Global law firm Baker McKenzie has been named FDA Regulatory Firm to Watch in the annual Americas LMG Life Sciences Awards, which recognize the individuals and companies behind the most innovative and challenging Life Sciences work of the past year.
The Firm to Watch Award is given to select firms that have made notable strides in the life sciences industry through growth, high profile client engagements and high profile star partners moving to the firm. Baker McKenzie's North America FDA practice is led by Veleka Peeples-Dyer, who was short-listed for FDA Attorney of the Year in the LMG Awards this year and has been listed as a LMG Life Sciences Star for FDA Regulatory: Pharmaceuticals in 2018 and 2019. The practice is focused on assisting clients with a broad range of regulatory, compliance and enforcement matters for FDA-regulated products, including drugs, medical devices, food and cosmetics. The team represents clients in research, pre-launch, launch, commercialization and licensing activities for first-in-class products and other innovative products.
"We are very pleased to receive this recognition, which speaks to our market-leading capabilities for companies seeking to navigate the complex FDA regulatory environment," said Randall Sunberg, chair of Baker McKenzie's North America Healthcare & Life Sciences Group. "Our practice continues to grow as many of our Life Sciences clients seek regulatory support to develop and bring to market innovative therapies, treatments and vaccines, including to combat COVID-19."
Highlights of the group's work over the past year have included assisting companies in launching new products and new indications, including assisting with submissions to the FDA, global pharmacovigilance agreements and M&A post acquisition integration work for some of the largest acquisitions and collaborations in the industry; extensive advertising, labeling and promotional work for companies ranging from emerging to globally-established corporations; assisting with complex collaboration and licensing deals; and in this COVID-19 pandemic environment, matters dealing with emergency use authorizations, manufacturing and distribution issues affecting global supply chains, cross-jurisdictional regulatory issues, BARDA and EUAs, among other issues.
Baker McKenzie's FDA practice also includes Partner Khelin Aiken who was a finalist for the 2020 FDA Rising Star Award from LMG Life Sciences. Khelin leverages her deep understanding of the US Food, Drug and Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the FDA to help clients develop and achieve their strategic business objectives.
Winners of the LMG Life Sciences Awards were selected following a nomination process and are based on interviews and surveys of lawyers active in the Life Sciences sector.
About Baker McKenzie's Healthcare & Life Sciences Group
As one of the first law firms to advise life sciences companies on their global expansion 60 years ago, our deep knowledge in the industry, honed over the past six decades, is rooted in our corporate DNA. Our group is one of the largest of any international law firm comprising over 800 lawyers in 47 countries. Many of our team members dedicate more than 50% of their time to industry clients - including in the top 10 largest healthcare and life sciences markets in the world.
Our client base comprises big pharma, biotech, medical device companies, medtech and digital health companies, CROs, healthcare information providers, hospital systems, universities, non-profit institutions, veterinary drug companies and other service providers/companies in the life sciences and healthcare ecosystem. We have worked on a broad range of products and breakthroughs for clients including complex and innovative collaboration and strategic alliance structures for new technologies, drugs, biologics, biosimilars and devices, in areas such as nanotechnology, cell and gene therapy and editing, vaccines and other drug development, as well as medical foods, dietary supplements, and other consumer products that are regulated by the FDA.