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India's clinical trial norms are getting in sync with global standards: Paul Stoffels

Livemint:  February 08, 2017

Mumbai: Johnson & Johnson (J&J), the world’s largest health care company whose consumer products such as baby powder and shampoos are a household name in India, plans to grow its pharmaceutical business in India through a number of new product launches and is involved in conducting research and development (R&D) activities in the country for novel drugs for the global market.

In an interview, Paul Stoffels, executive vice president, chief scientific officer and worldwide chairman, pharmaceuticals, of J&J, talks about restarting clinical trials in India, the importance bringing a new drug to the market and balancing innovation and pricing of products. Edited excerpts:

Globally, pharmaceuticals is the biggest business for J&J, while in India, the biggest business is consumer health care. What are the company’s plans to grow the pharma business in India?

J&J’s presence in consumer health care is significant but last year if you see, our pharma business was the fastest growing among all MNCs (multinational companies) in India. With the impetus on new product launches, I think it will grow. Pharma business is dependent on innovations. In India, we have introduced eight innovative medicines in the last five years and we are working towards introducing eight additional innovative products across oncology, neuroscience, infectious diseases and diabetes over the next five years.

What kind of research does J&J conduct in India? Is the company doing any clinical trials?

We have been in India for 70 years and have three segments—pharma, consumer healthcare and medical devices. We have late-stage development (work in India), where we have always done a lot of clinical trials. Over the last few years we have had some issues there but those have been solved, so now we can go forward and continue to do what we did before. We have already started with a few clinical trials. Globally, approximately 87,000 patients are enrolled in our clinical development programme, which spans 350 clinical trials at 15,100 sites and across 60 countries, including India. At present, we have seven clinical trial programmes underway in India, spanning prostate cancer, breast cancer, HIV, diabetes and rheumatoid arthritis. The clinical trial norms in India are starting to get harmonized more or less with global norms. We also have a pharmaceutical development unit, where we do R&D work on new types of formulations. We are also working to accelerate infectious disease research in the country by collaborating with institutions and government. We rolled out our newest drug for tuberculosis in collaboration with the government.

Competition has intensified over the years with generics and biosimilars coming into the market. How does J&J deal with it and how does it balance the focus on innovation and pricing of drugs?

We calculate the benefit of what we do in years of life saved and then the governments have to judge on how much they reward a company for this. I think we can justify the value we bring through our drugs. People are aware that innovation will be needed to have a healthy long life. We are very efficient in R&D and we have to make our case to the government on why we need to invest so much. In 2016, we invested more than $9 billion in R&D globally. Our pipeline was ranked the fourth largest globally in 2015 with approximately 70 new compounds in early development, and 15 potential new medicines in late development. Pricing will always be a concern. As a company, what we do is price the product according to the ability to pay in a country. We work with governments across the world on what is the appropriate price level for the type of innovation we bring in.

I don’t see that as an issue. I see the issue much more in scientific challenges like how are we going to cure cancer, how are we going to prevent Alzheimer’s. That is the real challenge, the government hurdles are doable.

What is the company doing to bring new products into the market faster?

If you have an idea, somebody else has that idea too. So time of development becomes essential to be competitive. When we do drug development now on a global basis, we count it in days and weeks and not months. Bringing the best science fast is the most important part of being competitive in the world.

Globally, in which therapeutic areas is the maximum research work happening?

I think oncology is one of the major areas. Technologies around human genetics have advanced so fast that now we can try to understand pathways of cancer. Immuno-oncology research is growing fast and more than 1,000 combination studies are ongoing in the world at the moment. We are learning that activating a body to fight cancer is one of the strong mechanisms, combined with direct cancer agents. Initially, the first immune oncology drugs were very broad immuno-stimulants but now more and more, we can target specific tumours. In five years, we are going to see a revolution in cancer because of the combination of direct cancer drugs with immuno-oncology.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.