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
John Bentivoglio is a partner at Skadden Arps in the life sciences enforcement and regulatory team in Washington, DC. Previously he served as Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.
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
Sally Molloy is the Chief, Strategy, Policy & Training Unit for the Fraud Section of the Department of Justice. Her previous positions with the Fraud Section include Assistant Chief, Health Care Fraud Unit and Trial Attorney, Health Care Fraud Unit. Prior to working at the Fraud Unit, DOJ, she was an Assistant US Attorney in the United States Attorney’s Office for the Northern District of Georgia. She began her career as a Trial Attorney in the Antitrust Division of the Atlanta Field Office for the US Department of Justice.
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
Christine Camelio is Vice President and Deputy Chief Compliance Officer at Celgene Corporation with responsibility for the US Healthcare Compliance Program, the Corporate Compliance Program (Policies, Investigations, Spend Transparency and Due Diligence) and the Enterprise Risk Management Program. She is also Celgene’s Compliance Integration and Divestment lead for M & A activities. Christie started her career in sales and marketing and then went to the agency side leading brand strategy projects for consumer and pharmaceutical companies. She then spent 14 years with Novartis Pharmaceuticals in various positions in Legal, Medical, Commercial and Risk Management.
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
Julie Wagner is Assistant General Counsel at PhRMA with responsibility for compliance, and enforcement matters. Prior to joining PhRMA, Julie served in the Office of the Inspector General at the U.S. Department of Health & Human Services where she worked in the Industry Guidance Branch as an Anti-kickback Statute subject matter expert, advising on fraud and abuse issues.
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
Mr. White is the Chief Operating Officer and General Counsel of Advanced Medical Technology Association (AdvaMed). Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is an Advisory Board Member to the GWU School of Medicine and Health Sciences. As Chief Operating Officer, he manages the Association’s HR, IT, Facilities, and, governance and provides counsel on contract, corporate, tax exemption, HR, and legislative and regulatory matters.
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
Over his career, Thomas Costa has provided legal and compliance guidance and advice to pharmaceutical companies as outside counsel, in-house counsel, head of a U.S Compliance team and today as a Compliance Consultant. He has experience leading domestic and international legal and compliance teams worldwide.
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
As the North America Compliance Officer, Shannon Kelley has oversight of the North American compliance program spanning all NA Business Units and Global Functions. In particular, she is responsible for monitoring Sanofi US and Sanofi Genzyme activities within the framework of the Corporate Integrity Agreement. Shannon was formerly the Senior Director of North America Compliance for Genzyme. She joined Sanofi from Boston Scientific Corporation where she held various Global Compliance and Commercial Legal roles. Earlier in her career, Shannon spent over a decade in enforcement roles with the U.S. Federal Government: including serving as a Trial Attorney for DOJ in Washington, D.C. and an AUSA and Deputy Chief of Litigation for the Boston U.S. Attorney’s Office where she prosecuted a variety of federal civil and criminal healthcare and economic crime cases.
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
Jonathan Turner is Vice President Global Ethics & Compliance leader, with Smith & Nephew. He has experience in medical device, pharmaceuticals, banking and finance sectors, specializing in transforming compliance programs and driving effective solutions. He is an author, speaker and Adjunct Professor in graduate and undergraduate programs.
Christine Handel, JD
Vice President, Global Compliance Operations, Walgreens Boots Alliance, Deerfield, IL
Vice President, Global Compliance Operations, Walgreens Boots Alliance, Deerfield, IL
Christine Handel is currently the Vice President, Global Compliance Operations for WBA. Before joining WBA, she served as the Ethics and Compliance Officer, Operations and the Vice President, Ethics and Compliance Officer, Business Compliance Support at Abbvie. Over the course of nearly fifteen years, she held several positions at Abbott and the joint venture TAP Pharmaceuticals in the compliance and finance departments, including Director, Compliance Audit at Abbott where she established the global internal audit compliance function. Prior to joining Abbott, Christine practiced law in Chicago with the firm of Haskell & Perrin.
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
Jenny M. McVey – Over 14 years of experience combined working and consulting in the life science industry focused on compliance matters. Experiences range from compliance risk assessment and management, mitigation plans, medical affairs and commercial operations, third-party engagement, FCPA/ABAC matters, global commercialization product launches, education and training and device pre-clinical filing studies. Jenny is currently heading Novo Nordisk’s E&C RAMP program, assessing and ranking compliance risks, and developing mitigation plans in accordance with US gov’t expectations.
