Why did GVK BIO introduce Clinogent as a separate division of the company as a clinical development solution at a time when the CRO industry in India is in a state of upheaval?
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Chetan Tamhankar
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Though the Indian industry is going through some challenging times, we believe it is the right opportunity to invest now as the time will change for better in the coming months. We have invested during the downturn so that we are ready to grab the opportunity on the upturn.
By integrating our clinical pharmacology and late phase clinical trial (CT) units under one brand identity, we have created an integrated service offering that will differentiate itself with intelligent and innovative solutions for our customers.
There are a number of domestic as well as multinational CROs in India. How can Clinogent compete with them and what strategies have you chalked out?
There are Bioavailability and Bioequivalence (BA/BE) CROs apart from late phase CROs. None of the other CROs have integrated offering that is as mature as Clinogent. With our clinical pharmacology offering for generic companies, late phase trials for research-based companies and state-of-the-art data, statistics and medical communication solutions, we offer an integrated and differentiated solution and hence are confident that we will be able to compete well with other CROs. We are also working on creating new solution offerings that are innovative and integrated for our customers.
The Indian CRO industry has seen regulatory reforms in the last one and half years. According to you, are these reforms rational? How will they impact the industry’s growth? Will they act as a key for success or will they mark the start of a downward spiral?
Yes. Robust scientific and ethical review and approval process, ensuring patient/subject rights are protected, making sure that patient/subject is fully informed about what to expect when he/ she agrees to participate in a trial and taking care of patient if he/she has experienced injury/illness due to participation in study. All these reforms and regulatory changes are rational and in the right direction. The concern was lack of clarity, and extended delays in decision making. We are optimistic that if now the new Government moves ahead with proper decision making quickly and with clarity, it will act as key to success for the industry.
By what percentage has the clinical trial approval rate decreased in the last two-three years? What impact has this had on your company’s growth?
The approval rate of BA/BE studies for generic products did not decrease, however, for new drugs approval, the rates were dramatically impacted in 2013. Approval rate dropped over 90 per cent in 2013 as compared to previous year, which has of course impacted the industry significantly.
The company has announced that it will carry out studies for both large and small molecules. How will this differentiate Clinogent from other companies?
It is estimated that six of top 10 blockbuster drugs will be biologics in coming years and it is necessary for CROs to align their offering to meet this market demand. Expertise in large molecules that are primarily biologics will help us position correctly to meet the market expectations.
Do you think Turkey is a key market for Clinogent? Which other markets can be tapped?
Turkey is as important an market as other markets for us. We are focusing on the US, Europe and Asia as well. India of course remains a crucial market for us.
How will your industry experience leverage the company to grow much faster?
GVK BIO has over 10 years of experience in servicing our customers across the range of service offerings. I am sure we will bring significant value to our customers to help us grow quickly through our innovative service offering.
Presently, how many research sites do you have and what are your future plans?
We have two clinics (Ahmedabad and Hyderabad for clinical pharmacology studies) and have access to over 300 investigator sites across India, Bangladesh, Nepal and Sri Lanka for late phase trials.
Tell us about the company’s short and long-term plans
We are evaluating various options and it is difficult to specify as of now. We will invest in expanding bioanalytical facility at Ahmedabad and expand and strengthen our data, statistics and medical communication services further. These are near term steps. We are still working on our long-term plans.