Building an Accessible and Sustainable Global Healthcare System with Innovative Solutions

The global pharmaceutical sector is expected to reach a valuation of $1,470bn by 2028. Yet, amidst this growth, it's imperative to ensure that pharmaceutical products are not only affordable but also accessible worldwide.

Lamark Biotech Pvt. Ltd., an IKP-supported start-up and recipient of the Biotechnology Ignition Grant (BIG 18) by the Biotechnology Industry Research Assistance Council (BIRAC) in the drug and drug delivery category, is emerging as a key player in this landscape. With a global vision, Lamark is developing innovative solutions in the biopharma sector to improve the accessibility and affordability of molecular medicines.

Here, we speak with Vaibhav Bhatia, Founder and CEO of Lamark Biotech, to learn more about his vision for the company’s growth, and how partnerships with organisations like IKP Knowledge Park and BIRAC have helped him in his journey.

How does Lamark Biotech help provide affordable healthcare solutions globally?

Lamark started with the objective of innovating in the biopharma space to address some of the biggest challenges in this industry, and to the healthcare system. We realised that there are a lot of life-saving medicines—many of them already out there, others upcoming—but a lot of the design of healthcare has happened around the developed world. The developing nations have not got the benefit.

And for fair reasons. Such nations typically do not spend a lot on R&D or have sufficient resources to develop new medicines, and patents are also generally controlled by developed countries.

So, we thought, why not work with the mindset of global healthcare?

We started with insulin, one of the earliest biopharmaceuticals, but a huge portion of the global population does not have access to insulin. In fact, 80% access to insulin globally is one of the goals of the World Health Organization (WHO). We were quite surprised by these statistics. If a 100-year-old drug is not accessible to everybody, what will happen to other medicines?

When we investigated the underlying reasons, we realised that it was not the cost— drug stability was a major challenge. We wanted to address this pain point, which is something other people were not working on. So, we decided to focus on the stability aspect of drug development and constructed our business model around formulation. Our core idea is that if you make a medicine, it has to be accessible to every individual on Earth—even the remotest person on the globe.

So, your technology essentially works toward improving the shelf life of a particular drug, right?

Yes, that is right in the case of insulin. Our Proteostrong technology can greatly stabilise the drug, extending its shelf life. But that is not the only implication that our technology has.

For example, through our proprietary therapeutic molecule for age-related macular degeneration (AMD), we are addressing dosage frequency. In AMD, individuals suffer from progressive decay in vision owing to age-induced damage to the macula. For treatment, patients have to get intravitreal injections every month. Now imagine a 75-year-old who has to go to the doctor every month to get an injection in the eye! That is very painful.

So, this is a scenario where the medicine is available, but you don't get an optimal outcome in the real-life scenario. Of course, cost could also be an issue here, but one of the major obstacles is the frequency of these painful injections, which deters the elderly. So, in the case of AMD, using the same technology we can bring down the frequency of the required injections—this will enable better clinical outcomes at a lower cost.

What impact do you anticipate your innovative technology will have on society?

I believe we have very good technology, and I'm very happy about that, but we are not a technology-centric start-up. Yes, we have been trying to focus on one or two molecules with one technology, but pharma today does not work with one technology. The landscape is evolving. So, we say we are not a technology but a solution-based company. Whether it's about approaching quality by design, using AI or other methods to improvise robotics, or automated manufacturing—we have the mindset that we should be able to absorb these various approaches and technologies without a huge overhead cost or capital expenditure.

We are very collaborative—we partner with big companies, universities, and even other small start-ups. Because the idea here is to create solutions. So, to answer your question, we think that with our core technology, along with other people, other technologies, and all the support that we are getting, we should be able to create solutions that will benefit society.

In which areas do you see Lamark making a significant difference?

Well, insulin is one. Macular degeneration is another.

Interestingly, macular degeneration is generally considered to be a developed world problem because of the ageing population there. But it's not the case anymore. India has a large number of patients with AMD who are looking for treatments. Hence, we decided to make it a focus. We are working on a new drug which could help those patients who do not respond to the current treatments—the proportion of these non-responder patients is almost 25%. So, we are using our technology, as well as bringing in other technologies, to create a solution for macular degeneration.

