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Executive Summary

J&J’s chief scientific officer, Dr. Paul Stoffels, and Novartis’ global head of drug development and chief medical officer, Dr. Vasant Narasimhan, were both among the global industry attendees at the recent BioAsia 2017 meeting in Hyderabad. They shared with Scrip their big picture perspectives on a range of key talking points around R&D, including the cost conundrum and the next big things in the world of medicine.


 five big questions for J&J


Johnson & Johnson‘s chief scientific officer, Dr. Paul Stoffels, and Novartis AG’s global head, drug development and chief medical officer, Dr. Vasant Narasimhan, were part of the star speaker line-up at the BioAsia 2017 meeting held recently in the charming city of Hyderabad, India.

In exclusive interviews with Scrip, both executives shared their views on a wide spectrum of topics including the challenging and exciting aspects of the world of pharma R&D, people issues amid the Trump administration’s tough position on immigration, and where the world of medicine in general is headed.

“Disease interception” and an HIV vaccine were some of the big expected developments referred to by Stoffels, while Narasimhan highlighted, among other topics, the broad new world of targeted therapeutics and the value of the microbiome. Both were measured on the impact on science and talent of the evolving US geopolitical situation, with Narasimhan underscoring the importance of “staying the course”.

Q: Scrip: These are exciting and challenging times for pharma R&D - immunotherapy, partnering with non-traditional players etc. - amid shrinking healthcare budgets, price pressures and a growing emphasis on real world data. What’s your take on the big R&D picture and what’s the most interesting bit?

A: Paul Stoffels: From a scientific medical perspective, times have never been never more exciting than now on the scientific platforms which we can work on. Immuno-oncology is a huge revolution and it’s only the beginning. We’ll go from very broad immune-oncology drugs to much more specific targeted drugs. Lot’s happening there.
With the human genome, the targets/pathways knowledge becomes so strong that we are very capable of influencing the biology by different pathways. We learn about how cancers escape pathways, so we can target cancers in different ways to block them. If you look at the microbiome and the influence on the immune system on diabetes, on the body… it’s only starting to understand but we now realize it has an important role.

Molecular diagnostics, personalized medicines, new platforms - the antibody platform, vaccine platform, cell therapy, tissue - there’s never been a better time to advance medical solutions than now. Combine that with new technology - information technology as well as devices and diagnostics - I think we are at a unique time for big breakthroughs. That is going to be needed to come up with the solutions for healthcare in the pressures described.

We will have to find much more effective solutions on a large scale to solve big problems in the world. We are at the breakthrough of science and technology where many of the medical solutions of the future, we should be able [though this is visionary, he emphasizes] to bring that to very large parts of the population with very good solutions. If you are not optimistic in this business, you shouldn’t be in it; the science makes you optimistic today.

A: Vasant Narasimhan: R&D in the industry goes in waves. Right now we are in a situation where we continue to produce more and more innovative medicines but there’s more uncertainty about the access those medicines will get and peak sales they might achieve.


Our challenge is to continue to invest in R&D, the way we invest in it. The way we look at it in Novartis is we currently have a situation where there’s so much new technology out there and it’s going to lead to a new wave of innovation. If we achieve the next level of breakthroughs, we think society will find ways to pay for these medicines, assuming they deliver those outcomes.

What’s clear to us when we now look at an R&D project is that we know it has to deliver significant outcome/symptom benefits for patients. Patient-reported and patient-oriented outcomes are more and more important for people in terms of quality of life benefit. And then we need to show a healthcare system benefit. That’s probably the big shift now in our thinking, where we move from a world where it was enough to show the clinical outcome that a regulator wanted to now having to show this healthcare system effect.

There’s so much more better understanding of the biology of disease, so many more new technologies whether its CRISPR, protein degradation, immunotherapy, cell therapy, the microbiome, all of these will lead to new therapies that will improve patient lives.

Q: How are you managing people issues in the backdrop of what we hearing from the new Trump administration in the US?

A: Stoffels: We are a global company. More than half of what we do is outside the US. We have companies from all origins - Janssen was a Belgian company, Synthes, a Swiss company. We have brought in, over the years, companies from the UK, Europe, Asia; we have a community in J&J which is a real global community.
And short term issues which are appearing now will not bring us down or have a significant influence. We have so many opportunities for talented people to work wherever in the world; we will always be able to employ people in the world wherever we need them.

From the science perspective, we go to where the best science is and that depends a little on capabilities in countries - institutional capabilities, the biotech environment. The ideal world is where there’s good basic science with top talent and there is good biotech/technology company capability. That’s when you have the real space for innovation and that’s where you will see us significantly more present.

Today, we have about 400 external collaborations, whether through venture capital, incubators or collaborations and we’ll continue to expand that. I don’t see the current hiccup in international relationships as a fundamental challenge for the science going forward.

A: Narasimhan: It’s too soon to judge what a Trump administration will or won’t do. The way we look at it is that we have to stay the course and focus on science-based innovation and keep trying to attract the best people and retain them because in the end, R&D is very much a people-oriented enterprise.

You need great scientists and clinicians in order to develop these medicines. We’ll adapt based on what we learn from the policies that are actually rolled out.


Q: The US Tufts Center for the Study of Drug Development had, in 2014, pegged the cost of developing a prescription drug that gains market approval at $2.6bn. Can pharma really afford such cost levels given the current pricing pressures or has technology pruned this number significantly?

