State of Florida; Washington, DC
Mergers and Acquisitions
FDA & Life Sciences
Licensing and Technology Transfer
Latin America and Caribbean Practice
Catholic University of America (J.D.); University of Illinois, Abraham Lincoln School of Medicine ( M.D. Candidate); The University of Chicago (BA, Biology)
English (Native); Spanish (Native)
Mr. Asebey's experience includes counseling clients on complex regulatory strategies and product approval/clearance matters as well as representation of clients before the FDA, FTC, USDA and EPA. He has managed pharmaceutical, medical device and food product recalls and regularly provides enforcement defense services to food and life science companies. Mr. Asebey counsels clients and performs regulatory due diligence in support of financings, public offerings and M&A transactions. He advises stem cell and regenerative medicine companies on regulatory compliance matters and has also advised telemedicine and health IT companies on the intricacies of FDA regulation of Medical Device Data Systems (MDDS), mobile medical apps, and clinical decision support (CDS) software. Most recently, he has advised companies in the CBD (hemp) and THC (marijuana) space with regard to State and Federal regulatory compliance, advertising and labeling compliance and has led numerous negotiations in support of corporate transactions.
Mr. Asebey assists clients in the preparation of FDA submissions, including NDAs, ANDAs 510(k) premarket notifications and NDIs and has in-depth knowledge on implementation of and compliance with the Food Safety Modernization Act (FSMA). He has advised the governments of Colombia and Japan on FDA regulatory compliance matters and has led FDA regulatory seminars in Osaka, Nagoya, Tokyo, Bogota, Cali, Medellin and Barranquilla. He currently serves as outside counsel to a medical device and two in vitro diagnostic companies.
Previously, Mr. Asebey was a partner in the Health Care and Life Sciences practice group at Jones Day where he advised life science and food clients on acquisitions ranging from $240M to $1.9B. Early in his career, he worked as a patent and licensing advisor at the U.S. National Cancer Institute (NCI) at NIH where he evaluated inventions for patentability, drafted and negotiated CRADAs and sponsored research agreements and patent licensing agreements with pharmaceutical and biotechnology companies. After leaving the NCI, Mr. Asebey founded and ran a drug discovery company specialized in discovering and developing novel anti-cancer compounds derived from natural products.
Mr. Asebey earned a Juris Doctor from the Catholic University of America (Washington, DC). He was an M.D. candidate at the Abraham Lincoln School of Medicine at the University of Illinois where he conducted research on cAMP-Protein Kinase binding and was awarded the Dean's Scholarship for Undergraduate Research. Mr. Asebey studied molecular biology at the University of Chicago and worked in the laboratory of Prof. Kwen Sheng Chiang and was awarded the Edmundson-Garber Scholarship for Undergraduate Research.