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I’m the only practicing physician in the room today. I do medicine and haematology at the Christian Medical College. We established a centre for stem cell research at this institute in 2005, and in 2007, it became a translational unit of the Institute for Stem Cell Research and Regenerative Medicine Bangalore.

As a physician, I greatly appreciate the Indian pharmaceutical industry in terms of the range of products that they have brought to the people in this countrysmall molecules, peptides and monoclonal antibodies. I collaborated with Dr Reddy’s Laboratories for the first biosimilar they brought into the world.

Dr Cathy Charedi and Agha group collaborated to do some clinical trials that brought the first biosimilar rentex into the world.

Unfortunately, the risk appetite has not been there in India’s pharmaceutical space. It is not for lack of funds because research is much less expensive in this country than in Western countries.

We have access to a good range of conventional and classical products. But we have fallen behind when it comes to the more modern therapeutic space, like targeted therapies, more advanced monoclonal antibodies, and of course, cell and gene therapy.

And a space where it is hurting us a lot as a country is the entire car T cell therapy for cancers, where we have a neighbour-China- that did not innovate, but it is fast following in a way that now beats the leader- the U.S.-strongly.

At CMC, we realized that cell and gene therapy would be important, leading to the creation of the Centre for Stem Cell Research.

I had the privilege to have a ringside view of some of the developments in the world in the haematology space with gene therapy, and, therefore, I knew that it was possible to do this in India.

We have just put the right components together and received support from the Department of Biotechnology of the Government of India to establish the centre. In the last five to 10 years, we have innovated and established strategic collaborations with two universities in the U.S.

With that knowledge, scientists here have innovated enough that we now have proof of concept studies completed for gene therapy of three or four major unmet needs in India and the world. I’m talking about bleeding disorders, like haemophilia, which is at the forefront of gene therapy approval products worldwide. I’m talking about the major haemoglobin disorders like sickle cell disease, where one product is approved, and more are soon to come. We have several technologies that are both vector-based as well as gene-editing approaches.

The important next step for us would be to collaborate with the industry because it’s good to complete the proof-of-concept studies at the academic level. But unless we can collaborate with the industry to take it forward, it will remain as IPs and publications.

That has been a challenge, and we have been searching for this collaboration for nearly a decade. Thankfully, in the last two or three years, there have been at least two groups that have dared to commit to this investment and engagement. India does not allow phase one studies to be done with products developed outside India. We don’t trust ourselves to understand science developed outside. We fear we would be unable to protect our participants in clinical trials if a product is made outside and not, you know, owned, or developed in India.

But things are changing. We are doing the first lentivirus Vector base mattapoisett extensor autologous transfused factory gene therapy for haemophilia with a product manufactured in a U.S. academic facility but undergoing phase one trial in India. The justification was that we had co-developed the research, and therefore, we have the license freedom to operate with that product in India.

Even though it was not manufactured here, it will be considered an Indian product because the research was collaborative.

There have been other situations where if we had trusted ourselves and our ability to evaluate science, we would allow others to bring phase one service to India, with, of course, the negotiation of allowing access to such products if they go further within our healthcare system.

These are exciting times, and there are challenges in this country. But there is also a lot of positivity about developing this area. And I’m hopeful that in the model that we’re trying to function, at least in this small space of Haematology disorders, and gene therapy, we could do something very significant in the next two to three years.

DR ALOK SRIVASTAVA, Head of Stemcell Research, Christian Medical College (CMC) Vellore.

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We operate in a very limited resource ecosystem in India. So rather than go for the full marathon, one can go for a low-hanging fruit. But rather than look at single-molecule drugs, one can look at the solid-state crystalline complexes, the supramolecular complexes of drugs. And this moves the innovation from 10,000 molecules or 10,000 possible molecules leading to a drug at the end of the long tunnel to something which is a much more telescoped and truncated process.

ENTRESTO, launched by Novartis, is an acute cardiac drug, a combination of supramolecular, hydrogen-bonded tri sodium pentahydrate, Hemi pentahydrate, salt of valsartan and sacubitril.

It was the first in-class drug to be approved in the category by the US FDA. And it has proved to be the best in class and has a blockbuster status today. At least half a dozen drugs are in the late stages of clinical trials and are likely to hit the market very soon.

The Indian pharmaceutical industry, which is largely a generics industry today because of historical reasons, can enter the innovation space but with a calculated risk and a timeline that is not going to be a decade long but something more like one- or two-years R&D. Another area of innovation in India could be in the con- tinuous flow process intensification. Several academic institutes like CSIR, Institute of Chemical Technology, IIT Bombay etc., are working on this. Collaboration in the area of flow process intensification, which is more towards manufacturing rather than for drug discovery, will accelerate and bring the manufacturing process of the drugs at par with Western pharmaceutical companies.

