A HYBRID CONFERENCE AND INTERNET EVENT 18th Annual
A HYBRID CONFERENCE AND INTERNET EVENT18th AnnualPharmaceuticaland Medical DeviceCompliance Congresswww.PharmaCongress.comMANDARIN ORIENTAL WASHINGTON, DCNOVEMBER 6 - 8, 2017For Early Bird RegistrationDiscount Register byFriday, September 22!CO CHAIRS:Matthew D’Ambrosio, JD,MBA, Senior Vice President,Chief Compliance and EthicsOfficer, Sunovion Pharmaceuticals Inc.; Chair, PharmaceuticalCompliance ForumSujata T. Dayal, JD,Vice President, Health CareCompliance and Privacy,Pharmaceuticals Group,Johnson & JohnsonJeffrey Kawalek, MBA,Senior Director, Ethics &Compliance, North America,Ipsen Biopharmaceuticals, Inc.PLATINUM GRANTOR:SILVER GRANTORS:MEDIAPARTNERS:Thomas W. Abrams, RPh, MBA,Director, Office of Prescription DrugPromotion, FDAJennifer McGee, JD,Vice President and ChiefCompliance Officer, OtsukaAmerica Pharmaceutical, Inc.Charles Cain, Esq., DeputyChief, FCPA Unit, US SECMargaret Sparks, JD,Associate Vice President, NorthAmerica Ethics and BusinessIntegrity, Sanofi, USSusan Dentzer, Presidentand Chief Executive Officer,NEHI; Health Policy Analyst,The NewsHourFEATURING AN INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANKAND AN INVITATION-ONLY CHIEF COMPLIANCE OFFICER ROUNDTABLESPONSOR:KEYNOTE SPEAKERS:CONTINUING EDUCATION CREDITS:Accounting Professionals: Approved for up to18.5 NASBA CPE credits.Compliance Professionals: The Congress iscurrently pending approval to offer ComplianceCertification Board (CCB) Credits.Attorneys: The Congress is currently pendingapproval to offer Pennsylvania MCLE Credit.Jacob T. Elberg, JD, Chief,Health Care and GovernmentFraud Unit, United StatesAttorney’s Office, District ofNew Jersey, US DOJTarek Helou, Esq., AssistantChief, FCPA Unit, Fraud Section,Criminal Division, US DOJColin M. Huntley, JD,Assistant Director, Fraud Section,Civil Division, US DOJBRONZE GRANTORS:Jason Mehta, JD, Assistant USAttorney, United States Attorney’sOffice Middle District of Florida,US DOJPablo Quiñones, JD, Chief,Strategy, Policy and Training Unit,Fraud Section, Criminal Division,US DOJMary E. Riordan, Esq., SeniorCounsel, Office of Counsel to theInspector General, OIG, HHSGregg Shapiro, JD, AssistantUS Attorney, US Attorney’s Office,District of Massachusetts, US DOJJames Sheehan, JD, Chief,Charities Bureau, AttorneyGeneral of New YorkJim Stansel, JD, ExecutiveVice President & General Counsel,PhRMADarryl Wegner, JD,Unit Chief, InternationalCorruption Unit, FBI
18TH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESSOVERVIEWBSimply register, travel to theconference city and attend inperson.PROS: subject matter immersion;professional networkingOnsiteopportunities; faculty interaction.The Congress is the oldest and largest gathering of pharmaceutical and medical device compliance professionals and in-housecounsel who come together annually to discuss best practices in legal and regulatory compliance. It is a part of a global pharmacompliance congress series which has featured congresses in Berlin, Brussels, Budapest, Dubai, Istanbul, Paris, Rome, Warsawand Lisbon (the International Pharma Compliance Congress) Singapore, Shanghai, Kuala Lumpur and Manila (the Asia PacificPharma Compliance Congress); Sao Paolo and Mexico City (the Latin American Pharma Compliance Congress); and Washington,DC (the PCF Pharma Compliance Congress).LIVE AND ARCHIVEDINTERNET ATTENDANCEWe would like to thank the Congress sponsor, the Pharmaceutical Compliance Forum (PCF), the 2017 PCF co-chairs, planningcommittee, grantors and exhibitors and faculty for their direction and insight into timely updates to applicable statutes, regulations and program requirements impacting our industry.Watch the conference in livestreaming video over the Internetand at your convenience at anytime 24/7 for six months following the event.At your office . . .The archived conference includesspeaker videos and coordinatedPowerPoint presentations.PROS: Live digital feed and 24/7Internet access for the next sixmonths; accessible in the office,at home or anywhere worldwidewith Internet access; avoid travelexpense and hassle; no time away. . . or homefrom the office.This year’s Pharma Congress host esteemed keynote speakers including representatives of Office of Inspector General (OIG),Department of Justice (DOJ), Securities and Exchange Commission (SEC), Federal Bureau of Investigation (FBI), Food & DrugAdministration (FDA), Pharmaceutical Research and Manufacturers of America, PhRMA, Qui Tam Attorneys, and numerousGlobal Chief Compliance Officers.These stakeholders together with our expert panelists and you bring together the brightest minds to engage in meaningfuldiscussion, address timely compliance issues, and provide a rich opportunity for networking.AGENDA AT A GLANCEMONDAY, NOVEMBER 6, 2017Morning Invitation-only CCO RoundTableMorning Pre-conferences:Advanced Medical Affairs Compliance IssuesThe Basics of Managed MarketsMedical Device Best Practice Compliance UpdatesGovernment Programs for the Compliance OfficerTUESDAY, NOVEMBER 7, 2017Morning Plenary Session:FDA Compliance UpdateQui Tam RoundtableDemonstrating the Value of the Compliance OrganizationMorning Mini Summit Block A:Using Behavioral Economics to ImproveCompliance Messaging StickinessHCP Engagement: The Road to ProactiveRisk ManagementBest Practices for Patient Assistance andReimbursement SupportManaged Market Considerations for Huband Specialty Pharmacy ArrangementsCompliance and Ethics Considerations in R&DUsing Data Analytics to Tell the ComplianceEffectiveness StoryInternational Organization for Standardization (ISO) 37001Networking Luncheon/Luncheon Mini Summits:FDA Regulation and Cutting Edge TechnologyAdvancing Compliance: Pulling Critical Leversto Improve EffectivenessThe Evolution of Compliance Programs after Wells FargoInnovation and Compliance, They are notMutually ExclusiveAfternoon Opening Plenary Session:OIG Compliance UpdateDOJ Evaluation of Corporate Compliance ProgramsDOJ, SEC and FBI FCPA Enforcement UpdateAUSA RoundtableChief Compliance Officer RoundtableNetworking ReceptionAfternoon Mini Summit Block B:Third Party Risk Management/Due Diligence UpdateCompliance in the Transactional ContextManaging an Internal Investigation under CIA, DPAand Data Analytics FailureRecent FDA Guidance: Manufacturer Communicationsand Off-Label MemoSmall and Mid-Sized Pharma and Device CompaniesCompliance ConsiderationsAdvanced Issues in Global ComplianceEffective and Balanced Monitoring ProgramBased on RiskAfternoon Mini Summit Block C:Advanced Compliance Issues When Contractingwith Third PartiesThe Next Generation of Agg Spend SolutionsCyber Security for Pharma and Medical Device CompaniesPricing Considerations (Mylan Epipen, MarathonPharmaceuticals, et al)Optimizing Data Collection for Risk Assessments,Monitoring, and AuditingBalancing Risks in Patient and Product SupportAfternoon Closing Plenary Session:Role of Behavioral Economics in Ethics and CompliancePhRMA Priorities and Policy InitiativesOverview of the Policy and Politics of Pharma PricingRewarding Results: Value-Based Contracting forBiopharmaceuticalsWEDNESDAY, NOVEMBER 8, 2017: Morning Industry-only Compliance Best Practices Think Tank(Industry-only session for pharmaceutical company compliance professionals and in-house counsel only)2PARTICIPATION OPTIONSTRADITIONALONSITE ATTENDANCEe a part of the premiere compliance event for pharmaceutical and medical device