Establishing the 5,000 sq ft oncology unit in Shanghai, China expands South Texas Accelerated Research Therapeutics’ (START) Phase I network into Asia. The site allows multinational sponsors to tap into China, supports local research and improves access to experimental drugs.
START is opening the unit, a joint venture with China-based Cenova Ventures, on the fourth floor of the Fudan University Shanghai Cancer Center (FUSCC). An estimated 600,000 patients visit FUSCC each year, giving sponsors access to a significant number of potential trial participants.
“We expect to enrol our first patient in July”, said Gina Mangold, chief operating officer at START. Before then START will train staff, renovate clinical space, purchase equipment and secure sponsors. START hopes to have a 50/50 split between local and multinational pharma sponsors.
When operational the site will house 10 transfusion chairs for use in conducting Phase I trials. Initially 11 people will work at the unit but START plans to hire a further 18 employees within two years of opening.
International oncology expansion
The Shanghai site follows the launch of START Phase I units in San Antonio, Texas and Madrid, Spain. START plans to open more Phase I units, Anthony Tolcher, clinical director at company, told Outsourcing-Pharma, but a specific timeline or target geographies are yet to be decided.
“When researchers are ending the day in one START location, our colleagues will be starting their day and will pick up right where we left off”, said Tolcher in a press statement.
Phase I in China
The site will boost Phase I oncology capabilities, an underdeveloped area at FUSCC and throughout China, to further its drug development aspirations in an important, expanding therapeutic area.
“It is important for us to upgrade our capabilities in conducting early phase and first-time-in-human (FTIH) clinical studies”, said Jin Li, director of the oncology unit at FUSCC. Most previous trials at FUSCC have been Phase II and III.
FUSCC has limited Phase I experience but has a heritage in clinical trials and is keen to expand capabilities. It was among the first sites to receive a Chinese State Food and Drug Administration (SFDA) experimental drug test license and is now moving to the forefront of Phase I oncology.
“For us, we can learn the American experience in drug development, improve our system in drug tests and increase our center’s impact in the world. We are excited about this collaboration”, said Guoliang Jiang, president of FUSCC.