Investors are looking at short timelines during which they want to see value for return. One way to achieve this is to move from traditional metal-based catalysis to bio-fermentation and biocatalytic processes. Pharmaceutical R&D could focus on bio-fermentation and biocatalytic enzymatic processes.

The areas which I would like to emphasize are that rather than going for the full-scale drug discovery model, we should opt for the telescoped version, the accelerating rate, med Chem discovery, and the drug development, that are supramolecular complexes.

And last but not least, spe cialized processes based on biocatalysts fermentation and handling of fluorine through the flow reactors.

PROF. ASHWINI NANGIA, Dean, School of Chemistry, at the University of Hyderabad and

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The industry-Academia collaboration is an important aspect. This is happening now with more interdisciplinary research activities.

There is consistency in collaboration which is critical. But there are several questions to be answered.

Is the research more application oriented? Papers are being published, but convincing scientists to collaborate with industry is taking time; change however,

The single target-based small molecule design may not work, and we should be going more towards a combination of synthetic chemistry and synthetic biology and targeting the

Nanomaterials are emerging as an important set of components that can regulate biological processes.

The knowledge we gained from biological systems and biochemistry is moving towards the chemical biology approach when using chemicals, small molecules, and other materials to regulate biological systems.

And that is where more academic research focus is going on. And in those areas, collaboration with industries is important.

Funding is a major challenge. Funding is inconsistent, and even if it comes for one year, for the second or third year, there is no assurance it will continue. So how can anyone venture into risk-oriented research without the financial wherewithal? This is the situation in many academic institutions.

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The Bangalore-based National Centre for Biological Science led the building and setting up of the Bangalore Life Science cluster, a model of innovation and an academic institution with a programme that goes beyond fundamental research. This is a step towards creating an ecosystem for the start-up industry to engage with scientists.

Bangalore Life Science Cluster (BLiSC) is a unique hub of excellence in biological research in India. Nucleated by the National Centre for Biological Sciences (NCBS), a premier centre for cutting-edge biological research and training in India, the Bangalore Life Science Cluster includes two other research institutions in Bangalore – inStem and CCAMP.

Each of these additional entities has its scientific mandate but benefits from and contributes to the rich environment in basic biology already offered by NCBS.

It is envisioned that these synergistic associations at the Cluster will have a far greater impact on life sciences research than the sum of individual contributions from each institution.

The BLiSC, therefore, is, in some sense, a microcosm of a research innovation hub, utilising the power of genetic technology along with collaborators like the Tata Institute for Genetics and Society.

It is providing the wherewithal to translate DNA and nuclear nucleic acid-based technologies for the benefit of society.

This collaboration worked very well during the COVID pandemic. At the beginning of the pandemic, there were no tests for COVID, and everything had to be imported. Some of the small, medium-scale industries began to innovate. They borrowed technology and began to create the structure of COVID tests, which were exorbitantly expensive globally.

So, we took it upon ourselves to create an affordable alternative. So, affordability is also a hallmark of what the innovation industry in this country or the innovation potential in this country can lay claim to. We set up a large platform that included 200 SMEs to build the pipeline for COVID diagnostics.

From Rs 1400 per test, with a substitution of Indian-made molecules, including nucleotides, primers, probes, fluorescent dyes, or whatever is needed to make these diagnostic kits, the cost of a single test came down to Rs 15! This took about six months to set up.

Academic institutions like NCBS, IISc, Bangalore, and ICER Pune joined to provide chemistry support, collect clinical samples etc. Today, all units’ combined capacity is about 10 million tests a month.

The ecosystem is now being repurposed to make it broader-based or making it more, more disease agnostic. Several small and medium-scale industries continue to connect to the academic centres, which act like Centres of Excellence for various kinds of needs that these industries have.

So, in a sense, they have their back-to-back research structures in these industries. There is zero funding coming from the government for this support; we got all our money from outside. In fact, this whole effort was supported by the Rockefeller Foundation, of course, facilitated by the principal scientific adviser to the government.

We can always build and ramp up and pivot academic institutions towards crises. But the interest of academics, too, must be ensured. Money cannot be pumped into academic research without asking questions about the research and what is translatable. This is critical for the ecosystem, or the funding pipeline through public and private engagement will dry up.

And even more pernicious, is a nationalist sort of jingoism. Whatever we do here, is done as part of a human species and, therefore, cannot be exceptional.

This exceptionalism must not be allowed to creep into the policy sphere, or it will stifle the potential for innovation in the country. We were fortunate that we were able to get the AstraZeneca vaccine from Oxford, or we would not have fared as well as we did.

We are living in an incredibly globalised space. And it is to our advantage that we are part of that global ecosystem and play on an equal footing in this challenge of looking at the future.

India will be the brand face of climate change, which will be overwhelming. We need our innovations, but also, we need to see what is happening in the rest of the world so that we can borrow and repurpose innovations that will help us mitigate these crises.

There is a huge opportunity here for an open, engaged scientific system, well-funded with an indus try ecosystem.