Cutting-edge gene therapy arrive in Hungary too - Interview with the CEO of Novartis Hungária

When starting new R&D projects, the largest pharmaceutical companies such as Novartis need to anticipate the future due to the long-lasting development of medicines: what is the disease you need to find a solution for in the next 5-10-15 years. What are the areas, diseases, groups of diseases that Novartis is focusing on now and why? How many people in total are affected by these diseases?

Matt Zeller: The uniqueness of the R&D portfolio of Novartis is its diversity.  Novartis, as a research focused company is searching for solutions for a wide variety of diseases and disease-groups.

We reach about 800 million people with our product portfolio globally.

If we are talking about our R&D portfolio, we should raise the question to ourselves of what are the impacts we would want to achieve with our medicines in the future. We are analyzing what are those unmet patient needs currently or in the future and how we can solve them with unique therapy solutions.

How many research you are running currently?

We have 150 projects in clinical development globally. This includes projects in early development phase as well as projects in the ‘close-to-final’ phase too. We are confident that these R&D projects will answer to unmet patient needs globally as well as in Hungary, offering access to innovative, leading therapies. Simultaneously, we are putting emphasis on our targeted gene therapy researches that can be milestones in the international battle with rare diseases.   

How should one imagine Novartis’ answer to develop a solution for a disease? How typical it is that R&D is still in-house or acquisitions and mergers are more popular if you meet a qualified project internationally? In recent years what are the trends in this area, is it rather acquisitions that are dominating?

We need to put it into context how our R&D is working globally. The Novartis Institutes for Biomedical Research Center is located in Cambridge, Massachusetts, the headquarters of the company is in Basel, Switzerland, while we also have an R&D facility in Shanghai. These 3 locations are the most significant from our R&D work point of view. In terms of the realization of R&D projects, we typically have had a hybrid model, meaning to have projects in-house and with 3rd parties too. To quote James Bradner, President, Novartis Institutes for BioMedical Research: „We don't suffer from ‘not invented here’ syndrome”. We aim at bringing a new way of thinking, a new methodology, innovating a new medicine. However,

during the past decades, Novartis was focusing on improving the level of R&D partnerships:

currently we are in contact with over 300 scientific and 100 industry representatives, and these cooperations are not only improving our effectiveness but also help us to access early development stage research projects that we consider advancing for patients.

Having already mentioned the collaborating partners and their importance, we cannot go beyond the announcement made a few weeks ago with Semmelweis University and the Department of Innovation and Technology. Would you introduce us to the details?

It is a tripartite agreement based on three pillars. Clinical research play an important role in this, where our goal is to exploit the potential of digitization and to accelerate processes; the other component of the agreement aims to tackle CVD in an entirely new way, committing to new CV research and a focus on using new tools and experimentation with data & analytics, artificial intelligence and machine learning-based, HCP & patient education, and drug and non-drug interventions to answer that question of “how can we make an impact on CVD in Hungary”.. The third element of new partnership specifically aimed at fostering gene therapy

In which areas specifically?

This field is currently one of the most exciting slices of science and innovation in Hungary and around the world.

For Hungary, this area will be especially exciting because, as a result of the cooperation, we will be able to achieve results of international significance in cell and gene therapy in the field of SMA (spinal muscular atrophy) and genetic eye diseases by connecting key players in the innovation ecosystem. Pharmaceutical innovation and public health impact are both a priority for us; given this potential societal impact, our planned collaboration to tackle cardiovascular diseases can hardly be overstated.  It is well known that this is one of the biggest disease groups and public health problems in Hungary.

Let me illustrate this with some numbers: every 8 minutes 1 person dies in cardiovascular disease in Hungary; over 60,000 deaths occur in this context each year, and a significant proportion of health expenditure is accounted for by cardiovascular disease. From this point of view, it is definitely justified to start our joint program. The goal is to reach 50,000 patients in the first 3 years and identify new ways to prevent and treat cardiovascular disease nationwide. Being a founding member of such a public healthcare program is a unique and historical task of importance for a pharmaceutical company.

How do you split the investments and resources among the partners?

All 3 partners agreed to contribute, which can be finance or professional resources and capacities behind the program. Currently we planning the executional process. 

How typical are such collaborations for Novartis, how special is this project in Hungary?

Over the past 2-3 years, Novartis has been looking for answers to the question about how it could cooperate differently with the members of the health care ecosystem representatives globally. This takes the form of various collaborations and investments within the company. One of our biggest press coverage collaborations was when we partnered with the London NHS two years ago to also treat cardiovascular disease more effectively. Our goal was to reduce the risk of heart attacks, strokes, and resulting deaths.

