Michael Langley, DVM, MBA, RAC Joins the Anson Group as a Regulatory Consultant
Indianapolis, IN (Vocus) January 30, 2010 -- The Anson Group announces today the addition of Dr. Michael Langley to its regulatory consulting (www.ansongroup.com) practice. Dr. Langley is joining Anson Group 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 and 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 (www.ansongroup.com) at Eli Lilly. His experience includes establishing research priorities and timelines, successfully leading teams through US and EU marketing applications.
As the Director for Regulatory Affairs for Eli Lilly, Dr. Langley led project teams in label negotiations with the FDA, and several sNDA (www.ansongroup.com) and sBLAapplications which resulted in approvals. Additionally, he has successfully guided several IND (www.ansongroup.com) submissions, and also worked with FDA officials to remove a clinical hold placed on one molecule.
“As we further expand the depth and breadth of our regulatory team, the addition of Dr. Langley’s oncology and CVM experience significantly contributes to our goal of providing the most experienced personnel needed to meet the exacting demands of every client project.” states Colleen Hittle, RAC, Managing Partner.
About Anson Group
Headquartered in Carmel Indiana, Anson Group is a minority-owned (www.ansongroup.com) 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 (www.ansongroup.com) start-ups.
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