Michael Best is pleased to announce the addition of Karl M. Nobert to the firm’s FDA practice group. He joins as senior counsel in the firm’s Washington, D.C. office.
With more than 15 years of experience in pharmaceutical and FDA regulatory strategy, Nobert joins the firm from ReCellerate Inc., a veterinary pharmaceutical company he founded in 2014 that develops cell-based drug products for commercialization. In his role as CEO and Regulatory Counsel, Nobert oversaw the company’s FDA Drug Approval Program for six pending applications for products intended for animal use, and also directed efforts to develop innovative cell-based technologies intended for the treatment and repair of various therapeutic conditions.
“Karl’s addition to our D.C. office and Transactions group greatly improves the work we’re doing in the pharmaceutical regulatory sector,” said Eric Callisto, the Chair of Michael Best’s Regulatory Practice Group. “His entrepreneurial spirit and depth of FDA expertise strategically expands our current bench of FDA regulatory attorneys. We’re excited to welcome him to the firm.”
In addition to acting as ReCellerate’s regulatory legal advisor, Nobert also served as a principal of The Nobert Group LLC, where he worked for five years focused on providing FDA regulatory counsel, developing approval strategies for human Rx drugs, ensuring food manufacturers are ready for retail product launch, drafting 510(k) medical device clearance notifications, reviewing OTC drug labels for regulatory compliance, and preparing clients for FDA facility inspections, among other responsibilities.
Nobert’s addition comes on the heels of other recent lateral activity at Michael Best, notably the addition of Mark Yacura to the FDA group in Washington D.C., and Marianne Dwight and Sharmila Kassam to the Transactions Practice Group in Austin.
Prior to founding ReCellerate, Nobert served as counsel at Squire Sanders LLP where he was involved in the expansion of the firm’s food and drug regulatory and life science practice areas and successfully obtained one of the first 510(k) device clearances of a handheld mobile medical device and corresponding software application.
Michael Best’s multidisciplinary FDA Regulatory subgroup is a leader in advising clients on various legal matters concerning statutory and regulatory compliance, intellectual property, environmental, and corporate concerns, among others. The firm also assists companies with issues involving multiple regulatory agencies, such as the interplay between FDA and the FTC in regulating advertising, the control of narcotics and other substances by FDA and the DEA, and the food safety system overseen by the U.S. Department of Agriculture and FDA.
Nobert received his J.D. from Villanova University School of Law. He also earned his M.B.A from Villanova University School of Business and his B.A. from the University of North Carolina.