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AGENDA: SPECIAL MORNING SESSION / PRECONFERENCE / DAY 1
MONDAY, NOVEMBER 6, 2017
7:00 am
Registration Opens
SPECIAL MORNING SESSION, INVITATION-ONLY: CHIEF COMPLIANCE OFFICER ROUNDTABLE
8:00 am
Networking Breakfast
8:45 am
Introductions, Moderated Discussion and Q&A
PCF Co-chairs
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 the law firm of Skadden Arps in the Health Care Enforcement and Regulatory Group in Washington, DC. Before entering private practice, John was an Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.
The Role and Place of Compliance within Life Sciences: The Imperative of Chief Ethics and Compliance Officer Independence
Kathleen Boozang, JD LLM
Dean and Professor of Law, Seton Hall Law School, Newark, NJ
Dean and Professor of Law, Seton Hall Law School, Newark, NJ
Kathleen Boozang has been Dean of Seton Hall Law since July 2015. Dean Boozang came to Seton Hall in 1990 as the founder of the Law School’s Center for Health & Pharmaceutical Law & Policy which has been ranked by US News as a top 20 program for two decades. Dean Boozang, together with others in this room, founded the Law School’s global compliance training program that this year was held in Buenos Aires for the first time, and will be in Warsaw for the first time in the Spring.
Tim Glynn, JD
Associate Dean of Graduate and Professional Education & Miriam T. Rooney Professor of Law, Seton Hall University, Newark, NJ
Associate Dean of Graduate and Professional Education & Miriam T. Rooney Professor of Law, Seton Hall University, Newark, NJ
11:15 am
Adjournment
PRECONFERENCE SYMPOSIA (Optional, Choose only one)
PRECONFERENCE I: ADVANCED MEDICAL AFFAIRS COMPLIANCE ISSUES
8:00 am
Welcome and Overview
- The Interfaces Between Medical Affairs and Commercial at the Strategic Level
- The Evolving Role of Medical Affairs in the Field
- Medical Affairs Personnel as Speakers — When is it Scientific Exchange and When is it Promotion?
- The Role of Medical Affairs with Payors: Health Economics and Outcomes Research (HEOR) and Real-World Evidence (RWE)
Sarah diFrancesca, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY
Sarah diFrancesca advises life sciences and healthcare companies on fraud and abuse, compliance and regulatory matters. Sarah represents companies in connection with federal and state government investigations, inquiries, settlements and voluntary disclosures. She has handled matters involving the DOJ, OIG, FBI, and state Medicaid Fraud Control Units. Sarah also advises on federal and state transparency laws; conducts internal compliance reviews and investigations; advises Boards of Directors, compliance committees and senior management on internal investigations and compliance-related matters; and counsels clients on federal and state healthcare fraud and abuse issues, compliance and regulatory parameters and industry guidance.
Amy Gregory, CCEP
Compliance Director, AstraZeneca, Gaithersburg, MD
Compliance Director, AstraZeneca, Gaithersburg, MD
Amy Gregory is the Director, Compliance US Oncology at AstraZeneca. She leads the US Oncology Leadership Team, Immuno0Oncology, Hematology and is involved in multiple product launches and diagnostics. During her time at Astra Zeneca she was also the Director, Corporate Compliance. Previously, Ms. Gregory was the Area Business Manager – Biologic/Vaccine for MedImmune and District Sales Manager for Pfizer. She is a Certified Compliance and Ethics Professional(CCEP), receiving her certification from the Society of Corporate Compliance and Ethics SCCE.
Monica Kwarcinski, PharmD
Head of External Medical Affairs, Purdue Pharma LP, Stamford, CT
Head of External Medical Affairs, Purdue Pharma LP, Stamford, CT
Monica Kwarcinski is the Head of External Medical Affairs at Purdue Pharma and is responsible for Medical Information, Medical Science Liaisons, Patient & Professional Relations, Clinical Communications, and External Medical Affairs Operations/Compliance. Monica previously led the Purdue Medical Services Department and held various positions with increasing responsibilities within Abbott Laboratories Medical Services Department. She received her PharmD from Creighton University in Omaha, NE followed by a Drug Information Residency at Glaxo and University of North Carolina, Chapel Hill. Monica has over 20 years of industry experience and frequently presents on topics related to Medical Communications compliance and department processes.
