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
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.
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
Monica Kwacinski, PharmD
Head of External Medical Affairs, Purdue Pharma LP, Stamford, CT
Head of External Medical Affairs, Purdue Pharma LP, Stamford, CT
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
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)
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
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
William Hrubes, MHA
Vice President, Chief Compliance Officer, ACell, Inc., Columbia, MD
Vice President, Chief Compliance Officer, ACell, Inc., Columbia, MD
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
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
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)
Cortnaye Swan
Senior Manager, Deloitte & Touche LLP, Kansas City, MO (Co-Moderator)
Senior Manager, Deloitte & Touche LLP, Kansas City, MO (Co-Moderator)
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)
Jeffrey M. Kawalek, MBA
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ (Co-chair)
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ (Co-chair)
Jennifer McGee, JD
Chief Compliance Officer, Otsuka Pharmaceuticals, Inc., Princeton, NJ (Co-chair)
Chief Compliance Officer, Otsuka Pharmaceuticals, Inc., Princeton, NJ (Co-chair)
Jennifer McGee is Vice President and Chief Compliance Officer at Otsuka America Pharmaceutical, 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
Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi, US, Bridgewater, NJ (Co-chair)
Associate Vice President, North America Ethics and Business Integrity, Sanofi, US, Bridgewater, NJ (Co-chair)
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
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
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)
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
Announcements of Major Consulting Changes
Andy Bender, MS, MBA
General Manager, QuintilesIMS, New York, NY
General Manager, QuintilesIMS, New York, NY
Andy Bemder is leading QuintilesIMS’ Global Compliance Center of Excellence, providing Global Compliance Technology Solutions for our Pharmaceutical and Medical Device clients. Our solutions include Consulting, Aggregate Spend, HCP/O management, Fair Market Value, Third Party Interactions, Data Management and Analytics, etc. Our products and services are global, efficient and scalable. Our team includes Delivery (Implementation and Support), Product Development, Management Consulting, Go-To-Market, in the US, Europe and Asia. Andy Lectures at INSEAD on Auditing and Monitoring and Risk Assessments.
Paul Silver
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte & Touche LLP, Atlanta, Georgia
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte & Touche LLP, Atlanta, Georgia
5:00 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
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
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)
6:00 pm
Adjournment and Networking Reception