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Agenda

The World’s Largest Bio/Pharma Event for Compliance and Legal Professionals

April 16-18, 2019
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

CONGRESS PRELUDES Tuesday, April 16, 2019

2:30 – 3:00PM

Prelude Registration

3:00 – 5:00PM

BENEFIT FROM ONE OF THREE TAILORED COMPLIANCE PRELUDES

PRELUDE A Healthcare Compliance and Policy Course

Designed for those new to compliance or new to the bio/pharma industry, this session acts as a primer for the conference as the main program is built off of the key elements discussed. Benefit from foundational knowledge in healthcare compliance basics before you embark on two content rich days covering emerging, high-risk areas.

Russell Rose
Senior Manager
Deloitte

Brian Miller, PhD
Senior Director, Training and Documentation, Ethics and Compliance
Otsuka America Pharmaceutical Inc.

Arivee Vargas
Head of Global Anti-Corruption and Assurance Programs
Vertex Pharmaceuticals

Ashley Riley
Manager
Deloitte Life Sciences Advisory

Simone Gaines
Manager, Office of Business Integrity and Ethics
Vertex Pharmaceuticals Inc.

PRELUDE B Compliant Nurse Educator Programs

As scrutiny of nurse educator programs heats up, industry must ensure the proper guardrails are in place to maintain compliance for these critical patient support programs. During this session, gain foundational and operational knowledge needed to structure and maintain compliant programs.

Manny Tzavlakis
Managing Partner
Helio Health Group

Erin Parsons
Health Care Compliance Officer
Janssen Pharmaceuticals

Chuck Bell
Former Compliance Officer
Kedrion Biopharma Inc.

Eric Greig
Associate
Latham & Watkins LLP

PRELUDE C Women’s Executive Leadership Forum
Powered by:   

This highly-acclaimed Forum showcases women in leadership within the compliance and life sciences community. Hear compelling stories of personal career success, reflect on professional development paths, discover flashpoint moments and ways to inspire and elevate the compliance team. Attendees discover meaningful mentorships and insights into optimal job placement and professional pathways.

Laura Skinner
Senior Manager
Deloitte

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

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

Veleka Peeples-Dyer
Partner
McDermott Will & Emery LLP

Adam Dubow
Chief Compliance and Ethics Officer
Bristol-Myers Squibb

Jim Massey
Global Vice President, Global Sustainability
AstraZeneca

5:00 – 6:00PM
SIGNATURE COCKTAIL RECEPTION CO-HOSTED BY:   

DAY ONE Wednesday, April 17, 2019

7:00

Main Congress Registration and Continental Breakfast

7:50

CBI Welcome

8:00

Chairman’s Welcome and Opening Remarks

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

8:10

“Compliance Year in Review” Video Reveal

8:15

Good Morning, PCC! Industry News Update and Policy Briefing

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

John Shakow
Partner
King & Spalding LLP

8:45

LUMINARY SHOWCASE A Spotlight on Partnerships, Integration and Advancements Transforming the Industry

MODERATOR:

Angela Rodin
Principal, Risk Advisory
KPMG LLP

I. Vision and Future of Value-Based Healthcare

James Stansel
Executive Vice President and General Counsel
PhRMA

II. Patient Support, Empowerment and Engagement —
A Patient Advocacy Perspective

Kristen Santiago
Senior Director, Public Policy Initiatives
LUNGevity

Debbie Drell
Director of Membership
NORD

III. Artificial Intelligence Aiding Digital Innovation

Justin Hoss
Partner
KPMG LLP

Bharat Rao
Partner
KPMG LLP

IV. Moderated Q&A and Exchange

10:00

CCO EXCHANGE Top of Mind Topics for Life Science Leaders

MODERATOR:

Regina Cavaliere
Principal
KPMG LLP

PANELISTS:

Michael Clarke
Former Vice President, Corporate Compliance
Indivior, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

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

10:45

Networking and Refreshment Break Hosted by:

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

11:15

Past and Present Prosecutor Parley

PARLEY MODERATOR:

