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.

Judy Lynch is Senior Vice President, Employee Services at GlaxoSmithKline and its predecessor SmithKline Beecham. Lynch currently is working on the HR implementation Team on the 3 Part Deal between GSK and Novartis which will close in 2015. She was also a lead in the integration of the acquisition of Human Genome Sciences acquired by GSK in mid 2012 for $3b. Lynch has lead the implementation of the HR components of GSK's Corporate Integrity Agreement (CIA) with the US Government. This has given Judy experience in the risk management and compliance areas of the company.

Michelle Shwery, MSc, MBA has been employed by Eli Lilly and Company for 24 years based at corporate headquarters in Indianapolis for the past 17 years. Currently she is the Senior Director, Ethics and Compliance responsible for the corporate functions (R&D, Medical Affairs, Marketing, Corporate Affairs & G&A). Prior to this assignment she was responsible for Lilly's Enterprise Risk Management program. Ms. Shwery spent 5 years as the Senior Director responsible for medical operations in affiliates throughout South America, Asia, Middle East, Africa, as well as for the countries of Australia, Canada, Mexico, Russia and Turkey.

Erinn Hutchinson is a Partner in PwC's Pharmaceutical and Life Sciences Practice, based in Shanghai. Erinn has fifteen years of experience providing business advisory services to pharmaceutical and medical device companies in the areas of compliance , risk management, and performance improvement. Her expertise includes providing comprehensive risk assessment services on a broad range of health care and pharmaceutical operational issues including corporate compliance, monitoring and auditing, corporate integrity agreements, commercial regulations, reimbursement, anti-bribery, and due diligence for mergers and acquisitions. In addition to extensive experience in the U.S. and China, Erinn has performed compliance assessment reviews in Brazil, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Italy, Mexico, Poland, Portugal, Russia, and the Ukraine.

Jamie M. Bennett joined Ashcraft & Gerel, LLP after over twenty years as an Assistant United States Attorney in the United States Attorney's Office for the District of Maryland. Ms. Bennett spent the last decade of her government service investigating civil and criminal fraud claims on behalf of the United States under the False Claims Act. Her successful investigations include a 2009 Anti-Kickback settlement with Alpharma Pharmaceuticals, Inc. and a 2010 settlement with St. Joseph Medical Center. Before she became a member of the USAO's civil frauds enforcement unit, Ms. Bennett was assigned to the Narcotics Division where she prosecuted drug and drug-related murder cases, including the first federal death penalty case in Maryland.

Suzanne E. Durrell is the founder of Durrell Law Office, an affiliate of the Whistleblower Law Collaborative in Boston. The Collaborative has successfully represented relators in many cases including ones involving Amgen, Pfizer, Forest, Elan, Eisai, WellCare, and Amedisys. Ms. Durrell served as Chief, Civil Division, U. S. Attorney's Office, Boston, supervising and prosecuting False Claims Act cases, and as Deputy Associate Attorney General at the Department of Justice in Washington, D.C. She received the Attorney General's Award for Exceptional Service, the most prestigious recognition bestowed by the Department. Ms. Durrell is a graduate of Georgetown University Law Center and Swarthmore College.

Lesley Ann Skillen is a partner in Getnick & Getnick LLP, a Manhattan-based law firm focusing on anti-fraud litigation and business integrity. She coordinates the firm's False Claims Act qui tam whistleblower practice area and has been representing qui tam plaintiffs since 1993. Cases include a $750 million settlement with GlaxoSmithKline relating to adulterated drugs, a $251 million drug pricing case against Bayer and a $182 million recovery from LabCorp relating to billing for unnecessary blood tests. She and her partners have twice been nominated for the Public Justice Foundation Trial Lawyer of the Year Award for their whistleblower cases.

Virginia Gibson is a partner at Hogan Lovells in its Investigations and White Collar Defense group. She focuses on internal investigations, defense against government investigations, and criminal and civil False Claims Act litigation in the life sciences and health industries. A federal prosecutor for over 20 years in Philadelphia and Delaware, she served variously as First Assistant, Executive Assistant and Civil Chief and prosecuted some of the largest pharmaceutical and health care fraud cases to date.

