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Agenda

Industry’s Leading Event for CCOs, Compliance and Legal Executives Featuring Powerful Programming and Compelling Content Designed to Deliver

April 23-25, 2018
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

PCC PRELUDES Monday, April 23, 2018

2:30 – 3:00PM

Prelude Registration

3:00 – 5:00PM

BENEFIT FROM ONE OF THREE TAILORED COMPLIANCE SUMMITS

FOUNDATION SUMMIT Healthcare Compliance and Policy Applications

This foundational course is designed for those new to compliance or new to the bio/pharmaceutical industry and acts as a primer for the congress as the main program is built off the key elements discussed. Benefit from foundational knowledge in healthcare compliance basics before you embark on two content rich days covering existing and emerging, high-risk areas.

Linda Pollitz
Senior Director Regulatory Affairs, Advertising and Promotional Labeling
Alkermes

Perri Pomper
Senior Manager, Strategy and Communications
Novo Nordisk

Augusta Jonhart
Director
KPMG LLP

CRITICAL LEARNING SUMMIT Patient Support Programs —
Leading Frameworks to Ensure Access while Minimizing Risk

This timely summit dives into industry’s most pressing risk area right now — Patient Support Programs (PSPs). Bringing compliance, legal and business professionals together for this Summit, this summit explores PSPs and how to develop a proactive compliance framework to drive successful PSPs, while minimizing risk.

Richard Liner
Senior Compliance Counsel
Bayer

Joanne A. de Vries
Head, Immunology Patient Support and Clinical Education
Shire Pharmaceuticals

Eric Baim
Managing Director
Dovetail Consulting Group

Laura Hoey
Partner
Ropes & Gray

PERSONAL DEVELOPMENT SUMMIT Women’s Executive Leadership Forum

High-touch networking and learning summit tailored to senior-level women executives within the life sciences community. This collective insight of C-suite leaders in compliance illustrates how women in all facets of bio/pharma are climbing the leadership ladder and redefining career path and empowerment.

Beth Levine
Senior Vice President, Associate General Counsel, Chief Compliance Officer
Regeneron Pharmaceuticals, Inc.

Melissa Lozner
Head, Ethics and Compliance, US Oncology
Novartis Pharmaceuticals Corporation

Jim Massey
Global Vice President, Sustainability Engagement and Strategy
AstraZeneca

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

Veleka Peeples-Dyer
Partner
McDermott Will & Emery LLP

Clarissa Crain
Senior Manager
Deloitte & Touche LLP

Polaris logo
Verisys logo 5:00 – 6:00PM
PCC WELCOME RECEPTION
HOSTED BY:

DAY ONE Tuesday, April 24, 2018

7:00

Main Congress Registration and Continental Breakfast

7:50

CBI Welcome

8:00

Chairman’s Welcome and Opening Remarks

Michael Shaw
Vice President, Ethics and Compliance Officer, US Pharma
GlaxoSmithKline

8:10

“Compliance Year in Review” Video Reveal

8:15

LUMINARY ADDRESS
Politics Impacting Pharma — Navigating the Future of Our Healthcare Industry

Jim Massey
Global Vice President, Sustainability Engagement and Strategy
AstraZeneca

Anne Phelps
Principal, US Health Care Regulatory Leader
Deloitte & Touche LLP

8:45

KEYNOTE PANEL
CCO Exchange —
Adapting and Evolving Compliance Programs in Support of Innovation

MODERATOR:

Regina Cavaliere
Principal
KPMG LLP

PANELISTS:

Margaret Feltz
Vice President, Ethics and Compliance
Purdue Pharma L.P.

Jennifer McGee
Vice President, Chief Compliance Officer
Otsuka

Jill Fallows Macaluso
Chief Compliance Officer and Vice President
Novo Nordisk Inc.

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

9:45

STAKEHOLDER SPOTLIGHT
Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide

MODERATOR:

Erik Eglite
Senior Vice President, General Counsel and Chief Corporate Compliance Officer
Aurinia Pharmaceuticals

PANELISTS:

Gail Cawkwell
Senior Vice President, Medical Affairs
Intercept Pharmaceuticals

Cecilia Matthews
Director, Human Resources
MedImmune, A member of the AstraZeneca Group

Gregory Moss
Senior Vice President, Deputy General Counselor
Kadmon Holdings, Inc

10:30

Networking and Refreshment Break

11:00

HIGHLY-ACCLAIMED U.S. HEALTHCARE
FRAUD AND ENFORCEMENT PANEL

Past and Present Prosecutor Parley

As settlements and investigations involving bio/pharmaceutical companies continue to dominate the headlines, this session delves into recent settlements and on-going investigations with the opportunity to hear directly from regulatory leaders across the nation who are spearheading the charge against healthcare fraud. In this point/counterpoint session, hear directly from the prosecution and defense side on the top issues impacting the industry in 2018.

