Emerging Markets Clinical Trials: Asia Harnessing the Best of the East and the West to Advance Clinical Development



Pharma IQ
09/15/2011

The buzz around Asia as a clinical trial location is growing and the advantages of carrying out drug development for many can be summed up as lower costs and greater patient pools.

Although figures differ, estimates per patient costs could be slashed as much as 60 percent for clinical trials held in India and China, which conveniently are also among the most populous countries in the world.

By 2021, China is expected to be the world's second largest market for clinical trial services, and the companies which achieve the greatest success in the region are the ones which manage to harness the best of the east and west.

Countries, including China, are recognising the benefits of bringing in western trained doctors to hospitals and combining the knowledge of what they know with local medical professionals, and clinical research organisations are taking a similar approach – albeit on a much larger scale.

International drug development and commercialisation firm MakroCare recently signed an alliance agreement with Korean CRO LSK, with the aim of strengthening their offerings in Asia.

Last year saw Chiltern open new offices in Singapore, naming the Asia Pacific region as being essential for growth.

Along with customer demand, spokeswoman Natalie Chong told Outsourcing Pharma that drivers for development was the greater acceptance of data by regulators, size of the patient population and the expanding number of investigators expanding in the region.

Indian CRO Siro also looked to expand its presence further in the region with the opening of an office in Malaysia, showing companies are now becoming more acutely aware of the benefits of the individual markets which exist within Asia.

"Besides advantages common to other Asian countries, what attracted us to Malaysia was a robust regulatory framework with compliant timelines, strong government commitment towards clinical research and modern medical facilities," Ajit Nair PhD, president of Asia Business for Siro, explained.

The cooperation of governments is likely to be one of the factors driving clinical trials to countries such as Taiwan and South Korea, as well as Malaysia, and are a symbol of the synergetic relationship which exists between drug developers and Asian authorities.

As Quintiles noted in a recent white paper, Asian companies are looking for new commercialisation opportunities, while western players are looking to reduce their costs. But harnessing these aims to their fullest will require a shift in the way in which clinical development is undertaken, the paper claimed.

Dr. Amar Kureishi, head of strategic drug development in Asia for Quintiles, wrote: "This new model will transform from a linear structure, in which one firm owns all of the pieces, to one of multiple partnerships, with a focus on collaboration instead of control."

He added: "The model can be represented by a 'wheel and spokes' with companies such as a full-service CRO or a large biopharma at the center of the wheel, outsourcing many of the tasks it previously performed in house.

"In this model, the biopharma company and CRO will play a more strategic role in clinical drug development and help foster innovation."

A recent announcement from Eisai also suggested changes are taking place behind the scenes which could reduce the time taken to complete late stage clinical trials, an example of how eastern finance systems could be harnessed to the benefit of western companies.

The deal signed between Eisai and SFJ will see external funding provided for Phase III studies with E7080 (lenvatinib) in thyroid cancer. The study will be wholly funded by SFJ and Eisai will then be required to make milestone payments if the compound is approved, while retaining commercial rights to the drug.

Eisai has also previously entered into a relationship with Quintiles in the field of oncology, with the aim of reducing development costs. And, if Quintiles is to be believed, it is collaborative deals like this which will truly allow the best of the east and west to be harnessed to advance clinical development.

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