Manipal AcuNova, the clinical research organization (CRO) is investing $1 million for its new BA/BE (Bio -Availability/Bio Equivalence Studies) facility at Mangalore. The facility is scheduled for opening next month. The company is also investing between $ 1 and $ 2 million for market development. This BA/BE centre at Mangalore will be the second facility for the company after its centre at the Kasturba Medical College Hospital at Manipal.
The BA/BE studies are performed for generic drugs, new drug delivery systems and new chemical entities.
"The investments come in as part of our expansion plans. With the new BA/BE facility, we should be able to provide high quality capacities and mixed gender labs that can provide special population studies," DA Prasanna, vice chairman and MD, Manipal AcuNova Pvt. Ltd. told Pharmabiz.
Currently, the company has 70 per cent of its business generated from the global arena and 30 per cent from the domestic market. "The contract research and clinical trials in India are on an upward swing primarily because of a shortfall of investigators and patients in US and Europe. In this area of research speed of completion is vital. Right now Indian CROs are preferred for their promptness and dependability and that is why there is a growth in the sector. The other advantages are the accessibility to English speaking investigators, vast patient population, speed of recruitment, consistency in revisit of patients and economical costs. These key factors attract global pharma-biotech majors to shortlist India as a potential destination for trials. In this connection, Manipal AcuNova with an investment of $1 to $2 million for market development wants to find its niche and grow, informed Prasanna.
The two subsidiaries of Manipal AcuNova- AcuNova Lifesciences, US and AcuNova Lifesciences ,UK, have chalked out an aggressive plan to strike alliances with global majors to get orders. Early this year, the company set-up the Asia Clinical Research Centre at Whitefield, near Bangalore at an investment of $2 million to carry out clinical drug development and drug discovery research.
The company is a single source provider of clinical research and related services in Clinical Development Services like Bio-Availability/Bio Equivalence, Phase I Clinical Trials, Clinical Trials from phase II to phase IV, Clinical Data Management Services, Clinical Reference Lab, Contract research in bio Pharma discovery using KMC Life Science Lab at Manipal and Stem Cell Lab at Bangalore
Its clients include leading companies such as Quintiles, Ranbaxy, Biocon and Novartis amongst others. It also partners with the University of Minnesota and National Centre of Biological Sciences in research.
For the future, Manipal AcuNova in contract research will restrict its activities to an area close to clinical trails. "We are trying to focus on biomarkers for clinical trails in the area of infectious diseases to begin with and alter move on to oncology and central nervous system," added Prasanna.
Delving into the problems of the sector, Prasanna stated that until Indian CRO's have audits from the global regulatory authorities, the industry will continue to portray the risk of doing research. There is a critical need to set benchmarks in research requirements for recognition, added Prasanna.