Tom Gregory
Partner Global leader – Life sciences,Forensic & Integrity Services
Ernst & Young LLP

Current Prosecutors Panel

I. Top Enforcement Trends and Focal Points for 2019 and Beyond

PANELISTS:

Nathaniel Mendell
First Assistant U.S. Attorney
U.S. Attorney’s Office, District of Massachusetts

David Eskew
Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office, District of New Jersey

Former Prosecutors Panel

II. New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud

PANELISTS:

Terra Reynolds
Partner, White Collar and Investigations, Latham and Watkins LLP;
former Deputy Chief and Assistant U.S. Attorney,
U.S. Attorney’s Office, Northern District of Illinois

John Richter
Partner, King & Spalding LLP;
former Deputy Chief and Assistant U.S. Attorney,
U.S. Attorney’s Office, Western District of Oklahoma

Jacob T. Elberg
Associate Professor, Seton Hall University School of Law;
former Assistant U.S. Attorney, U.S. Attorney's Office, District of New Jersey

12:30

Networking Luncheon

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

HOSTED BY:

ABOUT OUR SUMMIT HOST John Patrick Oroho, Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia. Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Commercialization Department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Anti-Kickback Statute, False Claim Act, and Medicare and Medicaid fraud and abuse. Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance.

*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.

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

Summit Overview:

The CCO Summit provides world-class thought-leadership and is 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.

Summit Outline:

I. Keynote Address on Ethics and Leadership

Sheelah Kolhatkar
Staff Writer, The New Yorker;
PBS Host, Playing By The Rules

II. Candid Conversations on Key Business and Industry Topics

Summit Leader:

Kevin Espinoza
Senior Vice President, Corporate Compliance and Privacy Officer
BTG

4:25

Close of CCO Summit

1:45

CHOOSE FROM FIVE CONTENT STREAMS (A-E)

A Patient Assistance (PAPs) and Support Programs (PSPs)

1:45

Track Chair’s Opening Remarks

BJ D'Avella
Senior Manager
Deloitte

1:50

Navigate the Complex Legal Landscape of PAPs

Meena Datta
Partner
Sidley Austin LLP

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

Chetan Shankar
Director, Specialty Reimbursement and Operational Compliance
GSK

2:30

Examine PSP Enforcement Trends as Scrutiny Heats Up

David Tolley
Partner, White Collar and Investigations
Latham and Watkins LLP

Francisco Ribeiro Filho
Senior Director, Head of U.S. Compliance
TESARO, Inc

Ann-Marie Tejcek
Senior Director, North American Ethics and Compliance Officer
Eli Lilly and Company

B Medical Affairs and MSL Oversight

1:45

Track Chair’s Opening Remarks

Mathieu Gagné
Partner
Fasken

1:50

Key Issues in Medical Affairs Compliance

Jon Wilkenfeld
President
Potomac River Partners

Stephanie Macholtz, JD, MBA
Director, Compliance and Ethics, Global Medical
Affairs & Business Development
Alexion Pharmaceuticals, Inc.

2:30

Demonstrate the Impact of MSL Interactions with Value and Access Stakeholders within a Controlled Framework

MODERATOR:

Mark DeWyngaert
Managing Director
Deloitte

PANELISTS:

Brad Glazer, PharmD
Senior Director, Medical Affairs Governance and Medical Information, Medical Affairs
BD

Gary Del Vecchio
Healthcare Compliance Officer Cardiovascular, Metabolism and Puerto Rico
Janssen Pharmaceuticals

Jeremy Lutsky
Counsel, Manatt
Phelps & Phillips, LLP

C Transparency and Aggregate Spend

1:45

Track Chair’s Opening Remarks

Jeff Summers
Chief Marketing Officer
CyberGrants

1:55

CMS ADDRESS CMS Transparency and Open Payments Update

Robin Usi
Director, Division of Data and Informatics
CMS

2:30

Prepare for Sunshine Expansion —
Reporting Payments Made to Advance Practice Nurse and PAs

Jonathan Wozniak
Manager, Compliance, Transparency and Reporting
Daiichi Sankyo, Inc.

