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Agenda

Achieve ADF Labeling • Reduce Abuse Potential • Integrate Technologies to Support Deterrence

March 7-8, 2017
  • Alexandria, VA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MARCH 7, 2017

7:30

Conference Registration and Continental Breakfast

8:15

Co-Chairs’ Welcome and Opening Remarks

Penny Levin
Director, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals

Dan Cohen
Executive Vice President, Government & Public Relations, KemPharm;
Chair, Abuse Deterrent Coalition Forum

8:30

Align Market Objectives and Policy for National Public Health

Shruti Kulkarni, JD
Policy Director
Center for Lawful Access and Abuse Deterrence (CLAAD)

9:15

Protecting Against Oral Abuse and Overdose with Next Generation Technologies

Greg Sturmer
President and CEO
Elysium Therapeutics

10:00

Networking and Refreshment Break

10:30

Adventures in Category 4 — Can we prove that ADF opioids really are?

Richard Dart, MD
Director
Rocky Mountain Poison and Drug Center

11:15

Abuse Deterrent Formulations — A Private Payer View

Paul Eiting
Senior Manager, Office of Policy and Representation
Blue Cross Blue Shield

12:00

The Role of Patient Advocacy in Preventing Abuse

Jon Rodis
Patient Advocate Living with Marfan Syndrome
Global Patient Advocate

12:30

Networking Luncheon

1:30

State of the Industry — An FDA Regulatory Exposition

Douglas Throckmorton, MD
Deputy Center Director, Regulatory Programs
U.S. Food and Drug Administration

2:15

Forward Steps in the Generic ADF Lifecycle

Mark Hendrickson
Senior Director, Sciences and Regulatory Affairs
Association for Accessible Medicines (AAM)

Candis Edwards
Senior Vice President, Clinical Regulatory Affairs
Amneal Pharmaceuticals

Gregg DeRosa
Vice President, Global Clinical R&D Global Generic Medicines
Teva Pharmaceuticals

3:15

Networking and Refreshment Break

3:45

Identifying Key Characteristics and Habits of the Recreational Drug User

Beatrice Setnik, PhD
Vice President Scientific Affairs, Early Phase
INC Research

4:30

Scaling the Value of Abuse Deterrent Formulations in Treatment and Prevention

Peter Pitts
President & Co Founder
Center for Medicine in the Public Interest

Paul Eiting
Senior Manager, Office of Policy and Representation
Blue Cross Blue Shield

Lynn Webster, MD
Past President
American Academy of Pain Medicine

5:15

Chairperson’s Re-cap of Day One

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, MARCH 8, 2017

7:30

Continental Breakfast

8:15

Co-Chairs’ Review of Day One

Penny Levin
Director, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals

Dan Cohen
Executive Vice President, Government & Public Relations, KemPharm;
Chair, Abuse Deterrent Coalition Forum

8:30

Looking Beyond the Opioid Epidemic —
Minimize Risk of Abuse Across Multiple Categories

Alexander Kraus
Vice President Product Development, Technical and Government Affairs
Grünenthal USA

9:15

Understanding and Addressing Abuse of ADHD Stimulants

David Baker
Chief Commercial Officer
Alcobra Inc.

10:00

Networking and Refreshment Break

10:30

EXTENDED SESSION
An Interdisciplinary Team Approach to Safely and Effectively Treat Chronic Pain and Reduce the Potential for Opioid Abuse

Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP
Adjunct Associate Professor, Pharmacy Practice & Pain Management
Albany College of Pharmacy & Health Sciences

12:00

Networking Luncheon

1:00

CASE STUDY
Design and Interpretation of Category 1 Data

Karsten Lindhardt
Senior Vice President R&D, Site Management
Egalet Corp.

Torben Elhauge
Senior Science Specialist
Egalet Corp.