professionals at the 18th Annual Compliance Congress. Join compliance professionals, regulators, lawyers and consultants to share ideas for ways to cultivate aculture of compliance with the highest integrity enabling better care and outcomes for patients. This forum is ideal forcompliance professionals new to developing a compliance program or experienced professionals continuing to evolve theirprograms to best suit their organization’s needs to address new challenges.WHO SHOULD ATTEND: Pharmaceutical and Health Care Executives and Board MembersCompliance ExecutivesHealth Plan, Health System and Physician OrganizationsMedical DirectorsPhysiciansPharmacists and Pharmacy TechniciansPurchasers, including Private Employers and Public PurchasersPharmaceutical ManufacturersGeneric Pharmaceutical ManufacturersSite Management OrganizationsClinical Research OrganizationsPharmacy Benefit Management CompaniesNursesHealth Plans and Health InsurersWholesale, Retail, Mail Order and Internet PharmaciesHealth Care Attorneys and In-house CounselCompliance OfficersPrivacy OfficersEthics OfficersFood and Drug Law AttorneysPharmaceutical ConsultantsInvestment BankersVenture CapitalistsHealth Care Regulators and Policy MakersHealth Services Researchers and AcademicsAuditors
ABOUT THE PHARMACEUTICAL COMPLIANCE FORUMABOUT THE PHARMACEUTICAL COMPLIANCE FORUMThe Pharmaceutical Compliance Forum (PCF) is a not-for-profitmembership coalition of compliance professionals and legalcounsel from 70 distinguished research-based pharmaceuticalmanufacturers and biotech companies.The PCF was founded in early 1999 by compliance professionals fromthe pharmaceutical industry to promote effective corporate complianceprograms. The members meet twice a year, for two days, focusing onopen and informal sharing of compliance information, best practices,and current developments in the field. PCF sponsors a three-dayCompliance Congress each Fall.Generally, representatives from the companies who attend the meetingsare compliance officers, compliance attorneys or other professionalswith responsibility for oversight or other aspects of their respectivecorporate compliance programs.MISSION STATEMENTThe purpose of the Pharmaceutical Compliance Forum is to discuss education and otherindustry practices regarding compliance with the ultimate aim of promoting effectivepharmaceutical corporate compliance and ethics programs in accordance with theFederal Organization Sentencing Guidelines and the OIG Compliance Guidance forPharmaceutical Manufacturers.JOIN PCFNon-member companies who are interested in joining PCF may contactDebra Scanlon, Administrator, Pharmaceutical Compliance Forum atinfo@pharmacomplianceforum.org.BENEFITS OF BECOMING A PCF COMPANY MEMBER Save 500 off your first year’s membership dues when becoming a member Unlimited number of employees can join- No additional fees! All included in yourannual corporate membership dues. All members have access to our exclusive Member Only website for networkingwith fellow members and viewing of past meeting materials, benchmarkingsurveys and other valuable resources! Exclusive invitation to the members only PCF Annual Spring and complimentaryFall Regional Meetings Monthly newsletter to stay informed on the latest news and meeting information. Save up to 500 with discounted registration fees for each employee to PCFsponsored Pharma Congress in Washington DC each year Save up to 500 with discounted registration fees for each employee to PCFsponsored International Pharmaceutical Regulatory and Compliance Congress andthe Asia Pacific Pharmaceutical and Medical Device Compliance Congress Complimentary compliance & legal job postings on the PCF website. A superiorrecruiting