PARLEY MODERATOR:

Kathleen Meriwether
Americas Life Sciences Leader, Principal,
Fraud Investigation & Dispute Services
Ernst & Young LLP

CURRENT:

Louis Lappen
Acting U.S. Attorney
U.S. Attorney’s Office for the Eastern District of Pennsylvania

William Weinreb
Assistant U.S. Attorney
U.S. Attorney’s Office for the District of Massachusetts

Justin Herdman
U.S. Attorney
U.S. Attorney’s Office for the Northern District of Ohio; Attorney General’s Advisory Committee

Whitman G.S. Knapp
Deputy Chief, Business and Securities Fraud Section
U.S. Attorney’s Office for the Eastern District of New York

Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney's Office for the District of New Jersey

FORMER:

Joe Mack
Senior Compliance Counsel, Bayer;
Former Deputy Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office District of New Jersey

John Richter
Partner, King & Spalding LLP;
Former U.S. Attorney, U.S. Attorney’s Office for the Western District of Oklahoma

Brian Stretch
Partner, Sidley Austin LLP;
Former U.S. Attorney
U.S. Attorney’s Office for the Northern District of California

FORMER PROSECUTOR:

John Kelly
Member and Managing Partner, Bass Berry & Sims, Washington DC;
Former Assistant Chief, Health Care Fraud, Department of Justice

12:30

Networking Luncheon and Beginning of Invitation Only-CCO Summit

CLOSED-DOOR AND INVITATION-ONLY* CHIEF COMPLIANCE OFFICER SUMMIT

Reimagined and Reinvented — Introducing our new CCO Summit structure and format, providing world-class thought-leadership and designed to deliver high-quality information that C-suite leaders can develop into an action plan. Collaborate with your distinguished colleagues to gain valuable insights through a blend of innovative, thought-provoking keynotes coupled with an interactive and engaging working group.

*Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a life sciences company (at the time of the congress). Final eligibility approval is at the discretion of CBI.

HOSTED BY:

12:30

Private Networking Luncheon

1:30

Summit Host Welcome and Anti-Trust Guideline Reminders

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

I. Luminary Segment — Top of Mind Topics for CCOs

II. Reactionary Insights, Knowledge Sharing and Advanced Application

SUMMIT LEADERS:

Jill Fallows Macaluso
Chief Compliance Officer and Vice President
Novo Nordisk Inc.

Michael Clarke
Vice President, Corporate Compliance
Indivior Inc

Bryant Aaron
Vice President, Chief Compliance Officer, U.S. Country Head, Ethics and Compliance
Novartis Pharmaceuticals Corporation

4:25

Reconvene in Ballroom for Closing General Session Keynote Sessions

1:30

MASTER CLASS SERIES
CHOOSE FROM 5 CONCURRENT MASTER CLASSES (A-E)

A Drug Pricing Transparency and Reimbursement

Josh O'Harra
Assistant General Counsel
Eli Lilly and Company

T. Reed Stephens
Partner
McDermott Will & Emery LLP

Clay Willis
Senior Manager
Deloitte & Touche LLP

B Off-Label Communication — Deep-Dive into the New Regulatory Updates and Actions

Angela Rodin
Principal
KPMG LLP

Laura Terrell
Partner
DLA Piper LLP

C Industry’s Guide to GDPR Compliance

MODERATOR:

J. Mark Farrar
Managing Director
Navigant

PANELISTS:

Helen Ong, Esq., CIPP/US, CIPP/M
Executive Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

Jessica Lee
Partner
Loeb & Loeb LLP

D Patient Assistance Programs (PAPs) and Reimbursement Hub Services Compliance —
A New Wave of Enforcement Actions

MODERATOR:

Jane H. Yoon
Of Counsel, Litigation Department
Paul Hastings LLP

PANELISTS:

Peter Agnoletto
Senior Director, US Ethics and Business Integrity
Sanofi

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

Evan Bartell
Advisory Managing Director
KPMG LLP

E Global Compliance — Emerging Markets
and Third-Party Due Diligence

MODERATOR:

Gildas Durand
Principal, Fraud Investigation & Dispute Services
Ernst & Young LLP

PANELISTS:

David Styler
Head, Global Compliance Governance and Investigations
Takeda Pharmaceuticals

Richard Wright
Vice President, Global Head of Compliance Audit
Teva Pharmaceuticals

Brian Burke
Partner
Shearman & Sterling

2:15

Close of Session and Brief Transition Break

2:25

MASTER CLASS SERIES 2
CHOOSE FROM 5 CONCURRENT MASTER CLASSES (F-J)

F Updating the Corporate Compliance Framework
to Tackle Data Privacy and Cybersecurity

William J. Hughes, Jr.
Principal
Porzio, Bromberg & Newman

James G. Mottola
Vice President, Data Privacy, Investigations and Security
Porzio Compliance Services, LLC

G Medical Affairs and MSL Oversight

Tina Beamon
Global Head, Compliance and Ethics, R&D, Medical Affairs and Operations
Alexion Pharmaceuticals

Lauren Crane
Director, US, Oncology Ethics and Compliance
Novartis

Christine O’Connor-Fiore
Director, Specialty Care and Analytics and Insight
Boehringer Ingelheim

H Managed Markets Compliance

Richard Liner
Senior Compliance Counsel
Bayer

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

John Moose, MBA, ABV
Principal
Polaris, a QuintilesIMS company

I Foreign Corrupt Practices Act (FCPA),
Anti-Bribery and Anti-Corruption (ABAC) Programs and ISO 37001 Guidance

MODERATOR:

Greg Naviloff
Director
RSM US LLP

PANELISTS:

Daryl Kreml
Chief Compliance Officer
SAGE Therapeutics

Tara Giunta
Partner, Litigation Department
Paul Hastings LLP

Kelly Clay
Assistant General Counsel, Legal Department
GlaxoSmithKline

J HCP Engagement Strategies and Contracting

Brian P. Sharkey
Principal
Porzio Life Sciences

Christine N. Bradshaw
Vice President
Porzio Life Sciences

Sheea Sybblis
Senior Counsel
Boehringer Ingelheim

Melanie Fagan
Medical and Compliance Manager, Lead US External Expert Engagement HUB
GlaxoSmithKline

3:10

Close of Session and Brief Transition Break

3:20

MASTER CLASS SERIES 3
CHOOSE FROM 6 CONCURRENT MASTER CLASSES (K-P)

K Compliance Oversight —
Mergers and Acquisitions

MODERATOR:

