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

  • Day One
  • Day Two

Day One

 

8:45AM – 9:00AM

Introduction from Chairperson
Alexander Kraus, former Vice President, Business Unit North America, GRUNENTHAL

 ADAPTING TO REGULATORY CHANGE

9:00AM – 9:40AM

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

9:40AM – 10:20AM

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

10:20AM – 11:00AM

Tampering Methods and Routes of Administration – Perspectives From Recreational Drug Users
Beatrice Setnik, VP, Scientific and Medical Affairs, INC Research / inVentiv Health

11:00AM – 11:30AM

Networking Break

11:30AM – 12:10PM

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

12:10PM – 12:50PM

Spotlight New Drugs of Abuse and Their Opioid Interaction Risks
Janetta Iwanicki, Associate Medical Director, ROCKY MOUNTAIN POISON & DRUG CENTER / RADARS SYSTEM

12:50PM – 1:50PM

Luncheon

1:50PM – 2:30PM

Effectiveness of ADFs: A Law Enforcement Perspective
John Burke, President, INTERNATIONAL HEALTH FACILITY DIVERSION ASSOCIATION

3:10PM – 3:40PM

Networking Break

Sponsored by Grünenthal Group

3:40PM – 4:20PM

Use the Totality of Evidence to Gain Abuse Deterrence Label Claims During an ANDA Registration
Torben Elhauge, Senior Science Specialist, EGALET

4:20PM – 5:00PM

PANEL: The Dual Role of Opioids: Pain Management and Reducing Opioid Abuse. What Have We Achieved – And Where Are We Headed?
MODERATOR:
Alexander Kraus, former Vice President, Business Unit North America, GRUNENTHAL

PANELISTS:
John Burke, President, INTERNATIONAL HEALTH FACILITY DIVERSION ASSOCIATION
Peter Pitts, President, CENTER FOR MEDICINE IN THE PUBLIC INTEREST
Marta Sokolowska, Vice President, Medical and External Affairs, DEPOMED

5:00PM – 6:15PM

Cocktail Networking Reception

Sponsored by Altasciences 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
Ernest Kopecky, Vice President, Clinical Development, Head, Global Pain Medicine, TEVA


Day Two

 

8:00AM – 8:45AM

Continental Breakfast

 

R&D INNOVATIONS

8:45AM – 9:00AM

Introduction From Track Chairperson

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

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

11:45AM – 12:30PM

Are All ADFs Created Equal? Comparing and Evaluating Abuse Liability and Regulatory Outcomes Between Different Drugs

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

12:30PM – 1:30PM

Luncheon

MARKETPLACE PROGRESS

8:45AM – 9:00AM

Introduction from Track Chairperson

Jeremy Adler, COO, PACIFIC PAIN MEDICINE

9:00AM – 9:45AM

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

Angela DeVeaugh-Geiss, Director, Epidemiology, PURDUE PHARMA

9:45AM – 10:30AM

ADF Effectiveness: Making the Case to Payers and Clinicians

Theresa Cassidy, Vice President, Health Analytics, INFLEXXION

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Revise Physician Outreach to Emphasize Reduced Diversion Potential for ADFs

Jeremy Adler, COO, PACIFIC PAIN MEDICINE

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