Mark Lange, JD
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Mark Lange is an Assistant General Counsel with Eli Lilly and Company in Indianapolis, Indiana. He has over 19 years of in-house experience providing global drug law counsel across clinical development, medical affairs, privacy, quality, business ethics and bioethics, pharmacovigilance and regulatory affairs. His current practice focus is global medical affairs. Prior to joining Lilly, he was in private practice with Warner, Norcross and Judd in Grand Rapids, Michigan.
Pamela Lonzer, MJ
US Medical Advisor, Shire; Former Associate Director, Global Medical Affairs Compliance, Baxalta; Former Assistant Director, Research and Development-Global Compliance, Astellas Pharma; Chicago, IL
US Medical Advisor, Shire; Former Associate Director, Global Medical Affairs Compliance, Baxalta; Former Assistant Director, Research and Development-Global Compliance, Astellas Pharma; Chicago, IL
Pamela Lonzer is a conscientious and forward-thinking healthcare professional with twenty years of clinical and pharmaceutical experience. She has held various leadership roles in Compliance supporting various global and domestic research & development (R&D), medical affairs and commercial clients.
Maureen Lloyd
Director, Pharmaceutical and Life Sciences, PwC; Former Executive Director, Medical – External Medical Communications, Pfizer Inc.; New York, NY (Moderator)
Director, Pharmaceutical and Life Sciences, PwC; Former Executive Director, Medical – External Medical Communications, Pfizer Inc.; New York, NY (Moderator)
Maureen Lloyd specializes in working with clients in the pharmaceutical, biotech and medical device industries, directing innovative strategies in Medical Affairs, External Medical Communications, R&D, Compliance, Governance and Risk. As a PwC Director, Maureen leverages her industry experiences, including her experience in and leadership of Publications, Independent Investigator Sponsored Research, Independent Medical Education, Healthcare Donations (including independent Patient Assistance Programs) and Expanded Access/Compassionate Use.
12:00 pm
Preconference Adjournment/Lunch on your Own
PRECONFERENCE II: THE BASICS OF MANAGED MARKETS
8:00 am
Welcome and Overview
- The Changing Landscape of Payor Communications
- View from the Marketplace: Rewarding Results: Moving Forward for Value-Based Contracting for Biopharmaceuticals
- Pre-Approval Information Exchange with Payors
Michelle Drozd, ScM
Deputy Vice President, Policy and Research, PhRMA, Washington, DC
Deputy Vice President, Policy and Research, PhRMA, Washington, DC
Michelle Drozd is a Deputy Vice President in the Policy and Research department at the Pharmaceutical Research and Manufacturers of America (PhRMA). Michelle focuses on addressing the barriers to value-based contracting, and policies related to the pharmaceutical supply chain. Prior to joining PhRMA, Michelle worked in quality improvement and business planning at Partners Healthcare, an integrated delivery system. She also worked at RTI International in implementing demonstration projects for the Centers for Medicare & Medicaid Services. Michelle holds a BA in economics and public policy from Duke University and a SM in health policy and management from Harvard School of Public Health.
David J. Farber, JD
Partner, Healthcare Lobbyist and Litigator, King & Spalding LLP, Washington, DC
Partner, Healthcare Lobbyist and Litigator, King & Spalding LLP, Washington, DC
David Farber is a partner in the FDA and Life Sciences practice at King & Spalding, resident in the firm’s Washington DC office, where he maintains a health care practice focused on government advocacy and regulatory counseling. A leading national expert on Medicare matters, David works on Capitol Hill, before FDA and CMS on coverage, reimbursement and pricing matters.