Timothy Squire
Partner
Fasken

Amie Phillips Pablo
Director, Ethics and Compliance
Novo Nordisk

D Promotional Compliance

1:45

Track Chair’s Opening Remarks

Scott Liebman
Partner & Co-Chair of Life Sciences
Loeb & Loeb LLP

1:50

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

2:30

Industry Update — Evolution of Manufacturer Communication

MODERATOR:

Dominick P. DiSabatino
Associate
Loeb & Loeb LLP

PANELISTS:

Sheetal Patel
Head, Regulatory Advertising and Promotion
Johnson & Johnson

Gina Vestea
Senior Director, Regulatory Affairs, Advertising and Promotion
Sanofi

Alessandra Ravetti
Vice President, Associate General Counsel
Regeneron Pharmaceuticals, Inc.

E Auditing, Monitoring and Data Analytics

1:45

Track Chair’s Opening Remarks

1:50

INTERACTIVE BENCHMARKING Industry’s Bucket List — Key Areas for Oversight Amidst an Evolving Ecosystem

MODERATOR:

Stephanie Lewko, CFE
Director of Governance, Risk Management and Compliance
Navigant

PANELISTS:

Kelly Pitt
Director, Legal and Compliance, North America
Sobi, Inc.

Joyce Hsu
Lead Mandated Monitoring
Sanofi US

Jim Knepp
Director, Oversight and Monitoring
Johnson & Johnson

2:30

Collaboration Corner —
Harmonize Data Sources and Business Partners for Advanced Analytics

Corey Dunbar
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

David Gonzalez III
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

3:10

Networking and Refreshment Break Hosted By:

3:40

CHOOSE FROM FIVE INTERACTIVE WORKSHOPS (1-5)

1 HCP/HEE Interactions and Contracting

WORKSHOP LEADERS:

Rahul Khara, PharmD
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Brian P. Sharkey
Principal
Porzio Life Sciences, LLC

Kiran Vuppala
Assistant Vice President of Compliance Technology
Porzio Life Sciences, LLC

2 Beyond Due Diligence —
Auditing and Monitoring Third-Parties

WORKSHOP LEADERS:

Kris Curry
Principal, Forensic & Integrity Services
Ernst & Young LLP

Chris Matteson
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

Lori Queisser
Senior Vice President, Global Chief Compliance Officer
Teva Pharmaceuticals

3 Drug Pricing —
From State Transparency Reporting to DTC Ads

WORKSHOP LEADERS:

Sheea Sybblis
Senior Counsel
Boehringer Ingelheim

Marc Eida
Director, Privacy Services
Porzio Life Sciences, LLC

4 Risks Associated with the Hub and
Field Reimbursement Teams

WORKSHOP LEADERS:

Jack Tanselle
Managing Director
Deloitte

Sarah Whipple
Vice President, Legal and Chief Compliance Officer
Akebia Therapeutics, Inc.

Richard Konzelmann
Lead U.S. Risk Assessment and Compliance Audit
Sanofi US

Joe Philipose
Vice President, US and Enterprise Compliance
Alexion Pharmaceuticals

Meena Datta
Partner
Sidley Austin LLP

5 Role of Compliance in IPOs, M&A and
Joint Ventures

WORKSHOP LEADERS:

Gregory Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Angela Wood
Senior Director, Consumer Health Care Compliance North America and Global Functions Leader
Johnson & Johnson

T. Reed Stephens
Partner
McDermott Will & Emery LLP

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

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

4:25

Brief Transition Break

4:40

CHOOSE FROM FIVE THINK TANK SESSIONS (6-10)

6 Speaker Programs —
Best Practice Benchmarking

MODERATOR:

Mark Scallon
Senior Principal
IQVIA Commercial Compliance

PANELISTS:

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

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

Peter J. Agnoletto, CPA
Senior Director, US Ethics and Business Integrity
Sanofi US

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

7 Investigations and Internal Audits

Daniel Font
Director, Compliance Investigations, Policy and Training
Daiichi Sankyo, Inc

Mark Pearson
Partner
Deloitte

8 Clinical and R&D Compliance

Patricia Cone
Head, Global R&D Compliance
Takeda

Edward Buthusiem
Managing Director
Berkeley Research Group

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

9 Social Media —
Practical and Pragmatic Guidance

Nikki Reeves
Partner,
King & Spalding

Jennifer Sanfilippo
General Counsel
Melinta Therapeutics, Inc.