Paul Kalb, who heads the firm's national Healthcare practice and serves as a Global Coordinator of its Life Sciences practice, 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 wide range of healthcare clients. He has successfully represented many of the world's leading drug, biotech and device manufacturers and hospitals in criminal, civil, and administrative enforcement actions involving healthcare fraud and abuse and off-label promotion. He has led teams that defended numerous matters and negotiated ground-breaking settlement agreements and Corporate Integrity Agreements.

Tom Cornely is currently a Health Care Compliance Officer at Johnson & Johnson. In his current role, Tom has Health Care Compliance oversight of the Janssen Biotech Immunology Commercial team. He has held this role for the past 18 months and also has 2 additional years of Health Care Compliance experience within Johnson & Johnson's Consumer Products sector.

Tom also has over 17 years of experience at Johnson & Johnson, including Management roles within the Information Technology, Marketing, and Procurement functions. Tom is a Certified Compliance & Ethics Professional and a graduate of LaSalle University in Philadelphia.

Mr. Pina is the Managing Principal of Core Risks Ltd. (CRL). His practice focuses upon:

• Compliance & Ethics programming
• Internal corporate investigations
• Enterprise Risk Management
• Corporate Crisis Management
• Arbitration of complex commercial and insurance disputes

A graduate of the Dickinson School of Law, Pennsylvania State University, and the Rutgers University College of Pharmacy, Mr. Piña has served as an Adjunct Professor of Food and Drug Law at Temple University and is co-editor of An Introduction to Food and Drug Law and Regulation (FDLI), used to teach Food and Drug Law in numerous law schools and graduate regulatory programs.

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.

Eric Siegel is Executive Vice President & General Counsel for Incyte Corporation in Wilmington, DE. In this role, he has responsibility and oversight for all legal and compliance matters for the company. He joined Incyte in October of 2010. Prior to his role at Incyte, Eric was the Chief Compliance Officer at EMD Serono, Inc. as well as Vice President, Deputy General Counsel & Chief Compliance Officer at Cephalon, Inc. In earlier years, Eric held roles of increasing responsibility with SmithKline Beecham and GlaxoSmithKline.

Mr. Jack Tanselle is a Managing Director at Navigant Consulting, Inc. with over fifteen years of life sciences experience in management roles and consulting. Jack has extensive experience in the pharmaceutical, biotechnology, and medical device industries assisting clients with the identification, mitigation and management of key business, legal and compliance risks.

Jack's subject matter expertise is focused on compliance effectiveness, serving as the advisor to the Board of Directors for a top ten biopharmaceutical company, serving as the Independent Review Organization for multiple pharmaceutical companies under Corporate Integrity Agreements (CIA), and supporting numerous other clients with improving compliance program effectiveness, including through program development and rollout, effectiveness assessments, and annual compliance auditing and monitoring.

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.

Michael Driscoll is currently a Senior Manager at Johnson and Johnson in the Pharmaceutical Sector of its Health Care Compliance Department. He leads the Department's Oversight & Monitoring Group, focused on compliance and analytics of HCP interactions. Mr. Driscoll has a Bachelors Degree in Accounting from Muhlenberg College and a Masters of Business Administration from Rutgers University. He is a Certified Public Accountant, Certified Fraud Examiner, Chartered Global Management Accountant and Certified Compliance and Ethics Professional. He also serves on the Board of Directors for the Cystic Fibrosis Foundations New Jersey Chapter.

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.

Mark Scallon is a Partner in KPMG's Forensics Practice and co-leads its Life Sciences Compliance Advisory team. Mark has over 15 years of experience advising life sciences companies on global compliance matters and focuses on conducting compliance risk assessments, compliance auditing and monitoring, FCPA reviews and global transparency reporting roadmap development. Mark also works with companies under investigation and has led 7 IRO engagements for companies who have signed CIAs.

Brian C. Barry, Esq., Compliance Counsel, EMD Serono, Inc., the US biopharmaceutical subsidiary of Merck KGaA, Darmstadt, Germany. As Compliance Counsel, Brian is responsible for implementing and enforcing the company's compliance infrastructure and its recently-ended Corporate Integrity Agreement Addendum. Previously, Brian was an associate with Choate, Hall & Stewart LLP and Weil, Gotshal & Manges LLP working in the Government Enforcement and Major Commercial Litigation groups with a focus on representation of companies and individuals in government investigations. Brian received his J.D. from the University of Virginia School of Law and B.A. from the College of the Holy Cross.