tool! Non-members companies pay 600 per posting. Special PCF Member discount on subscriptions to Life Science Compliance Update.For more information go to www.pharmacomplianceforum.org.2017 PCF PHARMA CONGRESS PLANNING COMMITTEECO CHAIRSMatthew D’Ambrosio, JD, MBA,Senior Vice President, Chief Complianceand Ethics Officer, SunovionSujata T. Dayal, JD, Vice President,Health Care Compliance & Privacy,Pharmaceuticals Group, Johnson & JohnsonJeffrey Kawalek, MBA, Senior Director,Ethics & Compliance, North America, IpsenJennifer McGee, JD, Vice Presidentand Chief Compliance Officer, OtsukaMargaret Sparks, JD, Associate VicePresident, North America Ethics and BusinessIntegrity, SanofiMike Joachim, JD, ComplianceBusiness Partner, Sanofi GenzymeJonathon L. Kellerman, ExecutiveVice President, Global Chief ComplianceOfficer, Allergan PLCShannon Kelley, Vice President,Head of North America Compliance, SanofiDaniel A. Kracov, JD, Partner andHead, FDA and Healthcare Practice,Arnold & Porter Kaye Scholer, LLPTerri Ledva, MS, Senior Manager,Iroko PharmaceuticalsChristine Longawa, MA, CPA, CFE,Associate Director, Navigant ConsultingTony Alvizu, FTI ConsultingMaureen McGirr, JD, Vice PresidentOffice of Ethics, Global ComplianceOrganization, MerckEric Baim, JD, Vice President,Head of Compliance US, ShireEd Nowicki, JD, Vice President andGeneral Counsel, Pfizer, Inc.Scott Bass, JD, Partner and Head,Global Life Sciences Team, Sidley Austin LLPNeil O’Flaherty, Partner, Baker McKenzieMEMBERSYogesh Bahl, CPA, MBA,Managing Director, Alix PartnersJohn Patrick Oroho, JD, Executive VicePresident, and Chief Strategy Officer, PorzioLife Sciences, LLCJohn T. Bentivoglio, JD,Partner, Skadden Arps LLPLori Queisser, Senior Vice President andGlobal Chief Compliance Officer, TevaThomas Beimers, JD,Partner, Hogan LovellsArjun Rajaratnam, JD, MS, ChiefCompliance Officer, Smith & NephewAndy Bender, MS, MBA,President and Founder, PolarisDavid Ralston, JD, MPH, SeniorDirector, Associate General Counsel,Business Conduct, Gilead SciencesKathleen M. Boozang, JD, LLM,Dean and Professor of Law, Seton HallUniversity School of LawMichael R. Clarke, JD, Vice President,Corporate Compliance, IndiviorKelly N. “Nikki” Reeves, MPA, JD,Partner, King & SpaldingKris Curry, MBA, Principal, EYMichael Shaw, JD, Vice President andCompliance Officer, US Pharmaceuticals,GlaxoSmithKlineMichael B. Dusseau, Vice President,Compliance Operations, Allergan PLCPaul Silver, Principal,Deloitte & Touche LLPMargaret K. Feltz, MA, JD, Vice President,Ethics and Compliance, Purdue Pharma LPCarlos Tessi, MD, PhD, Vice President,Compliance, ShionogiGary F. Giampetruzzi, JD, Partner andVice-Chair of Investigations, Paul HastingsDonna Wachman, National IndustryMarketing Leader, Grant Thornton LLPWendy C. Goldstein, JD, Partner,Health Care and Life Sciences RegulatoryPractice, Cooley, LLPJulie Wagner, JD,Assistant General Counsel, PhRMASteven Guymon, Senior Advisor, GlobalEthics and Compliance Capabilities, Eli LillySeth B. Whitelaw, JD, LLM, SJD,President and Chief Executive Officer,Whitelaw Compliance Group, LLCLaura G. Hoey, JD, Partner,Ropes & Gray LLPErinn Hutchinson, Partner,Advisory Services, PwC3
