AGENDA: CHIEF COMPLIANCE OFFICER ROUNDTABLE / PRECONFERENCE / DAY 1
WEDNESDAY, NOVEMBER 6, 2019
7:00 am
Registration Opens and Networking Breakfast
INVITATION-ONLY: CHIEF COMPLIANCE OFFICER ROUNDTABLE
(Jointly Sponsored by PCF and PhRMA)
7:45 am
Networking Buffet Breakfast Hosted by PhRMA and PCF
8:15 am
Welcome & Introductions
8:25 am
Antitrust Admonition
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC
8:30 am
DOJ’s Evaluation of Corporate Compliance
Sally Molloy, JD
Chief, Strategy, Policy and Training Unit, Fraud Section, US Department of Justice, Washington, DC
Chief, Strategy, Policy and Training Unit, Fraud Section, US Department of Justice, Washington, DC
9:15 am
Closed Door Discussions: How to Operationalize the DOJ Guidance?
9:45 am
Break
10:00 am
The Chief Compliance Officer (CCO) Connection Program
Christie Camelio
Vice President and US Healthcare Compliance Officer, Celgene; Former Head of Risk Management, Novartis, Summit, NJ
Vice President and US Healthcare Compliance Officer, Celgene; Former Head of Risk Management, Novartis, Summit, NJ
10:10 am
PhRMA Updates
Julie Ritchie Wagner, JD
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS, Washington, DC
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS, Washington, DC
10:30 am
AdvaMed Updates
Christopher L. White, JD
Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC
Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC
10:50 am
Strategic Discussion with Board of Directors
Thomas Costa, JD
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC
Shannon Kelley, JD
Vice President, Head of North America Compliance, Sanofi; Former Assistant US Attorney and Deputy Chief of Litigation, Boston US Attorney’s Office, Cambridge, MA
Vice President, Head of North America Compliance, Sanofi; Former Assistant US Attorney and Deputy Chief of Litigation, Boston US Attorney’s Office, Cambridge, MA
11:30 am
Open Discussions
11:55 am
Meeting Adjournment
PRECONFERENCE SYMPOSIA (Optional; Separate registration required. Preconferences 1/2, 3 and 4 are concurrent: please choose only one. Preconferences 1 and 2 are consecutive: you may register for both.)
PRECONFERENCE I: RISK ASSESSMENT RECOMMENDATIONS BASED ON DOJ UPDATED GUIDANCE
On April 30, 2019 the Criminal Division of the U.S. Department of Justice (DOJ) released new guidance, “The Evaluation of Corporate Compliance Programs,” which updates a prior version of the guidance first issued in February 2017.
During this session we will discuss and address how to best implement this guidance, the requirements and how this affects how we’ve historically thought about conducting Risk Assessments knowing the direct impact on a healthcare compliance program’s design, implementation and effectiveness.
With our industry panelists we will address the following:
- How to best utilize Risk Assessments and their outputs to exemplify that a corporation’s compliance program is well designed?
- Better practices and insights regarding how companies are identifying, assessing, and defining their risk profiles.
- Overview of organizational structures, dedicated resources, and budgets devoted to their Risk Assessment program.
- Better practices and insights regarding the scope of healthcare compliance Risk Assessments, including, but not limited to: considering location of operations, industry sectors, competition, business partners, transactions with foreign governments, payments to foreign officials, use of third parties, gifts, travel & entertainment expenses, and charitable and political donations.
- Better practices and insights regarding a company’s Risk Management Process (methodology, metrics and how the information is used to communicate with management and tailor the program)
8:00 am
Welcome and Overview
Jonathan Turner, MSc
Vice President, Global Compliance Leader, Smith & Nephew; Adjunct Faculty, Florida State University and University of Memphis; Association of Certified Fraud Examiners, Memphis, TN
Vice President, Global Compliance Leader, Smith & Nephew; Adjunct Faculty, Florida State University and University of Memphis; Association of Certified Fraud Examiners, Memphis, TN
Christine Handel, JD
Vice President, Global Compliance Operations, Walgreens Boots Alliance, Deerfield, IL
Vice President, Global Compliance Operations, Walgreens Boots Alliance, Deerfield, IL
Jenny McVey, PhD
Associate Director, Risk Strategy and Mitigation, Novo Nordisk, Inc.; Former Compliance Officer, Hands International, Princeton, NJ
Associate Director, Risk Strategy and Mitigation, Novo Nordisk, Inc.; Former Compliance Officer, Hands International, Princeton, NJ
Jean McKiernan, MBA
Managing Director, Dovetail Consulting Group, LLC, Chicago, IL (Moderator)
Managing Director, Dovetail Consulting Group, LLC, Chicago, IL (Moderator)
10:00 am
Preconference I Adjournment
PRECONFERENCE II: THIRD PARTY INTERACTIONS, INCLUDING DISTRIBUTORS AND NON-DISTRIBUTOR 3RD PARTY VENDOR COMPLIANCE
Managing third parties, including distributors, continues to challenge organizations from both a strategic business and compliance perspective. This mini-summit will discuss challenges and opportunities in managing third parties, and setting pragmatic oversight and monitoring goals that engage the business in managing risk.