10 PAP and PSP Benchmarking —
How Is Industry Adapting?

Casey J. Horton, CFE
Director of Governance, Risk Management and Compliance
Navigant

Stefanie Doebler
Of Counsel
Navigant

5:25

Close of Day One

Cocktail Reception Commences at the Close of Day One

DAY TWO Thursday, April 18, 2019

7:15

Continental Breakfast

8:00

Chairman's Review of Day One

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

8:05

From the Trenches An Inside Look at the Forces and Pressures that Drive People to Violate the Law

KEYNOTE SPEAKER:

J. Kevin Foster
Founder and CEO, Business Ethics Advisors, LLC;
Former Executive Vice President, Finance,
Peerless Real Estate Services, Inc.

MODERATOR:

Vito A. Gagliardi
President and CEO
Porzio Life Sciences, LLC

8:45

Enforcement Spotlight —
Recent Trends and High-Priority Risk Areas Impacting the Life Sciences Sector

MODERATOR:

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings LLP

PANELISTS:

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

June Im
Attorney, Health Care Division
Federal Trade Commission

Michael Doyle
Supervisory Special Agent
FBI

Tarek Helou
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division
U.S. Department of Justice

9:30

BRAIN TEASER Rethinking the Compliance Profession — Where Should We Go from Here?

MODERATOR:

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

PANELISTS:

Alex Fell
Head of Risk International
Amicus Therapeutics

Melissa Tearney
Litigation Department Co-Chair
Choate Hall & Stewart LLP

Donna Boehme
Partner
Compliance Strategists LLC

10:30

Networking and Refreshment Break

11:00

CHOOSE FROM FIVE IN-DEPTH SUMMITS (I-V)

I Small to Mid-Sized Company Resource Center

MODERATOR:

Jeff Rosenbaum
Co-Founder and Partner
Dovetail Consulting Group LLC

PANELISTS:

Rahul Khara, PharmD
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Leslie Zacks
General Counsel and Chief Compliance Officer
Clearside Biomedical, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

II Market Access Compliance

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

Amy Greenstein
Engagement Manager
IQVIA Commercial Compliance

Sarah Franklin
Partner
Covington & Burling LLP

III Compliant Patient Interactions

MODERATOR:

Alicia Whittlesey
Director of Compliance Services
Porzio Life Sciences, LLC

PANELISTS:

Sarah Whipple
Vice President, Legal and Chief Compliance Officer
Akebia Therapeutics, Inc.

Aida L. Gonzalez
Director, Health Care Compliance Officer
Johnson & Johnson

Rupa Cornell
General Counsel, Americas
Stallergenes Greer

Laurie Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

IV Global Compliance —
Spotlight on High-Risk Markets

Ryan Lenz
Vice President and Head of Europe,
Middle East, Africa and Asia Audit and Assurance
GSK

Tiffany Moseley
Partner
Loeb & Loeb LLP

David King
Ethics and Compliance Officer
Merck & Co Inc

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

V Data Privacy and Cybersecurity — What Every Compliance Professional Needs to Know

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

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

Jessica Lee
Co-Chair, Privacy, Security and Data Innovations
Loeb & Loeb LLP

12:15

Networking Luncheon

1:15

INAUGURAL BENCHMARKING SURVEY RESULTS REVEALED

Exclusive Intelligence on the State of Bio/Pharma Compliance

Benefit from a comprehensive wrap-up of benchmarking results representing the collective intelligence of the compliance community from a sampling of companies (brand/generic, large/small and private/public). Content of the survey covers top priorities and emerging risk areas.

