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The Tufts Center for the Study of Drug Development aims to plug the knowledge gap at the lower end of China's trade business through a partnership with Shanghai’s Fudan University.
Despite its sheer size, China’s $60+ billion medicines market – the world’s second largest, after the US – remains a work in progress. Change is the dominant strategic and operational theme; it’s a “paint as you go” canvas whose color fields are only gradually being filled in.
For Western-based drug makers, the big need is for more predictability and less risk, by raising local standards of business practice closer to the global norm. Cooperative business development partnerships to accomplish this objective are flourishing within the industry itself, particularly among the largest multinational players. But there is less engagement with the services/vendor side responsible for execution as well as between local academia and the public sector, which play key roles in defining China’s often opaque rules on drug development, market approval and commercialization.
Says Tufts Center for the Study of Drug Development [TCSDD] Director and Professor Dr. Ken Kaitin: “a key segment of growth in the China market is small boutique service companies with ambitions to manage pre-discovery and early-stage clinical testing for biotech and other smaller Western-based drug-makers, to help them defray the high costs of these activities in the US or Europe. Just a few years ago, local service vendors were heavily focused on narrow, incremental activities like molecular chemistry. Today, their aspirations are much higher. Everyone wants to leverage the fact that it’s cheaper to do drug development in China.”
Frequent trips to Beijing and Shanghai has allowed Kaitin to observe the market transitions first hand. “Outsourcing essential parts of the global development chain to China shows no signs of slowing; in fact it’s becoming bigger and more sophisticated. Nevertheless, there is a persistent knowledge gap at the lower end of the trade business, one that has to be addressed if foreigners’ confidence in the Chinese market is to continue,” Kaitin told Pharm Exec.
MOU with Fudan
The TCSDD has made a commitment to plug that gap through a novel partnership with Shanghai’s Fudan University, an institution with solid links to the local biopharmaceutical community as well as the national drug regulatory authorities. In January 2014, TCSDD signed an MOU with Fudan’s Shanghai Center for Drug Discovery and Development [SCDDD], headed by a former local executive from Massachusetts-based Sunovion Pharmaceuticals, Dr. Liming Shao. Shao, a medicinal chemist, is a Professor at Fudan’s School of Pharmacy, in addition to serving as Director of SCDDD. Kaitin has also been given an appointment as Advisory Professor at Fudan’s Shanghai Medical College.
The Tufts-Fudan collaboration consists of four key objectives:
Last month, the TCSDD-SCDDD partnership held its first symposia, in Shanghai, which focused on building a strong biotech sector in China. In addition, a joint research study is underway with the aim of uncovering areas of “volatility” in the drug development and approval process in the US and Chinese systems, including the incorporation of development milestone data to identify bottlenecks that slow the pace of approvals through, for example, delays in the set up and monitoring of clinical trials. A company product survey covering both markets is being prepared, and the conclusion will emphasize whether delays in the release of new drugs are impairing the fulfillment of essential public health priorities.
Says Kaitin, “the overriding goal here is to contribute independent, rigorously documented advice to help drive improvements to the drug development and approval process, in both countries.” Specifically, Kaitin notes that the MOU with Fudan does not carry any government or direct industry financial support. “Each of us is contributing from our own academic grants and budget, as we want to avoid any consequence where government sponsorship ends up being too prescriptive.”
If there is one metric for this project, it is to spread the language of quality, safety and efficacy in the evolving Chinese standards for drug development and commercialization. And to bring these forward to a place beyond the top tier of industry, to the service providers who disproportionately account for real time, real world execution – what happens after rules are set. Comments Kaitin, “we want to show how a strong drug regulatory regime can positively affect the state of public health in China, particularly as it relates to the graying of the population and the therapies that can help, whether these be of Western or traditional Chinese origin. We want to open the debate and learn from each other.”