Jim Gibney is Senior Director, Corporate Compliance. Jim and his team are responsible for leading efforts to enhance and manage various elements of an effective compliance program. Responsibilities include policy development, developing and delivering company-wide compliance training, Global, Federal and State aggregate spend reporting, executing a compliance communication strategy, and providing Compliance related support to Regeneron's various business functions.

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.

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.

Richard Bistrong spent much of his career as an international sales executive and currently consults and speaks on foreign bribery, ethics and compliance issues from that front-line perspective. Richard was named one of Ethisphere's 100 Most Influential in Business Ethics for 2015 and is a Contributing Editor of the FCPA Blog. Richard's chapter "The Anatomy of a Bribe" appears in the 2016 edition of the Trace International How to Pay a Bribe. Richard was also recognized by JD Supra as Top Author in the 2016 Readers Choice Awards, for Compliance. He can be contacted via his website www.richardbistrong.com or richardtbistrong@gmail.com

In 2013, Supervisory Special Agent McEachern was selected to the FBI's International Corruption Unit where he managed the FBI's Foreign Corrupt Practices Act (FCPA) global investigations program and helped architect the newly formed FBI International Corruption Squads based in Washington, Los Angeles, New York, Miami, Houston, San Francisco, Boston and New Orleans.

Currently, Supervisory Special Agent McEachern supervises the Washington Field Office International Corruption Squad with a focus on FCPA, International Money Laundering, Kleptocracy and Antitrust investigations. Supervisory Special Agent McEachern is a Certified Fraud Examiner (CFE) and a Certified Anti-Money Laundering Specialist (CAMS).

Gary Giampetruzzi is a Global Vice-Chair of the Investigations and White Collar practice in the Litigation Department of Paul Hastings, based in the firm's New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), the Foreign Corrupt Practices Act ("FCPA"), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world's most prominent biotech, pharmaceutical, and medical device companies.

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 Deputy Compliance Officer responsible for international compliance investigations and programs. He is highly regarded by counsel, healthcare industry insiders, and regulators for his strategic thinking and sound judgment, and brings unique experience and perspective to each representation, having himself been the client for more than a decade.

Floyd Abrams is a member of the Executive Committee and Cahill Gordon & Reindel LLP's litigation practice group.

Floyd has a national trial and appellate practice and extensive experience in high-visibility matters, often involving First Amendment, securities litigation, intellectual property, public policy and regulatory issues. He has argued frequently in the Supreme Court in cases raising issues as diverse as the scope of the First Amendment, the interpretation of ERISA, the nature of broadcast regulation, the impact of copyright law and the continuing viability of the Miranda rule. Most recently, Floyd prevailed in his argument before the Supreme Court on behalf of Senator Mitch McConnell as amicus curiae, defending the rights of corporations and unions to speak publicly about politics and elections in Citizens United v. Federal Election Commission. Floyd's clients have included The McGraw-Hill Companies in a large number of litigations around the country involving claims against its subsidiary, Standard & Poor's Financial Services LLC, The New York Times in the Pentagon Papers case and others, ABC, NBC, CBS, CNN, Time Magazine, Business Week, The Nation, Reader's Digest, Hearst, AIG, and others in trials, appeals and investigations.

Kellie Combs is Counsel in the Life Sciences group at Ropes & Gray LLP, where she provides legal and strategic advice to pharmaceutical, biotechnology, and medical device manufacturers on a wide range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She serves as co-counsel to the Medical Information Working Group, represented Pacira in its litigation against FDA, and has extensive experience handling matters implicating FDA promotional rules and the First Amendment. Kellie also counsels clients on lifecycle management, regulation of clinical research, and post-approval compliance.

Lisa M. Dwyer is a partner in King & Spalding's Washington, D.C. office and a member of the FDA & Life Sciences practice group. Lisa has more than 15 years of experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner's Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, Lisa provided strategic counseling to FDA's senior leadership on the agency's most significant and complex issues. Her portfolio included managing a cross-Agency working group on off-label marketing issues.

In addition, she often served as a liaison for the FDA or worked closely with other parts of the federal government, including HHS and Congress. Before joining the FDA, Lisa practiced food and drug law at two prominent Washington D.C. law firms.

Dr. Joshua M. Sharfstein is Associate Dean for Public Health Practice and Training and faculty in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health.

From March 2009 to January 2011, Dr. Sharfstein served as Principal Deputy Commissioner of the U.S. Food and Drug Administration. A pediatrician, he is a former Health Commissioner of Baltimore and a former Health Secretary in Maryland.

Coleen Klasmeier leads Sidley Austin LLP's Food, Drug and Medical Device Regulatory practice within the global Life Sciences team, managing matters on behalf of the world's leading biopharmaceutical, medical technology, and food and consumer product companies. Since joining from the Office of the Chief Counsel at the Food and Drug Administration in 2005, Ms. Klasmeier has concentrated her practice on FDA litigation and dispute resolution, and on regulatory strategy and risk management. Ms. Klasmeier's litigation matters have included United States v. Caronia, 703, F.3d 149 (2d Cir. 2012) (amicus curiae), in which she was also cited; Cook v. Food and Drug Administration, 733 F.3d 1 (D.C. Cir. 2013); Sottera, Inc. v. Food and Drug Administration, 627 F.3d 891 (D.C. Cir. 2010) (amicus curiae); and United States v. Harkonen, 510 Fed. Appx. 633 (9th Cir. 2013), cert. denied 134 S.Ct. 824, Dec. 16, 2013. Praised by clients for her broad experience and attentiveness to client needs, and her tremendous and encyclopedic knowledge of FDA rules, history, and contacts (Chambers USA 2011-2012), Ms. Klasmeier was named a Life Sciences Star in the inaugural edition of LMG Life Sciences 2012. She is highly ranked by The Practical Law Company in The Cross-Border Life Sciences Handbook (since 2007); The Legal 500 United States (2011); and Who's Who Legal 100 (2012). Ms. Klasmeier is past chair of the Food and Drug Committee of the American Bar Association's Section on Administrative Law and Agency Practice. She is a nationally recognized speaker, and her work has been published in the American Journal of Law and Medicine, in Health Affairs, and on the opinion page of The Wall Street Journal. She earned her law degree magna cum laude in 1996 from The Boston University School of Law, where she ranked first in her third-year class and was awarded The Bigelow Prize, awarded by the faculty for promise as a teacher and scholar of law. She taught food and drug law at Northwestern University Law School in 2014.