Jennifer Shimek
Principal
KPMG LLP

PANELISTS:

Erik Eglite
Senior Vice President, General Counsel and Chief Corporate Compliance Officer
Aurinia Pharmaceuticals

Patricia Wylie
Director
KPMG LLP

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

L Speaker Programs and the Continued
Rise of Kickback Allegations

MODERATOR:

Christine E. Longawa
Associate Director
Navigant

PANELISTS:

Peter Agnoletto
Senior Director, US Ethics and Business Integrity
Sanofi

Brian Conner
Vice President, Corporate Compliance
Strongbridge Biopharma plc

Dominick DiSabatino
Associate
Loeb & Loeb LLP

M Manufacturing and Supply Chain Compliance

Samantha Wilson Jones
Senior Director, Corporate Counsel, Global Technical Operations
Incyte

N Crisis Management Preparedness — Proactive and Reactive Compliance for Cybersecurity

Robert Silvers
Partner, Paul Hastings LLP;
Former Assistant Secretary of Homeland Security for Cyber Policy

O Social Media —
New Challenges and Opportunities

Elizabeth Kim
Senior Counsel
Loeb & Loeb LLP

P Behavioral Compliance — Using Behavioral Psychology to Make Compliance Programs More Effective

Jon Smollen
Practice Professor and Director, Center for Compliance and Ethics, Temple Law School;
Former Executive Vice President and Chief Compliance Officer, Endo

Kevin Ryan
Senior Director, Ethics and Compliance
Novo Nordisk Inc.

Yogesh Bahl
Managing Director, Life Sciences and Healthcare
AlixPartners, LLP

Charlene E. Davis, Esq.
Head of Healthcare Compliance North America
Sun Pharma Corporate Services, North America

4:05

Networking and Refreshment Break

ATTENDEES RECONVENE IN BALLROOM FOR
DAY ONE CLOSING KEYNOTE SESSIONS

4:35

Critical CIA and Enforcement Learnings —
Zero-In on Emerging Trends to Elevate Compliance Safeguards

MODERATOR:

Paul Silver
Principal, Life Sciences Regulatory & Compliance Leader
Deloitte & Touche LLP

PANELISTS:

BJ D’Avella
Senior Manager
Deloitte & Touche LLP

Seth Lundy
Partner
King & Spalding LLP

John Rah
Partner
DLA Piper LLP

5:10

Emergence of Artificial Intelligence (AI) in the Bio/Pharmaceutical Industry and the Implications of Its Utilization for Compliance Programs

Regina Cavaliere
Principal
KPMG LLP

William Nowacki
Advisory Management Director
KPMG LLP

5:45

Close of Day One

Cocktail Reception Commences at
the Close of Day One Hosted by:

DAY TWO Wednesday, April 25, 2018

7:15

Continental Breakfast

8:00

Chairman's Review of Day One

Michael Shaw
Vice President, Ethics and Compliance Officer, US Pharma
GlaxoSmithKline

8:05

CCO Scenario Symposium — What Would You Do?

MODERATOR:

Gary Giampetruzzi
Partner, Litigation Department
Paul Hastings LLP

PANELISTS:

Beth Levine
Senior Vice President, Associate General Counsel, Chief Compliance Officer
Regeneron Pharmaceuticals, Inc.

Ashley Watson
Senior Vice President, Chief Ethics and Compliance Officer
Merck

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

Keith McGahan
Senior Vice President, Chief Legal Officer and Chief Compliance Officer
Spectrum Pharmaceuticals, Inc.

9:00

Meeting of the Enforcement Minds

MODERATOR:

Sarah Franklin
Partner
Covington & Burling LLP

I. Key Enforcement Trends from the FTC Perspective

Heather Johnson
Attorney, Health Care Division, Bureau of Competition
Federal Trade Commission

II. DOJ Spotlight — High Priority Risk Areas

Sally Molloy
Assistant Chief, Corporate Strike Force,
Fraud Section, Criminal Division
U.S. Department of Justice

III. OIG Insight—Recent Trends and Oversight

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

IV. Moderated Q&A

9:40

PhRMA ADDRESS
PhRMA Update — Priorities and Policy Initiatives

James Stansel
Executive Vice President and General Counsel
PhRMA

10:00

Networking and Refreshment Break

10:30

CHOOSE FROM 6 CONCURRENT CONTENT STREAMS (1-6)

1 Promotional Compliance

10:30

Track Chair’s Opening Remarks

Daina Selvig
Assistant General Counsel, Legal Affairs
Sunovion

10:45

FDA/OPDP ADDRESS
OPDP Hot Topics, Guidances, Enforcement Trends and Warning Letter Review

Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion
FDA

11:25

Industry Pulse on Off-Label —
Are Policies Changing in Aftermath of Groundbreaking Rulings?

Jennifer A. Romanski
Principal
Porzio Life Sciences

12:05

Ensure Compliant Pre-Approval Product Communications

MODERATOR:

Ashley Riley
Manager, Deloitte Life Sciences Advisory
Deloitte & Touche LLP

PANELISTS:

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

Daina Selvig
Assistant General Counsel, Legal Affairs
Sunovion

Michael Clarke
Vice President, Corporate Compliance
Indivior Inc

Linda Pollitz
Senior Director Regulatory Affairs, Advertising and Promotional Labeling
Alkermes

2 Patient Support Programs

10:30

Track Chair’s Opening Remarks

Patrik Florencio
Senior Vice President, Global Chief Compliance and Risk Officer
Amicus Therapeutics

10:45

Evolving Role and Landscape of Patient Advocacy in Life Sciences

Patrik Florencio
Senior Vice President, Global Chief Compliance and Risk Officer
Amicus Therapeutics

