Anson Group adds Michael Langley, DVM, MBA, RAC as a Regulatory Consultant
(INDIANAPOLIS IN) January 27, 2010 – The Anson Group announces today the addition of Dr. Michael Langley. Dr. Langley is joining Anson Group as a Regulatory Consultant after his recent retirement from Eli Lilly and Co. He has worked in the pharmaceutical industry since 1983, and has had a range of responsibilities for a broad variety of pharmaceutical products.
Early in his career, Dr. Langley worked for Elanco Animal Health, a Division of Eli Lilly, in a number of roles with increasing responsibilities including market research manager, project manager of animal health research, Director of European Regulatory and Clinical Affairs, and finally director of clinical research.
In 2002, Dr. Langley transitioned from animal health products to human pharmaceuticals at Eli Lilly. His experience includes establishing research priorities and timelines, and successfully leading teams through US and EU marketing applications.
As Director of Regulatory Affairs for Eli Lilly, Dr. Langley led project teams in labeling negotiations with the FDA, and several sNDA and sBLA applications which resulted in approvals. Additionally, he has successfully guided several IND submissions, and also worked with FDA officials to remove a clinical hold.
“We are very pleased to add Mike to our team,” states Managing Partner Colleen Hittle, RAC. “As we further expand our regulatory team, the addition of Dr. Langley’s oncology and CVM experience significantly contributes to our goal of providing the most experienced personnel to every client project.”
About Anson Group
Headquartered in Carmel Indiana, Anson Group is a minority-owned independent consulting organization with over 14 years experience as a leading provider of services and strategies for FDA product approval and compliance for devices, drugs, biologics, and combination products. Anson Group’s team of experienced industry experts tailors both enterprise strategies and clearly-defined action plans that help its clients address crucial issues throughout the product life cycle. Anson works with clients in the United States, Europe, and Asia, from global pharmaceutical manufacturers to small pre-IPO or VC biotechnology and medical device start-ups.