There is a lot of similar cooperation going on, but

I can proudly say that Hungary is among the first in the European Union to announce such level of cooperation.

We also consider it extremely important that our cooperating partner, Semmelweis University, is one of the most important and knowledgeable research institutes in Central and Eastern Europe.

This new program will be a perfect pilot program where we can try things like artificial intelligence, machine learning, new methods of teaching, new tools, new systems, new programs and new campaigns.

And as we launch the program, we’re constantly analyzing the data in the background so we’ll see what works and what doesn’t.

Still focusing on the relationship between Novartis and Hungary. The last time the company was under the spotlight here in Hungary was when Novartis’ gene therapy treatment got included into reimbursement.

That's right, it was a very important milestone that Hungarian patients also have access to the latest therapies. With such act, it becomes clear what impact our pioneering therapies can have on patients, because it is an extremely stressful disease for families affected by SMA. However, with treatment based on gene therapy, we have the opportunity to reprogram the defective gene.

Is this also strong evidence that gene therapies could be of immense importance in the future?

Although gene therapy falls into the category of science fiction for many, gene therapy is already present and can have an extraordinary effect in patient treatment.

Novartis is investing $9.5 billion internationally in R&D covering a wide range of diseases. It is true that these targeted therapies are primarily for the treatment of rare diseases and therefore affect only a few families, however, these treatments can change the entire lives of the families involved, and the platforms we are investing in have the potential to treat even more patients in need in the future

How can Novartis Hungary be positioned within the group and among domestic pharmaceutical companies?

In terms of local revenue, we are talking about the largest pharmaceutical company,

and we are still working on how we can play a greater role in the development of the Hungarian healthcare ecosystem.

We are currently investing 3 billion HUF in clinical trials locally

that is about 10% of all clinical trials in Hungary that are related to Novartis, which illustrates our weight. Hungary is one of the most important countries in Central and Eastern Europe for Novartis. We find that there is a real commitment to the late- and early-stage researches. The Hungarian infrastructure and healthcare ecosystem are still competitive in the area of clinical trials.

What trends do they see in the field of clinical research and how does Hungary fit into these?

It is a common phenomenon that

clinical trials are also becoming increasingly more digital,

with less personal physical contacts, and that databases are becoming increasingly important. This is a global trend, and Hungary is no exception from its effects either. The tripartite partnership agreement we have concluded will be the tool for Hungary to catch up and have access to the latest technologies that will determine the future of research. In terms of data availability and databases, the Hungarian EESZT and the recently announced eMedsol platform together move Hungary closer to the unique position of having a „national” platforms that are a wealth of data and can help Hungary to advance patient care and HCP coordination in the years ahead”. It would be really important for everyone to recognize the importance of this, and it is also used boldly by patients, for example, but doctors also need to be involved in this process. The aim would be to get the most out from these digital systems.

Digitization also means that the process involves less paperwork, administration and saves time. In addition to all this, smart devices have revolutionized the possibility of digital tracking, there is no need for as many physical meetings in the doctor-patient relationship either.

And we have arrived at another critical trend that influences the future of health care, that is telemedicine. How do you see Hungary in this area?

Thanks to the Covid pandemic, Hungary has made great improvements in telemedicine. We have also experienced that over the past two years, decision-makers have taken the necessary steps and created the necessary regulatory environment for this. I see that there is an effort, an investment by the decision makers, however there is another important question, that is how we can allocate the health care resources, be it financial or other resources, in a way that can have the biggest impact for the lives of patients.

Perhaps we can also say that there is such an urge because healthcare is the area for which money is never enough, there could always be more.

That’s right, financial constraints are present in every country when it comes to healthcare budget. The situation in Hungary is not unique either in this respect. We need to face with the aging population, but we also need to recognize the new opportunities that technological change has brought. Nowadays, there is a great need for new approaches, new ideas, we need to monitor what works and what doesn’t, and be comfortable with shifting resources to where the impact is the highest. The goal is to achieve the greatest healthcare benefit for the society from every invested forint.

Healthcare budgets are limited, but in the meantime, developments, researches and the medicines will not be cheaper. How can this contradiction be resolved?

Indeed, everything is getting more expensive: raw materials, labor, technology, professionals. Meanwhile, the success of the pharmaceutical industry as a sector so far has been due to its ability to find areas that will have a major impact in 10-15 years. It has never been easy, but by now it may be even harder to find the points that can have a significant impact on people. And these require even greater risk-taking and investment by the companies, and Novartis is bravely taking these risks for the benefit of patients.

Cover photo: Novartis