At the Forefront of Change: Dr. Rajeshwari Adhiseshan’s Endeavors at the Gates Foundation

Dr. Rajeshwari Adhiseshan is a Senior Program Officer at the Bill & Melinda Gates Foundation, where she plays a pivotal role in global health initiatives, particularly in the vaccine development sector. With a robust background in pharmacy and a PhD from Pune University, Dr. Rajeshwari has extensive experience both in research and regulatory affairs, having previously worked with organizations like Serum Institute of India and Dr. Reddy's Laboratories. At the Gates Foundation, she is instrumental in driving collaborations with vaccine manufacturers and partners across the globe to improve access to life-saving vaccines, especially in low- and middle-income countries. Her work focuses on enhancing manufacturing capacities, ensuring quality compliance, and accelerating the licensure of vaccines through innovative funding and technical support strategies.

Pharma Now: Dr. Rajeshwari Adhiseshan, welcome to Pharma Now. Thank you for sharing your time. I think your work at the Gates Foundation is really amazing. But for our audience, can you explain what the Bill & Melinda Gates Foundation is and how it works?

Dr. Rajeshwari: Yes. So, it's been 25 years since Bill and Melinda Gates started this foundation with a dream to rid the world of the infection caused by the Rotavirus. Over the last few years, we have done a lot of work. As I am a part of the vaccine team, I can only speak on that front. But, I would say that we have done incredible work towards reducing the disease burden and helping eradicate many infectious diseases, including polio. That is at the very top of Bill's list "the eradication of polio". While we still haven't achieved this goal, we are continuously working towards it. 

Pharma Now: I think you’ve made great strides on this front. I heard that you have been working towards vaccine development for polio. Can you tell us more about this valuable project?

Dr. Rajeshwari: Yes, absolutely. We have recently developed a novel polio vaccine. It has been approved in two countries by two different manufacturers. We were the driving force behind the technology, its scale-up, and licensing in both countries and one of them is India. So yes, I'm very proud to be part of the Bill and Melinda Gates Foundation. 

Pharma Now: I understand you are the lead at the vaccine program in the Foundation. So, what exactly does the foundation contribute and how does it contribute to the complete ecosystem? 

Dr. Rajeshwari: At the foundation, our goal is to reach out to the poorest of the poor. So, in the farthest and deepest corners of the world, say in Africa or other lower middle-income countries, including India where, each child should be able to get a vaccine. That's the mainstay of our work. To provide that to every child, we need to have vaccine manufacturers supplying millions of vaccine doses to these countries at a low cost. This has been our business plan, and that's why we predominantly work with manufacturers in India. 

Did you know that 60% of the vaccines that are used for immunization around the world come from India. So, the Foundation works with Indian manufacturers because of their incredible capacity to scale-up. Because they have the skill set and support from government agencies and regulatory bodies but more than that, they have the willingness. There's a different kind of spirit in companies to be able to provide and reach out to across the world. That's the reason why we’ve worked with companies like the Serum Institute, Biological E and many other companies. 

We're also working with many startups now. On this front, with startups, we help increase their capacities and invest in their infrastructure, quality systems, good manufacturing practices (GMP), and provide end-to-end support. The idea is that they should obtain the WHO prequalification (PQ) because only once they obtain the WHO prequalification will they be able to supply to UNICEF and other procuring agencies. At that stage, you need to provide high-quality products.

Pharma Now: So the Foundation is helping manufacturers to raise their quality standards and obtain the WHO prequalification. But, what is the role of the foundation is this – do you do it, through consulting or funding?

Dr. Rajeshwari: So, there are different mechanisms. First, of course, is direct funding, where we directly interact with the manufacturer. Second, there is indirect funding, where we see that a lot of technical support is needed or their quality management systems need to be improved. In such cases, we work with partners like Program Appropriate Technology in Health (PATH), who help us. They are the conduits between the Foundation and manufacturers Another partner is International Vaccine Institute (IVI); they help with tech transfers. For example, a multinational company or a company outside of India has the technology, but it has to be transferred. The IVI help with these tech transfers, and they make sure that the facilities meet the required quality standards. When inspectors or auditors visit, the facility follow the Good Manufacturing Practices. This is indirect funding.