10:00 am
Welcome and Overview
Paul J. Melling, MA
Partner, Baker McKenzie Moscow, Moscow, Russia
Partner, Baker McKenzie Moscow, Moscow, Russia
Gregory Paw, JD
Partner, Freeh, Sporkin & Sullivan; Former Director, New Jersey Division of Criminal Justice; Former Assistant US Attorney, US Attorney’s Office, Eastern District of Pennsylvania, New York, NY
Partner, Freeh, Sporkin & Sullivan; Former Director, New Jersey Division of Criminal Justice; Former Assistant US Attorney, US Attorney’s Office, Eastern District of Pennsylvania, New York, NY
Nancy S. Travis, MS
Vice President, International Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Vice President, International Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Angela Rodin, MBA
Principal, KPMG; Former Vice President, Global Head of Investigations and Monitoring, GlaxoSmithKline Pharma GmbH, Washington, DC (Moderator)
Principal, KPMG; Former Vice President, Global Head of Investigations and Monitoring, GlaxoSmithKline Pharma GmbH, Washington, DC (Moderator)
12:00 pm
Preconference II Adjournment/Lunch on your Own
PRECONFERENCE III: INVESTIGATIONS: INTERCONNECTIVITY OF AUDITING, MONITORING, AND INVESTIGATIONS, INCLUDING PRIVILEGE
This Preconference will provide an overview of the following:
- Presentation of the results of 2019 NCI survey on Internal Investigations
- Update on recent legal issues
- Guidance on how to organize and determine what to investigate vs. what not, the use of dedicated Investigators vs. HR vs. Internal Audit, how data analytics help with issues, issues for a big company vs. a small company, and privacy concerns.
- Discussion on the outcomes of investigations, how to present to your management and the Board, how best to ensure topics get re-integrated into the compliance programs, strategies for how best to work with the business, and how to help support an effective investigations culture.
8:00 am
Welcome and Overview
Keith Burn
Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS, Former Detective Constable, London Metropolitan Police, Amersham; Slough, UK
Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS, Former Detective Constable, London Metropolitan Police, Amersham; Slough, UK
Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY
Betania Glorio, LLM
Global Compliance Officer, Healthcare, Merck KGaA, Darmstadt, Germany
Global Compliance Officer, Healthcare, Merck KGaA, Darmstadt, Germany
Franziska Janorschke
Global Head, Business Practices Office, Novartis International AG, Basel Area, Switzerland
Global Head, Business Practices Office, Novartis International AG, Basel Area, Switzerland
Casey J. Horton, CFE
Director, Life Sciences, Governance, Risk and Compliance, Navigant, Chicago, IL (Moderator)
Director, Life Sciences, Governance, Risk and Compliance, Navigant, Chicago, IL (Moderator)
12:00 pm
Preconference III Adjournment/Lunch on your Own
PRECONFERENCE IV: EMERGING ROLE OF ANALYTICS, BIG DATA & AI OPPORTUNITIES FOR LIFE SCIENCES: IMPLICATIONS FOR ETHICS AND COMPLIANCE
This session will address:
- Data and the Life Sciences: Overview of the Changes to Come
- The GDPR, State Privacy Laws and the Pharmaceutical Industry
- Regulation of AI in Life Sciences: Compliance and Ethics Implications
- Potential Data Privacy and AI Risks in the Product Life Cycle of a Medical Device
- Data and Compliance — Mitigating the Risk of Government Enforcement, Individual Liability, and Corporate Integrity Agreements through Analytics
8:00 am
Welcome & Introductions
8:15 am
Data and the Life Sciences: Overview of the Changes to Come
Oscar Rodriguez
Senior Director, Innovation & Technology, BlackThorn Therapeutics; Co-chair, Technology and Standards Subcommittee, The Alliance for Artificial Intelligence in Healthcare (AAIH), New York, NY
Senior Director, Innovation & Technology, BlackThorn Therapeutics; Co-chair, Technology and Standards Subcommittee, The Alliance for Artificial Intelligence in Healthcare (AAIH), New York, NY
Sarah Venable, JD, MS
Risk Analytics Manager, Independent Business Manager, GlaxoSmithKline, Raleigh, NC
Risk Analytics Manager, Independent Business Manager, GlaxoSmithKline, Raleigh, NC
