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

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

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

Natasha Leskovsek is an FDA regulatory partner in Cooley's Washington, DC office. Natasha advises regulated industry and its investors on strategic pathways to commercialization and pre- and postmarket compliance requirements. Prior to practicing law, Natasha worked as a clinical research nurse at NIH and in project management for a CRO. She received her J.D. from Georgetown University Law Center and BSN and MBA degrees from the University of Maryland. Natasha is a member of the Food and Drug Law Institute and the American Health Lawyers Association.

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

Saul is a Managing Director at Navigant Consulting, Inc. and global practice leader for the Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations practice, providing support in investigations, litigation, regulatory and compliance matters involving healthcare and life sciences companies. Applying his knowledge secured through working in international marketing and clinical development in industry, Saul has led projects involving expert witness testimony related to the life sciences industry, litigation support, cGMP and cGCP evaluations, regulatory support, compliance monitorships, compliance implementation and assessment and investigation support in both internal and external investigations, including off-label promotion, kick-backs, anti-bribery and anti-corruption.

Ms. Rose is President of Lucy Rose and Associates, LLC, a life sciences regulatory consulting and training firm. For 12 years, she has consulted to, and provided training for, over 150 life sciences firms and their supporting companies. For 16 months during that period, Lucy served as the National Managing Director for Deloitte and Touche's Life Sciences Regulatory Practice.

From 1995-97, Ms. Rose served as the Director of the Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration. There she designed and implemented programs to improve external communications with the pharmaceutical industry, health care professionals, and consumers.

Ms. Rose led CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers.

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.

Chris Castro is an Associate Director in Navigant's Healthcare & Life Sciences Disputes, Regulatory, Compliance, and Investigations practice. He has over a two decades of life sciences experience encompassing, sales as a representative and district manager, brand and field training, compliance and management and has served clients ranging from large Fortune 500 public companies to middle market privately held companies. Chris has provided support in investigations, litigation and compliance integration matters involving life sciences, device, and lab testing companies.

Kerry Clem has been the head of Sales at Acorda since January 2011. In his role, Mr. Clem is responsible for the Sales Force, Sales Training, Market Development, and Promotional Operations.

Before joining Acorda, Mr. Clem was Vice President of Sales at Allos Therapeutics, Inc. where he built the organization's inaugural sales force to launch their first commercially available product. Mr. Clem also served as Vice President of Sales and Marketing at Solstice Neurosciences, Inc., which included overseeing the European commercial business. Mr. Clem has over 18 years of sales and marketing experience in the areas of neurology, oncology, movement disorders, cardiology, anesthesiology and pain. Over the span of his career he has been involved in the development of commercial organizations and multiple product launches.

Dr. Wendy Heckelman leverages her twenty-five years of experience and expertise in compliance, cultural transformation, change management, and strategic implementation to address complex business performance challenges. She uses a rigorous and scientific lens to diagnose business performance issues, challenges, and opportunities for organizational effectiveness. Wendy leads a team of experienced consultants who develop clear recommendations and custom solutions for each client engagement.

Dr. Heckelman has also patented a unique compliance process utilizing software to minimize once commonplace compliance errors. Her distinct approach has garnered a number of clients seeking to maximize the efforts of both their sales and compliance teams.

Gary Keilty is a Managing Director with FTI Consulting's National Health Solutions practice and is based in Washington, D.C. Gary has over twenty five years experience as a management consultant and specializes in providing financial, investigative, operational and industry expertise assistance to Life Sciences companies, healthcare providers and health law firms. Gary's areas 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.

Dan DOVDAVANY is Assistant General Counsel, North America Litigation & Investigations, at Sanofi U.S. 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 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.

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, has been appointed to lead the development of a 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. Prior to her current role, she was the project manager responsible for the U.S. Pharmaceuticals' business implementation of the company's Corporate Integrity Agreement. 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. 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).

With over 30 years of life sciences experience, Scot leverages his training and award-winning sales background to partner and facilitate key compliance initiatives with his clients. In 2005 he was recruited to the compliance team at Astellas Pharma US, Inc. (Fujisawa) and led the development and delivery of all corporate compliance training programs while also serving as an advisor and investigator across therapeutic areas. Scot founded SCS Compliance Group LLC in 2012. Scot's firm is focuses-on compliance field ride-along audits, speaker program and advisory board monitoring, and compliance training development/deployment.

Gary has over 25 years experience in the pharmaceutical industry as a Compliance Officer, Trainer Medical Science Liaison, and Sales Representative. Gary's current position in Compliance involves annual product risk assessments, development and execution of a field monitoring plan, development and delivery of compliance training, and general compliance guidance on appropriate interactions with healthcare providers. Gary also has developed a strong expertise in Speaker Programs, Sponsorships and joint Medical/Commercial Interactions.

Corey Dunbar is a Senior Manager with Ernst & Young's Fraud Investigation & Dispute Services (FIDS) practice. He specializes in data analytics pertaining to the detection of fraud, bribery, corruption, and compliance risks occurring within accounting, financial, and communicational data. Corey has experience working with Fortune 100 Life Sciences companies in designing, developing and implementing compliance monitoring solutions as well as analytical approaches to conducting audit related activities. Corey has also led large, global investigations including matters related to the Foreign Corrupt Practices Act and the UK Bribery Act.

Andy Bender is Polaris' founder. 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.

Polaris has over 110 pharmaceutical and med device clients and employs a staff of more than 250, including five healthcare law attorneys. Polaris has offices in New York, Amsterdam, San Francisco, Paris and Boston.

Samir Hans is a Principal in the Regulatory, Forensics Advisory Market Segment in Deloitte Advisory. Samir helps lead the Analytics Insight business competency. He also leads the analytics practice in the Forensics Investigation Market Offering. His area of focus principally involves Rare Event Modeling (REM), which is a practice area dedicated to helping clients generate value from their data through the detection of faint signals. He has led REM engagements in a number of domains, including fraud and compliance, quality and safety recall, and program integrity, in both the commercial and public sectors. Over the past several years, he had led a number of important strategic firm initiatives, including the acquisition of a large electronic discovery business, technology vendor alliances, and scaling new market offerings. Beginning his career as a software developer in the Silicon Valley, he brings that same sense of entrepreneurship with advanced technologies into his practice each day.

Nathaniel Edmonds is a partner in the Litigation Department of Paul Hastings based in the firm's Washington, D.C. office. 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 oversaw the investigation and prosecution of companies, business executives, and others for making improper payments to foreign officials in international business transactions. Mr. Edmonds also assisted in the drafting 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), available at http://www.justice.gov/criminal/fraud/fcpa/guide.pdf.

Mr. Edmonds advises companies on regulatory compliance matters around the world, including FCPA and anticorruption investigations, risk assessments and due diligence, as well as developing and overseeing anticorruption compliance programs. Mr. Edmonds also assists companies in determining the scope of potential liability stemming from improper payments and how to best respond to potential enforcement actions by U.S. and foreign law enforcement authorities.

SCOTT BASS heads the firm's global Life Sciences team, coordinating pharmaceutical, medical device, food and dietary supplement matters in the United States, Europe and Asia. He is ranked internationally among the top authorities on FDA-related enforcement and regulatory issues, and has led audits and investigations involving off-label promotion, pharmacovigilance, PDMA, GMP, and fraud and abuse issues, as well as DEA and FTC matters. Scott has also acted as an expert on an EU Commission panel, an advisor on new China drug and device legislation, and as an advisor on an FDA dietary supplement website.

Scott has represented such companies as Bayer, Genentech, Colgate Palmolive, Allergan, Novartis, Cargill, Herbalife and Roche in a number of regulatory or enforcement matters.

Henrique Krüger Frizzo is graduated from Universidade de São Paulo with a degree in Law in 2003. LL.M in State and Governmental Affairs at Escola de Formação de Governantes, associated with Universidade de São Paulo in 2004. Extension Course on Public-Private Partnerships (PPPs) at Escola Superior do Ministério Público de São Paulo - 2005. Specialization in "Contracts with the Public Administration", at Fundação Getulio Vargas -- 2007.