Jean McKiernan, MBA
Managing Director, Dovetail Consulting Group, LLC, Chicago, IL (Moderator)
Managing Director, Dovetail Consulting Group, LLC, Chicago, IL (Moderator)
Jean McKiernan is a managing director at Dovetail Consulting Group. She has almost two decades of global industry experience in the pharmaceutical, biotech, and medical device fields. Jean is an expert in risk consulting and compliance operations who builds trust and rapport with her clients. Throughout her consulting experience, Jean has advised major companies on global compliance programs and operational frameworks, assisting chief compliance officers in mitigating and managing regulatory and compliance risk. Her program build experience includes: mergers & acquisitions, patient assistance foundations/patient support programs, IRO Services, CIA preparedness services, governance design, training, written standards and, specific to medical device, asset tracking. Prior to joining Dovetail Consulting Group, Jean consulted in the Pharmaceutical and LifeSciences Risk Consulting practice of PwC. She began her career at Abbott Laboratories HPD, Hospira (DBA Pfizer), and a healthcare portfolio company of WaterStreet Healthcare Partners private equity.
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
Paul Melling is an English lawyer who has spent his entire career practicing law in the USSR/Russian Federation. He founded the Moscow office of Baker McKenzie in 1989 and has been a Moscow resident for over 30 years. He also opened Baker McKenzie’s Almaty office. He leads his Firm’s Russia/CIS Life Sciences Industry Group as well as its Russia/CIS Compliance & Investigations Group. He has been the Honorary Legal Adviser to the British Ambassador in Moscow for 30 years and the Honorary Legal Adviser to Russia’s Association of International Pharmaceutical Manufacturers (AIPM) since 1994.
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
A former federal prosecutor and past director of the New Jersey Division of Criminal Justice, Greg Paw is a partner with Freeh, Sporkin & Sullivan. Drawing on his unique international law enforcement work investigating regime war crimes in Iraq, Greg now provides the benefit of his experience in criminal litigation and knowledge of international compliance and risk management to advise clients on enforcement and compliance issues arising in international business.
Previously, Greg served as a federal prosecutor in the Philadelphia U.S. Attorney’s Office, volunteered to serve in Iraq from 2004 to 2005 as deputy chief of the team of U.S. prosecutors and investigators, and served as the director of the New Jersey Division of Criminal Justice.
Greg is a trustee at the Moorestown Friends School, a Quaker-based institution. He also serves on the finance committee of the Forman S. Acton Educational Foundation, which advances educational opportunities for students in Salem, New Jersey.
Previously, Greg served as a federal prosecutor in the Philadelphia U.S. Attorney’s Office, volunteered to serve in Iraq from 2004 to 2005 as deputy chief of the team of U.S. prosecutors and investigators, and served as the director of the New Jersey Division of Criminal Justice.
Greg is a trustee at the Moorestown Friends School, a Quaker-based institution. He also serves on the finance committee of the Forman S. Acton Educational Foundation, which advances educational opportunities for students in Salem, New Jersey.
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
Nancy Travis is Vice President for International Compliance and Governance for the Advanced Medical Technology Association (AdvaMed). Travis is responsible for the Association’s efforts to advance the highest ethical standards for business interactions in the medical technology sector worldwide.
Travis has more than 20 years of international affairs and economics experience, with a particular focus on Asia-Pacific trade issues. She worked on China and Taiwan’s World Trade Organization accession negotiations, Korea Free Trade Agreement discussions and has been involved in assessing compliance with WTO and FTA commitments. Throughout her career, she has received a number of exceptional performance and superior honor awards.
Travis has more than 20 years of international affairs and economics experience, with a particular focus on Asia-Pacific trade issues. She worked on China and Taiwan’s World Trade Organization accession negotiations, Korea Free Trade Agreement discussions and has been involved in assessing compliance with WTO and FTA commitments. Throughout her career, she has received a number of exceptional performance and superior honor awards.
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)
Background:
Angela Rodin is a principal in KPMG’s Washington, DC Risk Advisory Forensic Practice. Prior to joining KPMG in April 2017, Angela served a top 10 pharmaceutical company for 17 years in a number of leadership roles including VP, Compliance Officer for global support functions, VP, Head of Global Investigations & Business Monitoring, and Head of Global Internal Audit. In industry, Angela had responsibility for integrating and leading a global audit team, developing and maintaining comprehensive ethics and compliance programs, and providing assurance to the Board and Audit Committee on key risks, auditing & monitoring outcomes, and internal investigations. In her most recent industry role, she oversaw sensitive and privileged investigations, and optimized risk based, objective and proportionate monitoring of key business activities that give rise to bribery and corruption, and commercial practices risk.