Greg Sherman, JD
Commercial Counsel, Gilead Sciences, Foster City, CA
Commercial Counsel, Gilead Sciences, Foster City, CA
Greg Sherman serves in Gilead’s Commercial Legal Department where he provides counsel on a wide variety of issues including trade and distribution, commercial contracting, patient access programs, government price reporting, government affairs, and investigations. Prior to joining Gilead, Greg was an associate at Sidley Austin LLP where he advised life science companies on healthcare fraud and abuse, reimbursement, and price reporting issues. Greg began his legal career at Hooper, Lundy & Bookman, PC where he advised institutional healthcare providers on compliance, Medicare and Medicaid reimbursement, licensing, and privacy issues.
Ann E. Beasley, JD
Director, Navigant Consulting; Former Senior Vice President, Chief Compliance Officer, Biogen; Boston, MA (Moderator)
Director, Navigant Consulting; Former Senior Vice President, Chief Compliance Officer, Biogen; Boston, MA (Moderator)
12:00 pm
Preconference Adjournment/Lunch on your Own
PRECONFERENCE III: MEDICAL DEVICE COMPLIANCE BEST PRACTICE UPDATE
10:00 am
Welcome and Overview
- Compliance issues as it pertains to AdvaMed Code, the AdvaMed China Code, and MedTech
- Interactions with healthcare professionals (e.g., HCP arrangements, royalties, FMV)
- Compliance Policies and Procedures and associated training
- Interactions with regulatory enforcement agencies (e.g., OIG under a DPA/CIA)
Jonathan Glazier, JD, MBA
Senior Legal Counsel, US Compliance Lead, Philips Electronics North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America; Andover, MA
Senior Legal Counsel, US Compliance Lead, Philips Electronics North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America; Andover, MA
Jonathan Glazier is Senior Legal Counsel, U.S. Compliance Lead at Philips North America LLC in Andover, MA. In this role, Jonathan leads the legal compliance function at Philips focusing on healthcare compliance concerns and serves as the Company’s Ethics Officer. Previously, Jonathan was Senior Director of Corporate Compliance, Privacy and Information Security Officer at Fresenius Medical Care North America out of Waltham, MA. In that role and in his prior roles at the German headquartered dialysis and infusion products and services company, Jonathan developed significant legal compliance experience on health care and non-health care related matters.
William Hrubes, MHA
Vice President, Chief Compliance Officer, ACell, Inc., Columbia, MD
Vice President, Chief Compliance Officer, ACell, Inc., Columbia, MD
Bill Hrubes has served as Vice President and Chief Compliance Officer at ACell since 2015, after serving as Senior Director of Compliance and Risk Management since 2014. He has more than 15 years of experience in the development, implementation, and management of compliance and ethics programs in the life sciences industry. Mr. Hrubes previously served as the Compliance Officer for the Joint Reconstruction business of Johnson & Johnson. He has held other leadership roles in compliance and risk management at companies including Smith & Nephew, Novation, Gambro, and Fresenius Medical Care North America.
Andrew R. Van Haute, JD
Associate, Sidley Austin LLP; Former Associate General Counsel, AdvaMed; Washington, DC
Associate, Sidley Austin LLP; Former Associate General Counsel, AdvaMed; Washington, DC
Andy Van Haute is an associate Sidley’s Washington, D.C. office who counsels life sciences companies on a wide range of FDA and healthcare regulatory issues. As part of Sidley’s Healthcare group, Andy advises pharmaceutical and medical device manufacturers on compliance with the Federal Anti-Kickback Statute and other fraud and abuse laws, healthcare compliance programs, federal healthcare program reimbursement and Sunshine Act compliance. And as a member of Sidley’s Food, Drug, and Medical Device Regulatory group, Andy provides advice to FDA-regulated companies on clinical trials, product approvals and clearances, advertising and promotional claims and adverse event reporting obligations.