His area of expertise is Public Law, Government Affairs and Regulatory, with focus on consultancy matters. Mr. Frizzo is recognized by Chambers & Partners as a leading lawyer in Public Law and Regulatory. He is a speaker in events related to compliance in contracts with the government and regulatory.

Joseph Coniker is a Principal in Grant Thornton LLP and national practice leader for Business Analytics. Coniker has over 20 years of professional experience, including 15 years focused on Oracle, Siebel and Hyperion based technologies. Projects that Coniker influenced have resulted in more than $1 billion in working capital improvements.

Coniker is a member of the AICPA, and Oracle Customer Advisory Council. He is a published author on data analytics matters, and frequent speaker at regional and national events, including Oracle Open World, and guest speaker at the doctoral program on technology and warehousing at Robert Morris University, and finance programs at the University of Richmond.

Jeff Antoon, Director Internal Audit, joined Johnson & Johnson in June 1987 as an Auditor.

As Director of Corporate Internal Audit's Audit Services Group, Jeff is responsible for worldwide audits in the areas of Foreign Corrupt Practices Act, and Sensitive Issue (fraud) reviews.

Jeff has delivered presentations at various Johnson & Johnson and industry conferences. His external presentations include the Institute of Internal Auditors, Association of Corporate Counsels, the Center for Business Intelligence, the American Conference Institute, c5, exl pharma, American Leaders, Q1 Productions, Marcus Evans, and The Economist.

Prior to joining Johnson & Johnson, Jeff worked for two years each at PricewaterhouseCoopers and Engelhard Corporation. He has a Bachelors degree in Accounting from Villanova University, and a Masters in Business Administration from the University of Maryland. Jeff is a Certified Public Accountant.

Vivian Robinson QC became a barrister in 1967 and practised at the English criminal bar for over forty years. He was appointed Queen's Counsel in 1986, became Head of QEB Hollis Whiteman Chambers in 2006 and served as Treasurer of Inner Temple in 2009.

In 2009 he left the practising bar to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO's enforcement strategy on the UK Bribery Act 2010 and was the SFO's principal liaison with the business community on this subject.

In 2011 he joined US law firm McGuireWoods, becoming a member of the firm's Government, Regulatory and Criminal Investigation team. He advises clients on compliance and white collar crime issues, both in the UK and internationally.

He is a co-author of "The FCPA and UK Bribery Act -- A Ready Reference for Business and Lawyers".

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.

Mr. Del Vecchio has been with Bristol-Myers Squibb for 26 years. His experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, education and training, and compliance and ethics program development and support. Gary has been a member of the US Pharmaceuticals Compliance and Ethics department for 10 years and currently holds the position of Executive Director, USP Compliance and Ethics. In this role he provides compliance and ethics leadership to the Sales, Marketing, Medical, Access and Global Commercialization organizations along with managing the US Compliance and Ethics investigations team. His initial compliance role focused primarily on the creation and implementation of the company's comprehensive US Compliance and Ethics education and training program. Gary is currently serving as a Co-Chair of the Pharmaceutical Compliance Forum, a coalition of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers. The PCF was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.

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

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

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

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.

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.

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.

Assistant United States Attorney Charlene Keller Fullmer is the Deputy Chief for Affirmative Litigation in the Civil Division of the United States Attorney's Office in the Eastern District of Pennsylvania, where she supervises and prosecutes health care and affirmative fraud matters. She led the Philadelphia civil prosecution team that investigated and resolved allegations of off-label promotion of the atypical antipsychotic drug Risperdal by Johnson and Johnson and its subsidiary Janssen Pharmaceuticals, which resulted in a $2.2 billion global settlement with the Department of Justice, the largest paid for a single drug. In 2009, she served on the team that investigated and resolved allegations of off-label promotion and kickbacks by Pfizer, Inc. The $2.3 billion civil and criminal resolution was at the time the largest health care fraud settlement in the history of the Department of Justice. For her efforts in these matters, she was the recipient of the 2014 Attorney General's Award for Fraud Prevention, an Award of Commendation from the Assistant Attorney General for the Civil Division, Tony West, and the 2014 National Health Care Anti-Fraud Association's Investigation of the Year. In October 2010, Attorney General Eric Holder presented her with the Attorney General Award for Exceptional Service, the Department of Justice's highest commendation.

Ms. Fullmer returned to the Justice Department in 2007 after six years in private practice at Duane Morris LLP in Philadelphia, where she litigated defensive matters, including False Claims Act, health care, white collar, antitrust, and insurance coverage litigation. Prior to that time, she served as an Attorney Advisor in Washington, DC and Quantico, VA with the Federal Bureau of Investigation, Office of Professional Responsibility, the Bureau's Internal Affairs.

She is a 1993 graduate of Lehigh University, cum laude, and a 1996 graduate of Temple University School of Law, cum laude, where she served on the Law Review.

Jeffrey Steger is an Assistant Director in the Consumer Protection Branch, Civil Division, United States Department of Justice. His responsibilities include civil and criminal enforcement of the Federal Food, Drug, and Cosmetic Act. Mr. Steger started with the Department of Justice in 1994, following a clerkship for Judge Jane Roth on the United States Court of Appeals for the Third Circuit. Mr. Steger worked for the United States Senate Committee on Governmental Affairs from 1986 to 1993. As a trial attorney for the Consumer Protection Branch, Mr. Steger has litigated a broad range of civil and criminal cases on behalf of the United States, including cases brought under the Food, Drug, and Cosmetic Act as well as prosecutions of investment and financial fraud. He received his BA in economics from Brandeis University and his JD from Georgetown University.

John Bentivoglio represents pharmaceutical, medical device and biotechnology manufacturers 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.

Mr. Bentivoglio previously served as associate deputy attorney general and special counsel for health care fraud at the DOJ, was a special assistant to the assistant attorney general, Criminal Division and served as a professional staff member to Sen. Joseph R. Biden Jr., chairman, Committee on the Judiciary.

He serves on the board of directors of the Children's Law Center in D.C., and co-chairs the guardian ad litem pro bono team in Skadden's D.C. office.

Jeffrey S. Sallet is the Section Chief (SC) of the Public Corruption and Civil Rights Section of the Criminal Investigative Division within the Federal Bureau of Investigations (FBI). In this capacity, he has oversight and responsibility over all Public Corruption, Civil Rights, International Human Rights, Foreign Corrupt Practices Act (FCPA), Antitrust, International Money Laundering and Threat Finance investigations FBI wide. SC Sallet has spearheaded several new FCPA initiatives to include: overseas deployments of Agents and Analysts using a newly developed corruption matrix, forging new strategic private sector relationships, advancing internal FBI FCPA training geared toward a proactive shift utilizing sophisticated techniques and implementing a unique corruption global intelligence collection platform.

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, compliance inquires and in strategizing responses to government subpoenas and other inquiries.

Kris is a compliance and regulatory professional with more than 20 years of life science experience. Prior joining EY, Kris was the Vice President and Chief Compliance Officer for the Pharmaceutical Sector of Johnson & Johnson. As the CCO she was responsible for the development and implementation of a comprehensive global compliance program. She has first-hand experience managing and responding to government investigations, including the negotiating of settlements agreements.

Kris brings deep, relevant experience in health care and life sciences, and she is a frequent lecturer at industry events. Her significant regulatory and compliance experience includes such diverse areas such as promotional compliance, research and development, sales and marketing practices, including off-label, fraud and abuse, government pricing and relationships with third parties.

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.

Ms. Rose is President of Lucy Rose and Associates, LLC, a life sciences regulatory consulting and training firm. For 12 years, she has consulted to, and provided training for, over 150 life sciences firms and their supporting companies. For 16 months during that period, Lucy served as the National Managing Director for Deloitte and Touche's Life Sciences Regulatory Practice.

