AHLA Pharmaceutical and Medical Device Compliance Manual (Non-Members)

Ela Bochenek (Editor) was the Assistant Dean Graduate and Professional Education at Seton Hall University School of Law at the time this book was written. In this position, she directed the Law School’s global Healthcare Compliance Certificate Programs, oversaw the Law School’s Center for Health and Pharmaceutical Law & Policy and collaborated with faculty, students, industry professionals, and enforcement officials to enhance educational offerings.  She was previously Vice President, Global Compliance at Insmed Incorporated, a global biotech orphan drug pharmaceutical company based in New Jersey, where she led the compliance function. 

Prior to joining Insmed, Ms. Bochenek was a Vice President and Associate General Counsel at NPS Pharmaceuticals, Inc., another global biotech orphan drug company, where she was in charge of the international law department and led the international compliance and commercial functions.  Ms. Bochenek was also Associate General Counsel - International for C.R. Bard, Inc., a New Jersey-based multinational medical device company, where she was responsible for providing legal oversight and counsel to all of Bard's global operations on a variety of commercial and compliance matters.  Before joining Bard, Ms. Bochenek was a member of the International Legal Departments of Schering-Plough and Bristol-Myers Squibb Company.   Prior to that, she practiced at two Philadelphia law firms, Morgan, Lewis & Bockius and Pepper, Hamilton & Sheetz, as a general corporate attorney with a concentration in international business transactions. 

Ms. Bochenek’s law degree is from the University of Pennsylvania Law School, where she was a member of the Law Review. She won the Global Counsel Award 2009 in the Best Individual Commercial Lawyer category; the award is sponsored by the International Law Office and the Association of Corporate Counsel. Ms. Bochenek now serves as Vice President and Chief Compliance Officer at Nabriva Therapeutics.

Carl H. Coleman (Editor) is Professor of Law at Seton Hall University School of Law. He is the lead author of the textbook, The Ethics and Regulation of Research with Human Subjects (2d ed. Lexis 2015), as well as numerous articles on health law and policy in leading legal and heath policy journals. He previously served as Bioethics and Law Advisor at the World Health Organization, as Executive Director of the New York State Task Force on Life and the Law, and as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) of the U.S. Department of Health & Human Services. He received his J.D., magna cum laude, from Harvard Law School, where he was Supervising Editor of the Harvard Law Review.  Following law school, he served as law clerk to the Hon. James L. Oakes, Chief Judge of the U.S. Court of Appeals for the Second Circuit.

Amy Matey (Editor) is the Executive Director of Health Care Compliance Education at Seton Hall University School of Law. In this role, she develops educational programs and events for the Law School’s Center for Health & Pharmaceutical Law & Policy and manages its highly regarded global health care compliance programs. Previously, she was an associate attorney at the law firm of Porzio, Bromberg & Newman. She then served as Assistant Counsel to Governor Chris Christie. She received her B.A. from Rutgers University and her J.D. from Seton Hall University School of Law.

Marc Adler (Chapter 13, Compliance 2.0: Compliance Analytics in the Era of Big Data) is the President and Founder of Global Compliance Strategies where he assists life science manufacturers with establishing and managing global health care compliance programs to ensure compliance with government laws, regulations and expectations.

In addition to serving as an outsourced Global Chief Compliance Officer for life science companies, Mr. Adler oversees a range of outsourced compliance functions and provides guidance on a variety of compliance and health care fraud and abuse matters. He frequently presents and writes on health care compliance, including as faculty for the Seton Hall School of Law Healthcare Compliance Certification Program. Prior to founding Global Compliance Strategies, he led the Healthcare Compliance Service division at one of the largest health care service companies in the world and was responsible for supporting compliance engagements for over 120 life science companies. Mr. Adler received his J.D. from the Seton Hall University School of Law with a Concentration in Health Law.

Joseph S. Calarco (Chapter 13, Compliance 2.0: Compliance Analytics in the Era of Big Data) is Chief Compliance Officer for Neos Therapeutics in Blue Bell, Pennsylvania. In this role, Mr. Calarco is responsible for the establishment and oversight of the U.S. Compliance Program. His responsibilities include the implementation of policies and procedures, education and training, risk assessment activities, monitoring and auditing, and implementation of corrective action initiatives.

