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Agenda

Collaboration, Regulation and Innovation to Reduce the Risk of Addiction, Abuse, Misuse and Overdose

March 13-14, 2018
  • Silver Spring, MD

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MARCH 13, 2018

PRE-CONFERENCE WORKSHOP Methods for Clinical Innovations of Abuse-Deterrent Formulations

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leader’s Opening Remarks

Workshop Objective:

This workshop provides innovations of abuse-deterrent formulations provides critical information about both formulation and process considerations for making abuse-deterrent formulations.

I.Guidance

II.Process and Formulations

III.How Do You Prove it Will Be Abuse-Deterrent In Vitro

Workshop Leaders:

Piyush Patel
Formulation Technologies Manager
Colorcon

Chris Altomare
Director of Pharmaceutical Services
Drug Scan Inc.

Amie Gehris
Technical Service Manager
Dow Food, Pharma & Medical, Company

There will be a 30 minute networking and refreshment break at 10:00

12:00

Close of Workshop

MAIN CONFERENCE

12:00

Conference Registration and Refreshments

Chairman’s Opening Remarks

Greg Sturmer
Chairman, CDO and Founder
Elysium Therapeutics

1:15

KEYNOTE Pharmacological Response to Mitigating the Opioid Crisis

Steven Passik, PhD
Vice President, Scientific Affairs, Education and Policy
Collegium Pharmaceutical, Inc.

2:00

Economics of Abuse-Deterrent Formulations

Bob Jones
CEO
Acura Pharmaceuticals

2:45

Networking and Refreshment Break

3:15

Discussion of General Principles of Latest FDA Report on Generics

Frederick R. Ball
Partner
Duane Morris

4:00

CDC Guidelines —
Their Impact on Patients and the Physicians Who Try to Treat them

Gary W. Jay, MD, FAAPM, FACFEI
Clinical Professor, Department of Neurology, Division: Headache and Pain
University of North Carolina, Chapel Hill, NC

4:45

Risk Evaluation and Mitigation Strategy (REMS) —
Opioids for a Changing Landscape

Colville Brown MD
Medical Director
Egalet

5:30

Close of Day One

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

DAY TWO WEDNESDAY, MARCH 14, 2018

7:30

Continental Breakfast

8:15

Chairman’s Welcome and Review of Day One

Greg Sturmer
Chairman, CDO and Founder
Elysium Therapeutics

8:30

PANEL DISCUSSIONPutting the Pieces of Partnership Together —
Opportunities and Challenges

MODERATOR:

Jan Berger
CEO, Health Intelligence Partners;
Former Chief Clinical Strategist, Quantum Health;
Former Senior Vice President and Chief Clinical Officer,
CVS Caremark

PANELISTS:

Sandra Morris
Principal, About Quality Benefits Design;
Former Senior Manager, Employee Benefit Design, Procter and Gamble

Steven Passik, PhD
Vice President, Scientific Affairs, Education and Policy
Collegium Pharmaceutical, Inc.

Lauren B. Nelson, Esq.
Director, Policy and Regulatory Affairs
Massachusetts Department of Public Health,
Bureau of Health Professions Licensure

Ronald E. Smith, MD, PhD
Board Certified Physician in Addiction Medicine,
Internal Medicine and Emergency Medicine;
Former Chairman, Department of Psychiatry, National Naval Medical Center;
Psychiatric Consultant, Senate and House

9:15

FIRESIDE CHAT Innovative Solutions for Reducing Barriers and Increasing Effectiveness of Treatment for Abuse and Addiction

MODERATOR:

Colville Brown MD
Medical Director
Egalet

PANELISTS:

Gary W. Jay, MD, FAAPM, FACFEI
Clinical Professor, Department of Neurology, Division: Headache and Pain
University of North Carolina, Chapel Hill, NC

Denise Milovan, PhD, C.Psych.
Research Scientist, Neuropsychologist, Early Phase
Syneos Health

10:00

Networking Break

10:30

Outlining a Multidisciplinary Approach to Lessening the Impact of Abuse in the Workplace

Sandra Morris
Principal, About Quality Benefits Design;
Former Senior Manager, Employee Benefit Design, Procter and Gamble

11:15

Analytical Methodologies for Testing Novel Abuse-Deterrent Products

Brandon C. Presley
Abuse-Deterrent Formulations Team Leader
NMS Labs

12:00

Networking Luncheon

1:00

Update on legislative initiatives in the state of Massachusetts — Legislating Solutions to the Opioid Crisis

Lauren B. Nelson, Esq.
Director, Policy and Regulatory Affairs
Massachusetts Department of Public Health,
Bureau of Health Professions Licensure

1:45

FDA KEYNOTE FDA Update on Recently Released Policies for
Fighting the Opioid Epidemic

Douglas Throckmorton
Deputy Director, Regulatory Programs
FDA

2:15

Measures of ADF Effectiveness: Alignment of Intended Impact and Postmarket Outcome Measures

Jody L Green, PhD, CCRP
Chief Scientific Officer
Inflexxion, Inc.