9:00 am
The GDPR, State Privacy Laws and the Pharmaceutical Industry
Pearl Hsieh, JD
Senior Counsel, US Commercial, Group Counsel, Smith & Nephew, Columbia, MD
Senior Counsel, US Commercial, Group Counsel, Smith & Nephew, Columbia, MD
Kimberly J. Gold, JD
Partner, ReedSmith, New York, NY (Moderator)
Partner, ReedSmith, New York, NY (Moderator)
9:45 am
Regulation of AI in Life Sciences: Compliance and Ethics Implications
Kelliann H. Payne, JD
Partner, Hogan Lovells LLP; Former Assistant General Counsel, QVC, Inc., Philadelphia, PA
Partner, Hogan Lovells LLP; Former Assistant General Counsel, QVC, Inc., Philadelphia, PA
10:30 am
Break
10:45 am
Potential Data Privacy and AI Risks in the Product Life Cycle of a Medical Device
Bernadette Broccolo, JD
Partner, McDermott Will & Emery LLP, Chicago, IL
Partner, McDermott Will & Emery LLP, Chicago, IL
11:30 am
Data and Compliance — Mitigating the Risk of Government Enforcement, Individual Liability, and Corporate Integrity Agreements through Analytics
Jared D. Crafton
Principal, Assurance Services, Forensic & Integrity Services, EY, Boston, MA (Moderator)
Principal, Assurance Services, Forensic & Integrity Services, EY, Boston, MA (Moderator)
12:00 pm
Preconference IV Adjournment/Lunch on your Own
OPENING PLENARY SESSION
1:00 pm
Welcome and Introduction: PCF Co-chairs
Sujata T. Dayal, JD
Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Co-chair)
Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Co-chair)
Jeffrey M. Kawalek, MBA
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Philadelphia, PA (PCF Chair)
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Philadelphia, PA (PCF Chair)
Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Co-chair)
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Co-chair)
Donna White, CCEP
Vice President, Contracts and Compliance, Chiesi, USA, Cary, NC (PCF Co-chair)
Vice President, Contracts and Compliance, Chiesi, USA, Cary, NC (PCF Co-chair)
Joe Zimmerman
Vice President and Chief Compliance Officer, US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-chair)
Vice President and Chief Compliance Officer, US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-chair)
Antitrust Admonition
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC
1:15 pm
20th Anniversary Dialogue: Lessons Learned from 20 Years of Pharma and Medical Device Investigations, Prosecutions, Ethics and Compliance
Douglas M. Lankler, JD
Executive Vice President, General Counsel, Pfizer; Former Assistant US Attorney, Southern District of New York, US Department of Justice, New York, NY
Executive Vice President, General Counsel, Pfizer; Former Assistant US Attorney, Southern District of New York, US Department of Justice, New York, NY
Daniel Ronald Levinson, JD
Former Inspector General, US Department of Health and Human Services; Former Inspector General, US General Services Administration; Former Chairman, US Merit Systems Protection Board; Former General Counsel, US Consumer Product Safety Commission, Washington, DC
Former Inspector General, US Department of Health and Human Services; Former Inspector General, US General Services Administration; Former Chairman, US Merit Systems Protection Board; Former General Counsel, US Consumer Product Safety Commission, Washington, DC
Lori Queisser
Senior Vice President and Global Chief Compliance Officer, Teva Pharmaceuticals; Former Senior Vice President, Global Compliance and Business Practices; Schering-Plough Corporation; Former Vice President, Chief Compliance Officer, Eli Lilly; Former Member, PCF Executive Committee, Horsham, PA
Senior Vice President and Global Chief Compliance Officer, Teva Pharmaceuticals; Former Senior Vice President, Global Compliance and Business Practices; Schering-Plough Corporation; Former Vice President, Chief Compliance Officer, Eli Lilly; Former Member, PCF Executive Committee, Horsham, PA
Arjun Rajaratnam, JD, MS
Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Raleigh, NC
Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Raleigh, NC
James Sheehan, JD
