Overview


Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.

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Results


  • Worked with innovator drug companies to develop strategies for approval of new drug applications (NDAs), including those filed as 505(b)(2) NDAs and biologics license applications (BLAs) (including biosimilar products filed as 351(k) applications. The approval strategies included developing clinical strategies, pre-investigational new drug applications (INDs) and pre-NDA/pre-BLA FDA meetings.*
  • Worked with companies to develop strategies for approval of combination drug/device and combination drug products, including clinical programs, for example, an artificial pancreas incorporating marketed glucose monitors and insulin pumps and smartphone applications and algorithms, in view of FDA’s mobile medical application and information technology guidance.*
  • Worked with innovator and generic companies to address and evaluate FDA’s filing, complete response and other regulatory correspondence/compliance letters.*

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Community


  • Co-Chair, Intellectual Property Community (Section), DC Bar
  • Executive Committee Member (Chair 2014-2020), Food, Drug and Cosmetic Law Section, New York State Bar Association
  • Member, (Co-Chair 2017-2020), Committee on Cannabis Law, New York State Bar Association

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Credentials


Education
University of Maryland, BS (Biochemistry), 2004
The George Washington University Law School, JD, 1991
The George Washington University, BA, cum laude with Special Honors in Economics, 1988

Admissions
District of Columbia
Maryland
New York

Brian J. Malkin

Insights & Events / Media

Virtual Event / McDermott Event / October 20 - November 17, 2020

Webinar / Speaking Engagements / October 15, 2020

Virtual Event / McDermott Event / October 7 - 29, 2020

Webinar / Speaking Engagements / September 14-18, 2020

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