Matt Wetzel, JD
Vice President and Assistant General Counsel, Advanced Medical Technology Association (AdvaMed); Former Senior Counsel, Global Compliance and Ethics, Boston Scientific; Washington, DC
Vice President and Assistant General Counsel, Advanced Medical Technology Association (AdvaMed); Former Senior Counsel, Global Compliance and Ethics, Boston Scientific; Washington, DC
Matt Wetzel is Vice President & Assistant General Counsel of AdvaMed, the world’s largest medical device trade association, where he focuses on legal issues related to health care fraud and abuse, anti-bribery/anticorruption, and transparency, both in the United States and around the world. In addition to leading industry working groups on key legal issues and advocating before government bodies on behalf of the medical technology industry, Matt also spearheads the Association’s tort reform efforts and amicus curiae program. Prior to joining AdvaMed in 2015, Matt served as Senior Counsel at Boston Scientific Corporation, where he oversaw several critical elements of the company’s Global Compliance Program and served as the company’s lead lawyer on fraud and abuse and anti-corruption issues. Previously, he practiced law with Latham & Watkins LLP and Reed Smith LLP in Washington, D.C.
Becky Osowski, MJ
Senior Manager, Fraud Investigation and Dispute Services Practice, EY; Former US Healthcare Compliance Officer and Deputy Compliance Officer, Zimmer; Chicago, IL (Moderator)
Senior Manager, Fraud Investigation and Dispute Services Practice, EY; Former US Healthcare Compliance Officer and Deputy Compliance Officer, Zimmer; Chicago, IL (Moderator)
Becky Osowski is a Senior Manager in EY’s Health/Life Sciences FIDS practice. Becky is a Certified Internal Auditor and Certified Compliance & Ethics Professional with more than 15 years of experience working with clients in matters pertaining to compliance. Becky works with providers, pharmaceutical and medical device clients to assist with the development, implementation, assessment and enhancement of compliance programs and related processes. Prior to joining EY, Becky worked with a large international law firm as the Director of Healthcare Compliance. Prior to that, Becky served as the US Healthcare Compliance Officer for a large international medical device manufacturer.
12:00 pm
Preconference Adjournment/Lunch on your Own
PRECONFERENCE IV: GOVERNMENT PRICING COMPLIANCE AFTER AN ACQUISITION
10:00 am
Welcome and Overview
- Considerations for the Compliance Officer related to Government Programs when assessing the value of a target – What are the right questions to ask during the pre-close evaluation phase?
- Consolidating and aligning disparate Government Pricing programs and methodologies after an acquisition – Which areas of the integration can be the most challenging and why?
Megan Falkowski
Director, Government Pricing & Government Contracting Policy, Pfizer Inc., New York, NY
Director, Government Pricing & Government Contracting Policy, Pfizer Inc., New York, NY
Megan Falkowski is the Director of Government Pricing & Contracting Policy at Pfizer, primarily responsible for ensuring corporate compliance with CMS, VA and 340B drug pricing programs. Before joining Pfizer, she was a Project Manager for PwC’s Health Industries Advisory practice and developed compliance programs for pharmaceutical manufacturers during the implementation of government pricing systems. Megan had previously worked for Envision Consulting Group and IMS Health as an Engagement Manager and Principal, driving client projects for large and mid-tier pharmaceutical manufacturers in the Government Pricing, Contracting and Reporting Compliance space.
Kristin M. Hicks, JD
Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC
Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC
Kristin Hicks is a Partner in Arnold & Porter Kaye Scholer’s life sciences and healthcare regulatory practice group. Kristin’s practice focuses on counseling and litigation for clients in the pharmaceutical industry. Her work includes advising clients regarding all aspects of government price reporting, including counseling on issues under the 340B program, Medicaid, Medicare, the Federal Supply Schedule program, and the TRICARE retail pharmacy program. She often assists clients in preparing drug price reporting policies and reasonable assumptions, and provides guidance on internal audits and price recalculation projects. She also focuses on fraud and abuse compliance, federal contracting requirements, and legislative and public policy issues. In addition, Kristin represents clients in litigation matters regarding government price reporting requirements.