Jim Gibney is Senior Director of Compliance at Regeneron Pharmaceuticals. Jim is responsible for leading efforts to enhance and manage all elements of an effective compliance program. Responsibilities include policy development, developing and delivering company-wide compliance training, Federal and State aggregate spend reporting, executing a compliance communication strategy, internal investigation management, global anti-bribery and anti-corruption program implementation, and maintaining an internal monitoring program.

Jim began his career at Pfizer in 1992 and has held various positions in sales, operations, and compliance.

Jim served 9 years in the United States Naval Reserve and is a graduate of Rutgers University.

Dr. Saul Helman has over two decades of life sciences experience, both in management roles and consulting. Saul has significant international experience in healthcare, bio-pharmaceutical and medical device companies.

Saul is a Managing Director at Navigant Consulting, Inc. and Life Sciences Practice leader, providing support in investigations, litigation and compliance integration matters involving healthcare and life sciences companies. Applying his knowledge secured through working in international marketing and clinical development in industry, Saul has led projects involving expert witness testimony, litigation support, compliance implementation and assessment and investigation support. Saul has led the support of clients and external counsel with investigations of fraud and abuse in industry.

Saul's experience includes the development and implementation of global healthcare compliance programs, support of clients through Deferred Prosecution Agreements and Corporate Integrity Agreements, Pre-IRO support, Board and Executive level support through compliance program implementation or evaluation, auditing and monitoring of healthcare compliance programs, support of outside counsel through complex litigation matters including off-label promotion, clinical data management and disclosure, fraud and abuse (False Claims Act, Anti-Kickback Statute and Foreign Corrupt Practices Act) and aggregate spend reporting (Physician Payment Sunshine Act). In addition Saul has conducted risk assessments and remediation of manufacturing, regulatory, clinical, marketing and sales departments.

Susan has over 25 years of experience areas related to corporate financial reporting. This includes 15 years in the Enforcement Division at the SEC, focusing on financial fraud and reporting investigations. During the last five years of her tenure with the SEC, she served as Chief Accountant where she was involved in many significant enforcement actions but also involved in policy decisions working closely with Commission staff. She has also served as an auditor for both public and non-public entities and has provided litigation support to a vast array of industries and various types of corporate financial investigations.

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.

Chris Fletchall is currently a Senior Director for Eli Lilly and Company's Ethics and Compliance organization. He leads Lilly's 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 Eli Lilly and Company as a pharmaceutical sales representative. He has had a variety of experiences with Lilly including a business analyst role supporting Lilly's managed markets team, a human resource role, and a regional account manager role supervising account managers who have responsibility for cultivating relationships with large federal healthcare accounts.

Wendy C. Goldstein is a member of the Cooley business department and is a partner in the firm's Health Care & Life Sciences Regulatory practice. Ms. Goldstein concentrates in healthcare fraud and abuse and government health care program matters relevant to manufacturers, payors and other ancillary providers in the health care life sciences space. Ms. Goldstein speaks and writes extensively on issues relating to fraud and abuse, board governance, government program pricing, corporate compliance, government enforcement activity relevant to the life sciences and managed care industries and health care reform. She serves on the board of directors of several non-profit health care associations, and educational institutions. She also is actively involved in pro bono activities relating to the pediatric oncology research and other health care education and access initiatives.

Barbara is the Director, Corporate Integrity Agreement ("CIA") Operations for AstraZeneca Pharmaceuticals. She is accountable for all CIA related deliverables and reporting and provides oversight for the audit activities conducted by the Independent Review Organization. She also serves as the Secretariat to the Compliance & Ethics Leadership Team for the Company.

Prior to this role, Barbara was the Director, Healthcare Compliance Integration and successfully prepared AstraZeneca's internal and external stakeholders for readiness and compliance with the Sunshine Act. Previously Barbara directed efforts to optimize speaker program strategy and training across AstraZeneca's portfolio. Barbara was instrumental in developing and implementing Fair Market Value methodology for HCP contracting prior to joining the compliance team.

