Agenda – Precon/Day 1

Michael R. Clarke is the Vice President, Corporate Compliance for Indivior Inc. He is responsible for managing the global compliance program for Indivior across its business operations in the North American, European, Middle East, African, China and Pacific Rim regions. Previously, Mr. Clarke was V.P., Ethics & Compliance – Americas for Actavis plc, and Vice President and Compliance Officer for EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies. He also served in an ethics & compliance officer role for the University of Medicine & Dentistry of New Jersey; Edison Schools and Medco Health Solutions. Before working in-house as a compliance professional, Mr. Clarke practiced corporate, civil and criminal law as a litigation partner with the law firm of Drinker Biddle & Reath LLP, as an associate at the law firms of Hannoch Weisman and Scarinci & Hollenbeck and as an Assistant Deputy Public Defender in Essex County, New Jersey.

Sujata Dayal is the Vice President Health Care Compliance & Privacy, Pharmaceuticals for Johnson & Johnson. She is responsible for overseeing health care compliance organization and program for the global pharmaceutical group. Previously, she was the Global Chief Compliance Officer and Corporate Vice President for Biomet, Inc. There she was responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption. She was also, Partner with Karmact, LLC, and Ethics and Compliance Officer for Abbott Laboratories. Ms. Dayal is experienced in setting up global compliance programs, including conducting risk-assessments, policy and procedure writing, training, monitoring and promotional review. Her areas of expertise include health care compliance, FCPA and regulatory law and her specialties include: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy

Jeffrey Kawalek is a compliance professional with nearly 20 years of pharmaceutical experience with a focus on developing and implementing effective pharmaceutical compliance programs, mitigating risk, and advancing compliance with Company policy and Federal and state healthcare laws.

Jeff is the Senior Director, Ethics & Compliance North America for Ipsen. He oversees, maintains and enhances the U.S. Ethics & Compliance Program. He executes on various aspects of the U.S. Ethics & Compliance program including: policies, training, communications, monitoring, investigations and risk management. Previously he was Director, Compliance at Novo Nordisk where he supported the Chief Compliance Officer to set and accomplish the strategic objectives of the corporate compliance program. He also provides tactical compliance support to the Oncology, Neurology, and endocrinology brand and field teams as well as U.S. Medical/HEOR, Value & Access, and Transparency Operations. He collaborates with the Global Ethics & Compliance team on global compliance initiatives.

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

Margaret Sparks has been with Sanofi US or its predecessor company since November 2001, when she joined the Aventis Pharmaceuticals Legal Department, supporting the Respiratory franchise. Margaret moved to the Compliance team in 2007, and now supports a variety of business groups and compliance functions. Prior to Sanofi US, Margaret was part of the Litigation group at Patterson, Belknap, Webb & Tyler, LLP in New York.

Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, leadership development, training, management, and sales. He has held his current position at Ferring since 2016. Prior to Ferring, Mr. Zimmerman operated a health care compliance and business operations consulting company. Until late 2015, he served as Senior Vice President and Chief Compliance Officer for two multi-billion dollar publicly traded companies: Actavis (now Allergan) and Forest Laboratories (acquired by Actavis). He held the position of Global Chief Compliance Officer for Forest starting in 2004.

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.

Richard Bistrong spent much of his career as an international sales executive and currently consults and speaks on foreign bribery, ethics and compliance issues from that front-line perspective. Richard was the Vice President of International Sales for a large, publicly traded manufacturer of police and military equipment in the UK. In 2007, as part of a cooperation agreement with the United States Department of Justice and subsequent Immunity from Prosecution in the UK, Richard assisted the United States, UK, and other governments in their understanding of how FCPA, bribery and other export violations occurred and operated in international sales. In 2012, Richard was sentenced as part of his own Plea Agreement for violating the FCPA, and served fourteen-and-a-half months at a Federal Prison Camp, returning home in December 2013. Richard now consults, writes and speaks about current front-line anti-bribery and compliance issues.

Lillian Hardy is a partner in the Investigations, White Collar with & Fraud Group of Hogan Lovells. She focuses on compliance program implementation, investigations, and crisis management. She has worked on behalf of life sciences companies throughout her career.

