Meena Datta is a nationally-recognized health care lawyer practicing at Sidley Austin LLP. Meena specializes in all areas of health care regulatory law for health care companies, including fraud and abuse, government pricing, coverage and reimbursement, and managed care contracting. Meena is lead health care counsel to several pharmaceutical companies and medical device manufacturers.

Assistant General Counsel, Pricing Reimbursement and Access at Eli Lilly & Company. Kirk has served as in-house counsel for mid-size bio pharma and large pharmaceutical manufacturers for the past decade providing legal advice and counsel for a variety of functions including: Drug Research, Clinical Development, Regulatory, Medical Affairs, Sales/Marketing, Compliance, Commercial, Procurement, Manufacturing and Distribution. Kirk has developed practical expertise and experience on the laws, rules, regulations, and programs pertaining to development, manufacture, sale and distribution of pharmaceutical products. Kirk is currently supporting Lilly's Managed Healthcare Services group advising on issues pertaining to pricing, reimbursement and access.

John Shakow is a nationally-recognized expert in all aspects of drug pricing and price reporting. He has counseled pharmaceutical and biotechnology clients on their rights and obligations under the Medicaid, Medicare, Federal Supply Schedule, 340B and TRICARE programs for almost twenty years. John regularly advises manufacturers on the spectrum of regulatory, commercial and litigation matters relating to pricing and government payor programs. He has extensive experience helping clients resolve commercial, strategic, organizational and other legal challenges while maintaining the integrity of their government pricing compliance efforts.

Susan Dentzer is the President and Chief Executive Officer of The Network for Excellence in Health Innovation (NEHI), a not-for-profit membership organization that seeks to foster changes driving toward better health and health care at sustainable cost. One of the nation's most respected health and health policy thought leaders and journalists, was formerly senior policy advisor to the Robert Wood Johnson Foundation; editor-in-chief of the journal Health Affairs; and on-air health correspondent for the PBS NewsHour. Dentzer, a frequent speaker and television and radio commentator, is an elected member of the National Academy of Medicine and the Council on Foreign Relations, and a member of the boards of directors of the American Board of Medical Specialties; Research!America; the International Rescue Committee; and the Public Health Institute. She is also a fellow of the Hasting Center, an institution dedicated to bioethics and the public interest; a member of the Kaiser Commission on Medicaid and the Uninsured; and a member of the advisory board of the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. An alumna and trustee emerita of Dartmouth, she previously chaired Dartmouth's Board of Trustees, and has been a longtime member of the Board of Overseers of Dartmouth's Geisel School of Medicine.

Robert W. Dubois, MD, PhD, is the chief science officer and executive vice president of the National Pharmaceutical Council (NPC). In this role, he oversees NPC's research on policy issues related to the appropriate role of real-world evidence in decision-making, how best to determine value of health care services, the relationship between access and health outcomes, and approaches to maintain an environment supportive of innovation.

Dr. Dubois, who is board certified in internal medicine, brings more than 25 years of experience in health care research, with a particular focus on understanding and ensuring that patients receive high value health care. He has co-founded and led various health care research organizations in developing quality research with practical application. Most recently, he was the Chief Medical Officer at Cerner LifeSciences, where he focused on comparative effectiveness and the use of an electronic health records infrastructure to implement clinical change.

Prior to joining Cerner in 2001, Dr. Dubois co-founded Protocare Sciences and was its executive vice president, chief medical officer, and later its CEO.

Throughout his career, Dr. Dubois' primary interest has centered on defining "what works" in health care and finding ways for that evidence to inform health care decision making. He is a recognized expert in the areas of defining best practice, disease management and appropriateness of care. He has authored 150 peer-reviewed articles on comparative effectiveness, evidence-based medicine, the development of practice guidelines and determining the optimal use of high-cost medical services.

Dr. Dubois received his AB from Harvard College, his MD from the Johns Hopkins School of Medicine and his PhD in Health Policy from the RAND Graduate School. He is a member of the Medicare Evidence Development and Coverage Advisory Committee, Steering Committee for the Electronic Data Methods Forum, and the Advisory Board of the Institute for Clinical and Economic Review. Additionally, he is the associate editor of the Journal of Comparative Effectiveness Research and is on the editorial board for Health Affairs and The American Journal of Managed Care.

Dr. Pezalla is Vice President for Pharmaceutical Policy and Strategy at Aetna where he is responsible for coordination of pharmaceutical coverage policy and strategy, and the adoption of new methods for technology assessment and innovative contracting.

Dr. Pezalla is an industry leader in pharmaceutical coverage policy and has participated in a number of industry work groups and publications including the President's Council of Advisors on Science and Technology, the Margolis Health Policy Center at Duke University, and the NEWDIGS project at the Center for Biomedical Innovation at MIT. He has published papers on adaptive pathways for drug approval, management market entry, and innovative approaches to funding payment for curative therapies.

