McDermott Will & Emery, the nation’s leading health law firm, announces Brian Malkin has joined as partner in the FDA practice of its Health Industry Advisory group based in Washington, DC. Brian’s practice complements McDermott’s broader life sciences and healthcare capabilities with decades of experience and perspective on critical regulatory and strategic business issues that life sciences, pharmaceutical and biologic companies seek in bringing new products to market and managing product life cycles.
“Aligning FDA regulatory and intellectual property strategy for drug development is more critical than ever and Brian’s unique background will give our clients a strategic advantage,” said Eric Zimmerman, head of McDermott’s Health Industry Advisory practice group and a Washington, DC-based partner. “Incorporating Brian’s practice into our existing FDA practice further strengthens our ability to assist innovators through all stages of approval.”
“As the market and regulatory landscape evolves to focus on novel therapies, including orphan drugs and biosimilars, our team needs to deftly navigate the complex regulatory, policy and strategic business considerations for this space. Brian is a thought-leader on these issues and has helped several companies successfully bring life-saving products to market. We’re thrilled to join forces, added Vernessa Pollard, head of McDermott’s FDA practice and a Washington, DC-based partner.”
Brian counsels pharmaceutical and biologic clients on FDA regulatory matters and intellectual property law, with an emphasis on patent strategy and litigation. His position at the intersection of FDA regulated products and patent law makes him an invaluable partner to drug developers, biotechnology clients, medical device companies and cannabis companies as they protect their innovations, bring their products to market and pursue transactional opportunities.
He is a key advisor regarding FDA regulated drugs development strategies and patent strategies, including: New Drug Applications (NDAs) and orphan/specialty drugs; 505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products; biologics and biosimilars; and cannabis-derived products. Additionally, he is an experienced litigator of Hatch-Waxman Act cases for both pharmaceutical and biotechnology clients and a strong partner in the boardroom, providing FDA and IP due diligence for deals and transactions in the life sciences space.
“Joining McDermott’s industry-leading health platform and becoming part of its talented FDA team will no doubt be an asset to my clients,” Brian added. “I’m also thrilled to bring my experience to McDermott’s existing clients as we work to expand their drug and biologics presence by guiding them through the complex FDA regulatory environment.”
Brian holds a JD from The George Washington University Law School and a BA also from The George Washington University. While practicing law, Brian earned a BS in Biochemistry from the University of Maryland.
McDermott Will & Emery is the nation’s leading health law firm. The Health Industry Advisory group is the only health practice to receive top national rankings from U.S. News – Best Lawyers “Best Law Firms,” Chambers USA, The Legal 500 US, and Law360. The practice was also recognized by Chambers as “Health Team of the Year” in 2010, 2013, 2017 and 2019. McDermott has held the top spot in PitchBook’s League Tables as the most active firm for healthcare private equity since 2017.
McDermott Will & Emery partners with leaders around the world to fuel missions, knock down barriers and shape markets. Our team works seamlessly across practices, industries and more than 20 locations to deliver highly effective—and often unexpected—solutions that propel success. More than 1,200 lawyers strong, we bring our personal passion and legal prowess to bear in every matter for our clients and the people they serve.
SOURCE McDermott Will & Emery