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 calculations, managed care contracting, collaborations, Sunshine Act, health care reform, privacy, and coverage and reimbursement. Meena routinely serves as an advisor to established and emerging pharmaceutical and medical device companies.

Vice President, Business Development and Pre-Commercialization Services

Neil leads Commercialization Consulting Services, which provides strategy, analysis and compliance support for manufacturers evaluating holistic commercialization options for their product. He works with emerging and established manufacturers to provide consulting services and strategy development for commercialization functions related to sales, marketing and contracting for products distributed in the US market. He specializes in advising clients on their pre-commercialization needs related to third-party logistics, elevation of channel and contracting strategy with distribution partners, and HUB support. Neil joined after 11 years with Cardinal Health, where he filled roles ranging from finance to acquisitions. As Director of Sales at Cardinal, Mr. DeHenes was responsible for facilitating commercialization strategies for specialty drug launches and providing third-party logistical services for pharmaceutical and biotech manufacturers. He is a graduate of Indiana University's Kelley School of Business.

Chris is an industry thought leader offering compliance consulting services and outsource operations services to pharmaceutical, biotech, and medical device companies. Focused on areas of regulatory compliance within commercial programs and pricing, sales and marketing, government programs (Medicaid, Medicare, PHS), and federal contracting, Chris has more than 16 years in the industry with extensive experience in government programs and pricing which includes working with manufacturers of all types and sizes in areas such as policy and methodology, assessment and audit, recalculations and restatements, class of trade (COT) analysis, PHS membership, bona fide service fees, and recalculations as well as strategic business process outsourcing for statutory pricing calculations, chargebacks, and rebates processing

John Shakow, Partner, FDA & Life Sciences Practice Group, King & Spalding - 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.

Principal at Ernst & Young

Ed is a Principal in Ernst & Young LLP's Fraud Investigation & Dispute Services practice serving the Life Sciences industry. He is a Certified Fraud Examiner with over 20 years of investigative, electronic discovery, forensic data analytics, and forensic computer science experience. He has testified in US federal courts as an expert in forensic computer science and data analysis. He has assisted clients in forensic accounting, FCPA, OFAC, regulatory compliance, internal investigation matters, cyber forensics matters (data leakage including aircraft designs, drug development data, and software code).

Ed leads EY's Life Sciences forensic technology team that helps clients address reactive investigation and proactive compliance monitoring efforts. He helps Life Sciences clients develop anti-fraud and risk-based compliance monitoring solutions using data-driven approaches including forensic data and text mining techniques. He also helps develop in-house/co-sourced eDiscovery solutions that include designing preservation, collection, and early case assessment protocols.

Since 2013, Mike has led EY's global FCPA investigation of an SEC registrant multinational company, conducting onsite investigations in Czech Republic, Greece, Israel, Italy, Kazakhstan, Poland, Russia, Ukraine and Slovakia, and supervising investigations in other countries, globally coordinating EY's procedures. He recently concluded the post-acquisition due diligence for a transaction between two SEC registrant companies, conducting onsite FCPA audits of rep offices and distributors in the Philippines, South Korea, Thailand, and Vietnam.

He has over 12 years of experience as an attorney including conducting forensic anti-corruption investigations around the world in over 25 countries including China. Mike has participated in every phase of investigations, including external audits and compliance counseling, initial responses to whistleblower allegations, supervising the processing, review and translation of millions of documents, conducting initial and in-depth interviews of hundreds of employees and third parties, supervising disgorgement analyses and valuation exercises, and negotiating liability and damages/penalties at the table with the DOJ and SEC.

Principal at Ernst & Young

Ed is a Principal in Ernst & Young LLP's Fraud Investigation & Dispute Services practice serving the Life Sciences industry. He is a Certified Fraud Examiner with over 20 years of investigative, electronic discovery, forensic data analytics, and forensic computer science experience. He has testified in US federal courts as an expert in forensic computer science and data analysis. He has assisted clients in forensic accounting, FCPA, OFAC, regulatory compliance, internal investigation matters, cyber forensics matters (data leakage including aircraft designs, drug development data, and software code).

