38 DRUG DISCOVERY & DEVELOPMENT
Via ‘ethnobridging’,
companies developing drugs in Europe can collect and analyse data from native Asians living in other countries to employ cost-eff ective, multi-ethnic approaches to clinical trial programmes.
Stanford Jhee, vice president, Scientifi c Aff airs, Early Phase, Parexel International
Speeding drug development Studies involving ethnobridging must meet strict ‘bridging’ criteria if they are to be accepted by Japan and China’s regulatory authorities, as must the volunteers that take part in them.
Rules state that all volunteers should be natives of the country and cannot have lived outside of their homeland for more than fi ve-to-10 years at the time of the participation. Factors including lifestyles and a participant’s diet should also be considered.
Additionally, other health-related factors cannot have changed signifi cantly since relocating. Such stringent requirements mean that volunteers are usually found in areas with large Asian communities, such as London, where they are more likely to have upheld their native lifestyles.
T rough the early evaluation of effi cacy, safety, dosage and dosing regimen ethnobridging can signifi cantly reduce the cost of drug development and accelerate the speed at which the Phase I process can be completed; expenditure can be reduced by as much as 30 to 40%.
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In Japan specifi cally, a bridging study is used to cut time from the four or fi ve additional years it takes to complete local studies (compared with those in the West) – a challenge known as ‘drug-lag’.
One example of this comes from PMDA (the Japanese regulatory agency), which showed a new drug approval taking just 32 months when employing a Japanese bridging strategy, compared to 56 when not.
Key considerations T ere are several key challenges to consider when deciding whether to develop products for Asian markets outside of those territories. Not only will pharmaceutical companies have to negotiate complex regulatory issues, they must also bear in mind the tight timeframe of trials and the possibility that ethnic variability will impact the safety and effi cacy of medicines.
Before starting an ethnobridging study there are a number of questions to ask: is initial development in the EU? Will Phase II or Phase III global trials include China, Japan or South Korea? Or, will the next trial conducted by the pharmaceutical
company or clinical research organisation involve China, Japan or South Korea? T e answers to these questions will determine the strategic design of the Phase I programme. Perhaps only Japan will be considered for Phase II, and the Phase I programme will be limited to adding Japanese subjects.
A strategic approach would include a Japanese, Korean and Chinese subject in Phase I, establishing a more solid and diverse foundation that allows for true global development. A scientifi c understanding of potential ethnic diff erences, especially pharmacokinetics, and satisfying the Phase I regulatory requirement with authorities will help set a sound stage for further global development.
T e governments of China, Japan and South Korea, and of course, their pharmaceutical industries, have a vested interest in accelerating and growing the marketing of novel therapeutics.
While regulatory requirements are evolving it will be those companies that recognise how to make use of ex-Asian populations in their global development strategy that gain the best advantage.
One important success factor is involving Asian subjects as early in the development process as possible.
By introducing them in Phase I, it becomes possible to detect ethnic diff erences early on compared to Western subjects. For example, diff erences in PK related to absorption, tolerability or drug metabolism.
T e advantage is realised when companies are able to plan early for later phase studies; the later the inclusion of Asian subjects, the more money that could be lost as a result of unforeseen, late- stage modifi cations.
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