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

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   Monday, November 3, 2014
   Preconference Symposia (Optional; Choose one)

7:30 a.m.

Congress Registration Opens

    8:30 a.m.

Preconferences Commence (Choose one)



8:30 a.m.

Introduction, Panel Discussion and Q&A

Brian A. Bohnenkamp, JD, MHA
Senior Associate, FDA & Life Sciences Practice Group, King & Spalding, Washington, DC

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

    Speaker Bio

    Principal of Porzio, Bromberg & Newman, P.C. and Executive Vice President, Porzio Life Sciences, LLC

    He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their understanding of acceptable practices and conduct in meeting compliance requirements of all 50 states and the District of Columbia.

    He is also a principal of the law firm, Porzio, Bromberg & Newman, P.C., and practices in the Pharmaceutical Marketing and Sales Compliance 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 serves 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 a 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.

9:15 a.m.

Domestic Commercial Transparency: Disclosure, Aggregate Spend and Sunshine

Kate Farrington
Associate Director, Aggregate Spend, Actavis, New York, NY

9:45 a.m.

Global Transparency

Anthony Brennan
Senior Director, HCC Governance, Metrics and Reporting, Johnson & Johnson, New York, NY

Katrina Cahill
Global Transparency Lead, Biogen Idec, Cambridge, MA

    Speaker Bio

    Katrina Cahill is the Global Transparency Lead in the Global Compliance department at Biogen Idec based in the US headquarters in Cambridge where she is responsible for the design and implementation of all the global disclosure requirements. Katrina was responsible for the Sunshine Act implementation in the US over the past 2 years along with state reporting. Over the past 12 months, Katrina has led an assessment of each country requirement including the EFPIA Disclosure Code to provide strategic direction to Biogen Idec to ensure compliance with all the disclosure Codes and Laws. Prior to joining Biogen Idec, Katrina built and led a US Finance Operations team at Genzyme Corporation. Katrina holds a Masters degree in Modern History from St. Catherine's College, Oxford University and a Bachelors degree from the University of Wales, Swansea.

David Wysocky, MBA
Partner, PwC, New York, NY

10:30 a.m.


10:45 a.m.

Global Transparency (Continued)

11:30 a.m.

R&D and Medical Affairs Transparency

Karen D. Green
R&D Health Care Compliance Officer, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ

    Speaker Bio

    Karen is responsible for providing strategic Health Care Compliance support to the therapeutic areas and centers of excellence within Janssen Research & Development, LLC. Karen provides leadership and strong partnership to identify and implement policy, procedure, process and oversight in an effort to continue to strengthen our HCC framework.

    Most recently, Karen was Director, Health Care Compliance for Janssen Commercial North America, Central Nervous System. In this role, Karen was responsible for the implementation of an effective compliance program through the creation and facilitation of systems and transactions that define allowable practices under the health care regulatory, fraud and abuse and privacy laws; and through the provision of appropriate education, training, and regular guidance to employees.

    Karen holds a BA from Mount Saint Mary's University and is a certified Green Belt and Certified Compliance and Ethics Professional.

Seth Whitelaw, JD, LLM, SJD
Director, Life Sciences Regulatory Compliance Practice, Deloitte & Touche LLP; Former R&D Compliance Officer, GlaxoSmithKline; Former Legal Compliance Officer, SmithKline Beecham, Philadelphia, PA

    Speaker Bio

    Seth is a Director in Deloitte & Touche's Enterprise Risk Services Group focusing on Health Sciences. He has more than 20 years of experience in the Life Sciences and Healthcare industries in the areas of food and drug law, and transparency as well as corporate governance and compliance for medical devices, pharmaceutical sales and marketing, and pharmaceutical R&D. Most recently, Seth served as Compliance Officer for GlaxoSmithKline R&D. Previously, he was Legal Compliance Officer, Pharmaceuticals NA for SmithKline Beecham Pharmaceuticals and before that, Senior Attorney and Compliance Coordinator for C. R. Bard, Inc. where he was responsible for implementing and managing Bard's Global Compliance Program in addition to providing advice on various food and drug matters.

