GVK grows in the CRO space

GVK grows in the CRO space

GVK BIO has collaborated with INC Research to form INC GVK BIO Private Limited, which would establish a resource capability to offer Phase I-IV clinical development programmes in India for INC’s global clients. Shabbir Rangwala, the Director of Clinical Research and Data Management of GVK Biosciences speaks on the development

Which are the companies that the JV will offer Phase I-IV clinical development programmes for?

The JV will service clients from pharma, biotech and CRO industries. With hands-on experience in various therapeutic areas, we are all set to provide total clinical programme development with special expertise in CNS, neurology, pain, psychiatry, infectious diseases, oncology and pediatrics.

How has GVK Bio benefited from the alliance with INC?

This joint venture adds significant value to our global service offering, as it combines INC Research’s global drug development experience and therapeutic foresight with the depth of our regional expertise and strong clinical research experience. This partnership will enable both the companies to further expand their global reach and support our growth plan.

The CRO market in India is projected to grow dramatically over the next five years. And through this novel partnership, INC GVK BIO will be able to draw on INC’s global clinical research expertise and relationships with major pharmaceutical companies in the United States, Europe and Japan in addition to GVK’s knowledge of the Indian market.

The JV is strategic in nature, as it gives our company an opportunity to leverage our domain capability and provide our products, solutions and services across the pharma value chain. At the same time, it would enhance GVK BIO’s global capabilities as an established CRO in the oncology and neuro-psychiatry market segment as we gain INC’s substantial experience in conducting such clinical trials. We believe the strategic alliance will bring mutual clinical research opportunities to each group and INC-GVK BIO service brand will also have access to leading clinical sites in India with competent staffing and significant patient population.

What is GVK BIO’s positioning based on the quality and ranking in the CRO industry?

GVK BIO is India’s leading contract research services company providing an integrated platform of research services across the pharma R&D value chain.

How is GVK BIO different from other CROs?

Unlike many other Indian CRO’s whose services are restricted mainly to one or other work areas, GVK BIO has the distinct advantage of being a one stop solution provider to its clients. And this is possible by virtue of having a presence in all the research areas such as medicinal chemistry, biology, informatics, clinical research and data management and even a process scale up plant. The ability to anticipate and respond to industry and client challenges is at the core of GVK’s business approach. We are constantly striving towards providing cutting edge research in a cost effective and competitive manner to our global biopharmaceutical clientele who are looking at maximising their value proposition.

Why is the company focusing on different areas?

While we offer individual services through our seven different SBUs (informatics, medicinal chemistry, clinical pharmacology, process research, clinical research, biology and KPO), we also offer integrated services to clients, making GVK BIO a full services research company. We will keep continuing to strengthen our services in all areas while adding unique models to our portfolio.

What are the areas the company is presently working on? Who are the company’s clients in the global market?

Currently we are working in five different therapeutics areas in clinical research. GVK BIO services 12 of the top 20 global big pharma companies. Our client’s list includes several biotech and CROs across the American, European, Japanese and Indian markets.

What is your take on CRO industry in India?

India holds a lion’s share of the world’s contract research business as activity in the pharma market continues to explode in this region. In 2005 contract research in India was valued at $100-120million (€78-94m) and growing at a rate of 20-25 percent each year, according to a report by the Chemical Pharmaceutical Generic Association. India holds nearly double the business of its nearest rival, Italy, with a market value of $60-70million, and nearly four times as much as the next competitor, Spain, with $25-33million, said the report, titled ‘Competition in the world APIs market.’ The activity in India is being fuelled by the direct presence in the country of over 15 prominent contract research organizations (CROs), who are now operating in the country, attracted by India’s ability to offer efficient R&D on a low-cost basis. 35 percent of business is in the field of new drug discovery where as the bulk-65 percent-of business is in the clinical trials arena, the single largest expense for drug companies during drug development.

Specific to Clinical Research, I think there will be a continuing trend toward the pure clinical development part being outsourced to Indian CROs. Currently, globally 20-22 percent of the work of clinical development is being outsourced to CROs and the rest are kept in-house. We expect that to expand to 30 percent or one-third over a period of 4 or 5 years and a substantial part of the same would definitely be diverted to India. I also think we’ll see a trend toward more careful evaluation where work is done.

Studies will be more closely tailored to where the disease patterns are with a better understanding of epidemiology and disease prevalence. It will be less an issue of cost than of disease patterns. Clinical Trials are a CRO’s core competency just as any pharma company’s core competency is usually developing drug pipelines and marketing. To get a better idea of the contributions CROs have made-in 2004, leading CROs managed 23,000 Phase I-IV trials worldwide, monitored more than 150,000 clinical investigators, and enrolled more than 640,000 new subjects, according to a Tufts study.