PHILADELPHIA—Thermo Fisher Scientific Inc. has entered a new strategic partnership with Megaware Inc., a life science technology organization with offices in Westborough, Mass., and Mumbai, India, to deliver a bioanalysis and equivalence solution and joint support services for pharmaceutical, biotech and contract research organizations (CROs).
The two companies will initially target the market for bioanalysis and equivalence studies in India, followed by the Far East and later other markets. The market in India for clinical trials is growing particularly fast because the average cost of trials is significantly lower than in the United States and Europe, the companies note. In fact, the global management consulting firm McKinsey & Company estimates that U.S. and European pharmaceutical companies will spend $1.5 billion per year on clinical trials in India by 2010.
Under the terms of the deal, Thermo Fisher and Megaware will offer a new comprehensive software solution that is said to provide bioequivalence functionality on a single platform to help speed up and manage clinical trials. Rapid market growth in generic drug production is driving the requirement for fast efficient bioequivalence studies to meet FDA's Abbreviated New Drug Application guidelines, the companies point out.
"A lot of the work that people do in this area has been traditionally handled manually and with specific solutions for specific needs and steps in the process," says Ajit Nagral, president of Megaware. "What is different here is that for the first time, we put together a true end-to-end solution. As you can imagine, what this does is increase throughput and productivity, reduce transmission errors, bring greater levels of compliance and more standardization of bioequivalence processes, among other benefits."
Thermo Fisher and Megaware plan to jointly sell, market and support the new solution in the field, with Thermo Fisher bringing its bioanalytical expertise to the partnership and Megaware delivering the end-to-end technological focus combined with on-the-ground market knowledge, particularly in India.
"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," says Dave Champagne, VP and GM of informatics for Thermo Fisher. "Thermo Fisher's unparalleled strength in this field complements Megaware's in-depth experience with the CRO industry in the market. Our collaboration with Megaware will lead to the first total solution for this market, eliminating time and administrative burden from the bioequivalence challenge."
Although pharmaceutical companies are often slow at migrating from older solutions to newer ones, those dealing with bioanalysis and equivalence work seem more eager than most to adopt an end-to-end solution like this and to do so quickly, says Kim Shah, director marketing and business development at Thermo Fisher Scientific Informatics. This is particularly true in India because the rapid market growth.
"By the end of this year, when the offering has been fully rolled out and there are a number of customers on board in India and the Far East and the proof of concept is well established, we'll be looking to roll it out in Europe and the States in the first quarter of next year," Shah says.