FOR IMMEDIATE RELEASE: May 1, 2017
Coté Orphan LLC
Coté Orphan Expands Services Through Expertise
Dr. Michael Klein, former Director of Controlled Substances for the FDA joins Coté Orphan
Silver Spring, MD: Dr. Timothy Coté, Principal and CEO, is excited to announce and welcome Dr. Michael Klein to the Coté Team. Dr. Klein will head the Controlled Substances Division at Coté Orphan as its Director of Controlled Substances and will lead the newest strategic consulting services being offered by Coté Orphan LLC.
Dr. Klein joins Coté Orphan following a short consulting role as founder and CEO of Controlled Substances Scientific Solutions LLC, where he provided strategic consulting to drug companies that aimed to advance controlled substance drug approval through the FDA. Previous to Klein’s consultancy work, he led a successful tenure with the FDA, where he served in a number of leadership roles within the FDA’s Center for Drug Evaluation & Research (CDER). During his time with the FDA and CDER, Dr. Klein led initiatives in design and criteria for drug abuse studies, drafted scientific abuse potential reviews on new drug products, and provided expert input into product labeling and post marketing data needs.
Dr. Klein’s additional contributions to the Controlled Substances field include his most recent principal authorship of the 2017 FDA Guidance for Industry on Assessment of Abuse Potential of Drugs as well as numerous publications and guidance throughout his career. Dr. Klein also holds a Ph.D. in Medicinal Chemistry Pharmacy from the University of Illinois at the Medical Center and a Bachelor of Science in Pharmacy from the University of Illinois, College of Pharmacy.
To contact Dr. Klein at Coté Orphan and learn more about his consultant services in the Controlled Substances field, he can be reached at firstname.lastname@example.org or 202.759.0892/202.494.2850.
About Coté Orphan: Coté Orphan is a boutique full-service regulatory group with a laser focus on Orphan Drugs. From the lab to the market, we take your idea to the FDA and EMA for approval. With over 300 innovative biotechnology and pharmaceutical clients, Team Coté is led by Dr. Tim Coté, the former Director of the FDA’s Office of Orphan Products Development (OOPD).