From 1995-97, Ms. Rose served as the Director of the Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration. There she designed and implemented programs to improve external communications with the pharmaceutical industry, health care professionals, and consumers.

Ms. Rose led CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers.

Melissa Stapleton Barnes became senior vice president, enterprise risk management, and chief ethics and compliance officer for Eli Lilly and Company in January 2013. She also serves as a member of the company's executive committee.

Prior to taking this role, Melissa was vice president and deputy general counsel, global litigation and specialty legal. Since joining Lilly in 1994, she has held a variety of legal and business roles, including general counsel for Lilly Diabetes and Lilly Oncology, managed market segment leader for national accounts, and Six Sigma black belt.

Melissa earned a Bachelor of Science degree with highest distinction from Purdue University and a law degree from Harvard Law School. Prior to joining Lilly, Melissa was a litigator at the law firm of Baker & Daniels in Indianapolis.

In 2012, Melissa was recognized by the Healthcare Businesswomen's Association as a "Rising Star," and in 2015 was recognized by Ethisphere as an "Attorney Who Matters."

Michael 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.

Larry Platkin is currently Vice President and head of the Compliance Center of Excellence for Bayer Corporation. He was named Vice President and Compliance Officer of Bayer HealthCare in June, 2008, responsible for the implementation of BHC's 2008 Corporate Integrity Agreement, as well as compliance strategy, development of policies and procedures, investigations, communications and training. Prior to that, he held positions in the Bayer Law and Patents Department, counseling the pharmaceuticals business (and its predecessor, Berlex Laboratories, Inc.). Prior to that, he held positions in the Legal Departments of Ciba-Geigy Corporation and American Home Products Corp. Larry was in private practice in Newark, NJ prior to that. He is a graduate of Rutgers College, New Brunswick, NJ and Rutgers University School of Law, Newark, NJ.

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

Cheryl Scarboro is a Partner in the Washington, D.C. office of Simpson Thacher & Bartlett LLP. She represents corporations, financial institutions and individuals in SEC and other regulatory enforcement proceedings. Cheryl joined the Firm following a 19-year tenure at the Securities and Exchange Commission, most recently as the first Chief of the SEC's FCPA Unit in the Division of Enforcement. She is recognized by Benchmark Litigation as one of the "Top 250 Women in Litigation" in the U.S. and is consistently recommended by The Legal 500 in white collar. Cheryl is a member of the Board of Visitors of Duke University School of Law.

Gary F. Giampetruzzi is one of the most recognized anti-corruption/FCPA compliance and enforcement attorneys and thought leaders, and highly regarded by peers, life science industry insiders, and regulators for his strategic thinking and insight into compliance program, internal investigations and government enforcement issues. Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA and U.S. healthcare landscapes. He has been a leader in this growing area of practice for the past 15 years, having led the development of cutting edge compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, North Africa, Europe, the Middle East and Latin America). A recent addition to Paul Hastings Investigations and White Collar practice in February 2014, Mr. Giampetruzzi spent 13 years at Pfizer Inc. as its Vice President, Assistant General Counsel and Head of Government Investigations, and earlier on served as Pfizer's Deputy Compliance Officer, where he was also responsible for international compliance investigations and the implementation and maintenance of compliance programs throughout the company's international operations, with a particular focus on emerging markets.

Mr. Mizer heads the Department's Civil Division, which, among other things, enforces criminal and civil statutes to ensure the safety of food and medicines, and recovers billions of taxpayer dollars through affirmative litigation. Previously, he served as Counselor to Attorney General Holder, and as a Deputy Assistant Attorney General in the Department's Office of Legal Counsel. Before joining the Department, he was the Solicitor General of Ohio. He clerked for Justice John Paul Stevens of the United States Supreme Court and Judge Judith W. Rogers of the United States Court of Appeals for the D.C. Circuit. He is a graduate of the University of Michigan Law School and the College of Wooster.

Michael K. Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the United States and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks had most recently served as acting U.S. attorney and first assistant U.S. attorney for the District of Massachusetts.

Since joining Skadden in 2010, Mr. Loucks' practice has focused on representing companies in government criminal investigations, in False Claims Act and other civil litigation, in regulatory matters with the Food and Drug Administration and the Office of Inspector General, and in Foreign Corrupt Practices Act investigations. He has represented companies and individuals around the world from a wide variety of industries, including health care, pharmaceutical and biotech, and medical devices among others.

Doug Brown currently serves as the Acting Director of the Data Sharing & Partnership Group at the CMS Center for Program Integrity. Doug is responsible for implementing large-scale information systems, supporting technologies, partner engagement and other educational activities and campaigns which support transparency and anti-fraud programs. Prior to joining the Center for Program Integrity, Mr. Brown was the director of the Division of Health Information Technology for the Quality Measure and Health Assessment Group in the Center for Clinical Standards and Quality, overseeing the development, implementation and collection of Clinical Quality Measures used in the EHR Incentive Program. Mr. Brown holds a Masters of Healthcare Services in Healthcare Policy and Finance from the Johns Hopkins Bloomberg School of Public Health.

Paul Silver is a Managing Director and Practice Leader for Huron's Life Sciences practice. Paul has 26 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.

Jillian Estes is a partner at the Tampa-based firm of James, Hoyer, Newcomer & Smiljanich, P.A., which represents relators in False Claims Act cases nationwide. Ms. Estes worked extensively on a recent $192 million off-label pharmaceutical settlement and was lead counsel in a 2014 ground-breaking case involving the application of the Stark statute to Medicaid payments. Since 2008, she has represented relators in cases which have recovered more than $350 million for the Government. Ms. Estes is an active member of Taxpayers Against Fraud and is a regular volunteer for the U.S. Department of State's Hague Convention Attorney Network.

Loren Jacobson is a partner at Waters & Kraus, LLP in Dallas, Texas. Ms. Jacobson manages the firm's False Claims Act & Qui Tam practice, representing whistleblowers in the pharmaceutical, medical device, hospice and home health care, government contracting, and construction industries, among other areas. She has achieved government or state intervention in many of her qui tam cases, and her clients have been part of several large Department of Justice settlements. Ms. Jacobson also litigates False Claims Act and other qui tam cases in state and federal court.

Joseph Trautwein is an attorney with over sixteen years' experience in complex civil litigation, including twelve years with the U.S.Department of Justice as Assistant U.S. Attorney in the civil division of the Philadelphia office primarily focused on health care fraud and abuse and defense contractor fraud.

Following his service with the U.S. Department of Justice, Mr. Trautwein established his own practice specializing in qui Tam/False Claims Act disputes. To date Mr. Trautwein has led and assisted in the recovery of over $5 billion of taxpayer dollars through landmark settlements against drug manufacturing, health care companies and other government contractors.

Jonathan Diesenhaus is a partner in the Investigations and White Collar Defense Group at Hogan Lovells. His practice focuses on healthcare fraud and abuse investigations, litigation and counseling, and federal and state False Claims Act litigation.

Prior to joining what was then Hogan & Hartson in 2005, Mr. Diesenhaus served as a senior trial counsel in the Civil Division of the U.S. Department of Justice in Washington, D.C. From 1998 to 2005, he handled civil health care fraud and False Claims Act matters. He represented the government in a number of matters involving allegations that violations of the Antikickback Statute, the Stark Law, and of the Food, Drug and Cosmetic Act resulted in the submission of false claims to the federal healthcare programs.

PAUL KALB brings an uncommon clinical perspective, grounded in his experience as an attending physician at the Memorial Sloan-Kettering Cancer Center, to bear in his work for a range of healthcare clients. He has successfully represented many of the world's leading drug, biotech and device manufacturers as well as hospitals and other providers in criminal, civil, and administrative enforcement actions involving healthcare fraud and abuse and off-label promotion. He has defended numerous matters and negotiated ground-breaking settlement agreements and Corporate Integrity Agreements. Paul counsels both boards of directors and companies on compliance issues, including compliance program effectiveness and CIA implementation and management.

