ATLANTA — The non-profit Hamner Institutes for Health Sciences and China Medical City inked an agreement yesterday creating a new drug-development institute intended to create a biotechnology bridge between North Carolina and China.
The new institute, called the Hamner-China Medical City Institute for International Drug Development, will receive $5 million from Chinese-American CRO Newsummit Biopharma, and will attempt to leverage each partner's strengths in translational research, business development, and education to produce new biomedical technologies.
The partnership is also expected to create a gateway for Chinese biomedical companies to do business in North Carolina and elsewhere in the US, and to expand Hamner's model of blending academic and industrial research overseas, officials said.
Officials from Hamner and China Medical City announced the alliance during a news conference at the Biotechnology Industry Organization annual meeting, held here this week.
During the first phase of the agreement, the partners will establish the new institute at Hamner's campus in Research Triangle Park, NC, where scientists will focus on preclinical drug development and compliance with US Food and Drug Administration regulatory standards.
The partnership "will help China to meet worldwide GMP [and] GLP standards and to be an international pharmaceutical" player, He Rong, president of China Medical City, said during the conference.
After the partners validate research capabilities and new technologies at the Hamner campus, they will transfer them to China Medical City, a life-science park located in the Yangtze River Delta north of Shanghai.
Responding to a question from BTW, William Greenlee, president and CEO of the Hamner Institutes, said that new intellectual property created under the joint venture would be "handled on a case-by-case basis. For operations in the US, it will operate under US law."
As part of the agreement, Newsummit Biopharma will establish its North American business center on the Hamner campus.
Newsummit, which describes itself as a CRO-"plus" organization in that it also provides project-based investments, offers its clients support for commercialization, intellectual property, and staffing in science and technology parks throughout China. The organization has a US holding company currently based in Delaware called the Newsummit Holding Company.
Newsummit's new US headquarters will be located in Hamner's Bioscience Accelerator, an incubator facility launched by the research institute last year. The facility currently houses two startup companies: BioMedomics, a clinical diagnostics company founded in 2006 by Chinese-American scientists, and b3bio, an RNA therapeutics company using technology licensed from Duke University and the University of Texas.
Officials said that the partnership creates a "vital bridge of opportunity" between North Carolina and China, and lauded the RTP area as "an ideal location for companies from China that seek to enter the US market."
Also, as part of the agreement, Hamner will work with the North Carolina Department of Commerce and North Carolina Biotechnology Center to create a North Carolina-China partner network to support Chinese business and educational initiatives.
Other members of this alliance include the North Carolina China Center, the North Carolina China Business Association, the Council for Entrepreneurial Development, the North Carolina Research Parks Network, and economic-development organizations in counties such as Wake and Durham.
Meantime, China Medical City and Newsummit are expected to use their business-development networks to assist North Carolina-based R&D companies, CROs, and academic institutions that want to establish strategic alliances, research sites, or branch offices in China, officials said.
Thus far, the new Hamner Bioscience Center in China Medical City and the NC Department of Commerce office in Shanghai have been assisting companies to develop markets in China. Firms include contract pharmaceutical developer Cirrus, research facility provider Specialty Operations Solutions, and medical technology firm Synecor.
Greenlee said that representatives from his institution and China Medical City first discussed the formation of the new partnership at last year's BIO conference in San Diego, and "created an initial memorandum of understanding almost the next day." The organizations spent the next several months hammering out details, and the partnership has progressed "rapidly," he said.
The Hamner institute began in 1974 as The Chemical Industry Institute of Toxicology, an independent research institute formed by leaders from 11 major chemical companies to address growing concerns about the effects of small-molecule chemicals on the environment and human health.
Since then, the institute, named for North Carolina and RTP biotech pioneer Charles Hamner, has broadened its mission to include translational research in biopharmaceutical safety, metabolic disorders, respiratory disease, oncology, and nanosafety.
The institute, which receives support from a number of industry and government sponsors, aims to blend research from those sectors as well as academic institutions.
Last year, the institute signed an agreement with the University of North Carolina-Chapel Hill to create an integrated Center for Drug Safety Sciences to study the safety of biotechnology and pharmaceutical products. The institute has also established research and business-development agreements with Duke, North Carolina State University, and Wake Forest University.