pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress



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Preconference / Day 1 | Day 3

    Day II: Pharma Congress
    Thursday, October 22, 2015


PHARMA CONGRESS PRESENTATIONS
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7:00 a.m.



Registration Opens; Continental Breakfast in Exhibit Hall




    MORNING PLENARY SESSION




8:00 a.m.





Welcome and Introductions

Elizabeth V. Jobes, Esq.
Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Philadelphia, PA (Co-chair)










8:15 a.m.





US DOJ Civil Section Update

Benjamin Mizer, Esq.
Principal Deputy Assistant Attorney General and Head of the Civil Division, US Department of Justice; Former Counselor to Attorney General Eric H. Holder, Jr., Washington, DC

    Speaker Bio

    Mr. Mizer heads the Department's Civil Division, which, among other things, enforces criminal and civil statutes to ensure the safety of food and medicines, and recovers billions of taxpayer dollars through affirmative litigation. Previously, he served as Counselor to Attorney General Holder, and as a Deputy Assistant Attorney General in the Department's Office of Legal Counsel. Before joining the Department, he was the Solicitor General of Ohio. He clerked for Justice John Paul Stevens of the United States Supreme Court and Judge Judith W. Rogers of the United States Court of Appeals for the D.C. Circuit. He is a graduate of the University of Michigan Law School and the College of Wooster.






Introduction by Michael K. Loucks, Esq.
Partner, Skadden Arps LLP; Former Acting United States Attorney, US Attorney's Office for the District of Massachusetts, Washington, DC

    Speaker Bio

    Michael K. Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the United States and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks had most recently served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts.

    Since joining Skadden in 2010, Mr. Loucks' practice has focused on representing companies in government criminal investigations, in False Claims Act and other civil litigation, in regulatory matters with the Food and Drug Administration and the Office of Inspector General, and in Foreign Corrupt Practices Act investigations. He has represented companies and individuals around the world from a wide variety of industries, including health care, pharmaceutical and biotech, and medical devices among others.










8:45 a.m.





Update from CMS on Open Payments

Douglas Brown
Deputy Director, Data Sharing & Partnership Group, Center for Program Integrity, Centers for Medicare and Medicaid Services, US Department of Health and Human Services, Baltimore, MD

    Speaker Bio

    Doug Brown currently serves as the Acting Director of the Data Sharing & Partnership Group at the CMS Center for Program Integrity. Doug is responsible for implementing large-scale information systems, supporting technologies, partner engagement and other educational activities and campaigns which support transparency and anti-fraud programs. Prior to joining the Center for Program Integrity, Mr. Brown was the director of the Division of Health Information Technology for the Quality Measure and Health Assessment Group in the Center for Clinical Standards and Quality, overseeing the development, implementation and collection of Clinical Quality Measures used in the EHR Incentive Program. Mr. Brown holds a Masters of Healthcare Services in Healthcare Policy and Finance from the Johns Hopkins Bloomberg School of Public Health.






Introduction by Paul Silver
Practice Leader and Managing Director, Huron Life Sciences, Atlanta, GA

    Speaker Bio

    Paul Silver is a Managing Director and Practice Leader for Huron's Life Sciences practice. Paul has 26 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 has provided expert testimony on behalf of pharmaceutical companies in litigation matters involving sales and marketing practices.










9:15 a.m.





Qui Tam Panel

Jillian Estes, Esq.
Partner, James Hoyer Newcomer & Smiljanich, PA; Former Case Assistant, International Division, National Center for Missing and Exploited Children, Tampa, FL

    Speaker Bio

    Jillian Estes is a partner at the Tampa-based firm of James, Hoyer, Newcomer & Smiljanich, P.A., which represents relators in False Claims Act cases nationwide. Ms. Estes worked extensively on a recent $192 million off-label pharmaceutical settlement and was lead counsel in a 2014 ground-breaking case involving the application of the Stark statute to Medicaid payments. Since 2008, she has represented relators in cases which have recovered more than $350 million for the Government. Ms. Estes is an active member of Taxpayers Against Fraud and is a regular volunteer for the U.S. Department of State's Hague Convention Attorney Network.






Loren Jacobson, Esq.
Partner, Waters & Kraus LLP, Dallas, TX

    Speaker Bio

    Loren Jacobson is a partner at Waters & Kraus, LLP in Dallas, Texas. Ms. Jacobson manages the firm's False Claims Act & Qui Tam practice, representing whistleblowers in the pharmaceutical, medical device, hospice and home health care, government contracting, and construction industries, among other areas. She has achieved government or state intervention in many of her qui tam cases, and her clients have been part of several large Department of Justice settlements. Ms. Jacobson also litigates False Claims Act and other qui tam cases in state and federal court.






Joseph Trautwein, Esq.
Joseph Trautwein & Associates LLC; Former Assistant US Attorney, Eastern District of Pennsylvania, Philadelphia, PA

    Speaker Bio

    Joseph Trautwein is an attorney with over sixteen years' experience in complex civil litigation, including twelve years with the U.S.Department of Justice as Assistant U.S. Attorney in the civil division of the Philadelphia office primarily focused on health care fraud and abuse and defense contractor fraud.

    Following his service with the U.S. Department of Justice, Mr. Trautwein established his own practice specializing in qui Tam/False Claims Act disputes. To date Mr. Trautwein has led and assisted in the recovery of over $5 billion of taxpayer dollars through landmark settlements against drug manufacturing, health care companies and other government contractors.






Jonathan Diesenhaus, Esq.
Partner, Hogan Lovells LLP; Former Senior Trial Counsel, Fraud Section, Civil Division, US Department of Justice, Washington, DC (Moderator)

    Speaker Bio

    Jonathan Diesenhaus is a partner in the Investigations and White Collar Defense Group at Hogan Lovells. His practice focuses on healthcare fraud and abuse investigations, litigation and counseling, and federal and state False Claims Act litigation.

    Prior to joining what was then Hogan & Hartson in 2005, Mr. Diesenhaus served as a senior trial counsel in the Civil Division of the U.S. Department of Justice in Washington, D.C. From 1998 to 2005, he handled civil health care fraud and False Claims Act matters. He represented the government in a number of matters involving allegations that violations of the Antikickback Statute, the Stark Law, and of the Food, Drug and Cosmetic Act resulted in the submission of false claims to the federal healthcare programs.
    Presentation Material (Acrobat)










10:00 a.m.





Recent Developments in the Debate over Off-Label Communications and the First Amendment

Paul E. Kalb, JD, MD
Partner and Global Coordinator, Life Sciences Practice, Sidley Austin LLP, Washington, DC

    Speaker Bio

    PAUL KALB brings an uncommon clinical perspective, grounded in his experience as an attending physician at the Memorial Sloan-Kettering Cancer Center, to bear in his work for a range of healthcare clients. He has successfully represented many of the world's leading drug, biotech and device manufacturers as well as hospitals and other providers in criminal, civil, and administrative enforcement actions involving healthcare fraud and abuse and off-label promotion. He has defended numerous matters and negotiated ground-breaking settlement agreements and Corporate Integrity Agreements. Paul counsels both boards of directors and companies on compliance issues, including compliance program effectiveness and CIA implementation and management.
    Presentation Material (Acrobat)






Introduction by Gary Del Vecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ (Co-chair)

    Speaker Bio

    Mr. Del Vecchio has been with Bristol-Myers Squibb for 26 years. His experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, education and training, and compliance and ethics program development and support. Gary has been a member of the US Pharmaceuticals Compliance and Ethics department for 10 years and currently holds the position of Executive Director, USP Compliance and Ethics. In this role he provides compliance and ethics leadership to the Sales, Marketing, Medical, Access and Global Commercialization organizations along with managing the US Compliance and Ethics investigations team. His initial compliance role focused primarily on the creation and implementation of the company's comprehensive US Compliance and Ethics education and training program. Gary is currently serving as a Co-Chair of the Pharmaceutical Compliance Forum, a coalition of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers. The PCF was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.










10:30 a.m.



Networking Break




    MINI SUMMITS BLOCK A -- 11:00 am to 12:00 pm




MINI SUMMIT I:




MANAGING SPEAKER PROGRAM COMPLIANCE: BENCHMARKING AND BEST PRACTICES



11:00 a.m.



Introduction, Panel Discussion and Q&A

Gregory Beeman
Lilly USA Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN

    Speaker Bio

    Greg Beeman is the Ethics and Compliance Officer for Lilly-USA, LLC. As a member of the Affiliate Leadership team, Greg is responsible for providing support and guidance for strategic business decisions made in U.S. operations. His team, in alignment with the business, has successfully delivered on the requirements of a Corporate Integrity Agreement and has integrated business processes to meet expectations of external regulators. Prior to this role, Greg was the Vice President of U.S. Neuroscience Sales. During his 29 year career with Lilly, Greg has held numerous sales leadership positions as well as roles in Human Resources, New Product Development, and Business Operations.

    Greg received his Bachelor degree in Pharmacy from the State University of New York at Buffalo.