Ed leads EY's Life Sciences forensic technology team that helps clients address reactive investigation and proactive compliance monitoring efforts. He helps Life Sciences clients develop anti-fraud and risk-based compliance monitoring solutions using data-driven approaches including forensic data and text mining techniques. He also helps develop in-house/co-sourced eDiscovery solutions that include designing preservation, collection, and early case assessment protocols.

Yogesh Bahl is a managing director at AlixPartners, where he leads the life sciences practice for the firm's Financial Advisory Services group. Yogesh has more than 20 years of experience with leading global investigations, litigation support, and enterprise improvement projects in the life sciences industry. He also has served as an arbitrator and an expert in matters involving pricing, marketing, breach-of-contract, intellectual-property and antitrust issues.

Yogesh's areas of expertise include fraud and corruption investigations, third-party due diligence, compliance programs, and supply-chain risk management. He has helped companies manage issues with complex accounting, product diversion, counterfeiting and contract compliance.

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

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

Jon Smollen, Director, Temple Law, Center for Compliance and Ethics

Jon was recently appointed as the Director of Temple Law's Center for Compliance and Ethics. The Center focuses on preparing students, compliance professionals and executives to better understand and address the compliance and ethical issues facing today's corporations. It also aims to foster an ongoing dialogue between the private and public sectors on these issues. Jon also teaches at Temple Law School.

Prior to this appointment, Jon served as Executive Vice President and Chief Compliance Officer for Endo International, a global pharmaceutical company. Prior to Endo, Jon held a variety of leadership positions in the private and public sectors as Vice President and Chief Compliance Officer for Siemens Healthcare USA and Chief Privacy Officer for Wyeth Pharmaceuticals.

Kristin Graham Koehler is a partner at Sidley Austin LLP and a member of the firm's Executive Committee. She was commended in the 2015 edition of Chambers USA: America's Leading Lawyers for Business as a leader in White-Collar Crime and Government Investigations Litigation and as "very practical, collaborative and strategic." Kristin has handled numerous United States Department of Justice (DOJ) Criminal and civil investigations involving healthcare fraud, antitrust, securities fraud, and violations of the Foreign Corrupt Practices Act (FCPA). She has significant experience representing clients in qui tam matters, State AG investigations, and congressional investigations, and has negotiated numerous Corporate Integrity Agreements with the HHS Office of Inspector General.

Michael K. Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the U.S. and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts. He repeatedly has been selected for inclusion in Chambers USA: and The Best Lawyers in America.

Partner, Litigation Department, Washington, DC

Nathaniel Edmonds serves as the Chair of the firm's litigation practice in Washington, D.C, which houses over 80 lawyers handling a variety of litigation matters, including intellectual property and patent litigation, international arbitration, sanctions and export controls, antitrust, white collar crime, anti-corruption compliance and internal corporate investigations.

Mr. Edmonds focuses on global internal investigations, specializing in anti-corruption matters and the challenges arising from multi-jurisdictional investigations into complex economic crime. As a former Assistant Chief of the Foreign Corrupt Practices Act (FCPA) Unit of the Fraud Section in the Criminal Division of the Department of Justice (DOJ), Mr. Edmonds assisted in the supervision of all FCPA cases in the United States and was one of the principal drafters of A Resource Guide to the U.S. Foreign Corrupt Practices Act, published in November 2012 by the DOJ and the Securities and Exchange Commission (SEC). Mr. Edmonds also specializes in anti-corruption compliance risk assessments and due diligence, as well as developing and overseeing compliance programs.

George Fife is a French Partner at EY, in the EMEIA Life Sciences Compliance, Fraud Investigation & Dispute Services practice. George specializes in assisting companies with global risk and compliance assessments and investigations. George works closely with management teams, chief compliance officers, general counsels and chief audit executives to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives to prevent, detect and respond to compliance risks.

George is a compliance and ethics professional with more than 17 years of in-house compliance life science experience. He has first-hand international experience in building, managing and assessing effectiveness of compliance programs, in the area of anti-corruption and anti-bribery.

He assists clients to develop and assess pragmatically their compliance and monitoring programs based on company culture and level of maturity, driving investigations and developing forensic technology analytical solutions into their monitoring programs.

Evelyne Lemaire is Head of Compliance, Europe & Canada at Takeda Pharmaceuticals International GmbH. She is based in Zurich.