Prior to joining Neos Therapeutics, Mr. Calarco was a Director of Compliance Operations at Bristol-Myers Squibb where he led Compliance risk assessment and remediation activities across multiple business units. At Shire Pharmaceuticals he served as a Director of Corporate Compliance where he developed and implemented a Compliance Monitoring and Investigations program. Mr. Calarco received his B.S. in Psychology from Drexel University and Master of Social Service from Bryn Mawr College.

Bret A. Campbell (Chapter 7, International Anti-Bribery and Anti-Corruption), is principal and founder of Northstar Consulting LLC. At Northstar, Mr. Campbell advises clients on corporate governance issues and on the implementation of compliance codes. He helps companies assess risks in their international operations, and counsels on the development and implementation of policies, procedures, and systems designed to prevent and detect potential violations of law. Mr. Campbell also consults on Foreign Corrupt Practices Act  (FCPA) and regulatory compliance due diligence reviews in connection with mergers, acquisitions, and other complex corporate transactions. He has extensive experience managing internal corporate investigations and cross-border criminal and regulatory matters, often in proceedings before the U.S. Department of Justice and the U.S. Securities and Exchange Commission.

Before founding Northstar, Mr. Campbell was a partner in the White-Collar Defense and Investigations group of Cadwalader, Wickersham & Taft LLP and served in various management roles, including as a co-managing partner of the firm’s Washington, DC office. Mr. Campbell received his J.D. from Vermont Law School.

Colleen A. Conry (Chapter 2, Thou Shalt Not Buy Business: The Implications of the Anti-Kickback Statute on the Drug and Device Industry), is a partner in the Litigation and Enforcement Group of Ropes & Gray LLP in Washington, DC. Ms. Conry has extensive experience in representing multinational corporations and their executives in government investigations of potential violations of the Foreign Corrupt Practices Act, export control regulations and anti-money laundering laws, Food Drug and Cosmetic Act, and the various securities fraud statutes, as well as criminal prosecutions for economic espionage or theft of trade secrets. Ms. Conry also advises clients on internal investigations and compliance matters and has worked with clients around the globe across the health care, life sciences, financial services, manufacturing, and telecommunications industries. She worked with her team to obtain a judgment of acquittal at the close of the government’s case for a former associate General Counsel at a major pharmaceutical company who was charged with obstruction of justice and making false statements in connection with a Food and Drug Administration (FDA) inquiry into the company’s marketing practices.

Prior to joining the firm, Ms. Conry served as a Senior Litigation Counsel in the Fraud Section of the Criminal Division in the United States Department of Justice. In 2007, Ms. Conry received the Attorney General’s Award for Distinguished Service and the Federal Bureau of Investigation Director’s Annual Award for Outstanding Criminal Investigation. Prior to joining the Criminal Division, Ms. Conry served for seven years in the Commercial Litigation Branch of the Civil Division where she tried multiple cases involving claims against the government in excess of $3 billion. Ms. Conry received her J.D. from Boston College.

Scott Cunningham (Chapter 5, Drug and Device Development and Approval) is a partner in Covington & Burling's Food, Drug, and Device regulatory practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  After spending the first twelve years of his career in Washington, DC., Mr. Cunningham now practices in the firm's San Francisco office, where he routinely works with gene therapy, cell therapy, and other innovative regenerative medicine clients.  Mr. Cunningham also has an active pro bono practice representing children in immigration rights cases.

Scott D. Danzis (Chapter 5, Drug and Device Development and Approval) is a partner in the law firm of Covington & Burling LLP, where he is a member of the firm’s Food & Drug practice group.  Mr. Danzis’s practice focuses on medical device regulatory matters, including premarket strategies and postmarket requirements, including advertising and promotion, postmarket reporting, recalls, and enforcement actions, among other things. 

From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration.  He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif.  He holds a Master’s Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.  Following law school, Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit.  In addition to his practice, Mr. Danzis is an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on drug and device law.

Sujata Dayal (Chapter 10, Elements of an Effective Compliance Program), is Vice President, Health Care Compliance and Privacy, Pharmaceuticals for Johnson & Johnson in Titusville, New Jersey. In this role, Ms. Dayal is responsible for establishing and overseeing a global compliance program including adopting policies and procedures, conducting training and monitoring, conducting risk assessments and implementing corrective action.

Prior to joining Johnson & Johnson Ms. Dayal worked for Biomet, Inc., Karmact, LLC, Abbott Laboratories, and Jones, Day, Reavis & Pogue. Ms. Dayal received her LL.B from Rajasthan University, India.  She also has a JD from Chicago Kent School of Law and an LL.M. from Columbia University School of Law.