Overview
With the increasing difficulties in internally-generated product development, drug, biologics, and device firms of all sizes are looking to acquisitions to augment product lines. Whether in the form of single products or whole companies, transactions can make or break the future of a company. However, often lost in the frenzy of a deal involving highly-regulated biomedical companies or products is the critical need to ensure that regulatory, clinical, and quality considerations do not undermine the value or viability of an investment. This webinar will focus on the key regulatory, quality, and clinical issues, including data integrity failings, that must be reviewed when purchasing an FDA-regulated product or company and how to adequately address those concerns in the due diligence phase. The presentation will highlight issues that can undermine a deal altogether or create burdens in the integration phase and how to ensure these issues are properly addressed in advance. The panel will address a “checklist” of items acquiring companies should consider as part of their due diligence, followed by a discussion of specific techniques these companies can use to determine whether due diligence issues exist.
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Speakers
Ann Begley, Partner, Morgan, Lewis & Bockius LLP
Jack Garvey, Chief Executive Officer, Compliance Architects LLC
Michael Swit, Managing Principal, Law Offices of Michael A. Swit
JACK GARVEY is the Founder and Chief Executive Officer at Compliance Architects LLC. He has had a career-long passion for embracing innovation and leading improvement initiatives within FDA-regulated manufacturing operations. As both a chemical engineer and practicing attorney, Jack helps life sciences companies navigate issues and challenges found at the intersections of science, engineering, business, and law. Known for “outside-the-box” thinking, Jack’s love of tinkering, problem solving, science and computers has allowed him to bring new approaches and solutions to long-standing Quality and Compliance operational challenges, helping to create sustainable systems, effective business processes and profitable operating models.
MICHAEL A. SWIT is Managing Principal at the Law Offices of Michael A. Swit and has been addressing critical U.S. Food and Drug Administration (FDA) legal and regulatory issues since 1984. Before returning to private law practice in late 2017, he served for three years at Illumina, Inc., the world’s leading developer of gene sequencing technology, as its chief regulatory counsel. Prior to that, Swit was a special counsel in FDA Practice at the global law firm of Duane Morris LLP in its San Diego office. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics, and therapeutic biotech products. His FDA legal and regulatory work also has included tenures in the food and drug law practices McKenna & Cuneo (now Denton’s) and Heller Ehrman, and as vice president, general counsel, and secretary of Par Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the company’s recovery from prior management’s involvement in the Generic Drug Scandal of the late 1980’s. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his AB, magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University. 