Ronni E. Fuchs, Esq.
Partner, Pepper Hamilton LLP, Princeton, NJ

    Speaker Bio

    Ronni Fuchs is a partner in the Princeton office of Pepper Hamilton LLP, in the Health Effects Litigation Practice Group. She has represented pharmaceutical, medical device, and consumer products manufacturers in products liability, consumer fraud and related mass torts litigation for over 20 years. She provides litigation and regulatory counseling to companies prior to product approval as well as in response to challenges, such as adverse event reports, results from clinical trials, regulatory actions, and investigations.





Raymond S. Wysmierski, MBA, MJP
Associate Director, Compliance, Avanir Pharmaceuticals, Inc., Aliso Viejo, CA





Katherine Buckley, MBA
Principal, Pharmaceutical and Life Sciences Advisory Practice, PwC, Philadelphia, PA (Moderator)

    Speaker Bio

    Experienced pharmaceutical and life sciences industry consultant with over 13 years of experience providing regulatory compliance, commercial contracting and operations, risk management and dispute resolution services to the pharmaceutical industry. Katherine's experience includes program design, risk identification, policy and procedure development, policy adherence assessments, compliance training, and design and vision of future state contracting, government price reporting and healthcare professional interaction compliance programs.
    Presentation Material (Acrobat)



12:00 p.m.



Networking Luncheon












MINI SUMMIT II:




R&D COMPLIANCE: PREPARE NOW FOR FUTURE ENFORCEMENT



11:00 a.m.



Introduction, Panel Discussion and Q&A

Dennis K. Barnes, JD, MBA, CPA
Vice President, Chief Compliance Officer, PAREXEL International, Waltham, MA

    Speaker Bio

    Dennis Barnes is currently the Vice President & Chief Compliance Officer at PAREXEL International, Inc., which is headquartered in Waltham, Massachusetts. PAREXEL is a clinical research organization (CRO) focused upon assisting its pharmaceutical and medical device manufacturer clients with executing the necessary clinical trials that allow their products to be evaluated by regulatory authorities in markets throughout the world. Prior to joining PAREXEL in 2014, Dennis held various positions with pharmaceutical manufacturers and consulting firms that service the pharmaceutical industry over the last 17 years, including:
    • Sanofi US
    • GlaxoSmithKline
    • Navigant Consulting
    • KPMG
    • PwC
    Dennis earned a BA in Economics from Bucknell University, a Juris Doctor (JD) from the University of Notre Dame School of Law, and an MBA from the University of Texas at Austin Graduate School of Business. Dennis is also a Certified Public Accountant.





Paul Curtin, JD, CFE
Executive Director, R&D Compliance, Allergan; Former Head of Compliance - Ex-US, Forest Laboratories, Jersey City, NJ

    Speaker Bio

    Paul Curtin is currently the Head of Global Research & Development Compliance for Allergan, plc (formerly Actavis, plc) after having served as the International Compliance Officer & Deputy Compliance Officer for Forest Laboratories, Inc. prior to its acquisition by Actavis last year. Paul has been a Compliance professional in the pharmaceutical and life sciences industry since 2001, and has established and managed compliance programs in domestic and international markets. Prior to his career in the pharmaceutical industry, Paul was a healthcare and regulatory attorney in private practice.





Daniel A. Kracov, Esq.
Partner and Head, FDA and Healthcare Practice, Arnold & Porter, Washington, DC

    Speaker Bio

    Dan Kracov heads the FDA and healthcare practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. His experience in US Food and Drug Administration (FDA) strategic advice and crisis management has been recognized by Chambers, the Legal Times, and numerous other publications.

    Mr. Kracov regularly advises on regulatory strategies, product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.





George K. Ng, Esq.
Executive Vice President & Chief Legal Officer, Sorrento Therapeutics, Inc., San Diego, CA

    Speaker Bio

    George Ng is Executive Vice President & Chief Legal Officer for Sorrento Therapeutics, Inc., where he heads the legal, human resources, compliance, quality and intellectual property functions. Prior to joining the company, Mr. Ng held various senior management positions, including General Counsel, Chief Compliance Officer and Chief Intellectual Property Counsel, with publicly-traded, global biotechnology and pharmaceutical companies, including BioDelivery Sciences International, Inc. (NASDAQ: BDSI), Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) and Alpharma, Inc. (now, a part of Pfizer Inc.).





Yogesh Bahl, CPA, MBA
Managing Director, Alix Partners, New York, NY (Moderator)

    Speaker Bio

    Yogesh Bahl is a managing director at AlixPartners, where he leads the life sciences practice for the firm's Financial Advisory Services group. Yogesh has more than 20 years of experience with leading global investigations, litigation support, and enterprise improvement projects in the life sciences industry. He also has served as an arbitrator and an expert in matters involving pricing, marketing, breach-of-contract, intellectual-property and antitrust issues.

    Yogesh's areas of expertise include fraud and corruption investigations, third -party due diligence, compliance programs, and supply-chain risk management. He has helped companies manage issues with complex accounting, product diversion, counterfeiting and contract compliance.
    Presentation Material (Acrobat)



12:00 p.m.



Networking Luncheon












MINI SUMMIT III:




BUSINESS DEVELOPMENT PART 1: MERGERS AND ACQUISITIONS -- PREPARING TO BE ACQUIRED AND PRE-DEAL DUE DILIGENCE



11:00 a.m.



Introduction, Panel Discussion and Q&A

Timothy Ayers, JD, MPH
Vice President, Chief Compliance Officer, Horizon Pharma plc; Former Vice President, Chief Compliance Officer, Dendreon, Chicago, IL

    Speaker Bio

    Tim Ayers is the VP, Chief Compliance Officer for Horizon Pharma plc. In that role, is the global compliance officer and responsible for the compliance program. Prior to that, he was the Vice President, Chief Compliance Officer for Dendreon Corporation. He has held various legal and compliance roles at small oncology biotech companies where he established and implemented the compliance programs, and also provided legal counsel to all areas of the business.

    Prior to joining the in-house ranks, Tim was an attorney in the healthcare group for the Washington, DC Office of Winston & Strawn, LLP. Tim is a graduate of Georgetown University, where he also obtained his J.D. in 1998. He subsequently obtained his Masters in Public Health from Columbia University in 2000.





Justin Dillon
Senior Director - Compliance, Auditing & Monitoring, Incyte, Wilmington, DE





Michael B. Dusseau
Vice President, Compliance Operations, Allergan plc; Former Vice President, Compliance, Bayer, Parsippany, NJ

    Speaker Bio

    Michael has held senior leadership roles in the Compliance Organizations of Schering­ Plough, Merck, Bayer and Allergan with broad responsibilities including the negotiation, implementation and operation of Corporate Integrity Agreements, global compliance training and privacy programs, monitoring, transparency, hotlines and compliance investigations. Michael has experience in both the Rx and Consumer segments of the business and in the design and implementation of compliance organizations and programs.

    With over 30 years of experience in the pharmaceutical industry Mike has held positions in sales, sales operations, information technology and compliance.

    Michael holds a bachelor's degree in science from California State University, Long Beach.





William I. Intner, Esq.
Partner, Hogan Lovells LLP, Baltimore, MD

    Speaker Bio

    William Intner is a partner with Hogan Lovells US LLP focused on corporate transactions. William regularly represents pharmaceutical, biotechnology and healthcare clients in an array of transactions, including complicated mergers, acquisitions and product divestitures. With experience working on transactions with some of the smallest to some of the largest companies in the industry, he understands the importance of integrating the compliance function in the overall approach to transaction management





Virginia "Ginny" A. Gibson, Esq.
Partner, Hogan Lovells LLP; Former Executive Assistant U.S. Attorney, Eastern District of Pennsylvania, Philadelphia, PA (Moderator)

Presentation Material (Acrobat)



12:00 p.m.



Networking Luncheon












MINI SUMMIT IV:




EVALUATING COMPLIANCE PROGRAM EFFECTIVENESS -- BOARD RESPONSIBILITIES, BOARD ADVISORS, AND COMPLIANCE EXPERTS



11:00 a.m.



Introduction, Panel Discussion and Q&A

Thomas E. Costa, Esq.
Compliance Consultant; Former Vice President, US Pharmaceuticals Compliance, Bristol-Myers Squibb, Yardley, PA

    Speaker Bio

    Thomas Costa has over 35 years of Legal and Compliance leadership experience in the Bio-Pharmaceutical industry. He has lived and worked in the United States and Europe with Bristol-Myers Squibb. Today he is an independent Pharmaceutical Compliance Consultant.





Christopher Fletchall, MBA
Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN

    Speaker Bio

    Chris Fletchall is currently a Senior Director for Lilly's Ethics and Compliance organization. He leads the Ethics and Compliance Global Operations function. This function is responsible for many of the operational aspects of implementing the company's global compliance program. Previously, he has been part of Lilly USA's compliance program in a variety of different roles.

    Chris started his career with Lilly as a sales representative. He has had a variety of experiences with Lilly including managed markets business analyst, human resources, and a role supervising account managers who have responsibility for cultivating relationships with large federal healthcare accounts.

    Chris received his BS degree in Business Administration and Finance from Indiana University, and his MBA from Clemson University.





