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Agenda

Proactive Strategies for Managing Risks in Patient Support Services, Specialty Pharmacy Contracting and Government Price Reporting

September 13-14, 2018
  • Boston, MA

Agenda

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, SEPTEMBER 13, 2018

7:00

Registration and Continental Breakfast

8:00

Co-Chair’s Welcome and Opening Remarks

Daryl Kreml
Chief Compliance Officer, Vice President
SAGE Therapeutics

8:15

KEYNOTE ADDRESSThe Future of Life Science Compliance —
We Have Seen It; It is Here, It is Now and It is Us!

L. Stephan Vincze, JD, LLM, MBA
President & CEO
TRESTLE Compliance

8:45

Prosecutors’ Perspectives PanelExamine the High-Priority Risk Areas for Biotech and Specialty Pharma

MODERATOR:

Darren Jones
Senior Principal, Former Partner
Polaris, a QuintilesIMS company

PANELISTS:

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

Gregg Shapiro
Assistant U.S Attorney, Chief of Affirmative Civil Enforcement Unit
U.S Department of Justice (Boston)

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings LLP

9:45

Networking and Refreshment Break

10:15

Industry Response & DiscussionPut Your Compliance Program under the Magnifying Glass

FACILITATORS:

Bill Hrubes
Vice President, Chief Compliance Officer
ACell, Inc.

Amy Wilson, MBA, MSJ
Director, Enterprise Compliance
Alexion Pharmaceuticals

Building Blocks for a Compliant Culture
in Your Organization

10:45

Coping Strategies for the Lonely Compliance Officer

MODERATOR:

Jonathan Wilkenfeld
President
Potomac River Partners

PANELISTS:

Heather Golding
Vice President, Head of Legal & Compliance
Sobi, Inc.

Jerald Korn
Vice President, Assistant General Counsel,
Chief Compliance Officer
TESARO, Inc.

Adam Oakley
Director
Potomac River Partners

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

11:45

EXPERT PANELEvaluate the Risks Associated with Disease State Awareness and Other
Pre-Launch Activities

MODERATOR:

Katherine Chaurette
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

PANELISTS:

Brian Conner
VP, Head of Corporate Compliance
Strongbridge Biopharma plc

Bethany Fox
Senior Director, Commercial Legal Affairs and Compliance
Exelixis, Inc.

Lisa Taylor, JD
Vice President, Head of Healthcare Law and Compliance,
Juno Therapeutics

12:30

Networking Luncheon

1:30

Ensure Transparency in Contributions to Independent Patient Assistance Foundations

MODERATOR:

Amy Greenstein
Manager
Polaris, a QuintilesIMS company

PANELISTS:

Shoshanna Clark
Head of Operations, NA Ethics & Business Integrity
Sanofi

Stefanie Doebler
Of Counsel
Covington & Burling LLP

Alessandro Martuscelli
Chief Global Therapeutics Counsel
Bioverativ

2:15

Reboot Your Approach to Patient Assistance Programs (PAPs) and Reimbursement HUB Support

Meenakshi Datta
Partner
Sidley Austin LLP

3:00

Networking and Refreshment Break

3:30

Shed Light on Regulatory and Compliance Concerns for Specialty Pharmacy Distribution

MODERATOR:

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

PANELISTS:

Paul Ham
Senior Director, Ethics and Business Integrity
Sanofi

Rupa Cornell
Senior Director, Legal
SAGE Therapeutics

4:15

Key Considerations for Working with Nurse Educator Field Teams

MODERATOR:

Emily Hodge
Partner
Choate Hall & Stewart LLP

PANELISTS:

Laura Gamel
Senior Director, Ethics and Business Integrity
Sanofi

Alessandro Martuscelli
Chief Global Therapeutics Counsel
Bioverativ

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

Carrie Hanover-Martin
Associate General Counsel, Legal Department
EMD Serono

5:00

Close of Day One

5:00

SPECIAL NETWORKING EVENT COMPLIANCE UNPLUGGED Take this opportunity to switch gears, catch up with colleagues and make new friends over hors d’oeuvres and refreshments.

DAY TWO FRIDAY, SEPTEMBER 14, 2018

7:30

Continental Breakfast

8:00

Co-Chair’s Review of Day One

Meenakshi Datta
Partner
Sidley Austin LLP

8:15

Daybreak DiscussionSpecialty Café — Forecasting Priorities from Now to 2020

Grab your tea or coffee and sit down at one of the tables for a collaborative dialogue. Ask questions, take notes and share proactive approaches to managing forthcoming risk areas in the next two years. After Round I, switch tables for a new topic. Table hosts welcome newcomers to their tables and brief them on the group’s conversation so far.