A: Stoffels: It is expensive. Technology has helped us in different forms – not just IT platforms, the know-how on pharmacology, the insights on molecular biology. The probability of success is increasing significantly. We prune portfolios very early based on very good scientific insights and those products we bring to the clinic have a significantly higher probability of success. We focus on a number of disease areas (you can’t do everything) and are very good in those and then we bring the best possible science in. And we try to bring the next breakthrough in that area. That has proven to be very successful for us - bring the cost per molecule down and accelerating the time to result. That has to do with global development capabilities.

If you can go fast with very good science on a global basis, you can still afford it; if you go slow with less good science on a regional basis, it is very challenging. It’s very difficult to develop a drug just for one region in the world. You need the world to pay for the development cost of a drug today and therefore you have to be global, fast and best science. It is expensive and [the cost] can’t be generalized but it is still productive if you do it well.

A: Narasimhan: There’s a huge variability in how much it costs to bring a drug to market. The Tufts Centre tries to account for all the attrition/failures that happen in the pipeline. We don’t publicly quote a number but depending on the indication you can go after, you can find a wide variance. A biosimilar can cost very little to bring to market whereas obviously if you go into cardiovascular outcome studies the costs will go up quite dramatically for a single project.

What we have to keep focusing on is applying technology to bring down the cost of development – every element of drug development. At Novartis, we are investing in continuous manufacturing and other novel technologies which will allow us to bring down the cost of producing drugs, clinical trial material etc. We are investing in digital technologies and infrastructure, so that we can automate more and more of the drug development process to bring down the cost of a clinical trial.

There is lot of opportunity there when you think about how we can apply technology to clinical trial sites, how we handle data/run our operations. The third big area is to use technology to come up with better end points which allow us to get the answers that we need much more quickly whether that’s using digital sensors or other technology. I think if we could do that, we could drive down the costs of drug development across the board.

The other element is getting smarter about the early stages, the preclinical science that defines which compounds we will take into the clinic. Some of the things we could get better at is looking at how to predict which compounds will have toxicity in humans; animal models have, in general, been not great in predicting toxicity or efficacy. If we could do all of that, we could make better decisions of which compounds we take forward, pull down the cost of drug development.

We can actually demonstrate that there are economies of scale to being a large pharmaceutical company that has expertise in doing large-scale global development. We feel quite confident in that. Our goal is to drive down the costs of development significantly and we are making the investments to do that.


Q: Do you see potential value that can be derived from reverse innovation - for example innovations that are designed and created for emerging markets, and then maybe brought to developed nations? In the devices space, GE Healthcare has created a portable, rechargeable and low-cost electrocardiogram that was designed to service rural and low-income areas of India but has potential value in several other markets.

A: Stoffels: The first place where it is happening a lot is in consumer. Our consumer group does a lot of innovation in Asia, which comes back into the US. It’s remarkable how much innovation is done in the consumer, the beauty space in Asia. In medical devices, it is going fast because it is engineering and technology - that’s where we also have innovation which we do in Asia in the surgery space which will eventually come back. In pharmaceuticals, where it comes to simplifying therapy like making combination pills or applications from existing [therapies], typically in the generic space, it goes well. The most advanced pharmaceutical science – to do the newest antibodies or the most advanced cancer immunology – it’s not reverse engineering.

What happened over time in most diseases - you have a certain target and a maximum achievable benefit with that technology. You have a first invention, a second, third and then the best-in-class – once you have best-in-class typically there is no space for innovation anymore. And if that becomes generic, you have different types of innovation.

For example, the pharma industry worked for a long time on different antihypertensives. Today there is almost no innovation but when it then comes to the multi-pill, the diabetes combination with hypertension, you have things which come back.

A: Subodh Deshmukh (head of global development India at Novartis): When you have an integrated R&D set-up like we have, there is always an exchange of ideas. For an upcoming malaria medicine, a combination, one component of that combination was optimized out of an idea that came out of the team in India, essentially enabling a once-a-day dosage which is very important given the compliance needs for malaria.

It’s a kind of innovation that we can contribute from India and we are very well set up to do that across all our programs whether in the clinical space, data mining or actual product innovation.


Q: What’s the next big thing that you believe could potentially impact, positively, the world of medicine like never before?

A: Stoffels: The next big thing, not from a company perspective, is preventing diseases from happening or intercepting them, and that will have to do with early diagnosis and curative therapy. And all the platforms are there to do it and we have now to implement it.The next big thing we are working on is an HIV vaccine. That for me is the next big thing. If we could prevent HIV in the world we could prevent massive amounts of suffering in the years to come – that’s just one example.

A: Narasimhan: We are going to get much better at targeting our drugs to patient populations and identifying patient populations that will truly benefit whether that’s through genetics, biomarkers. I think we are really getting the understanding beyond cancer to actually target medicines much better.

If you look at some of the work being done in areas like severe asthma, rheumatology, we are going to be able to target these medicines better and show that benefit. That will also enable us to do the outcomes-based work. That’s an area that is opening up.

There’s going to be this whole new world of therapeutics where what we think of as a therapeutic is going to change over time. You start to see that now with autologous cell therapies and we’ll see if we can get to allogeneic cell therapies. That opens the doors; then you start to think about digital technology being combined with a drug to actually show the benefit.

Things like altering the microbiome – can we intercept much earlier in the world of autoimmune diseases? Each one of those can also turn into a whole new set of therapeutics, which we perhaps had not even thought about as therapeutics. There’s no question that CRISPR-CAS9 and the related technologies will lead to completely new sets of therapies; it’s changed how we can think about altering disease.

The third is how do we expand access to these medicines. The global obesity/hypertension epidemic is no longer a problem of just the developed world, it’s a global epidemic. The WHO has made that rightfully clear. The imperative now is going to be how do we think of creative ways to get much more patients access to these medicines.


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