

2:15PM – 3:00PM

Revise Physician Outreach to Emphasize Reduced Diversion Potential for ADFs

Jeremy Adler, COO, PACIFIC PAIN MEDICINE