Larry Platkin 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.

Gary has over twenty five years experience as a healthcare management consultant specializing in providing regulatory, financial, transactional, investigative & litigation support, operational, acquisition due diligence and industry expertise assistance to healthcare providers, pharmaceutical and medical device manufacturers and health law firms. Gary has significant knowledge and application of Medicare and Medicaid reimbursement laws and regulations, provider billing and coding requirements, Stark and Anti-Kickback laws, Federal and State HCP aggregate spending tracking requirements, CIA requirements and IRO project management, current federal investigative and enforcement initiatives and targeting and audit methodologies used by various State and Federal agencies. Gary is a frequent publisher and speaker on issues facing providers and life sciences companies.

Ms. Bromson is Senior Corporate Counsel and Head of Privacy for Jazz Pharmaceuticals, Inc. Her primary areas of responsibility include legal support for the pain product portfolio; managed markets, trade and distribution and government pricing; information technology; and commercial and clinical contracts. In her role as Head of Privacy, she has responsibility for developing and implementing the global privacy program for the company and advising on all privacy matters. Previously, Ms. Bromson was Senior Counsel, Commercial and Privacy for AstraZeneca Pharmaceuticals LP and was Chief Privacy Officer for the US business from 2003 until 2010.

Agatha is the Head of Privacy at Shire Pharmaceuticals. Prior to joining Shire, Agatha was a Manager with 7 years of experience in PwC's Privacy and Security Practice. Her experience includes assisting clients in various industries including retail, technology, telecommunications and pharmaceutical to assess their current state and identify gaps provided current laws and industry requirements. Agatha has conducted several global, integrated privacy, security and identity theft prevention assessments and has helped companies develop and roll out corporate policy documents relating to privacy, international data transfers and IT security. Agatha has assisted in the development of documents including online privacy policies, employee privacy policies, incident response policies, training and awareness.

James Koenig joined Booz Allen Hamilton's Commercial Business as Leader of our Privacy Practice across industries and Co-Leader of Incident Response. Jim is a recognized authority on security and privacy issues affecting telecommunications, media, Internet, healthcare, financial services, and direct marketing. Prior to joining Booz Allen, Jim led PwC's Privacy Practice and co-led its Security Practice. His business, technology, and legal background includes marketing, management, and legal positions at QVC; MaMaMedia.com; and Weil, Gotshal and Manges LLP. Jim is also an inventor or co-inventor on six patent applications relating to different security and privacy-enhancing technologies.

He currently serves on a variety of industry boards, including:

• Co-Founder and General Counsel, International Association of Privacy Professionals
• (former)
• Privacy Council, the Direct Marketing Association
• American National Standards Institute (ANSI) Technical Advisory Group (TAG), International Organization for Standardization (ISO) Technical Management Board (TMB), Task Force on Privacy

He has a finance degree from MIT, with a minor from the MIT Media Lab (Film and Media Studies), and a JD from the University of Miami School of Law, where he also was a member of the Law Review.

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.

Matthew is a Business Advisory Services senior manager and focuses on Corporate Governance and Compliance and specifically the Foreign Corrupt Practices Act. He has extensive experience managing and implementing compliance-related programs and is responsible for the development of multiple programs designed to assess the risk of all third parties for large, international life sciences clients. Matthew acted as the global project manager of an Ethics and Compliance campaign for a Global Fortune 500 corporation with more than 115,000 employees.

Lisa is a principal and national leader of Grant Thornton's Life Sciences Advisory Services. She is also the Business Advisory Services practice leader in Philadelphia. With more than 18 years of business consulting experience, Lisa has expertise in providing strategic business planning, operational improvement and compliance consulting, with a special emphasis on delivering corporate compliance, marketing, sales and customer relationship management (CRM) solutions, business transformation and legal technology solutions.