John Knighton, JD
Vice President, Head of Global Compliance, Orexigen Therapeutic; Former Vice President, CCO, MicroPort Medical (Group) Co., Ltd.; San Diego, CA
Vice President, Head of Global Compliance, Orexigen Therapeutic; Former Vice President, CCO, MicroPort Medical (Group) Co., Ltd.; San Diego, CA
John Knighton has been working on complex Legal and Compliance matters in the Life Sciences industry for over 15 years. This includes developing and implementing comprehensive compliance programs and working through corporate mergers, divestitures, product launches, investigations, settlement actions, DPAs and CIAs. John has worked on the Life Sciences team at Ernst & Young, and has served in house at Solvay Pharmaceuticals, King Pharmaceuticals, Wright Medical Technology, MicroPort Orthopedics, and is currently Vice President and Head of Global Compliance at Orexigen Therapeutics.
Teresa Muckel
Associate Director, Government Price Reporting, Genentech, USA, South San Francisco, CA
Associate Director, Government Price Reporting, Genentech, USA, South San Francisco, CA
Teresa Muckel has been in the pharmaceutical industry for over 30 years, with a concentration in Government Price Reporting for the last 17 years. Teresa is currently an Associate Director at Genentech USA leading a highly effective, enthusiastic calculations team comprised of subject matter experts in all Government Pricing Calculations and Analytics. She has held wide variety of positions at several companies from small startups to worldwide corporations such as Syntex Laboratories, Sequues Pharmaceuticals, Stieffel Labs and Gilead Sciences. Teresa is passionate about accuracy, compliance, process improvements and is skilled at interpreting and implementing government regulations.
Ron Sandhu
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY (Co-Moderator)
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY (Co-Moderator)
Ron Sandhu is a Senior Manager in Deloitte & Touche LLP’s Life Sciences practice, specializing in Pricing, Contracting and Analytics. Ron brings deep experience in commercial pricing strategy, government pricing, gross-to-net, biosimilar product launches, analytics for customer segmentation and contract performance. Ron’s experience has included managing large, multi-faceted business and systems integrations, determining the optimal gross/net pricing strategy for biosimilar product launches, and establishing/managing U.S.-based operations for government contracting and pricing for manufacturers under outsourcing engagements.
Cortnaye Swan
Senior Manager, Deloitte & Touche LLP, Kansas City, MO (Co-Moderator)
Senior Manager, Deloitte & Touche LLP, Kansas City, MO (Co-Moderator)
Cortnaye Swan is a Senior Manager in Deloitte’s Risk and Financial Advisory practice. She has over 17 years of experience in health care, life sciences and regulatory consulting. Cortnaye specializes in providing commercial compliance services and solutions to the life sciences industry sector and has experience assisting clients with financial and compliance due diligence, investigations, self-disclosure strategies and negotiations with enforcement agencies. She has significant experience helping companies resolve commercial, strategic, and organizational challenges in alignment with industry leading practices and regulatory requirements related to pricing and contracting.
12:00 pm
Preconference Adjournment/Lunch on your Own
OPENING PLENARY SESSION
1:00 pm
Co-Chair Welcome and Introduction
Matthew D’Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair; PCF Chair)
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair; PCF Chair)
Matthew D’Ambrosio is Senior Vice President and Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc. Prior to joining Sunovion served as Vice President, US Legal Affairs and Chief Compliance Officer at Prostrakan, Inc. prior to their acquisition by Kyowa Hakko Kirin. He is formerly, Chief Compliance Officer at Reliant Pharmaceuticals, Inc. which was acquired by GSK in 2007 and he spent 11 years with Johnson & Johnson including six years heading compliance programs in each of J&J’s three core sectors: Pharmaceutical, Medical Device & Diagnostics and Consumer Products. He also served as adjunct faculty at Seton Hall Law in the Health Law & Policy Program.
Sujata Dayal, JD
Vice President, Health Care Compliance and Privacy, Global Chief Compliance Officer, Pharmaceuticals, Johnson & Johnson, Titusville, NJ (Co-chair)
Vice President, Health Care Compliance and Privacy, Global Chief Compliance Officer, Pharmaceuticals, Johnson & Johnson, Titusville, NJ (Co-chair)
Sujata Dayal is the Vice President Health Care Compliance and Privacy and the Global Chief Compliance Officer, Pharmaceuticals for a 3 billion dollar global medical device company. She is responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption, Attorney with general corporate transactional and FDA regulatory experience. 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 and privacy.