MaryAnn Northrup, CFE, CHRC
Senior Director, FTI Consulting, Indianapolis, IN

    Speaker Bio

    Mary Ann Northrup is a Senior Director in the FTI Consulting Health Solutions practice and has twenty-five years of experience in the consulting, life sciences, and healthcare industries. In an advisory role, she has performed compliance program effectiveness reviews on behalf of the Board of Directors of a global pharmaceutical company as well as an integrated health system in support of their corporate integrity agreement obligations. Additionally, she has conducted compliance risk assessments, independent review organization reviews, and compliance auditing and monitoring activities. Prior to entering consulting, Ms. Northrup worked in a global bio-pharmaceutical company as well as a large non-profit healthcare system.





Lawrence P. Platkin
Vice President and Head, U.S. Compliance Center of Excellence, Bayer Corporation, Whippany, NJ

    Speaker Bio

    Larry Platkin is currently Vice President and head of the Compliance Center of Excellence for Bayer Corporation. He was named Vice President and Compliance Officer of Bayer HealthCare in June, 2008, responsible for the implementation of BHC's 2008 Corporate Integrity Agreement, as well as compliance strategy, development of policies and procedures, investigations, communications and training. Prior to that, he held positions in the Bayer Law and Patents Department, counseling the pharmaceuticals business (and its predecessor, Berlex Laboratories, Inc.). Prior to that, he held positions in the Legal Departments of Ciba-Geigy Corporation and American Home Products Corp. Larry was in private practice in Newark, NJ prior to that. He is a graduate of Rutgers College, New Brunswick, NJ and Rutgers University School of Law, Newark, NJ.





Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC (Moderator)



12:00 p.m.



Networking Luncheon












MINI SUMMIT V:




PAYERS AND PROVIDERS PART 1: EVOLVING HEALTHCARE SYSTEMS AND PROMOTIONAL INTERACTIONS



11:00 a.m.



Introduction, Panel Discussion and Q&A

Chris Cobourn
Managing Director, Huron Life Sciences, New York, NY

    Speaker Bio

    Chris is an industry thought leader offering compliance consulting services and outsource operations services to pharmaceutical, biotech, and medical device companies. Focused on areas of regulatory compliance within commercial programs and pricing, sales and marketing, government programs (Medicaid, Medicare, PHS), and federal contracting, Chris has more than 16 years in the industry with extensive experience in government programs and pricing which includes working with manufacturers of all types and sizes in areas such as policy and methodology, assessment and audit, recalculations and restatements, class of trade (COT) analysis, PHS membership, bona fide service fees, and recalculations as well as strategic business process outsourcing for statutory pricing calculations, chargebacks, and rebates processing.





Seth H. Lundy, Esq.
Partner, King & Spalding LLP, Washington, DC

    Speaker Bio

    Seth Lundy is a partner in the Washington, D.C., office of King & Spalding and deputy chair of the FDA & Life Sciences Practice Group. Seth focuses his practice on the federal and state regulation of medical device and pharmaceutical manufacturers and suppliers, including corporate compliance, aggregate spend, the Anti-Kickback Statute, the Stark Law, False Claims Acts, disclosure requirements, and Medicare and Medicaid reimbursement. His experience includes working closely with federal regulators and legislators to create, revise and interpret new laws, regulations and policies; developing business and marketing strategies within changing federal regulatory schemes; corporate compliance; government investigations; healthcare contracting; healthcare mergers, acquisition and start-ups; Medicare and Medicaid reimbursement and billing advice; and civil and criminal litigation.





Joseph Zimmerman
Former Senior Vice President and Chief Compliance Officer, Actavis plc; Former Global Chief Compliance Officer, Forest Laboratories, New York, NY





James Moran, JD, CPA
Managing Director, PwC, St. Louis, MO (Moderator)

    Speaker Bio

    I am a Managing Director in the Health Industires Advisory practice of PwC with a focus on risk and regultory compliance and analytics. I work with large payer organizations, hospital systems, pharma / device companies, academic medical centers and federal and state government entities to improve compliance operations, manage regulatory risk, improve the quality of care and identify innovative opportunities grow revenue, control cost and improve operations in the highly regulated environments of Healthcare and Life Sciences.

    I have more than 20 years of experience working with these organizations as an Healthcare Consultant, Chief Compliance Officer, and Chief Operating Officer
    Presentation Material (Acrobat)



12:00 p.m.



Networking Luncheon












MINI SUMMIT VI:




PATIENT SUPPORT PROGRAMS PART 1: GETTING CLOSER TO THE PATIENT



11:00 a.m.



Introduction, Panel Discussion and Q&A

Thomas M. Glavin, Esq.
Vice President, Deputy Compliance Officer, Shire, Philadelphia, PA

    Speaker Bio

    Tom Glavin joined Shire in November of 2005 as the compliance officer for Shire's U.S. businesses. He led the development of the company's compliance program and the implementation and management of that program in the U.S. Tom's responsibilities include providing compliance support to Shire's U.S. businesses, the development and implementation of policies, the development and delivery of training, the management of compliance program audits and monitoring, and the management of investigations. Tom also leads Shire's Compliance Committee and has primary responsibility for interacting with OIG in connection with implementation of Shire's Corporate Integrity Agreement.





Michael Joachim, Esq.
Head of Global Corporate Compliance, Genzyme, Cambridge, MA

    Speaker Bio

    Michael Joachim is Head of Global Corporate Compliance at Genzyme, a Sanofi Company, and is a member of Sanofi's Global Compliance management team. Mike ensures the implementation of the Sanofi Global Compliance program within Genzyme and serves as Genzyme's liaison with Sanofi's Compliance organization. He provides strategic Compliance leadership and acts as the primary point of contact at Genzyme for implementing, promoting, and enforcing Compliance standards.

    Prior to joining Genzyme, Mike worked in the Legal Department at Blue Cross and Blue Shield of Massachusetts and in the Health Care Department at Choate, Hall & Stewart in Boston.





Stephen M. Lawniczak, Esq.
Senior Counsel, AbbVie, Chicago, IL

    Speaker Bio

    Stephen is a Senior Counsel at AbbVie where he counsels cross-functional departments including Commercial, Medical Affairs and Regulatory Affairs regarding a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals. Stephen joined Abbott in 2012 after 10 years practicing with Gordon & Rees in San Francisco as part of its Drug and Medical Device team.





Phillip Lo Scalzo, Esq.
Senior Vice President, Chief Compliance Officer, BioMarin Pharmaceutical Inc., Novato, CA

    Speaker Bio

    Philip Lo Scalzo joined BioMarin Pharmaceutical Inc. in 2007 and currently serves as its Senior Vice President, Compliance & Ethics and its Chief Compliance Officer. In his role, Mr. Lo Scalzo is responsible for creating and maintaining the company's global compliance program which includes healthcare compliance, GxP compliance, and Internal Audit. His responsibilities include chairing the Company's Compliance Steering Committee; overseeing the development and implementation of compliance policies as well as employee and partner training; managing GxP audits of both company facilities and vendors; scoping and executing financial and operational internal audits, including audits of third-party vendors; coordinating enterprise risk assessments and analysis; review and approval of promotional materials; monitoring of promotional events and other interactions with healthcare professionals; management of investigations; and implementation of corrective actions.





Eve M. Brunts
Partner, Ropes & Gray LLP, Boston, MA (Moderator)



12:00 p.m.



Networking Luncheon












    MINI SUMMITS BLOCK B -- 1:15 pm to 2:15 pm




MINI SUMMIT VII:




PREDICTIVE ANALYTICS



1:15 p.m.



Introduction, Panel Discussion and Q&A

Brian J. Conner
Senior Director, Asst. Corporate Compliance Officer, Shire, Philadelphia, PA

    Speaker Bio

    Brian Conner is currently a member of Shire's Global Compliance & Risk Management team in April 2012 as Sr. Director. Brian provides compliance leadership to the Neuroscience and GI business units in the U.S. and Canada. He also provides primary compliance support to our aggregate spend efforts and team.

    Brian possesses a wealth of cross functional biopharmaceutical experience. He has held positions within the areas of corporate ethics and compliance, general management, regulatory affairs, quality assurance, manufacturing, sales/marketing and healthcare communications. He has worked for large and small companies like Merck, Saatchi and Saatchi, Stiefel Labs, and Genzyme.





Holly Kramen
Vice President, Global Compliance Officer, Circassia Pharmaceuticals Inc., Chicago, IL

    Speaker Bio

    HOLLY KRAMEN is VP Global Compliance Officer for Circassia Pharmaceuticals, a life science company specializing in asthma and allergy. She is an experienced industry compliance leader having lived the challenges and best practices of building Legal and Compliance programs in companies of all sizes designing, leading and implementing processes, policies and systems from the ground up. Her previous companies include Pfizer, Gilead Sciences and Given Imaging. While at Pfizer she created and co-authored the first pharmaceutical compliance manual and built the first US aggregate spend system. Prior to joining Circassia, she was Principal at Porzio, Bromberg, Newman and VP at Porzio Life Sciences.





John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio Bromberg & Newman, PC, Morristown, NJ

    Speaker Bio

    John Patrick Oroho, Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia.

    Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Commercialization Department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Antikickback statute, False Claim Act, and Medicare and Medicaid fraud and abuse.

    Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance.

    Mr. Oroho has an extensive pharmaceutical regulatory and compliance background. He spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.

    Mr. Oroho received a J.D. from the University of Notre Dame School of Law in 1985 and a B.S. from the United States Merchant Marine Academy, where he graduated with honors in 1978.





Mark Linver, MS
Managing Director, Huron Life Sciences, New York, NY (Moderator)

Presentation Material (Acrobat)



2:15 p.m.



Transition Break












MINI SUMMIT VIII:




COORDINATING RISK MANAGEMENT ACROSS THE CONTROL FUNCTIONS: AUDIT, COMPLIANCE, FINANCE, LEGAL, REGULATORY AND QUALITY -- AN OPPORTUNITY TO LEVERAGE TECHNOLOGY



1:15 p.m.



Introduction, Panel Discussion and Q&A

Jennifer Neuenhoff, CPA
Associate Director, Compliance Auditing and Monitoring, Allergan PLC, Parsippany, NJ

    Speaker Bio

    Jennifer is an experienced audit professional with over 20 years of combined Internal Audit and Compliance experience working within various industries, ten years specifically in the pharmaceutical industry, specializing in business process, global risk assessment, financial, operational, compliance and IT controls. Jennifer has held leadership roles in both in­ house and outsourced internal audit departments. In her role as Associate Director, Compliance Monitoring and Auditing with ForestlActavis/Aliergan, she has fostered relationships with varying levels of senior management, audit committee and board compliance committee members. Prior to that, Jennifer held various management roles in Internal Audit at BMS and Deloitte.





Neely O'Donnell
Senior Manager, Corporate Compliance, Biogen, Cambridge, MA

    Speaker Bio

    Neely is a Compliance Officer (CO) at Biogen leading Corporate Compliance's risk management program. Neely recently designed and implemented a system supporting Biogen's risk mitigation activities. Prior to the current role, Neely supported multiple departments as a CO. Prior to becoming a CO, Neely was an Internal Auditor responsible for auditing Biogen's affiliates/functions to ensure procedures adhered to internal requirements, and various laws and regulations governing the Company's business activities. Prior to Biogen, Neely worked at Protiviti as an independent risk consultant providing advice on risk mitigation. Neely holds a CPA, MBA and a Master's in Business Ethics and Compliance.





John Conrad
Principal, Deloitte, Philadelphia, PA (Moderator)

Presentation Material (Acrobat)



2:15 p.m.



Transition Break












MINI SUMMIT IX:




MANAGING MULTI-NATIONAL HCP MEETINGS: COMPLYING WITH THE CODES AND TRANSPARENCY REQUIREMENTS



1:15 p.m.



Introduction, Panel Discussion and Q&A

Hwa-Soo Chung, Esq.
Chair, Health Law Group, Kim & Chang Law Firm, Seoul, South Korea

    Speaker Bio

    Hwa Soo is chair of the Health Practice Group at Kim & Chang, which is Korea's largest law firm. For over 20 years, Hwa Soo and her team have advised the large majority of multinational pharmaceutical and medical device companies that do business in Korea, in many areas and on a wide range of issues. A major focus of her practice has been compliance, including defending companies in compliance-related investigations, setting up compliance programs, and carrying out internal compliance audits. Notably she co-led the defense teams for major pharma and medical device companies in the industry-wide investigations that the Korean competition authorities carried out in the last ten years for the giving of kickbacks."





Tali Guy, Esq.
Senior Director, Global R&D Compliance Officer, Teva Pharmaceutical Industries Ltd., Petah Tikva, Israel

    Speaker Bio

    Tali has been a member of the Israeli Bar Association since 1998, and has extensive legal experience, having worked for several well-known law firms in Israel prior joining Teva in 2007 as Senior Legal Counsel, where she lead the legal support of the Global R&D Division from early stages to clinical trials.

    Since 2010 Tali assumed additional responsibilities as a Compliance specialist, and at the end of 2012, became the Global R&D Compliance Officer, supporting the entire division.

    In her current role, Tali is responsible for developing and leading the R&D Compliance program in 40 countries. She ensures the implementation of a strong program to meet highest ethical standards and transparency requirements, by use of global IT systems.





Yuet Ming Tham, Esq.
Partner, Sidley Austin LLP, Former, Asia-Pacific Regional Compliance Director, Pfizer, Former Deputy Public Prosecutor, Singapore, Hong Kong





Marc Eigner, MBA, MS
Senior Partner and Co-Founder, Polaris, New York, NY (Moderator)

    Speaker Bio

    As a co-founder of Polaris Solutions and head of the technology practice, Marc Eigner is considered one of the founding fathers of pharmaceutical commercial-compliance technology and the leading expert this field, particularly in HCP/HCO spend automation and aggregate spend systems. He is a frequent lecturer and author on these topics. Under Marc's direction, Polaris' technology practice has grown from a core team to become the largest pharmaceutical compliance-focused technology group in the industry, implementing more than one hundred spend management and aggregation systems worldwide. Thanks to his leadership, Polaris continues to innovate, enlarging the scope of its technology practice and introducing a consistent stream of new products while delivering technology strategy expertise in support of Polaris Management Partners' consulting practice.

    Before joining Polaris, Marc worked for Andersen Consulting / Accenture and IBM. Marc holds a BS and MS in Computer & Systems Engineering and an MBA focused on Technology Entrepreneurship, all from Rensselaer Polytechnic Institute. Marc has participated in several executive education programs at the Harvard Business School, including 'Leading Professional Services Firms.'



2:15 p.m.



Transition Break












MINI SUMMIT X:




BUSINESS DEVELOPMENT PART 2: MERGERS AND ACQUISITIONS -- POST-DEAL DUE DILIGENCE AND INTEGRATION CHALLENGES



1:15 p.m.



Introduction, Panel Discussion and Q&A

Corey R. Amundson, Esq.
First Assistant United States Attorney and Chief, Criminal Division, United States Attorney's Office, Middle District of Louisiana, Baton Rouge, LA

    Speaker Bio

    Corey has been a federal prosecutor for over 13 years, focusing primarily on corporate and white collar crime. He currently serves as both First Assistant U.S. Attorney and Chief of the Criminal Division at the U.S. Attorney's Office for the Middle District of Louisiana. He has prosecuted dozens of organizations and executives and has been recognized by the U.S. Attorney General and FBI Director for successfully trying numerous high-profile corruption matters. Before becoming a prosecutor, Corey practiced white collar criminal defense with King & Spalding in Washington, D.C., and served as a law clerk for a U.S. District Judge.





Jeffrey L. Handwerker, Esq.
Partner, Arnold & Porter LLP, Washington, DC

    Speaker Bio

    Jeffrey L. Handwerker is a Partner in the FDA/Health Care and Business Litigation practice groups at Arnold & Porter LLP. He advises pharmaceutical, biotechnology and medical device clients on a range of compliance issues at both the federal and state levels, including, among others, federal drug price reporting requirements, federal and state anti-kickback act compliance, and healthcare reform implementation. He also represents pharmaceutical manufacturers in connection with the establishment of, and implementation of, Corporate Integrity Agreements with the HHS OIG and with related government investigations. He currently is defending a number of drug manufacturers in qui tam litigations involving price reporting, drug promotion, and anti-kickback compliance matters. Mr. Handwerker also recently represented both AstraZeneca in the landmark 340B litigation resolved by the Supreme Court in Astra USA, Inc. et al. v. County of Santa Clara,, and PhRMA in its successful First Amendment challenge to the Vermont prescriber-identifiable data law, IMS, et. al. v. Sorrell. The Santa Clara case held that 340B entities do not have enforceable rights to sue for breach of the 340B Pharmaceutical Pricing Agreement. The Sorrell decision established important First Amendment protections for truthful and non-misleading promotion of pharmaceuticals. Mr. Handwerker is a frequent lecturer and author on these topics.





Mark A. Jensen, Esq.
Partner, Special Matters and Government Investigations Team, King & Spalding, Washington, DC

    Speaker Bio

    Mark Jensen is a partner in the Special Matters and Government Investigations Practice Group in King & Spalding's Washington, D.C., office. Mark's practice includes litigating criminal and civil cases at the trial and appellate levels, as well as defending individuals and companies in prosecutions and investigations by U.S. Attorneys' Offices, state AGs, multiple divisions of the Department of Justice, the SEC, FDA, EPA, NOAA and Congress. He regularly represents pharmaceutical, biotechnology, medical device and healthcare companies and their executives in criminal and civil investigations and successfully has defended clients in high-stakes qui tam whistleblower matters in key jurisdictions throughout the country.





Joanne Lahner, Esq.
Vice President, GHH Compliance, Merck & Co., Inc., North Wales, PA

    Speaker Bio

    Joanne, with over 20 years of industry experience, is Vice President, Merck Global Human Health Compliance, responsible for Merck's CIA and US human health compliance program. She started at Merck in the Regulatory Legal Group and later led the Vioxx US product liability litigation team. Joanne then led the legal group for the US human health business and Merck Research Laboratories. She is a graduate of American University, Washington, DC and University of California, Boalt Hall School of Law, Berkeley, California and a former litigation associate at Drinker Biddle & Reath, Philadelphia, PA.