Jonathan Connell is a Senior Counsel within the U.S. Commercial Law and Compliance organization at Bristol-Myers Squibb. Jonathan has been working in the pharmaceutical industry for 15+ years. His current work includes advising clients regarding government price reporting obligations, fraud and abuse compliance, federal and commercial contracting requirements, the federal anti-kickback statute, coverage and reimbursement issues, addressing US market access challenges, and product promotion regulations. In the pricing area, Mr. Connell regularly advises on government price reporting and compliance, as well as commercial contracting with GPOs, IDNs, MCOs, and specialty pharmacies. Prior to joining BMS, Jonathan was in private practice as a member of Arnold & Porter LLP's FDA and Healthcare practice. Mr. Connell earned both a JD and a MBA from Duke University. Prior to graduate school, Mr. Connell worked for years as a management consultant to the pharmaceutical industry, focusing on drug pricing strategy, compliance with federal pricing programs, and systems integrations. Mr. Connell is also a regular speaker at pharmaceutical industry seminars and conferences.

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

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

Jennifer McGee 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.

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

Natasha Leskovsek is an FDA regulatory partner in the Washington D.C. office of Cooley LLP. Natasha advises regulated industry and its investors on strategic pathways to commercialization and pre- and post-market compliance issues. Natasha received her J.D. from Georgetown University and her B.S.N. and M.B.A. degrees from the University of Maryland; she is a member of the Food and Drug Law Institute and the American Health Lawyers Association.

Sue Seferian is the global R&D Health Care Compliance Officer for the Johnson & Johnson Pharmaceuticals Group. Sue's team is responsible for the implementation and maintenance of programs designed to ensure compliance with applicable regional/local health care fraud and abuse laws, anti-corruption and anti-bribery laws, advertising and promotion laws, privacy laws, codes of conduct and J&J company policies governing the R&D organization's activities.

Sue joined the Johnson & Johnson Law Department in 1999, where she provided legal support for the creation, implementation, and management of corporation-wide fraud and abuse and compliance programs. In 2006, Sue joined the World Wide Office of Health Care Compliance & Privacy (WWOHCC & P) where she provided support and oversight to the medical device franchise HCC programs. In 2008, she joined the Pharmaceuticals Group Health Care Compliance organization.

Michelle Shwery leads R&D compliance for Eli Lilly and Company. Previous leadership roles include Enterprise Risk Management and Global Clinical Operations / Medical Quality throughout South America, Asia, the Middle East, Africa, and Australia, Canada, Mexico, Russia and Turkey. Shwery has led Early Drug Development Operations, Global Clinical Diagnostics and Global Medical Training. She joined Lilly in Canada where she led Clinical Research, Customer Service, Medical Information and Wholesaler/Pharmacy Accounts.

Shwery holds an MBA (Chicago Booth), MSc. (U of Toronto), BSc. (U of Guelph). She serves on Women United Steering Committee (UWCI) and is Past Board President of DFS Indianapolis.

Dan Kracov is co-chair of Arnold & Porter's Life Sciences and Healthcare Regulation Practice, which was recently named the top Healthcare practice in the country by Law360. For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and other publications. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device and diagnostic companies, including start-up companies, trade associations, and large manufacturers, negotiate challenges relating to the development, approval and marketing of FDA-regulated products. In addition to day-to-day counseling on regulatory strategies and compliance concerns, Mr. Kracov regularly handles product and compliance-related government and internal investigations, the development of global corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.

Mike Ace is currently an Ethics and Compliance Advisor on Global Policies for Eli Lilly and Company. Mike leads Lilly's Global Policy Center of Expertise, which has recently made significant progress in the company's movement toward judgment-based decision making and fostering a culture of integrity. For the last 3 years, Lilly E&C has made it a priority to simplify our policies, streamline the policy governance process, and improve awareness of available resources. When not making compliance policies easier-to-access and easier-to-understand, Mike enjoys time on his family farm, playing with his two daughters, and losing in fantasy football.

Himani Shah is part of the Global Compliance Department at AstraZeneca Pharmaceuticals, responsible for global policies and focusing on anti-bribery/anti-corruption issues. Himani joined AstraZeneca 10 years ago, first as in-house counsel, then transitioning to various Compliance roles. She began her legal career as a Food & Drug Associate at the Washington, DC office of Covington & Burling.

Dr. Whitelaw has more than 20 years of industry experience in the life sciences and healthcare sectors, as an attorney, compliance officer and consultant. A former compliance officer for both C.R. Bard, Inc. and GlaxoSmithKline, currently he is the President and CEO of Whitelaw Compliance Group, the Editor of Life Science Compliance Update and Senior Fellow & Adjunct Professor, Life Sciences Compliance for Mitchell Hamline School of Law.

He holds an S.J.D. in Health Law from Widener University School of Law, an LL.M. in administrative law from George Washington University Law School, a J.D. from Washington & Lee University School of Law and an A.B. from Bowdoin College.

Anthony Greco is a Director in PwC's Pharmaceutical & Life Sciences Advisory practice with a focus on our clients' Government Risk and Compliance related matters. Anthony has worked with his clients to assess and design enhancements to their corporate compliance programs against the expected elements of an effective compliance program as defined by the applicable laws, regulations, and industry codes and leveraging his experience to provide insight into industry better practices and trends. He also has worked with senior level executives (including c-suite) to develop multi-year compliance strategy, including both short-term and long-terms goals and worked closely with his clients to implement program enhancements that support this strategy. He has also led projects to assess pharmaceutical companies' upcoming readiness for its obligations under a Corporate Integrity Agreement, including conducting mock-IRO reviews. Anthony currently also focuses on other aspects of a Pharmaceutical & Life Science companies risk & regulatory considerations including Government Pricing, Commercial Contracting (including Gross to Net and Managed Markets) and Aggregate Spend Reporting.

Stacy Hornaday has over 15 years of combined industry and consulting experience in pharma/biotech and medical device with a focus on compliance risk identification and mitigation. Stacy specializes in Transparency and has effectively helped many organizations to address their Transparency regulatory reporting requirements.

Clarissa has over 12 years of life sciences industry experience with a focus in healthcare compliance. She works with manufacturers to address the complexities of interactions based compliance across comprehensive HCP and third party engagement, as well as transparency reporting requirements. She has overseen the delivery of transparency reporting for over 30 manufacturers, and has provided services a variety of advisory engagements related to HCP engagement and FMV.

Tony Alvizu is a Managing Director at FTI Consulting and is based in Chicago. He has more than 20 years of experience assisting companies, boards and their counsel conduct financial, accounting, computer, corruption and other types of investigations in countries across the globe. Over the past five years Mr. Alvizu has been exclusively focused on proactive, remediation/monitoring and reactive anti-corruption, investigation and compliance matters with a focus on third-party risk management and due diligence. Mr. Alvizu helped develop an anti-corruption compliance solution that continuously manages third-party risk and due diligence.