FACILITATOR:

Rahul Khara, PharmD
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

2:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

CONGRESS PRELUDES Tuesday, April 16, 2019

2:30 – 3:00PM

Prelude Registration

3:00 – 5:00PM

BENEFIT FROM ONE OF THREE TAILORED COMPLIANCE PRELUDES

PRELUDE A Healthcare Compliance and Policy Course

Designed for those new to compliance or new to the bio/pharma industry, this session acts as a primer for the conference as the main program is built off of the key elements discussed. Benefit from foundational knowledge in healthcare compliance basics before you embark on two content rich days covering emerging, high-risk areas.

Russell Rose
Senior Manager
Deloitte

Brian Miller, PhD
Senior Director, Training and Documentation, Ethics and Compliance
Otsuka America Pharmaceutical Inc.

Arivee Vargas
Head of Global Anti-Corruption and Assurance Programs
Vertex Pharmaceuticals

Ashley Riley
Manager
Deloitte Life Sciences Advisory

Simone Gaines
Manager, Office of Business Integrity and Ethics
Vertex Pharmaceuticals Inc.

PRELUDE B Compliant Nurse Educator Programs

As scrutiny of nurse educator programs heats up, industry must ensure the proper guardrails are in place to maintain compliance for these critical patient support programs. During this session, gain foundational and operational knowledge needed to structure and maintain compliant programs.

Manny Tzavlakis
Managing Partner
Helio Health Group

Erin Parsons
Health Care Compliance Officer
Janssen Pharmaceuticals

Chuck Bell
Former Compliance Officer
Kedrion Biopharma Inc.

Eric Greig
Associate
Latham & Watkins LLP

PRELUDE C Women’s Executive Leadership Forum
Powered by:   

This highly-acclaimed Forum showcases women in leadership within the compliance and life sciences community. Hear compelling stories of personal career success, reflect on professional development paths, discover flashpoint moments and ways to inspire and elevate the compliance team. Attendees discover meaningful mentorships and insights into optimal job placement and professional pathways.

Laura Skinner
Senior Manager
Deloitte

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

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

Veleka Peeples-Dyer
Partner
McDermott Will & Emery LLP

Adam Dubow
Chief Compliance and Ethics Officer
Bristol-Myers Squibb

Jim Massey
Global Vice President, Global Sustainability
AstraZeneca

5:00 – 6:00PM
SIGNATURE COCKTAIL RECEPTION CO-HOSTED BY:   

DAY ONE Wednesday, April 17, 2019

7:00

Main Congress Registration and Continental Breakfast

7:50

CBI Welcome

8:00

Chairman’s Welcome and Opening Remarks

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

8:10

“Compliance Year in Review” Video Reveal

8:15

Good Morning, PCC! Industry News Update and Policy Briefing

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

John Shakow
Partner
King & Spalding LLP

8:45

LUMINARY SHOWCASE A Spotlight on Partnerships, Integration and Advancements Transforming the Industry

MODERATOR:

Angela Rodin
Principal, Risk Advisory
KPMG LLP

I. Vision and Future of Value-Based Healthcare

James Stansel
Executive Vice President and General Counsel
PhRMA

II. Patient Support, Empowerment and Engagement —
A Patient Advocacy Perspective

Kristen Santiago
Senior Director, Public Policy Initiatives
LUNGevity

Debbie Drell
Director of Membership
NORD

III. Artificial Intelligence Aiding Digital Innovation

Justin Hoss
Partner
KPMG LLP

Bharat Rao
Partner
KPMG LLP

IV. Moderated Q&A and Exchange

10:00

CCO EXCHANGE Top of Mind Topics for Life Science Leaders

MODERATOR:

Regina Cavaliere
Principal
KPMG LLP

PANELISTS:

Michael Clarke
Former Vice President, Corporate Compliance
Indivior, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

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

10:45

Networking and Refreshment Break Hosted by:

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

11:15

Past and Present Prosecutor Parley

PARLEY MODERATOR:

Tom Gregory
Partner Global leader – Life sciences,Forensic & Integrity Services
Ernst & Young LLP