Maureen McGirr, Esq.
Vice President, Office of Ethics, Global Compliance Organization, Merck & Co., Inc., Kenilworth, NJ (Moderator)

    Speaker Bio

    Maureen is an experienced legal and compliance leader with over two decades of pharmaceutical industry experience. She is currently Vice President within the Global Compliance Organization at Merck & Co., Inc. where she is responsible for leading the Office of Ethics, including: oversight of global compliance programs for investigations, anti-bribery and corruption, third party, policies, training and communications. Previously, Maureen held a number of positions within Merck's Office of General Counsel.

    Maureen also was on international assignment based in Japan as Legal Counsel for two years.
    Presentation Material (Acrobat)



2:15 p.m.



Transition Break












MINI SUMMIT XI:




THE IMPACT OF PUBLIC DISCLOSURES ON OPERATIONS AND PROCESSES WITHIN LIFE SCIENCE ORGANIZATIONS



1:15 p.m.



Introduction, Panel Discussion and Q&A

Carolyn Bruguera
Vice President Consulting Services, R-Squared, Princeton, NJ





Michael O'Connor, MS
Senior Director, Compliance and Ethics, Alexion Pharmaceuticals, Inc., Cheshire, CT

    Speaker Bio

    Mike is a consistent big picture, strategic thinker and creative problem solver with a talent for understanding complex situations, implementing solutions, and achieving results. He has over 18 years of international experience assisting clients in the Pharmaceutical industry with addressing business issues in areas such as Corporate Compliance, eDiscovery, Sales and Marketing Optimization, Regulatory Compliance, Document/records Management, Master Data Management and Information Management. Mike also has over 15 years of experience building and managing project teams throughout project life cycles, including business assessments, advisory, vendor selection, and realization with a key focus on delivering business results. Mike is currently at Alexion where he is the Global Head of Compliance Operations.





Gus Papandrikos, MBA
Global Head of Compliance Operations, Shire; Former Senior Director, Compliance, Daiichi Sankyo, Parsippany, NJ

    Speaker Bio

    Gus Papandrikos is a well-rounded management professional with extensive pharmaceutical industry experience. He is currently the Global Head of Compliance Operations for Shire.

    Prior to his current position, he was the Director of Compliance for Daiichi Sankyo. Prior to Daiichi Sankyo, he was the Director within the Medical Affairs group of Sanofi, responsible for Aggregate Spend reporting across the Sanofi group of companies. As the Director of Transparency operations he is responsible for the development, validation and certification of all the spend reports. In addition, Gus was responsible for the development of the Aggregate Spend data collection process for Sanofi. Gus holds a BA in Accounting from Pace University and an MBA in Pharmaceutical Management from Rutgers Business School.





Elizabeth Schwartz, MBA, CCEP
Director, US External Reporting and Transparency, Global Operations, Johnson & Johnson, New York, NY

    Speaker Bio

    Elizabeth Schwartz, MBA, CCEP is the Director, US External Reporting & Transparency, Health Care Compliance & Privacy for Johnson & Johnson. Elizabeth is responsible for leading the team responsible for Open Payments, State Reporting and Voluntary Transparency disclosures for the Medical Device & Consumer sectors. Elizabeth's experience around Open Payments includes analysis and development of assumptions documentation, building systems requirements, launching a training and communications plan, and the roll-out of a dispute resolution program. Elizabeth leads the team responsible for monitoring health care professional expense activity. Her compliance experience covers multiple J&J operating companies and includes providing compliance support for the companies by developing trainings, performing testing and monitoring, and drafting policy and procedures. Prior to her career at J&J, Elizabeth was with Deloitte & Touche.





William Buzzeo, MS
General Manager, US Compliance, IMS Health, Plymouth Meeting, PA (Moderator)

    Speaker Bio

    Reporting to IMS Health US President, leads the newly formed US compliance business unit with a focus on expanding our compliance services across the different verticals within the life sciences market by leveraging our current technology and information assets in addition to evaluating strategic areas for investment.
    Presentation Material (Acrobat)



2:15 p.m.



Transition Break












MINI SUMMIT XII:




PATIENT SUPPORT PROGRAMS PART 2: PRIVACY AND PHARMACOVIGILANCE CONSIDERATIONS



1:15 p.m.



Introduction, Panel Discussion and Q&A

William Greenrose, MA, MBA
Director, Advisory - Governance Regulatory and Risk Strategies Practice, Deloitte & Touche, LLC, Boston, MA

    Speaker Bio

    Bill Greenrose is a Director in Deloitte & Touche's Regulatory, Forensics & Compliance Advisory practice. He has over 33 years of experience (23 in industry) in FDA and DEA regulated Life Science industries including compliance, regulatory, clinical, quality assurance, quality control, laboratory, R&D, manufacturing, core lab, and corporate/operations. Bill has helped companies develop, implement and revise programs for pre and post market commitment tracking as well as for PV, AEs and ADEs. He is a former Lead Auditor for a Notified Body and was qualified by Health Canada to conduct audits for compliance with Canadian CAN/CSA-ISO 13485 and CMDCAS.





Megan Mikkelsen, CIPP/US, CHPS
Director, US Chief Privacy Officer, TevaPharmaceuticals, Kansas City, MO

    Speaker Bio

    Megan has served as the North America Chief Privacy Officer for Teva Pharmaceuticals since 2012. She also provides Compliance Leadership support to Teva's Patient Services and Support division located in Overland Park, Kansas.

    Prior to joining Teva, Megan had spent nearly 15 years at other healthcare and technology organizations such as the Hospital Corporation of America, Truman Medical Centers and Cerner Corporation in a variety of compliance, privacy and security related leadership roles.





Terra L. Reynolds, Esq.
Of Counsel, Litigation Department,Paul Hastings LLP; Former Assistant U.S. Attorney, Northern District of Illinois, Chicago, IL

    Speaker Bio

    Terra Reynolds is Of Counsel at Paul Hastings in Chicago. Prior to joining Paul Hastings she served for nearly eleven years as an Assistant U.S. Attorney, prosecuting matters involving health care fraud, racketeering, corporate, securities, and tax fraud, and multinational narcotics trafficking conspiracies. Since arriving at Paul Hastings, Terra has spent considerable time assisting pharmaceutical companies with internal investigations to ensure U.S. regulatory compliance, assisting with due diligence and integration related to a multi-billion dollar, multi-national pharmaceutical transaction, and representing a respondent in an ICC arbitration concerning fraud allegations related to an international pharmaceutical transaction.





Stephanie Wisdo, Esq.
Corporate Attorney, Otsuka America Pharmaceutical, Inc., Princeton, NJ





Regina Gore Cavaliere, Esq.
Principal, Advisory, KPMG; Former Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Short Hills, NJ (Moderator)

    Speaker Bio

    Regina is a Principal in KPMG's Regulatory Enforcement & Compliance group within the Forensic Advisory Services practice in Short Hills, NJ. Regina has experience building comprehensive ethics, compliance and quality programs for life sciences companies. Regina's most recent role was as the VP & Chief Compliance Officer for US affiliates of a Japanese-based pharmaceutical/medical device company. She led the Ethics, Quality & Compliance group and had responsibility for healthcare law compliance, internal investigations, auditing & monitoring, training, privacy, information security, transparency, policies/procedures, document control, contact call center, manufacturing quality and clinical trial/GCP quality.
    Presentation Material (Acrobat)



2:15 p.m.



Transition Break












    MINI SUMMITS BLOCK C -- 2:30 pm to 3:30 pm




MINI SUMMIT XIII:




INNOVATION IN TRAINING AND COMMUNICATIONS



2:30 p.m.



Introduction, Panel Discussion and Q&A

Rachel Batykefer, CCEP
Associate Director, Global Compliance, Teva Pharmaceuticals, Frazer, PA

    Speaker Bio

    Rachel Batykefer joined Teva in September 2013 as Associate Director, Global Compliance. She and her team are responsible for developing, coordinating, and managing Global Compliance and Ethics training and awareness programs for all employees. As part of her role, Rachel collaborates closely with Global HR, Global Communications and other key functions to execute these programs. Prior to joining Teva, Rachel was a Senior Manager at Tyco International managing their global Compliance Education function to an audience of 140,000 employees in more than 60 countries, covering 30 languages.





Margaret K. Feltz, MA, JD
Executive Director, Corporate Compliance, Purdue Pharma LP; Former Member, PCF Executive Committee, Stamford, CT

    Speaker Bio

    Ms. Feltz is Executive Director, Corporate Compliance at Purdue Pharma L.P., a pharmaceutical company headquartered in Stamford, Connecticut. Maggie's primary focus at Purdue is on the Sales & Marketing functions. She likewise oversees Purdue's aggregate spend efforts, ensuring compliance with state and federal marketing reporting requirements, as well as training and communication efforts company-wide.