Professional and industry experience:
Angela brings experience and provides services with compliance, audit and investigations. Career highlights include:
Angela Rodin is a principal in KPMG’s Washington, DC Risk Advisory Forensic Practice. Prior to joining KPMG in April 2017, Angela served a top 10 pharmaceutical company for 17 years in a number of leadership roles including VP, Compliance Officer for global support functions, VP, Head of Global Investigations & Business Monitoring, and Head of Global Internal Audit. In industry, Angela had responsibility for integrating and leading a global audit team, developing and maintaining comprehensive ethics and compliance programs, and providing assurance to the Board and Audit Committee on key risks, auditing & monitoring outcomes, and internal investigations. In her most recent industry role, she oversaw sensitive and privileged investigations, and optimized risk based, objective and proportionate monitoring of key business activities that give rise to bribery and corruption, and commercial practices risk.
Professional and industry experience:
Angela brings experience and provides services with compliance, audit and investigations. Career highlights include:
- Leading pre and post-acquisition due diligence reviews and investigations across multiple jurisdictions
- Transforming the commercial, operational, financial and IT global audit groups into an integrated, outcomes-driven, client-focused team, providing strategic assurance to executive management.
- Developing and implementing the strategy and vision for an integrated investigations and independent business monitoring unit to reduce risk and strengthen business practices of a $31.9bn organization of 101,000+ people in 150+ countries.
- Reducing global monitoring costs by 46% and increasing assurance through a rigorous focus on key risks, business activities and a restructure of a supporting 3rd party co-source arrangement.
- Successfully negotiating with the Office of the Inspector General (OIG) to replace a Corporate Integrity Agreement Independent Review Organization with risk-based internal monitoring, enabling $2.4m savings.
- Creating and implementing the compliance program for a $1.7bn global business unit, successfully integrating risk management and compliance at the heart of the business strategy and service model.
- Closely coordinating with the legal department, outside counsel and executive leadership on negotiations with the U.S. Department of Justice, Securities and Exchange Commission, OIG and the U.K. Serious Fraud Office.
- Initiating a global Information Protection program, in recognition of the emerging information security risk, and accelerating the creation of the Chief Information Security and Privacy Office.
- Industry focus includes Pharma, Medical Devices, Automotive and Financial Services.
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
Mr. Keith Burn worked for 30 years with the Metropolitan Police in London as a detective, part of Scotland Yards Serious & Economic Crime Command, investigating murder and fraud before joining the International Unit dealing with extradition and obtaining evidence for foreign jurisdictions. On retiring, he worked in the private sector as an investigator before starting a company conducting investigations for UK law firms. He also worked as an investigator for The Parliamentary and Health Service Ombudsman investigating complaints against politicians and the Health Service. During this time, he conducted an investigation into the death of a 3yr old child from Sepsis resulting in a report “Learning from Mistakes” that formed the basis for a Parliamentary sub-committee looking into how the NHS could improve its investigations and learn from mistakes. He is currently employed by Ipsen as the Global Director of Investigations where he introduced and oversees the whistleblowing policy & platform and investigations policy and procedures.
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
Gary Giampetruzzi is a partner in the Investigations and White-Collar practice in the Litigation Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, the Foreign Corrupt Practices Act (“FCPA”), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world’s most prominent biotech, pharmaceutical, and medical device companies.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Betania Glorio, LLM
Global Compliance Officer, Healthcare, Merck KGaA, Darmstadt, Germany
Global Compliance Officer, Healthcare, Merck KGaA, Darmstadt, Germany
Betania Glorio is an experienced legal counsel focused for more than 10 years within legal and compliance positions across several territories within well-known pharmaceutical companies. She started her career within compliance as Regional Compliance Director for Latin America and Canada at Pfizer where she was responsible for the implementation of the first Anti-Corruption and Anti-Bribery procedure in said territory as well as to lead several investigations continuing with other territories such as Western Europe. She was also Senior Director Legal & Compliance EMEA at Raptor Pharmaceuticals. Betania is currently the Global Compliance Officer Healthcare at Merck KGaA.