We do hope to diversify in future, especially into oncology and vaccines, especially veterinary vaccines, which we think could benefit farmers. The improved shelf life that our technology offers could be crucial for rural areas that don’t have access to local cold storage facilities. In addition, our technology platform to produce extra-stable vaccines will become critical in future challenges like the Covid-19 pandemic.

What are the challenges that you faced when trying to promote this solution through your start-up, for instance, in terms of marketing or commercialising? How were you able to address these challenges?

I was in Europe for around 10 years. When I came back to India, it was a big shock for me! Because when I left for Europe, I remember it used to be very difficult to find even a single penny to do your proof-of-concept experiments. The pharma sector was also not that open to investments. But when I came back, BIRAC-BIG was there, grants were there to try new ideas. I had expected funding to be a big problem in India but was pleasantly surprised to find that this challenge had greatly reduced.

Of course, there are other challenges. While you can find funding support in the early stages, as soon as you get the proof of concept done, you have to face other hurdles—scaling up, having pilot-scale manufacturing, regulatory support, GLP manufacturing, etc. I can easily, off the top of my head, give names of around 30–35 companies who need support in terms of manufacturing and/or regulatory support, and it's not accessible to them because of cost and other reasons. So, this is one major challenge for Indian start-ups that I believe needs to be resolved in the next 5 years or so.

Currently, we are addressing these challenges through collaboration. We use a lot of facilities that we have access to, but these are scattered. So, what might help is having hubs, something similar to a CRO, where you go in, get your work done, and come out. There is a big manufacturing challenge.

Apart from this, I think finding trained personnel is another challenge. It's very hard to find college graduates or experienced researchers who have an industrial experience or mindset. So, they have to be trained and this is a huge cost for start-ups.

What motivated you to apply for the BIG scheme? And what kind of support did you receive from BIRAC and IKP?

Actually, IKP was the reason I applied for BIG.

I came to attend the 20th celebration of IKP in 2019, and the event completely changed my understanding of the Indian start-up ecosystem. At the event, all these big stalwarts of the pharma sector had come together and were talking about translating so many good ideas. I connected with so many people, and we even won an award for our insulin idea! Visu (Viswanadham Duppatla, Vice President, IKP Knowledge Park) told me to apply for BIRAC BIG with this concept. We had applied for BIRAC-BIG as well as NBM (National Biopharma Mission, a funding programme by BIRAC), and we ultimately got both grants, albeit after a few failures.

It was not just initial motivation but hand-holding followed after that. IKP helped us a lot in terms of creating an interface between the granting agency and us. Because having an idea and putting it into a business plan is difficult, but getting a grant for it is an even bigger challenge. You need to understand the whole interface, why somebody is funding, what are their objectives and vision, etc. That part was played by IKP, and they did an excellent job. They would tell us outright if something was not good and needed to be changed. Deepanwita ma’am, Visu, Ranajit sir, all of them were very helpful. Making a company out of technology is very essential, and that’s what they did during proposal drafting. They helped us realise that technology is an important part, but we should also focus on what kind of company we want to be. And that’s how Lamark became a platform company.

When you got the BIG grant, how did it help you to scale up your company?

IKP helped us first and then came BIRAC’s technical rounds. We were blasted with questions. We had to re-write our grant application twice, and it was accepted on our third try. With the grant, I was able to hire two of the best people who are still working with me today. We also got a lot of recognition and scientific advisory input.

However—and I tell this to everyone—I think the biggest value that comes from BIRAC BIG is when they fail you, they train you and help you understand that your technology is not your company. Just having great technology is not enough—you have to become a company, there must be more to the story. BIRAC helped us do just that. We were able to convert from an idea stage to a presentable company and getting that 50 lakh was proof that we were ready to go out and approach other investors and collaborators in India, which we did successfully. It was a great learning experience.

The 24th call for the BIG grant has been announced. What message would you like to give to start-ups and innovators who are applying for the BIG grant?

I would say don’t just think of the money. Think of the kind of advisory input you would be getting during the process—it is more important than the output here. Whether you fail or pass, whether you think your idea is good or bad, doesn’t matter—you should apply.