Alison Fethke is a counsel in the health care group of Ropes & Gray. Alison brings to clients her experience managing complex legal and regulatory matters in the health care and life sciences industries. She provides regulatory advice on a wide range of issues, including health care and FDA compliance matters such as product registrations, Good Manufacturing Practices, clinical trials, advertising and promotion, and Corporate Integrity Agreement compliance. Before joining Ropes & Gray, Alison was Division Counsel, Legal Regulatory & Compliance at Abbvie, Inc., the pharmaceutical company resulting from the separation of the Abbott Laboratories in 2012.

Education

• JD, cum laude, 2000, New York University School of Law, Note Development Editor, New York University Law Review
• BA (Public Policy Studies/English), cum laude, 1997, Duke University

Brad Patrick is a Division Counsel for AbbVie Inc., a global biopharmaceutical company based in Illinois. He is legal and strategic advisor to commercial, medical, research and other functions, with a focus in the immunology therapeutic area. Brad was formerly Senior Counsel at Abbott Laboratories until its corporate split that created AbbVie. Prior to joining Abbott, he was Assistant General Counsel at Invacare Corporation in Ohio, a global leader in home and long-term medical care products. He began his legal career with the Cleveland firm Mansour, Gavin, Gerlack & Manos after graduating Case Western Reserve University School of Law.

Ron Wisor counsels healthcare and life sciences companies on regulatory, compliance, and reimbursement matters. The primary focus of Ron's practice is healthcare fraud and abuse, with an emphasis on helping clients navigate the application of anti-kickback, self-referral, and false claims prohibitions in ways that allow them to engage in competitive business arrangements. Ron assists a broad base of clients -- including drug and device manufacturers, hospital systems, physician organizations, clinical laboratories, and health information technology companies -- develop business strategies and structure their transactions and marketing initiatives to meet the requirements of a dynamic compliance landscape.

Dr. Eglite is Vice President, Chief Compliance Officer and Corporate Counsel for Lundbeck in Deerfield, Illinois. Prior to that, he was Vice President, Chief Compliance Officer and Corporate Counsel for Ovation Pharmaceuticals and Global Chief Compliance Officer and Corporate Counsel for Aspreva Pharmaceuticals.

Before entering the pharmaceutical industry, Erik worked as Assistant General Counsel for the Department of Human Services and as a medical malpractice defense litigation and intellectual property/patent attorney for Querry & Harrow in Chicago, Illinois. He is a licensed podiatric physician and surgeon and is registered to practice before the United States Patent and Trademark Office, the U.S. Court of Appeals for the Federal Circuit, the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Seventh Circuit Court of Appeals.

Jeremy Perisho is a partner and leader of the Life Sciences & Health Care industry practice at Deloitte Financial Advisory Services LLP ("Deloitte FAS"). Jeremy has more than 25 years of experience with Deloitte and has served as client service and engagement partner on Financial Advisory Services projects for some of the leading global companies in the life sciences industry. In particular, she has wide-ranging experience in handling both internal and government investigations of corruption and health care fraud, as well as SEC accounting investigations.

Jonathan Turner is the Senior Director, Corporate Compliance for Wright Medical Technology, where he focuses on Compliance Process Improvement, covering M&A, CAPA, Aggregate Spend and Investigations. As part of his M&A responsibilities, he leads the Compliance integration process for newly acquired entities and serves as the Deputy Compliance Officer for two of Wright's business units. Prior to joining Wright in September of 2012, Jonathan spent over 20 years consulting on ethics, investigations, diligence and financial fraud related areas on a global basis. He is a published author, frequent speaker and serves as an adjunct faculty member in the Graduate Business Program of the University of North Carolina at Chapel Hill and in the undergraduate program at the University of Memphis.

Wright Medical Technology is a global medical device company that has been active in the M&A space with five acquisitions and one significant divestiture completed in the past 18 months.

Steve Vincze is the Managing Partner of Polaris' newest office in Boston, Massachusetts. As a former counsel to a U. S. House of Representatives Oversight Committee, a former Chief Compliance Officer/senior executive, and a successful entrepreneur and consultant, who has worked directly with the OIG in drafting industry compliance guidance and who himself was recommended to be the HHS Inspector General in 2001, Steve brings a unique blend of experiences, perspectives, and, most importantly -- credibility -- to his clients. Steve has worked on some of the most challenging/cutting-edge commercial compliance settlements, investigations and CIA's in the industry.

