Ten years after it launched its first office in Japan, contract research organization (CRO) Parexel announced a new office in Hyderabad, India. A city of 8 million in the heart of the subcontinent, Hyderabad is the sixth largest in India and a leading center for IT and biotechnology.

“Our foray into India, we started four or five years ago,” says Josef von Rickenbach, the company’s chairman and CEO. He met a few trade journalists at the 2007 annual meeting of the Drug Information Association (DIA). During the meeting, the Waltham, Mass. company celebrated its 25th anniversary.

A co-founder, von Rickenbach noted that the company had expanded its ownership of a joint venture with India’s Synchron. That entity does Phase II-III studies in India.

India’s recent efforts to make itself more attractive to industry were one factor in the U.S. company’s decision, von Rickenbach said. “The regulatory environment was not conducive to clinical trials until recently,” he said. “The regulations have changed. You need a motivated government, which I believe they have now.”

Population Equation

Is he worried about the genetic variances between the population of India and the U.S. and Europe? Hardly. Von Rickenbach said human genome research had shown genetic variation between ethnic groups and individuals to be minimal. “We are not as different as people thought or expected or hoped we might be,” he mused.

The ability to easily recruit patients is one of the allures of India, von Rickenbach acknowledged. “Patients are not the problem,” he says. “They probably won’t be for a long time.”

If They Build It

But roads, utilities and telephone networks are another matter. Perhaps one Indian citizen in ten has a landline telephone, according to U.S. estimates. “These things are completely inadequate to sustain the ambitions that seem to be there,” he said. “You would need much better infrastructure.”

In Hyderabad, von Rickenbach said, there could be an opportunity for outsourcing activities related to both paper- and image-based clinical trial data: “The growth potential for that could be much greater,” von Richenbach said.

Growing The Community

There are perhaps 300 licensed investigators ready to participate in industry-funded trials in India, roughly equivalent to the number in Argentina. But an unidentified firm is specializing solely in training sites and investigators. “That’s very reassuring,” von Rickenbach says. “It gave us some comfort.”

In general, von Rickenbach said, he expects the community of clinical trial professionals in India to blossom, with participants from private hospitals, industry and government learning from each other. “We all kind of grow together,” he says.

Don’t Ask, Don’t Tell

The reporters had been summoned to the conversation with von Rickenbach at an hour of the morning during which a) business is routinely transacted and b) journalists are typically in their pajamas. Several invited reporters never quite arrived to enjoy the breakfast Parexel provided.

But two journalists asked von Rickenbach about lessons learned after a controversial London trial on behalf of TeGenero. He declined to comment, citing litigation that the company is trying to settle. Other Parexel executives steered the conversation back to India—and another opportunity for dialogue between an embattled industry and the media had slipped away.