Michael R. Clarke is the Vice President, Corporate Compliance for Indivior Inc., a Richmond, VA based global specialty pharmaceutical company that markets addiction treatment therapies. He is responsible for managing the global compliance program for Indivior across its business operations in the North American, European, Middle East, African, China and Pacific Rim regions. His duties include overseeing third party due diligence; providing education and guidance on appropriate HCP, HCO and governmental interactions; developing and revising ethics policies; training direct employees; monitoring sales and marketing practices; counseling on OFAC requirements; overseeing internal investigations and implementing processes to mitigate corruption, fraud and bribery risks.

Tom Costa is a Compliance Consultant with 35 years of experience in the pharmaceutical industry. He worked for Bristol-Myers Squibb in both London and Princeton, N.J. and headed up the U.S. Compliance and Ethics Department.

Francisco Ribeiro is a Sr. Director for Corporate Compliance at Biogen in Cambridge, Massachusetts. Prior to that, Francisco worked for Sandoz (Novartis) group and for Johnson & Johnson.

He possesses more than thirteen years of professional experience in the pharma & biotech industry and has held multiple positions in Compliance globally, including extensive work in bribery and corruption risk-management, including compliance oversight on interactions with distributors and other third-party intermediaries. Francisco is admitted to the bar as a lawyer in Brazil and has devoted years of study and practice in the legal arena in the U.S. as well.

Bill Olsen is a Principal and national practice leader for the Corporate Compliance practice of Grant Thornton LLP's Forensic Advisory Services. Bill is a former member of the special prosecutions section of the New Jersey attorney general's office and was the global security manager for a Fortune 500 company. He was with a Big 5 Accounting firm prior to joining Grant Thornton. Bill authored The Anti-Corruption Handbook and is a frequent speaker on global corruption matters. He was named one of the Top 25 Consultants of 2012 by Consulting magazine and also the National Law Journals top 50 Trailblazers and Pioneers of 2014.

Michaeline Daboul is the President and CEO of MMIS and has spent her career working in the life science industry. Michaeline works closely with companies to improve compliance operations and business practices. She has spent the past 13 years as the founding president of MMIS, leading the company to develop MediSpend, the new standard in global, cloud-based enterprise compliance solutions. She enjoys working closely with MediSpend customers to solve business problems, helping companies manage relationships with physicians and improving business processes. Ms. Daboul is a graduate of Rutgers University and currently resides in Portsmouth, NH.

Amy is the Head of U.S. Compliance & Ethics Monitoring & Data Analytics for Bristol-Myers Squibb Company (BMS). She has responsibility for overseeing BMS's U.S. compliance monitoring program and, most recently, was appointed to lead the development and implementation of the U.S. compliance data analytics program. Amy has been with BMS since 1999 and has held various analytical and strategic roles of increasing responsibility in finance, project management, pricing & reimbursement, and operations. She demonstrates influential leadership and a solutions-oriented approach. Amy is highly adept in identifying gaps and risk exposure in operations as well as developing and implementing strong systems of control that achieve both compliance and business results. Prior to her roles in Compliance, she was a project manager responsible for the entire U.S. Pharmaceuticals' business implementation of the company's Corporate Integrity Agreement (CIA). Prior to joining BMS, Amy was a Manager in the Audit and Business Assurance practice as well as the Consulting practice at PricewaterhouseCoopers in Philadelphia. She received a BS, cum laude, from Villanova University School of Business and was captain of the Division I softball team. She was a CPA and is currently a certified Project Management Professional (PMP), Lean Six Sigma Green Belt, and Certified Compliance and Ethics Professional (CCEP).

Bryan Timer is an Associate Director of Data Analytics and Transparency at Merck and Company. He is responsible for leading the implementation of Merck's current compliance analytics program within the US market and continues to be a driving force behind the ongoing evolution of that program. In addition to US market analytics program, Bryan works with other compliance groups within Merck to help them realize the benefits of data analytics. Prior to joining Merck, Bryan spent seven years working for two custom software companies where he implemented over 40 custom solutions within the pharmaceutical and consumer packaged goods industries.

Heather McCollum currently serves as the Director of Compliance at Shionogi Inc., a mid-size pharmaceutical company located in Florham Park, NJ. Her responsibilities span all areas of compliance, with a special emphasis on aggregate spend, auditing and monitoring, and investigations.

Prior to joining Shionogi, Heather was a Manager at Polaris Management Partners, focusing on compliance program assessments, monitoring and auditing programs, IRO services and FCPA.

Heather received her JD/MHA with Health Law Certificate from Saint Louis University and a BS in Criminology from The College of New Jersey. She is a member of the Health Law Section of the American Bar Association, and was named a Rising Star by the Healthcare Businesswomen's Association.

Ellen Carman is a Manager in Grant Thornton's business advisory services practice focusing on process optimization and technology projects. She works with life sciences clients to optimize or implement new processes and technologies and provide insights to achieve business objectives, increase efficiencies and reduce risk. She helps clients develop continuous improvement capabilities and business insights as well as monitor risk through reporting and analytics initiatives such as: data management strategy, data identification and integration, and custom report development.

Lee Taurman is the National Life Sciences Advisory Leader for Grant Thornton. He is a seasoned life sciences executive with more than 15 years of experience in strategic and operational capacities in both consulting and industry roles. He is a corporate strategist with a practical approach to link strategy to execution through visibility to measurable metrics and accountability for results. Lee is also a proven consulting leader with a track record of building high performing Life Sciences consulting teams. He has been a thought leader dedicated to the idea that life sciences companies need to rethink their role in the healthcare ecosystem and move "beyond the pill" to drive patient outcomes through innovative solutions in collaboration with payers and providers.
Prior to Grant Thornton, Lee was Executive Vice President of Corporate Strategic Development for Mylan, Inc., a Fortune 500 specialty pharmaceutical manufacturer. In this role, he was responsible globally for Corporate Strategy, Business Transformation, Business Analytics, and Health Innovation Solutions. Prior to this role, Lee held positions of increasing responsibility with PricewaterhouseCoopers and IBM Global Business Services where he was a Partner and led the Strategy and Transformation practice for Life Sciences in North America.

Lee has worked with both large and emerging pharmaceutical companies to plan for and execute transformational programs. His areas of focus include Corporate Strategy, Sales and Marketing, Managed Markets, and functional transformations in HR, Finance, Legal, and IT. He has also worked with a number of clients to develop strategies and implement solutions in compliance, including Aggregate Spend reporting solutions, process and policy solutions for dealing with third-party vendors (such as speaker programs), and strategies to meet additional compliance requirements that resulted from Corporate Integrity Agreements.