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.

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.

Edward Leskauskas is currently the Vice President of Ethics and Compliance at Ipsen Biopharmaceuticals. He joined Ipsen earlier this year and has responsibility for ethics and compliance in North America. He is charged with enhancing the corporate and commercial compliance functions in addition to overseeing related compliance concerns in pricing, research and development, and quality in multiple locations. He is also responsible for all state and federal transparency reporting. Prior to Ipsen, Edward spent 10 years at Bristol-Myers Squibb in where he was a leader in both corporate and commercial compliance functions with responsibilities in coordinating and tracking multiple facets of the global and United States Compliance and Ethics program including the management of the BMS Corporate Integrity Agreement.

Jean McKiernan is a Director with PwC's Pharmaceutical & LifeScience Practice in Chicago. Jean's compliance experience includes implementing global compliance programs with corporate policies, procedures, training and monitoring programs for interactions with healthcare professionals, the Foreign Corrupt Practices Act (FCPA), anti-bribery / anti-corruption laws and anti-kickback laws. In addition, she helps her clients with Corporate Integrity Agreement (CIA) preparedness services and has provided IRO services.

Jean's experience capitalizes 14 years of pharmaceutical and medical device industry experience coupled with an educational background in business and communications. Her healthcare background includes experience with not only corporate ethics and compliance, but also marketing and sales.

Matthew Yesko, CPLP is a Senior Training Consultant with Aquinas Leadership Group, a leading provider in custom training solutions. He is recognized for his expertise in training compliance issues.

Steve Sitek leads Novartis' learning, education and communications to support all compliance activity at Novartis. Recently, he has led efforts to transform learning and communications processes and programs resulting in highly favorable impact on associate confidence and knowledge. Prior to his current role, Steve was the Director of Talent Management and Organizational Development in Novartis Pharmaceuticals North America. Prior to Novartis, Steve was the Executive Director of Enterprise Learning and Leadership Development at Wyeth, and the Director of Global Learning and Organizational Development at BMS. Steve is a recognized leader in the field of Learning and Organization Development who has facilitated global transformational change at world re-known corporations, including: Novartis, Wyeth, Bristol-Myers Squibb, GE, Ernst & Young, and Sony.

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.

Howard L. Dorfman is Associate Vice President, U.S. Litigation and Government Affairs at Ferring Pharmaceuticals Inc. in Parsippany, NJ, where he previously served as Vice President General Counsel. Prior to joining Ferring, he served as a Counsel in the Life Sciences group at Ropes & Gray LLP in New York, where he focused his practice on the pharmaceutical, medical device and biotech industries. Mr. Dorfman's areas of expertise include FDA regulatory law, fraud and abuse, compliance programs, risk management processes, mergers and acquisitions, corporate governance and licensing and product liability.

Stephanie Macholtz is the Director, Corporate Compliance at Biogen Idec supporting the Global Medical and R&D functions. Stephanie has over fourteen years of life sciences experience both in-house and as a consultant. Prior to joining Biogen Idec in 2013, Stephanie was a member of the Corporate Ethics and Compliance Department at Eisai, Inc. and a consultant for KPMG LLC where she assisted clients with identifying and mitigating compliance risks relating to late-phase development activities.

Cliff Saffron is a Principal in KPMG's Life Sciences Regulatory Enforcement and Compliance Practice. For over a decade (1994–2005) he was the senior legal officer of publicly traded pharmaceutical and biotech companies, where he advised senior management and boards of directors on a broad array of legal and compliance matters. In this connection, Cliff provided practical business oriented advice to key functional areas including sales & marketing, commercial operations, medical affairs, regulatory affairs, clinical affairs, research and development, manufacturing, finance, corporate communications and human resources.

Since joining KPMG in 2005, Cliff has concentrated his efforts in the areas of sales & marketing compliance, IRO services, regulatory compliance, enterprise risk management, contract compliance, corporate governance, and forensic investigations. Utilizing KPMG methodologies he has assisted in the conduct of enterprise risk management engagements and the assessment of key risks and impacts in the context of business continuity planning.