A graduate of Facultés Universitaires Notre-Dame de la Paix in Namur, Belgium, Evelyne has over 25 years of auditing and advisory experience, with more than 15 years dedicated to projects in the pharmaceutical, biotech and medical device industries. Most recently, Evelyne was a Director in the Global Advisory Practice at PriceWaterhouseCoopers where she led the Life Sciences Governance, Risk and Compliance Team at a regional level.

She has been in her current role at Takeda since May 1st, 2015.

Current Professional Position
Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA's General Management.

Since 2008, Ms Pickaert is coordinating EFPIA's ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.

In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA's relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.

Education
Master in Economic Science from the Vrije Universiteit te Brussel (Belgium) - with honours

Thesis: Economic and Social Impact of Education and the Value of Human Capital - first class honours

Continued education and specialisation - postgraduate / executive training
-- Applied Psychology in Economics (2 years)
-- Auditing and Valuation of Enterprises (2 years)
-- Hospital Management (1 year)

George Fife is a French Partner at EY, in the EMEIA Life Sciences Compliance, Fraud Investigation & Dispute Services practice. George specializes in assisting companies with global risk and compliance assessments and investigations. George works closely with management teams, chief compliance officers, general counsels and chief audit executives to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives to prevent, detect and respond to compliance risks.

George is a compliance and ethics professional with more than 17 years of in-house compliance life science experience. He has first-hand international experience in building, managing and assessing effectiveness of compliance programs, in the area of anti-corruption and anti-bribery.

He assists clients to develop and assess pragmatically their compliance and monitoring programs based on company culture and level of maturity, driving investigations and developing forensic technology analytical solutions into their monitoring programs.

I received my degree in Veterinary Technology from Michigan State University in 1987. I joined Eli Lilly in 1989 and was a bench scientist in diabetes research for 18 years. Upon leaving the lab I accepted a position in the Research Operations group where I was responsible for multiple compliance initiatives. I joined Global Transparency in 2012 and am the transparency liaison for Research and Global Process Owner for FMV.

D. Jeffrey Campbell is the President and CEO of Porzio Life Sciences, LLC. Mr. Campbell sets the strategic goals of the company and is primarily responsible for evaluating business opportunities such as geographic expansion, joint ventures, partnerships and acquisitions. Mr. Campbell is integrally involved in development decisions concerning Porzio GST®, Porzio's third generation international spend aggregation and reporting solution. He also works closely with personnel to ensure the continuous improvement of the company's products and services and to maintain the organization's leadership in the field of pharmaceutical sales and marketing compliance consulting. Mr. Campbell is also the Chairman and President of Porzio, Bromberg & Newman P.C. His law practice is concentrated in Porzio's Life Sciences Compliance and Regulatory Counseling Department. Mr. Campbell is a member of the International Association of Defense Counsel and is active in its Drug, Device and Biotech Committee.

Brian P. Sharkey is a Vice President with Porzio Life Sciences, LLC. Mr. Sharkey collaborates with company directors, managers, and regulatory professionals to maintain the content of our products and services. Mr. Sharkey focuses on international transparency laws, codes, and regulations affecting the life sciences industry. Specifically, he analyzes the reporting obligations that companies have under governmental regulatory schemes or industry self-regulation in countries outside the United States and counsels clients on how to comply with them. Mr. Sharkey has also been involved in the development of Porzio's International Life Sciences Transparency Database, and has written and spoken extensively on the topic of international transparency. Mr. Sharkey is also a Principal of Porzio, Bromberg & Newman PC and a member of the firm's Life Sciences Compliance and Regulatory Counseling Department.

Mike focuses his practice on representing clients in investigations, transactions, and regulatory matters related to economic sanctions, export controls, money laundering, international corruption, customs, and the CFIUS review process.

Mike has represented companies in investigations initiated by the Department of Justice, the SEC, the Office of Foreign Assets Control, the Bureau of Industry and Security, the Directorate of Defense Trade Control, and U.S. Customs and Border Protection. He has conducted numerous internal investigations involving potential violations of economic sanctions, export controls, anti-bribery laws, and anti-money laundering laws in the United States, Europe, Asia, South America and Central America. He has also represented individuals in pending and threatened litigation related to potential violations of the International Emergency Economic Powers Act and the Foreign Corrupt Practices Act.