Mr. Del Vecchio has been with Bristol-Myers Squibb for 26 years. His experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, education and training, and compliance and ethics program development and support. Gary has been a member of the US Pharmaceuticals Compliance and Ethics department for 10 years and currently holds the position of Executive Director, USP Compliance and Ethics. In this role he provides compliance and ethics leadership to the Sales, Marketing, Medical, Access and Global Commercialization organizations along with managing the US Compliance and Ethics investigations team. His initial compliance role focused primarily on the creation and implementation of the company's comprehensive US Compliance and Ethics education and training program. Gary is currently serving as a Co-Chair of the Pharmaceutical Compliance Forum, a coalition of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers. The PCF was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.

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.

Ronni Fuchs is a partner in the Princeton office of Pepper Hamilton LLP, in the Health Effects Litigation Practice Group. She has represented pharmaceutical, medical device, and consumer products manufacturers in products liability, consumer fraud and related mass torts litigation for over 20 years. She provides litigation and regulatory counseling to companies prior to product approval as well as in response to challenges, such as adverse event reports, results from clinical trials, regulatory actions, and investigations.

Experienced pharmaceutical and life sciences industry consultant with over 13 years of experience providing regulatory compliance, commercial contracting and operations, risk management and dispute resolution services to the pharmaceutical industry. Katherine's experience includes program design, risk identification, policy and procedure development, policy adherence assessments, compliance training, and design and vision of future state contracting, government price reporting and healthcare professional interaction compliance programs.

Dennis Barnes is currently the Vice President & Chief Compliance Officer at PAREXEL International, Inc., which is headquartered in Waltham, Massachusetts. PAREXEL is a clinical research organization (CRO) focused upon assisting its pharmaceutical and medical device manufacturer clients with executing the necessary clinical trials that allow their products to be evaluated by regulatory authorities in markets throughout the world. Prior to joining PAREXEL in 2014, Dennis held various positions with pharmaceutical manufacturers and consulting firms that service the pharmaceutical industry over the last 17 years, including:

• Sanofi US
• GlaxoSmithKline
• Navigant Consulting
• KPMG
• PwC

Dennis earned a BA in Economics from Bucknell University, a Juris Doctor (JD) from the University of Notre Dame School of Law, and an MBA from the University of Texas at Austin Graduate School of Business. Dennis is also a Certified Public Accountant.

Paul Curtin is currently the Head of Global Research & Development Compliance for Allergan, plc (formerly Actavis, plc) after having served as the International Compliance Officer & Deputy Compliance Officer for Forest Laboratories, Inc. prior to its acquisition by Actavis last year. Paul has been a Compliance professional in the pharmaceutical and life sciences industry since 2001, and has established and managed compliance programs in domestic and international markets. Prior to his career in the pharmaceutical industry, Paul was a healthcare and regulatory attorney in private practice.

Dan Kracov heads the FDA and healthcare practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. His experience in US Food and Drug Administration (FDA) strategic advice and crisis management has been recognized by Chambers, the Legal Times, and numerous other publications.

Mr. Kracov regularly advises on regulatory strategies, product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.

George Ng is Executive Vice President & Chief Legal Officer for Sorrento Therapeutics, Inc., where he heads the legal, human resources, compliance, quality and intellectual property functions. Prior to joining the company, Mr. Ng held various senior management positions, including General Counsel, Chief Compliance Officer and Chief Intellectual Property Counsel, with publicly-traded, global biotechnology and pharmaceutical companies, including BioDelivery Sciences International, Inc. (NASDAQ: BDSI), Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) and Alpharma, Inc. (now, a part of Pfizer Inc.).

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.

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

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

Michael 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.

William Intner is a partner with Hogan Lovells US LLP focused on corporate transactions. William regularly represents pharmaceutical, biotechnology and healthcare clients in an array of transactions, including complicated mergers, acquisitions and product divestitures. With experience working on transactions with some of the smallest to some of the largest companies in the industry, he understands the importance of integrating the compliance function in the overall approach to transaction management

Thomas Costa has over 35 years of Legal and Compliance leadership experience in the Bio-Pharmaceutical industry. He has lived and worked in the United States and Europe with Bristol-Myers Squibb. Today he is an independent Pharmaceutical Compliance Consultant.

Chris Fletchall is currently a Senior Director for Lilly's Ethics and Compliance organization. He leads the Ethics and Compliance Global Operations function. This function is responsible for many of the operational aspects of implementing the company's global compliance program. Previously, he has been part of Lilly USA's compliance program in a variety of different roles.

Chris started his career with Lilly as a sales representative. He has had a variety of experiences with Lilly including managed markets business analyst, human resources, and a role supervising account managers who have responsibility for cultivating relationships with large federal healthcare accounts.

Chris received his BS degree in Business Administration and Finance from Indiana University, and his MBA from Clemson University.

Mary Ann Northrup is a Senior Director in the FTI Consulting Health Solutions practice and has twenty-five years of experience in the consulting, life sciences, and healthcare industries. In an advisory role, she has performed compliance program effectiveness reviews on behalf of the Board of Directors of a global pharmaceutical company as well as an integrated health system in support of their corporate integrity agreement obligations. Additionally, she has conducted compliance risk assessments, independent review organization reviews, and compliance auditing and monitoring activities. Prior to entering consulting, Ms. Northrup worked in a global bio-pharmaceutical company as well as a large non-profit healthcare system.

Larry Platkin is currently Vice President and head of the Compliance Center of Excellence for Bayer Corporation. He was named Vice President and Compliance Officer of Bayer HealthCare in June, 2008, responsible for the implementation of BHC's 2008 Corporate Integrity Agreement, as well as compliance strategy, development of policies and procedures, investigations, communications and training. Prior to that, he held positions in the Bayer Law and Patents Department, counseling the pharmaceuticals business (and its predecessor, Berlex Laboratories, Inc.). Prior to that, he held positions in the Legal Departments of Ciba-Geigy Corporation and American Home Products Corp. Larry was in private practice in Newark, NJ prior to that. He is a graduate of Rutgers College, New Brunswick, NJ and Rutgers University School of Law, Newark, NJ.

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.

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.

I am a Managing Director in the Health Industires Advisory practice of PwC with a focus on risk and regultory compliance and analytics. I work with large payer organizations, hospital systems, pharma / device companies, academic medical centers and federal and state government entities to improve compliance operations, manage regulatory risk, improve the quality of care and identify innovative opportunities grow revenue, control cost and improve operations in the highly regulated environments of Healthcare and Life Sciences.

I have more than 20 years of experience working with these organizations as an Healthcare Consultant, Chief Compliance Officer, and Chief Operating Officer

Tom Glavin joined Shire in November of 2005 as the compliance officer for Shire's U.S. businesses. He led the development of the company's compliance program and the implementation and management of that program in the U.S. Tom's responsibilities include providing compliance support to Shire's U.S. businesses, the development and implementation of policies, the development and delivery of training, the management of compliance program audits and monitoring, and the management of investigations. Tom also leads Shire's Compliance Committee and has primary responsibility for interacting with OIG in connection with implementation of Shire's Corporate Integrity Agreement.

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

Prior to joining 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.

Stephen is a Senior Counsel at AbbVie where he counsels cross-functional departments including Commercial, Medical Affairs and Regulatory Affairs regarding a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals. Stephen joined Abbott in 2012 after 10 years practicing with Gordon & Rees in San Francisco as part of its Drug and Medical Device team.

