Clinigene International Pvt Ltd. and Syngene International, the clinical research and custom research subsidiaries if the Bangalore-based biotech major Biocon are currently in the process of leveraging their strengths in an effort to optimise utilities.
Clinigene and Syngene have allowed maximising the research and development resources and bringing in speed and efficiency in delivering research programmes, said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited in the company's latest report to the shareholders.
Clinigene, a fully owned subsidiary of Biocon has entered into a collaboration for global clinical trials. Syngene International, which is another subsidiary of Biocon, is an internationally reputed custom research company with multi-disciplinary skills in synthetic chemistry and molecular biology. The two subsidiaries are drawing up strategies to attract global clinical trial and research programmes to expand its business. .
Clinigene: Global clinical trial capability
As India's first clinical research laboratory which adheres to standards prescribed by CAP (College of American Pathologists) and an NABL accreditation, Clinigene has the distinct advantage to initiate collaborative programmes. The significant investment made over the past decade in systems, processes, and people are now paying off for the company as it recently went on to ink a pact with Scirex Corporation, a wholly owned subsidiary of the Omnicom Group where both companies signed a Letter of Intent (LOI) to collaborate on global clinical trials, she stated. With this global collaborative initiative, customers can have instant access to expertise in clinical investigation in India and Clinigene would offer its platter of services that include bio equivalence, bio-availability studies and phase I to IV clinical trails.
Clinigene headed by Dr AS Aravind was set up in 2000 to initiate collaborative programmes in diabetes and asthma with Surromed Inc., a California start-up company. The programme linked up speciality clinics in the select disease segments and collated clinical data utilising Surromed's proprietary technology to develop advanced diagnostics and therapies. Since inception it has been supporting Biocon in clinical trial development. Some of the major assignments included research on diabetology, creation of a diabetic registry that helped to validate Biocon's indigenously developed recombinant human insulin, 'Insugen'. In association with the Curie Center of Oncology, the cancer care wing of St. Johns Medical College and Hospital, Clinigene developed the oncology registry. The two registries have added value to basic research and helped the scientific community understand the complexities of diabetes and cancer. Its 26-bed dedicated human pharmacology unit (HPU) located at the well-known Sagar Apollo hospital in Bangalore in September 2003 saw completion of several bio equivalence studies for a number of global pharmaceutical companies.
For the company's insulin project, Clinigene successfully conducted phase II trials for Insugen and is presently conducting IIb trials for its novel anti EGF r monoclonal antibody for head and neck cancer. In fact this study is the first such study being undertaken for a new antibody in the country, informed Shaw.
Further the clinical trial organisation has also tied up with Germany-based ClinTech International a CRO to leverage the huge potential of drug development.
The company has an edge in the market because of its resources to conduct clinical studies among large patient population. It can also perform phase II and phase III studies, conduct longitudinal studies to extend to other disease segments notably asthma, lipidemia and arthritis and setting up state-of-the-art clinical labs. "We have constantly set international benchmarks in the field of clinical trials and clinical research. Our strong intellectual base and a commitment to high ethical standards is the thrust to achieve new horizons in the medical field which has led us to gain the confidence of pharmaceutical majors worldwide,'' said Shaw.
Syngene International: Striking partnerships in drug discovery
As the business of research outsourcing represents significant growth opportunities for the future which is based on rapidly growing needs for outsourced research services, Syngene International has emerged as one of the country's pre-eminent custom research organizations offering a cost-competitive edge in early stage drug discovery and development to its global clients.
The company has grown from Full Time Equivalency (FTE) based custom research company into a knowledge-led proactive partner in drug discovery. The new skills added to synthetic chemistry portfolio are library synthesis, microwave chemistry,
medicinal chemistry, PRD, analytical methods and cGMP synthesis. In the area
of Molecular Biology, the value added services include novel gene hunt, mammalian cell culture, in-vivo assay, CACO 2 culturing and library construction.
The facility of Syngene at the 'Biocon Park', Bommasandra Industrial Area - Phase IV close to the present Biocon facility at the Hebbagodi is spread over 50000 sq. ft. is a state-of-the-art research centre ISO 14000 compliant facility employing over 200 scientists.
In the fiscal year 2004-05, the company enrolled a number of new customers and the most significant being Novartis Institutes for Biomedical Research, Inc. to carry out research projects to support new drug discovery and development.