Mike regularly advises private equity sponsors and their portfolio companies, hedge funds, pharmaceutical companies, medical device manufacturers, and international logistics providers on compliance issues. He has drafted policies and procedures for numerous U.S. and foreign companies in a wide range of industrial sectors and regularly works with companies in implementing state of the art compliance programs.

Colleen Conry focuses her practice on white collar criminal defense and complex civil litigation. Colleen has extensive experience in representing multinational corporations and their executives in government investigations of potential violations of the Foreign Corrupt Practices Act, Food Drug and Cosmetic Act, and various securities fraud statutes. Colleen also served as a Senior Litigation Counsel in the Fraud Section of the Criminal Division in the United States Department of Justice.

David Ludlow is a partner in the Washington, D.C. office of Sidley Austin LLP. He represents life science companies in compliance and enforcement matters, including internal investigations, government investigations, qui tam litigation, risk assessments, and compliance counseling. His practice covers a range of issues, including clinical trials, GMP/QSR, marketing practices, pricing and reimbursement, product diversion, fraud, and anti-kickback and Foreign Corrupt Practice Act (FCPA) issues.

David has significant international experience conducting internal investigations and advising companies on cross-border compliance issues. He has conducted numerous investigations in Asia and regularly advises multinational companies on related compliance topics.

Matthew D'Ambrosio is currently Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc.

Prior to joining Sunovion, Mr. D'Ambrosio served as Vice President, U.S. Legal Affairs and Chief Compliance Officer at Prostrakan, Inc.

Previously, Mr. D'Ambrosio served as Chief Compliance Officer for Reliant Pharmaceuticals, Inc., one of the country's largest privately-held pharmaceutical companies which was acquired by GSK in 2007. He began his career with Johnson & Johnson where he headed compliance programs in each of J&J's three core sectors: Pharmaceuticals, Medical Device & Diagnostics and Consumer Products

Mr. D'Ambrosio was previously adjunct faculty at Seton Hall Law in the Health Law Program.

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.

Lori Queisser joined Teva Pharmaceuticals in June of 2015 in the key role of Senior Vice President and Global Chief Compliance Officer. She reports directly to the CEO.

In this role, Lori is responsible for leading the organization's compliance efforts globally, and setting the strategy for the implementation of compliance programs across the business. She will also engage the organization in promoting a culture of compliance, based on our values and Code of Conduct.

Lori brings significant, diverse, global experience in the Compliance and Pharmaceutical industry to the Teva team. She has held senior roles in Eli Lilly and Schering Plough before consulting in the field as both President/Owner of Queisser and Associates and as a Principal at KPMG. Most recently, she was employed at DePuy Synthes, a Johnson and Johnson Company, as their Healthcare Compliance Officer.

Lori holds a Bachelor of Science in Business Administration from Indiana University and is a Past Chair of the Pharmaceutical Compliance Forum.

Currently responsible for leading a values-based compliance program for GlaxoSmithKline U.S. Pharmaceuticals, serving as interim Global Head of Monitoring, and contributing compliance leadership to the global enterprise. Previously, served as Global Head of Ethics & Compliance for Novartis Oncology, Deputy Compliance Officer for Novartis Pharmaceuticals Corporation, Director in PricewaterhouseCoopers' Global Pharmaceutical & Health Sciences Practice, Senior Counsel in the Office of Inspector General of the U.S. Department of Health and Human Services, and in-house counsel for Olsten Health Services. International speaker on fraud and compliance issues. Quoted in numerous healthcare industry and compliance publications. Currently the Chair of the Chief Compliance Officer Committee of the Pharmaceutical Research & Manufacturers of America (PhRMA) and former Co-Chair in the Pharmaceutical Compliance Forum (PCF). Named Funniest Compliance Officer in America in 2011. Previously, served as an Adjunct Professor at Seton Hall School of Law teaching Healthcare Fraud & Abuse Law.

Matthew D'Ambrosio is currently Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc.

Prior to joining Sunovion, Mr. D'Ambrosio served as Vice President, U.S. Legal Affairs and Chief Compliance Officer at Prostrakan, Inc.