Dr. Pezalla is a graduate of Georgetown University, a board certified pediatrician and holds the Masters in Public Health from the University of California at Berkeley.

Robert A. Spurr is US Country Head and Vice President, Patient Access and Health Policy for US General Medicines at Novartis Pharmaceuticals Corporation.

Bob Spurr is responsible for strategically aligning resources to strengthen the value the company brings to customers. He also leads US Health Policy, State Government Affairs and Patient & Specialty Services, as well the company's Established Medicines business.

Bob has more than 25 years of commercial pharmaceutical experience. He holds a BS from Keene State College in New Hampshire, and earned an Executive MBA from Rutgers, The State University of New Jersey.

Robert W. Dubois, MD, PhD, is the chief science officer and executive vice president of the National Pharmaceutical Council (NPC). In this role, he oversees NPC's research on policy issues related to the appropriate role of real-world evidence in decision-making, how best to determine value of health care services, the relationship between access and health outcomes, and approaches to maintain an environment supportive of innovation.

Dr. Dubois, who is board certified in internal medicine, brings more than 25 years of experience in health care research, with a particular focus on understanding and ensuring that patients receive high value health care. He has co-founded and led various health care research organizations in developing quality research with practical application. Most recently, he was the Chief Medical Officer at Cerner LifeSciences, where he focused on comparative effectiveness and the use of an electronic health records infrastructure to implement clinical change.

Prior to joining Cerner in 2001, Dr. Dubois co-founded Protocare Sciences and was its executive vice president, chief medical officer, and later its CEO.

Throughout his career, Dr. Dubois' primary interest has centered on defining "what works" in health care and finding ways for that evidence to inform health care decision making. He is a recognized expert in the areas of defining best practice, disease management and appropriateness of care. He has authored 150 peer-reviewed articles on comparative effectiveness, evidence-based medicine, the development of practice guidelines and determining the optimal use of high-cost medical services.

Dr. Dubois received his AB from Harvard College, his MD from the Johns Hopkins School of Medicine and his PhD in Health Policy from the RAND Graduate School. He is a member of the Medicare Evidence Development and Coverage Advisory Committee, Steering Committee for the Electronic Data Methods Forum, and the Advisory Board of the Institute for Clinical and Economic Review. Additionally, he is the associate editor of the Journal of Comparative Effectiveness Research and is on the editorial board for Health Affairs and The American Journal of Managed Care.

Gregg Shapiro has been an Assistant United States Attorney in the District of Massachusetts since 2005 and is currently Chief of the Affirmative Civil Enforcement Unit. His work primarily involves health care fraud, including kickbacks and Medicare and Medicaid price reporting violations. During his DOJ career, he has worked on matters resulting in the recovery of over $2 billion for American taxpayers. Prior to joining the United States Attorney's Office, Gregg worked in private practice and in the Consumer Protection Bureau of the Federal Trade Commission. He is a graduate of Harvard Law School and Stanford University.

Tom Beimers is a partner in the health care and life sciences group at Hogan Lovells. He was previously senior counsel with the Department of Health and Human Services' Office of the Inspector General. From 2008 to 2010, he served as Special Assistant United States Attorney in Detroit, prosecuting criminal health care fraud cases as part of the Justice Department's Medicare Fraud Strike Force.

At the Inspector General's office, Tom collaborated with other state and federal agencies on False Claims Act investigations. Thomas also negotiated and monitored compliance agreements with health care providers including hospitals and physician practices. In addition, Thomas developed and brought exclusion actions against individual providers.

In his current practice, Thomas assists clients with health care fraud investigations and represents them in criminal, civil and administrative proceedings. He also advises clients on regulatory compliance matters.

Sarah Franklin is vice-chair of Covington's Life Sciences Litigation and Investigations practice group.

Ms. Franklin has defended numerous criminal and civil enforcement actions and conducted internal investigations covering a broad range of health care compliance issues, including fraud and abuse, advertising and promotion, price reporting, and manufacturing. She also draws on her enforcement experience and industry knowledge to advise pharmaceutical and medical device companies on mitigating risks and implementing compliance programs.

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

Jeffrey Handwerker focuses his practice on pharmaceutical pricing and investigations, government contracts, and commercial litigation involving the pharmaceutical, medical products, and biotechnology industries. In the pharmaceutical pricing area, Mr. Handwerker regularly advises pharmaceutical and medical technology companies on pricing and contracting matters arising under, among other things, the Veterans Health Care Act; the Medicaid Rebate Act; the Deficit Reduction Act of 2005; the Medicare Prescription Drug, Improvement, and Modernization Act; and the Patient Protection and Affordable Care Act. He also has advised pharmaceutical companies on some of the most important and cutting­edge issues confronting the industry, including healthcare reform implementation, application of the First Amendment to pharmaceutical communications with healthcare professionals, and novel issues under the federal and state Anti­Kickback laws.