Round I 8:15 – 8:40

Round II 8:45 – 9:10

1. Risk-based Approaches for Advanced Therapies

Chad Morin
Senior Director, Healthcare Compliance
bluebird bio

2. PBM Contracting Considerations

Katherine Chaurette
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

3. Compliant Medical Affairs and Commercial Interactions

Alessandra Ravetti
Executive Director and Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

Jeremy Lutsky
Senior Legal and Compliance Counsel
Theravance Biopharma US

Risk Planning and Business Strategy Alignment
in a Value-Based Marketplace

9:15

Explore the Trends in Drug Pricing Legislation and Other State Initiatives

John P. Oroho
Executive Vice President & Chief Strategy Officer
Porzio Life Sciences, LLC

10:00

Networking and Refreshment Break

10:30

Shine a Spotlight on Market Access Agreements and Outcomes-Based Contracts

Kelly Pitt
Director, Legal & Compliance
Sobi, Inc.

Keren Tenenbaum
Assistant General Counsel, Patient Health and Impact
Pfizer Inc

Think Global, Act Local —
Setting Controls Across New Ventures

11:15

Scale Up Your Compliance Program for Global Operations

Masha Chestukhin
Associate Director, Compliance Officer R&D, IA, FMV
Sanofi US

Darryl D. Williams
Senior Director of Analytics
MediSpend

12:00

Networking Luncheon

1:00

CO-PRESENTATION:GDPR Is Here — Now What Do We Do?

David Ryan
Vice President, Associate General Counsel, Chief Compliance Officer
Epizyme

Trish Shorey
Privacy Officer, Global Compliance and Risk Management
Shire

1:45

Pinpoint the Risk Factors in Mergers, Acquisitions and Joint Ventures

MODERATOR:

Andrea Kocharyan
Vice President, Legal Affairs
Boston BioMedical

PANELISTS:

Amy Wilson, MBA, MSJ
Director, Enterprise Compliance
Alexion Pharmaceuticals

Heidy Abreu
Vice President, Legal and Corporate Secretary
Axcella Health, Inc.

2:30

Closing Remarks from Co-Chairs

2:35

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, SEPTEMBER 13, 2018

7:00

Registration and Continental Breakfast

8:00

Co-Chair’s Welcome and Opening Remarks

Daryl Kreml
Chief Compliance Officer, Vice President
SAGE Therapeutics

8:15

KEYNOTE ADDRESSThe Future of Life Science Compliance —
We Have Seen It; It is Here, It is Now and It is Us!

L. Stephan Vincze, JD, LLM, MBA
President & CEO
TRESTLE Compliance

8:45

Prosecutors’ Perspectives PanelExamine the High-Priority Risk Areas for Biotech and Specialty Pharma

MODERATOR:

Darren Jones
Senior Principal, Former Partner
Polaris, a QuintilesIMS company

PANELISTS:

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

Gregg Shapiro
Assistant U.S Attorney, Chief of Affirmative Civil Enforcement Unit
U.S Department of Justice (Boston)

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings LLP

9:45

Networking and Refreshment Break

10:15

Industry Response & DiscussionPut Your Compliance Program under the Magnifying Glass

FACILITATORS:

Bill Hrubes
Vice President, Chief Compliance Officer
ACell, Inc.

Amy Wilson, MBA, MSJ
Director, Enterprise Compliance
Alexion Pharmaceuticals

Building Blocks for a Compliant Culture
in Your Organization

10:45

Coping Strategies for the Lonely Compliance Officer

MODERATOR:

Jonathan Wilkenfeld
President
Potomac River Partners

PANELISTS:

Heather Golding
Vice President, Head of Legal & Compliance
Sobi, Inc.

Jerald Korn
Vice President, Assistant General Counsel,
Chief Compliance Officer
TESARO, Inc.

Adam Oakley
Director
Potomac River Partners

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

11:45

EXPERT PANELEvaluate the Risks Associated with Disease State Awareness and Other
Pre-Launch Activities

MODERATOR:

Katherine Chaurette
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

PANELISTS:

Brian Conner
VP, Head of Corporate Compliance
Strongbridge Biopharma plc

Bethany Fox
Senior Director, Commercial Legal Affairs and Compliance
Exelixis, Inc.

