| April 12, 2007 : - Globalization is often pretty simple. A large western company travels to a distant land, hires the local workforce, and resells its labor with a suitable markup. |
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| There's just one problem with this scenario: Who needs the large western company? Isn't it just adding a crusty layer of overhead and management to the final cost of the trial? Why not just cut that out? |
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| That's the plan of contract research organization (CRO) Manipal AcuNova Life Sciences of Bangalore, India, and Kiecana Clinical Research, a CRO based in Warsaw, Poland. They're partnering strategically, with an eye toward setting up a synchronized, similarly trained network of investigators in India and Eastern Europe. |
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| Clinical Bedfellows |
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| The news was announced at this year's Partnerships with CROs conference, organized by the Institute for International Research (IIR). |
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| The key idea, both companies say, is that trials comprised solely of Indian or Polish patients will not always be acceptable for regulatory or pharmacogenetic reasons. Using a harmonized set of standard operating procedures, AcuNova and Kiecana will be able to recruit large numbers of patients in three major geographical regions after a planned Latin American subsidiary (to be established by AcuNova in Brazil or Argentina) rounds out the partnership. |
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| Regional Networks |
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| "We thought we should go to the new, interesting part of Europe," says D.A. Prasanna, vice chairman and managing director of Manipal Acunova. He was involved in Wipro and, incidentally, took GE Medical from #5 to #1 in India as its first CEO, building a $400 million diagnostics business there. |
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| AcuNova's goal is to be a regional power, not a global goliath like Quintiles or Covance. Prasanna says the data from treatment-naïve patients is often more valuable for lack of medical histories with other confounding medications. AcuNova has a central lab in India, developed to address the fact that biological samples degraded after protracted journeys across the country. |
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| Linked SOPs |
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| The central lab, in turn, led the company to offer data management, biostatistics, medical writing and other services. |
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| For now, while the SOPs are being harmonized, any new trial running in both regions will use the SOPs of the company facing the customer. Eventually, a single set of SOPs may be developed. Quality, quality, quality was the refrain when we spoke with the companies at the IIR conference. |
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| In contrast to the fuzzy FDA guidelines, which may never be canonized into regulation, much less law, good clinical practices (GCP) in India are statutory and strictly enforced. For additional peace of mind, however, some of the Acunova sites are registered with the U.S. National Institutes of Health, as are its central lab and ethics committees. |
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| Certification & Accreditation |
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| "We are the first CRO in India to get ISO-certified," notes Kohkan Shamsi, president and CEO of AcuNova Life Sciences. (Kiecana also has ISO certification.) Shamsi's a radiologist and based in the U.S. "If you cannot maintain the quality, time savings and cost savings do not matter." |
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| In concert with recent news coverage, Shamsi reports the general economic boom in India is drawing well-educated clinicians and other professionals from the U.S. and Europe back to their native India. Salaries that are modest by western standards can support life styles in India that verge on the regal. |
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| Paying Full Fare |
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| When founding the firm less than three years ago, the Indians anticipated that 90 percent of their clients might be in the U.S. But the Indian pharmaceutical and generics sectors are growing rapidly, and now comprise 40% of AcuNova's clients, with the remainder split between U.S. and European customers. |
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| Ironically, the global expansion of the Indian sponsors has forced such companies to pay more to run trials in the environs of Paris or Princeton. In those locations, "they are paying global rates," says Prasanna with a smile. |
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| Local Knowledge |
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| The view from Poland is similarly bullish. Adam Kruszewski, VP and CEO of Kiecana Clinical Research, is an MBA and anesthesiologist who knows many of the physicians in Poland by name. Prior to joining Kiecana, he established two physician networks in the region. "I know that system. I know how patients are being recruited and how to retain them," Kruszewski notes. His company also operates in Russia, the Baltic states, and the Czech republic. |
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| Large western companies may be tempted to parachute into Eastern Europe and execute their trials. It may go smoothly. But Kiecana has a nice business rescuing fumbled efforts as well, Kruszweski says. "It's not enough to put a foot in the door," Kruszewski says. "It takes local knowledge." |
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| 'Two Hottest Regions' |
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| Another factor is that the largest CROs cannot always dispatch their best people to Eastern Europe. Kiecana is small enough to pay attention to the details and handle crises when they arise. Half of all its site monitors are physicians or PhDs, an unheard-of proportion elsewhere in the world. |
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| "We are building a kind of global CRO that is virtual," Kruszewski says of his firm and his Indian partner. "We cover the two hottest regions. We are complementary in terms of projects." |
