“Clinical research environment is improving at a decent pace”

In an exclusive interaction with the BioVoice News on the occasion of the International Clinical Trial Day on 20th May, Dr Renu Razdan, Senior Vice President, JSS Research and Former Co-Chairperson, Association of Contract Research Organizations (ACRO) expressed her views on the clinical research scenario in India besides sharing few updates on her company’s latest operations. Read on:

Please tell us about the JSS Research in India. What are your immediate areas of focus and priorities?

JSS Research has grown significantly over the last three years. Now that the team is part of global company, multinational trials conducted in geographies of India, Europe, Latin America and North America have been initiated. The group continues to focus on Clinical Trials in the space of Phase II & III and with the recent requirements in the regulatory scenario in India, a number of Phase IV clinical trials mandated by the regulators have also been initiated. In addition to this, there are significant opportunities in the space of Real World Epidemiological Studies and Health Outcome Research Studies

How has been the company doing in terms of revenue and growth? What kind of opportunities do you foresee for the company?

The revenues of the company in the fiscal of 17-18 have crossed 100 crores. There were intervening years of de-growth which impacted the entire CRO industry and our revenues also decreased as a result.

A significant increase in revenues is expected from the multi-country, large clinical trials. We expect that a large percentage of increase revenues will come from mid-sized international companies. The interest of Indian pharma companies for clinical research is also a welcome move and we think this is good for Indian population as the dual purpose of a good price along will a very good quality can be achieved. The guidance of Indian regulators in this direction has to be appreciated.

What would be the current estimated market size of Indian CRO industry and its growth in percentage over last few years?

While various market analysis report has estimated to the market at 700 to 800 billion USD in 2017. It is expected that the market will grow at a CAGR of around 12-13% for the next 5 years. The biggest contribution will come from late and early phase clinical trials.

How do you look at the current clinical research business environment in India? Have the regulatory changes for clinical trials (new guidelines issued in 2014) really helped the industry?

We feel that clinical research environment is improving at a decent pace. Of course, the macro environment regarding the discovery part of drug development and innovation can be further improved through right vision and investment. Having said that the constant improvement in the regulatory scenario for the conduct of clinical trials is a welcome move. We see a lot of time-bound decisions being taken by the offices of regulators.

Are there any evasive challenges that remain despite periodic discussions between CDSCO and the industry members? How could be these overcome?

There has been a significant increase in the dialogue between the industry and CDSCO and every round of interaction has been able to generate actions in the right direction. The introduction of Subject Expert Committees which was a fantastic step in itself has been yielding further dividends as there is a significant improvement in the wave the scientific and medical aspects of Clinical studies/protocol are looked up by them. With the combined expertise of scientific members and the regulators, we can look forward to an increased understanding regarding the clinical research protocols or studies.

The CRO industry seems to be no longer on the list of big-ticket opportunity areas as compared to mere 5-6 years ago. What kind of future outlook do you predict for the CRO industry in India?

While India may not see Billion Dollar revenues from Clinical research, we still feel that there are significant opportunities in terms of Data Management, Statistics and Medical Writing. Large captive centers have been opened here by large multinationals like Novartis. There is a very attractive significant pool of young men women who contribute significantly to drug development process for these large multinationals. With the advent of personalized medicine and digital healthcare India should be able to tap these opportunities as well.

It is also important that learning curve for a lot of activities involved in drug development and clinical research has to significantly improved at a fast pace so that Indian subjects also benefit as a result.