Lisa Taylor, JD
Vice President, Head of Healthcare Law and Compliance,
Juno Therapeutics

12:30

Networking Luncheon

1:30

Ensure Transparency in Contributions to Independent Patient Assistance Foundations

MODERATOR:

Amy Greenstein
Manager
Polaris, a QuintilesIMS company

PANELISTS:

Shoshanna Clark
Head of Operations, NA Ethics & Business Integrity
Sanofi

Stefanie Doebler
Of Counsel
Covington & Burling LLP

Alessandro Martuscelli
Chief Global Therapeutics Counsel
Bioverativ

2:15

Reboot Your Approach to Patient Assistance Programs (PAPs) and Reimbursement HUB Support

Meenakshi Datta
Partner
Sidley Austin LLP

3:00

Networking and Refreshment Break

3:30

Shed Light on Regulatory and Compliance Concerns for Specialty Pharmacy Distribution

MODERATOR:

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

PANELISTS:

Paul Ham
Senior Director, Ethics and Business Integrity
Sanofi

Rupa Cornell
Senior Director, Legal
SAGE Therapeutics

4:15

Key Considerations for Working with Nurse Educator Field Teams

MODERATOR:

Emily Hodge
Partner
Choate Hall & Stewart LLP

PANELISTS:

Laura Gamel
Senior Director, Ethics and Business Integrity
Sanofi

Alessandro Martuscelli
Chief Global Therapeutics Counsel
Bioverativ

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

Carrie Hanover-Martin
Associate General Counsel, Legal Department
EMD Serono

5:00

Close of Day One

5:00

SPECIAL NETWORKING EVENT COMPLIANCE UNPLUGGED Take this opportunity to switch gears, catch up with colleagues and make new friends over hors d’oeuvres and refreshments.

DAY TWO FRIDAY, SEPTEMBER 14, 2018

7:30

Continental Breakfast

8:00

Co-Chair’s Review of Day One

Meenakshi Datta
Partner
Sidley Austin LLP

8:15

Daybreak DiscussionSpecialty Café — Forecasting Priorities from Now to 2020

Grab your tea or coffee and sit down at one of the tables for a collaborative dialogue. Ask questions, take notes and share proactive approaches to managing forthcoming risk areas in the next two years. After Round I, switch tables for a new topic. Table hosts welcome newcomers to their tables and brief them on the group’s conversation so far.

Round I 8:15 – 8:40

Round II 8:45 – 9:10

1. Risk-based Approaches for Advanced Therapies

Chad Morin
Senior Director, Healthcare Compliance
bluebird bio

2. PBM Contracting Considerations

Katherine Chaurette
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

3. Compliant Medical Affairs and Commercial Interactions

Alessandra Ravetti
Executive Director and Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

Jeremy Lutsky
Senior Legal and Compliance Counsel
Theravance Biopharma US

Risk Planning and Business Strategy Alignment
in a Value-Based Marketplace

9:15

Explore the Trends in Drug Pricing Legislation and Other State Initiatives

John P. Oroho
Executive Vice President & Chief Strategy Officer
Porzio Life Sciences, LLC

10:00

Networking and Refreshment Break

10:30

Shine a Spotlight on Market Access Agreements and Outcomes-Based Contracts

Kelly Pitt
Director, Legal & Compliance
Sobi, Inc.

Keren Tenenbaum
Assistant General Counsel, Patient Health and Impact
Pfizer Inc

Think Global, Act Local —
Setting Controls Across New Ventures

11:15

Scale Up Your Compliance Program for Global Operations

Masha Chestukhin
Associate Director, Compliance Officer R&D, IA, FMV
Sanofi US

Darryl D. Williams
Senior Director of Analytics
MediSpend

12:00

Networking Luncheon

1:00

CO-PRESENTATION:GDPR Is Here — Now What Do We Do?

David Ryan
Vice President, Associate General Counsel, Chief Compliance Officer
Epizyme

Trish Shorey
Privacy Officer, Global Compliance and Risk Management
Shire

1:45

Pinpoint the Risk Factors in Mergers, Acquisitions and Joint Ventures

MODERATOR:

Andrea Kocharyan
Vice President, Legal Affairs
Boston BioMedical

PANELISTS:

Amy Wilson, MBA, MSJ
Director, Enterprise Compliance
Alexion Pharmaceuticals

Heidy Abreu
Vice President, Legal and Corporate Secretary
Axcella Health, Inc.

2:30

Closing Remarks from Co-Chairs

2:35

Close of Conference