Current Prosecutors Panel

I. Top Enforcement Trends and Focal Points for 2019 and Beyond

PANELISTS:

Nathaniel Mendell
First Assistant U.S. Attorney
U.S. Attorney’s Office, District of Massachusetts

David Eskew
Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office, District of New Jersey

Former Prosecutors Panel

II. New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud

PANELISTS:

Terra Reynolds
Partner, White Collar and Investigations, Latham and Watkins LLP;
former Deputy Chief and Assistant U.S. Attorney,
U.S. Attorney’s Office, Northern District of Illinois

John Richter
Partner, King & Spalding LLP;
former Deputy Chief and Assistant U.S. Attorney,
U.S. Attorney’s Office, Western District of Oklahoma

Jacob T. Elberg
Associate Professor, Seton Hall University School of Law;
former Assistant U.S. Attorney, U.S. Attorney's Office, District of New Jersey

12:30

Networking Luncheon

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

HOSTED BY:

ABOUT OUR SUMMIT HOST John Patrick Oroho, Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia. Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Commercialization Department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Anti-Kickback Statute, False Claim Act, and Medicare and Medicaid fraud and abuse. Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance.

*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.

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

Summit Overview:

The CCO Summit provides world-class thought-leadership and is 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.

Summit Outline:

I. Keynote Address on Ethics and Leadership

Sheelah Kolhatkar
Staff Writer, The New Yorker;
PBS Host, Playing By The Rules

II. Candid Conversations on Key Business and Industry Topics

Summit Leader:

Kevin Espinoza
Senior Vice President, Corporate Compliance and Privacy Officer
BTG

4:25

Close of CCO Summit

1:45

CHOOSE FROM FIVE CONTENT STREAMS (A-E)

A Patient Assistance (PAPs) and Support Programs (PSPs)

1:45

Track Chair’s Opening Remarks

BJ D'Avella
Senior Manager
Deloitte

1:50

Navigate the Complex Legal Landscape of PAPs

Meena Datta
Partner
Sidley Austin LLP

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

Chetan Shankar
Director, Specialty Reimbursement and Operational Compliance
GSK

2:30

Examine PSP Enforcement Trends as Scrutiny Heats Up

David Tolley
Partner, White Collar and Investigations
Latham and Watkins LLP

Francisco Ribeiro Filho
Senior Director, Head of U.S. Compliance
TESARO, Inc

Ann-Marie Tejcek
Senior Director, North American Ethics and Compliance Officer
Eli Lilly and Company

B Medical Affairs and MSL Oversight

1:45

Track Chair’s Opening Remarks

Mathieu Gagné
Partner
Fasken

1:50

Key Issues in Medical Affairs Compliance

Jon Wilkenfeld
President
Potomac River Partners

Stephanie Macholtz, JD, MBA
Director, Compliance and Ethics, Global Medical
Affairs & Business Development
Alexion Pharmaceuticals, Inc.

2:30

Demonstrate the Impact of MSL Interactions with Value and Access Stakeholders within a Controlled Framework

MODERATOR:

Mark DeWyngaert
Managing Director
Deloitte

PANELISTS:

Brad Glazer, PharmD
Senior Director, Medical Affairs Governance and Medical Information, Medical Affairs
BD

Gary Del Vecchio
Healthcare Compliance Officer Cardiovascular, Metabolism and Puerto Rico
Janssen Pharmaceuticals

Jeremy Lutsky
Counsel, Manatt
Phelps & Phillips, LLP

C Transparency and Aggregate Spend

1:45

Track Chair’s Opening Remarks

Jeff Summers
Chief Marketing Officer
CyberGrants

1:55

CMS ADDRESS CMS Transparency and Open Payments Update

Robin Usi
Director, Division of Data and Informatics
CMS

2:30

Prepare for Sunshine Expansion —
Reporting Payments Made to Advance Practice Nurse and PAs

Jonathan Wozniak
Manager, Compliance, Transparency and Reporting
Daiichi Sankyo, Inc.