Jayne Gershkowitz
Global Chief Patient Advocate
Amicus Therapeutics

Ellen Rosenberg
Global General Counsel and Corporate Secretary
Amicus Therapeutics

11:25

Mitigate Risk Within Hub Operations

Sarah Franklin
Partner
Covington & Burling LLP

12:05

Legal Nuances and Limitations of Drug Copayment Offset Programs

Seth Lundy
Partner
King & Spalding LLP

3 Clinical Research and R&D Compliance

10:30

Track Chair’s Opening Remarks

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

10:45

Shifting Focus —
Ramp up Resources for Clinical and R&D Oversight to Ensure Compliance

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

Mark A. DeWyngaert, PhD
Managing Director
Deloitte & Touche LLP

Julie Song
Chief Compliance Officer
IQVIA

11:25

Compliant and Impactful Use of HEOR, RWE and Comparative Effectiveness Research

Daryl Kreml
Chief Compliance Officer
SAGE Therapeutics

Holly Kramen
Chief Compliance Officer and Privacy Officer
PolarityTE, Inc.

12:05

It’s More Than Just the Data—Innovating Compliance for Smaller R&D Companies

Dr. Seth Whitelaw
President and CEO
Whitelaw Compliance Group, LLC.
Editor for the Life Science Compliance Update,
and Senior Fellow and Adjunct Professor, Life Sciences Compliance
Mitchell Hamline School of Law

4 Small to Mid-Sized Bio/Pharma Working Group

10:30

Track Chair’s Opening Remarks

Casey J. Horton
Director
Navigant

10:35

A Look at the OIG-HCCA Guidance Through a Small to Mid-Sized Pharma Lens

Jon Wilkenfeld
President
Potomac River Partners

Carla-Marie Ulerie
Manager
Potomac River Partners

11:10

Beyond the Seven Elements of Effective Compliance Program —
What Else Are You Doing?

MODERATOR:

Stefanie Doebler
Of Counsel
Covington & Burling LLP

PANELISTS:

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

Chad Morin
Senior Director, Healthcare Compliance
bluebird bio

Leslie Zacks
Vice President, General Counsel and Chief Compliance Officer
Arbor Pharmaceuticals, LLC

Gregory Moss
Senior Vice President, Deputy General Counselor
Kadmon Holdings, Inc

11:45

Maximization of Compliance Resources

Chad Morin
Senior Director, Healthcare Compliance
bluebird bio

Daniel O’Connor
Senior Vice President, PharmaCertify™
NXLevel Solutions

Laurie Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

12:15

Key Considerations and Takeaways for Start-up Specialty Pharma Companies

Meenakshi Datta
Partner
Sidley Austin LLP

L. Stephan Vincze, JD, LLM, MBA
Interim Chief Compliance Officer
Kastle Therapeutics, LLC

5 Transparency and Aggregate Spend

10:30

Track Chair’s Opening Remarks

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

10:35

CMS Transparency and Open Payments Update

Robin Usi
Director
Division of Data and Informatics, CMS

11:05

Existing and Emerging State Laws Governing Transparency Reporting

Margaret Feltz
Vice President, Ethics and Compliance
Purdue Pharma L.P.

Brian Bohnenkamp
Partner
King & Spalding LLP

Michael Grandison
Manager, Ethics and Compliance
Purdue Pharma L.P.

11:35

“Transparency as a Good Business Practice” — Explore How Transparency Can Drive Best Practices in Business and Compliance Strategy

Robert Shropshire
Director
Polaris, a QuintilesIMS company

Mark Scallon
Senior Principal
Polaris, a QuintilesIMS company

Amie Phillips Pablo
Associate Director, Ethics and Compliance Government Reporting
Novo Nordisk

12:10

Considerations for Global Disclosure Reporting

Tim Robinson, Esq.
Chief Knowledge Officer and General Counsel
MediSpend

6 Auditing, Monitoring and Data Analytics

10:30

Track Chair’s Opening Remarks

Angela Rodin
Principal
KPMG LLP

10:35

Leading Framework for World-Class Investigations —
Spearhead the Charge Against Uncovering Non-Compliance

MODERATOR:

Haiyan Tang
Partner, Litigation Department
Paul Hastings LLP

PANELISTS:

David Styler
Head, Global Compliance Governance and Investigations
Takeda Pharmaceuticals

Joe Mack
Senior Compliance Counsel, Bayer;
Former Deputy Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office District of New Jersey

Lauren Howard
Vice President
Verisys Corporation

11:10

Monitoring and Auditing Efforts in a Changing Risk Landscape

MODERATOR:

Kiley Smith Kelly
Principal, Fraud Investigation & Dispute Services
Ernst & Young LLP

PANELISTS:

John Hong
Senior Compliance Counsel,
US Compliance Monitoring and Analytics Lead
Pfizer

Mike Driscoll
Director, Testing and Monitoring Services
Johnson & Johnson

Alexis Wong
Executive Director Compliance,
Transparency, Monitoring and Analytics
Allergan

11:45

Leveraging Data Analytics to Bridge Management, Legal and Compliance

MODERATOR:

Wei Wei
Director
AlixPartners

PANELISTS:

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

John Rah
Partner
DLA Piper LLP

Boris Luzhansky
Director
AlixPartners

Jon Smollen
Practice Professor and Director, Center for Compliance and Ethics
Temple Law School;
Former Executive Vice President and Chief Compliance Officer
Endo

12:20

Modernizing Auditing and Monitoring Programs

Jack Tanselle
Managing Director
Deloitte & Touche LLP

Kirk Petrie
Advisory Principal
Deloitte Transactions and Business Analytics LLP

12:45

Networking Luncheon

1:30

2:30

Close of Congress

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

PCC PRELUDES Monday, April 23, 2018

2:30 – 3:00PM

Prelude Registration

3:00 – 5:00PM

BENEFIT FROM ONE OF THREE TAILORED COMPLIANCE SUMMITS

FOUNDATION SUMMIT Healthcare Compliance and Policy Applications

This foundational course is designed for those new to compliance or new to the bio/pharmaceutical industry and acts as a primer for the congress as the main program is built off the key elements discussed. Benefit from foundational knowledge in healthcare compliance basics before you embark on two content rich days covering existing and emerging, high-risk areas.