Mary Bradley, PharmD
Healthcare Compliance Officer, Johnson & Johnson, Titusville, NJ (Moderator)

    Speaker Bio

    Mary Bradley is the Health Care Compliance Officer for Janssen Global Services, Pharmaceuticals Group Healthcare Compliance, Johnson & Johnson. In this role, Mary provides HCCguidance and support for the global commercial organizations in the Pharmaceutical Sector. Mary has held previous compliance roles in support of US Commercial and Medical Affairs organizations as well as roles within Medical Affairs. Prior to joining Johnson & Johnson, Mary worked in academia and clinical practice. Mary received her Bachelor in Pharmacy and Doctor of Pharmacy degrees from Rutgers University.

12:00 p.m.

Preconference Adjournment; Lunch on your Own



  • The Use of Risk Assessments to Guide Audit Planning and Ensuring Alignment with the Business
  • Compliance Auditing Best Practice
    • Drivers for Continued Focus on Compliance Auditing -- Data Collection, Analysis and Reporting, etc.
    • Compliance Audit Focus Areas -- Where are We Seeing the Highest Risks?
    • Strategies for Conducting Effective Risk-Based Control Audits
    • Legal Considerations -- When Should an Audit be Privileged, if Ever?
  • Compliance Monitoring Best Practices
    • Drivers for Continued Focus on Compliance Monitoring -- CIA's, Commercial, R&D, etc.
    • Types of Monitoring -- Physical, Electronic, Risk-Based Targeting and Scoring Process
    • Strategies for Identifying Trends in Monitoring Results
  • Maintaining Appropriate Stakeholder Awareness of Compliance Risk through Effective Reporting
  • Panel/Audience Discussion on Different Approaches, Perspectives and Practices
  • A Look to the Future: What's Needed, What's Wanted, and What Do We Need to Get There in the Next 2-5 Years?

8:30 a.m.

Welcome and Introduction

BJ D'Avella, MBA
Director, Huron Consulting Group, New York, NY

    Speaker Bio

    BJ D'Avella has worked with global life sciences companies for over 11 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 technology-enabled performance improvement, data analytics, 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 Clinical Trial Disclosures and Data Quality, Monitoring Program Design and Automation, Corporate Integrity Agreement (CIA) support, and Fair Market Value (FMV) assessments.

Jae Burnett
Director of Compliance, Masimo, Los Angeles, CA

    Speaker Bio

    Ms. Burnett is the Director of Compliance at Masimo Corporation. In her role, Ms. Burnett is responsible for enhancing, coordinating, and implementing the Corporate Compliance Program. Prior to joining Masimo, Ms. Burnett was a leader in Deloitte's Regulatory Consulting practice where she worked with numerous global pharmaceutical and medical device clients to identify compliance risks, develop risk frameworks, conduct remediation activities, develop compliance controls, establish policies and procedures, and define ongoing monitoring processes. Her experience includes business process and systems transformation and rationalization, designing, implementing and executing on compliance programs and overall compliance activities to satisfy OIG guidance, PhRMA Code and AdvaMed standards.

Eve Costopoulos
Vice President, Chief Ethics and Compliance Officer, Eisai Inc., Woodcliff Lake, NJ

    Speaker Bio

    Eve Costopoulos is vice president and chief ethics and compliance officer of Eisai Inc., responsible for leading the company's commercial and R&D compliance programs as well as internal audit activities. She also serves as a member of the company's Executive Committee.

    Prior to joining Eisai in 2010, Ms. Costopoulos was employed at Schering-Plough Corporation, where she was responsible for managing the activities of the company's global compliance officers. During her tenure there, she implemented and oversaw compliance training activities, the global privacy program, integrity action line and compliance-related investigations, and compliance-related board support. Earlier in her career, Ms. Costopoulos worked as an attorney holding the position of in-house counsel with Schering-Plough and, prior to that, in private law practice.

