This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
Recognizing the growing number of generic drug studies being conducted in India and the proliferation of contract research organizations in that country, Thermo Fisher Scientific this week announced that it is collaborating with Megaware to provide an automated software solution for bioequivalence studies.
Many manufacturers of liquid chromatography and mass spectrometers have noted over the past few years the increasing importance of the Indian market for research instrumentation. They have said that the generic drug market, in particular, has become a potentially lucrative opportunity for such instruments as more CROs set up shop in India.
HPLC and LC/MS-MS are the most commonly used instruments in the generic drug research and development market, said Ajit Nagral, president of Megaware, which focuses on laboratory automation and works with other vendors on software development. He told BioCommerce Week that there are other instruments that the collaboration could target as well, such as diagnostics and clinical instrumentation.
“With the Thermo Fisher-Megaware combined solution we provide an end-to-end automation of the entire bioequivalence process, starting from volunteer management and going on to protocol management, managing the clinic and the study itself, then going into bioanalytical and eventually doing the reporting,” said Nagral.
“What we found as a company and when we started working with Thermo Fisher Scientific was that many of these customers are looking to automate the entire process, whether it’s to improve their throughput or to get a better handle on compliance,” he said. “Those are a couple of the drivers.”
There are solutions that target specific parts of the bioequivalence process but none that offers an end-to-end package, such as the one developed by Thermo Fisher and Megaware, said Nagral. “Some of the higher-end [LC] instrumentation would have its own software … [and] lower-end instruments may not even have standard software,” he said, pointing to limitations of currently used software.
“In emerging markets like India these companies don’t have large IT staff, so the closer to a complete solution they can get from one vendor will lower the amount of support headaches,” said Kim Shah, director of marketing and business development for informatics at Thermo Fisher Scientific.
“There’s also the issue of standardization in emerging markets,” added Nagral. “It’s easier to train people and it’s easier to manage the workforce.”
Nagral said the software would be an open system and would work with Thermo Fisher’s instruments as well as those made by competitors. “We recognize that these organizations are going to have a mixture of instrumentation, whether it’s Thermo Fisher’s or somebody else’s,” said Nagral.
Westborough, Mass.-based Megaware has focused on the life sciences market for 16 years and the CRO space, in particular, for the past five years, said Nagral. The firm has operations in Mumbai, India, that work with customers and collaborators in that country.
“Particularly when it comes to bioequivalence, we understand this process inside out,” he said. “I have people on staff who are not only software people but who are also scientists who come from the industry … and who work primarily with generic companies in India.”
“In emerging markets like India these companies don’t have large IT staff, so the closer to a complete solution they can get from one vendor will lower the amount of support headaches.”
Nagral used to head NuGenesis, which was spun out of Megaware in 1996 and was acquired by Waters in 2004.
Primary and Secondary Markets
Thermo Fisher is one of several LC and MS vendors to seek business from the growing generics and CRO markets in India.
During their third-quarter conference call last October, officials from Waters said they were seeing a lot of “new activity take place” in sales to CROs (see BioCommerce Week 10/25/2006). Likewise, Applied Biosystems’ executives said last summer that the growing trend of outsourcing drug studies to CROs had led to surging mass spec demand in emerging markets, such as India and China (see BioCommerce Week 8/2/2006).
“The generic companies are doing really well,” said Nagral. “And the bioequivalence process lends itself very well to automation, [because] it’s a well-defined process.”
He said five years ago generic companies worldwide were doing fewer than 200 studies at one time, but now some of the larger CROs are doing more than 100 bioequivalence studies each. “Automation is becoming more and more critical, which is why I think the timing is right” for the new software product.
The companies intend to eventually roll out the solution in more industrialized markets, but the Indian market, with its proliferation of generic drug firms and CROs, was the logical starting point, said Nagral and Shah.
“It is a good fit for the developed markets as well,” said Shah. “It just so happened because of the current excitement in the Indian market specifically, that is where we essentially found and solved the problem first. But very soon we’ll want to move beyond that into the other markets.”
The firms had already launched the product in India, and have targeted the Asian market next.
Thermo Fisher usually holds its large informatics user group meetings in the fourth quarter and expects to show users the new product at that time. A US launch could come as early as the first quarter of next year, according to Shah.