Linda Pollitz
Senior Director Regulatory Affairs, Advertising and Promotional Labeling
Alkermes

Perri Pomper
Senior Manager, Strategy and Communications
Novo Nordisk

Augusta Jonhart
Director
KPMG LLP

CRITICAL LEARNING SUMMIT Patient Support Programs —
Leading Frameworks to Ensure Access while Minimizing Risk

This timely summit dives into industry’s most pressing risk area right now — Patient Support Programs (PSPs). Bringing compliance, legal and business professionals together for this Summit, this summit explores PSPs and how to develop a proactive compliance framework to drive successful PSPs, while minimizing risk.

Richard Liner
Senior Compliance Counsel
Bayer

Joanne A. de Vries
Head, Immunology Patient Support and Clinical Education
Shire Pharmaceuticals

Eric Baim
Managing Director
Dovetail Consulting Group

Laura Hoey
Partner
Ropes & Gray

PERSONAL DEVELOPMENT SUMMIT Women’s Executive Leadership Forum

High-touch networking and learning summit tailored to senior-level women executives within the life sciences community. This collective insight of C-suite leaders in compliance illustrates how women in all facets of bio/pharma are climbing the leadership ladder and redefining career path and empowerment.

Beth Levine
Senior Vice President, Associate General Counsel, Chief Compliance Officer
Regeneron Pharmaceuticals, Inc.

Melissa Lozner
Head, Ethics and Compliance, US Oncology
Novartis Pharmaceuticals Corporation

Jim Massey
Global Vice President, Sustainability Engagement and Strategy
AstraZeneca

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

Veleka Peeples-Dyer
Partner
McDermott Will & Emery LLP

Clarissa Crain
Senior Manager
Deloitte & Touche LLP

Polaris logo
Verisys logo 5:00 – 6:00PM
PCC WELCOME RECEPTION
HOSTED BY:

DAY ONE Tuesday, April 24, 2018

7:00

Main Congress Registration and Continental Breakfast

7:50

CBI Welcome

8:00

Chairman’s Welcome and Opening Remarks

Michael Shaw
Vice President, Ethics and Compliance Officer, US Pharma
GlaxoSmithKline

8:10

“Compliance Year in Review” Video Reveal

8:15

LUMINARY ADDRESS
Politics Impacting Pharma — Navigating the Future of Our Healthcare Industry

Jim Massey
Global Vice President, Sustainability Engagement and Strategy
AstraZeneca

Anne Phelps
Principal, US Health Care Regulatory Leader
Deloitte & Touche LLP

8:45

KEYNOTE PANEL
CCO Exchange —
Adapting and Evolving Compliance Programs in Support of Innovation

MODERATOR:

Regina Cavaliere
Principal
KPMG LLP

PANELISTS:

Margaret Feltz
Vice President, Ethics and Compliance
Purdue Pharma L.P.

Jennifer McGee
Vice President, Chief Compliance Officer
Otsuka

Jill Fallows Macaluso
Chief Compliance Officer and Vice President
Novo Nordisk Inc.

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

9:45

STAKEHOLDER SPOTLIGHT
Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide

MODERATOR:

Erik Eglite
Senior Vice President, General Counsel and Chief Corporate Compliance Officer
Aurinia Pharmaceuticals

PANELISTS:

Gail Cawkwell
Senior Vice President, Medical Affairs
Intercept Pharmaceuticals

Cecilia Matthews
Director, Human Resources
MedImmune, A member of the AstraZeneca Group

Gregory Moss
Senior Vice President, Deputy General Counselor
Kadmon Holdings, Inc

10:30

Networking and Refreshment Break

11:00

HIGHLY-ACCLAIMED U.S. HEALTHCARE
FRAUD AND ENFORCEMENT PANEL

Past and Present Prosecutor Parley

As settlements and investigations involving bio/pharmaceutical companies continue to dominate the headlines, this session delves into recent settlements and on-going investigations with the opportunity to hear directly from regulatory leaders across the nation who are spearheading the charge against healthcare fraud. In this point/counterpoint session, hear directly from the prosecution and defense side on the top issues impacting the industry in 2018.

PARLEY MODERATOR:

Kathleen Meriwether
Americas Life Sciences Leader, Principal,
Fraud Investigation & Dispute Services
Ernst & Young LLP

CURRENT:

Louis Lappen
Acting U.S. Attorney
U.S. Attorney’s Office for the Eastern District of Pennsylvania

William Weinreb
Assistant U.S. Attorney
U.S. Attorney’s Office for the District of Massachusetts

Justin Herdman
U.S. Attorney
U.S. Attorney’s Office for the Northern District of Ohio; Attorney General’s Advisory Committee

Whitman G.S. Knapp
Deputy Chief, Business and Securities Fraud Section
U.S. Attorney’s Office for the Eastern District of New York

Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney's Office for the District of New Jersey

FORMER:

Joe Mack
Senior Compliance Counsel, Bayer;
Former Deputy Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office District of New Jersey

