QnA
Interview | December 26, 2024
Pharma Now: Welcome to Pharma Now, Pritha Aggarwal. You’re currently the Associate Director of Product Development at IAVI. It’s our pleasure to have you here at Pharma Now.
Ms. Aggarwal: Thank you so much for having me. This is a great opportunity to connect with you guys.
Pharma Now: Before I ask about your journey and your accomplishments, I’d like to understand what falls under your purview as the Associate Director of Product
Development. What activities do you oversee at IAVI?
Ms. Aggarwal: I have been working in the vaccine and antibody development space for more than a decade. I'm passionate about taking innovation from research and making it accessible to the public. Within this spectrum, my role is to identify gaps in the novel product development ecosystem, see who's doing what, build outward-thinking strategies, and implement these strategies–which include fundraising, building collaborations, and risk management in projects. I work with companies; I work with various academics and industries in India. Of course, we (IAVI) have global collaborations that help bring this together.
Pharma Now: IAVI focuses primarily on vaccines and has an extensive portfolio. Can you share some information about your vaccine portfolio?
Ms. Aggarwal: At IAVI, we focus primarily on vaccines as well as on vaccine and antibody development for public healthcare. One of our primary focus areas is HIV. That's where our name originates from, IAVI is an abbreviation of the International AIDS Vaccine Initiative. Over the years, we've evolved because we realized that our technologies can be utilized beyond HIV. Now, we're working in the tuberculosis (TB) space.
The other important spectrum that we are targeting is pandemic diseases, especially diseases such as Lassa, which targets a very niche population in the African regions but has a pandemic-level potential. In India, we are working on a very interesting disease: the Snakebite disease. It targets a neglected population. There has been no work or innovation in the past century on this disease, so we are trying to tackle it. Next is antimicrobial resistance–which I and the world believe–is a new pandemic. We, as an organization, are trying to bridge all the work done in big pharma and the discovery space.
Pharma Now: You handle quite a diverse portfolio. How did you come to this position? You’ve achieved a degree from the Indian Institute of Technology (IIT), Bombay. How did your degree lead you here, and why did you choose this specific–rare diseases–field?
Ms. Aggarwal: I always wanted to do something in biology. When I was in school, I used to think that you have cells and enzymes and all these other matters that drive humanity. I think my love for the subject (biology) led me to my Master's in Biotechnology at IIT Bombay. There, my brilliant professors and the ecosystem made me fall more in love with the subject rather than the field.
Pharma Now: Have you been passionate about biotechnology since childhood?
Ms. Aggrawal: I wouldn't say childhood, but yes, science has always fascinated me. I always wanted to know more or dive deep into a subject. When I was studying, I didn’t want to be restricted to researching, I also wanted to apply (my knowledge) to something.
So, after completing my graduation, I moved to Bangalore for some time. I worked at Strand Life Sciences, which was a startup specializing in bioinformatics. They were trying to figure out how data can be converted into actual applicability. Then, I took this opportunity at IAVI. I've been working at IAVI for almost 10 years now, but I’m not doing the same work. So, their diverse portfolio has allowed me to experiment in different fields. I think–for me–the breaking point was the convergence of science, innovation, public health, and building nations. These elements forged me to be what I am.
You can imagine a 25-year-old who's just done a lot of science and is motivated to do this and is allowed to be a part of nation-building. I think that's what brought me here. It was because of the government and visionaries in the government who wanted to think beyond what was already happening in India. They thought, “India is doing a lot of biosimilar work, but why can't we do innovation? Why can't we do novel work?” They thought about what it would take for India to do novel work. So, they engaged young professionals–like me–to figure out why India couldn’t do innovative work in this field. And, that's what we did: We mapped what was there in the country, we talked to people, and we talked to people abroad. We identified the small pain points, and said, “If these pain points can be removed, maybe we can move the envelope a little further.” That's how we started building a nation by thinking 10-15 years beyond what we can do now, which will have an impact 10-15 years later and here we are.
We started something 10 years ago, and now we’re seeing fruitful results. I think the best validation for our thinking was during COVID. The world was in a pandemic, but at that time, there were elements that we had thought about 5-6 years before and started implementing.
Let’s discuss a simple thing: Clinical immunological assay. Because we could not even develop normal products, assays required for clinical trials were done outside India. So, when we thought, “If India wants to manufacture a novel vaccine, we need to have the capacity to do novel assay work here in India.” Then, we asked the government to fund and build that ecosystem. We thought about this back when dengue was an important disease. So, we built an assay for dengue.
When COVID hit, there was a facility with people who already knew how to do clinical assays. They had trained their people, and they had regulatory resources. So, the assay approval process happened quickly and the entire facility was used for doing assays for COVID vaccines. So, we didn't have to send those tests to somebody outside India. So, that was the validation that we were thinking in the right direction because the elements we had built could be very quickly leveraged for COVID vaccine development. Now, COVID is a four-year-old story, but it was an early sign of validation.
As we move ahead, other pandemic diseases and pandemic-potential diseases are emerging. So, we should not think about what's been done already or what could be done better. Instead, let's think about what's going to happen 15 years down the line. We can push the envelope right now so that we're ready for the next 15-20 years. I think that's where we are today.
Pharma Now: As you said earlier, you have always been very passionate about science and applying it in the real world. You also mentioned a very important point: “Building a nation”. So, how did this idea get stuck in your mind? What motivates you to build the nation or contribute to its growth?