Dan Dalton, MBA, JD
Senior Vice President, Chief Compliance Officer, Salix Pharmaceuticals, Raleigh, NC

    Speaker Bio

    Dan Dalton, MBA, JD is Senior Vice President and Chief Compliance Officer at Salix Pharmaceuticals, Inc. in Raleigh, NC. Prior to joining Salix, Dan was Managing Counsel at Merck & Co. Inc. and most recently was Vice President and Chief Compliance Officer at Hill-Rom. Dan studied at Lehigh University where he obtained his BS in Accounting and then his MBA. Dan also studied at University of Pennsylvania where he received his JD. Dan possesses a robust legal background and is an expert in Compliance and Government Investigations, Healthcare Regulations including FDA and Fraud & Abuse, Sales, Marketing, Promotion and Pricing Practices as well as Litigation Management.

Erik Eglite, MBA, JD, DPM
Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Pharmaceuticals, Chicago, IL

Kevin L. Espinoza, MBA
Vice President, Ethics & Compliance, BTG International, Raleigh, NC

    Speaker Bio

    Kevin Espinoza, Global Vice President of Ethics & Compliance at BTG International, has spent over a decade introducing, managing and leading Pharmaceutical and Medical Device Compliance Programs. At large and Mid-Size companies, Kevin has been responsible for international and US commercial compliance. Kevin has also served as an R&D Compliance Officer. Prior to his work in Compliance, Kevin served in various sales, marketing, and corporate affairs roles at a large Pharmaceutical Manufacturer. Kevin, his family of six, and stable of animals live in Wake Forest North Carolina.

David Gherlein, Esq.
Director, R&D Compliance at Takeda Pharmaceuticals USA, Chicago, IL

Darren R. Jones
Director, Polaris, New York, NY

Paul J. Silver
Practice Leader and Managing Director, Huron Consulting Group, 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.

L. Stephan Vincze, LD, LLM, MBA
Partner, Polaris; Former Senior Vice President, Chief Compliance Officer, Warner Chilcott; Former Vice President, Ethics and Compliance Officer/Privacy Officer, TAP Pharmaceutical Products Inc., Boston, MA (Moderator)

12:00 p.m.

Preconference Adjournment; Lunch on your Own



  • Internal Investigations
    • Best Practices in Conducting Internal Investigations
    • Issues Related to Voluntary Disclosure
    • Attorney-Client Privilege
    • How to Conduct Internal Investigation Cross Examinations
    • Coordination with HR, Legal and Business
  • Responding to Government Investigations
    • Best Practices in Responding to Government Investigations
    • Search Warrant
    • Grand Jury Subpoena

8:30 a.m.

Welcome and Introduction

Sarah K. diFrancesca, Esq.
Associate, Health Care and Life Sciences Regulatory Group, Cooley, LLP, New York, NY

    Speaker Bio

    Sarah K. diFrancesca is a senior associate in the Health Care & Life Sciences Regulatory group at Cooley LLP. Ms. diFrancesca's practice focuses on fraud and abuse, compliance, and regulatory issues within the pharmaceutical, medical device, and biotechnology industries. Ms. diFrancesca's experience includes representing health care entities in connection with federal and state government investigations, inquiries, settlements, and voluntary disclosures; advising on federal and state transparency laws; conducting internal compliance reviews and investigations; advising Boards of Directors on internal investigations and compliance-related matters; and counseling clients on federal and state health care fraud and abuse issues, compliance and regulatory parameters, and industry guidance.

Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY

    Speaker Bio

    Gary F. Giampetruzzi is a partner in the Litigation Department of Paul Hastings, based in the firm's New York office. Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc., with responsibility for government investigations across the company's multiple business units and operations globally, and associated government litigation with U.S. and international prosecutor offices.