Franziska Janorschke
Global Head, Business Practices Office, Novartis International AG, Basel Area, Switzerland
Global Head, Business Practices Office, Novartis International AG, Basel Area, Switzerland
Franzi Janorschke manages the Novartis whistleblower function and oversees the internal investigation process. She is a German qualified lawyer who worked in private practice before joining Novartis. At Novartis she has experience in Pharma and Corporate HR, joined the Novartis Business Practices Office in 2010 as Region Head for Europe and Russia and took the global lead for the Whistleblower Program in 2013.
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)
Casey Horton has over twenty years of experience leading numerous risk, compliance and operational improvement projects, both in the US and across the globe. Casey brings Navigant clients a unique perspective and understanding of the regulatory and operational challenges facing life sciences companies. His practice focuses on performing compliance assessments and investigations, reviewing and optimizing organizational processes and implementing effective and sustainable compliance solutions. A practice leader in Navigant’s Global Life Sciences Governance, Risk Management and Compliance practice, Casey brings deep experience and knowledge of compliance program development, Corporate Integrity Agreements (“CIAs”), compliance and enterprise risk assessment execution, global monitoring and investigations initiatives, anti-bribery / anti-corruption issues, third-party due diligence review programs, patient services and assistance program reviews and financial and economic damage calculations.
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
Oscar Rodriguez is the Senior Director, Innovation & Technology at BlackThorn Therapeutics, a clinical stage biopharmaceutical company that integrates multidisciplinary data science and technology teams to drive advances in neuroscience. He is responsible for the technology vision and implementation of BlackThorn’s PathFinder™ platform. He is also the Co-Chair of the Technology and Standards subcommittee within AAIH (Alliance for Artificial Intelligence in Healthcare).
Previously, he spent 25 years conceiving and executing technology strategies and solutions for a multitude of enterprise-wide initiatives across pharmaceutical, life sciences, healthcare, insurance, automotive, retail, financial services, high technology, telecom, and consumer goods industries including Accenture, Cloud Technology Partners, Google, Pfizer, and Cloud Sherpas.
Previously, he spent 25 years conceiving and executing technology strategies and solutions for a multitude of enterprise-wide initiatives across pharmaceutical, life sciences, healthcare, insurance, automotive, retail, financial services, high technology, telecom, and consumer goods industries including Accenture, Cloud Technology Partners, Google, Pfizer, and Cloud Sherpas.
Sarah Venable, JD, MS
Risk Analytics Manager, Independent Business Manager, GlaxoSmithKline, Raleigh, NC
Risk Analytics Manager, Independent Business Manager, GlaxoSmithKline, Raleigh, NC
Sarah Venable works as a Risk Analytics Manager for Independent Business Monitoring within GSK’s Global Ethics and Compliance organization. Prior to joining GSK in September 2018, Sarah worked as a Technical Consultant for SAS Institute, specializing in education policy analytics.
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
Pearl Hsieh is Senior Counsel of Smith & Nephew, a leading medical technology company. Throughout her legal career, Pearl has counseled on data privacy and security matters in complex transactions to support operational expansion, sales growth, mergers and acquisitions in life sciences and technology industries. The data privacy and security matters encompass corporate governance and oversight programs, and risk assessments in compliance, prevention, detection and response initiatives
Kimberly J. Gold, JD
Partner, ReedSmith, New York, NY (Moderator)
Partner, ReedSmith, New York, NY (Moderator)
Kim Gold is a partner at Reed Smith LLP. Her practice focuses on data privacy, cybersecurity, digital health, and transactional matters. She advises clients in the life sciences, health care, retail, and technology industries on privacy compliance, research and big data initiatives, complex transactions (including M&A, private equity, and technology transactions), government investigations, corporate governance, and cybersecurity incident planning and response. Kim has extensive experience advising health care, life sciences, digital health, media, and retail clients on regulatory, transactional, and privacy matters. She counsels companies on data privacy and security issues relevant to digital transformation and innovation, advertising and marketing, mobile apps, health information technology, data sharing and analytics, research collaborations, artificial intelligence, cloud services, connected devices, blockchain, and telemedicine.
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
As a Partner at Hogan Lovells LLP, Kelliann Payne focuses her practice on FDA law with emphasis on medical devices, including development, regulation, and advertising. Her science education and background in the medical device industry allow her to quickly understand emerging medical device technology and informs her current focus on related legal and business issues. Her experience includes the development, regulation, advertising, and litigation of medical devices.