Jeffrey E. Fleming, Vice President & Chief Compliance Officer

Jeff is the Vice President & Chief Compliance Officer at Vertex Pharmaceuticals in Boston, MA. In that role, he is responsible for leading the Vertex global compliance program. He is a member of the Legal & Compliance Leadership Team and chairs the company's Compliance Committee.

Jeff brings more than 20 years of legal and compliance experience to the role. Prior to joining Vertex, Jeff was the VP Compliance North America for AstraZeneca, an attorney in the Legal Department at AstraZeneca and its predecessor companies, an associate at Morgan Lewis and a federal law clerk.

Jeff earned his bachelor's degree from Ohio University and his juris doctorate from Villanova University School of Law. Jeff resides in West Chester, PA with his wife and three children.

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

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

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.

Ann E. Beasley, JD, is a Director in the Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations practice. She has over 17 years of in-house healthcare and life sciences experience for companies in pharmaceutical, biologics, vaccine, device and genetic testing. She has practiced in both legal and compliance departments and just prior to joining Navigant, was the Chief Compliance Officer and Senior Vice President at Biogen. Ann has significant international experience having built and led global compliance programs for major pharmaceutical and biotechnology companies, including developing the organizational infrastructure of the function and the individual skill development of compliance professionals. She has built and managed local and global corporate compliance programs and initiated specific projects including performing complex investigations, building investigation protocols, Codes of Conduct and other structural elements of a Corporate Compliance Program. These elements include risk assessments, policy development, training and communications, and developing robust monitoring plans and requisite data analytics and feedback to management. She also has extensive experience in implementation of business processes and controls and overall program assessment. She has specific legal and regulatory expertise in advertising and promotion, kick-backs, anti-bribery and anti-corruption, grants and charitable contributions, conflicts of interest, healthcare practitioner fee for service arrangements, spend transparency, Phase IV clinical trial processes, Investigator Initiated Studies, issues related to medical affairs practices including advising on field interactions, publication processes and use, and secondary research. Ann is also very familiar with US and international privacy regulations and the practical impact upon life sciences companies' business operations including consent, security and anonymization. Ann has run executive management corporate compliance committees and presented regularly at Board and Board Committee meetings.

Brian is a proven senior-level compliance professional with 22 years of biopharmaceutical industry experience within the areas of corporate ethics and compliance, general management, regulatory affairs, basic R&D, manufacturing, sales/marketing and advertising. Prior to joining Huron, Brian was the Assistant Compliance Officer of the Americas for Shire Pharmaceuticals. He developed and implemented the company's compliance program in the U.S. and Canada within the Specialty and regenerative medicine business units.

Bill Hrubes has served as Vice President and Chief Compliance Officer at ACell since 2015, after serving as Senior Director of Compliance and Risk Management since 2014. He has more than 15 years of experience in the development, implementation, and management of compliance and ethics programs in the life sciences industry. Mr. Hrubes previously served as the Compliance Officer for the Joint Reconstruction business of Johnson & Johnson. He has held other leadership roles in compliance and risk management at companies including Smith & Nephew, Novation, Gambro, and Fresenius Medical Care North America.

Kevin Ryan is a Senior Director in the Novo Nordisk Inc. Compliance Department where he focuses on risk and accountability. Prior to joining the Compliance Department he spent seven years as in-house counsel in the Novo Nordisk Legal Department.

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 FDA and healthcare regulatory compliance matters, including product advertising/promotion, clinical trial regulation, quality system regulation/good manufacturing practices, FDA enforcement actions, and federal healthcare compliance programs. Nikki is an expert on state transparency laws targeting the pharmaceutical and device industries and the federal Physician Payment Sunshine provisions enacted as part of the Affordable Care Act and implemented by CMS.

She leads the K&S Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical and medical device manufacturers that she advises on these state and federal transparency/disclosure laws. She also leads the K&S International Marketing and Disclosure Compliance Group, a separate coalition of pharmaceutical manufacturers, on the growing area of global transparency/disclosure laws and industry codes of conduct applicable to the pharma and medical device industry.

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

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

Dan Dovdavany is Associate General Counsel, North America Litigation & Investigations, at Sanofi US in Bridgewater, NJ. At Sanofi, Dan manages government investigations, qui tam litigation and health care compliance internal investigations. Prior to joining Sanofi, Dan worked at an international law firm representing health care companies in product liability, antitrust and commercial litigation. Dan graduated from Cornell University in 1996, the Benjamin N. Cardozo School of Law in 2000 and is admitted to the New York, New Jersey, District of Columbia and Massachusetts State Bars.

Duane Hughes has worked for Eli Lilly & Company for 13 years. Duane has spent most of his career working in Lilly sales organizations including the Neuroscience, Long Term Care and Cardiovascular divisions. In 2015 Duane joined the Ethics & Compliance organization where he supports multiple sales and marketing organizations nationally from an E&C perspective.

Lisa LaMond began her career in Pharma in 1988, and has held numerous positions of increasing responsibility as she gained experience in all facets of commercial operations. Lisa also obtained additional skill outside of the Pharma industry as a successful Chief Commercial Officer and Change Agent for a privately held firm. Lisa continues to widen her experience in effective leadership through her current position at Merck & Co. as Executive Director of Strategy Planning, and is responsible for developing and heading the US & Go to Market strategy.

Lisa has a Bachelor of Science in Health Science, and a Master's in Business Administration. She and her family reside in Bucks County, PA., where her husband and two children are active in community sports programs and charity. Lisa enjoys yoga, investing, and continues to stay involved in mentoring programs.

Linda Sarnecki, Director, Business Partnership Transparency and Compliance, Sanofi, Bridgewater, NJ. Linda serves as the liaison between transparency reporting, compliance and the business stakeholders. She brings over 25 years of healthcare and pharmaceutical experience to this role. She has achieved sustained success in field sales and field leadership across therapeutic areas. Linda joined the Transparency Operations team in 2012 and has served with increasing levels of responsibility to help Sanofi meet the Open Payments reporting and compliance requirements. Since 2013 Linda has also managed the team that facilitates international affiliate and global requests for US HCP contracted services. Linda contributes to organizational continuous improvement with responsibility for the change management associated with audit-related remediation.

Director Data, Analytics & Transparency, Compliance Officer, Merck & Co Inc

Proven leader in compliance, operations, analytics and auditing with over 20 years' experience in the pharmaceutical industry. Expertise in talent development, strategic planning, risk assessments, monitoring and managing complex issues. Recognized leader in data analytics, compliance and transparency.