Previously, Mr. D'Ambrosio served as Chief Compliance Officer for Reliant Pharmaceuticals, Inc., one of the country's largest privately-held pharmaceutical companies which was acquired by GSK in 2007. He began his career with Johnson & Johnson where he headed compliance programs in each of J&J's three core sectors: Pharmaceuticals, Medical Device & Diagnostics and Consumer Products

Mr. D'Ambrosio was previously adjunct faculty at Seton Hall Law in the Health Law Program.

Glenna Shen is Executive Director, Compliance with responsibility for the US Business and Global Functions at Amgen. Ms. Shen joined Amgen in 2000, and has held various positions in the Law Department and with Worldwide Compliance and Business Ethics, most recently heading up the Compliance function at Onyx Pharmaceuticals, and Amgen subsidiary. Ms. Shen obtained her Bachelor of Arts degree in Biology from the University of Miami and her Juris Doctor and Master of Business Taxation from the University of Southern California.

As Chief Compliance Officer and Vice President for Novo Nordisk Inc., Jill Fallows Macaluso Esq., RN, is charged with developing, operating, and overseeing the implementation of an effective Health Care Compliance program within the United States.

Utilizing 15 years of industry experience, Ms. Fallows Macaluso has been instrumental in driving the evolution of Novo Nordisk Inc.'s compliance program. She chairs the Executive Team and Board of Directors Compliance Committee, and sits on the Novo Nordisk Inc. leadership team. Ms. Fallows Macaluso leads the Compliance Department, including organizing resources, defining strategy, and addressing matters related to the Novo Nordisk Inc. compliance program. Ms. Fallows Macaluso has responsibility for the development and maintenance of a comprehensive compliance program that includes Health Care Compliance, internal and external investigations, auditing and monitoring and training.

Prior to joining the Compliance Department, she was Senior Corporate Counsel in the Novo Nordisk Inc. Legal Department for nine years where she held several key positions. Previously, Ms. Fallows Macaluso was with the General Corporate and Healthcare practice of Day Pitney, LLP. She holds a Bachelor of Science in Nursing from the University of Pennsylvania and a Juris Doctorate from Rutgers University School of Law.

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.

Jonathon currently serves as the Executive Vice President, Global Chief Compliance Officer for Allergen plc and sits on the Chief Executive Officer's Executive Leadership Team (ELT). In his role, he is responsible for leading a global team of 50+ professionals, including four direct reports who are responsible for US Commercial Compliance, Global R&D Compliance, International Compliance and Compliance Operations. Global Compliance at Allergan has a span of control that covers corporate compliance, Allergan's Code of Conduct and related corporate policies and standards, Health Care Compliance globally (false claims act, ant-bribery, government pricing, etc.), Anti-Bribery/Anti-Corruption (FCPA, UK Bribery, etc.), Data Privacy as well as Global Spend Transparency. Jonathon and his team actively support Allergan's BOLD vision - we collaborate with our business partners to build bridges, act fast, power ideas, drive results and always do what is right. Jonathon reports in to the CEO through the Chief Operating Officer and directly to the Board of Directors; he also is a member of the Audit &; Compliance Committee of the Allergan Board of Directors. Jonathon is also an active member of the Global Quality Review Board, the Information Security Risk Board and the company's Disclosure Committee. As a member of the CEO's ELT, Jonathon has the opportunity to work with the industry's leading leadership team in setting and executing company strategy, evaluating business and people performance, leading our growth agenda, managing and mitigating risk, overseeing critical company initiatives, etc.

Jonathon is a member of the Board of Directors for the Allergan Foundation and a former member of the Board of Directors of the American Heart Association NJ Chapter. Jonathon, a graduate of Franklin & Marshall College, has also completed the INSEAD executive training program and is a frequent speaker at industry congresses and contributor to industry leading thought leadership.

Lori Queisser joined Teva Pharmaceuticals in June of 2015 in the key role of Senior Vice President and Global Chief Compliance Officer. She reports directly to the CEO.

In this role, Lori is responsible for leading the organization's compliance efforts globally, and setting the strategy for the implementation of compliance programs across the business. She will also engage the organization in promoting a culture of compliance, based on our values and Code of Conduct.