Kelliann drafts premarket submissions for diagnostic and therapeutic medical devices, evaluates and formulates applicable regulatory strategies, and reviews the accuracy of marketing claims. She helps companies in their preclinical and clinical programs and leads due diligence reviews for investments and acquisitions.
Kelliann drafts premarket submissions for diagnostic and therapeutic medical devices, evaluates and formulates applicable regulatory strategies, and reviews the accuracy of marketing claims. She helps companies in their preclinical and clinical programs and leads due diligence reviews for investments and acquisitions.
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
Bernadette Broccolo counsels the full range of health industry stakeholders on the transactional and compliance dimensions of complex health industry innovation strategies, including big data collaborations for streamlining and accelerating biomedical research and precision medicine, strategic partnerships to develop and deploy artificial intelligence and other digital health and innovation solutions, and creation and implementation of and participation in innovation centers, funds and commercialization strategies. Her areas of concentration include digital health innovation compliance, privacy law, health information technology licensing and implementation, transactions, health information network formation, human subject research compliance, and conflict of interest program compliance programs.
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)
Jared Crafton is a Principal in Ernst & Young’s Forensic & Integrity Services practice where he leads the Forensic Technology practice in the Boston office as well as Forensic Data Analytics for the Life Sciences sector nationally. Jared has extensive experience handling the data, analytics, and electronic discovery needs for large scale litigation, investigations and compliance programs.
He was previously a Senior Associate with Deloitte Financial Advisory Services LLP.
He was previously a Senior Associate with Deloitte Financial Advisory Services LLP.
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)
Sujata Dayal is the Vice President Health Care Compliance & Privacy, Pharmaceuticals for Johnson & Johnson. She is responsible for overseeing health care compliance organization and program for the global pharmaceutical group. Previously, she was the Global Chief Compliance Officer and Corporate Vice President for Biomet, Inc. There she was responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption. She was also, Partner with Karmact, LLC, and Ethics and Compliance Officer for Abbott Laboratories. Ms. Dayal is experienced in setting up global compliance programs, including conducting risk-assessments, policy and procedure writing, training, monitoring and promotional review. Her areas of expertise include health care compliance, FCPA and regulatory law and her specialties include: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy
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)
Jeffrey Kawalek is a compliance professional with nearly twenty years of pharmaceutical experience with a focus on developing and implementing effective pharmaceutical compliance programs, mitigating risk, and advancing compliance with Company policy and Federal and state healthcare laws including: Food, Drug, and Cosmetic Act, Federal Anti-kickback Statute, False Claims Act, Federal Physician Payments Sunshine Act (‘Open Payments’), EFPIA, and Foreign Corrupt Practices Act.
Jeff is the Deputy, Chief Compliance Officer for Jazz Pharmaceuticals. Prior to this, he was Senior Director, Ethics & Compliance North America for Ipsen and Director, Compliance at Novo Nordisk.
Jeff is the Deputy, Chief Compliance Officer for Jazz Pharmaceuticals. Prior to this, he was Senior Director, Ethics & Compliance North America for Ipsen and Director, Compliance at Novo Nordisk.
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)
Jennifer McGee is Vice President and Chief Compliance Officer at Otsuka America Pharmaceutical, Inc, with responsibility for the comprehensive compliance program, including privacy and information security at both Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. She joined Otsuka in January 2011 as Senior Compliance Counsel, overseeing compliance with the Corporate Integrity Agreement, implementation of the company’s Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 ½ years as a litigation attorney in the White Collar Group at the Washington, D.C. office of Shook, Hardy & Bacon, focused on the representation of pharmaceutical and medical device manufacturers in government investigations. Jennifer also served on active duty in the US Army for more than 13 years, trying more than 70 felony cases, and recently retired from the Army Reserves.
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)
Donna White is the Vice President, Compliance, for Chiesi USA, Inc. During her long tenure in the pharmaceutical industry, Donna has worked in most functional areas, supporting multiple therapeutic classes in the hospital, retail, rare disease, specialty, brand and generic spaces. Currently, she, along with her team, oversees Corporate Compliance, Pricing, Government Programs, Aggregate Spend, PDMA, Fair Market Value, and Class of Trade, with other responsibilities throughout the organization. At Chiesi USA, Donna chairs the Compliance Committee and the Pricing Committee. She also serves on the Pharmaceutical Compliance Forum’s Leadership Team as a Member 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)
Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, leadership development, training, management, and sales. He has held his current position at Ferring since 2016. Prior to Ferring, Mr. Zimmerman operated a health care compliance and business operations consulting company. Until late 2015, he served as Senior Vice President and Chief Compliance Officer for two multi-billion dollar publicly traded companies: Actavis (now Allergan) and Forest Laboratories (acquired by Actavis). He held the position of Global Chief Compliance Officer for Forest starting in 2004.