Mr. Handwerker represents clients in litigation matters, internal investigations, and government audits and investigations, including investigations initiated by the United States Attorney's Offices in Philadelphia and Boston, among others. He also has extensive experience litigating cases on behalf of pharmaceutical companies under both state and federal false claims acts.

Tom Hubbard works with NEHI's multi-sector membership of 90-plus organizations to find common ground on complex issues of innovation in health care. His responsibilities include projects on comparative effectiveness research, Real World Evidence, medication management and patient medication adherence.

Tom previously served as Vice President at the Massachusetts Technology Collaborative (MTC), as economic affairs aide to U.S. Senator John Kerry, and as Deputy Director of Development for Massachusetts Governor Michael Dukakis.

Tom is a graduate of Harvard College and the Harvard Kennedy School of Government.

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

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

Blake Bolinger works at Bristol-Myers Squibb, where he serves as Head, Access and Policy, U.S. Compliance and Ethics. His current focus is managed markets/access issues, state and federal transparency issues, and policy management for the company's U.S. Commercial Organization. During his time with the BMS compliance organization, Blake has handled issues including Corporate Integrity Agreement administration and reporting, policy development, investigations, managed markets/access, and HCP engagements. Blake has also served as the compliance lead for BMS's global marketing/commercialization business unit. Previously, Blake served in various capacities within the BMS Law Department. He joined the company in 1998, starting in its medical device division, ConvaTec. Prior to that, he was in private practice at a general litigation law firm in Freehold, New Jersey. Blake's education includes a JD from Rutgers School of Law -- Camden, and a B.A. in history/political science from the University of Washington.

Jennifer has been Chief Compliance Officer at Otsuka Pharmaceutical Development & Commercialization since June 2015. She joined Otsuka in January 2011, overseeing compliance with the Corporate Integrity Agreement, implementation of the company's Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 ½ years as a litigation attorney in the White Collar Group at the Washington, D.C. office of Shook, Hardy & Bacon, focused on the representation of pharmaceutical and medical device manufacturers in government investigations. Jennifer also served on active duty in the US Army for more than 13 years, trying more than 70 felony cases, and still serves in the Army Reserves.

For healthcare and life sciences companies uncompromising in their commitments to both business success and regulatory compliance, Ron Wisor is a valued strategic advisor, counselor, and advocate.

Whether it be a cutting-edge business plan, a key acquisition, or a high-stakes government investigation, Ron brings his deep understanding of healthcare regulation and his practical problem solving skills to bear in guiding health industry leaders through their most challenging legal compliance issues.

The primary focus of Ron's practice is healthcare fraud and abuse compliance, with an emphasis on helping clients navigate application of the anti-kickback, "Stark" self-referral, and false claims prohibitions in ways that allow them to engage in competitive business arrangements and promote greater access to their products and services.

A recognized leader among Washington D.C. healthcare lawyers, Ron also regularly advises clients on coverage and reimbursement of new technologies, assists clients in addressing Medicare and Medicaid billing issues, and has vast experience in dealing with other complex regulatory issues in areas such as research compliance, genomics, personalized medicine, and digital health.

When the government comes calling through audits and investigations, Ron is a respected and effective advocate with the U.S. Department of Justice, the HHS Office of Inspector General, and the Centers for Medicare & Medicaid Services.

Nightingale's Healthcare News has named Ron as one of the "outstanding healthcare fraud and compliance lawyers" in the United States. His clients include multinational companies in the pharmaceutical, biotech, medical device, and clinical lab industries, as well as a number of leading healthcare providers and academic medical centers. Ron's broad client base and depth of experience allows him to benchmark clients' compliance safeguards against industry norms and evolving expectations of government regulators and enforcement authorities.

Seth Lundy is a partner and Deputy Chair of the firm's FDA and Life Sciences Practice Group in Washington, D.C. Seth focuses his practice on the federal and state regulation of pharmaceutical and medical device manufacturers and of healthcare providers and suppliers of such products, including corporate compliance, the Anti-Kickback Statute, the Stark Law, False Claims Acts, state law compliance and reporting regulations, and Medicare and Medicaid reimbursement. His experience includes working closely with federal regulators and legislators to create, revise and interpret new laws, regulations and policies in the healthcare field, developing business and marketing strategies to cope with changing federal regulatory schemes, corporate compliance, government investigations, healthcare contracting, the creation of new healthcare entities, reimbursement and billing advice, and civil and criminal litigation. Seth is recognized as one of the leading national health care fraud and abuse experts by many sources, including Chambers USA Guide, Expert Guides, Guide to the Leading Healthcare Lawyers, Washington DC Super Lawyers, and Washingtonian Magazine.