“Good to find India well represented in fight against anti-microbial resistance”

In an exclusive interview with the BioVoice News, Mr Daniel Berman, Lead, Longitude Prize shared his view on the Indian bioscience sector and much more

Daniel Berman most recently worked for the World Health Organization in Ethiopia on a local pharmaceutical production project and was the general director of Médecins Sans Frontières (MSF) Southern Africa office in Johannesburg, South Africa. He brings to Nesta more than 15 years of international public health experience as well as expertise in stimulating and developing innovation in both medicines and diagnostic products.

The £10 million Longitude Prize, run by innovation foundation Nesta, was announced in 2013 by then UK Prime Minister David Cameron as a step towards conserving antibiotics for future generations. Recently, Mr Daniel Berman, Lead, Longitude Prize, was in India to attend a series of workshops for creating awareness about the competition among startups in various cities. In a freewheeling discussion with the BioVoice News, Daniel talked about the steps taken by Nesta to help Indian innovators to speed up their R&D to develop affordable diagnostic solutions. Read his detailed insights below:

BV_icon-150x150Why has the Longitudinal Prize worth £10 million been kept only for diagnostic products that offer solution to antibiotic resistance?

Yes, the focus is anti-microbial resistance and as you know, globally there is a crisis as there are only few antibiotics left with no or little resistance. It is a fact now that for most of the respiratory diseases including TB, the 70 percent of antibiotics don’t work. These people have viral infections and the antibiotics don’t do anything. There are less and less antibiotics to turn to. The problem today is that these is no test that is affordable, available, sensitive or specific enough. We are looking for a test with high sensitivity to infections.

There is a risk that we are going to the pre-antibiotic era. There would be crisis in the longer run where  surgeries such as Cesarean operations would become difficult because of not enough antibiotics to prevent infection. Any other surgery too would become difficult life threatening. In case of oncology, the patients taking chemotherapy could become immuno- compromised if there is no way to protect yourself against infection. Here in India, the one of the most critical of diseases is tuberculosis but we are looking at it from the global perspective as well. At the same time, it is good to find that India is well represented in the fight against the anti-microbial resistance.

BV_icon-150x150What is the methodology that startups must adopt for product development to win the Prize?

The idea must be clear and that is to develop the rapid diagnostic test which must give the result within 30 minutes of the sample being deposited for examination. It should not be dependent on mains electricity for plug-in and must be handy. Moreover, it should be addressing the problem globally. There are different ways of developing a test. For example, if a test that can differentiate between virus and bacteria is developed, it could win too. Today there is no test available that is sensitive enough to detect the resistant bacteria. We are, therefore, looking at a test with high sensitivity. We are also currently looking at finding a solution that is relevant globally.

While the confidence in the idea is great, they must also have data to show that it works beside a plan and facility ready to scale it up. However, let me clarify that to win they don’t require the complete clinical data validation. Nesta and its partners could help in designing the clinical studies and fund them as well.

BV_icon-150x150You said Indian companies have done well so far while participating in this competition? How many of these teams are from India?

Let me explain how this works. To participate, one needs to just sign up on our website and it is quite easy. Of course, few are rejected and many are accepted based on the fulfillment of criteria. Some basic information about the work and team and the registration is done. So, the idea is that to win this  £8 million prize, you need to register as a team to compete.

There are five Indian teams so far that have been selected to work on their idea under Discovery Award. Out of total 240 teams registered across world, 50 belong to India and that is quite substantial. In terms of research, some of them are sitting in the Institutions, few are companies, some are individuals. Team could be led by the engineers or the microbiologists or any other expert with clear idea of developing product. It is good to see that India is well represented and the reason for that is our close partnership with BIRAC which is using its network with incubators and accelerators to identify the teams that can compete and make these rapid diagnostics.

“There is a risk that we are going to the pre-antibiotic era. There would be crisis in the longer run where  surgeries such as Cesarean operations would become difficult because of not enough antibiotics to prevent infection”

BV_icon-150x150How many of these applicants are inching closer to realizing the goals?

So far we have got 240 applications. Some have got rejected and some have been given specific inputs on improving their path to technology development. The final deadline is September, 2019. So there are close to two years still left for the teams to work on their products. As I mentioned, to win or apply, you need three prototypes, business plan and 30 minute criteria.

BV_icon-150x150Have the members of industry and academia joined hands in few cases to jointly pitch their idea as a team?

It is a good point. In order to develop a viable solution, the team has to have a strong medical advise. It is a real risk and drawback for few teams which develop a product prototype without medical inputs. There are many examples where we see industry and academia together. There is a Delhi University team that has joined hands with a private hospital.