Philip Lo Scalzo joined BioMarin Pharmaceutical Inc. in 2007 and currently serves as its Senior Vice President, Compliance & Ethics and its Chief Compliance Officer. In his role, Mr. Lo Scalzo is responsible for creating and maintaining the company's global compliance program which includes healthcare compliance, GxP compliance, and Internal Audit. His responsibilities include chairing the Company's Compliance Steering Committee; overseeing the development and implementation of compliance policies as well as employee and partner training; managing GxP audits of both company facilities and vendors; scoping and executing financial and operational internal audits, including audits of third-party vendors; coordinating enterprise risk assessments and analysis; review and approval of promotional materials; monitoring of promotional events and other interactions with healthcare professionals; management of investigations; and implementation of corrective actions.

Brian Conner is currently a member of Shire's Global Compliance & Risk Management team in April 2012 as Sr. Director. Brian provides compliance leadership to the Neuroscience and GI business units in the U.S. and Canada. He also provides primary compliance support to our aggregate spend efforts and team.

Brian possesses a wealth of cross functional biopharmaceutical experience. He has held positions within the areas of corporate ethics and compliance, general management, regulatory affairs, quality assurance, manufacturing, sales/marketing and healthcare communications. He has worked for large and small companies like Merck, Saatchi and Saatchi, Stiefel Labs, and Genzyme.

HOLLY KRAMEN is VP Global Compliance Officer for Circassia Pharmaceuticals, a life science company specializing in asthma and allergy. She is an experienced industry compliance leader having lived the challenges and best practices of building Legal and Compliance programs in companies of all sizes designing, leading and implementing processes, policies and systems from the ground up. Her previous companies include Pfizer, Gilead Sciences and Given Imaging. While at Pfizer she created and co-authored the first pharmaceutical compliance manual and built the first US aggregate spend system. Prior to joining Circassia, she was Principal at Porzio, Bromberg, Newman and VP at Porzio Life Sciences.

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.

Jennifer is an experienced audit professional with over 20 years of combined Internal Audit and Compliance experience working within various industries, ten years specifically in the pharmaceutical industry, specializing in business process, global risk assessment, financial, operational, compliance and IT controls. Jennifer has held leadership roles in both in­ house and outsourced internal audit departments. In her role as Associate Director, Compliance Monitoring and Auditing with ForestlActavis/Aliergan, she has fostered relationships with varying levels of senior management, audit committee and board compliance committee members. Prior to that, Jennifer held various management roles in Internal Audit at BMS and Deloitte.

Neely is a Compliance Officer (CO) at Biogen leading Corporate Compliance's risk management program. Neely recently designed and implemented a system supporting Biogen's risk mitigation activities. Prior to the current role, Neely supported multiple departments as a CO. Prior to becoming a CO, Neely was an Internal Auditor responsible for auditing Biogen's affiliates/functions to ensure procedures adhered to internal requirements, and various laws and regulations governing the Company's business activities. Prior to Biogen, Neely worked at Protiviti as an independent risk consultant providing advice on risk mitigation. Neely holds a CPA, MBA and a Master's in Business Ethics and Compliance.

Hwa Soo is chair of the Health Practice Group at Kim & Chang, which is Korea's largest law firm. For over 20 years, Hwa Soo and her team have advised the large majority of multinational pharmaceutical and medical device companies that do business in Korea, in many areas and on a wide range of issues. A major focus of her practice has been compliance, including defending companies in compliance-related investigations, setting up compliance programs, and carrying out internal compliance audits. Notably she co-led the defense teams for major pharma and medical device companies in the industry-wide investigations that the Korean competition authorities carried out in the last ten years for the giving of kickbacks."

Tali has been a member of the Israeli Bar Association since 1998, and has extensive legal experience, having worked for several well-known law firms in Israel prior joining Teva in 2007 as Senior Legal Counsel, where she lead the legal support of the Global R&D Division from early stages to clinical trials.

Since 2010 Tali assumed additional responsibilities as a Compliance specialist, and at the end of 2012, became the Global R&D Compliance Officer, supporting the entire division.

In her current role, Tali is responsible for developing and leading the R&D Compliance program in 40 countries. She ensures the implementation of a strong program to meet highest ethical standards and transparency requirements, by use of global IT systems.

As a co-founder of Polaris Solutions and head of the technology practice, Marc Eigner is considered one of the founding fathers of pharmaceutical commercial-compliance technology and the leading expert this field, particularly in HCP/HCO spend automation and aggregate spend systems. He is a frequent lecturer and author on these topics. Under Marc's direction, Polaris' technology practice has grown from a core team to become the largest pharmaceutical compliance-focused technology group in the industry, implementing more than one hundred spend management and aggregation systems worldwide. Thanks to his leadership, Polaris continues to innovate, enlarging the scope of its technology practice and introducing a consistent stream of new products while delivering technology strategy expertise in support of Polaris Management Partners' consulting practice.

Before joining Polaris, Marc worked for Andersen Consulting / Accenture and IBM. Marc holds a BS and MS in Computer & Systems Engineering and an MBA focused on Technology Entrepreneurship, all from Rensselaer Polytechnic Institute. Marc has participated in several executive education programs at the Harvard Business School, including 'Leading Professional Services Firms.'

Corey has been a federal prosecutor for over 13 years, focusing primarily on corporate and white collar crime. He currently serves as both First Assistant U.S. Attorney and Chief of the Criminal Division at the U.S. Attorney's Office for the Middle District of Louisiana. He has prosecuted dozens of organizations and executives and has been recognized by the U.S. Attorney General and FBI Director for successfully trying numerous high-profile corruption matters. Before becoming a prosecutor, Corey practiced white collar criminal defense with King & Spalding in Washington, D.C., and served as a law clerk for a U.S. District Judge.

Jeffrey L. Handwerker is a Partner in the FDA/Health Care and Business Litigation practice groups at Arnold & Porter LLP. He advises pharmaceutical, biotechnology and medical device clients on a range of compliance issues at both the federal and state levels, including, among others, federal drug price reporting requirements, federal and state anti-kickback act compliance, and healthcare reform implementation. He also represents pharmaceutical manufacturers in connection with the establishment of, and implementation of, Corporate Integrity Agreements with the HHS OIG and with related government investigations. He currently is defending a number of drug manufacturers in qui tam litigations involving price reporting, drug promotion, and anti-kickback compliance matters. Mr. Handwerker also recently represented both AstraZeneca in the landmark 340B litigation resolved by the Supreme Court in Astra USA, Inc. et al. v. County of Santa Clara,, and PhRMA in its successful First Amendment challenge to the Vermont prescriber-identifiable data law, IMS, et. al. v. Sorrell. The Santa Clara case held that 340B entities do not have enforceable rights to sue for breach of the 340B Pharmaceutical Pricing Agreement. The Sorrell decision established important First Amendment protections for truthful and non-misleading promotion of pharmaceuticals. Mr. Handwerker is a frequent lecturer and author on these topics.

Mark Jensen is a partner in the Special Matters and Government Investigations Practice Group in King & Spalding's Washington, D.C., office. Mark's practice includes litigating criminal and civil cases at the trial and appellate levels, as well as defending individuals and companies in prosecutions and investigations by U.S. Attorneys' Offices, state AGs, multiple divisions of the Department of Justice, the SEC, FDA, EPA, NOAA and Congress. He regularly represents pharmaceutical, biotechnology, medical device and healthcare companies and their executives in criminal and civil investigations and successfully has defended clients in high-stakes qui tam whistleblower matters in key jurisdictions throughout the country.

Joanne, with over 20 years of industry experience, is Vice President, Merck Global Human Health Compliance, responsible for Merck's CIA and US human health compliance program. She started at Merck in the Regulatory Legal Group and later led the Vioxx US product liability litigation team. Joanne then led the legal group for the US human health business and Merck Research Laboratories. She is a graduate of American University, Washington, DC and University of California, Boalt Hall School of Law, Berkeley, California and a former litigation associate at Drinker Biddle & Reath, Philadelphia, PA.

