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
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