1:15 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.
2:00 pm
US DOJ Keynote: DOJ Evaluation of Corporate Compliance Program
Pablo Quiñones, JD
Chief, Strategy, Policy and Training Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Chief, Strategy, Policy and Training Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Colin M. Huntley, JD
Assistant Director, Civil Division, Fraud Section, U.S. Department of Justice, Washington, DC
Assistant Director, Civil Division, Fraud Section, U.S. Department of Justice, Washington, DC
Colin M. Huntley is an Assistant Director with the Fraud Section of the Commercial Litigation Branch in the U.S. Department of Justice Civil Division. Mr. Huntley has investigated, litigated, and resolved numerous False Claims Act matters involving allegations of fraud committed against a wide variety of government agencies and federal programs. He devotes a substantial portion of his practice to matters involving medical device and pharmaceutical manufacturers, institutional healthcare providers, and government contractors. During his tenure with the Department, Mr. Huntley has received numerous awards from the Department and federal agencies, including the Attorney General’s Award for Exceptional Service.
Gejaa T. Gobena, JD
Partner, Hogan Lovells; Former Deputy Chief, Fraud Section, Criminal Division; Former Trial Attorney, Civil Division, Fraud Section, US Department of Justice; Washington, DC (Moderator)
Partner, Hogan Lovells; Former Deputy Chief, Fraud Section, Criminal Division; Former Trial Attorney, Civil Division, Fraud Section, US Department of Justice; Washington, DC (Moderator)
Gejaa Gobena uses his almost two decades of experience as both a former senior prosecutor and private attorney to help companies and individuals thoughtfully navigate high-stakes investigations and government enforcement actions, particularly in the area of healthcare fraud. Prior to joining Hogan Lovells, Gejaa served as Deputy Chief of the Fraud Section in the Criminal Division of the United States Department of Justice. As Deputy Chief, he led the Criminal Division’s 50-attorney healthcare fraud unit, supervising prosecutions brought by Medicare Fraud Strike Force teams across the country and spearheading the unit’s recent shift to investigating and prosecuting broader corporate healthcare fraud schemes. Prior to joining the Criminal Division, Gejaa spent six years in the Civil Division, investigating and prosecuting False Claims Act and qui tam matters that resulted in hundreds of millions of dollars in judgments and settlements.
2:45 pm
FCPA Enforcement Keynote: DOJ, SEC and FBI Update
Charles Cain, Esq.
Deputy Chief, FCPA Unit, US Securities and Exchange Commission, Washington, DC
Deputy Chief, FCPA Unit, US Securities and Exchange Commission, Washington, DC
Charles Cain is the Deputy Chief of the Foreign Corrupt Practices Act Unit within the Securities and Exchange Commission’s Division of Enforcement. He has been in the SEC’s FCPA Unit since its formation and with the Division of Enforcement for seventeen years. As the Deputy Chief, his roles include oversight of the National FPCA program, coordination with the DOJ and FBI, and supervision of individual investigations. During his tenure with the SEC, he has been responsible for numerous significant FCPA matters, as well as cases across a broad range of other areas including financial fraud, insider trading, offering fraud, market manipulation, disclosure fraud, and broker dealer practices.
Tarek Helou, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Tarek Helou is an Assistant Chief in the U.S. Department of Justice’s FCPA Unit. As an Assistant Chief, Tarek supervises attorneys who work with law enforcement agents to prosecute and investigate violations of the FCPA and related laws. He was an Assistant U.S. Attorney in San Francisco from 2007 to 2012, where he prosecuted cases involving drug trafficking, firearms offenses, racketeering, money laundering, tax violations, child exploitation, fraud, and immigration offenses. From 2001 to 2007, Tarek was an associate at Orrick in Silicon Valley and San Francisco. He graduated from Johns Hopkins University and New York University School of Law.