Maureen is an experienced legal and compliance leader with over two decades of pharmaceutical industry experience. She is currently Vice President within the Global Compliance Organization at Merck & Co., Inc. where she is responsible for leading the Office of Ethics, including: oversight of global compliance programs for investigations, anti-bribery and corruption, third party, policies, training and communications. Previously, Maureen held a number of positions within Merck's Office of General Counsel.

Maureen also was on international assignment based in Japan as Legal Counsel for two 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.

Gus Papandrikos is a well-rounded management professional with extensive pharmaceutical industry experience. He is currently the Global Head of Compliance Operations for Shire.

Prior to his current position, he was the Director of Compliance for Daiichi Sankyo. Prior to Daiichi Sankyo, he was the Director within the Medical Affairs group of Sanofi, responsible for Aggregate Spend reporting across the Sanofi group of companies. As the Director of Transparency operations he is responsible for the development, validation and certification of all the spend reports. In addition, Gus was responsible for the development of the Aggregate Spend data collection process for Sanofi. Gus holds a BA in Accounting from Pace University and an MBA in Pharmaceutical Management from Rutgers Business School.

Elizabeth Schwartz, MBA, CCEP is the Director, US External Reporting & Transparency, Health Care Compliance & Privacy for Johnson & Johnson. Elizabeth is responsible for leading the team responsible for Open Payments, State Reporting and Voluntary Transparency disclosures for the Medical Device & Consumer sectors. Elizabeth's experience around Open Payments includes analysis and development of assumptions documentation, building systems requirements, launching a training and communications plan, and the roll-out of a dispute resolution program. Elizabeth leads the team responsible for monitoring health care professional expense activity. Her compliance experience covers multiple J&J operating companies and includes providing compliance support for the companies by developing trainings, performing testing and monitoring, and drafting policy and procedures. Prior to her career at J&J, Elizabeth was with Deloitte & Touche.

Reporting to IMS Health US President, leads the newly formed US compliance business unit with a focus on expanding our compliance services across the different verticals within the life sciences market by leveraging our current technology and information assets in addition to evaluating strategic areas for investment.

Bill Greenrose is a Director in Deloitte & Touche's Regulatory, Forensics & Compliance Advisory practice. He has over 33 years of experience (23 in industry) in FDA and DEA regulated Life Science industries including compliance, regulatory, clinical, quality assurance, quality control, laboratory, R&D, manufacturing, core lab, and corporate/operations. Bill has helped companies develop, implement and revise programs for pre and post market commitment tracking as well as for PV, AEs and ADEs. He is a former Lead Auditor for a Notified Body and was qualified by Health Canada to conduct audits for compliance with Canadian CAN/CSA-ISO 13485 and CMDCAS.

Megan has served as the North America Chief Privacy Officer for Teva Pharmaceuticals since 2012. She also provides Compliance Leadership support to Teva's Patient Services and Support division located in Overland Park, Kansas.

Prior to joining Teva, Megan had spent nearly 15 years at other healthcare and technology organizations such as the Hospital Corporation of America, Truman Medical Centers and Cerner Corporation in a variety of compliance, privacy and security related leadership roles.

Terra Reynolds is Of Counsel at Paul Hastings in Chicago. Prior to joining Paul Hastings she served for nearly eleven years as an Assistant U.S. Attorney, prosecuting matters involving health care fraud, racketeering, corporate, securities, and tax fraud, and multinational narcotics trafficking conspiracies. Since arriving at Paul Hastings, Terra has spent considerable time assisting pharmaceutical companies with internal investigations to ensure U.S. regulatory compliance, assisting with due diligence and integration related to a multi-billion dollar, multi-national pharmaceutical transaction, and representing a respondent in an ICC arbitration concerning fraud allegations related to an international pharmaceutical transaction.

Regina is a Principal in KPMG's Regulatory Enforcement & Compliance group within the Forensic Advisory Services practice in Short Hills, NJ. Regina has experience building comprehensive ethics, compliance and quality programs for life sciences companies. Regina's most recent role was as the VP & Chief Compliance Officer for US affiliates of a Japanese-based pharmaceutical/medical device company. She led the Ethics, Quality & Compliance group and had responsibility for healthcare law compliance, internal investigations, auditing & monitoring, training, privacy, information security, transparency, policies/procedures, document control, contact call center, manufacturing quality and clinical trial/GCP quality.

Rachel Batykefer joined Teva in September 2013 as Associate Director, Global Compliance. She and her team are responsible for developing, coordinating, and managing Global Compliance and Ethics training and awareness programs for all employees. As part of her role, Rachel collaborates closely with Global HR, Global Communications and other key functions to execute these programs. Prior to joining Teva, Rachel was a Senior Manager at Tyco International managing their global Compliance Education function to an audience of 140,000 employees in more than 60 countries, covering 30 languages.

Ms. Feltz is Executive Director, Corporate Compliance at Purdue Pharma L.P., a pharmaceutical company headquartered in Stamford, Connecticut. Maggie's primary focus at Purdue is on the Sales & Marketing functions. She likewise oversees Purdue's aggregate spend efforts, ensuring compliance with state and federal marketing reporting requirements, as well as training and communication efforts company-wide.

In her role, Maggie collaborated with other attorneys and compliance professionals to negotiate Purdue's Corporate Integrity Agreement. Since initiation of Purdue's CIA in July 2007, Maggie has partnered with Purdue colleagues and management to ensure smooth implementation of the CIA.

From 2009 - 2014, Maggie served as Co-Chair of the Pharmaceutical Compliance Forum.

Samantha Hand, Government Contracting & Pricing Compliance Officer, Medical Device Sector, Johnson & Johnson started her career in the Pharmaceutical sector where she held numerous sales positions before transitioning to an in-house position. In that realm, she has spent the last eight years in sales training and then Health Care Compliance.

In her last position as Training Manager, Health Care Compliance & Privacy, Pharmaceutical sector, Johnson & Johnson, she was responsible for Health Care Compliance training which included ensuring all CIA-related training was carried out effectively to meet requirements.

Matthew is a Senior Manager focusing on instructional design, change management, training, survey design and analysis and business process improvement. Additionally, Matthew has extensive experience developing, implementing, and managing compliance-related programs for large, multinational clients.

Mr. Neiberg is a Director with HealthCare Appraisers and has an extensive background in healthcare business valuation and financial analysis. His nine years of experience includes valuation of ambulatory surgery centers, healthcare systems and life sciences companies. Prior to joining HealthCare Appraisers Mr. Neiberg held positions as manager of valuation services at WTAS, LLC in West Palm Beach, Florida, and as an associate with Deloitte and Touche.

Mr. Neiberg holds a Master of Accounting from the Fisher School of Accounting at the University of Florida and a Bachelor of Science in Management with concentrations in Finance and Accounting from the A. B. Freeman School of Business at Tulane University. He is a CFA charter holder and a certified public accountant (CPA) licensed in the State of California and is a member of the Florida Institute of Certified Public Accountants, the American Institute of Certified Public Accountants and the CFA Society of Miami. He is a frequent speaker on fair market value and healthcare valuation topics.

An attorney and registered pharmacist, Lee Rosebush focuses his practice on the intersection between pharmacy and FDA regulatory, compliance and enforcement issues pertaining to drugs, biologics and medical devices. Lee has handled matters involving all 51 (including DC) state boards of pharmacy and assists clients with healthcare-related issues stemming from Medicare, Medicaid and state regulatory requirements. This includes state licensing requirements for healthcare providers and pharmacies, as well as drug and device manufacturers and distributors. Lee advises clients in matters relating to FDA regulatory compliance, including governance in the clinical trial, marketing, promotion and advertisement and approval process. He regularly provides counsel to pharmaceutical, medical device and dietary supplement manufacturers.

