Saturday, September 1, 2018

PHARMA SPECIAL.....‘Our Chief Focus for Future Investments will be on Increasing R&D Footprint Here’


 ‘Our Chief Focus for Future Investments will be on Increasing R&D Footprint Here’

We continue to focus on product development... What we have done is design clinical trials in India, which is a shift from where we were a year ago

Earlier this year, Vasant ‘Vas’ Narasimhan (42) was named CEO of Novartis, the $50-billion Swiss pharmaceutical behemoth. An American of Indian origin, Narasimhan is a Harvard Medical School-educated physician and has deep experience in the development of breakthrough medicines.
Kymriah is one such cell-based therapy that recently received the USFDA approval where Vas was closely involved. On a short trip to Hyderabad, Narasimhan spoke to Vikas Dandekar & CR Sukumar and covered a wide spectrum of issues — from India’s ambitious healthcare programme to the direction of the US drug pricing debate amid a firm pushback from President Donald Trump. Edited excerpts:

India is giving shape to the largest health protection scheme with coverage for ten million families. How does Novartis see this development?
We are trying to understand how all this will work from the hospital settings and the outpatients setting. Overall, we continue to invest and expand our sites here. On the new health insurance schemes, most of the times we have seen that they increase patient access. That is good for public health and also helps companies like ours. The biggest topic for us is the role for innovative medicines and access to innovative medicines. How will such a system evolve? For the population, it will be great to have preventive care and care in the hospitals. There are questions but I am quite hopeful that this will lead to an expansion of opportunities for companies like us.

Will you look at driving R&D in India?
We have 8,000 associates in multiple locations in India. Our chief focus for future investments will be on increasing our R&D footprint here over time. Second is data and digital. I believe immensely in data and digital. There is an explosion in terms of opportunities in data and digital and there is a lot happening here in healthcare in data and digital. We certainly would like to build capacity to leverage that opportunity in the future. Third, we continue to see opportunities in business services in India, which remains our hub.

In R&D, what exactly will you look at doing?
We continue to focus on product development and that includes running our operations for clinical trials. Now, what we have done is actually design clinical trials here in India, which is a shift from where we were about a year ago. We have teams here that are designing clinical trials for our global programmes and for novel medicines in malaria and other major diseases. We continue to focus on chemistry work and chemical capabilities.

What about doing full-fledged drug discovery in India?
At some point, we would like to start looking at drug discovery and there we are very cautious. We have scaled operations here — from the drug development standpoint, India is our second largest centre in the world.

What are your needs for the discovery research centre?
Most of the times it has to be a cluster development where we see universities, start-ups coming together with big companies and in most places that we invest, we see a sustainable research cluster. We are still waiting to see that fully evolve. The ecosystem is evolving very rapidly but may be not at the same level as other countries in basic science and medicine.

Kymriah, the pioneering cell-based therapy for cancer treatment, is being much talked about. Where do things go from here for Novartis? The initial uptake of Kymriah is below the expectations of analysts.
We are really looking at Kymriah as a five-year journey. This is an extraordinary medicine and one-of-its-type approved in children and provides patients who have no other option of treatment. It is a science to take the cells out of the body and reprogramming them is really remarkable; but it is also so new that it will take time for the hospitals to be ready to take this on and manage such a complex therapy. From our side, we need to scale up the operations. Overall, it is in line with the expectations and we always knew that this will be a long-term strategy for cell therapy.
The important thing is as we go global, and we have announced the addition of a manufacturing site in France, we will build the infrastructure that also links us to all of these hospitals. We are focusing on three areas — one is to invest in manufacturing and make it very efficient and scale up; second, we are looking at expanding to more cancer types and we would think of covering all B-cell cancers. My hope as a physician is to live in a world where no patient should die from B-cell cancer. We believe there is a new science emerging that will allow us to create new cell therapies with different targets that cell therapies can attack, which we hope can apply to areas like solid tumors and that could possibly be the next breakthrough.
Our mindset is for the long term, of a five-year journey to get this to a blockbuster enterprise and that’s our overall goal. Our aspiration is that this could be a significant part of the Novartis portfolio.

The US has been at the centre of most healthcare debates and lately President Trump has been giving a strong pushback to price increases. How does Novartis see the future of drug pricing?
We as a company are very supportive to try and find a sustainable approach for the US healthcare system. We have to find ways to improve patient affordability and get the innovations to have a broad access. I would like to think that we need value-based pricing and have things like cost-effective research and have sustainable prices. We are watching very carefully and discussing solutions with the US government and we have to see how the coming months evolve as initiatives roll out.
Overall, the directions taken by the health department is right and in many areas they are targeting different elements of the system and seeing how we think of different classes of drugs and how we see biosimilars and reduce patient costs at the pharmacy counter. All of these are elements that are going to be important for a sustainable solution and I am optimistic that will be seen in the coming months.

Prices of newly approved drugs are moving steeply. Where does the value-based performance or pay-for-performance debate go?
We have to keep in mind whether it is for a chronic therapy or a one-time therapy. In the case of Kymriah, it is a one-time therapy and it becomes cost effective…The second thing to see is how efficacious is the therapy. In the case of Kymriah again, it has a 90% response rate, which is very high. It is important for us to explain to patients and society that some of these cell and gene therapies have an extraordinary level of efficacy — a single infusion — and the patient does not need to be treated again. So that will have a different price point than something that is chronically given every single month or every single day for thirty years.
ET 21AUG18

No comments: