April 22, 2013 -- The clinical trial market in Asia is booming with an annual 20% growth in clinical trials. US pharmas and biotechs are looking to extend their products’ reach into Asian countries and therefore require access to various ethnicities in order to fulfil local regulatory requirements for their early phase clinical trials. This will eventually enable launch of these products into Asian countries.
Australian-based CRO, CPR Pharma Services, is launching a unique service particularly targeting U.S.-based companies wanting to access the Asia-Pacific region. While access to therapeutically naive populations in Asia to conduct late phase studies is not new, CPR is focused on early phase studies, utilising its network of experienced phase 1 units with access to various ethnicities to address this gap in the CRO market for small to medium biotech and pharma.
CPR’s Access2Asia service will be launched at the Partnerships in Clinical Trials conference in Orlando. The service aims to connect U.S. companies with CPR and its network of clinical trial centres to deliver ethno-bridging studies, allow incorporation of ethnicity arms into Phase 1 trials and offer local management of phase 2a and 2b study support with providers that have the knowledge to navigate the local regulatory environment.
CPR Pharma Services – with last year’s opening of its Singapore office and this month’s launch of its Large Molecule Immunochemistry Analytical Service - is now a regional leader in the provision of clinical trial services, albeit with a core focus in Phase 1 and bridging studies.
U.S. companies usually find that there is an inherent risk in accessing sites in the region due to concerns over quality and potential project delays caused by complex local regulatory processes. Australian-based CRO, CPR, is launching a novel service – Access2Asia – aimed at assisting U.S. based pharmas and biotech in navigating the regulatory minefield by supporting all aspects of conducting trials in Asia.
Because of CPR’s extensive network and experience in the region, it has set up Access2Asia – providing U.S. companies with a link to phase 1 units across Asia. Any selected site is then overlayed with CPRs specialist early phase expertise. CPR provides best practice project management, monitoring, data management, quality assurance, pharmacokinetic, bio-statistical, report writing and bio-analytical support services that constitute a high quality clinical trial package.
According to CPR Pharma Services CEO, Jason Valentine, the service allows U.S. companies to not only access “Western-style high quality clinical trials at a fraction of what it costs in the US or Europe”, but also provides access to the booming Asian market. “Asia, and particularly China, has a growing middle class that wants access to pharmaceuticals. In order to access this market Western companies need to trial their drugs in the region. CPR can help these US companies navigate the often complex regulatory systems across Asia,” he said.
For example, Mr Valentine said that gaining approval for a typical Phase 1 trial in China can take up to 20 months. “By using Access2Asia a trial could be started in Australia in as little as 3-6 weeks and by incorporating an ethnicity arm into the study, the process of starting the regulatory process in China can start much sooner, potentially taking two years off of the current timeline for access to the Chinese market.” he said. “We can access Chinese populations in early stage development in Singapore and across Asia, which allows a biotech or pharma to jump start their regulatory process in China.”
For early stage clinical trials CPR can provide the bio-analytical services in its Singapore laboratory as well as in its Adelaide facilities which are FDA-audited. For phase 2a and 2b trials CPR can manage and monitor the trials through its network of hospital sites across Asia as well as deal with local regulatory authorities through their local agents.
“CPR Pharma Services is the only CRO in the region that can offer a quick turnaround in early phase trials in Asia, as well as the opportunity for US companies to have an on-the-ground expert managing all aspects of the trials. At all stages CPR has dedicated senior staff who will oversee each project. ”
WHY ASIA IS A TARGET FOR US CLINICAL TRIAL COMPANIES:
Singapore, South Korea and Taiwan in particular all have world-class early phase clinical trial infrastructure and local government support for small-scale clinical trials. With a decade of large pharma present in these countries running early phase trials the regulatory authorities and ethics committee’s are experienced and the inherent compliance culture in these countries makes them well suited to the rigours of early phase clinical trials.
Emerging countries such as Philippines, Indonesia and Malaysia have a highly educated, English-speaking healthcare infrastructure and a large population making them the next likely Western trial destinations.