    In her role, Maggie collaborated with other attorneys and compliance professionals to negotiate Purdue's Corporate Integrity Agreement. Since initiation of Purdue's CIA in July 2007, Maggie has partnered with Purdue colleagues and management to ensure smooth implementation of the CIA.

    From 2009 - 2014, Maggie served as Co-Chair of the Pharmaceutical Compliance Forum.





Samantha Hand
Global Training Manager, Johnson & Johnson, Titusville, NJ

    Speaker Bio

    Samantha Hand, Government Contracting & Pricing Compliance Officer, Medical Device Sector, Johnson & Johnson started her career in the Pharmaceutical sector where she held numerous sales positions before transitioning to an in-house position. In that realm, she has spent the last eight years in sales training and then Health Care Compliance.

    In her last position as Training Manager, Health Care Compliance & Privacy, Pharmaceutical sector, Johnson & Johnson, she was responsible for Health Care Compliance training which included ensuring all CIA-related training was carried out effectively to meet requirements.





Matthew Ruble, MS
Senior Manager, Grant Thornton, Philadelphia, PA (Moderator)

    Speaker Bio

    Matthew is a Senior Manager focusing on instructional design, change management, training, survey design and analysis and business process improvement. Additionally, Matthew has extensive experience developing, implementing, and managing compliance-related programs for large, multinational clients.



3:30 p.m.



Networking Break












MINI SUMMIT XIV:




COMPLIANCE CONSIDERATIONS WHEN EVALUATING NON-TRADITIONAL HCP COMPENSATION ARRANGEMENTS: ROYALTIES, STOCK OPTIONS, AND LICENSING AGREEMENTS



2:30 p.m.



Introduction, Panel Discussion and Q&A

Stuart A. Neiberg, MAcc, CPA, CFA
Director, HealthCare Appraisers, Delray Beach, FL

    Speaker Bio

    Mr. Neiberg is a Director with HealthCare Appraisers and has an extensive background in healthcare business valuation and financial analysis. His nine years of experience includes valuation of ambulatory surgery centers, healthcare systems and life sciences companies. Prior to joining HealthCare Appraisers Mr. Neiberg held positions as manager of valuation services at WTAS, LLC in West Palm Beach, Florida, and as an associate with Deloitte and Touche.

    Mr. Neiberg holds a Master of Accounting from the Fisher School of Accounting at the University of Florida and a Bachelor of Science in Management with concentrations in Finance and Accounting from the A. B. Freeman School of Business at Tulane University. He is a CFA charter holder and a certified public accountant (CPA) licensed in the State of California and is a member of the Florida Institute of Certified Public Accountants, the American Institute of Certified Public Accountants and the CFA Society of Miami. He is a frequent speaker on fair market value and healthcare valuation topics.
    Presentation Material (Acrobat)





Lee H. Rosebush, JD, PharmD, MS, MBA
Pharmacy Team Leader and FDA Partner, Baker & Hostetler LLP, Washington DC

    Speaker Bio

    An attorney and registered pharmacist, Lee Rosebush focuses his practice on the intersection between pharmacy and FDA regulatory, compliance and enforcement issues pertaining to drugs, biologics and medical devices. Lee has handled matters involving all 51 (including DC) state boards of pharmacy and assists clients with healthcare-related issues stemming from Medicare, Medicaid and state regulatory requirements. This includes state licensing requirements for healthcare providers and pharmacies, as well as drug and device manufacturers and distributors. Lee advises clients in matters relating to FDA regulatory compliance, including governance in the clinical trial, marketing, promotion and advertisement and approval process. He regularly provides counsel to pharmaceutical, medical device and dietary supplement manufacturers.
    Presentation Material (Acrobat)





Ann S. Brandt, PhD
Partner, HealthCare Appraisers, Inc., Delray Beach, FL (Moderator)

    Speaker Bio

    Dr. Brandt serves as the leader the life sciences service line at HealthCare Appraisers. Working primarily with medical device, pharmaceutical, and biotechnology companies, Dr. Brandt and her team of valuation professionals determine the fair market value of U.S. and global transactions including, healthcare provider ("HCP") compensation, intellectual property, royalty and licensing arrangements, as well as transactions related to data acquisition/sales and clinical trials. Dr. Brandt has more than 25 years of healthcare experience as a valuation professional, clinician, consultant, strategist and professor. She is an experienced presenter and has authored articles and book chapters on a variety of healthcare valuation topics.



3:30 p.m.



Networking Break












MINI SUMMIT XV:




NEW PRODUCT LAUNCHES AND THE PRE-LAUNCH PERIOD -- STRENGTHENING THE PARTNERSHIP WITH THE BUSINESS



2:30 p.m.



Introduction, Panel Discussion and Q&A

Terri Ledva, MS
Senior Manager Compliance, Iroko Pharmaceuticals LLC, Philadelphia, PA

    Speaker Bio

    Terri Ledva is an accomplished Healthcare Compliance Professional who specializes in Governance, Regulatory & Risk. She has over 15 years of experience within leading life sciences companies and across the product development life cycle. She has led cross-functional teams that implemented enterprise-wide solutions, new operating models, and stronger controls by overseeing the reengineering of policies and procedures and the development of effective training programs. Collaborating with stakeholders, she has successfully developed and enhanced regulatory and healthcare compliance programs through the integration of technology and sustainable practices that add business value.

    She designs and implements new operating models to assist clients with meeting requirements of a Corporate Integrity Agreement (CIA). And Implements stronger controls and sustainable practices that reduce risk; improve controls framework in R&D and Commercial areas to enhance compliance; and creates a compliant culture using leading practices, risk methodologies, and a collaborative approach with stakeholders.





Kari Loeser, Esq.
Senior Counsel, Jazz Pharmaceuticals, Palo Alto, CA

    Speaker Bio

    Senior counsel and senior director in the Corporate Compliance department at Jazz Pharmaceuticals. Advises on legal and compliance matters for the Oncology portfolio, medical affairs, and managed care/reimbursement activities. She also manages transparency and compliance field monitoring teams. She has published various articles, a book chapter on E­HEALTH AND ETHICS, and regularly presents at various conferences. She is currently authoring a book chapter in CANCER POLICY: PHARMACEUTICAL SAFETY. She is a licensed attorney, and is certified in Healthcare Compliance. She received her JD from DePaul University College of Law, and her BA with Honors from the University of Iowa.





Ben Rymzo
Managing Director, Huron Life Sciences, Boston, MA





Fernando Villegas, MS
Director, Oncology Marketing, Jazz Pharmaceuticals, Palo Alto, CA





Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP; Legal Counsel, Ad Hoc Sunshine and State Law Compliance Group, Washington, DC (Moderator)

    Speaker Bio

    Nikki Reeves is a partner in King & Spalding's FDA & Life Sciences Practice Group in Washington, D.C. She counsels pharmaceutical, biotechnology, and medical device companies on a broad range of FDA and healthcare regulatory compliance matters, including clinical trial regulation, product advertising/promotion, quality system regulation/good manufacturing practices, FDA enforcement actions, and federal healthcare compliance programs. Nikki is an expert on transparency laws applicable to life sciences manufacturers, including the federal Physician Payment Sunshine Act and state aggregate spend disclosure laws targeting the pharmaceutical and device industries. She co-leads the K&S Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical and device manufacturers that she advises on these state and federal laws. She also co-leads the International Marketing and Disclosure Compliance Group.
    Presentation Material (Acrobat)



3:30 p.m.



Networking Break












MINI SUMMIT XVI:




BUSINESS DEVELOPMENT PART 3: JOINT VENTURES AND CO-PROMOTION ARRANGEMENTS



2:30 p.m.



Introduction, Panel Discussion and Q&A

Yogesh Bahl, CPA, MBA
Managing Director, Alix Partners, New York, NY

    Speaker Bio

    Yogesh Bahl is a managing director at AlixPartners, where he leads the life sciences practice for the firm's Financial Advisory Services group. Yogesh has more than 20 years of experience with leading global investigations, litigation support, and enterprise improvement projects in the life sciences industry. He also has served as an arbitrator and an expert in matters involving pricing, marketing, breach-of-contract, intellectual-property and antitrust issues.

    Yogesh's areas of expertise include fraud and corruption investigations, third -party due diligence, compliance programs, and supply-chain risk management. He has helped companies manage issues with complex accounting, product diversion, counterfeiting and contract compliance.





Kathleen Hamill, Esq.
Assistant General Counsel, Johnson & Johnson, Philadelphia, PA





Kellie Combs, Esq.
Counsel, Ropes & Gray, Washington, DC (Moderator)

    Speaker Bio

    Kellie Combs provides legal and strategic advice to pharmaceutical and biotechnology companies on a broad range of regulatory issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Kellie has advised clients on promotional compliance matters, lifecycle management, regulation of clinical research, government investigations, and internal investigations and compliance audits. She has also performed regulatory due diligence in connection with transactions involving global life sciences companies and has served as FDA counsel in litigation involving First Amendment challenges to FDA's regulatory scheme governing manufacturer speech.
    Presentation Material (Acrobat)



3:30 p.m.



