December 2005 – The CenterWatch Monthly : PDF
China on Fast Track to Becoming Developed Market
China has all the typical advantages of an emerging market—large numbers of treatment-naïve patients funneled into centralized hospitals, GCP-trained and Western-educated investigators and a disease pattern that increasingly reflects the West. But, its trump card is its potential market of 1.3 billion people. However, China’s unacceptably long clinical trial approval process and its incomplete protection of intellectual property prevent it from attracting an even greater number of global clinical trial programs. But, as the hurdles lessen, companies are betting that China will eventually be the biggest market outside the U.S.
Biotech Changing the Clinical Trial Landscape
From patient recruitment to data monitoring, the practice of conducting clinical trials in the biotech era is already creating unique hurdles even for the most seasoned professionals. A number of biotech firms will choose to develop their biologically based drugs in-house, with the hope of increasing their product's value or even the value of the companies themselves. Given these companies' lack of experience conducting trials, most are expected to outsource to CROs.
Small Biotechs Feel Brunt of CT Directive
The longer timelines for study startup threaten to slow clinical development of biotech products at a time when the number of European biotech products is gathering pace.
Eye on: Rare Disorders
Since 1983, more than 200 drugs and biological products for rare diseases have been brought to market. CenterWatch has identified a pipeline of 12 drugs in development for orphan diseases.