India formalises industry partnerships for phase one clinical trials

One key project is a study on CAR-T cell therapy for chronic lymphocytic leukaemia. 

The Indian Council of Medical Research (ICMR) has signed memorandum of agreements (MoAs) with industry and academic partners to drive first-in-human phase one clinical trials for four new pharmaceutical agents.

The agreements cover a range of research projects, including a study of a small molecule for multiple myeloma, a Zika vaccine, a seasonal influenza virus vaccine trial, and a CAR-T cell therapy study for a new indication of chronic lymphocytic leukaemia.

Meanwhile, the network of phase one clinical trials includes four institutions, namely KEMH & GSMC in Mumbai, ACTREC in Navi Mumbai, SRM MCH&RC in Kattankulathur, and PGIMER in Chandigarh, all supported by a central unit at ICMR headquarters in New Delhi. 

The infrastructure and manpower at these institutions are intended to support the efficient conduct of early-phase clinical trials.

“Establishing phase one clinical trial infrastructure is a key component in fostering the development of Indigenous molecules and cutting-edge treatments,” said Dr. Rajiv Bahl, secretary of the Department of Health Research and Director General of ICMR.