    He advises clients on day-to-day compliance matters, and represents corporations in federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, the Foreign Corrupt Practices Act ("FCPA"), and oversees other complex civil and criminal litigation matters.

Elizabeth J. Gorman, Esq.
Vice President, Legal Commercial, Acorda Therapeutics, Inc., Ardsley, NY

    Speaker Bio

    Elizabeth Gorman, J.D., has been with Acorda Therapeutics since 2013. Ms. Gorman serves as Vice President, Legal managing the commercial legal team and responsible for the legal support of various departments including Commercial as well as Corporate Communications. Before joining Acorda, Ms. Gorman was with UCB, Inc., for three years and with Schering-Plough Corporation for seven years, holding various leadership positions, including Associate General Counsel and Executive Director and Associate General Counsel, respectively. Previously, Ms. Gorman specialized in litigation at Dewey Leboeuf. Ms. Gorman graduated magna cum laude from Seton Hall University, and earned her J.D. from Seton Hall University School of Law.

Liz Lewis, Esq.
Chief Counsel and Chief Compliance Officer and Head, Patient Advocacy, Takeda Pharmaceuticals International Co/Millennium: The Takeda Oncology Company, Boston, MA

    Speaker Bio

    Liz Lewis is Chief Counsel & Chief Compliance Officer Millennium: The Takeda Oncology Company/Takeda Pharmaceuticals International Co. She has been instrumental in creating Millennium's legal and compliance functions that support the global oncology business and has played an integral role in the successful launch, commercialization and market expansion of VELCADE. Liz has more than 20 years of legal expertise advising manufacturers, payors and other ancillary providers in the health care life sciences space. Prior to Millennium, she served as a partner in the national health law practice of Epstein, Becker & Green, a D.C.-based law firm. She was inducted into the Takeda Leadership Institute, serves as the chair for various steering committees, and is an active participant in industry trade organizations, PhRMA and BIO, often being asked to provide legal and compliance leadership. Most recently, the Boston Business Journal named Liz as one of the top 20 "2014 Women to Watch" in the life sciences industry.

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

    Speaker Bio

    Michael K. Loucks, a nationally recognized health care fraud prosecutor, joined the firm as a litigation partner in the Boston office in July 2010. With 25 years in public service, Mr. Loucks most recently was Acting U.S. Attorney and First Assistant U.S. Attorney for the District of Massachusetts, where he led major criminal and civil investigations, as well as many of the most high-profile health care fraud prosecutions of the past two decades.

    Before serving as Acting U.S. Attorney, Mr. Loucks had a long history in the Massachusetts U.S. Attorney's Office. He was First Assistant U.S. Attorney (2005-2009); White Collar Crime Section Chief (2005); Health Care Fraud Unit Chief (1997-2004); and Health Care Fraud Coordinator (1992-2004).

    Mr. Loucks speaks frequently at seminars and symposia on prosecutions, corporate compliance and litigation-related issues associated with the health care, pharmaceutical and medical devices sectors. He also writes extensively on these topics and is the co-author of Prosecuting and Defending Health Care Cases, the leading treatise in the area.

    In 2011, Mr. Loucks received the Burton Award for Legal Achievement, which recognizes excellence in legal scholarship. He was selected in the Boston Business Journal's inaugural "Who's Who in Legal Services" (March 11, 2011).

12:00 p.m.

Preconference Adjournment; Lunch on your Own



  • Implementing a Global Compliance Program: Practical Operational Challenges and Issues
  • Sponsorship of HCPs: Understanding the New Landscape
  • Negotiating, Managing, Auditing and Monitoring Third Party Relationships
  • Global HCP/KOL Engagement Management
  • Developing Effective Strategies for Working with the Business
  • Medical/Commercial Boundaries in the Global Context

8:30 a.m.

Welcome and Introduction

Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners, 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.

Rachel Batykefer, CCEP
Associate Director, Compliance, Teva Pharmaceuticals; Former Manager, Compliance Education, Tyco International, Philadelphia, 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.

Michael D. Bell, Esq.
President, R-Squared, Princeton, NJ

    Speaker Bio

    Michael is a nationally recognized compliance attorney who frequently consults, publishes and presents on topics of healthcare corporate compliance, privacy and third party coverage and reimbursement issues.

    With more than 15 years of direct involvement in compliance and regulatory matters, Michael serves on manufacturer, health system and health plan compliance committees, as well as several Advisory Boards, including those for BNA's Medical Device and Law Report, Matthew Bender/LexisNexis Healthcare, AIS Report on Patient Privacy, and Seton Hall University School of Law's Corporate Compliance Officer Certification Program.

Paul Curtin, Esq.
Compliance Officer - Global Research and Development, Actavis; Former Head of Compliance - Ex-US, Forest Laboratories, New York, NY

    Speaker Bio

    Paul Curtin is currently the Head of Global Research & Development Compliance for Actavis, plc after having served as the International Compliance Officer & Deputy Compliance Officer for Forest Laboratories, Inc. prior to its acquisition by Actavis earlier this 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.

David Hodgson, CPA
Partner, Deloitte & Touche LLP, New York, NY

    Speaker Bio

    David Hodgson is a Partner with Deloitte & Touche LLP where he serves as the Global Leader of Enterprise Risk Services for Life Sciences and Healthcare. David's focus is on helping organizations enhance their risk management capabilities and their mechanisms for responding to high-impact risks. David specializes in the Life Sciences industry and has worked extensively with large, global companies to assist them in responding to the requirements of laws, regulations and industry codes. In this capacity he has worked extensively with the world's largest Life Sciences companies on Compliance-related issues.

Kirt Kraeuter, MGA
Head of Compliance, European Markets, Australia/New Zealand, and Canada, Bristol-Myers Squibb, Philadelphia, PA

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

    Speaker Bio

    YUET MING THAM is a partner at Sidley Austin in Hong Kong. She has extensive experience advising major U.S./European pharmaceutical, medical devices and healthcare services companies on regulatory and compliance issues, clinical trials, labeling, promotional and marketing regulations as well as on a variety of contractual/commercial matters.

    She was previously a Deputy Public Prosecutor in Singapore, and the Asia-Pacific Regional Compliance Director for Pfizer, during which she was responsible for compliance and investigations. Prior to joining Sidley, Yuet was the Head of the Asia Life Sciences Practice at another international law firm.

    Yuet is admitted to practice in England and Wales, Hong Kong, Singapore as well as New York, and she speaks fluent English, Malay, Mandarin and Cantonese. Yuet sits on the Advisory Board of Seton-Hall University's Healthcare Compliance Program for Asia.

    Ms. Tham is acknowledged as a leading lawyer by Chambers Asia Pacific in four categories, namely, Dispute Resolution, Anti-Corruption, Life Sciences and Contentious Financial Regulatory. Additionally, she is recognized in the Regulatory categories in IFLR 1000 and Asia Pacific Legal 500. In 2014, Yuet was the only lawyer awarded the Client Choice award by International Law Office in the Hong Kong White Collar Crime practice.

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

    Speaker Bio

    Keith Korenchuk is a partner in the FDA and Healthcare practice of Arnold & Porter, LLP in Washington D.C. He counsels and advises pharmaceutical, life sciences, medical device, biotechnology, and specialty pharmacy companies in the United States and worldwide on regulatory and compliance matters, including on the following matters:
    • US and global compliance systems design, implementation, and ongoing assessment
    • Regulatory matters involving healthcare professionals, including fraud and abuse, off-label promotion, False Claims Act and transparency related issues
    • Global anti-bribery legislation, including the US Foreign Corrupt Practices Act, the Organization for Economic Co-operation and Development (OECD) Anti-bribery Convention, and related national implementing legislation
    • Internal and government initiated investigations
    • State legislation involving pharmaceutical and medical device marketing and disclosure
    • Global, regional, and country specific codes of practice and conduct, including codes issues by Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and Eucomed
    • Enterprise-wide risk management systems and programs
    • Pharmaceutical price reporting and third party/managed markets negotiations

12:00 p.m.