3:00

Chairman’s Closing Remarks

Greg Sturmer
Chairman, CDO and Founder
Elysium Therapeutics

3:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MARCH 13, 2018

PRE-CONFERENCE WORKSHOP Methods for Clinical Innovations of Abuse-Deterrent Formulations

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leader’s Opening Remarks

Workshop Objective:

This workshop provides innovations of abuse-deterrent formulations provides critical information about both formulation and process considerations for making abuse-deterrent formulations.

I.Guidance

II.Process and Formulations

III.How Do You Prove it Will Be Abuse-Deterrent In Vitro

Workshop Leaders:

Piyush Patel
Formulation Technologies Manager
Colorcon

Chris Altomare
Director of Pharmaceutical Services
Drug Scan Inc.

Amie Gehris
Technical Service Manager
Dow Food, Pharma & Medical, Company

There will be a 30 minute networking and refreshment break at 10:00

12:00

Close of Workshop

MAIN CONFERENCE

12:00

Conference Registration and Refreshments

Chairman’s Opening Remarks

Greg Sturmer
Chairman, CDO and Founder
Elysium Therapeutics

1:15

KEYNOTE Pharmacological Response to Mitigating the Opioid Crisis

Steven Passik, PhD
Vice President, Scientific Affairs, Education and Policy
Collegium Pharmaceutical, Inc.

2:00

Economics of Abuse-Deterrent Formulations

Bob Jones
CEO
Acura Pharmaceuticals

2:45

Networking and Refreshment Break

3:15

Discussion of General Principles of Latest FDA Report on Generics

Frederick R. Ball
Partner
Duane Morris

4:00

CDC Guidelines —
Their Impact on Patients and the Physicians Who Try to Treat them

Gary W. Jay, MD, FAAPM, FACFEI
Clinical Professor, Department of Neurology, Division: Headache and Pain
University of North Carolina, Chapel Hill, NC

4:45

Risk Evaluation and Mitigation Strategy (REMS) —
Opioids for a Changing Landscape

Colville Brown MD
Medical Director
Egalet

5:30

Close of Day One

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

DAY TWO WEDNESDAY, MARCH 14, 2018

7:30

Continental Breakfast

8:15

Chairman’s Welcome and Review of Day One

Greg Sturmer
Chairman, CDO and Founder
Elysium Therapeutics

8:30

PANEL DISCUSSIONPutting the Pieces of Partnership Together —
Opportunities and Challenges

MODERATOR:

Jan Berger
CEO, Health Intelligence Partners;
Former Chief Clinical Strategist, Quantum Health;
Former Senior Vice President and Chief Clinical Officer,
CVS Caremark

PANELISTS:

Sandra Morris
Principal, About Quality Benefits Design;
Former Senior Manager, Employee Benefit Design, Procter and Gamble

Steven Passik, PhD
Vice President, Scientific Affairs, Education and Policy
Collegium Pharmaceutical, Inc.

Lauren B. Nelson, Esq.
Director, Policy and Regulatory Affairs
Massachusetts Department of Public Health,
Bureau of Health Professions Licensure

Ronald E. Smith, MD, PhD
Board Certified Physician in Addiction Medicine,
Internal Medicine and Emergency Medicine;
Former Chairman, Department of Psychiatry, National Naval Medical Center;
Psychiatric Consultant, Senate and House

9:15

FIRESIDE CHAT Innovative Solutions for Reducing Barriers and Increasing Effectiveness of Treatment for Abuse and Addiction

MODERATOR:

Colville Brown MD
Medical Director
Egalet

PANELISTS:

Gary W. Jay, MD, FAAPM, FACFEI
Clinical Professor, Department of Neurology, Division: Headache and Pain
University of North Carolina, Chapel Hill, NC

Denise Milovan, PhD, C.Psych.
Research Scientist, Neuropsychologist, Early Phase
Syneos Health

10:00

Networking Break

10:30

Outlining a Multidisciplinary Approach to Lessening the Impact of Abuse in the Workplace

Sandra Morris
Principal, About Quality Benefits Design;
Former Senior Manager, Employee Benefit Design, Procter and Gamble

11:15

Analytical Methodologies for Testing Novel Abuse-Deterrent Products

Brandon C. Presley
Abuse-Deterrent Formulations Team Leader
NMS Labs

12:00

Networking Luncheon

1:00

Update on legislative initiatives in the state of Massachusetts — Legislating Solutions to the Opioid Crisis

Lauren B. Nelson, Esq.
Director, Policy and Regulatory Affairs
Massachusetts Department of Public Health,
Bureau of Health Professions Licensure

1:45

FDA KEYNOTE FDA Update on Recently Released Policies for
Fighting the Opioid Epidemic

Douglas Throckmorton
Deputy Director, Regulatory Programs
FDA

2:15

Measures of ADF Effectiveness: Alignment of Intended Impact and Postmarket Outcome Measures

Jody L Green, PhD, CCRP
Chief Scientific Officer
Inflexxion, Inc.

3:00

Chairman’s Closing Remarks

Greg Sturmer
Chairman, CDO and Founder
Elysium Therapeutics

3:15

Close of Conference