MONDAY, NOVEMBER 6, 20177:00 amRegistration OpensSPECIAL MORNING SESSION, INVITATION-ONLY:CHIEF COMPLIANCE OFFICER ROUNDTABLE8:00 amIntroductions, Moderated Discussion and Q&APCF Co-chairsAntitrust AdmonitionJohn T. Bentivoglio, JD, Partner, Skadden Arps LLP; Former Special Counsel forHealthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DCPRECONFERENCE SYMPOSIA (Optional, Choose only one)10:00 amWelcome and Overview The Importance of Corrective and Preventive Action (CAPA)for Medical Device Development Complaint Procedures (21 CFR 820.198) Medical Device Reporting Procedures ( 21 CFR 803.17.) Nonconforming Product ProceduresJonathan Glazier, JD, MBA, Senior Legal Counsel, Legal Compliance, Philips ElectronicsNorth America; Former Senior Director of Corporate Compliance and Privacy Officer, FreseniusMedical Care North America, Andover, MAPamela W. Guthrie, JD, Senior Counsel, Professional Affairs and Compliance, MicroPortOrthopedics, Arlington, TNWilliam Hrubes, JD (Invited), Vice President, Chief Compliance Officer, ACell, Inc.,Columbia, MDPRECONFERENCE I: ADVANCED MEDICAL AFFAIRSCOMPLIANCE ISSUESJessica R. Puathasnanon, JD (Invited), Senior Director and Global Chief ComplianceOfficer, Medtronic Diabetes Group, Medtronic Plc, Los Angeles, CA8:00 amAndrew R. Van Haute, JD, Associate, Sidley Austin LLP; Former Associate General Counsel,AdvaMed, Washington, DCWelcome and Overview The Interfaces Between Medical Affairs and Commercialat the Strategic Level The Evolving Role of Medical Affairs in the Field Medical Affairs Personnel as Speakers — When is it ScientificExchange and When is it Promotion? The Role of Medical Affairs with Payors: Health EconomicsOutcomes Research and Real World EvidenceBrian Conner, Vice President, Head of Corporate Compliance, Strongbridge BioPharma plc;Former Senior Director, Asst. Compliance Officer, Global Compliance, Shire; Former GeneralManager, Vice President, Regulatory and Quality Operations, Synageva; Former ComplianceOfficer of the Americas, Stiefel Laboratories, Feasterville Trevose, PASarah diFrancesca, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP,New York, NYMonica Kwacinski, PharmD, Head of External Medical Affairs, Purdue Pharma LP,Stamford, CTMark Lange, JD, Assistant General Counsel, Eli Lilly and Company, Indianapolis, INPamela Lonzer, MJ, US Medical Advisor, Shire; Former Associate Director, Global MedicalAffairs Compliance, Baxalta; Former Assistant Director, Research and Development-GlobalCompliance, Astellas Pharma, Chicago, ILDavid Ralston, JD, MPH, Senior Director, Associate General Counsel, Business Conduct,Gilead Sciences, Former Section Head, Abbott Laboratories, Former Senior Legal Director,Schering Plough, Foster City, CAMaureen Lloyd, Director, Pharmaceutical and Life Sciences, PwC; Former Executive Director,Medical - External Medical Communications, Pfizer Inc., New York, NY (Moderator)NoonPreconference Adjournment/Lunch on your OwnPRECONFERENCE II: THE BASICS OF MANAGED MARKETS8:00 amWelcome and Overview The Changing Landscape of Payor Communications View from the Marketplace: Rewarding Results: Moving Forwardfor Value-Based Contracting for Biopharmaceuticals Pre-Approval Information Exchange with PayorsMichelle Drozd, ScM (Invited), Deputy Vice President, Policy and Research, PhRMA,Washington, DCDavid J. Farber, JD, Partner, Healthcare Lobbyist and Litigator, King & Spalding LLP,Washington, DCGreg Sherman, JD, Commercial Counsel, Gilead Sciences, Foster City, CAAnn E. Beasley, JD, Director, Navigant Consulting; Former Senior Vice President, ChiefCompliance Officer, Biogen, Boston, MA (Moderator)Noon4PRECONFERENCE III: MEDICAL DEVICE COMPLIANCE BESTPRACTICE UPDATEPreconference Adjournment/Lunch on your OwnMatt Wetzel, JD, Vice President and Assistant General Counsel, Advanced MedicalTechnology Association (AdvaMed); Former Senior Counsel, Global Compliance and Ethics,Boston Scientific, Washington, DCBecky Osowski, MJ, Senior Manager, Fraud Investigation and Dispute Services Practice, EY;Former US Healthcare Compliance Officer and Deputy Compliance Officer, Zimmer, Chicago, IL(Moderator)NoonPreconference Adjournment/Lunch on your OwnPRECONFERENCE IV: GOVERNMENT PRICING COMPLIANCEAFTER AN ACQUISITION10:00 amWelcome and OverviewAnisa