CPR Pharma Services, an Australian-based CRO, is launching Access2Asia, a service 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, utilizing its network of experienced phase I units with access to various ethnicities to address this gap in the CRO market for small to medium biotech and pharma.
The Access2Asia service aims to connect U.S. companies with CPR and its network of clinical trial centers to deliver ethno-bridging studies; incorporation of ethnicity arms into phase I trials; and local management of phase IIa and IIb study support with providers that have the knowledge to navigate the local regulatory environment.
“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 U.S. companies to have an on-the-ground expert managing all aspects of the trials,” said Jason Valentine, CEO of CPR.
Valentine also said 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 U.S. or Europe,” but also provides access to the growing 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 U.S. companies navigate the often complex regulatory systems across Asia.”
For example, Valentine said that gaining approval for a typical phase I 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 IIa and IIb 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.