• Lead all activities relating to Merck's Federal, State and Corporate Integrity Agreement (CIA) transparency requirement including data collection, validation and reporting. Act as primary point for external agencies such as PhRMA, CMS and OIG. Speaker at industry conferences.
• Lead Analytics and Monitoring team in developing risk assessments and mitigation plans, creating complex analytical models using large data sets and bringing new unique technologies into Merck to establish ourselves as a leader in the analytics field. Extensive interactions with senior leaders. Excellent negotiation and conflict resolution skills.
• Expertise in policy/process development, project management and attracting and retaining top talent to build best in class teams. Manage team of 6 professionals with various backgrounds and skill sets.

Jack has over 18 years of experience in the pharmaceutical, biotechnology, and medical device industries, ranging from product and therapeutic area strategic planning to enterprise risk management and compliance effectiveness. Over the last decade, Jack has assisted life sciences clients with assessing, developing and implementing compliance programs and their associated technology systems, meeting requirements stemming from government settlements (e.g., Independent Review Organization (IRO), Pre-IRO, and Board Advisor), providing expert testimony related to commercial practices and compliance effectiveness, and assisting companies with maintaining compliance with various state and national transparency laws and regulations.

Jonathan P. Glazier is Senior Counsel, Legal Compliance at Philips Electronics North America Corporation in Andover, MA. In his role, Jonathan leads the legal compliance function at Philips focusing on healthcare compliance concerns and serves as the Company's Ethics Officer.

Previously, Jonathan was Senior Director of Corporate Compliance, Privacy and Information Security Officer at Fresenius Medical Care North America of Waltham, MA. In that role and in his prior roles at the German headquartered dialysis and infusion products and services company, Jonathan developed significant legal compliance experience on health care and non-health care related matters.

Jonathan received his Bachelor of Arts from American University in Washington, DC. He received respectively his Juris Doctor and his Master of Business Administration from Suffolk University School of Law and the Suffolk University, Sawyer School of Management both in Boston, MA.

Jill Mason is the Chief Ethics and Compliance Officer for Orthofix International, N.V. Orthofix is a diversified, global medical device company headquartered in Lewisville, Texas with operations in more than 50 countries around the world. In her role, she oversees the company's global ethics, compliance and privacy programs. She is also the Chairperson of the Steering Committee for the North Texas Ethics and Compliance Council, an organization of compliance executives based in Dallas-Fort Worth. The constituents represent various major business sectors, including aerospace, consumer goods, food & beverage, healthcare, manufacturing, oil & gas, retail, technology, and transportation.

Jill began her compliance career at St. Jude Medical in 2006. While there, she took on roles of increasing responsibility, ultimately becoming the Chief Compliance Officer in 2011. Prior to St. Jude Medical, Jill was a corporate attorney in private practice with a multi-national law firm.

Jill received her Bachelor of Arts in political science from Texas A&M University and her Juris Doctor degree from Baylor University School of Law.

Steve Sitek leads Novartis' learning, education and communications to support all integrity and 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, and has consulted on talent and leader development strategies with many Fortune 200 organizations. He possesses comprehensive expertise in developing and executing strategies to produce high impact learning programs, align global organizations, drive change, and optimize talent management programs and functions.

Steve is an adjunct professor at Rutgers Business School, teaching MBA classes in Organizational Behavior, Group Dynamics, Negotiations, and Business Ethics. He earned a Masters in Education from the University of Vermont, and a Bachelor of Arts from Gettysburg College.

Gary Keilty is a Managing Director with FTI Consulting's National Health Solutions practice and is based in Washington, D.C. Gary has over 25 years' experience as a management consultant and specializes in providing financial, investigative, operational and industry expertise to Life Sciences companies, healthcare providers and health law firms. Gary's area of expertise includes assisting clients and their outside counsel during large government investigation and commercial litigation cases, assisting clients with regulatory compliance assessments and compliance program development and providing Independent Review Organization services.

Corporate compliance and commercial attorney with substantial in-house legal experience and a focus on international legal and compliance matters. Extensive experience in pharmaceutical, medical device, consumer and nutritional products companies, within a wide variety of legal jurisdictions worldwide. Proven track record of success in developing and implementing best in class international compliance programs. Experienced transactional attorney, with substantial expertise and success in establishing and maintaining direct business operations around the globe. Proven success handling a heavy caseload annually while simultaneously improving client satisfaction. Recognized for intellectual flexibility, solid business judgment, collaborative interpersonal skills and ability to work effectively in muli-cultural environments. Winner of prestigious Global Counsel Award 2009 in Best Individual Commercial Lawyer category (www.globalcounselawards.com). Gave multiple compliance presentations at international conferences.

John DeMarrais is a Managing Director in the Deloitte Life Sciences Advisory Practice, based out of Parsippany, New Jersey. John has over 22 years of experience within the life sciences industry, advising clients on issues related to healthcare law and regulatory compliance and commercial contracting. He has deep knowledge of key issues within compliance. He has a strong grasp of the critical elements present within the PhRMA Code as well as the ?Anti-Kickback? statute and how these frameworks affect the crafting of life science policies, procedures and SOPs.

His regulatory work has included compliance reviews and assessments within areas such as interactions with health care professionals, sales force T & E and detail activity reporting, Sunshine Act/transparency reporting, speaker programs, coupon and sampling programs, consultant arrangements, compendia, call plans, educational grants and research funding, medical publications and MSL activities, medical affairs and pharmacovigilance as well as industry specific clinical investigations and litigation support.

John has been a key architect in the development of Deloitte's Life Science third party vendor review program.

John has a B.A. Economics and Political Science from Indiana University, Bloomington, IN and an MBA in Finance and Marketing from Wake Forest University in Winston-Salem, NC.

Partner, Arnold & Porter LLP

Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.

Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented "hands-on" educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.

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

As a hands-on executive, Andy has been involved in a wide variety of compliance-related engagements for pharmaceutical and device manufacturers, ranging from policy development and process automation to organizational change. His expertise ranges from the sales and marketing to medical and clinical departments of the client organization. Andy is still involved in many of Polaris' client assignments, and has personally led many FMV, auditing and monitoring projects, as well as numerous international transparency reporting and HCP/O implementations. He has implemented in excess of fifty Request Management Systems for clients, focused on grants, charitable contributions and IIS requests.

Andy has designed and developed many of the concepts, programs and methodologies that have made Polaris an international leader in the healthcare law compliance business.