Darryl Wegner, JD
Unit Chief, International Corruption Unit, FBI, Washington, DC
Unit Chief, International Corruption Unit, FBI, Washington, DC
Darryl Wegner leads the Federal Bureau of Investigation’s International Corruption Unit which program manages the FBI’s investigations involving the Foreign Corrupt Practices Act, Kleptocracy, Antitrust, corruption of US public officials and US government fraud occurring outside the US. In addition to international corruption matters, Mr. Wegner previously investigated financial crimes and international terrorism. Prior to the FBI, Mr. Wegner was a corporate attorney in New York with a focus on international business transactions and was also a mechanical engineer in in the automotive industry in Michigan.
Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY, USA (Moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY, USA (Moderator)
Gary F. Giampetruzzi is one of the most recognized anti-corruption/FCPA compliance and enforcement attorneys and thought leaders, and highly regarded by peers, life science industry insiders, and regulators for his strategic thinking and insight into compliance program, internal investigations and government enforcement issues. Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA and U.S. healthcare landscapes. He has been a leader in this growing area of practice for the past 15 years, having led the development of cutting edge compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, North Africa, Europe, the Middle East and Latin America). Mr. Giampetruzzi is a Partner at Paul Hastings in their Investigations and White Collar practice. Previously, he spent 13 years at Pfizer Inc. as its Vice President, Assistant General Counsel and Head of Government Investigations, and earlier on served as Pfizer’s Deputy Compliance Officer.
3:30 pm
Break
4:00 pm
AUSA Roundtable
Jacob T. Elberg, JD
Chief, Health Care and Government Fraud Unit, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ
Chief, Health Care and Government Fraud Unit, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ
Jake Elberg is Chief of the Health Care and Government Fraud Unit at the U.S. Attorney’s Office for the District of New Jersey. In that role, Mr. Elberg supervises 15 AUSAs and directs all of the Office’s criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, violations of the Federal Food, Drug & Cosmetic Act, and the improper diversion of prescription drugs, as well as all health care-related actions brought by the Office under the False Claims Act. In addition, Mr. Elberg supervises and directs investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs.
Jason Mehta, JD
Assistant US Attorney, United States Attorney’s Office Middle District of Florida, US Department of Justice, Jacksonville, FL
Assistant US Attorney, United States Attorney’s Office Middle District of Florida, US Department of Justice, Jacksonville, FL
Jason Mehta is an Assistant United States Attorney in the Middle District of Florida. Jason has prosecuted civil and criminal white-collar healthcare fraud cases. Jason has recovered nearly $200 million and his cases have appeared in publications such as the Wall Street Journal and the New York Times. Jason was recognized as the Fraud Fighter of the Year for 2015 by the State of Florida. He is the 2017 recipient of the Department of Justice’s Director Award.
Gregg Shapiro, JD
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA
Gregg Shapiro has been an Assistant United States Attorney in the District of Massachusetts since 2005 and is currently Chief of the Affirmative Civil Enforcement Unit. His work primarily involves health care fraud, including kickbacks and price reporting violations. Recently, he was lead counsel for the government in the $465 million settlement with Mylan involving the Medicaid Drug Rebate classification of EpiPen, and in the $785 million settlement with Wyeth involving false Medicaid best price reports. Prior to joining the United States Attorney’s Office, Gregg worked in private practice and in the Consumer Protection Bureau of the Federal Trade Commission.
John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice; Washington, DC (Moderator)
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice; Washington, DC (Moderator)
John Bentivoglio is a partner at the law firm of Skadden Arps in the Health Care Enforcement and Regulatory Group in Washington, DC. Before entering private practice, John was an Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.