Dhalla (Invited), Head, Ethics and Compliance, Americas, UCB, Atlanta, GAJohn Knighton, JD, Vice President, Head of Global Compliance, Orexigen Therapeutic;Former Vice President, CCO, MicroPort Medical (Group) Co., Ltd., San Diego, CACortnaye Swan, Senior Manager, Deloitte & Touche LLP, Kansas City, MO (Moderator)NoonPreconference Adjournment/Lunch on your OwnHOTEL INFORMATION/RESERVATIONSThe Pharmaceutical and Medical Device Compliance Congress does notcontract with any third party organization to make hotel reservations forattendees of the Congress. All attendees should make their hotel reservations directly with the hotel and not with a third party vendor.The Mandarin Oriental, Washington DC is the official hotel for the EighteenthAnnual Pharmaceutical and Medical Device Compliance Congress. A special group rateof 315.00 Deluxe Room per night (plus tax) has been arranged for Congress Attendees. To make reservations at the group rate, go to www.PharmaCongress.comand click on the TRAVEL/HOTEL tab. Or, make reservations by calling The MandarinOriental directly at (202) 787 – 6140 or Toll Free (888) 888 – 1778 and request thePharma Congress Group Rate. Reservations at the group rate will be accepted whilerooms are available or until the cut-off date of Monday, October 9, 2017. After thisdate, reservations will be accepted on a space-available basis at the prevailing rate.Mandarin Oriental 1330 Maryland Avenue SW Washington, DC 20024
MONDAY, NOVEMBER 6, 20174:00 pmJacob T. Elberg, JD, Chief, Health Care and Government Fraud Unit,US Attorney’s Office, District of New Jersey, US Department of Justice,Newark, NJPHARMA CONGRESS: AGENDA DAY IOPENING PLENARY SESSION1:00 pmDOJ Evaluation of Corporate ComplianceProgram and Other UpdatesJason Mehta, JD, Assistant US Attorney, United States Attorney’s OfficeMiddle District of Florida, US Department of Justice, Jacksonville, FLMatthew D’Ambrosio, JD, MBA, Senior Vice President, Chief Complianceand Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA(Co-chair; PCF Chair)Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, Districtof Massachusetts, US Department of Justice, Boston, MAJohn T. Bentivoglio, Esq., Partner, Skadden Arps LLP; Former SpecialCounsel for Healthcare Fraud and Chief Privacy Officer, US Department ofJustice, Washington, DC (Moderator)Sujata Dayal, JD, Vice President, Health Care Compliance and Privacy,Global Chief Compliance Officer, Pharmaceuticals, Johnson & Johnson,Titusville, NJ (Co-chair)Jeffrey Kawalek, MBA, Senior Director, Ethics and Compliance, NorthAmerica, Ipsen Biopharmaceuticals, Inc., New York, NY (Co-chair)4:45 pmPaul Silver, Principal, Regulatory & Compliance Life Sciences Leader,Deloitte & Touche LLP, Atlanta, GeorgiaMargaret Sparks, JD, Associate Vice President, North America Ethicsand Business Integrity, Sanofi, US, Bridgewater, NJ (Co-chair)5:00 pmKeynote: OIG UpdateUS DOJ Keynote: DOJ Evaluation of CorporateCompliance ProgramMargaret K. Feltz, MA, JD, Vice President, Ethics & Compliance, PurduePharma LP; Former Member, PCF Executive Committee, Stamford, CTPablo Quiñones, JD, Chief, Strategy, Policy and Training Unit, FraudSection, Criminal Division, US Department of Justice, Washington, DCArjun Rajaratnam, JD, MS, Chief Compliance Officer, Smith & Nephew;Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; FormerMember, PCF Executive Committee, Raleigh, NCColin M. Huntley, JD, Senior Trial Counsel, Fraud Section, CommercialLitigation Branch, Civil Division, US Department of Justice, Washington, DCDavid Ralston, JD, MPH, Senior Director, Associate General Counsel,Business Conduct, Gilead Sciences; Former Section Head, Abbott Laboratories;Former Senior Legal Director, Schering