Katherine Buckley is an experienced pharmaceutical and life sciences industry consultant with over 18 years of experience providing regulatory compliance, commercial contracting and operations, risk management and dispute resolution services to the pharmaceutical industry. Katherine's experience includes compliance program design, policy and procedure development, policy adherence assessments, risk assessments, analytics, monitoring, compliance training, and design and vision of future state contracting, government price reporting and healthcare professional interaction compliance programs.

Sergio Alegre is the Vice President, Global Compliance for Osmotica Pharmaceutical. In this position, Sergio is principally responsible for the development and implementation of the company's compliance program on a global basis. He also serves as a member of the Company's Executive Committee. Sergio has over 15 years of compliance and legal experience both inside and outside of the pharmaceutical industry. He holds a JD from Fordham University School of Law and a Bachelor's Degree from Rutgers University.

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

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

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

Maggie Feltz is Purdue's Executive Director, Ethics & Compliance. She has extensive experience in all facets of compliance and ethics, with special focus on commercial business activities. She has led multi-disciplinary teams and accomplished successful implementation of a corporate integrity agreement, including frequent engagement with our federal government monitor. She likewise sponsored company-wide projects in the areas of training, aggregate spend/transparency, and integrity and ethics. Likewise, her expertise includes hotline implementation, identifying and mitigating risks, conducting investigations, and implementing preventative and corrective action plans.

Prior to joining Purdue, Maggie served as Compliance Counsel at Boehringer Ingelheim Pharmaceuticals, Inc. and practiced health care law at McDermott, Will & Emery. She is a 2001 graduate of Case Western Reserve University School of Law, where she received her J.D. She also holds an M.A. in Medical Ethics from Case Western Reserve University and a B.A. in Bioethics from Wellesley College.

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 FDA and healthcare regulatory compliance matters, including product advertising/promotion, clinical trial regulation, quality system regulation/good manufacturing practices, FDA enforcement actions, and federal healthcare compliance programs. Nikki is an expert on state transparency laws targeting the pharmaceutical and device industries and the federal Physician Payment Sunshine provisions enacted as part of the Affordable Care Act and implemented by CMS.

She leads the K&S Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical and medical device manufacturers that she advises on these state and federal transparency/disclosure laws. She also leads the K&S International Marketing and Disclosure Compliance Group, a separate coalition of pharmaceutical manufacturers, on the growing area of global transparency/disclosure laws and industry codes of conduct applicable to the pharma and medical device industry.

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

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

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

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

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

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 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 conduct internal investigations and regularly advises pharmaceutical, biotech, and medical device companies on mitigating risks and implementing compliance programs.

Tom Gregory is a Partner in EY's Fraud Investigation & Dispute Services practice where he specializes in leading complex investigations in the life sciences industry. He has over twenty years of experience advising management teams, boards of directors, law firms and regulatory authorities on fraud and abuse and compliance matters. His work includes all phases of the investigation and dispute resolution process up to and through damage calculations and presentations to regulators and enforcement officials in both a civil and criminal setting.

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.

Tom Beimers is a partner in the health care practice at Hogan Lovells US LLP. Tom was previously senior counsel with the Department of Health and Human Services' Office of the Inspector General, where he was a member of the Pharma Team. In that capacity, Tom investigated False Claims Act and other fraud matters and negotiated and monitored corporate integrity agreements. 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. Since returning to private practice in 2012, Tom has assisted clients responding to False Claims Act investigations and has provided advice and counsel regarding fraud and abuse issues.

Jose M. Ayala is currently Program Director for Medtronic's Global Channel Compliance organization based at the company's corporate function in Minneapolis, MN, having previously worked in Finance and Sales Operations & Strategy roles. He has earned a MBA in Finance from the W. P. Carey School of Business at Arizona State University and a B.S. in Aerospace Engineering from the A. James Clark School of Engineering at the University of Maryland.

In 2012, Mr. Ayala completed a one-year deployment with NATO's International Security Assistance Force in Afghanistan as part of Combined Joint Inter-agency Task Force (CJIATF) Shafafiyat (Transparency), where he led the Governance and Rule of Law Division and worked directly with the International Community, the Afghan Government and Civil Society to reduce corruption within the Afghan Government. Mr. Ayala draws from his broad experience to create and implement programs designed to mitigate Medtronic's exposure to potential FCPA violations.

Marc Alain Bohn focuses on the Foreign Corrupt Practices Act (FCPA) and other areas of international corporate compliance, including export controls and economic sanctions. He regularly advises multinational companies on compliance and enforcement matters and has broad experience conducting internal investigations and representing companies before the Department of Justice (DOJ) and Securities and Exchange Commission (SEC).

Mr. Bohn has worked on several large-scale FCPA investigations and is frequently engaged in due diligence exercises. He has also conducted numerous compliance-focused audits and assessments and regularly assists companies in developing risk-tailored compliance policies and procedures. In the course of his work, he has addressed compliance and corruption issues arising all over the globe and across several industries, including the life sciences, agricultural and oil and gas sectors.

Traci Coughlan, Principal of Advisory Services at The Red Flag Group, is a 20-year veteran of the legal services, compliance, and e-learning industries. Following seven years of commercial litigation, white collar crime defense, and extensive pro bono work at Kirkpatrick & Lockhart (now KL Gates) and Pepper Hamilton LLP, Ms. Coughlan spent over 10 years in-house at Sun Microsystems Inc., a Fortune 500 technology company.

Ms. Coughlan served in various capacities within the Sun Microsystems Legal and Compliance Department, including: Director of the Global Channels Legal Team; Chief Antitrust Counsel and; Associate General Counsel and Director for Sun's Business Conduct Office.

Immediately prior to joining The Red Flag Group, Ms. Coughlan served as Vice President of Business Development and Strategy for a leading compliance e-learning company.

Victoria Browning is the Compliance Officer for KARL STORZ North America. She is an experience compliance profession with over 20 years of compliance and legal experience and has played a leadership role in the development of comprehensive and integrated global compliance programs. Her experience includes work on government investigations and in the negotiation and implementation of Consent Decrees and Corporate Integrity Agreements. Prior to joining KARL STORZ, Victoria was with Allergan and Eli Lilly and Company.

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 cutting-edge 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 Anti-Kickback 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 act.

Susan Lee is a partner in Hogan Lovells' DC office. She provides sophisticated, pragmatic legal advice to innovative pharmaceutical and biotechnology companies on a range of FDA matters to advance clients' business objectives. Susan's particular areas of expertise include advertising and promotion, investigations and compliance, transactions and collaborative agreements, and digital health. Prior to her legal career, Susan was a consultant in the health care practice of a global strategic consulting firm.