Preconference Adjournment; Lunch on your Own

    DAY I
    Monday, November 3, 2014


1:00 p.m.

Welcome and Introduction

Gary DelVecchio
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.

Margaret K. Feltz
Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co-chair)

    Speaker Bio

    Ms. Feltz is 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.

    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. Outside of Purdue, Maggie serves as Co-Chair of the Pharmaceutical Compliance Forum.

Kelly B. Freeman, PhD
Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN (Co-chair)

    Speaker Bio

    Kelly B. Freeman, Ph.D. has been employed by Eli Lilly and Company for 26 years. Currently she is an Ethics and Compliance Officer within the Global Ethics and Compliance organization. Her current responsibilities include oversight of the strategy and capabilities for the global monitoring program. Previous assignments have included Ethics and Compliance Officer for Lilly Oncology, for Lilly Research Laboratories, and for Lilly USA. Other roles at Lilly before her career in Ethics and Compliance included Regulatory Scientist and Bioanalytical Chemist. In her role as a Regulatory Scientist, she was responsible for the NDA submission for the oncology drug Gemzar (gemcitabine HCI). Dr. Freeman received her B.S. in chemistry from Miami University in Oxford, OH and her Ph.D. in analytical chemistry from the University Of Oklahoma.

Elizabeth V. Jobes, Esq.
Senior Vice President, Chief Compliance Officer, Auxilium Pharmaceuticals Inc., Philadelphia, PA (Co-chair)

    Speaker Bio

    Elizabeth (Liz) is responsible for the compliance program for Auxilium Pharmaceuticals, Inc. located in Chesterbrook, Pennsylvania. Auxilium Inc. is a specialty bio-tech pharmaceutical company which specializes in Men's Health and currently has 12 products in its portfolio. Liz's primary role as Chief Compliance Officer is to support and enhance the compliance program for all functions within the company. Prior to joining Auxilium in May of 2012, Liz was Vice President, Chief Compliance Officer for Adolor Corporation. She created the compliance department for Adolor as the company's first commercial product was launched and stayed with the company until after it was acquired by Cubist Pharmaceuticals.

1:30 p.m.

OIG Update

Mary E. Riordan, Esq.
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC

    Speaker Bio

    Mary Riordan is a Senior Counsel in the Office Inspector General (OIG) for the U.S. Department of Health and Human Services. She primarily handles cases brought under the federal False Claims Act involving alleged fraud against the Medicare and Medicaid programs, and she focuses on matters involving drug and device manufacturers. She has represented the OIG in the negotiation of numerous settlements and Corporate Integrity Agreements with such providers. She was a co-author of the OIG's 2003 Compliance Program Guidance for Pharmaceutical Manufacturers and a co-organizer of the OIG's February 2012 Pharmaceutical Compliance Roundtable. In addition, Ms. Riordan handles prescription drug and device related issues associated with recent legislation, including the 2010 Affordable Care Act.

2:15 p.m.

US DOJ Update

Sara Miron Bloom, Esq. (Subject to DOJ Approval)
Assistant United States Attorney, US Attorney's Office, District of Massachusetts, US Department of Justice, Boston, MA

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

Charlene Keller Fullmer, Esq.
Assistant United States Attorney, US Attorney's Office, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA

John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)

    Speaker Bio

    John Bentivoglio represents pharmaceutical, medical device and biotechnology manufacturers in FDA and health care regulatory issues, compliance programs, and civil and criminal investigations by federal and state law enforcement agencies. He advises on federal and state anti-kickback and false claims statutes, FDA advertising and promotional rules, and Medicare and Medicaid regulatory issues. Mr. Bentivoglio has extensive experience developing, implementing and assessing corporate compliance programs in line with the U.S. Sentencing Commission and HHS OIG guidelines, and with state compliance program laws and regulations. In addition, he has assisted pharmaceutical and medical device manufacturers in investigations by various U.S. attorney's offices, the Criminal and Civil Divisions of the DOJ, and state attorneys general; and negotiated several corporate integrity agreements.

3:00 p.m.


Thomas W. Abrams, RPh, MBA
Director, Division of Drug Marketing, Advertising, and Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD

    Speaker Bio

    Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. Mr. Abrams has held the positions of Acting Director, Acting Deputy Director, and Branch Chief in DDMAC. He joined FDA as a reviewer in DDMAC where he was primarily responsible for reviewing promotional material for cardiovascular products. Prior to joining FDA, Mr. Abrams worked in pharmaceutical sales and marketing for Merck and Company. Mr. Abrams received his B.S. degree in pharmacy from the School of Pharmacy, Rutgers University and his M.B.A. degree from Rutgers School of Business.

3:30 p.m.


4:00 p.m.

Compliance Officer Roundtable

Regina Gore Cavaliere, Esq.
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Princeton, NJ

    Speaker Bio

    Since 2009, Ms. Cavaliere has led the Ethics, Quality & Compliance group comprised of corporate compliance, privacy and information security, quality management and clinical quality management teams. Prior to joining Otsuka, Ms. Cavaliere was the Vice President and Senior Counsel for Healthcare Law Compliance with Alpharma Pharmaceuticals. She also worked at Bristol-Myers Squibb for ten years in various roles. She was graduated magna cum laude from Seton Hall University with a B.A. in English and received her J.D. from Rutgers University School of Law, where she was the Managing Production Editor of, and published author in, the Rutgers Computer and Technology Law Journal. Ms. Cavaliere also pursued additional studies at the Jagiellonian University in Krakow, Poland.

Sujata Dayal
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

Laurie D'Alessio
Vice President, Global Compliance Organization, Merck & Co., Inc., Whitehouse Station, NJ

    Speaker Bio

    Lori is currently a member of Merck's Global Compliance Organization. She is Vice President and Divisional Compliance Officer, supporting the U.S. Market and the Global Human Health's headquarters functions. In this role, Lori leads the teams responsible for compliance of significant marketing, sales and support activities. Prior to joining the Global Compliance Organization, Lori was a member of Merck's Office of General Counsel, beginning in the Manufacturing Division in 1991. Lori then moved on to roles of increasing responsibility in Corporate (securities reporting, finance, tax and transactional practices) and Business Development, Licensing and Joint Ventures. After working on the Merck-Schering Plough merger transaction, Lori joined the Integration Management Office. She joined the GCO in December 2009.

    Lori received her J.D. from Cornell Law School and her B.A. in political science from Muhlenberg College.

Michael L. Shaw, Esq.
Vice President and Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services; Former Member, PCF Executive Committee, Philadelphia, PA

    Speaker Bio

    Mr. Shaw is currently responsible for leading a values-based compliance program for GlaxoSmithKline North America Pharmaceuticals and Global Franchises. Mr. Shaw previously served as Global Head of Ethics & Compliance for Novartis Oncology, Deputy Compliance Officer for Novartis Pharmaceuticals Corporation, Director in PricewaterhouseCoopers' Global Pharmaceutical & Health Sciences Practice, Senior Counsel in the HHS OIG, and in-house counsel for Olsten Health Services. Mr. Shaw is current Chair of the Chief Compliance Officer Committee of PhRMA and a former Co-Chair in the Pharmaceutical Compliance Forum.

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

5:00 p.m.

Adjournment and Networking Reception

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