Plough, Foster City, CAGejaa 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)2:45 pmChief Compliance Officer RoundtableJill 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, NYMary E. Riordan, JD, Senior Counsel, Office of Counsel to the InspectorGeneral, Office of Inspector General, Department of Health and HumanServices, Washington, DC2:00 pmAnnouncements of Major Consulting ChangesAndy Bender, MS, MBA, President and Founder, Polaris, New York, NYJennifer McGee, JD, Chief Compliance Officer, Otsuka Pharmaceuticals,Inc., Princeton, NJ (Co-chair)1:15 pmAUSA RoundtableFCPA Enforcement Keynote: DOJ, SEC andFBI UpdatePaul Silver, Principal, Regulatory & Compliance Life Sciences Leader,Deloitte & Touche LLP, Atlanta, Georgia (Moderator)6:00 pmADJOURNMENT AND NETWORKING RECEPTIONTarek Helou, JD, Assistant Chief, FCPA Unit, Fraud Section, CriminalDivision, US Department of Justice, Washington, DCCharles Cain, Esq., Deputy Chief, FCPA Unit, US Securities and ExchangeCommission, Washington, DCDarryl Wegner, JD, Unit Chief, International Corruption Unit, FBI,Washington, DCGary F. Giampetruzzi, JD, Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations,Pfizer Inc., New York, NY, USA (Moderator)3:30 pmBreak5
TUESDAY, NOVEMBER 7, 2017MINI SUMMITS BLOCK A 10:45 am – 11:45 amPHARMA CONGRESS: AGENDA DAY IIMini Summit I: Compliance Messaging: Using BehavioralEconomics to Improve Messaging Stickiness7:00 amBrian Miller, PhD (Invited), Director of Compliance and Ethics Training, Otsuka Pharmaceutical Companies, Senior Manager of Learning Technologies, AstraZeneca; Former AssociateDirector Learning Design & Technology, Merck, Philadelphia, PARegistration Opens: Continental Breakfastin Exhibit HallMORNING PLENARY SESSION8:00 amCo-chair Welcome and Introductions8:15 amFDA Keynote8:45 amMini Summit II: HCP Engagement: The Road to ProactiveRisk ManagementQui Tam RoundtableTom Glavin, JD, Chief Compliance Officer, Olympus; Former Vice President, US/AmericasCompliance Officer, Shire; Former US Corporate Compliance Officer, Sanofi-Aventis,Center Valley, PAMichael A. Morse, JD, Partner, Pietragallo, Gordon, Alfano, Bosick& Raspanti; Former Assistant District Attorney, Philadelphia DistrictAttorney’s Office, Philadelphia PADaniel A. Kracov, JD, Partner and Head, FDA and Healthcare Practice, Arnold & Porter KayeScholer LLP, Washington, DCRobert Patten, JD, President and Chief Executive Officer, TaxpayersAgainst Fraud and TAF Education Fund; Former Assistant Attorney Generaland Managing Attorney, Medicaid Fraud Division, The Commonwealth ofMassachusetts, Holliston, MAVirginia “Ginny” A. Gibson, JD, Partner, Hogan Lovells; FormerExecutive Assistant US Attorney, Eastern District of Pennsylvania,US Department of Justice, Philadelphia, PA (Co-Moderator)Kathleen Meriwether, Partner/Principal, EY; Former Assistant UnitedStates Attorney, Eastern District of Pennsylvania, US Department ofJustice, Philadelphia, PA (Co-Moderator)Demonstrating the Value of the ComplianceOrganizationKathleen M. Boozang, JD, LLM, Dean and Professor of Law, Seton HallUniversity School of Law, Newark, NJ10:15 amYogesh Bahl, CPA, MBA, Managing Director, Alix Partners, New York, NY (Moderator)Thomas W. Abrams, RPh, MBA, Director, Office of Prescription DrugPromotion, US Food and Drug Administration, Silver Spring, MDNeil V. Getnick, JD, Managing Partner, Getnick & Getnick LLP; FormerAssistant District Attorney, Manhattan District Attorney’s Office, New York, NY9:30 amJon Smollen, MA, JD, Director, Center for Compliance and Ethics, Temple Law School;Former Executive Vice President and Chief Compliance Officer, Endo; Former Vice Presidentand Chief Compliance Officer, Siemens Healthcare USA; Former Vice