Lori brings significant, diverse, global experience in the Compliance and Pharmaceutical industry to the Teva team. She has held senior roles in Eli Lilly and Schering Plough before consulting in the field as both President/Owner of Queisser and Associates and as a Principal at KPMG. Most recently, she was employed at DePuy Synthes, a Johnson and Johnson Company, as their Healthcare Compliance Officer.

Lori holds a Bachelor of Science in Business Administration from Indiana University and is a Past Chair of the Pharmaceutical Compliance Forum.

Currently responsible for leading a values-based compliance program for GlaxoSmithKline U.S. Pharmaceuticals, serving as interim Global Head of Monitoring, and contributing compliance leadership to the global enterprise. Previously, served as Global Head of Ethics & Compliance for Novartis Oncology, Deputy Compliance Officer for Novartis Pharmaceuticals Corporation, Director in PricewaterhouseCoopers' Global Pharmaceutical & Health Sciences Practice, Senior Counsel in the Office of Inspector General of the U.S. Department of Health and Human Services, and in-house counsel for Olsten Health Services. International speaker on fraud and compliance issues. Quoted in numerous healthcare industry and compliance publications. Currently the Chair of the Chief Compliance Officer Committee of the Pharmaceutical Research & Manufacturers of America (PhRMA) and former Co-Chair in the Pharmaceutical Compliance Forum (PCF). Named Funniest Compliance Officer in America in 2011. Previously, served as an Adjunct Professor at Seton Hall School of Law teaching Healthcare Fraud & Abuse Law.

Caroline West was appointed Global Chief Compliance Officer for Olympus Corporation on April 1, 2016 leading a compliance program with professionals located in Japan, Asia, the Americas, Europe, the Middle East and Africa. She joined Olympus Corporation of the Americas in January 2016 as Chief Compliance Officer for the Americas. Prior to joining Olympus, she served over 10 years as Senior Vice President, Chief Compliance & Risk Officer for Shire Pharmaceuticals where was responsible for building and leading a global compliance program. Prior to Shire, Caroline spent nearly 5 years with Aventis (later Sanofi) as VP Global Legal Compliance. Earlier in her career, she spent time in various legal and compliance positions at Rhone Poulenc Rorer, UGI Corporation and Pepper Hamilton LLP, where she began her career as a litigation associate.

Ms. West has an AB from Smith College and a JD from Penn State - Dickinson Law. She and her husband live in Philadelphia, PA and have two adult children.

Paul is Practice Leader for Huron's Life Sciences practice and has over 28 years of experience in the pharmaceutical, medical device, and consumer products industry, specializing in compliance and regulatory matters. Paul regularly works with in-house legal counsel, corporate compliance officers, senior operations professionals and outside legal counsel that support these professionals. Paul has provided expert testimony on behalf of pharmaceutical companies in litigation matters involving sales and marketing practices. The Life Sciences practice focuses on the Compliance, Operations and Strategic needs of pharmaceutical and medical device companies.

Paul joined Huron after nine years with Ernst & Young LLP where he was a director and a member of the four-person leadership team of the firm's national Fraud Investigation & Dispute Services practice. Paul was one of the founders of Ernst & Young's Pharmaceutical and Medical Device regulatory compliance service. He was also a member of the firm's Global Pharmaceutical Industry leadership team.

Paul held various roles in operations, and district and regional sales and marketing for multi-national pharmaceutical and medical device manufacturers. Paul's hands-on industry experience provides him with a real world perspective which he brings to the needs of his clients.

Joe Beemsterboer is a Deputy Chief in the Fraud Section, Criminal Division, U.S. Department of Justice. In addition, Mr. Beemsterboer is the Chief of the Fraud Section's Health Care Fraud Unit. Prior to his current role as Chief of the Health Care Fraud Unit, Mr. Beemsterboer was an Assistant Chief in the Health Care Fraud Unit, and supervised the Miami and Tampa Strike Forces.

TRACY PRICE is an Assistant Director in the Foreign Corrupt Practices Act Unit within the Enforcement Division of the U.S. Securities & Exchange Commission. Ms. Price handles complex securities investigations, including investigations of violations of the Foreign Corrupt Practices Act. Her investigations have led to more than thirty filed actions against companies and individuals for FCPA violations, and she has overseen numerous additional FCPA investigations. Ms. Price has also overseen numerous financial fraud, broker-dealer, insider trading, import-export controls, sanctions, and other complex securities investigations.

