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Agenda

Ensure Compliance in Specialty Pharmacy Arrangements, Patient Support Programs and Evolving Drug Pricing Transparency Legislation

December 4-5, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, DECEMBER 4, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Examine Current Enforcement Trends and Evolving Payer Contracting with PBMs
and Third-Party Vendors

8:45

Keynote Enforcement Panel
Discuss the Current Landscape of Recent Enforcement Actions Affecting Managed Markets

Moderator:

Joseph Mack
Senior Compliance Counsel, U.S. Office of Compliance
Bayer U.S.

Panelists:

Bernard Cooney
Assistant United States Attorney, District of New Jersey
U.S. Department of Justice

Eric Rubenstein
Special Agent, U.S. Department of Health and Human Services
Office of the Inspector General

9:30

Evaluate Risk in Evolving Payer Contracting with PBMs

Katherine Chaurette
Senior Director, Assistant General Counsel
Regeneron

Kosha R. Brightwell
Consultant

Michelle D. Axelrod
Principal, Porzio, Bromberg & Newman, PC;
Vice President, Porzio Life Sciences, LLC

10:30

Networking and Refreshment Break

11:00

Manage Risk in Contracting with Third-Party Vendors for Patient Support Programs

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

11:45

Interactive Q & A Session
Legal and Compliance Roles in Mitigating Risk in Managed Markets and the Contracting Process

Moderator:

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Panelists:

Jennifer McGee
Vice President and Chief Compliance Officer
Otsuka America Pharmaceutical, Inc.

Robert Duffield
Counsel
Novo Nordisk Inc.

Rahul Khara, Pharm.D., Esq.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Consider Managed Markets Compliance Implications as State Drug Pricing
Legislation Expands

12:30

Networking Luncheon

1:30

Understand the Current State of Drug Pricing Transparency Laws

William Sarraille
Partner
Sidley Austin LLP

Trevor Wear
Partner
Sidley Austin LLP

2:15

Panel Session
Evaluate the Impact of State Drug Pricing Transparency Laws on Managed Markets

MODERATOR

William Harris
Assistant General Counsel
Sanofi

PANEL

Allison Frisbee
Corporate Counsel, U.S. Market Access
Jazz Pharmaceuticals, Inc.

Jonathan Connell
Senior Counsel
Bristol-Myers Squibb

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

3:00

Networking and Refreshment Break

3:30

Proven Technologies to Ensure Copay Assistance Eligibility

Chris Dowd
Executive Vice President, Market and Product Development
ConnectiveRx

Explore Audit and Monitoring Activities for PSPs and Current Trends in Managing
Bona Fide Service Fees

4:15

Assess the Need for In-house Compliance Audits and Monitoring for Patient Support Programs

James Accumanno
Director, Risk, Monitoring & Auditing
Novo Nordisk Inc.

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Rahul Khara, Pharm.D., Esq.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

5:00

Bona Fide Service Fees — Ensure Compliance in Managed Markets

John Moose
Principal
Polaris, a QuintilesIMS Company

5:45

Close of Day One

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

DAY TWOWEDNESDAY, DECEMBER 5, 2018

7:30

Continental Breakfast

8:15

Chairperson’s Review of Day One

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Effective Strategies to Manage Risk
Around Communications

8:30

Panel Session
Implement FDA Guidance On Communications with Payors

Moderator:

Charles D. Rome, Esq.
Associate Director, Compliance Business Partner, Compliance Department
Novo Nordisk Inc.

Panelists:

Keren Tenenbaum
Assistant General Counsel
Pfizer Inc.

Robert Duffield
Counsel
Novo Nordisk Inc.

Kosha R. Brightwell
Consultant

9:15

Ensure Compliant Interactions with Specialty Pharmacies, Wholesalers and Distributors

Jim Vollins
General Counsel, Chief Compliance Officer
BioDelivery Services International, Inc.

Richard Konzelmann
Senior Manager, U.S. Ethics and Business Integrity
Sanofi US

10:00

Networking and Refreshment Break

10:30

Understand the Role of Managed Markets in Product Launches

Michelle D. Axelrod
Principal, Porzio, Bromberg & Newman, PC;
Vice President, Porzio Life Sciences, LLC

James Burns
Vice President, Commercial Healthcare Law and Chief Compliance Officer
Agios Pharmaceuticals

11:15

Panel Session
Managing Risk and Ensuring Compliant Interactions with Patient Support Programs

Moderator:

William Sarraille
Partner
Sidley Austin LLP

Panelists:

Stefanie L. Hill, Esq.
Senior Compliance Manager
Otsuka America Pharmaceutical, Inc.

Jim Vollins
General Counsel, Chief Compliance Officer
BioDelivery Services International, Inc.