1:45

Strategies for Developing Successful Partnerships in Category 1 ADF Testing — Key Elements of Effective Sponsor-Laboratory Collaborations

Brandon C. Presley
Team Leader, Abuse Deterrent Formulations (ADF)
NMS Labs

2:15

Category 1 Mock Testing Session

NMS Labs

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MARCH 7, 2017

7:30

Conference Registration and Continental Breakfast

8:15

Co-Chairs’ Welcome and Opening Remarks

Penny Levin
Director, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals

Dan Cohen
Executive Vice President, Government & Public Relations, KemPharm;
Chair, Abuse Deterrent Coalition Forum

8:30

Align Market Objectives and Policy for National Public Health

Shruti Kulkarni, JD
Policy Director
Center for Lawful Access and Abuse Deterrence (CLAAD)

9:15

Protecting Against Oral Abuse and Overdose with Next Generation Technologies

Greg Sturmer
President and CEO
Elysium Therapeutics

10:00

Networking and Refreshment Break

10:30

Adventures in Category 4 — Can we prove that ADF opioids really are?

Richard Dart, MD
Director
Rocky Mountain Poison and Drug Center

11:15

Abuse Deterrent Formulations — A Private Payer View

Paul Eiting
Senior Manager, Office of Policy and Representation
Blue Cross Blue Shield

12:00

The Role of Patient Advocacy in Preventing Abuse

Jon Rodis
Patient Advocate Living with Marfan Syndrome
Global Patient Advocate

12:30

Networking Luncheon

1:30

State of the Industry — An FDA Regulatory Exposition

Douglas Throckmorton, MD
Deputy Center Director, Regulatory Programs
U.S. Food and Drug Administration

2:15

Forward Steps in the Generic ADF Lifecycle

Mark Hendrickson
Senior Director, Sciences and Regulatory Affairs
Association for Accessible Medicines (AAM)

Candis Edwards
Senior Vice President, Clinical Regulatory Affairs
Amneal Pharmaceuticals

Gregg DeRosa
Vice President, Global Clinical R&D Global Generic Medicines
Teva Pharmaceuticals

3:15

Networking and Refreshment Break

3:45

Identifying Key Characteristics and Habits of the Recreational Drug User

Beatrice Setnik, PhD
Vice President Scientific Affairs, Early Phase
INC Research

4:30

Scaling the Value of Abuse Deterrent Formulations in Treatment and Prevention

Peter Pitts
President & Co Founder
Center for Medicine in the Public Interest

Paul Eiting
Senior Manager, Office of Policy and Representation
Blue Cross Blue Shield

Lynn Webster, MD
Past President
American Academy of Pain Medicine

5:15

Chairperson’s Re-cap of Day One

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, MARCH 8, 2017

7:30

Continental Breakfast

8:15

Co-Chairs’ Review of Day One

Penny Levin
Director, Global Regulatory Intelligence and Policy
Teva Pharmaceuticals

Dan Cohen
Executive Vice President, Government & Public Relations, KemPharm;
Chair, Abuse Deterrent Coalition Forum

8:30

Looking Beyond the Opioid Epidemic —
Minimize Risk of Abuse Across Multiple Categories

Alexander Kraus
Vice President Product Development, Technical and Government Affairs
Grünenthal USA

9:15

Understanding and Addressing Abuse of ADHD Stimulants

David Baker
Chief Commercial Officer
Alcobra Inc.

10:00

Networking and Refreshment Break

10:30

EXTENDED SESSION
An Interdisciplinary Team Approach to Safely and Effectively Treat Chronic Pain and Reduce the Potential for Opioid Abuse

Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP
Adjunct Associate Professor, Pharmacy Practice & Pain Management
Albany College of Pharmacy & Health Sciences

12:00

Networking Luncheon

1:00

CASE STUDY
Design and Interpretation of Category 1 Data

Karsten Lindhardt
Senior Vice President R&D, Site Management
Egalet Corp.

Torben Elhauge
Senior Science Specialist
Egalet Corp.

1:45

Strategies for Developing Successful Partnerships in Category 1 ADF Testing — Key Elements of Effective Sponsor-Laboratory Collaborations

Brandon C. Presley
Team Leader, Abuse Deterrent Formulations (ADF)
NMS Labs

2:15

Category 1 Mock Testing Session

NMS Labs

3:00

Close of Conference