John Richter
Partner, King & Spalding LLP;
Former U.S. Attorney, U.S. Attorney’s Office for the Western District of Oklahoma

Brian Stretch
Partner, Sidley Austin LLP;
Former U.S. Attorney
U.S. Attorney’s Office for the Northern District of California

FORMER PROSECUTOR:

John Kelly
Member and Managing Partner, Bass Berry & Sims, Washington DC;
Former Assistant Chief, Health Care Fraud, Department of Justice

12:30

Networking Luncheon and Beginning of Invitation Only-CCO Summit

CLOSED-DOOR AND INVITATION-ONLY* CHIEF COMPLIANCE OFFICER SUMMIT

Reimagined and Reinvented — Introducing our new CCO Summit structure and format, providing world-class thought-leadership and designed to deliver high-quality information that C-suite leaders can develop into an action plan. Collaborate with your distinguished colleagues to gain valuable insights through a blend of innovative, thought-provoking keynotes coupled with an interactive and engaging working group.

*Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a life sciences company (at the time of the congress). Final eligibility approval is at the discretion of CBI.

HOSTED BY:

12:30

Private Networking Luncheon

1:30

Summit Host Welcome and Anti-Trust Guideline Reminders

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

I. Luminary Segment — Top of Mind Topics for CCOs

II. Reactionary Insights, Knowledge Sharing and Advanced Application

SUMMIT LEADERS:

Jill Fallows Macaluso
Chief Compliance Officer and Vice President
Novo Nordisk Inc.

Michael Clarke
Vice President, Corporate Compliance
Indivior Inc

Bryant Aaron
Vice President, Chief Compliance Officer, U.S. Country Head, Ethics and Compliance
Novartis Pharmaceuticals Corporation

4:25

Reconvene in Ballroom for Closing General Session Keynote Sessions

1:30

MASTER CLASS SERIES
CHOOSE FROM 5 CONCURRENT MASTER CLASSES (A-E)

A Drug Pricing Transparency and Reimbursement

Josh O'Harra
Assistant General Counsel
Eli Lilly and Company

T. Reed Stephens
Partner
McDermott Will & Emery LLP

Clay Willis
Senior Manager
Deloitte & Touche LLP

B Off-Label Communication — Deep-Dive into the New Regulatory Updates and Actions

Angela Rodin
Principal
KPMG LLP

Laura Terrell
Partner
DLA Piper LLP

C Industry’s Guide to GDPR Compliance

MODERATOR:

J. Mark Farrar
Managing Director
Navigant

PANELISTS:

Helen Ong, Esq., CIPP/US, CIPP/M
Executive Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

Jessica Lee
Partner
Loeb & Loeb LLP

D Patient Assistance Programs (PAPs) and Reimbursement Hub Services Compliance —
A New Wave of Enforcement Actions

MODERATOR:

Jane H. Yoon
Of Counsel, Litigation Department
Paul Hastings LLP

PANELISTS:

Peter Agnoletto
Senior Director, US Ethics and Business Integrity
Sanofi

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

Evan Bartell
Advisory Managing Director
KPMG LLP

E Global Compliance — Emerging Markets
and Third-Party Due Diligence

MODERATOR:

Gildas Durand
Principal, Fraud Investigation & Dispute Services
Ernst & Young LLP

PANELISTS:

David Styler
Head, Global Compliance Governance and Investigations
Takeda Pharmaceuticals

Richard Wright
Vice President, Global Head of Compliance Audit
Teva Pharmaceuticals

Brian Burke
Partner
Shearman & Sterling

2:15

Close of Session and Brief Transition Break

2:25

MASTER CLASS SERIES 2
CHOOSE FROM 5 CONCURRENT MASTER CLASSES (F-J)

F Updating the Corporate Compliance Framework
to Tackle Data Privacy and Cybersecurity

William J. Hughes, Jr.
Principal
Porzio, Bromberg & Newman

James G. Mottola
Vice President, Data Privacy, Investigations and Security
Porzio Compliance Services, LLC

G Medical Affairs and MSL Oversight

Tina Beamon
Global Head, Compliance and Ethics, R&D, Medical Affairs and Operations
Alexion Pharmaceuticals

Lauren Crane
Director, US, Oncology Ethics and Compliance
Novartis

Christine O’Connor-Fiore
Director, Specialty Care and Analytics and Insight
Boehringer Ingelheim

H Managed Markets Compliance

Richard Liner
Senior Compliance Counsel
Bayer

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

John Moose, MBA, ABV
Principal
Polaris, a QuintilesIMS company

I Foreign Corrupt Practices Act (FCPA),
Anti-Bribery and Anti-Corruption (ABAC) Programs and ISO 37001 Guidance

MODERATOR:

Greg Naviloff
Director
RSM US LLP

PANELISTS:

Daryl Kreml
Chief Compliance Officer
SAGE Therapeutics

Tara Giunta
Partner, Litigation Department
Paul Hastings LLP

Kelly Clay
Assistant General Counsel, Legal Department
GlaxoSmithKline

J HCP Engagement Strategies and Contracting

Brian P. Sharkey
Principal
Porzio Life Sciences

Christine N. Bradshaw
Vice President
Porzio Life Sciences

Sheea Sybblis
Senior Counsel
Boehringer Ingelheim

Melanie Fagan
Medical and Compliance Manager, Lead US External Expert Engagement HUB
GlaxoSmithKline

3:10

Close of Session and Brief Transition Break

3:20

MASTER CLASS SERIES 3
CHOOSE FROM 6 CONCURRENT MASTER CLASSES (K-P)

K Compliance Oversight —
Mergers and Acquisitions

MODERATOR:

Jennifer Shimek
Principal
KPMG LLP

PANELISTS:

Erik Eglite
Senior Vice President, General Counsel and Chief Corporate Compliance Officer
Aurinia Pharmaceuticals

Patricia Wylie
Director
KPMG LLP

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

L Speaker Programs and the Continued
Rise of Kickback Allegations

MODERATOR:

Christine E. Longawa
Associate Director
Navigant

PANELISTS:

Peter Agnoletto
Senior Director, US Ethics and Business Integrity
Sanofi

Brian Conner
Vice President, Corporate Compliance
Strongbridge Biopharma plc

Dominick DiSabatino
Associate
Loeb & Loeb LLP

M Manufacturing and Supply Chain Compliance

Samantha Wilson Jones
Senior Director, Corporate Counsel, Global Technical Operations
Incyte

N Crisis Management Preparedness — Proactive and Reactive Compliance for Cybersecurity

Robert Silvers
Partner, Paul Hastings LLP;
Former Assistant Secretary of Homeland Security for Cyber Policy

O Social Media —
New Challenges and Opportunities

Elizabeth Kim
Senior Counsel
Loeb & Loeb LLP

P Behavioral Compliance — Using Behavioral Psychology to Make Compliance Programs More Effective

Jon Smollen
Practice Professor and Director, Center for Compliance and Ethics, Temple Law School;
Former Executive Vice President and Chief Compliance Officer, Endo

Kevin Ryan
Senior Director, Ethics and Compliance
Novo Nordisk Inc.

Yogesh Bahl
Managing Director, Life Sciences and Healthcare
AlixPartners, LLP

Charlene E. Davis, Esq.
Head of Healthcare Compliance North America
Sun Pharma Corporate Services, North America

4:05

Networking and Refreshment Break

ATTENDEES RECONVENE IN BALLROOM FOR
DAY ONE CLOSING KEYNOTE SESSIONS

4:35

Critical CIA and Enforcement Learnings —
Zero-In on Emerging Trends to Elevate Compliance Safeguards

MODERATOR:

Paul Silver
Principal, Life Sciences Regulatory & Compliance Leader
Deloitte & Touche LLP

PANELISTS:

BJ D’Avella
Senior Manager
Deloitte & Touche LLP

Seth Lundy
Partner
King & Spalding LLP

John Rah
Partner
DLA Piper LLP

5:10

Emergence of Artificial Intelligence (AI) in the Bio/Pharmaceutical Industry and the Implications of Its Utilization for Compliance Programs

Regina Cavaliere
Principal
KPMG LLP

William Nowacki
Advisory Management Director
KPMG LLP

5:45

Close of Day One

Cocktail Reception Commences at
the Close of Day One Hosted by:

DAY TWO Wednesday, April 25, 2018

7:15

Continental Breakfast

8:00

Chairman's Review of Day One

Michael Shaw
Vice President, Ethics and Compliance Officer, US Pharma
GlaxoSmithKline

8:05

CCO Scenario Symposium — What Would You Do?

MODERATOR:

Gary Giampetruzzi
Partner, Litigation Department
Paul Hastings LLP

PANELISTS:

Beth Levine
Senior Vice President, Associate General Counsel, Chief Compliance Officer
Regeneron Pharmaceuticals, Inc.

Ashley Watson
Senior Vice President, Chief Ethics and Compliance Officer
Merck

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

Keith McGahan
Senior Vice President, Chief Legal Officer and Chief Compliance Officer
Spectrum Pharmaceuticals, Inc.

9:00

Meeting of the Enforcement Minds

MODERATOR:

Sarah Franklin
Partner
Covington & Burling LLP

I. Key Enforcement Trends from the FTC Perspective

Heather Johnson
Attorney, Health Care Division, Bureau of Competition
Federal Trade Commission

II. DOJ Spotlight — High Priority Risk Areas

Sally Molloy
Assistant Chief, Corporate Strike Force,
Fraud Section, Criminal Division
U.S. Department of Justice

III. OIG Insight—Recent Trends and Oversight

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

IV. Moderated Q&A

9:40

PhRMA ADDRESS
PhRMA Update — Priorities and Policy Initiatives

James Stansel
Executive Vice President and General Counsel
PhRMA

10:00

Networking and Refreshment Break

10:30

CHOOSE FROM 6 CONCURRENT CONTENT STREAMS (1-6)

1 Promotional Compliance

10:30

Track Chair’s Opening Remarks

Daina Selvig
Assistant General Counsel, Legal Affairs
Sunovion

10:45

FDA/OPDP ADDRESS
OPDP Hot Topics, Guidances, Enforcement Trends and Warning Letter Review

Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion
FDA

11:25

Industry Pulse on Off-Label —
Are Policies Changing in Aftermath of Groundbreaking Rulings?

Jennifer A. Romanski
Principal
Porzio Life Sciences

12:05

Ensure Compliant Pre-Approval Product Communications

MODERATOR:

Ashley Riley
Manager, Deloitte Life Sciences Advisory
Deloitte & Touche LLP

PANELISTS:

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

Daina Selvig
Assistant General Counsel, Legal Affairs
Sunovion

Michael Clarke
Vice President, Corporate Compliance
Indivior Inc

Linda Pollitz
Senior Director Regulatory Affairs, Advertising and Promotional Labeling
Alkermes

2 Patient Support Programs

10:30

Track Chair’s Opening Remarks

Patrik Florencio
Senior Vice President, Global Chief Compliance and Risk Officer
Amicus Therapeutics

10:45

Evolving Role and Landscape of Patient Advocacy in Life Sciences

Patrik Florencio
Senior Vice President, Global Chief Compliance and Risk Officer
Amicus Therapeutics

