Contract research organization Quintiles is partnering with India’s largest hospital group to open Quintiles’ first phase I clinical trial unit in India.
The new 50-bed unit will open early next year on the Hyderabad campus of Apollo Hospital Group, Quintiles’ partner in this venture. Apollo was selected after Quintiles met with the clinical pharmacology departments at various Indian hospitals.
“They really are very forward thinking. They are very involved in technology, they’re very involved in IT, telemedicine and things like that. We began negotiations and discussions with them, and it was agreed that it would be the ideal opportunity for a joint venture,” said Eddie Caffrey, Quintiles’ senior vice president, global phase I.
The Hyderabad unit will be Quintiles’ fifth facility in India, but the first offering phase I services. The CRO’s existing offices in India— located in Mumbai, Ahmedabad, Bangalore, and Delhi—will provide key services to the phase I unit, such as data management and cardiac safety, Caffrey said.
Quintiles has other phase I units in Kansas, England and Sweden and had been looking to open another in a new location. India was selected based on the CRO’s existing presence in that country, the strength of Apollo as a partner and client demand for phase I services in that region.
“I think many of our larger clients looked at India, continued to do phase II/phase III trials in India, but, from a phase I point of view, haven’t found a group with the expertise that they would want to have in order to do phase I studies there. We have a number of clients already who have expressed an interest in working with us once we are up to speed and have the staff trained, etc.,” Caffrey said.
India’s regulations governing clinical trials do not allow first-in-man studies to be conducted on any molecules developed outside of India, Caffrey said, so for now, Quintiles’ new phase I unit will focus on bioequivalence and drug-to-drug interaction studies in healthy volunteers.
“It is not our intention at this point to do first-in-man there, but obviously as the regulations change and we gain more experience in India—provided the regulations allow— we would look to go in that direction,” Caffrey said.
Quintiles plans to grow the new unit to 100 beds within the first three years, depending on client demand. The company is still determining how many employees will be required when the unit opens in 2010.
Quintiles and Apollo list their combined investment for the new unit at $6 million, but Quintiles would not comment on the amount of its individual investment.