Dr. Brandt serves as the leader the life sciences service line at HealthCare Appraisers. Working primarily with medical device, pharmaceutical, and biotechnology companies, Dr. Brandt and her team of valuation professionals determine the fair market value of U.S. and global transactions including, healthcare provider ("HCP") compensation, intellectual property, royalty and licensing arrangements, as well as transactions related to data acquisition/sales and clinical trials. Dr. Brandt has more than 25 years of healthcare experience as a valuation professional, clinician, consultant, strategist and professor. She is an experienced presenter and has authored articles and book chapters on a variety of healthcare valuation topics.

Terri Ledva is an accomplished Healthcare Compliance Professional who specializes in Governance, Regulatory & Risk. She has over 15 years of experience within leading life sciences companies and across the product development life cycle. She has led cross-functional teams that implemented enterprise-wide solutions, new operating models, and stronger controls by overseeing the reengineering of policies and procedures and the development of effective training programs. Collaborating with stakeholders, she has successfully developed and enhanced regulatory and healthcare compliance programs through the integration of technology and sustainable practices that add business value.

She designs and implements new operating models to assist clients with meeting requirements of a Corporate Integrity Agreement (CIA). And Implements stronger controls and sustainable practices that reduce risk; improve controls framework in R&D and Commercial areas to enhance compliance; and creates a compliant culture using leading practices, risk methodologies, and a collaborative approach with stakeholders.

Senior counsel and senior director in the Corporate Compliance department at Jazz Pharmaceuticals. Advises on legal and compliance matters for the Oncology portfolio, medical affairs, and managed care/reimbursement activities. She also manages transparency and compliance field monitoring teams. She has published various articles, a book chapter on E­HEALTH AND ETHICS, and regularly presents at various conferences. She is currently authoring a book chapter in CANCER POLICY: PHARMACEUTICAL SAFETY. She is a licensed attorney, and is certified in Healthcare Compliance. She received her JD from DePaul University College of Law, and her BA with Honors from the University of Iowa.

Nikki Reeves is a partner in King & Spalding's FDA & Life Sciences Practice Group in Washington, D.C. She counsels pharmaceutical, biotechnology, and medical device companies on a broad range of FDA and healthcare regulatory compliance matters, including clinical trial regulation, product advertising/promotion, quality system regulation/good manufacturing practices, FDA enforcement actions, and federal healthcare compliance programs. Nikki is an expert on transparency laws applicable to life sciences manufacturers, including the federal Physician Payment Sunshine Act and state aggregate spend disclosure laws targeting the pharmaceutical and device industries. She co-leads the K&S Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical and device manufacturers that she advises on these state and federal laws. She also co-leads the International Marketing and Disclosure Compliance Group.

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.

Kellie Combs provides legal and strategic advice to pharmaceutical and biotechnology companies on a broad range of regulatory issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Kellie has advised clients on promotional compliance matters, lifecycle management, regulation of clinical research, government investigations, and internal investigations and compliance audits. She has also performed regulatory due diligence in connection with transactions involving global life sciences companies and has served as FDA counsel in litigation involving First Amendment challenges to FDA's regulatory scheme governing manufacturer speech.

Brian Conner is currently a member of Shire's Global Compliance & Risk Management team in April 2012 as Sr. Director. Brian provides compliance leadership to the Neuroscience and GI business units in the U.S. and Canada. He also provides primary compliance support to our aggregate spend efforts and team.

Brian possesses a wealth of cross functional biopharmaceutical experience. He has held positions within the areas of corporate ethics and compliance, general management, regulatory affairs, quality assurance, manufacturing, sales/marketing and healthcare communications. He has worked for large and small companies like Merck, Saatchi and Saatchi, Stiefel Labs, and Genzyme.

Mike is a member of the Food and Drug and Life Sciences practices at Covington & Burling LLP. Mike provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of life sciences cases, and works actively on corporate transactions and government investigations.

Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School. He clerked for the Honorable David M. Ebel on the U.S. Court of Appeals for the Tenth Circuit. He is a Fellow of the American Bar Association, and a member of Covington's Management Committee.

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.

Tom Beimers represents a wide range of health care and life science industry clients in False Claims Act cases, government investigations, and other criminal, civil and administrative proceedings. Tom's practice includes the following types of engagements: Health Care Fraud and Abuse, White Collar and Investigations, Compliance and Risk Management and Litigation.

Before joining Faegre Baker Daniels, Tom was senior counsel for administrative and civil remedies in the Department of Health and Human Services' Office of the Inspector General. At OIG, he investigated False Claims Act cases involving off-label marketing, drug pricing, Anti-Kickback Statute violations, and Medicaid and Medicare reimbursement. From 2008 to 2010, Tom served as Special Assistant U.S. Attorney in Detroit, prosecuting criminal health care fraud cases as part of the joint HHS-DOJ Medicare Fraud Strike Force.

Tom is a frequent national speaker and author on topics related to health care fraud and abuse, white collar criminal defense, and compliance matters.

Catherine Clements serves as Senior Legal Counsel for Express Scripts, Inc., supporting specialty supply chain contracting. She joined the company in June. Prior to her position at Express Scripts, Catherine was an associate in the Healthcare and FDA group at Faegre Baker Daniels. Before attending law school, Catherine gained extensive experience in clinical research and the pharmaceutical industry, serving as a medical writer and project manager for Eli Lilly and Company and as a hospital clinical research coordinator. Catherine currently serves on the Editorial Advisory Board for the Food and Drug Law Journal.

John ("Jack") S. Linehan is an attorney in the Health Care and Life Sciences practice group of Epstein Becker & Green, P.C. in Baltimore, MD, and Washington, D.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 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.

Kathleen A. Peterson is a member of the Cooley Business department and is special counsel in the Firm's Health Care & Life Sciences Regulatory practice.

Ms. Peterson has provided health regulatory counsel to a range of industry clients, including pharmaceutical and biologic manufacturers, distributors, PBMs, managed care organizations, specialty pharmacies, and investment firms.

Prior to joining Cooley, Ms. Peterson was a partner in another leading law firm, where she was a key member of the Pharmaceutical Industry Health Regulatory practice group. Separately, Ms. Peterson has worked in-house as Senior Corporate Counsel to a pharmaceutical company, where she was the primary internal legal counsel for commercial sales and marketing issues.

Education
• Boston University School of Law
  JD (with honors in Health Law Concentration), 2000
• State University of New York, College of Geneseo
  BA, 1997

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 a keen understanding of the challenges facing clients in 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 Strategic Program Management, Monitoring Program Design and Automation, Corporate Integrity Agreement (CIA) support, and Fair Market Value (FMV) assessments.

Sujata Dayal is the Chief Compliance Officer for a 3 billion dollar global medical device company. Responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption, Attorney with general corporate transactional and FDA regulatory experience. Experienced in setting up global compliance programs, including conducting risk-assessments, policy and procedure writing, training, monitoring and promotional review. Areas of expertise include health care compliance, FCPA and regulatory law.

Specialties: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy

Andrew Foose, J.D., vice president with NAVEX Global's Advisory Services team, is a former senior trial attorney in the U.S. Department of Justice's Civil Rights Division. Andrew is recognized among the country's leading experts on conducting lawful and effective internal investigations and has trained thousands of attorneys, compliance officers, auditors and human resource professionals on best-practice investigative techniques and on how to write effective, comprehensive investigative reports. He currently works with organizations ranging from large multi-national companies to smaller non-profits to assess their ethics and compliance programs and to provide guidance on ways to enhance program effectiveness and efficiency.

Dr. Ann E. Tenbrunsel (Ph.D., Northwestern University; M.B.A. Northwestern University; B.S.I.O.E. University of Michigan) is a professor in the College of Business Administration at the University of Notre Dame and is the David E. Gallo Professor of Business Ethics. Ann teaches at the executive, MBA, and undergraduate levels. Her research interests focus on the psychology of ethical decision making, examining why employees, leaders and students behave unethically, despite their best intentions to behave to the contrary. Ann is the author, co-author, or co-editor of six books on this topic -- including her most recent Blind Spots (with Max Bazerman)--and over 50 research articles and chapters. Her research has been featured in interviews and in a variety of publications, including MSNBC, National Public Radio, The New York Times, Wall Street Journal, US News and World Report, Sports Illustrated, Harvard Business Review, Forbes, Psychology Today and Freakonomics.