Networking Break












MINI SUMMIT XVII:




MARKETING AND MEDICAL AFFAIRS: WHERE IS THE LINE IN THE SAND?



2:30 p.m.



Introduction, Panel Discussion and Q&A

Brian J. Conner
Senior Director, Asst. Corporate Compliance Officer, Shire, Philadelphia, PA

    Speaker Bio

    Brian Conner is currently a member of Shire's Global Compliance & Risk Management team in April 2012 as Sr. Director. Brian provides compliance leadership to the Neuroscience and GI business units in the U.S. and Canada. He also provides primary compliance support to our aggregate spend efforts and team.

    Brian possesses a wealth of cross functional biopharmaceutical experience. He has held positions within the areas of corporate ethics and compliance, general management, regulatory affairs, quality assurance, manufacturing, sales/marketing and healthcare communications. He has worked for large and small companies like Merck, Saatchi and Saatchi, Stiefel Labs, and Genzyme.





Michael S. Labson
Partner, Covington & Burling LLP, Washington, DC

    Speaker Bio

    Mike is a member of the Food and Drug and Life Sciences practices at Covington & Burling LLP. Mike provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of life sciences cases, and works actively on corporate transactions and government investigations.

    Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School. He clerked for the Honorable David M. Ebel on the U.S. Court of Appeals for the Tenth Circuit. He is a Fellow of the American Bar Association, and a member of Covington's Management Committee.





Glenna Shen, JD, MBT
Executive Director, Worldwide Compliance and Business Ethics, Amgen Inc., Thousand Oaks, CA

    Speaker Bio

    Glenna Shen is Executive Director, Compliance with responsibility for the US Business and Global Functions at Amgen. Ms. Shen joined Amgen in 2000, and has held various positions in the Law Department and with Worldwide Compliance and Business Ethics, most recently heading up the Compliance function at Onyx Pharmaceuticals, and Amgen subsidiary. Ms. Shen obtained her Bachelor of Arts degree in Biology from the University of Miami and her Juris Doctor and Master of Business Taxation from the University of Southern California.





Mark A. DeWyngaert, MBA, PhD
Managing Director, Huron Life Sciences, New York, NY (Moderator)

Presentation Material (Acrobat)



3:30 p.m.



Networking Break












MINI SUMMIT XVIII:




STRUCTURING SPECIALTY PHARMACY DISTRIBUTION ARRANGEMENTS IN A TURBULENT REGULATORY ENVIRONMENT



2:30 p.m.



Introduction, Panel Discussion and Q&A

Thomas Beimers, Esq.
Healthcare, Compliance, and Government Investigations Attorney at Faegre Baker Daniels LLP, Minneapolis, MN

    Speaker Bio

    Tom Beimers represents a wide range of health care and life science industry clients in False Claims Act cases, government investigations, and other criminal, civil and administrative proceedings. Tom's practice includes the following types of engagements: Health Care Fraud and Abuse, White Collar and Investigations, Compliance and Risk Management and Litigation.

    Before joining Faegre Baker Daniels, Tom was senior counsel for administrative and civil remedies in the Department of Health and Human Services' Office of the Inspector General. At OIG, he investigated False Claims Act cases involving off-label marketing, drug pricing, Anti-Kickback Statute violations, and Medicaid and Medicare reimbursement. From 2008 to 2010, Tom served as Special Assistant U.S. Attorney in Detroit, prosecuting criminal health care fraud cases as part of the joint HHS-DOJ Medicare Fraud Strike Force.

    Tom is a frequent national speaker and author on topics related to health care fraud and abuse, white collar criminal defense, and compliance matters.





Catherine Clements
Senior Legal Counsel, Express Scripts, Indianapolis, IN

    Speaker Bio

    Catherine Clements serves as Senior Legal Counsel for Express Scripts, Inc., supporting specialty supply chain contracting. She joined the company in June. Prior to her position at Express Scripts, Catherine was an associate in the Healthcare and FDA group at Faegre Baker Daniels. Before attending law school, Catherine gained extensive experience in clinical research and the pharmaceutical industry, serving as a medical writer and project manager for Eli Lilly and Company and as a hospital clinical research coordinator. Catherine currently serves on the Editorial Advisory Board for the Food and Drug Law Journal.





John "Jack" S. Linehan, Esq.
Healthcare Attorney, Epstein Becker & Green, Washington, DC (Moderator)

    Speaker Bio

    John ("Jack") S. Linehan is an attorney in the Health Care and Life Sciences practice group of Epstein Becker & Green, P.C. in Baltimore, MD, and Washington, D.C. Jack specializes in pharmacy law and pharmaceutical distribution, reimbursement, and pricing issues. He counsels chain and independent pharmacies, drug manufacturers and distributors, managed care organizations, and other health care providers, suppliers, and payers on regulatory compliance matters. In addition, he represents health care clients in government investigations and civil and criminal enforcement actions involving the False Claims Act, the Anti-Kickback Statute, and the Food, Drug, and Cosmetic Act.
    Presentation Material (Acrobat)



3:30 p.m.



Networking Break












MINI SUMMIT XIX:




PAYERS AND PROVIDERS PART 2: VALUE PROPOSITIONS IN CONTRACTUAL RELATIONSHIPS -- REAL WORLD EVIDENCE, OUTCOMES RESEARCH, AND COMPARATIVE EFFECTIVENESS



2:30 p.m.



Introduction, Panel Discussion and Q&A

Kathleen Peterson, Esq.
Special Counsel, Cooley LLP, Washington, DC

    Speaker Bio

    Kathleen A. Peterson is a member of the Cooley Business department and is special counsel in the Firm's Health Care & Life Sciences Regulatory practice.

    Ms. Peterson has provided health regulatory counsel to a range of industry clients, including pharmaceutical and biologic manufacturers, distributors, PBMs, managed care organizations, specialty pharmacies, and investment firms.

    Prior to joining Cooley, Ms. Peterson was a partner in another leading law firm, where she was a key member of the Pharmaceutical Industry Health Regulatory practice group. Separately, Ms. Peterson has worked in-house as Senior Corporate Counsel to a pharmaceutical company, where she was the primary internal legal counsel for commercial sales and marketing issues.
      Education
    • Boston University School of Law
      JD (with honors in Health Law Concentration), 2000
    • State University of New York, College of Geneseo
      BA, 1997





Joseph Zimmerman
Former Senior Vice President and Chief Compliance Officer, Actavis plc; Former Global Chief Compliance Officer, Forest Laboratories, New York, NY





BJ D'Avella, MBA
Senior Director, Huron Life Sciences, New York, NY (Moderator)

    Speaker Bio

    BJ D'Avella has worked with global life sciences companies for over 12 years in the areas of regulatory compliance and compliance-focused business operations improvement. BJ has a keen understanding of the challenges facing clients in operations, data management, and support functions; he has leveraged this understanding to deliver performance improvement, results, and improved regulatory compliance to his clients.

    BJ has specialized in leading complex projects related to Commercial, Medical, and R&D Compliance, especially within the areas of Strategic Program Management, Monitoring Program Design and Automation, Corporate Integrity Agreement (CIA) support, and Fair Market Value (FMV) assessments.
    Presentation Material (Acrobat)



3:30 p.m.



Networking Break












    CLOSING PLENARY SESSION




4:00 p.m.





Millennials and the Future of Ethics and Compliance Programs: New Technologies and Eternal Issues

Sujata Dayal, Esq.
Vice President Health Care Compliance and Privacy, Pharmaceuticals, Johnson & Johnson; Former Global Chief Compliance Officer and Corporate Vice President, Biomet, Inc., Former Member PCF Executive Committee, Chicago, IL

    Speaker Bio

    Sujata Dayal is the Chief Compliance Officer for a 3 billion dollar global medical device company. 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. Experienced in setting up global compliance programs, including conducting risk-assessments, policy and procedure writing, training, monitoring and promotional review. Areas of expertise include health care compliance, FCPA and regulatory law.

    Specialties: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy






Andrew Foose, JD
Vice President, NAVEX Global's Advisory Services, Washington, DC

    Speaker Bio

    Andrew Foose, J.D., vice president with NAVEX Global's Advisory Services team, is a former senior trial attorney in the U.S. Department of Justice's Civil Rights Division. Andrew is recognized among the country's leading experts on conducting lawful and effective internal investigations and has trained thousands of attorneys, compliance officers, auditors and human resource professionals on best-practice investigative techniques and on how to write effective, comprehensive investigative reports. He currently works with organizations ranging from large multi-national companies to smaller non-profits to assess their ethics and compliance programs and to provide guidance on ways to enhance program effectiveness and efficiency.