President, CommercialExcellence and Compliance, Wyeth, Philadelphia, PALaura Skinner, Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte &Touche LLP, Austin, TX (Moderator)Mini Summit III: Enforcement Trends, Risk Assessments andBest Practices for Patient Assistance and ReimbursementSupportJennifer Chillas, JD, Senior Corporate Counsel, Bristol-Myers Squibb, Princeton Pike, NJNereyda Garcia, JD, Global Head, Ethics and Compliance, Alnylam Pharmaceuticals; FormerSenior Director, Compliance, Biogen Idec, Boston, MALaura G. Hoey, JD, Partner, Ropes & Gray LLP; Former Assistant US Attorney, US Attorney’sOffice, Eastern District of Arkansas, US Department of Justice, Chicago, ILCasey J. Horton, CFE, Director, Healthcare and Life Sciences Disputes, Regulatory,Compliance and Investigations, Navigant Consulting, Chicago, IL (Moderator)Mini Summit IV: Managed Market Considerations for Huband Specialty Pharmacy ArrangementsTerra Buckley, JD, Head of US Compliance, Helsinn; Former Director, Ethics and Compliance,North America, Ipsen; Former Associate Director, Compliance, Aptalis Pharma, Iselin, NJGreg Sherman, JD, Counsel III, Gilead Sciences, Foster City, CALisa Walkush, Principal, Advisory Services: National Life Sciences Sector Leader, GrantThornton LLP, Philadelphia, PASeth Lundy, JD, Partner, King & Spalding, Washington, DC (Moderator)Jonathon L. Kellerman, Executive Vice President, Global ChiefCompliance Officer, Allergan PLC, New York, NYMini Summit V: Compliance and Ethics Considerations in R&DMichael Shaw, JD, Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Senior Counsel, Office of InspectorGeneral, US Department of Health and Human Services; Former Member,PCF Executive Committee, Philadelphia, PAMichelle Shwery, Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, INErinn Hutchinson, Partner, Advisory Services, PwC, Philadelphia, PA(Moderator)Anup Kharode, MBA, Principal, Pharmaceutical & Life Sciences R&D Advisory Services,PwC, Philadelphia, PA (Moderator)BreakMini Summit VI: Compliance Program Effectiveness:Using Data Analytics to Tell the StoryDavid Cromley, Head, R&D Compliance, Merck, Philadelphia, PASue Seferian, Health Care Compliance Officer, Johnson & Johnson, Titusville, NJSeth B. Whitelaw, JD, LLM, SJD, President and Chief Executive Officer, Whitelaw ComplianceGroup, LLC; Editor, Life Science Compliance Update, West Chester, PAAnthony Brennan, MBA, Senior Manager, Fraud Investigation & Dispute Services, EY;Former Senior Director, Governance, Metrics and Reporting, Health Care Compliance, Johnson& Johnson, Iselin, NJ6
Mini Summit VII: International Organization forStandardization (ISO) 37001: A New Era of Anti-bribery/Anti-corruption (ABAC) ComplianceMichael K. Loucks, JD, Partner, Skadden Arps LLP; Former Acting United States Attorney,District of Massachusetts, US Department of Justice, Washington, DCLouis Ramos, JD, Partner, DLA Piper; Former Assistant General Counsel, Compliance Division,Pfizer; Former Assistant US Attorney, US Attorney’s Office, District of Columbia, Washington, DCPaul J. Peterson, CPA, CIA, CFE, CFF, Senior Manager, Forensic Advisory Services,Grant Thornton, Alexandria, VA (Moderator)11:45 amNETWORKING LUNCHEONOPTIONAL LUNCHEON MINI SUMMITS 11:55 am – 12:55 pmLuncheon Mini Summit VIII: FDA Regulation and CuttingEdge Technology - What Pharmaceutical and Medical DeviceCompanies Should Know Digital
Mary E. Riordan, Esq., Senior Counsel, Office of Counsel to the Inspector General, OIG, HHS Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US DOJ James Sheehan, JD, Chief, Charities Bureau, Attorney General of New York Jim Stansel, JD, Executive Vice President & General Counsel, PhRMA
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