News & Information | START In The News

September 19th, 2011

SA-based START opens Phase I Clinical Research Center in Shanghai, creating a new era in world-class cancer research in China

Read more about START Shanghai here >

(September 19, 2011, Shanghai — Today, START Shanghai and China’s Fudan University Shanghai Cancer Center, jointly announced the opening of the first Phase I cancer research center in China to meet all the standards of three of the major national regulatory agencies including China's State Food and Drug Administration (SFDA), the U.S. Food and Drug Administration (FDA) and the European Pharmaceutical Product Evaluation Agency (EMEA) for a Phase I Cancer Clinical Research Center. The groundbreaking partnership not only fills a gap for meeting China's vast anti-tumor drug clinical research needs, but helps further China's involvement in early drug development and helps START meet its goal of round the clock cancer research. START Shanghai will be located at Fudan University Shanghai Cancer Center, Shanghai’s largest cancer hospital.

Dr. Anthony Tolcher, president of START LLC, chairman of the board of START Shanghai and co-founder of START, said of today’s announcement, “This is just the beginning.  We plan to transform the way cancer clinical trials are done because our patients, all around the world, need more effective medicines.”

Cancer is a global problem and will be solved only by an integrated global research strategy.  START’s goal is to open Phase I centers, in strategic locations around the globe, that operate according to the same exceptional standard operating procedures and quality controls as have been established at START San Antonio and are now replicated in START Madrid.  This model allows for a profoundly different approach to cancer research and will result in faster completion of phase I clinical research and also makes the newest Phase I drugs available to end stage cancer patients who live in places where there is limited access to the newest anticancer drugs.  

With a population of 1.3 billion people and a rapidly expanding economy, China has recently emerged globally as the third largest pharmaceutical market.

START Shanghai is the second in a series of planned expansions for SA-based START which opened in 2007.  The first expansion took place in early 2010 in Madrid, Spain. The organization operates the world’s largest coordinated network of Phase I trials with senior clinical investigators who are among the most respected in the field of anticancer drug development.  

Dr. Tolcher calls this a “momentous achievement” for San Antonio, one that will result in bringing worldwide attention to the city’s exceptional biomedical assets.  “San Antonio,” Dr. Tolcher said, “can be a world leader, and should never believe it is in the shadow of any other city.” He says the key is to, “Support innovation, not institutions.” He said, “To compete globally, America must continue to innovate.”

Kenneth P. Trevett, chairman of BioMed SA, a non-profit industry cluster organization that represents San Antonio's healthcare and bioscience sector said, “The opening of START Shanghai Is another excellent example of the extraordinary international impact of San Antonio's biomedical sector.  We are changing the paradigm for clinical care and research, and lives are being saved as a result.”

START Shanghai will occupy approximately 7,000 square feet of dedicated space on the 4th floor of Fudan Cancer Hospital.  It will have eight treatment beds, eight treatment chairs expandable to 12, plus a facility for PK study.

Carol Zhu will serve as CEO for START Shanghai.  Junning Cao, MD, will serve as clinical director for START Shanghai. Dr. Jin Li serves as the director of Fudan’s Department of MedicalOncology.   Dr. Li said, “The Fudan-START Phase I center aims to become the most respected Phase I cancer center in China.”

According to Zhu, “Fudan-START Shanghai Phase I clinical research center is committed to continuing to the building of START’s overall international standard of clinical research platforms.  Our work here will give China the early clinical research data to compete in the global drug development, to help make available China's homegrown new anticancer drugs abroad and give Chinese cancer patients access to the newest anticancer drugs.”

START’s joint venture partner, Jun Wu, Ph.D., chairman and managing partner for Cenova Ventures, said, “We are one of the few industry specific RMB venture funds with a mission to focus on investing critical infrastructures and innovations in the life science and healthcare arena in China, and we are very pleased to be working with such a pioneer in the field.”  Walter Lau, Ph.D., managing partner for Cenova Ventures, said, “We expect many future innovations in the pharmaceutical industry will come from clinical development in China.  START Shanghai is set up to become an important gateway for U.S. based pharmaceutical/biotech companies going into China and for China-based pharmaceutical companies wanting to go beyond China. “

Dr. Tolcher added, “Never be afraid of working with others from around the world. Never be afraid of stepping out of your comfort zone.”

South Texas Accelerated Research Therapeutics (START) directs clinical trials of novel anticancer agents using a high quality and innovative information technology infrastructure to ensure accurate and rapid clinical trials in a setting that emphasizes personalized and compassionate clinical care. START’s head office is located in the heart of the San Antonio Medical Center. With centers located in San Antonio, Texas and Madrid, Spain, START conducts the world’s largest Phase I medical oncology program – putting more than 400 patients per year on Phase I trials. Patients travel from all over the world to participate in one or more of our Phase I drug trials. START consists of a team of highly trained physicians and staff with extensive experience in Phase I clinical trials research and are nationally recognized as thought leaders in cancer research and drug development.

Fudan University Shanghai Cancer Center (FUSCC)
Fudan University Cancer Hospital is directly under the Ministry of Health, medical treatment, teaching, research, prevention as one of the three A-level Cancer Hospital, is the long history and reputation of the Cancer Hospital. Than its predecessor is in the hospital treatment of radium, in March 1, 1931 was established, has been 80 years of history, is China's oldest cancer hospital. The hospital has a wealth of case resources, with full multi-disciplinary research and clinical departments, is also recognized by the Ministry of Health Food and Drug Administration Phase I clinical research base. Over the past decade, cancer hospital to complete more than one hundred new drug clinical studies, and the formation of a characteristic early clinical research system.
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The Cenova Venture Fund, located in Shanghai, is a newly formed healthcare RMB fund dedicated to China healthcare industry, and its main focus is on companies with significant growth potential in China healthcare sectors, such as pharmaceuticals, biotech, medical devices, diagnostics, and healthcare services. It is uniquely positioned in the China healthcare sector because it is the first attempt by the central and local government to back a life science venture fund that operates through a mechanism and structure that largely follows international standard practices, managed by independent healthcare investment professionals.