Paul Subacius is the Health Care Compliance Officer for Janssen Scientific Affairs, Pharmaceuticals Group Healthcare Compliance, Johnson & Johnson. In this role, Paul provides HCC guidance and support for US-based medical and scientific affairs organizations in the Pharmaceutical Sector. Paul has held previous roles in healthcare compliance training and clinical trial management. Paul received his Bachelor of Science degree in Biological Sciences from Rutgers University. He also holds certifications as a Certified Compliance & Ethics Professional and Project Management Professional.

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.

Ms. McKean Dieser is in-house Senior Counsel responsible for supporting the Pricing and Planning, Institutional Contracting, and Sales and Marketing departments concerning a broad range of legal, regulatory and compliance issues, including federal/state pricing and reporting laws and regulations, pharmacy and institutional contracting, FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act and competition law. Prior to joining AbbVie, Ms. McKean Dieser was Senior Counsel at UCB, Inc, Associate at Nelson, Mullins, Riley & Scarborough LLP, and Associate at Kilpatrick Townsend (f/k/a Kilpatrick Stockton).

Marcy Imada is a Principal with Deloitte & Touche LLP and has over 15 years of experience in consulting for the life sciences and health care industries. Marcy leads Deloitte & Touche LLP's national Government Pricing practice, which provides regulatory compliance services to life sciences companies related to pricing requirements of Federal and State government programs including, but not limited to, the 340B, Medicaid Drug Rebate, Medicare, and Federal Supply Schedule Programs. Marcy also specializes in helping life sciences companies address regulatory compliance and risk matters related to managed care and commercial pricing and interactions with health care professionals, customers, and other influencers of drug purchase.

Ms. Lee has spent over twenty years working with international corporations with her responsibilities focused upon commercial operations, pricing, analytics, and strategic planning. For over sixteen years, Ms. Lee's area of practice has been dedicated specifically to government and commercial contracting, pricing and reimbursement within the pharmaceutical, biotechnology and biologics industries.

Having commenced her pharmaceutical career in-house with Daiichi Pharmaceutical Corporation and serving as a consultant to various companies within the life sciences industry, Ms. Lee provides a unique perspective of contracting, pricing and reimbursement to her clients. Ms. Lee's clients range from developmental stage start-up to established large pharmaceutical companies, in addition to, specialty/niche-market biotechnology and biologic companies.

Elizabeth F. Lindquist is an Associate in King & Spalding LLP's FDA & Life Sciences Practice Group. Her practice focuses primarily on regulatory and enforcement issues related to federal health care agencies and programs, including the Department of Veterans Affairs Federal Supply Schedule Program, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the TRICARE Program, and the U.S. Food and Drug Administration. Ms. Lindquist has significant experience advising clients on complex regulatory, commercial, and litigation issues pertaining to pharmaceutical manufacturer government price calculation and reporting practices, including day-to-day counseling, risk analysis, and strategic pricing advice.

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.

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.

Involved in the American Medical Association since her first day of medical school, Maya A. Babu, MD, was elected to the AMA Board of Trustees in 2013. She has also served in the Minnesota Medical Association (MMA) and the Massachusetts Medical Society.

A native of Eagan, Minn., Dr. Babu attended college at the University of Minnesota, receiving a BS in neuroscience and BA in psychology, both summa cum laude with highest distinction in 2005. Dr. Babu attended Harvard Medical School and received an MD cum laude in 2010. She also attended Harvard Business School, where she received her MBA in 2010. She is presently a neurosurgical resident at the Mayo Clinic in Rochester, Minn.

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.

Charles Ornstein is a senior reporter at ProPublica, a nonprofit investigative news organization based in New York. Prior to joining ProPublica in 2008, he was a member of the metro investigative projects team at the Los Angeles Times. In 2004, Ornstein was a lead author on a series on Martin Luther King Jr./Drew Medical Center, a troubled hospital in South Los Angeles. The articles won the 2005 Pulitzer Prize for Public Service. In 2009, Ornstein co-authored a series of stories that detailed serious failures in oversight by the California Board of Registered Nursing and nursing boards around the country. The work was a finalist for the 2010 Pulitzer Prize for Public Service.

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.

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.