Aditi Taylor has over 16 years of experience in Compliance Risk Advisory Services. She specializes in the Life Sciences industry and has extensive experience advising numerous Life Sciences companies identify, analyze and manage regulatory and compliance risks while maintaining efficient and effective business processes.

Aditi advises companies on large transformational projects within an inherently dynamic regulatory and enforcement environment. She helps her clients understand the multiple dimensions and risks of varying customer interactions and engagement models, including healthcare professionals, payers and patients, in an effort to build efficient risk-based, sustainable compliance programs.

Aditi brings a deep knowledge of interoperability of compliance risks across a broad set of functions, including Commercial, Regulatory Affairs, Medical Affairs, Legal, and Compliance. Her experience spans across assisting companies evaluate and build their compliance programs and culture of ethics and integrity, conduct focused risk assessments, executing auditing and monitoring programs to deeper dives within specific areas of commercial compliance including advertising and promotional programs, anti-bribery/anti-corruption, medical affairs, interactions with healthcare professionals, payer interactions, patient engagement, etc. Aditi has served several top clients in the Life Sciences industry and often worked with companies under or coming out of enforcement scrutiny.

Aditi earned her Bachelor in Economics from University of Mumbai, India and a MBA from Bentley, University, Waltham, MA. She also has a Graduate Certificate in Pharmaceutical and Medical Device Law from Seton Hall Law School, NJ.

Mr. Blume is the Director of the Consumer Protection Branch of the United States Department of Justice. Mr. Blume joined the Consumer Protection Branch in 2011, after having spent nearly nine years as a federal prosecutor in the United States Attorney's Office for the Eastern District of Pennsylvania. He is the recipient of several Department of Justice Awards, including the Attorney General's Award for Distinguished Service. Mr. Blume also practiced for the City of Philadelphia, for a private law firm, and as a clerk to a federal judge. Mr. Blume is a 1996 graduate of the Harvard Law School, where he served as an Editor of the Harvard Law Review.

As Chief Compliance Officer and Vice President for Novo Nordisk Inc., Jill Fallows-Macaluso is responsible for Novo Nordisk's compliance program in the United States. Prior to joining the Compliance Department in 2012, Ms. Fallows-Macaluso was Sr. Corporate Counsel in the Novo Nordisk Inc. Legal Department since 2003. Previously, Ms. Fallows-Macaluso was with the general corporate and healthcare practice of Day Pitney, LLP. Ms. Fallows- Macaluso holds a Bachelor of Science in Nursing from the University of Pennsylvania and a Juris Doctorate from Rutgers University School of Law.

Barbara Rowland is a Principal in Post & Schell, P.C.'s Internal Investigations & White Collar Defense Practice Group resident in its Washington, D.C. Office. She focuses on representing corporations and their employees in various industries, including pharmaceutical and medical device manufacturing, retail pharmacy, pharmacy benefit management, health care and defense contracting. She conducts internal investigations, counsels clients subject to government investigation, and defends clients in litigation and at trial.

Ms. Rowland has spent the majority of her career overseeing or defending white collar government and internal investigations from the vantage points of prosecutor, defense counsel and, most recently, in-house counsel for two major health care corporations -- CVS Health Corporation and Merck & Co., Inc. Ms. Rowland was an Assistant U.S. Attorney for eight years with the Civil Division of U.S. Attorney's Office of the Eastern District of Pennsylvania where she successfully managed the False Claims Act investigations of a pharmacy benefit management company, a generic drug manufacturer, and a large dental device manufacturer. In 2006 she received the Attorney General's "Award for Distinguished Service" in recognition of her resolution of pharmaceutical fraud cases.

Experienced Compliance Officer in the Pharmaceutical industry with proven success in directing cross-functional, inter-departmental teams to ensure the development, implementation and enforcement of internal processes and procedures that promote compliance with applicable laws, industry guidelines and company standards. Adept at leveraging analytical and interpersonal skills to devise and implement tactical strategies that bring resolution to complex legal and business concerns.

Prior to joining PhRMA, Ms. Roth was a lawyer in the Washington D.C. office of Sidley Austin LLP, where her practice focused on defense of government investigations and advising health care companies regarding compliance with fraud and abuse laws. Ms. Roth maintained an active pro bono practice, including litigation involving child custody and Medicaid benefits disputes. Ms. Roth received her law degree from the University of Virginia, where she served as an Articles Editor for the Virginia Law Review.

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, compliance inquires and in strategizing responses to government subpoenas and other inquiries.

Kris is a compliance and regulatory professional with more than 20 years of life science experience. Prior joining EY, Kris was the Vice President and Chief Compliance Officer for the Pharmaceutical Sector of Johnson & Johnson. As the CCO she was responsible for the development and implementation of a comprehensive global compliance program. She has first-hand experience managing and responding to government investigations, including the negotiating of settlements agreements.

Kris brings deep, relevant experience in health care and life sciences, and she is a frequent lecturer at industry events. Her significant regulatory and compliance experience includes such diverse areas such as promotional compliance, research and development, sales and marketing practices, including off-label, fraud and abuse, government pricing and relationships with third parties.

Robert joined Transparency International UK in 2008 and was appointed as Executive Director in 2013. His areas of expertise include the Bribery Act, integrity in the private sector and corruption within the UK. Recent projects and publications include 'Anti-Bribery Due Diligence for Transactions', 'Adequate Procedures -- Guidance to the UK Bribery Act' and 'Corruption in the UK'. He was previously Director of Governance & Sustainable Investment at F&C Asset Management, and CEO (Europe) of the environmental research group Earthwatch Institute.

He was a member of the Ministry of Justice's Experts Group drafting the official guidance on the Bribery Act and formerly a member of the of the UK Government's Export Guarantees Advisory Committee. He has a degree from Oxford University, where he recently held a 3-year Visiting Fellowship, and a PhD from the European University Institute.

Christine Longawa, CPA, CFE is an Associate Director in Navigant's Healthcare and Life Sciences Disputes, Regulatory, Compliance, and Investigations Practice. Christine began her career in public accounting, specializing in financial statement audits of life sciences organizations. Since joining Navigant in 2008, Christine has assisted numerous clients in developing, analyzing, monitoring and auditing their global compliance programs. Christine has expertise in serving as and managing the Independent Review Organization (IRO) and Pre-IRO for several life sciences companies. She has experience working on Corporate Integrity Agreement Board Advisor engagements and compliance effectiveness reviews. In addition, Christine has supported her clients with their field force monitoring and aggregate spend obligations.

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.

Mr. Del Vecchio has been with Bristol-Myers Squibb for 26 years. His experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, education and training, and compliance and ethics program development and support. Gary has been a member of the US Pharmaceuticals Compliance and Ethics department for 10 years and currently holds the position of Executive Director, USP Compliance and Ethics. In this role he provides compliance and ethics leadership to the Sales, Marketing, Medical, Access and Global Commercialization organizations along with managing the US Compliance and Ethics investigations team. His initial compliance role focused primarily on the creation and implementation of the company's comprehensive US Compliance and Ethics education and training program. Gary is currently serving as a Co-Chair of the Pharmaceutical Compliance Forum, a coalition of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers. The PCF was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.

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

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

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

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.

Lauren Roth is an Assistant General Counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing the leading innovative biopharmaceutical research companies. Ms. Roth advises PhRMA on issues and advocacy related to government enforcement and corporate compliance with federal health care program laws and regulations. Ms. Roth also administers pharmaceutical company certifications to PhRMA's principles of conduct, including the Code on Interactions with Healthcare Professionals ("the PhRMA Code").