If your idea or proposal is bad, they will help you fine-tune it. They will give you a lot of questions—the right questions to answer, which will help you create a sustainable company using your idea or technology. Sure, you need to think about how you will budget the 50 lakhs, but the whole idea is not limited there. You also need to know—if your technology is successful, then what? If you can answer this question during the BIG grant, especially during the proposal, then automatically things will fall into place for you.

What is next for Lamark? How do you envision its growth in the next few years?

Abdul Kalam once gave an interview wherein he said if you want to understand how a country has grown, you should look at the poorest man and see how much he has grown. Similarly, I'm not worried about the people who have access to drugs like insulin today. I'm worried about the number of people who don't have access. So that is going to be our yardstick. So, if millions of people are dying because they have no access to insulin, can we reduce those counts? Those are the things we'll be measuring as a vision.

And as a company, our target in the next 18 or 24 months is very specific. We want to finish the human proof-of-concept experiments for the insulin product. We are in the preclinical stage and want to ensure that the first stage of regulatory requirements is completed soon.

I think, unless and until we do that and show that we can deliver on what we say our technology can achieve, nobody is going to believe our objectives about our other molecules or our broader vision. So, we want to get this first project to its completion stage and then expand this platform to others in future.

According to the Indian Economic Survey 2021, the pharma industry is expected to reach about $64 billion value by 2024 and about $130 billion by 2030. What factors do you believe will drive this growth, both domestically and in terms of exports?

Manufacturing and quality of manufacturing. It's the simplest answer you can give considering the current situation in India. If you want to create an industry, if you want to make something, you have to first have intellectual property (IP) rights. In India, we can create IPs, but we do not have the means to test it. For example, you can design the best car in the world, but if you can't make it and test it, safety of it, it's never going to be made, and it’s never going to become the best car in the world, right? So, manufacturing has to be world-class in India. The number of FDA inspections and warnings in Indian manufacturing units is still high and the international market is sensitive to concerns over manufacturing compliance. So, I believe India has to improve in terms of manufacturing quality to become a global leader.

Further, access to these facilities for smaller companies is crucial for growth. You can have a model where big companies provide access to smaller companies at reduced cost or couple with financial support from government agencies.

The next key to growth is innovation and IPs. Most of the big companies in India today are working with biosimilars, mainly because biosimilars can reduce costs, but they can't create your biggest revenues in terms of exports. You need to create IPs to be able to control the cost, to be able to export and create monopolies. So, we need start-up teams to take risks move to novel drugs and develop strong IPs. But IPs will only reach the market and get you value if you have a good manufacturing ecosystem and the financial power to perform clinical studies.

Manufacturing is a core issue today, along with manufacturing hubs which smaller companies can access to test their ideas at a pilot or slightly larger than a pilot scale.

If you look at the current forefront facilities like Venture Centre, Pune; or IKP, Hyderabad; C-CAMP and BBC, Bengaluru; etc., or other similar incubators in IITs, Universities etc., they are all focused on providing support at mainly the R&D stage and they have done it so well. But we also need something for the next level, which is the manufacturing zone. Look at China—they have not focused on innovation or IP, they started around manufacturing, cheaper manufacturing.

India has followed a very different model. We have created innovation hubs, but if these innovations don't reach the market, they are as good as dead. And they will reach the market only if they can be manufactured. So, we need a production ecosystem involving engineers, quality control systems, automation, and other technologies that will help scale up and produce reliable batches. So, I believe that is where we will be able to create wealth now.

What kind of SDG goals are your company's innovation aligned with?

One of the sustainability goals includes global accessibility to medicines. And, as I mentioned earlier, our core ideology is that we believe medicine and healthcare should be affordable and accessible. But drug designing, R&D cost, manufacturing cost, etc. often make healthcare expensive and inaccessible. So, we believe that by using smart technologies and designing good IPs we can reduce the costs. For example, if we have cold chain-independent insulin, there could be an easy reduction of around 10 to 12% of the cost of logistics and double the accessibility, especially in remote areas. It will lead to a reduction in the carbon footprint due to energy saving, and reduce the wastage of these medicines due to longer shelf lives.

To know more about BIG or for an LOI, send an email to teambig@ikpknowledgepark.com for further queries. IKP Knowledge Park, as a BIG Partner, is dedicated to guiding you on your journey to success!