Biocon’s Clinigene opens phase I clinical trial facility at Sagar Apollo – Corporate – Express Pharma Pulse

Biocon’s Clinigene opens phase I clinical trial facility at Sagar Apollo

EPP News Bureau, Bangalore

TO keep in pace with the emerging opportunities in India in clinical research, Clinigene International Pvt Ltd, a leading Clinical Research Organisation in Bangalore and a subsidiary of Biocon Ltd, India’s premiere biotechnology company has opened a state of the art Human Pharmacology Unit (HPU) at city’s Sagar Apollo Hospital.

The unit is equipped to conduct world class, cost effective phase I clinical trials and also bio-availability and bio-equivalence studies on healthy volunteers.

Clinigene offers clinical trial, regulatory and laboratory capabilities for drug development to global biotechnology and pharmaceutical companies. It is the first clinical diagnostic laboratory in India to be accredited by CAP (College of American Pathologists).

‘‘India’s vast and diverse disease and patient population represent an enormous clinical development opportunity. Conducting clinical trials is the biggest component of drug development costs which are escalating. This provides Indian CROs an opportunity to access the $12 billion global market for clinical trials,’’ explained Kiran Mazumdar Shaw, CMD of Biocon.

The new facility, with a dedicated team of qualified medical and research staff from Clinigene and supported by the staff of Sagar Apollo Hospital, is spread over 3000 square feet and has the capacity to accommodate 26 volunteers at a time.

It has facilities for volunteer housing, screening, counselling, blood sampling and includes a fully equipped intensive care unit to handle emergencies. The facility will ensure the highest levels of safety and protection of human subjects. The investigator and sponsor will conduct clinical trials in compliance with global ethical and regulatory standards like ICH, GCP and The Declaration of Helsinki (regarding protection of human subjects) said Dr Arvind Atignal, COO, Clinigene.

According to Shaw, the presence of a large pool of medical and para medical professionals in India is conducive to building strong clinical development infrastructure. The India advantage in clinical development is clearly the speed of patient enrollment and thereby shorter time-lines for clinical trials.

As per the OPPI report, current CRO estimation business in India is about $10m already. The Association of Biotechnology Led Enterprises sees a big opportunity in India as high as $1.5 bn by 2010. ‘‘But lot of failures in clinical research in India is mainly due to inability of enrolling patients for clinical research,’’ she opines.

Clinical research is a segment growing in India at the rate of 30 per cent per annum. The cost of clinical trial in India is 50 per cent less for phase I studies and 60 per cent less for phase II studies as compared to the US.

There is speed of patient enrolment and reduced drug development costs in India. ‘‘However, the challenges ahead of us are how do we change the medical mindset and how do we remodel our medical education where clinical research and disease management are touched upon. The challenge is how to make the data from Indian clinical research companies be accepted across the globe,’’ Shaw asserts.