4:45 pm
Chief Compliance Officer Roundtable
Jill Dailey, MBA, JD
Vice President and Chief Compliance Officer, Incyte; Former Assistant General Counsel and Asia Pacific Compliance Lead, Pfizer; Former Head, US Ethics and Compliance, Novartis; New York, NY
Vice President and Chief Compliance Officer, Incyte; Former Assistant General Counsel and Asia Pacific Compliance Lead, Pfizer; Former Head, US Ethics and Compliance, Novartis; New York, NY
Jill Dailey began her career in the pharmaceutical industry in 1999, and has held both Legal and Compliance roles in large and mid-sized companies. In February 2017, Jill joined Incyte Corporation as the Chief Compliance Officer after having spent 6 years at Pfizer, most recently as the Asia Pacific Regional Compliance Lead. She previously acted as the Head of US Compliance for Novartis Oncology and, in prior Legal roles, supported various internal clients including Marketing, Business Development, Clinical Operations and Manufacturing.
Sujata T. Dayal, JD
Vice President, Health Care Compliance & Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ
Vice President, Health Care Compliance & Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ
Sujata Dayal is the Vice President Health Care Compliance and Privacy and the Global Chief Compliance Officer, Pharmaceuticals for a 3 billion dollar global medical device company. She is responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption, Attorney with general corporate transactional and FDA regulatory experience. 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 and privacy.
Margaret K. Feltz, MA, JD
Vice President, Chief Compliance Officer, Ethics and Compliance, Purdue Pharma LP; Former Member, PCF Executive Committee; Stamford, CT
Vice President, Chief Compliance Officer, Ethics and Compliance, Purdue Pharma LP; Former Member, PCF Executive Committee; Stamford, CT
Maggie Feltz is responsible for managing the ethics and compliance program for Purdue Pharma L.P., a privately held pharmaceutical company founded by physicians more than 60 years ago. Purdue Pharma is a member company of a global network of independent associated companies which are engaged in the research, development, production, and marketing of prescription and over-the-counter medicines and healthcare products. Maggie has extensive experience in all facets of ethics and compliance, and in her role at Purdue has responsibility for leadership and strategic direction of Purdue’s comprehensive ethics and compliance program. She has led multi-disciplinary teams and accomplished successful implementation of a corporate integrity agreement, including frequent engagement with Purdue’s federal government monitor. Prior to joining Purdue, Maggie served as Compliance Counsel at Boehringer Ingelheim Pharmaceuticals, Inc. and practiced health care law at McDermott, Will & Emery.
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
Mr. Rajaratnam is Chief Compliance Officer and a member of the Executive Committee for Smith & Nephew. Among other things, Mr. Rajaratnam is responsible for the management of corporate ethics and compliance program including: regular reporting to Board and senior management; developing and implementing Code of Conduct and related policies and procedures. Mr.Rajaratnam was a founder and one of the first Co-Chairs of the Pharmaceutical Compliance Forum, the leading organization for pharmaceutical compliance officers. Previously, Mr. Rajaratnam was Director for Environmental Services for an engineering firm and lead the risk assessment and remediation of several major hazardous waste disposal facilities in Southern California. He serves as Adjunct Associate professor at the University of North Carolina at Chapel Hill, where he has given lectures on business ethics and compliance programs, and as a former member of the Board of Directors of the Friends of the Nasher Museum of Art at Duke University, and the Southern Documentary Fund.
Paul Silver
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte & Touche LLP, Atlanta, Georgia (Moderator)
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte & Touche LLP, Atlanta, Georgia (Moderator)
Paul is the Deloitte Advisory Life Sciences Regulatory and Compliance Leader. He has 30 years of experience in the pharmaceutical, medical device, and consumer products industry specializing in compliance and regulatory matters. Paul regularly works with in-house legal counsel, corporate compliance officers, senior operations professionals, and outside legal counsel that support these professionals. Paul provides industry insight on various government healthcare investigations related to the sales and marketing of drugs and devices and has provided expert testimony on behalf of pharmaceutical companies in litigation matters involving sales and marketing practices. Previously, Paul was a founder and Practice Leader for a publicly traded consulting firm’s Life Sciences practice and Director and a member of the leadership team of a “big four” accounting firm’s national Fraud Investigation & Dispute Services practice. Paul was also a leader of the firm’s Pharmaceutical and Medical Device regulatory compliance services team and was a member of the firm’s Global Pharmaceutical Industry leadership team.
6:00 pm
Adjournment and Networking Reception
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