Timothy Squire
Partner
Fasken

Amie Phillips Pablo
Director, Ethics and Compliance
Novo Nordisk

D Promotional Compliance

1:45

Track Chair’s Opening Remarks

Scott Liebman
Partner & Co-Chair of Life Sciences
Loeb & Loeb LLP

1:50

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

2:30

Industry Update — Evolution of Manufacturer Communication

MODERATOR:

Dominick P. DiSabatino
Associate
Loeb & Loeb LLP

PANELISTS:

Sheetal Patel
Head, Regulatory Advertising and Promotion
Johnson & Johnson

Gina Vestea
Senior Director, Regulatory Affairs, Advertising and Promotion
Sanofi

Alessandra Ravetti
Vice President, Associate General Counsel
Regeneron Pharmaceuticals, Inc.

E Auditing, Monitoring and Data Analytics

1:45

Track Chair’s Opening Remarks

1:50

INTERACTIVE BENCHMARKING Industry’s Bucket List — Key Areas for Oversight Amidst an Evolving Ecosystem

MODERATOR:

Stephanie Lewko, CFE
Director of Governance, Risk Management and Compliance
Navigant

PANELISTS:

Kelly Pitt
Director, Legal and Compliance, North America
Sobi, Inc.

Joyce Hsu
Lead Mandated Monitoring
Sanofi US

Jim Knepp
Director, Oversight and Monitoring
Johnson & Johnson

2:30

Collaboration Corner —
Harmonize Data Sources and Business Partners for Advanced Analytics

Corey Dunbar
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

David Gonzalez III
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

3:10

Networking and Refreshment Break Hosted By:

3:40

CHOOSE FROM FIVE INTERACTIVE WORKSHOPS (1-5)

1 HCP/HEE Interactions and Contracting

WORKSHOP LEADERS:

Rahul Khara, PharmD
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Brian P. Sharkey
Principal
Porzio Life Sciences, LLC

Kiran Vuppala
Assistant Vice President of Compliance Technology
Porzio Life Sciences, LLC

2 Beyond Due Diligence —
Auditing and Monitoring Third-Parties

WORKSHOP LEADERS:

Kris Curry
Principal, Forensic & Integrity Services
Ernst & Young LLP

Chris Matteson
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

Lori Queisser
Senior Vice President, Global Chief Compliance Officer
Teva Pharmaceuticals

3 Drug Pricing —
From State Transparency Reporting to DTC Ads

WORKSHOP LEADERS:

Sheea Sybblis
Senior Counsel
Boehringer Ingelheim

Marc Eida
Director, Privacy Services
Porzio Life Sciences, LLC

4 Risks Associated with the Hub and
Field Reimbursement Teams

WORKSHOP LEADERS:

Jack Tanselle
Managing Director
Deloitte

Sarah Whipple
Vice President, Legal and Chief Compliance Officer
Akebia Therapeutics, Inc.

Richard Konzelmann
Lead U.S. Risk Assessment and Compliance Audit
Sanofi US

Joe Philipose
Vice President, US and Enterprise Compliance
Alexion Pharmaceuticals

Meena Datta
Partner
Sidley Austin LLP

5 Role of Compliance in IPOs, M&A and
Joint Ventures

WORKSHOP LEADERS:

Gregory Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Angela Wood
Senior Director, Consumer Health Care Compliance North America and Global Functions Leader
Johnson & Johnson

T. Reed Stephens
Partner
McDermott Will & Emery LLP

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

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

4:25

Brief Transition Break

4:40

CHOOSE FROM FIVE THINK TANK SESSIONS (6-10)

6 Speaker Programs —
Best Practice Benchmarking

MODERATOR:

Mark Scallon
Senior Principal
IQVIA Commercial Compliance

PANELISTS:

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

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

Peter J. Agnoletto, CPA
Senior Director, US Ethics and Business Integrity
Sanofi US

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

7 Investigations and Internal Audits

Daniel Font
Director, Compliance Investigations, Policy and Training
Daiichi Sankyo, Inc

Mark Pearson
Partner
Deloitte

8 Clinical and R&D Compliance

Patricia Cone
Head, Global R&D Compliance
Takeda

Edward Buthusiem
Managing Director
Berkeley Research Group

Sue Seferian
Health Care Compliance Officer
Johnson & Johnson

9 Social Media —
Practical and Pragmatic Guidance

Nikki Reeves
Partner,
King & Spalding

Jennifer Sanfilippo
General Counsel
Melinta Therapeutics, Inc.