Mark is a Managing Director in Huron's Life Sciences. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the healthcare industry. Mark trained as molecular biologist and has ben actively involved in both research and business development roles for over 30 years. Mark specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.

Kara Bonitatibus, an Assistant General Counsel in the Compliance Division with Pfizer Inc., oversees the anti-corruption program office, compliance and corporate policies, and compliance support for the commercial operations function as well as serves as counsel to Pfizer's Corporate Audit team and manages divisional technology initiatives. She previously led the Compliance Monitoring & Analytics team and oversaw Pfizer's obligations with its former Corporate Integrity Agreement. Prior to joining Pfizer, Kara practiced as a products liability attorney with DLA Piper US LLP and as a patent attorney with Stroock & Stroock & Lavan LLP.

Tony is a Senior Manager with EY's Fraud Investigation & Dispute Services practice. He specializes in data analytics pertaining to Compliance risk in the Life Sciences industry. Prior to joining EY Tony had several years of diverse compliance, audit, finance and business experience with Johnson & Johnson both domestically and internationally. Part of his compliance experience included risk assessment, external reporting, policy and compliance monitoring and analytics. A Certified Corporate Accountant (FCCA), Certified Fraud Examiner (ACFE) and Society of Corporate Compliance and Ethics (SCCE) member.

Kevin Espinoza, Global Vice President, Ethics and Compliance Officer at BTG International, has spent over a decade introducing, leading and managing Pharmaceutical and Medical Device Compliance Programs. Kevin's roles have included that of a Healthcare Compliance Officer, R&D Compliance Officer and responsibilities for various companies' Anti-Corruption Programs. Kevin's experience includes resolving an FCPA matter with the US SEC, as well as preparation, negotiation and implementation of agreements with US DOJ and US OIG of HHS. Prior to his work in Compliance, Kevin served in various sales, marketing, and corporate affairs roles at a large Pharmaceutical Manufacturer. Kevin and his family, along with a stable of animals, live in Wake Forest North Carolina, USA.

Pamela Hrubey joined Crowe Horwath's regulatory compliance practice in January 2016 as a managing director after 28 years of experience from discovery research through commercialization at Eli Lilly. Her expertise includes credentials and experiences with responding to government inquiries, implementation of and oversight/support for corporate integrity agreement requirements, consent orders and remediation efforts related to working with regulators such as the DOJ, FTC, OIG/HHS, SEC, and international data protection authorities. Pamela served in roles including operations leader of ethics and compliance, chief privacy officer, and head of enterprise risk management prior to joining Crowe.

Chris Morris is a forensic accountant and compliance professional with over a decade of experience in the health care and life science sectors, including the development and execution of an FCPA probe investigation into a multinational company based upon a qui tam allegation related to Latin American interactions with Key Opinion Leaders. A Certified Public Accountant licensed in the state of Arizona, Mr. Morris has extensive experience in healthcare finance and accounting with a strong focus upon FCPA investigations and compliance assessments, and deep expertise in the development of new or enhanced reporting and auditing solutions for clients' various reporting needs. He has the developed customized and robust risk assessment processes for two pharmaceutical corporations.

Don Soong has 20+ years' experience in delivering technology solutions to life sciences companies. Over his career, Don has delivered commercial solutions to the industry for CRM, Sampling Accountability, Aggregate Spend and Disclosure reporting by combining technology, legislative knowledge and compliance lifecycle methodology. This unique combination of technical and business knowledge has established his expertise in the industry. He was named by PharmaVOICE magazine as one of the 2014's 100 Most Inspiring People in the Life-Sciences Industry.

In his current position as the General Manager for Transparency Solutions at IMS Health, Don is responsible for the commercial strategy and direction for IMS Health's Compliance and Transparency solutions.

Mohammad has spent a decade building analytical solutions and applications for the Fortune 1000 companies. Born in a family of entrepreneurs, Mohammad is passionate about building an organization with the right culture and grooming people to perform at their best. Prior to heading qordata, he was a Managing Partner/co-founder at Streebo where he grew the team from two to a hundred employees in five years.

Mohammad has a Bachelor in Computer Science from Rice University and EMP (Entrepreneurial Master's Program) from MIT. He serves on the board of Entrepreneur Organization as Strategic Alliances chair. He plays competitive cricket with the Houston Cricket League and lives in Sugar Land with his wife and three daughters.

Jeffrey Kawalek is a compliance professional with seventeen years of pharmaceutical experience with a focus on developing and implementing effective pharmaceutical compliance programs, mitigating risk, and advancing compliance with Company policy and Federal and state healthcare laws.

Jeff has worked at Novo Nordisk since 2007 and has supported the Chief Compliance Officer to set and accomplish the strategic objectives of the corporate compliance program. He has contributed to the development of the compliance program and has had responsibilities leading various functions including: Federal [Sunshine] Open Payments and state reporting, monitor and auditing, risk management, and components of the Corporate Integrity Agreement. He has also supported several global compliance initiatives.

He holds a Bachelors Degree in Business Administration from The University of Delaware and an MBA from the Fox School of Business at Temple University.

Eric Baim is the Vice President and Head of U.S. Compliance at Shire based in Lexington, MA. As a senior governance, risk and compliance executive, Eric has over 15 years of experience successfully leading, enabling and integrating governance, risk management, integrity and compliance responsibilities for pharmaceutical, medical device, biotech and other healthcare organizations. Prior to joining Shire, Eric has various compliance roles at Novartis in New Jersey and, before that, practiced as an attorney in Washington, DC. Eric has law and public policy degrees from Duke University and a Masters in Psychology from the University of Cincinnati. He did is undergraduate work at the University of North Carolina at Chapel Hill.

Maureen McGirr is an experienced legal and compliance leader responsible for managing a wide range of issues in the pharmaceutical industry for more than twenty years at Merck & Co., Inc., Kenilworth, N.J. Maureen currently is Vice President, Office of Ethics in the Global Compliance Organization at Merck. In this role, she is responsible for the global investigations program, compliance training, code of conduct, and anti-bribery and corruption compliance program. Previously, Maureen held a number of positions in the Office of General Counsel based in the U.S. headquarters of Merck & Co. and had an international assignment based in Japan.

Prior to joining Merck, Maureen was a Senior Associate at the law firm of Arnold & Porter and an Associate at the law firm of Hughes, Hubbard & Reed handling a broad range of litigation and regulatory counseling matters. Maureen has spoken at a number of legal, ethics and compliance conferences worldwide.

