||April 27, 2010
||Dr. Michael P. Thien
||Senior Vice President, Global Science, Technology & Commercialization, Merck Manufacturing Div., Merck & Co., Inc.
The AIDS pandemic continues to be a huge global health challenge. In the US, EU and Japan, those living with AIDS have been able to manage their disease through the use of modes of therapies discovered in the early- and mid-90's. Unfortunately, these populations are now showing resistance to these therapies. In addition, in the Developing World, many people with HIV/AIDS receive no therapy at all. The world's AIDS populations need new and different types of therapies.
Merck has recently received approval for ISENTRESS, an HIV therapy based on a new mode of action: inhibition of HIV integrase. The commercialization of this new and effective therapy has faced a variety of technical challenges that have been met by Merck's chemical engineers. This talk will describe the global context of the AIDS pandemic, the technical challenges faced by Merck's engineering team in bringing this to market, and the special challenges that are presented by bringing this therapy to the Developing World.
Dr. Thien has worked in new product and process development at Merck for 20 years. After receiving his B.S. in Chemical Engineering from Caltech (1982), an Sc.D. from MIT in biochemical engineering (1988) and a post doc at the Whitehead Institute of Biomedical Research, Mike joined the Merck Research Labs, working in vaccines and recombinant proteins. In 1991, Dr. Thien led a process development group for compounds made by organic synthesis, continuing in that capacity until 1997. During this time Dr. Thien was named a Merck Research Labs “Divisional Scientist” as a result of his development and plant start-up work on CRIXIVAN, one of the first HIV protease inhibitors in the marketplace. Between 1997 and 2003 Mike held roles of increasing responsibility including Senior Director of chemical pilot plant operations and Executive Director of chemical process development. Dr. Thien was named Vice President, Process R&D in 2003 covering analytical and engineering development of Merck's small molecules.
In 2005, Mike co-led a team to re-define the paradigm by which Merck brings new drugs to market. This effort resulted in the creation of a new function at Merck: the Global Pharmaceutical Commercialization organization. This group includes engineers and analysts from both R&D and manufacturing and reports up through manufacturing. In 2005 Mike was appointed to head this group and was made responsible for both late stage process development and the making of clinical and commercial launch supplies for all of Merck's new drugs, with responsibility for chemical and formulation development and manufacturing efforts at facilities in New Jersey, Pennsylvania and Ireland. In October of 2008 Mike took on the additional responsibilities of leading technical support for Merck's in-line small molecule and vaccine products. In April of 2009, Dr. Thien was appointed to Senior Vice President, Global Science, Technology and Commercialization where he became additionally responsible for developing Merck's late stage process development and technical manufacturing support capabilities for therapeutic proteins. Mike has made numerous invited conference presentations and guest lectures on the pharmaceutical industry and sits on the Advisory Board for MIT's Department of Chemical Engineering and chairs a similar board for the Department of Chemical and Biomolecular Engineering at Tufts University.