The opening of the Progenitor International Research’s new office in Buenos Aires, Argentina, a year ago signaled the beginning of a fundamental change to the company’s business model. Previously, Progenitor had worked exclusively as a CRO composed of teams in emerging markets who worked under a coordinated platform to deliver global development services. Progenitor’s office in Argentina represents the first organic growth of the company in an emerging market.

Progenitor International Research is an emerging market contract research organization (CRO) founded in 2005 with headquarters in Deidesheim, Germany. The company’s global management functions reside in Europe, and clinical research is conducted in 12 countries—Argentina, Chile, Peru, India, China, Korea, South Africa and countries in Southeast Asia.

Progenitor conducts clinical research in South Africa and in countries in Southeast Asia through partnerships, but the company is growing organically in the other countries in which it operates. The company has 800 clinical research professionals working together with Progenitor in emerging markets who have experience on more than 500 clinical trials.

CenterWatch caught up with three key members of the operations team at Progenitor International Research at the DIA EuroMeeting in Barcelona to find out how the new model was working and what plans the company had for growth in 2008 and beyond...

“We’ve experienced substantial organic growth over the past 12 months within Progenitor. After launching operations in Argentina last year, we’ve grown that organization and incorporated and launched operations in Chile. We’re starting our first breast cancer study this week in Chile. We’re staffing projects in Peru—especially oncology projects. We have a headcount of 25 in Latin America, and that’s growing,” Renée Moore, Ph.D., president, global operations, Progenitor International Research, GmbH.

The company benefits from management with long-term experience it has in place in the Latin America region. “On the team in Latin America, we have a very strong project manager with 15 years of experience and another with more than 25 years of experience, which is important for that region because it’s not easy,” said Patricia Moenaert, vice president, global operations, Progenitor International Research, GmbH.

Progenitor has added key personnel to its operations staff in the past year, including Patricia Moenaert who was hired in April 2007. She brings 29 years of experience in the pharmaceutical industry and works out of the company’s Barcelona, Spain, office where she had worked for the largest pharmaceutical company in Spain for the previous 14 years. All local offices globally report to Moenaert.

“We’re very excited about the experience that Patricia brings to the company, and the experience specifically in working across emerging market clinical trials, and her ability to globalize our processes and make Progenitor truly a globalized, quality clinical research organization,” said Moore.

Ambar Vaidya, M.Sc., MBA, assistant vice president and head of operations, Progenitor Clinical Research Pvt. Ltd., joined the company in November 2007 to head India office operations. Vaidya formerly worked at Ahmedabad, India-based CRO Lambda Therapeutics Research and prior to that at Quintiles where he was one of that company’s first employees in India in late 1996. He came from a background in the Indian pharmaceutical industry.

Vaidya discussed a few of the changes in clinical research conduct in India since 1996.

“India has seen vast growth, as far as emerging markets are concerned. The GCP [Good Clincal Practice] guidelines started in 1996. I remember when we started way back, we had a difficult time convincing doctors to learn GCP. Now it is not a situation, and everybody knows about it. What has recently changed is that, while the first exposure to humans is not allowed in India, a parallel phase I is now allowed. So, for a molecule that is discovered outside India, if the first exposure to humans is documented—if you provide all the documents—then we can carry on with a parallel phase I in India, which is a good, positive step. [The regulators] are constantly trying and they are consciously trying to improve,” said Vaidya.

Moenaert added that the situation is similar in Latin America.

“The regulatory are getting more organized. They are getting more staff because they have more demand. They know if they don’t add staff and get organized, well the delays will be the same as in other countries and they will be less attractive. India is the same. It has to get organized too. Regulatory takes time to get organized,” said Moenaert.

Progenitor has big plans for its Indian operations. The company has a database of ICH GCP-trained investigators in Sri Lanka and Bangladesh and plans to manage clinical research conducted in those countries out of its India office.

“We have just signed an office lease in Ahmedabad, which will house 25 in India. Our current plans are to be at 25 by the end of this year,” said Moore.

The company is also planning to offer its own data management services out of its India office.

“We are actively planning to have data management in India. We expect to go live in the first quarter of 2009,” said Vaidya.

Progenitor plans to continue its organic growth in Latin America by incorporating in Brazil and opening an office there later this year. Beyond that, Progenitor is looking into conducting clinical research in the Middle East and possibly North Africa.

Moore summed up Progenitor’s niche thus: “Progenitor fills the space between the global CROs and the local CROs by comprehensively covering emerging markets. Currently if a pharmaceutical company needed to do a clinical trial in India, China and Argentina, they’d have to go to a huge global CRO or they would have to work with 10 different little local CROs, so we provide the option of comprehensive coverage. It’s the only alternative. I don’t know if anybody else is doing it the way we’re doing it.”