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DAY ONE TUESDAY, DECEMBER 5, 2017

7:30

Conference Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

Consider Current Enforcement Trends and Managed Markets Compliance Risks

8:30

KEYNOTE ENFORCEMENT PANEL
Discuss the Current Landscape of Recent Enforcement Cases in Managed Markets

MODERATOR:

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

PANELISTS:

Charles Graybow
Assistant U.S. Attorney
U.S. Attorney’s Office, Newark, New Jersey

Charlene Fullmer
Deputy Chief for Affirmative Litigation, Civil Division
U.S. Attorney’s Office for the District of Eastern Pennsylvania

William D. Weinreb
First Assistant U.S. Attorney
District of Massachusetts

9:30

Navigate the Major Compliance Issues around Formularies

Julie K. Letwat
Counsel
Faegre Baker Daniels

10:15

Networking and Refreshment Break

10:45

CASE STUDY
Manage Compliance Risks Associated with Specialty Products

Christine O’Connor-Fiore
Director, Specialty Markets Compliance
Boehringer Ingelheim

Assess Compliance Challenges Inherent to Manufacturers’ Increasing Interactions
with Specialty Pharmacies

11:30

INTERACTIVE SESSION
Mitigate Risk in Interactions between Manufacturers and
Specialty Pharmacies

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

Curt Oltmans
Executive Vice President, General Counsel & Corporate Secretary
Array BioPharma

12:30

Networking Luncheon

1:45

FIRESIDE CHAT
Effective Strategies to Mitigate Fraud and Abuse Risks in
Patient Assistance Programs

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

Kevin M. Henley, Esq.
Senior Director, Senior Compliance Counsel
Otsuka America Pharmaceutical, Inc.

2:30

FDA Draft Guidance on Payor Communications —
Identifying and Managing Compliance Risk

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

Jessica Rickabaugh, Esq.
Health Sciences Department
Pepper Hamilton LLP

Keren Tenenbaum
Assistant General Counsel
Pfizer Inc

3:15

Networking and Refreshment Break

3:45

Ask the Experts Panel Session

MODERATOR:

Julie K. Letwat
Counsel
Faegre Baker Daniels

PANELISTS:

Ben Barrameda
Senior Counsel, Managed Markets and Pricing
Bayer Pharmaceuticals

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

Christina Flint
Vice President & General Counsel
Diplomat

Keren Tenenbaum
Assistant General Counsel
Pfizer Inc

4:30

Encouraging Growth in Value-based Contracting —
Mitigating Risk and Clarifying Guard Rails

Josh O’Harra
Assistant General Counsel
Eli Lilly and Company

5:15

Close of Day One

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

DAY TWOWEDNESDAY, DECEMBER 6, 2017

7:30

Continental Breakfast

8:15

Chairperson’s Review of Day One

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

Understand and Mitigate Risk in Value-based Contracting and 340B Contracting

8:30

Ensure Compliance Within Managed Care Contracts

Debbie Walters
Vice President, Assistant General Counsel
Pfizer Inc

9:15

Balancing Compliance Risks and Commercial Opportunities in Partnering with Customers

Darren Jones
Partner
Polaris

10:00

Networking and Refreshment Break

10:30

PANEL
Value-based Contracting — Expanding the Discussion

MODERATOR:

Alonzo Weems
Vice President and Deputy General Counsel
Eli Lilly and Company

PANELISTS:

Michelle Drozd
Deputy Vice President, Policy and Research
PhRMA

Ben Barrameda
Senior Counsel, Managed Markets and Pricing
Bayer Pharmaceuticals

Debbie Walters
Vice President and Assistant General Counsel
Pfizer Inc

11:15

340B Compliance Hot Topics

Jonathan Connell
Senior Counsel
Bristol-Myers Squibb

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

12:00

Close of Conference

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DAY ONE TUESDAY, DECEMBER 5, 2017

7:30

Conference Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

Consider Current Enforcement Trends and Managed Markets Compliance Risks

8:30

KEYNOTE ENFORCEMENT PANEL
Discuss the Current Landscape of Recent Enforcement Cases in Managed Markets

MODERATOR:

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

PANELISTS:

Charles Graybow
Assistant U.S. Attorney
U.S. Attorney’s Office, Newark, New Jersey

Charlene Fullmer
Deputy Chief for Affirmative Litigation, Civil Division
U.S. Attorney’s Office for the District of Eastern Pennsylvania

William D. Weinreb
First Assistant U.S. Attorney
District of Massachusetts

9:30

Navigate the Major Compliance Issues around Formularies

Julie K. Letwat
Counsel
Faegre Baker Daniels

10:15

Networking and Refreshment Break

10:45

CASE STUDY
Manage Compliance Risks Associated with Specialty Products

Christine O’Connor-Fiore
Director, Specialty Markets Compliance
Boehringer Ingelheim

Assess Compliance Challenges Inherent to Manufacturers’ Increasing Interactions
with Specialty Pharmacies

11:30

INTERACTIVE SESSION
Mitigate Risk in Interactions between Manufacturers and
Specialty Pharmacies

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

Curt Oltmans
Executive Vice President, General Counsel & Corporate Secretary
Array BioPharma

12:30

Networking Luncheon

1:45

FIRESIDE CHAT
Effective Strategies to Mitigate Fraud and Abuse Risks in
Patient Assistance Programs

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

Kevin M. Henley, Esq.
Senior Director, Senior Compliance Counsel
Otsuka America Pharmaceutical, Inc.

2:30

FDA Draft Guidance on Payor Communications —
Identifying and Managing Compliance Risk

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

Jessica Rickabaugh, Esq.
Health Sciences Department
Pepper Hamilton LLP

Keren Tenenbaum
Assistant General Counsel
Pfizer Inc

3:15

Networking and Refreshment Break

3:45

Ask the Experts Panel Session

MODERATOR:

Julie K. Letwat
Counsel
Faegre Baker Daniels

PANELISTS:

Ben Barrameda
Senior Counsel, Managed Markets and Pricing
Bayer Pharmaceuticals

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

Christina Flint
Vice President & General Counsel
Diplomat

Keren Tenenbaum
Assistant General Counsel
Pfizer Inc

4:30

Encouraging Growth in Value-based Contracting —
Mitigating Risk and Clarifying Guard Rails

Josh O’Harra
Assistant General Counsel
Eli Lilly and Company

5:15

Close of Day One

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

DAY TWOWEDNESDAY, DECEMBER 6, 2017

7:30

Continental Breakfast

8:15

Chairperson’s Review of Day One

Jennifer Chillas
Senior Corporate Counsel
Bristol-Myers Squibb

Understand and Mitigate Risk in Value-based Contracting and 340B Contracting

8:30

Ensure Compliance Within Managed Care Contracts

Debbie Walters
Vice President, Assistant General Counsel
Pfizer Inc

9:15

Balancing Compliance Risks and Commercial Opportunities in Partnering with Customers

Darren Jones
Partner
Polaris

10:00

Networking and Refreshment Break

10:30

PANEL
Value-based Contracting — Expanding the Discussion

MODERATOR:

Alonzo Weems
Vice President and Deputy General Counsel
Eli Lilly and Company

PANELISTS:

Michelle Drozd
Deputy Vice President, Policy and Research
PhRMA

Ben Barrameda
Senior Counsel, Managed Markets and Pricing
Bayer Pharmaceuticals

Debbie Walters
Vice President and Assistant General Counsel
Pfizer Inc

11:15

340B Compliance Hot Topics

Jonathan Connell
Senior Counsel
Bristol-Myers Squibb

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

12:00

Close of Conference