Chief, Charities Bureau, New York State Department of Law (Attorney General); Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration; Former NY Medicaid Inspector General; Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania, New York, NY
Chief, Charities Bureau, New York State Department of Law (Attorney General); Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration; Former NY Medicaid Inspector General; Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania, New York, NY
Susan Winkler, JD, MA
Founder, Winkler Law LLC; Former Assistant US Attorney and Head, Health Care Fraud Unit, US Attorney’s Office for the District of Massachusetts, Boston, MA
Founder, Winkler Law LLC; Former Assistant US Attorney and Head, Health Care Fraud Unit, US Attorney’s Office for the District of Massachusetts, Boston, MA
Kris Curry, MBA
Principal, Assurance Services, EY; Former Vice President, Global Chief Compliance Officer, Pharma Sector, Johnson & Johnson, Philadelphia, PA (Moderator)
Principal, Assurance Services, EY; Former Vice President, Global Chief Compliance Officer, Pharma Sector, Johnson & Johnson, Philadelphia, PA (Moderator)
2:15 pm
Keynote: OIG Update
Mary E. Riordan, JD
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC
3:00 pm
US DOJ Keynote
Brian Allen Benczkowski, JD
Assistant Attorney General, Criminal Division, US Department of Justice; Former Principal Deputy Assistant Attorney General for Legislative Affairs; Former Republican Staff Director, Committee on the Judiciary, US Senate; Former Staff, Senator Pete Domenici and Representative Jim Sensenbrenner, Washington, DC
Assistant Attorney General, Criminal Division, US Department of Justice; Former Principal Deputy Assistant Attorney General for Legislative Affairs; Former Republican Staff Director, Committee on the Judiciary, US Senate; Former Staff, Senator Pete Domenici and Representative Jim Sensenbrenner, Washington, DC
3:30 pm
Break
4:00 pm
FDA Keynote
Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD
Director, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD
4:30 pm
Developments in Pharmaceutical and Medical Device Pricing and Cost Containment: Implication for Ethics and Compliance Professionals
Susan Dentzer
Visiting Fellow, Robert J. Margolis Center for Health Policy, Duke University; Analyst on Health Policy, The NewsHour; Former President and CEO, NEHI, (The Network for Excellence in Health Innovation); Former Editor, Health Affairs, Washington, DC
Visiting Fellow, Robert J. Margolis Center for Health Policy, Duke University; Analyst on Health Policy, The NewsHour; Former President and CEO, NEHI, (The Network for Excellence in Health Innovation); Former Editor, Health Affairs, Washington, DC
5:00 pm
Annual Chief Compliance Officer Roundtable
Charlene E. Davis, JD
Vice President & Chief Compliance Officer, Aerie Pharmaceuticals, Inc.; Former Senior Compliance Counsel and Senior Director, Corporate Compliance and Compliance Operations, Otsuka Pharmaceutical, Princeton, NJ
Vice President & Chief Compliance Officer, Aerie Pharmaceuticals, Inc.; Former Senior Compliance Counsel and Senior Director, Corporate Compliance and Compliance Operations, Otsuka Pharmaceutical, Princeton, NJ
Adam Dubow, JD
Global Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ
Global Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer, Chevy Chase, MD
Vice President and Chief Compliance Officer, Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer, Chevy Chase, MD
Dominique Laymand, JD
Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Sunitha Ramamurthy, JD
Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals, Stamford, CT
Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals, Stamford, CT
Thomas J. Schumacher, JD
Vice President and Global Chief, Ethics and Compliance Officer, Medtronic, Fridley, MN
Vice President and Global Chief, Ethics and Compliance Officer, Medtronic, Fridley, MN
Paul Silver
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte & Touche LLP, Atlanta, GA (Moderator)
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte & Touche LLP, Atlanta, GA (Moderator)