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Agenda

Address Compliance Risks to Ensure Sustainable Patient Programs

September 25-26, 2018

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, SEPTEMBER 25, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Co-Chair’s Welcome and Opening Remarks

Tracy Weiner
Senior Director, Executive Counsel
Teva

Debbie Walters
Vice President & Assistant General Counsel
Pfizer Inc

Evaluate the Complex Legal Landscape for Patient Assistance Programs

8:45

Examine the Impact of Legal Actions and Developments Related to Patient Assistance Programs

Bill Sarraille
Partner
Sidley Austin LLP

9:30

PANEL DISCUSSION Examine the Legal and Compliance Considerations in Working with Field Reimbursement Teams

MODERATOR:

Garineh S. Dovletian, J.D.
Vice President, Legal and Compliance
Pernix Therapeutics

PANELISTS:

Pamela Politis
Executive Director U.S. Legal
Incyte

David Layfer
Senior Counsel
AbbVie

10:15

Networking and Refreshment Break

10:45

Analyze PAP Critical Risk Areas within the Anti-Kickback Statute (AKS), False Claims Act (FCA) and Other Key Laws

Sarah DiFrancesca
Partner
Cooley

11:30

PANEL DISCUSSION Discuss the Patient’s Perspective on the Critical Challenges in Providing Effective Assistance

MODERATOR:

Krista Zodet
President
HealthWell Foundation

PANELISTS:

Lisa Hoffman
Medications Assistance Coordinator
Ohio Health

Natalie Foss
Medication Assistance Program Supervisor
UnityPoint Health – Trinity

Melissa Paige
Patient Access Principal Coordinator
University of Virginia Health System

12:30

Networking Luncheon

1:30

Redefine Relationships between Manufacturers and 501(c)3 Foundations

Erin Atkins
Associate
Arent Fox LLP

Explore Risk Mitigation and
Compliance Monitoring

2:15

Build Effective Strategies to Balance Patient Centricity and Compliance in Patient Access

Jennifer DiFruscio
Commercial Counsel
Sunovion

3:00

Networking and Refreshment Break

3:30

Navigate the Differences in Providing Assistance for Government vs. Commercial Patients

MODERATOR:

Rebecca Simone
Partner
Nixon Peabody LLP

PANELISTS:

Christina Simmons
Senior Corporate Counsel
Pfizer

Annie D. Vanselow
Senior Associate
Hogan Lovells LLP

Hannah Bornstein
Partner
Nixon Peabody LLP

4:15

Develop and Implement an Effective PAP Compliance Program to Mitigate Legal/Regulatory Risks

Tom Herrmann, JD
Interim Chief Compliance Officer
Patient Access Network Foundation

Dan Klein
President & CEO
Patient Access Network Foundation

5:00

Close of Day One

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

DAY TWO WEDNESDAY, SEPTEMBER 26, 2018

8:00

Continental Breakfast

8:30

Co-Chair’s Review of Day One

Tracy Weiner
Senior Director, Executive Counsel
Teva

Debbie Walters
Vice President & Assistant General Counsel
Pfizer Inc

New Developments and Legal Nuances
of Patient Assistance

8:45

Dissect Evolving State Copay Card Legislation in California and Massachusetts

Venel Brown
Assistant General Counsel
GlaxoSmithKline

Tracy Weiner
Senior Director, Executive Counsel
Teva

9:30

PANEL Tackle Critical Challenges in Providing Assistance for Rare Disease and Specialty Therapeutics Patients

MODERATOR:

Debbie Walters
Vice President & Assistant General Counsel
Pfizer Inc

PANELISTS:

Howard Dorfman
Distinguished Visiting Professor, Seton Hall Law School;
Founder, H.L. Dorfman Pharmaceutical Consulting, LLC

Garineh S. Dovletian, J.D.
Vice President, Legal and Compliance
Pernix Therapeutics

Erin Atkins
Associate
Arent Fox LLP

10:15

Networking and Refreshment Break

10:45

Delve Into Patient Privacy in Patient Assistance Programs

Rebecca Simone
Partner
Nixon Peabody LLP

11:30

Explore Compliance for Bridge Programs, Quickstart Programs and Sample Vouchers

Howard Dorfman
Distinguished Visiting Professor, Seton Hall Law School;
Founder, H.L. Dorfman Pharmaceutical Consulting, LLC

Meenakashi Datta
Partner and Co-Leader of Healthcare Practice Team
Sidley Austin LLP

12:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, SEPTEMBER 25, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Co-Chair’s Welcome and Opening Remarks

Tracy Weiner
Senior Director, Executive Counsel
Teva

Debbie Walters
Vice President & Assistant General Counsel
Pfizer Inc

Evaluate the Complex Legal Landscape for Patient Assistance Programs

8:45

Examine the Impact of Legal Actions and Developments Related to Patient Assistance Programs

Bill Sarraille
Partner
Sidley Austin LLP

9:30

PANEL DISCUSSION Examine the Legal and Compliance Considerations in Working with Field Reimbursement Teams

MODERATOR:

Garineh S. Dovletian, J.D.
Vice President, Legal and Compliance
Pernix Therapeutics

PANELISTS:

Pamela Politis
Executive Director U.S. Legal
Incyte

David Layfer
Senior Counsel
AbbVie

10:15

Networking and Refreshment Break

10:45

Analyze PAP Critical Risk Areas within the Anti-Kickback Statute (AKS), False Claims Act (FCA) and Other Key Laws

Sarah DiFrancesca
Partner
Cooley

11:30

PANEL DISCUSSION Discuss the Patient’s Perspective on the Critical Challenges in Providing Effective Assistance

MODERATOR:

Krista Zodet
President
HealthWell Foundation

PANELISTS:

Lisa Hoffman
Medications Assistance Coordinator
Ohio Health

Natalie Foss
Medication Assistance Program Supervisor
UnityPoint Health – Trinity

Melissa Paige
Patient Access Principal Coordinator
University of Virginia Health System

12:30

Networking Luncheon

1:30

Redefine Relationships between Manufacturers and 501(c)3 Foundations

Erin Atkins
Associate
Arent Fox LLP

Explore Risk Mitigation and
Compliance Monitoring

2:15

Build Effective Strategies to Balance Patient Centricity and Compliance in Patient Access

Jennifer DiFruscio
Commercial Counsel
Sunovion

3:00

Networking and Refreshment Break

3:30

Navigate the Differences in Providing Assistance for Government vs. Commercial Patients

MODERATOR:

Rebecca Simone
Partner
Nixon Peabody LLP

PANELISTS:

Christina Simmons
Senior Corporate Counsel
Pfizer

Annie D. Vanselow
Senior Associate
Hogan Lovells LLP

Hannah Bornstein
Partner
Nixon Peabody LLP

4:15

Develop and Implement an Effective PAP Compliance Program to Mitigate Legal/Regulatory Risks

Tom Herrmann, JD
Interim Chief Compliance Officer
Patient Access Network Foundation

Dan Klein
President & CEO
Patient Access Network Foundation

5:00

Close of Day One

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

DAY TWO WEDNESDAY, SEPTEMBER 26, 2018

8:00

Continental Breakfast

8:30

Co-Chair’s Review of Day One

Tracy Weiner
Senior Director, Executive Counsel
Teva

Debbie Walters
Vice President & Assistant General Counsel
Pfizer Inc

New Developments and Legal Nuances
of Patient Assistance

8:45

Dissect Evolving State Copay Card Legislation in California and Massachusetts

Venel Brown
Assistant General Counsel
GlaxoSmithKline

Tracy Weiner
Senior Director, Executive Counsel
Teva

9:30

PANEL Tackle Critical Challenges in Providing Assistance for Rare Disease and Specialty Therapeutics Patients

MODERATOR:

Debbie Walters
Vice President & Assistant General Counsel
Pfizer Inc

PANELISTS:

Howard Dorfman
Distinguished Visiting Professor, Seton Hall Law School;
Founder, H.L. Dorfman Pharmaceutical Consulting, LLC

Garineh S. Dovletian, J.D.
Vice President, Legal and Compliance
Pernix Therapeutics

Erin Atkins
Associate
Arent Fox LLP

10:15

Networking and Refreshment Break

10:45

Delve Into Patient Privacy in Patient Assistance Programs

Rebecca Simone
Partner
Nixon Peabody LLP

11:30

Explore Compliance for Bridge Programs, Quickstart Programs and Sample Vouchers

Howard Dorfman
Distinguished Visiting Professor, Seton Hall Law School;
Founder, H.L. Dorfman Pharmaceutical Consulting, LLC

Meenakashi Datta
Partner and Co-Leader of Healthcare Practice Team
Sidley Austin LLP

12:00

Close of Conference