The Untold Story of COVID-19 Vaccine Development: Dr. Subhash Thuluva Speaks

Dr. Subhash Thuluva, Senior Vice President and Head of Clinical Development at Biological E. Limited, is a seasoned leader in clinical research with over two decades of experience in the pharmaceutical and biotech sectors. He specializes in guiding clinical strategies and execution for vaccines and biologics. Dr. Thuluva has played a key role in advancing clinical programs across various therapeutic areas, including infectious diseases and immunology. His expertise in navigating regulatory landscapes and leading cross-functional teams has been instrumental in bringing new treatments from clinical trials to market, enhancing global health outcomes.

Mr. Ravindra: Dr. Subhash, welcome to Pharma Now. We were going through your profile, and I think you have had an amazing journey. As a clinical scientist, I really wanted to dive deep into your journey—how you started, how you ended up being a clinical scientist, how your journey began from your graduation. I just wanted to understand that.

Dr. Subhash: So, I am basically a pharmacy graduate. During my graduation days, I never thought that I would enter into a field of clinical research or research and development. After my graduation, I was looking to go abroad for higher education, and someone suggested going to Germany, where there is a lot of life sciences research happening. So, that's where I went and did my master's and then my PhD.

During my PhD days, I started working in clinical trials. I closely worked on cholesterol drugs, understanding how people respond and do not respond to them, and engaged in a field called pharmacogenetics, where you measure the responsiveness of a particular drug and link it to the genetic constitution of certain transporters. That was my first experience with clinical trials. I got interested in it because it is a very important step in the drug development process. I continued my journey, and it's been almost 25 years now that I've been working in clinical trials, doing first phase, phase 2, phase 3, and all the post-marketing studies.

After my stay in Germany, I moved back to India. I worked with Ranbaxy as a senior scientist in their medical affairs clinical research group. I worked there for a couple of years, conducting many clinical trials for Indian submissions.

Then, I moved on to a company called Allergan, based in Bangalore. I worked on uro-neuro drugs, primarily conducting studies for US FDA submissions. Later, I headed the entire development center for Allergan in Bangalore.

From there, I moved to Novartis in Hyderabad as a clinical trial head, working on a very important drug for rheumatoid arthritis and ankylosing spondylitis. I managed two large global trials from Hyderabad, coordinating teams across the globe.

I then moved to a company called Clinigene, where I was the head, managing all operations. Clinigene eventually merged into Syngene and became Syngene Clinical Development. After a short stint with Quintiles, I spent the past seven years working on developing vaccines at Biological E, focusing on vaccines.

Mr. Ravindra: Wow. You mentioned vaccines, and I'm very curious. I heard you were one of the contributors during the creation of the COVID vaccine. What was that time like?

Dr. Subhash: The entire COVID period was life-changing and challenging, both personally and professionally. Being in the vaccine world and working on developing a COVID vaccine was very challenging.

During clinical trials, we couldn't sit inside and conduct trials remotely. We had to go to the sites and work with hospitals. It was very challenging during the lockdown and the waves of the pandemic. Convincing people to participate during lockdowns and managing all the logistics was tough. Developing vaccines for COVID was challenging because it was the first time, and nobody knew exactly what to do. We had to collaborate with many external agencies and scientific advisors. Thankfully, the Indian regulators and government were very supportive, helping with timely approvals and facilitating the process.

Mr. Ravindra: But what was the overall experience like? I know it was challenging since you were not allowed to move and conduct trials in person.

Dr. Subhash: It was very challenging because, again, we had to work remotely. We couldn't visit clinical trial sites or hospitals regularly to collect data. We used a lot of digital technology to gather information remotely. Interactions with doctors, clinical trial staff, and regulators were conducted online.

It was challenging because we were not used to this. Unlike IT companies with infrastructure for remote work, we had to invent new ways to work. Sometimes it was risky; we had special permissions to travel during lockdowns. My team did an excellent job, often risking their safety to ensure timely availability of data.

It was a difficult, nightmarish time, but we were driven by a sense of purpose, knowing we were doing something good for public health. Eventually, we succeeded in developing an excellent vaccine with a great safety profile, vaccinating close to 8 crore children.

Mr. Ravindra: At the end of COVID, what is the sense of satisfaction?

Dr. Subhash: There are a lot of questions about vaccines, such as whether they worked and their safety issues. But I firmly believe, as someone from the vaccine industry, that vaccines played a major role in controlling the COVID pandemic. Without vaccines, it would have been much more difficult.

Mr. Ravindra: Coming back to clinical development, AI has started to play a significant role. What innovations do you see in clinical development?

Dr. Subhash: The adoption of AI in clinical trials is growing. Multinational companies are conducting pilot runs and real-world trials using AI. AI will impact every aspect of clinical trials. For example, AI can help identify eligible patients for clinical trials by searching databases. Digital technologies like wearable devices can provide real-time monitoring and data collection, reducing errors and improving efficiency.

Mr. Ravindra: Certainly. What do you think the future of clinical development looks like beyond AI?

Dr. Subhash: Clinical development is crucial in the drug development process as it is the final step before approval. While the process will remain the same, digitalization will shorten timelines. AI can help in various trial phases, reducing manual reviews and speeding up the process. This will significantly impact how we conduct clinical trials in the future.

Mr. Ravindra: Amazing. Another question: now the world is more interconnected, with many collaborations happening. How does this affect clinical development?

Dr. Subhash: Clinical trials have always been global. During COVID, companies published their protocols and data, which was unprecedented. This allowed everyone access to valuable information. Collaboration is key, and we work with partners globally to develop vaccines. This exchange of ideas accelerates progress, and we learn from each other.

Mr. Ravindra: How many vaccines have you and your team developed?

Dr. Subhash: It’s a team effort involving many people from conceptualization to animal testing, preclinical, and clinical phases. In the past seven years, my team and I have worked on developing and bringing to market six vaccines, including WHO pre-qualification. Notably, we developed the 14-valent pneumococcal conjugate vaccine entirely with indigenous technology. This vaccine, developed over 9 to 10 years, is the highest-valent vaccine in India, affordable, and life-saving for infants.

Mr. Ravindra: Congratulations. Last question. What advice would you give to those wanting to enter clinical trials and development?

Dr. Subhash: The challenge for pharma students is that our education system is very theory-based, and applying this theory is crucial. My training in Germany changed my perspective. I advise students to see how to translate theory into practice. There is a vast opportunity in life sciences. It's important to understand the practical application of what you learn. The life sciences sector is the future, and I see it offering great opportunities.

Mr. Ravindra: Certainly. This is a very important message for the new generation. Thank you very much.

Dr. Subhash: Thanks, Ravindra.