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Brian leads the firm’s FDA regulatory teams. He has more than 20 years of food and drug law practice and over nine years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian’s regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies.

Immediately prior to law school, Brian worked as a legislative correspondent in the U.S. Senate Committee on Labor and Human Resources. He began his legal career as a regulatory counsel at the U.S. Food and Drug Administration, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At FDA, he focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration). Brian’s work resulted in new product approvals as well as new industry guidance documents and policies, such as the animal efficacy rule for counter-terrorism products.

Following several years of practice in an FDA law firm, Brian recognized an unmet need to understand both food-and-drug and intellectual-property law for lifecycle management and diligence, particularly concerning products affected by the Hatch-Waxman Act, such as generic and 505(b)(2) new drug applications. As a result, Brian returned to university to obtain a Bachelor of Science degree in biochemistry. Prior to joining McGuireWoods, he practiced for more than nine years at an intellectual property law firm, where he worked on a variety of new product evaluations, FDA and patent litigations, due diligence projects, patent prosecutions, and licensing and commercial transactions.

Given his particular experiences, Brian frequently is asked to speak and write on numerous FDA- and intellectual-property-law issues, including clinical trials and new product development for complex and challenging products, such as biotechnology products, orphan drugs, generic drugs, 505(b)(2) new drug applications, patent-term restoration under the Hatch-Waxman Act, biosimilar products, tobacco products, patent-term adjustment, risk management and due diligence.

Community

Brian has been actively involved in promoting the biotechnology community locally, nationally and internationally. Locally, Brian is working with BioBuzz to help stimulate a more active bioscience workforce and a more dynamic bioscience industry throughout Maryland, Virginia, the District of Columbia and beyond. In February 2014, Brian worked with the Montgomery County Department of Economic Development to present a program on “Innovative Strategies for New Product Development.” Brian also is working with McGuireWoods to sponsor the 2014 Biomanufacturing Technology Summit (biosimilars) to be held in June 2014 by the Institute for Bioscience and Biotechnology Research at the University of Maryland. In addition, Brian served on a board of judges for a local entrepreneur contest for a chemical and life sciences class at the University of Maryland’s Mtech Biotechnology Research and Education Program. He also currently mentors two health law students through a program coordinated by the Maryland State Bar Association’s health law group. Nationally and internationally, Brian has networked with biotechnology groups in Maryland, Massachusetts and Washington state, as well as with the Biotechnology Industry Organization. He also has presented at conferences featuring topics such as orphan drugs, biosimilars, and updates from FDA’s Center for Biologics Evaluation and Research. Brian was proud to join McGuireWoods in sponsoring and participating in Life Science Nation’s Redefining Early State Investments Conference, which was held in Boston in March 2014 and featured early-stage life sciences companies, investors and service providers. In November 2013, Brian co-presented a variety of programs for a Korea-Maryland USA Bio Expo in Rockville, Maryland, on the following topics: (1) current good manufacturing practice (cGMP) and its role in regulatory drug quality, (2) current drug shortages and orphan drug disease pharmaceutical development, and (3) innovative strategies for new drug development/biobetters.

Blogging

Brian is a co-editor of McGuireWoods LLP's FDA Life blog which covers news and trends impacting the FDA and life science industry.

Andrew Koopman works with investors and entrepreneurs to facilitate the formation of new life science companies that focus on the development and commercialization of NYU technologie, as well as working with these companies to obtain the capital and human resources for growth. In addition to more than a decade in academic technology transfer, Andrew has 16 years of varied experience in the biotechnology industry. He has held scientist, laboratory supervisor, and project manager positions in the course of his employment at two successful biotechnology startup companies, as well as Johnson & Johnson and Hoffman-LaRoche. During this period he was involved in the development of several therapeutic and diagnostic products which are currently on the market.  Prior to joining the NYU Office of Industrial Liaison, Andrew was the Managing Director of Biomedical and Biotechnology Industries at Beroff Associates, a merchant investment banking and strategic advisory group. He has also provided consulting to a number of startup companies, investment groups, and public agencies regarding technology assessment, market analysis, business development, and financing strategies. Andrew is an active board member and advisor of Zero Gravity Solutions, Inc. (Pink Sheets: ZGSI) and Applied Glycan, LLC.