Speakers

Brian Malkin is an Associate Counsel at Teva Pharmaceutical Industries (“Teva”) where he supports Research and Development (R&D), Regulatory Affairs (RA), Commercial, Quality, and other client groups by counseling on FDA regulatory law and strategy including expedited development pathways, labeling and safety issues, and pre-and post-approval development challenges. Brian serves as a Center of Excellence in regulatory law, including on issues arising under the FDCA, PHSA, BPCIA, PREA, BPCA, the Hatch-Waxman Act, the Orphan Drug Act, the User Fee Acts, and other laws. Brian represents Teva in informal and formal dispute resolution and litigation and develop advocacy strategies, submissions, appeals, and correspondence. Brian sits on R&D project teams across therapeutic areas to advise on legal and regulatory issues and post-approval developments for innovative and biosimilar pharmaceutical products. Brian develops and maintains relationships with health authorities, external facing organizations, trade associations, and pharmaceutical industry counterparts. Brian provides training for RA, R&D, and commercial functions on FDA legal and regulatory issues.

Brian has more than 30 years of FDA law and policy experience and over 20 years intellectual property law experience, including 9 years at the FDA (Office of the Commissioner and the Center for Drug Evaluation) and a number of boutique FDA and IP and international law firms in associate and partner capacities, where his practice focused on generic/biosimilar pharmaceutical, innovative/hybrid and biologic products, including medical devices and other FDA-regulated products. Brian has also supported the pharmaceutical and biotechnology community by mentoring pharmaceutical and biotechnology companies (e.g., MassChallenge) and serving as an adjunct professor at a variety of masters and legal programs in addition to being a frequent speaker at professional conferences and training programs. Brian am an Executive Committee member of the New York State Bar Association’s Food, Drug and Cosmetic Law Section and the Co-Chair of the Intellectual Property Community (Section) for the DC Bar Association.