Pharma Now: So, indirect funding is provided to manufacturers through partners. Are these the only two mechanisms you’ve implemented?

Dr. Rajeshwari: Another way is in cases of pandemic-related diseases, for example, suddenly we are hearing monkeypox or during COVID times. So, we work with larger groups like Coalition for Epidemic Preparedness (CEPI) or Global Alliance for Vaccines and Immunization (GAVI). So, we all work together to develop these pandemic-related vaccines very quickly. So, these are the three ways that we work. 

Pharma Now: I think this program must be keeping you very busy. Because in India itself, we have so many vaccine manufacturers. You must be traveling everywhere to stay in touch with all manufacturers and stay updated.

Dr. Rajeshwari: Yes, we touch base with them regularly virtually and also meet them. But yes, the capabilities are there. 

Pharma Now: In your work with so many vaccine manufacturers, you must have encountered challenges. So, what challenges do you find in vaccine manufacturing in India, especially on the innovation front? I’veI heard that we are the largest manufacturers in terms of vaccine volume. But when it comes to value addition, there is still a lot of scope. So, what’s your take on this? 

Dr. Rajeshwari: Agreed, so see, our investment in India started way back in 2001 with the Mening program, which we did with Serum Institute of India, PATH, and WHO. They collaborated together to create a vaccine called MenAfriVac, which was specifically for Africa but made by India. Since then, we have invested in a lot of traditional vaccines. I was part of the pneumococcal vaccine project as well, when I was at the Serum Institute of India. 

This space, in terms of innovation, it's quite advanced in India. So, we are now able to invest in proof-of-concept models or investments. We don't necessarily look straight at WHO PQ right away. We know that there are going to be challenges. It's not going to be an easier route to licensing than PQ. So, we are investing in a lot of novel or innovative vaccines, for example, the mRNA or circular RNA or virus-like particles or alternative hosts for protein production or monoclonal antibodies which will reduce the cost. So, these are some or even multivalent combination vaccines which are not very compatible otherwise. So these are innovative, but they pose a very high risk for us. Most of the time, we know that they may not work because it is such an innovative new space. There are no standards in place. So, even startups are figuring things out. But, we want to encourage this innovation and hopefully, if they demonstrate proof of concept and provide animal data that looks encouraging, we would connect them to a bigger biotech for scale-up, but it's still early days. It is a lot of investment, but we are willing to do it.

Pharma Now: So, in your expert opinion, is the innovation quotient in India in the vaccine area increasing now? 

Dr. Rajeshwari: Absolutely. We have such support from government bodies like the Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR), and Central Drug Standard Control Organization (CDSCO). There are a lot of public-private co-funding opportunities also. In fact, only recently, we heard that the ICMR may start a section-8 type company that may allow a public-private co-funding opportunity. The DBT already has the Biotechnology Industry Research Assistance Council (BIRAC). So, I would say that the landscape is promising. 

Pharma Now: So, the vaccine ecosystem is developing. Do you think we may be setting up the right platform now?

Dr. Rajeshwari: Absolutely, only yesterday I was on a panel discussion with the National Academies in US for Science, Engineering and Medicine. They want to partner with Indian bodies. So, there is a possible collaboration happening as we speak. It's not just us; the whole world is looking at India for collaborative efforts in innovative research. 

Pharma Now: That is very interesting. I, and I think our audience as well, have understood the excellent work you’re doing at the Bill and Melinda Gates Foundation. I’d like to do a detour, if you’re okay with that. A little bit personal, but can you tell us where are you from and did you always dream about working in the pharmaceutical industry? 

Dr. Rajeshwari: I'm from Chennai, Tamil Nadu – a metro city. No, no, I wanted to be an air hostess or something like that. Something more glamorous, because those days we flew very infrequently, but we saw such glamorous women on flights. So, people would tell me you should try and be one. That was not particularly a dream, but I definitely did not think about pharma. I just got into it, I guess by accident when I was at Delhi University. So, I did my B.Pharmacy. Then, I completed my post-graduation and recently I finished my PhD from Pune University.

Pharma Now: Wow, PhD from Pune University! Is this where you started your career from?

