Clinical research major, Clinigene International Pvt. Ltd. - a Biocon Company has slated the opening of its 26-bed dedicated human pharmacology unit (HPU) for conducting clinical studies, in September 2003. The facility is being constructed on the fifth floor of the premier tertiary care hospital - Sagar Apollo Hospital in Bangalore. Clinigene has signed a contract in this regard with Sagar Apollo Hospital.
The facility is getting ready and the infrastructure systems are being put in place. The HPU would be first certified by the Drugs Controller General of India (DCGI), after which international regulatory approvals will be sought. To start with, the HPU will conduct bio-equivalence (BE) and bio-availability (BA) studies on normal healthy volunteers, Dr. RS Nadig, vice president, medical services, Clinigene International told Pharmabiz.com
The trials undertaken at this facility would primarily be on molecules generated by the Biocon group of companies. It will also take up studies of molecules generated by Biocon for its partners apart from BE and BA studies on molecules that its clients have developed and need to go through a round of tests for regulatory approvals.
Since its inception in 2000, Clinigene has been working for the parent company and its clients on a variety of projects. Some of the current assignments of the company include research on diabetology to create the diabetic registry. It would shortly team-up with the Curie Center of Oncology, the cancer care wing of St. Johns Medical College and Hospital to develop the oncology registry. "The registry would add value to basic research and help the scientific community understand the complexities of cancer and work towards combating the same," informed Dr. Nadig.
It is also coordinating pre-clinical studies that involve animal bioassays, animal toxicology studies to ensure the efficacy and safety of the molecules under development. As of now, all its animal studies are outsourced basically because it has no in-house facility. We design, co-ordinate and confirm that the studies are in accordance with GLP (good laboratory practice) guidelines, he said.
In the next one year, Clinigene apart from associating with customers, would work in tandem with Syngene and Biocon to integrate and make Biocon group of companies a major player in the Biopharmaceutical market.
Clinigene will look at contract research opportunities for which it already has leads from companies within the country and outside India asking them to tie-up for conducting pre-clinical studies in animals, BE and BA studies in healthy volunteers. Companies are also approaching us to associate with them for conducting clinical studies (Phase II & Phase III)," said C Omprakash, manager, regulatory & data management, Clinigene International Pvt. Ltd. and added that as a resourceful Indian CRO, Clinigene can offer a gamut of services to help our customers from Discovery to Market.
In the wake of increasing competition in contract research, Dr. Nadig, said that the Biocon Group of Companies would ensure that there is something that differentiates Clinigene from the "also-rans" - "Perhaps the difference lies in our DNA".