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

12:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, DECEMBER 4, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Examine Current Enforcement Trends and Evolving Payer Contracting with PBMs
and Third-Party Vendors

8:45

Keynote Enforcement Panel
Discuss the Current Landscape of Recent Enforcement Actions Affecting Managed Markets

Moderator:

Joseph Mack
Senior Compliance Counsel, U.S. Office of Compliance
Bayer U.S.

Panelists:

Bernard Cooney
Assistant United States Attorney, District of New Jersey
U.S. Department of Justice

Eric Rubenstein
Special Agent, U.S. Department of Health and Human Services
Office of the Inspector General

9:30

Evaluate Risk in Evolving Payer Contracting with PBMs

Katherine Chaurette
Senior Director, Assistant General Counsel
Regeneron

Kosha R. Brightwell
Consultant

Michelle D. Axelrod
Principal, Porzio, Bromberg & Newman, PC;
Vice President, Porzio Life Sciences, LLC

10:30

Networking and Refreshment Break

11:00

Manage Risk in Contracting with Third-Party Vendors for Patient Support Programs

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

11:45

Interactive Q & A Session
Legal and Compliance Roles in Mitigating Risk in Managed Markets and the Contracting Process

Moderator:

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Panelists:

Jennifer McGee
Vice President and Chief Compliance Officer
Otsuka America Pharmaceutical, Inc.

Robert Duffield
Counsel
Novo Nordisk Inc.

Rahul Khara, Pharm.D., Esq.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Consider Managed Markets Compliance Implications as State Drug Pricing
Legislation Expands

12:30

Networking Luncheon

1:30

Understand the Current State of Drug Pricing Transparency Laws

William Sarraille
Partner
Sidley Austin LLP

Trevor Wear
Partner
Sidley Austin LLP

2:15

Panel Session
Evaluate the Impact of State Drug Pricing Transparency Laws on Managed Markets

MODERATOR

William Harris
Assistant General Counsel
Sanofi

PANEL

Allison Frisbee
Corporate Counsel, U.S. Market Access
Jazz Pharmaceuticals, Inc.

Jonathan Connell
Senior Counsel
Bristol-Myers Squibb

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

3:00

Networking and Refreshment Break

3:30

Proven Technologies to Ensure Copay Assistance Eligibility

Chris Dowd
Executive Vice President, Market and Product Development
ConnectiveRx

Explore Audit and Monitoring Activities for PSPs and Current Trends in Managing
Bona Fide Service Fees

4:15

Assess the Need for In-house Compliance Audits and Monitoring for Patient Support Programs

James Accumanno
Director, Risk, Monitoring & Auditing
Novo Nordisk Inc.

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Rahul Khara, Pharm.D., Esq.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

5:00

Bona Fide Service Fees — Ensure Compliance in Managed Markets

John Moose
Principal
Polaris, a QuintilesIMS Company

5:45

Close of Day One

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

DAY TWOWEDNESDAY, DECEMBER 5, 2018

7:30

Continental Breakfast

8:15

Chairperson’s Review of Day One

Debbie Walters-Francique
Vice President, Assistant General Counsel,
Pfizer Inc.

Effective Strategies to Manage Risk
Around Communications

8:30

Panel Session
Implement FDA Guidance On Communications with Payors

Moderator:

Charles D. Rome, Esq.
Associate Director, Compliance Business Partner, Compliance Department
Novo Nordisk Inc.

Panelists:

Keren Tenenbaum
Assistant General Counsel
Pfizer Inc.

Robert Duffield
Counsel
Novo Nordisk Inc.

Kosha R. Brightwell
Consultant

9:15

Ensure Compliant Interactions with Specialty Pharmacies, Wholesalers and Distributors

Jim Vollins
General Counsel, Chief Compliance Officer
BioDelivery Services International, Inc.

Richard Konzelmann
Senior Manager, U.S. Ethics and Business Integrity
Sanofi US

10:00

Networking and Refreshment Break

10:30

Understand the Role of Managed Markets in Product Launches

Michelle D. Axelrod
Principal, Porzio, Bromberg & Newman, PC;
Vice President, Porzio Life Sciences, LLC

James Burns
Vice President, Commercial Healthcare Law and Chief Compliance Officer
Agios Pharmaceuticals

11:15

Panel Session
Managing Risk and Ensuring Compliant Interactions with Patient Support Programs

Moderator:

William Sarraille
Partner
Sidley Austin LLP

Panelists:

Stefanie L. Hill, Esq.
Senior Compliance Manager
Otsuka America Pharmaceutical, Inc.

Jim Vollins
General Counsel, Chief Compliance Officer
BioDelivery Services International, Inc.

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

12:00

Close of Conference