Gejaa Gobena uses his almost two decades of experience as both a former senior prosecutor and private attorney to help companies and individuals thoughtfully navigate high-stakes investigations and government enforcement actions, particularly in the area of healthcare fraud.

Prior to joining Hogan Lovells, Gejaa served as Deputy Chief of the Fraud Section in the Criminal Division of the United States Department of Justice. As Deputy Chief, he led the Criminal Division's 50-attorney healthcare fraud unit, supervising prosecutions brought by Medicare Fraud Strike Force teams across the country and spearheading the unit's recent shift to investigating and prosecuting broader corporate healthcare fraud schemes. Prior to joining the Criminal Division, Gejaa spent six years in the Civil Division, investigating and prosecuting False Claims Act and qui tam matters that resulted in hundreds of millions of dollars in judgments and settlements.

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

Kenneth Abell joined the Civil Division of the United States Attorney's Office for the Eastern District of New York in 2008. Since that time, Ken has handled a wide range of matters, focusing on large fraud cases involving the False Claims Act. In July of 2014, Ken was promoted to Chief of the Health Care Fraud Unit, where he supervises the AUSAs in his division handling health care fraud matters. His practice covers the entire gamut of cases implicating federal health care programs, ranging from cases against large hospitals and pharmaceutical companies to individual providers.

Jake Elberg is Chief of the Health Care and Government Fraud Unit at the U.S. Attorney's Office for the District of New Jersey. Mr. Elberg supervises 15 AUSAs and directs all of the Office's criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, and violations of the Federal Food, Drug & Cosmetic Act, as well as all health care-related actions brought by the Office under the False Claims Act. In addition, Mr. Elberg supervises and directs investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs.

Mr. Elberg joined the U.S. Attorney's Office in 2007. Mr. Elberg received his JD in 2003 from Harvard Law School, graduating magna cum laude, after having received his BA in 2000 from Dartmouth College, from which he graduated cum laude and with honors. After graduating law school, Mr. Elberg served as a law clerk to the Honorable Nancy Gertner (District of Massachusetts).

Assistant US Attorney, US Attorney's Office, District of MA

Gregg Shapiro is an Assistant United States Attorney in the District of Massachusetts. His work there primarily involves health care fraud, including false claims, kickbacks, off-label marketing, and violations of the Medicaid Drug Rebate statute. 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

John Bentivoglio represents pharmaceutical, medical device and biotechnology manufacturers in criminal, civil and administrative enforcement actions by the U.S. Department of Justice, state attorneys general and other agencies. He has negotiated successful resolutions of such matters for Allergan, Calloway Laboratories, Jazz Pharmaceuticals, Merck & Co., Otsuka Pharmaceuticals and Serono, among others. He also has counseled more than a dozen companies on the negotiation and implementation of Corporate Integrity Agreements. In addition to assisting companies in enforcement actions, he regularly advises clients on compliance program issues and on federal and state anti-kickback and false claims statutes, FDA advertising and promotional rules, and Medicare and Medicaid regulatory issues.

Sophie Peresson is the Director of Transparency International's Pharmaceuticals and Healthcare programme (PHP). This global programme has been set up with a purpose to achieve genuine change in the pharmaceuticals and healthcare sector through reducing corruption and promoting transparency, integrity and accountability.

Sophie holds a Masters in Law from the Sorbonne University, a post-graduate degree from the School of Advanced International Studies (SAIS) Johns Hopkins University. She is currently completing an MSc in Global Health at the London School of Hygiene and Tropical Medicine (LSHTM).

She has over fifteen years' experience of working in public health, working for influential international NGOs such as the Red Cross and Marie Stopes International. Her experience spans both communicable and non-communicable diseases. She is an expert adviser to the European Institute for Women's Health and has held several board positions. She is also a contributor to the Global Burden of Disease Study. She has a well-established track record of collaborating in international projects, research initiatives and has been on the steering committee of several influential publications, e.g. Diabetes Policy Puzzle.