In terms of challenges, the point of care is an issue. Today when there is a fresh case, the patient’s sample is taken to a central laboratory. The amount of time used to send the test sample and get the result report is currently very huge. Doctors are giving the medicines immediately today because they can’t wait for results as the patient’s condition might deteriorate. A rapid test can help to determine the need for antibiotics or not. Here we are talking about a test that can be done in the doctor’s office or in a public facility or may be pharmacy. It would be rather run by a nurse or a technician at bedside. It has to be a point of care test.

This project collaboration with BIRAC, allows the interaction between Indian and UK teams. This partnership is interesting because this is an opportunity for diagnostic developers in India to connect with the researchers in UK and vice versa. We are holding a workshop in October to facilitate that. We have done it in Pune, Mumbai, Delhi and Bangalore.

BV_icon-150x150How has been the response from the individuals and startups at these workshops?

This prize has been open since 2014 but there are many in India who were not aware about it. So besides connecting with them, the workshops offer a platform to exchange and generate new ideas. The people are curious about the prize and thus ask lot of questions. One thing that is daunting is the 30 minutes of point of care. We are asking for the miniaturization and stable reagents, they don’t require refrigeration. From the sample taken and result delivered should not take more than 30 minutes. As a test developer, it is a big challenge.

BV_icon-150x150Talking about the Longitudinal Prize product outcome after 2019, how will the masses benefit from the innovation? What kind of product is expected?

The mission behind the Prize itself is to come up with an innovative and affordable product for tackling antibiotic resistance which is a mass issue.  It could be like pregnancy tests where the strips are thrown away after one use.  The tests will be for developing countries and hence based on type of test, the cost naturally will be much lesser comparatively. The hand held reader type device could be also good for patients due to miniaturization.

By chance, if the products are  still bit expensive, there is a precedent of having a subsidy by the government. If TB  and AIDS medicine are offered free to patients, on similar pattern it can certainly happen here too. Of course the test has to be piloted before it gets massively distributed. It would be an added advantage for the team that has also created a market plan.

BV_icon-150x150Are there any other priorities apart from AMR that would be chosen for the competition in longer run?

We are trying to make the surgeries cost effective, which as of now are highly expensive. Infact, there is a meeting that being held at Italy in December this year where this is one of the topics of discussion. The basic thought is to develop affordable products for masses in developing nations. For example, the biodegradable screw for child related torn ligaments in the Europe is highly costly and patented. At the same time, In India, doctors are still using metal screw and the children using these have to be operated upon to remove that later. It is shocking that such technology benefits are not accessed by masses. The local innovations and subsidies for mass applications could help in overcoming the shortages. If subsidies can happen in case of cancer drugs why not surgical products.

“Today when there is a fresh case, the patient’s sample is taken to a central laboratory. The amount of time used to send the test sample and get the result report is currently very huge. Doctors are giving the medicines immediately today because they can’t wait for results as the patient’s condition might deteriorate”

BV_icon-150x150How do you view the biotech sector in India as an outsider? How do you look at the strengths and challenges of Indian biotech system?

The biotech sector in India has certainly witnessed the transformation. The perception here is that the sector is a big opportunity with new dynamic set of workforce that is undergoing development currently. The researchers and new age entreprenurs have lot of opportunities based on low cost model as compared to other countries. New incubator spaces and technical support by organizations such as BIRAC is giving them confidence. I am pretty optimistic about the biotech sector in India.

I think the strength of Indian biotech ecosystem is the presence of highly intellectual and skilled researchers. The big challenge is to retain them as the lack of opportunities is driving them out of the country. For example, the IIT-Mumbai’s 50 percent of students are going abroad. I don’t know if the figures are old or the things are changing but the opportunities that are now being created are becoming rife. One more strength is the cost of developing the product which is much lower here as compared to manufacturing in the Europe or US.

Among the challenges is the lack of funding to the research initiatives. While it is improving now but needs more attention. Also, the translational part of the product development is still a challenge. The institutions don’t have the enough expertise on intellectual property rights. The BIRAC is doing its bit on these fronts but will take time to reach the needed levels.

The companies are doing the sub contracting for the tests developments of bigger global players. There is need to do the India specific development of such tests. That is another challenge. Another issue is that the clinical validation is required and due to issues in regulatory setup, the discouragement happens within the companies who are developing such products.

The biotech industry needs to engage the medical community who generally say that they have lot of patient load and can’t participate in such exercises. They need to be convinced. The non communicable disease such as diabetes, cardiovascular diseases need solutions that should work for life. The government must steer the capacity  strategies to ensure that the communities that are working for clinical validation get support. Ownership of the clinical trials is a must. For few patients who have no access to early products, the clinical trials are seen as a hope. But it would have some ramifications as it might backfire. The compassionate use selectively is fine.

In terms of discovery or development of molecules, it would be interesting that if Indian groups take advantage of the international funds. Even if it is risky, it might give at least a clue if not a product. There is also a need to utilize the vast traditional knowledge to create new chemical or biological entities. The key is to find ways of generating ideas through vast network of institutes, take them to industry and get the answer.