Dr.Rajeshwari: I started with Dr. Reddy’s Laboratories in Hyderabad. But yes, before that, I worked a short stint with American Remedies, which no longer exists I think. I started off with R&D formulations. Then, I moved on to the regulatory and quality space. In between, I got married also. So I had to move with my husband and my daughter. 

Pharma Now: Oh, wow, your career in pharma as a scientist is very interesting. But, how did you get into the Gates Foundation? When did this transition happen? 

Dr. Rajeshwari: Actually, I was already working with the Foundation when I was at the Serum Institute of India. So, we had a pneumococcal vaccine and that project really got me in touch with a lot of people from the Gates Foundation. That's when I came to know about the work they were doing and how much it helped our project at the Serum Institute, about the kind of support we received. So, when an opportunity came up, I thought that it was time to make a transition, and I did. But, the good part is I still work very closely with the Serum Institute and other companies that I have previous work with.

Pharma Now: Yes, you work with the same people now but on the other side of the table. You previously worked on regulatory teams. On that front, how difficult is the regulatory scenario in India right now?

Dr. Rajeshwari: It's streamlined a lot, to be very honest. In Biological E. actually, I started the regulatory affairs (RA) department. There was no RA department when I was in Biological E. Whereas, now, there's an extremely streamlined process in place, I must admit. It's extremely streamlined and there is a lot of support from the Central Drugs Standard Control Organisation (CDSCO) and Drugs Controller General of India (DGCI). The vaccine means it's not just a state-controlled product. The Central Regulatory Authority has the supreme power, and the State Authority works in conjunction with the Central Licensing Authority and makes sure that the licenses are given. But, the overarching regulations are done by the DCGI. So, the good part is, the submissions are almost paperless now, except for one or two applications. 

Pharma Now: That's wonderful. Once all documentation is digital and paperless, the process will be a lot faster, transparent and clear I think. Is this implementation a new development?

Dr. Rajeshwari: I have noticed that for the last 4-5 years, everything has become completely digital. The International Council for Harmonization (ICH), which is the international body, governs how a dossier or how an application should be made. There are set templates called common technical documents (CTD) templates or modules. The good thing is that even our regulatory authority has adopted the same template. So, now, if we want to submit to the DCG or another country or to the WHO, the same dossier can be sent to every place. 

This ease of submission has really transformed the regulatory space as far as India is concerned. And, there's a lot of alignment with the WHO PQ and our NRA. So, the WHO PQ representative comes and inspects our NRA to see what the maturity level is. We have to keep the NRA qualified for them to be able to accept submissions from the manufacturer and because our ultimate goal is WHO PQ. The DCGI is also working very hard to improve their systems, internal processes, and infrastructure. It's a constant improvement that they are working on to be able to meet WHO requirements.

Pharma Now: I think aligning our regulatory requirements with global requirements will certainly change how pharma companies can approach formulations, manufacturing and sales. I think it will help the world on a larger scale. I’m sure you’ll agree. So, what about the Gates Foundation? What’s the next step?

Dr. Rajeshwari: I love working at the Foundation, and it's been a transformative journey for me because I can see the impact that we are driving. It's also nice to see now that I'm outside of the biotech space that I previously worked in. I can see how much respect and appreciation that the world has for these companies. I didn't understand that as much when I was working elsewhere, but now I do. I feel so proud that we have achieved that at a global scale. 

Pharma Now: That’s wonderful. So, though I would like to continue our discussion, I understand your time is very valuable. So, one last question: When you started your pharma career, I am guessing it must have been very rare for a Tamilian female to get into the pharma sector. Now that you’ve achieved this huge feat, can you share how easy or difficult this journey was? And what's your message for the young girls who want to get into pharma and are looking to you for inspiration? 

Dr. Rajeshwari: I would say just follow your dream, I guess. I am a Tamilian, we are always pushing our kids to forever keep studying. So, you're always expected to achieve something to do the best. Most of us go into IT or software engineering or go abroad. I don’t have any specific message, really, just follow your dream and stay focused.

Pharma Now: Thank you, Dr. Rajeshwari for joining us. Your journey is very inspiring, and I’m sure our audience will understand and learn quite a lot. Thank you for taking the time to talk to Pharma Now. It was really a pleasure talking to you and understanding your journey and thank you for sharing so many insightful stories.

Dr. Rajeshwari: Thank you.