Simbec Research Limited, the Europe''s longest established and one of the largest pharmaceutical contract research organisations in the world, is currently looking at developing countries, including India, to spread its wings to the growing pharmaceutical research markets. Having established its liaisoning office in the country last year, the CRO major is scouting for strategic alliances with local partners along with exploring new contracts with pharmaceutical and biotechnology firms in India. Dr Tali Gill, Senior Research Manager of Simbec Research Ltd, and In-charge of Israel CPU, during his recent visit to India, shares his views on the country''s pharmaceutical research potential and the emerging importance of CROs among the local industry in an interview with C H Unnikrishnan of Pharmabiz.com.

Simbec has recently showed much interest to establish direct clientele base in India. What are your strategies here to begin with?

As a first initiative, we have established our Indian Liaison Office at Ahmedabad. Though it is quite early to talk about a comprehensive corporate strategy to proceed in the market now, our objectives are very clear and it will take some time to learn the industry here. However, we are confident of collaborating with few major pharmaceutical and biotechnology firms in the country focusing on accelerating their drug development process.

It is certain that your global exposure would help in coordinating drug development activities of clients in an international perspective. However, could you briefly explain about your global presence and the concerned activities concentrated in different locations?

Established in 1976, Simbec presently has Phase I trial clinics and offices in the UK, Israel and Spain with full bio-analytical support both in the UK and Israel. The CRO also has a joint venture in Switzerland to operate its successful Fast-into Man programme. Currently, Simbec has offices in France and Central and Eastern Europe for monitoring Phase III multi-centre trials and it operates a liaison office in Osaka, Japan and now in India.

Simbec Research has been known in the world for its experience in the services of bioequivalence studies, Phase I safety and tolerance studies, pharmacokinetics and pharmacodynamics. The research organisation has also expertise in Phase IIA and IIB studies, Phase III trials, Bioanalysis including Assay Development, Clinical Laboratory (Pathology) Testing, Central Laboratory Services, Drugs-of-abuse Detection Services, Regulatory Affairs and Gamma Scintigraphy.

How do you look at Indian pharmaceutical industry and its attitude towards contract research?

As far as the acceptance of the concept of contract research among the Indian industry is concerned, we are quite confident now. At least few Indian pharmaceutical companies have grown really big in the area of original drug research and reaching out to global market with their molecules. Simbec is hopeful of finalising contract for a few key research projects for new drug development with the Indian pharmaceutical and biotechnology companies soon. However, it is very early to reveal the names and project details of the collaborators now. The country is yet to pick up the concept of CROs and to understand the importance of it in the years to come as the companies are bit sceptical about sharing information with an outsider and the lack of confidence in undertaking the drug development for the needs of regulated markets on its own. But, it is changing slowly.

How about the regulatory compliance of the tests and studies conducted by Simbec?

Since we are a global CRO, the studies are conducted as per the international regulatory norms comprises of ICH, MCA, USFDA etc. So the documents prepared on the basis of the basic tests can be submitted anywhere in the world. At present, Simbec conducts Fast-into-Man, single and multiple rising dose safety and tolerance studies in healthy human volunteers in their 48-bed Clinical Pharmacology Unit (CPU) in UK. Typically these studies use surrogate markers to obtain an early indication of efficacy. Its Fast-into Man service in partnership with the Swiss Pre-clinical CRO, RCC, combines pre-clinical and clinical service, which is designed to accelerate drug development to get from the first dose in animals to the first dose in patients within 12 months.

Currently, Simbec also conducts early proof of principle, Phase II A, efficacy studies in small groups of patients before committing to the additional escalating costs of the main Phase II & Phase III studies. Simbec has over 25 years of experience in clinical research specializing in Phase I, having worked with almost all of the world''s major pharma, and many SMEs, covering a wide range of therapeutic areas. Also with the Phase I/II A Unit, Bio-analytical Lab and Clinical lab are all on the same site, it provides excellent communication and established links with specialised services including pre-clinical, Gamma Scintigraphy, Clinical Trials supplies to GMP and Radio-labelled Synthesis.

Our Israel clinic conducts bio-equivalence studies of drugs currently under patent, as well as off-patent drugs and the regulatory department of the international organisation provides all the necessary documentation supports.

Since you are interested to explore the potential clients in the country, will you be setting up your own facility here?

At present, setting up our own facility in India would not be a viable strategy. But, we want to have strategic alliance with a well-fit local partner in the CRO business. The company is already in talks with four local companies for the tie-up and one of them would be identified for the alliance shortly. We are not only looking for the local presence from the partnership but also the standards what we follow in the international market. Though India is yet to adapt to the concept of contract research, the market seems to be very encouraging. So the company does not want to miss the opportunities then.