Kelly B. Freeman, PhD
Vice President, Pharma and Medical Device Content, Global Health Care - Life Sciences, LLC, Former Senior Advisor, Ethics and Compliance, Eli Lilly and Company, Former Member, PCF Executive Committee, Indianapolis, IN






Professor Ann E. Tenbrunsel
Author of Blind Spots: Why We Fail to Do What's Right, and What We Can Do about It (with Max Bazerman); David E. Gallo Professor of Business Ethics, University of Notre Dame; Rex and Alice A. Martin Research Director of the Institute for Ethical Business Worldwide, Notre Dame, IN

    Speaker Bio

    Dr. Ann E. Tenbrunsel (Ph.D., Northwestern University; M.B.A. Northwestern University; B.S.I.O.E. University of Michigan) is a professor in the College of Business Administration at the University of Notre Dame and is the David E. Gallo Professor of Business Ethics. Ann teaches at the executive, MBA, and undergraduate levels. Her research interests focus on the psychology of ethical decision making, examining why employees, leaders and students behave unethically, despite their best intentions to behave to the contrary. Ann is the author, co-author, or co-editor of six books on this topic -- including her most recent Blind Spots (with Max Bazerman) -- and over 50 research articles and chapters. Her research has been featured in interviews and in a variety of publications, including MSNBC, National Public Radio, The New York Times, Wall Street Journal, US News and World Report, Sports Illustrated, Harvard Business Review, Forbes, Psychology Today and Freakonomics.






Aditi Taylor, MBA
Principal, Deloitte Advisory, Deloitte and Touche LLP, Boston, MA (Moderator)

    Speaker Bio

    Aditi Taylor has over 16 years of experience in Compliance Risk Advisory Services. She specializes in the Life Sciences industry and has extensive experience advising numerous Life Sciences companies identify, analyze and manage regulatory and compliance risks while maintaining efficient and effective business processes.

    Aditi advises companies on large transformational projects within an inherently dynamic regulatory and enforcement environment. She helps her clients understand the multiple dimensions and risks of varying customer interactions and engagement models, including healthcare professionals, payers and patients, in an effort to build efficient risk-based, sustainable compliance programs.

    Aditi brings a deep knowledge of interoperability of compliance risks across a broad set of functions, including Commercial, Regulatory Affairs, Medical Affairs, Legal, and Compliance. Her experience spans across assisting companies evaluate and build their compliance programs and culture of ethics and integrity, conduct focused risk assessments, executing auditing and monitoring programs to deeper dives within specific areas of commercial compliance including advertising and promotional programs, anti-bribery/anti-corruption, medical affairs, interactions with healthcare professionals, payer interactions, patient engagement, etc. Aditi has served several top clients in the Life Sciences industry and often worked with companies under or coming out of enforcement scrutiny.

    Aditi earned her Bachelor in Economics from University of Mumbai, India and a MBA from Bentley, University, Waltham, MA. She also has a Graduate Certificate in Pharmaceutical and Medical Device Law from Seton Hall Law School, NJ.










5:15 p.m.





Consolidation, Vertical Integration and Cross-Border Business: Confronting "Next Generation" Compliance Priorities

Michael S. Blume, Esq.
Director, Consumer Protection Branch, US Department of Justice, Civil Division, Washington, DC

    Speaker Bio

    Mr. Blume is the Director of the Consumer Protection Branch of the United States Department of Justice. Mr. Blume joined the Consumer Protection Branch in 2011, after having spent nearly nine years as a federal prosecutor in the United States Attorney's Office for the Eastern District of Pennsylvania. He is the recipient of several Department of Justice Awards, including the Attorney General's Award for Distinguished Service. Mr. Blume also practiced for the City of Philadelphia, for a private law firm, and as a clerk to a federal judge. Mr. Blume is a 1996 graduate of the Harvard Law School, where he served as an Editor of the Harvard Law Review.






Jill Fallows-Macaluso
Vice President, Chief compliance Officer, Novo Nordisk Inc., Plainsboro, NJ

    Speaker Bio

    As Chief Compliance Officer and Vice President for Novo Nordisk Inc., Jill Fallows-Macaluso is responsible for Novo Nordisk's compliance program in the United States. Prior to joining the Compliance Department in 2012, Ms. Fallows-Macaluso was Sr. Corporate Counsel in the Novo Nordisk Inc. Legal Department since 2003. Previously, Ms. Fallows-Macaluso was with the general corporate and healthcare practice of Day Pitney, LLP. Ms. Fallows- Macaluso holds a Bachelor of Science in Nursing from the University of Pennsylvania and a Juris Doctorate from Rutgers University School of Law.






Barbara Rowland, Esq.
Principal, Internal Investigations and White Collar Defense Group, Post & Schell, PC, Washington, DC

    Speaker Bio

    Barbara Rowland is a Principal in Post & Schell, P.C.'s Internal Investigations & White Collar Defense Practice Group resident in its Washington, D.C. Office. She focuses on representing corporations and their employees in various industries, including pharmaceutical and medical device manufacturing, retail pharmacy, pharmacy benefit management, health care and defense contracting. She conducts internal investigations, counsels clients subject to government investigation, and defends clients in litigation and at trial.

    Ms. Rowland has spent the majority of her career overseeing or defending white collar government and internal investigations from the vantage points of prosecutor, defense counsel and, most recently, in-house counsel for two major health care corporations -- CVS Health Corporation and Merck & Co., Inc. Ms. Rowland was an Assistant U.S. Attorney for eight years with the Civil Division of U.S. Attorney's Office of the Eastern District of Pennsylvania where she successfully managed the False Claims Act investigations of a pharmacy benefit management company, a generic drug manufacturer, and a large dental device manufacturer. In 2006 she received the Attorney General's "Award for Distinguished Service" in recognition of her resolution of pharmaceutical fraud cases.






Susan Williamson
Vice President and US Compliance Officer, Endo Pharmaceuticals, Philadelphia, PA

    Speaker Bio

    Experienced Compliance Officer in the Pharmaceutical industry with proven success in directing cross-functional, inter-departmental teams to ensure the development, implementation and enforcement of internal processes and procedures that promote compliance with applicable laws, industry guidelines and company standards. Adept at leveraging analytical and interpersonal skills to devise and implement tactical strategies that bring resolution to complex legal and business concerns.

    Prior to joining PhRMA, Ms. Roth was a lawyer in the Washington D.C. office of Sidley Austin LLP, where her practice focused on defense of government investigations and advising health care companies regarding compliance with fraud and abuse laws. Ms. Roth maintained an active pro bono practice, including litigation involving child custody and Medicaid benefits disputes. Ms. Roth received her law degree from the University of Virginia, where she served as an Articles Editor for the Virginia Law Review.






Kris Curry, MBA
Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP; Former Vice President, Health Care Compliance, Pharmaceuticals Group, Johnson & Johnson, Philadelphia, PA (Moderator)

    Speaker Bio

    Kris Curry is a Principal with Ernst & Young's Fraud Investigation & Dispute Services practice. Kris specializes in assisting health sciences companies with global risk and compliance assessments and analyses. Kris works closely with management teams and chief compliance officers to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives. Kris also assists clients in fraud investigations, compliance inquires and in strategizing responses to government subpoenas and other inquiries.

    Kris is a compliance and regulatory professional with more than 20 years of life science experience. Prior joining EY, Kris was the Vice President and Chief Compliance Officer for the Pharmaceutical Sector of Johnson & Johnson. As the CCO she was responsible for the development and implementation of a comprehensive global compliance program. She has first-hand experience managing and responding to government investigations, including the negotiating of settlements agreements.

    Kris brings deep, relevant experience in health care and life sciences, and she is a frequent lecturer at industry events. Her significant regulatory and compliance experience includes such diverse areas such as promotional compliance, research and development, sales and marketing practices, including off-label, fraud and abuse, government pricing and relationships with third parties.










6:00 p.m.





Keynote: Transparency International's New Pharma Industry Initiative

Robert Barrington, PhD
Executive Director, Transparency International-UK, London, UK

    Speaker Bio

    Robert joined Transparency International UK in 2008 and was appointed as Executive Director in 2013. His areas of expertise include the Bribery Act, integrity in the private sector and corruption within the UK. Recent projects and publications include 'Anti-Bribery Due Diligence for Transactions', 'Adequate Procedures -- Guidance to the UK Bribery Act' and 'Corruption in the UK'. He was previously Director of Governance & Sustainable Investment at F&C Asset Management, and CEO (Europe) of the environmental research group Earthwatch Institute.

    He was a member of the Ministry of Justice's Experts Group drafting the official guidance on the Bribery Act and formerly a member of the of the UK Government's Export Guarantees Advisory Committee. He has a degree from Oxford University, where he recently held a 3-year Visiting Fellowship, and a PhD from the European University Institute.
    Presentation Material (Acrobat)






Introduction by Christine Longawa, CPA, CFE
Associate Director, Healthcare & Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Inc., Chicago, IL

    Speaker Bio

    Christine Longawa, CPA, CFE is an Associate Director in Navigant's Healthcare and Life Sciences Disputes, Regulatory, Compliance, and Investigations Practice. Christine began her career in public accounting, specializing in financial statement audits of life sciences organizations. Since joining Navigant in 2008, Christine has assisted numerous clients in developing, analyzing, monitoring and auditing their global compliance programs. Christine has expertise in serving as and managing the Independent Review Organization (IRO) and Pre-IRO for several life sciences companies. She has experience working on Corporate Integrity Agreement Board Advisor engagements and compliance effectiveness reviews. In addition, Christine has supported her clients with their field force monitoring and aggregate spend obligations.










6:30 p.m.



Adjournment




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