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.