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 xAdministration. 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.

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

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

Prior to joining the Compliance Department, she was Senior Corporate Counsel in the Novo Nordisk Inc. Legal Department for nine years where she held several key positions. Previously, Ms. Fallows Macaluso was with the General Corporate and Healthcare practice of Day Pitney, LLP.

Jonathon Kellerman currently serves as the Executive Vice President, Global Chief Compliance Officer for Allergen plc and sits on the Chief Executive Officer’s Executive Leadership Team (ELT). In his role, he is responsible for leading a global team who are responsible for US Commercial Compliance, Global R&D Compliance, International Compliance and Compliance Operations. Jonathon is a member of the Audit & Compliance Committee of the Allergan Board of Directors and an active member of the Global Quality Review Board, the Information Security Risk Board and the company’s Disclosure Committee.

Jonathon formerly worked at PricewaterhouseCoopers LLP (PwC) in PwC’s Pharmaceutical & Life Sciences Advisory practice and has 25 years of consulting, advisory and complex transformational change experience working in the pharmaceutical, medical device and health care industries. Jonathon is a member of the National Board of Directors for the American Foundation for Suicide Prevention (AFSP), the Board of Directors for the Allergan Foundation.

Robert Ladd is the Global Head of Integrity & Compliance for Novartis Oncology, responsible for advising the business on compliance risk, the strategic design and implementation of the Oncology integrity and compliance program, and supporting the company’s mission. In this role, he is a member of the Oncology Executive Committee (OEC) and the Compliance Leadership Team (CLT). Robert has worked throughout his career in investment banking and healthcare. He joined Novartis in October 2017 and previously served as the General Counsel for GE Healthcare Partners. He has held senior commercial and transactional legal and leadership roles in compliance of increasing responsibility at GE Healthcare and Pfizer; Robert was previously a Vice President at Goldman Sachs. Prior to entering corporate law, Robert worked as an associate at Brown & Wood and Latham and Watkins in New York City; he began his legal career as a transactional attorney representing investment banks.

Puja Leekha has a decade of litigation experience with Drinker Biddle & Reath LLP representing pharma and medical device companies in product liability actions, and has spent the past 4 years in-house serving the medical device, pharmaceutical and healthcare consulting industries in all areas of legal and compliance.

Puja currently serves as Vice President, Chief Compliance Officer & Corporate Counsel for Lundbeck Pharmaceuticals and is responsible for the leadership, development, operation, management and implementation of Lundbeck’s Compliance Program for North America, focusing on all 7 Elements of an Effective Compliance Program.

Prior to joining Lundbeck, served as an IT and Business Process Consultant with Accenture, and the Associate Director of Investor Relations with The Weiser Group. Most recently, she served as Division Legal Counsel & Compliance Officer for Stryker, a $12b+ medical device company.

Lori Queisser joined Teva Pharmaceuticals in June of 2015 in the key role of Senior Vice President and Global Chief Compliance Officer. She reports directly to the CEO. In this role, Lori is responsible for leading the organization’s compliance efforts globally, and setting the strategy for the implementation of compliance programs across the business. She will also engage the organization in promoting a culture of compliance, based on our values and Code of Conduct. Lori brings significant, diverse, global experience in the Compliance and Pharmaceutical industry to the Teva team. She has held senior roles in Eli Lilly and Schering Plough before consulting in the field as both President/Owner of Queisser and Associates and as a Principal at KPMG. Most recently, she was employed at DePuy Synthes, a Johnson and Johnson Company, as their Healthcare Compliance Officer. Lori is a Past Chair of the Pharmaceutical Compliance Forum.

Eric Siegel has more than 25 years of legal and compliance experience with life science companies, currently serving as Chief Compliance Officer at Jazz Pharmaceuticals. Prior to his current role, he most recently served as Executive Vice President and General Counsel at Incyte Corporation. He has also held senior-level roles at EMD Serono, Cephalon and GlaxoSmithKline.

Paul Silver is Deloitte’s Life Sciences Regulatory and Compliance Leader. He has 30 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.