Doug Worthington is the Vice-President of Compliance & Ethics, U.S. Market, at Bristol-Myers Squibb, based in Princeton, NJ. He has responsibility for compliance policy development and implementation; training and education; and monitoring and analytics across BMS's full U.S. portfolio, including Commercial, Medical and Access & Pricing. He is a member of the BMS U.S. Leadership Team and the Compliance & Ethics Worldwide Leadership Team.

After several years in private practice, Doug joined BMS in 1999 as an attorney in the Business Development function, where he focused on asset and technology licensing. In 2003 he transitioned to a regulatory attorney role in BMS's U.S. Market, where he supported Commercial teams in the OTC, cardiovascular, virology and oncology lines of business over a five-year period. He then founded the Law Department's Contracts Center of Excellence, a worldwide team of 25 attorneys and paralegals.

In 2013 Doug joined BMS's Compliance & Ethics department and became the Head of C&E for Asia-Pacific, including China, Japan, Australia and India, based in Shanghai, China. He moved back to the U.S. in late 2014 when he accepted his current position.

Doug graduated from Princeton University and received his law degree from George Washington University.

Kris Curry is a Principal with Ernst & Young's Fraud Investigation & Dispute Services practice. Kris specializes in assisting health sciences companies with global risk and compliance assessments and analyses. Kris works closely with management teams and chief compliance officers to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives. Kris also assists clients in fraud investigations and compliance inquires. She has first-hand experience managing and responding to government investigations, including the negotiating of settlements agreements.

William T. Hassler is a partner in Steptoe and Johnson LLP's Washington office, where his practice has encompassed a broad range of criminal and civil cases. Prior to joining the firm, Mr. Hassler served as a prosecutor for the Office of Independent Counsel investigating the Iran/Contra affair, and in the Environmental Crimes Section of the US Department of Justice. He is a former Special Assistant to the Director of the Federal Bureau of Investigation (FBI).

John Lundquist is one of the most experienced white collar trial attorneys in the Midwest, representing clients in all area of criminal defense, False Claims Act defense, and regulatory enforcement. His practice focuses on healthcare organizations and executives with a strong emphasis on the device industry. He founded the White Collar & Regulatory Defense Practice at Fredrikson & Byron in Minneapolis nearly 20 years ago after practicing in a boutique defense firm. Among his recent trials is United States v. Vascular Solutions and Howard Root, which will be featured in today's panel discussion. He is a Fellow of the American College of Trial Lawyers and listed in Best Lawyers in America.

Joe Savage is a partner at Goodwin | Procter LLP where he is a member of the firm's White Collar and Government Investigations Group. He represents companies and individuals in a variety of civil and criminal cases involving investigations by federal, state and local law enforcement and government regulators. Mr. Savage is a member of the American College of Trial Lawyers and has tried approximately 50 cases in U.S. District Courts. He is former Chairman of the Board of the New England Innocence Project and was a federal prosecutor for 13 years. Mr. Savage was named by Best Lawyers® as 2017 Boston White Collar Criminal Defense "Lawyer of the Year."

Dan Kracov is co-chair of Arnold & Porter's Life Sciences and Healthcare Regulation Practice, which was recently named the top Healthcare practice in the country by Law360. For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and other publications. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device and diagnostic companies, including start-up companies, trade associations, and large manufacturers, negotiate challenges relating to the development, approval and marketing of FDA-regulated products. In addition to day-to-day counseling on regulatory strategies and compliance concerns, Mr. Kracov regularly handles product and compliance-related government and internal investigations, the development of global corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.

Tom DiLenge became President of BIO's Advocacy, Law & Public Policy Division in April 2016. Immediately prior to that, he served as BIO's General Counsel and Head of Public Policy since December 2013. Previously, Tom served as the General Counsel and Senior Vice President, Legal & Intellectual Property, from May 2006; and Deputy General Counsel, from November 2005. Prior to joining BIO, Tom served as the Chief Counsel and Policy Director for the House Homeland Security Committee and previously served as a senior counsel for the House Energy and Commerce Committee. On the Hill, he was a leading expert in the area of public health emergency preparedness. Prior to working on Capitol Hill, Tom worked at the Washington, D.C. office of the international law firm Mayer, Brown, where he participated in a sophisticated general and appellate commercial litigation practice. In this capacity, he represented a host of publicly traded and privately held corporations, including those in the agricultural, healthcare, and accounting industries. He worked closely with in-house corporate counsel on compliance, investigative, and litigation matters, with a particular focus on antitrust issues and investigations. Tom graduated summa cum laude from Fordham University in 1988 and graduated with honors from the University of Virginia School of Law in 1993.

As member of the Innovative Medicines Canada team and the Executive Director of Ethics and Compliance, Chrisoula Nikidis is responsible for the Code of Ethical Practices and related issues. Her key responsibilities include maintaining and updating the Code, managing the Code education program, answering Code related questions, offering guidance on the application of the Code while providing expertise on industry practices. Included in her responsibilities is advice and support to the President of Innovative Medicines Canada in matters that pertain to the International Federation of Pharmaceutical Manufacturers Association (IFPMA) and the Code Compliance Network.

Jim Stansel is General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he is responsible for leading a team of lawyers in supporting PhRMA's policy, advocacy and science priorities and in the development of sound legal policies impacting the pharmaceutical industry. Jim previously served as Acting General Counsel, Deputy General Counsel and Health Policy Counselor to the Secretary of the U.S. Department of Health & Human Services. He also was previously a partner and co-head of Sidley Austin LLP's Global Life Sciences Team. Jim is a graduate of Brigham Young University and Yale Law School.

Nancy Travis is Vice President for International Compliance and Governance for the Advanced Medical Technology Association (AdvaMed). Travis is responsible for the Association's efforts to advance the highest ethical standards for business interactions in the medical technology sector worldwide.

Travis has more than 20 years of international affairs and economics experience, with a particular focus on Asia-Pacific trade issues. She worked on China and Taiwan's World Trade Organization accession negotiations, Korea Free Trade Agreement discussions and has been involved in assessing compliance with WTO and FTA commitments. Throughout her career, she has received a number of exceptional performance and superior honor awards.

Alexis is a Director in PwC's Pharmaceutical and Life Sciences Advisory Practice experienced in assisting medical device and pharmaceutical companies in addressing areas of compliance risk and management.

Alexis has spent several years focused on assisting companies in addressing the challenges presented by complex and dynamic regulatory and compliance environment, including assessing, designing, and implementing global compliance programs. In addition, her experience includes developing the compliance strategy and vision for global programs, developing innovative methodologies for addressing the complexities of operating a cross-functional, global team across a range of requirements to meet regulations, meet short and long term Compliance objectives and drive value add for the broader business through processes, controls and business intelligence.