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
John Bentivoglio is a partner at Skadden Arps in the life sciences enforcement and regulatory team in Washington, DC. Previously he served as Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.
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
Doug Lankler joined Pfizer in 1999 and currently serves as general counsel. Prior to being named general counsel, Doug was Pfizer’s chief compliance and risk officer, a role he assumed in 2006.
Prior to joining the company, Doug was with the United States Department of Justice as an Assistant U.S. Attorney in the Southern District of New York. Doug was a recipient of the United States Attorney General’s Distinguished Service Award. While in the U.S. Attorney’s Office, he prosecuted white collar fraud, corporate crimes, traditional organized crime and terrorism. In 1999, Doug was a recipient of the United States Attorney General’s Distinguished Service Award.
Before joining the Department of Justice, Doug worked in the Litigation Department of Simpson Thacher & Bartlett in New York.
Prior to joining the company, Doug was with the United States Department of Justice as an Assistant U.S. Attorney in the Southern District of New York. Doug was a recipient of the United States Attorney General’s Distinguished Service Award. While in the U.S. Attorney’s Office, he prosecuted white collar fraud, corporate crimes, traditional organized crime and terrorism. In 1999, Doug was a recipient of the United States Attorney General’s Distinguished Service Award.
Before joining the Department of Justice, Doug worked in the Litigation Department of Simpson Thacher & Bartlett in New York.
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
Dan Levinson was Inspector General of the Department of Health & Human Services from 2004 until May, 2019. As IG, he supervised over 1,500 professionals charged with audit, investigation, and program evaluation oversight of the Department’s health care, research, and social service agencies, with annual Federal expenditures recently exceeding 1.2 trillion dollars. Major areas of OIG activity during Levinson’s tenure focused on effective oversight of Part D, the development of joint law enforcement task forces to address major false claims schemes across the country, and efforts to apply sound risk management to new health care delivery models and big data utilization.
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
Lori Queisser joined Teva Pharmaceuticals in June of 2015 in the key role of Senior Vice President and Global Chief Compliance Officer. She reports directly to the CEO. In this role, Lori is responsible for leading the organization’s compliance efforts globally, and setting the strategy for the implementation of compliance programs across the business. She will also engage the organization in promoting a culture of compliance, based on our values and Code of Conduct. Lori brings significant, diverse, global experience in the Compliance and Pharmaceutical industry to the Teva team. She has held senior roles in Eli Lilly and Schering Plough before consulting in the field as both President/Owner of Queisser and Associates and as a Principal at KPMG. Most recently, she was employed at DePuy Synthes, a Johnson and Johnson Company, as their Healthcare Compliance Officer. Lori is a Past Chair of the Pharmaceutical Compliance Forum.
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
Arjun Rajaratnam has spent over 25 years in Corporate Compliance Programs. His positons have included: Global Chief Compliance and Ethics Officer, Chief Risk Officer and Executive Committee member for Smith & Nephew, a large medical device company and U.S. Pharma Compliance Officer for GlaxoSmithKline, a large pharmaceutical company.
Arjun has built from the ground-up both a Global and a US Corporate Compliance program including: Board and senior management oversight and reporting; Code of Conduct and related global policies and procedures, ethics communications and training; global and market risk assessments; compliance monitoring and auditing; health care professional and third party controls, and investigation processes.
He has managed and overseen resolution of more than a thousand internal investigations, and has negotiated terms and operated under three separate corporate integrity agreements and one deferred prosecution agreement with the U.S.government, where he successfully completed the external monitor phase in 18 months or half the possible duration.
Arjun has built from the ground-up both a Global and a US Corporate Compliance program including: Board and senior management oversight and reporting; Code of Conduct and related global policies and procedures, ethics communications and training; global and market risk assessments; compliance monitoring and auditing; health care professional and third party controls, and investigation processes.