Jayne Gershkowitz
Global Chief Patient Advocate
Amicus Therapeutics

Ellen Rosenberg
Global General Counsel and Corporate Secretary
Amicus Therapeutics

11:25

Mitigate Risk Within Hub Operations

Sarah Franklin
Partner
Covington & Burling LLP

12:05

Legal Nuances and Limitations of Drug Copayment Offset Programs

Seth Lundy
Partner
King & Spalding LLP

3 Clinical Research and R&D Compliance

10:30

Track Chair’s Opening Remarks

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

10:45

Shifting Focus —
Ramp up Resources for Clinical and R&D Oversight to Ensure Compliance

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

Mark A. DeWyngaert, PhD
Managing Director
Deloitte & Touche LLP

Julie Song
Chief Compliance Officer
IQVIA

11:25

Compliant and Impactful Use of HEOR, RWE and Comparative Effectiveness Research

Daryl Kreml
Chief Compliance Officer
SAGE Therapeutics

Holly Kramen
Chief Compliance Officer and Privacy Officer
PolarityTE, Inc.

12:05

It’s More Than Just the Data—Innovating Compliance for Smaller R&D Companies

Dr. Seth Whitelaw
President and CEO
Whitelaw Compliance Group, LLC.
Editor for the Life Science Compliance Update,
and Senior Fellow and Adjunct Professor, Life Sciences Compliance
Mitchell Hamline School of Law

4 Small to Mid-Sized Bio/Pharma Working Group

10:30

Track Chair’s Opening Remarks

Casey J. Horton
Director
Navigant

10:35

A Look at the OIG-HCCA Guidance Through a Small to Mid-Sized Pharma Lens

Jon Wilkenfeld
President
Potomac River Partners

Carla-Marie Ulerie
Manager
Potomac River Partners

11:10

Beyond the Seven Elements of Effective Compliance Program —
What Else Are You Doing?

MODERATOR:

Stefanie Doebler
Of Counsel
Covington & Burling LLP

PANELISTS:

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

Chad Morin
Senior Director, Healthcare Compliance
bluebird bio

Leslie Zacks
Vice President, General Counsel and Chief Compliance Officer
Arbor Pharmaceuticals, LLC

Gregory Moss
Senior Vice President, Deputy General Counselor
Kadmon Holdings, Inc

11:45

Maximization of Compliance Resources

Chad Morin
Senior Director, Healthcare Compliance
bluebird bio

Daniel O’Connor
Senior Vice President, PharmaCertify™
NXLevel Solutions

Laurie Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

12:15

Key Considerations and Takeaways for Start-up Specialty Pharma Companies

Meenakshi Datta
Partner
Sidley Austin LLP

L. Stephan Vincze, JD, LLM, MBA
Interim Chief Compliance Officer
Kastle Therapeutics, LLC

5 Transparency and Aggregate Spend

10:30

Track Chair’s Opening Remarks

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

10:35

CMS Transparency and Open Payments Update

Robin Usi
Director
Division of Data and Informatics, CMS

11:05

Existing and Emerging State Laws Governing Transparency Reporting

Margaret Feltz
Vice President, Ethics and Compliance
Purdue Pharma L.P.

Brian Bohnenkamp
Partner
King & Spalding LLP

Michael Grandison
Manager, Ethics and Compliance
Purdue Pharma L.P.

11:35

“Transparency as a Good Business Practice” — Explore How Transparency Can Drive Best Practices in Business and Compliance Strategy

Robert Shropshire
Director
Polaris, a QuintilesIMS company

Mark Scallon
Senior Principal
Polaris, a QuintilesIMS company

Amie Phillips Pablo
Associate Director, Ethics and Compliance Government Reporting
Novo Nordisk

12:10

Considerations for Global Disclosure Reporting

Tim Robinson, Esq.
Chief Knowledge Officer and General Counsel
MediSpend

6 Auditing, Monitoring and Data Analytics

10:30

Track Chair’s Opening Remarks

Angela Rodin
Principal
KPMG LLP

10:35

Leading Framework for World-Class Investigations —
Spearhead the Charge Against Uncovering Non-Compliance

MODERATOR:

Haiyan Tang
Partner, Litigation Department
Paul Hastings LLP

PANELISTS:

David Styler
Head, Global Compliance Governance and Investigations
Takeda Pharmaceuticals

Joe Mack
Senior Compliance Counsel, Bayer;
Former Deputy Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office District of New Jersey

Lauren Howard
Vice President
Verisys Corporation

11:10

Monitoring and Auditing Efforts in a Changing Risk Landscape

MODERATOR:

Kiley Smith Kelly
Principal, Fraud Investigation & Dispute Services
Ernst & Young LLP

PANELISTS:

John Hong
Senior Compliance Counsel,
US Compliance Monitoring and Analytics Lead
Pfizer

Mike Driscoll
Director, Testing and Monitoring Services
Johnson & Johnson

Alexis Wong
Executive Director Compliance,
Transparency, Monitoring and Analytics
Allergan

11:45

Leveraging Data Analytics to Bridge Management, Legal and Compliance

MODERATOR:

Wei Wei
Director
AlixPartners

PANELISTS:

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

John Rah
Partner
DLA Piper LLP

Boris Luzhansky
Director
AlixPartners

Jon Smollen
Practice Professor and Director, Center for Compliance and Ethics
Temple Law School;
Former Executive Vice President and Chief Compliance Officer
Endo

12:20

Modernizing Auditing and Monitoring Programs

Jack Tanselle
Managing Director
Deloitte & Touche LLP

Kirk Petrie
Advisory Principal
Deloitte Transactions and Business Analytics LLP

12:45

Networking Luncheon

1:30

2:30

Close of Congress