SAN ANTONIO, TX—With pharmaceutical manufacturers clamoring for enrollees for Phase I clinical trials, it makes sense for a San Antonio clinical trials group to open a center in the most populated country in the world.
Unlike other cooperative trial projects between the United States and China, South Texas Accelerated Research Therapeutics (START) will own the Phase I center in Shanghai in partnership with the China-based venture-capital firm Cenova Ventures.
START, which opened in 2007, already operates a large Phase I trial program from its headquarters in San Antonio, and in 2009 opened a second center in Madrid.
START Shanghai will operate from a dedicated space in Fudan University Shanghai Cancer Center, which is Shanghai's largest cancer hospital.
START Clinical Director Anthony Tolcher, MD, said the project has been in the works for about 18 months, and that approximately 30 employees who will work in China will be hired there through the end of the year, and trained in San Antonio, including physicians, nurses, and clinical research associates. Clinical trials, he said, may begin as soon as August.
The START center is Madrid is already fully operational, Dr. Tolcher noted. There are about 100 employees between the San Antonio and Madrid facilities; employees in Spain were trained at START and then were recruited to the Madrid location.
“In clinical trials and investigational therapy it always comes down to finding the right people,” he said in an interview at the START headquarters here.
START has a long-range plan to put its centers in strategic cities around the globe, “So that we'll be able to have 24-hour operations,” Dr. Tolcher said. Shanghai became part of the plan because of the many U.S. trained physicians in China who want the opportunity to participate in cancer research and clinical studies, he said.
Shanghai also has a highly educated work force with excellent communications and infrastructure, Dr. Tolcher said.
“China has actually undertaken enormous building of new hospitals throughout the country. You can go into many medical centers there and find very modern facilities that aren't lacking for anything. It is quickly emerging, and it's going to be a center of excellence for health care, and we wanted to be a part of that.”
Hospitals in China are owned by the government, he noted, and the government of China is one of START Shanghai's bigger investors, underwriting some of the Chinese venture capital.
Cenova Venture Capital is investing $6 million dollars in the Shanghai operation, he said, and START is providing cash and intellectual input. Cenova is a newly formed health care investment fund backed by the central and local Chinese governments.
START expects to be initiating trials for US pharmaceutical companies, and some domestic Chinese biotechnology companies that have expressed interest, Dr. Tolcher said. He said some trials will be conducted exclusively in China while others will be take place in parallel in the United States and China, though trials in China will have distinct protocols with pharmacokinetic studies designed for an Asian population.
Dr. Tolcher stressed that China is not a “medical backwater,” but rather a country making enormous leaps forward.
“For them to develop a robust biotechnology or pharmaceutical industry, they are going to need world-class Phase I facilities,” he said.
Carol Zhu, MBA, will serve as CEO of START Shanghai, and Junning Cao, MD, is the new Clinical Director. Dr. Cao had been learning the ropes at START in San Antonio for several months, while Ms. Zhu had come to Texas just for the announcement.
Ms. Zhu said she serendipitously found her new position through a reception given by the US Chinese Anti-Cancer Association (USCACA) for visiting American business and medical leaders, where she was seated between a Cenova executive and Gina Mangold, START's COO in San Antonio.
Ms. Zhu was Director of Clinical Development for GSK China when Dr. Tolcher and Ms. Mangold followed up on that first meeting and persuaded her to take on the START China venture.
Dr. Cao noted that the Fudan center has conducted Phase III and late Phase II clinical trials for years, but only Phase I pharmacokinetic studies. As yet, she said, she did not know which anticancer agent will be tested in START Shanghai's first Phase I trial.
Dr. Cao said her first step will be interviewing and hiring pharmacists, statisticians, and nurses. She will work in the Fudan clinic while Ms. Zhu is opening a business office in the Xuhui district in downtown Shanghai.