He has managed and overseen resolution of more than a thousand internal investigations, and has negotiated terms and operated under three separate corporate integrity agreements and one deferred prosecution agreement with the U.S.government, where he successfully completed the external monitor phase in 18 months or half the possible duration.
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
Mr. Sheehan was appointed by New York Attorney General Eric Schneiderman in January 2014 as the new chief of the Charities Bureau, the division of the New York Attorney General’s office that supervises charitable organizations. The Charities Bureau is responsible for enforcement activities, trust regulation, oversight and public outreach for over 90,000 New York nonprofits whose employees make up the largest nonprofit sector in this country. Previously, Mr. Sheehan served as York’s first Chief Integrity Office of the Human Resources Administration (HRA), the nation’s largest social services agency with over 14,000 employees. Mr. Sheehan previously served as first New York State Medicaid Inspector General from 2007 through 2011, and pioneered the use of data analysis tools to identify improper claims in the nation’s most generous Medicaid program. He had been the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania (Philadelphia).
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
Susan Winkler recently established Winkler Law LLC, a small firm devoted to white collar criminal defense and to health care compliance, internal investigations, and assisting clients in responding to governmental criminal and civil False Claims Act investigations. Prior to that, she was at the U.S. Attorney’s Office for 25 years, including being devoted exclusively to prosecuting health care fraud, criminally and civilly, for 20 years. From 2005 to 2012, she was Chief of the Health Care Fraud Unit in Boston, where she led the Office to recoveries of over $10.8 billion, including several groundbreaking matters in the pharmaceutical, medical device, and biotech fields.
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)
Kris Curry is a compliance and regulatory professional with more than 25 years of life science experience. She has led both large and small organizations in the development of strategies to increase operational efficiencies and drive effectiveness. She is an International thought leader with extensive experience advising life science companies on market dynamics and regulations. Ms. Curry has extensive compliance experience including diverse areas such as promotional compliance, research and development, sales and marketing practices, including off-label, fraud and abuse, government pricing and relationships with third parties. Her areas of experience include strategic thinking, influencing and critical thinking, organization and talent development, large-scale project implementation, collaboration and teaming, and risk management.
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
Mary Riordan is a Senior Counsel in the Office Inspector General (OIG) for the U.S. Department of Health and Human Services. Mary specializes in cases and issues involving pharmaceutical and device manufacturers. She primarily handles cases brought under the federal False Claims Act involving alleged fraud against Medicare and Medicaid by drug and device manufacturers. She has represented the OIG in the negotiation of numerous settlements and Corporate Integrity Agreements (CIAs). Mary also monitors several CIAs with pharmaceutical manufacturers. In addition to her casework, she was a co-organizer of the OIG’s February 2012 Pharmaceutical Compliance Roundtable and a co-author of the OIG’s 2003 Compliance Program Guidance for Pharmaceutical Manufacturers.
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
Brian A. Benczkowski serves as the Assistant Attorney General for the Criminal Division, supervising over 600 attorneys who investigate and prosecute securities fraud, health care fraud, Foreign Corrupt Practices Act violations, public corruption, cybercrime, IP theft, money laundering, organized and transnational crime, child exploitation, and other crimes. Prior to his confirmation, Mr. Benczkowski was a partner at a large international law firm, where he focused on white-collar criminal defense and government and internal investigations. He also previously served in leadership positions at the Department, including as Chief of Staff for both the Attorney General and the Deputy Attorney General.
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
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. Mr. Abrams has held the positions of Acting Director, Acting Deputy Director, and Branch Chief in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical sales and marketing for Merck. Mr. Abrams received his B.S. degree in pharmacy from the School of Pharmacy, Rutgers University and his M.B.A.degree from Rutgers School of Business.
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
Susan Dentzer is one of the nation’s most respected health and health policy thought leaders and a frequent speaker and commentator on television and radio, including PBS and NPR, and an author of commentaries in Modern Healthcare, the New England Journal of Medicine and other publications. She is a Senior Policy Fellow at the Duke-Margolis Center for Health Policy, the Washington, DC-based arm of Duke that focuses on health system transformation, biopharmaceuticals policy, and other health policy issues. Dentzer previously served as editor-in-chief of the journal Health Affairs and on-air Health Correspondent for the PBS NewsHour. She is an elected member of the National Academy of Medicine.
