Thermo Fisher, Megaware Partner on Bioequivalence Solutions

Thermo Fisher Scientific, Inc. has entered a strategic partnership with Megaware, a life science technology organization, to deliver a new bioanalysis/equivalence solution and joint support services for pharma, biopharma and CROs.

Under the terms of the collaboration, the two companies will market a new end-to-end software solution that provides bioequivalence functionality on a single platform in an effort to hasten and manage clinical trials. Market growth in generic drug production has created the need for fast efficient bioequivalence studies to meet FDA ANDA guidelines.

“The market for bioequivalence studies in India and the Far East is growing rapidly, and the Thermo Scientific Watson LIMS is seen as the de facto standard for bioanalysis/equivalence. Thermo Fisher’s unparalleled strength in this field complements Megaware’s in-depth experience with the CRO industry in the market,” said Dave Champagne, vice president and general manager of informatics for Thermo Fisher. “Our collaboration with Megaware will lead to the first total solution for this market, eliminating time and administrative burden from the bioequivalence challenge.”

The two companies will target the market for bioanalysis/equivalence studies, initially in India, due to its lower cost and rapid growth of clinical trials, and then across the Far East and other markets. The consultancy firm McKinsey estimates that U.S. and European pharmaceutical companies will spend $1.5 billion per year on trials in India by 2010.

“We have an established customer base in contract research and pharmaceutical companies in India, who are encouraged by the development of robust enterprise automation solution to enable them to gain FDA approval quicker,” said Ajit Nagral, president of Megaware. “We believe that Thermo Fisher, and Megaware, together deliver the best-in-breed solution for this market.”