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.

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, 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 (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.

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

Brian Riewerts is the Principal, Global Governances Risk and Compliance Leader in PwC's Pharmaceutical and Life Sciences Advisory Practice and has global responsibility for our Life Sciences governance, risk management, and compliance practice. With over eighteen years of experience, Brian focuses his practice in the areas of compliance and enterprise-wide risk management program strategy and design, compliance auditing and monitoring, and CIA/IRO negotiation and implementation support. Brian is a frequent speaker and author on regulatory and compliance issues related to the pharmaceutical, bio-technology, and medical device industries.

Brian Bohnenkamp is an associate in King & Spalding's Washington, D.C., office and a member of the FDA & Life Sciences Practice Group. He has assessed a variety of regulatory compliance issues for manufacturers of drugs and medical devices. Specifically, he has assisted in advising companies on state law compliance issues, development and implementation of comprehensive compliance programs, fraud and abuse issues, and advertising and promotion practices. Mr. Bohnenkamp provides counsel to the Ad Hoc State Law Compliance Group (a coalition of pharmaceutical, biotechnology, and medical device manufacturers) on a variety of laws and regulations, including state marketing code of conduct laws, gift prohibition laws, marketing costs disclosure laws, and prescriber data privacy laws, as well as the federal Physician Payment Sunshine provisions.

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.

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.

Joan Meyer chairs the North America Compliance and Investigations Steering Committee. She has handled investigations and resolutions with enforcement authorities involving anti-corruption, government contracting and the false claims act and financial fraud for companies. Prior to joining the Firm, she was senior counsel to the Deputy Attorney General at the US Department of Justice, where she advised on corporate charging policies, corporate monitorships, and complex criminal litigation and corporate settlements. She also managed the operation of the President's Corporate Fraud Task Force. Ms. Meyer was the First Assistant United States Attorney and Criminal Chief of the United States Attorney's Office in the Western District of Michigan.

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.

John S. Rah is a partner in Morgan Lewis's Healthcare Practice. Mr. Rah provides advice to a wide variety of healthcare providers, suppliers, manufacturers, managed care organizations, and associations, including some of the nation's most prominent hospitals, healthcare systems, and drug and device manufacturers.

Mr. Rah provides counsel on investigations, audits, and informal inquiries undertaken by federal and state regulatory and enforcement agencies, including the U.S. Department of Justice (DOJ), the U.S. Department of Health & Human Services's (HHS's) Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services, as well as on the negotiation, implementation, and monitoring of complex corporate integrity agreements between and among healthcare organizations, DOJ, and OIG.