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
Charlene Davis is Vice President and Chief Compliance Officer at Aerie Pharmaceuticals, Inc. where she oversees the world wide compliance and privacy functions for the company. Prior to Aerie, Charlene was Associate Vice President and Head of Healthcare Compliance North America at Sun Pharmaceutical Industries, Inc. where she developed and oversaw its Comprehensive Compliance Program and Medical, Legal, and Regulatory (MLR) Review Program.
Prior to Sun, Charlene was Senior Compliance Counsel for Otsuka America Pharmaceuticals, Inc. and its U.S. and Canadian affiliates. Prior to her in-house roles, Charlene practiced corporate defense litigation in Pennsylvania and New Jersey. She also interned for the Strike Force Division of the U.S. Attorney’s Office in the Eastern District of Pennsylvania.
She has served as an adjunct professor of law for Seton Hall Law School and currently serves on the Advisory Board for The Center for Compliance & Ethics at Temple University Beasley School of Law.
Prior to Sun, Charlene was Senior Compliance Counsel for Otsuka America Pharmaceuticals, Inc. and its U.S. and Canadian affiliates. Prior to her in-house roles, Charlene practiced corporate defense litigation in Pennsylvania and New Jersey. She also interned for the Strike Force Division of the U.S. Attorney’s Office in the Eastern District of Pennsylvania.
She has served as an adjunct professor of law for Seton Hall Law School and currently serves on the Advisory Board for The Center for Compliance & Ethics at Temple University Beasley School of Law.
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
Adam Dubow is the Chief Compliance and Ethics Officer at Bristol-Myers Squibb. He oversees the company’s Compliance and Ethics organization, including the Centers of Expertise for Communication, Education, Procedural Documents and the Ombudsman; Monitoring and Analytics; Investigations and the Integrity Line; and Third-Party Due Diligence. Adam is also a member of the Company’s Leadership Team and Law Department Senior Leadership Team. Before joining Bristol-Myers Squibb, Adam was a Partner at Sedgwick, Detert, Moran & Arnold, a products liability law firm. He has held multiple roles with Bristol-Myers Squibb including, counsel to the U.S., Pharmaceuticals Group’s Oncology, Virology and, subsequently, the Immunoscience divisions, lead counsel for Asia Pacific and Japan, lead counsel for Europe, Middle East and Africa, and a Global and Corporate Policy role before he was appointed counsel for the Intercontinental Region, and then as Head of Legal for the European Markets, Australia and Canada (EMAC) Region.
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
Keith Korenchuk is Vice President and Chief Compliance officer at Danaher Diagnostics and Beckman Coulter. Prior to this role, he was a Partner at Arnold & Porter, LLP. Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
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
Dominique Laymand is Executive Vice-President, Chief Ethics and Social Responsibility Officer at Ipsen. She leads the Ethics and Social Responsibility Department and Strategy, based on a Business Integrity vision. In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb. Ms. Laymand is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals. Dominique is an active member of various Pharmaceutical Industry Associations and committees, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.
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
Sunitha Ramamurthy serves as Head of Compliance and Privacy at Loxo Oncology, a wholly owned subsidiary of Eli Lilly. She has over twenty years of experience in legal and healthcare compliance. In her current role, she provides compliance support through the acquisition by Eli Lilly. Previously, at Boehringer Ingelheim Pharmaceuticals Inc., she oversaw the Office of E&C supporting compliance business partnering, CIA implementation, T&D, ABAC, and compliance operations. She also worked at Eisai Inc., and as a litigator.
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
Tom Schumacher is Medtronic’s Vice President and Global Chief Ethics & Compliance Officer. As a global leader in medical technology, services and solutions, Medtronic improves the lives and health of millions of people each year. We use our deep clinical, therapeutic and economic expertise to address the complex challenges faced by healthcare systems today. In this role, Tom works to ensure Medtronic devotes the necessary focus and resources to the company’s Mission, Business Conduct Standards and Code of Conduct. He also has global responsibility to ensure ethics and compliance programs are administered on behalf of the company.
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)
Paul Silver is Deloitte’s Life Sciences Principal, Regulatory and Compliance Life Sciences Leader. He has 30 years of experience in the pharmaceutical, medical device, and consumer products industry, specializing in regulatory and compliance needs for pharmaceutical, medical device, and consumer products companies. Paul regularly works with in-house legal counsel, corporate compliance officers, senior operations professionals and outside legal counsel that support these professionals. Paul has provided expert testimony on behalf of pharmaceutical companies in litigation matters involving sales and marketing practices.