10 PAP and PSP Benchmarking —
How Is Industry Adapting?

Casey J. Horton, CFE
Director of Governance, Risk Management and Compliance
Navigant

Stefanie Doebler
Of Counsel
Navigant

5:25

Close of Day One

Cocktail Reception Commences at the Close of Day One

DAY TWO Thursday, April 18, 2019

7:15

Continental Breakfast

8:00

Chairman's Review of Day One

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

8:05

From the Trenches An Inside Look at the Forces and Pressures that Drive People to Violate the Law

KEYNOTE SPEAKER:

J. Kevin Foster
Founder and CEO, Business Ethics Advisors, LLC;
Former Executive Vice President, Finance,
Peerless Real Estate Services, Inc.

MODERATOR:

Vito A. Gagliardi
President and CEO
Porzio Life Sciences, LLC

8:45

Enforcement Spotlight —
Recent Trends and High-Priority Risk Areas Impacting the Life Sciences Sector

MODERATOR:

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings LLP

PANELISTS:

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

June Im
Attorney, Health Care Division
Federal Trade Commission

Michael Doyle
Supervisory Special Agent
FBI

Tarek Helou
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division
U.S. Department of Justice

9:30

BRAIN TEASER Rethinking the Compliance Profession — Where Should We Go from Here?

MODERATOR:

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

PANELISTS:

Alex Fell
Head of Risk International
Amicus Therapeutics

Melissa Tearney
Litigation Department Co-Chair
Choate Hall & Stewart LLP

Donna Boehme
Partner
Compliance Strategists LLC

10:30

Networking and Refreshment Break

11:00

CHOOSE FROM FIVE IN-DEPTH SUMMITS (I-V)

I Small to Mid-Sized Company Resource Center

MODERATOR:

Jeff Rosenbaum
Co-Founder and Partner
Dovetail Consulting Group LLC

PANELISTS:

Rahul Khara, PharmD
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Leslie Zacks
General Counsel and Chief Compliance Officer
Clearside Biomedical, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

II Market Access Compliance

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

Amy Greenstein
Engagement Manager
IQVIA Commercial Compliance

Sarah Franklin
Partner
Covington & Burling LLP

III Compliant Patient Interactions

MODERATOR:

Alicia Whittlesey
Director of Compliance Services
Porzio Life Sciences, LLC

PANELISTS:

Sarah Whipple
Vice President, Legal and Chief Compliance Officer
Akebia Therapeutics, Inc.

Aida L. Gonzalez
Director, Health Care Compliance Officer
Johnson & Johnson

Rupa Cornell
General Counsel, Americas
Stallergenes Greer

Laurie Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

IV Global Compliance —
Spotlight on High-Risk Markets

Ryan Lenz
Vice President and Head of Europe,
Middle East, Africa and Asia Audit and Assurance
GSK

Tiffany Moseley
Partner
Loeb & Loeb LLP

David King
Ethics and Compliance Officer
Merck & Co Inc

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

V Data Privacy and Cybersecurity — What Every Compliance Professional Needs to Know

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

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

Jessica Lee
Co-Chair, Privacy, Security and Data Innovations
Loeb & Loeb LLP

12:15

Networking Luncheon

1:15

INAUGURAL BENCHMARKING SURVEY RESULTS REVEALED

Exclusive Intelligence on the State of Bio/Pharma Compliance

Benefit from a comprehensive wrap-up of benchmarking results representing the collective intelligence of the compliance community from a sampling of companies (brand/generic, large/small and private/public). Content of the survey covers top priorities and emerging risk areas.

FACILITATOR:

Rahul Khara, PharmD
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

2:00

Close of Conference