Ms. Aggarwal: What drives me is innovation and science. I think we're not at a point where we have all the resources. Somewhere along the line, we have settled with mediocrity, but we need to strive for excellence. We have all the pieces in place, but we need to bring everything together and push the envelope. When I was in a conversation with Indian students earlier, I observed that our students (Indian students) are brilliant. We have a magnificent talent pool, but critical thinking is not inculcated in students. I'm not saying that we don't have the ability, but opportunities for critical thinking are not given to students. If provided proper training through a training mentor, we can have a strong base of people who can think about a problem and find the solution instead of deriving something from what is already available.
So to answer your question: My passion is not just nation-building, my passion is innovation in science. To do that, we have to cultivate and nurture something (students) that we already have and don't have a shortage of. It's just being able to build a path capable of taking innovations. It is even more critical for a nation like ours because we have our problems. When we talk about diseases, there are a multitude of regions within our country (India). We have an urban setup and a rural setup. We are just so many nations within a nation. So, for us to solve our problems, we need to have indigenous thinking and just looking at the world’s innovation is not going to be sufficient for us. That's why I said, “Innovation is what drives me.” And that's why I think: Innovation is a path to building a nation.
Pharma Now: That was very well said, Pritha. Over the years, what challenges have you faced because of your career path? As a woman, have you faced any different challenges than a man would? What innovative approach are you taking towards your life? I’m sure you’ve faced a lot of hurdles, but how did your family and those around you support you and encourage you?
Ms. Aggarwal: Being a woman or a man has nothing to do with how you portray your thoughts or ideas because intelligence matters, gender doesn't. As for your question, I’m very fortunate because I've always had female mentors, teachers, visionaries, and leaders, particularly those who have led the same path. When I was in college, my professor, Swati Patankar, was a brilliant professor and scientist. I had a female manager in my previous role. When I was working with government entities, one of my mentors was a brilliant visionary. So, I've never been in a room where I was the only woman. I've seen women who were sitting at the head of the table, leading meetings.
I think that is important because having leadership that is not gender differentiated helps you become a more fearless person. I don’t think that I have to dumb down my ideas for a person–a guy or a girl because I've never seen someone do that. I've seen people not let their gender rule their decisions, and I've been fortunate enough to do the same.
That being said, it's very difficult not to think about women in science and their situations, particularly when they’re in senior management. I'm probably not the right person to talk about women’s equality on the home front and in my career because I don't have children. However, I have seen very closely how the shared responsibilities of a household get in the way of leadership. It's just double the amount of work you need to do, but I think we're evolving. I don't like to think about it. Of course, we face our challenges, but it’s not a defined journey. I would rather focus on empowered female leaders I’ve met and need to take clues from–to come in a room and speak the truth without being intimidated.
Pharma Now: It’s wonderful that you have had so many very supportive leaders. Let's discuss more about the diseases you are working on. Is snakebites a very rare disease, and can you tell us more about it? How are vaccines developed for such rare diseases?
Ms. Aggarwal: Snakebite is not a rare disease. Only a selected population is affected by this disease. The casualties of snakebites include people working in rural forest areas, farmers, or people in tribal areas. When they are working in the field, they are bitten by snakes. Out in such places, going to a hospital takes time. They're not the only ones bitten, but they have limitations and don’t have quick access to healthcare. So, snakebites are not rare, but their burden is very high. There isn’t sufficient data to conclude that it's a big disease because the population affected is marginalized and also doesn’t have access to healthcare. When you look at all of this information, it is an important disease that has been neglected because of the population that primarily gets affected. I say it is neglected because our current intervention is the anti-snake venom.
The anti-venom technology is at least 100 years old. There has been no innovation in anti-venom technology for the last century. For context, the last century was 1924. So, there's not been a lot of innovation in this space. As a result, the anti-venom has a lot of limitations. One of them is that by the time the patient comes to the hospital, they must have already gone through a lot of toxicities. Another one is the way the antivenom is made. It does not protect against venom from all snake species. It protects against venom from only specific species. There are a lot of side effects as well: You get a lot of anaphylactic and anti-allergic responses because the anti-venom manufacturing process has not been updated, so there may be a lot of impurities in the product.
That's a neglected problem. No Big Pharma is going to work on it. So, we're trying to bring in the element of antibodies. The anti-venom that we (IAVI) have is a polyclonal antibody. We're trying to make it into a monoclonal antibody by making an antibody that targets a large species. There are multiple species of snakes, and there may be a protein common across all. We're making an antibody that targets this common epitope so you get one product that can neutralize a lot of vaccine species. It will not have side effects, and it will be safe because the original product is derived from humans. That's one of the ways the field is innovating.
We've also been thinking about improvements. The current product is very purified and concentrated. However, the field is really in its initial stages, and we don't have a lot of R&D investment. We have products that were before current regulations were implemented. So, when we try to create a new product, one of the toughest questions we face is, “How do you perform clinical trials for snake bites?” I think that's a burning question that we're trying to answer. So, all of these elements need to be thought through and have a little more pathway there.
Pharma Now: While we're on the topic of clinical trials, is it challenging to select a batch and perform clinical trials in rural areas?
Ms. Aggarwal: Absolutely. We have anecdotal data on where snake bites happen. We don't have actual data on a particular region with the highest number of snake bites. If we did, the clinical trials could be designed specifically for that area. So, going into clinical trials, there are a lot of questions. First, I need to identify the region I need to go to and design a trial. What's the statistical calculation? What's the average number of bites in the area in 2 years? I don't have this baseline data based on which I can compare or design my trials. I don't even have a pathway. So, if I'm designing a trial, I should have a pathway to get somebody to the clinic. For example, if I know somebody's getting bitten, I need to have a defined pathway–a standard routine of care–in that area. But, this is missing. Therefore, it’s (anti-venom technology) so neglected and not thought about. To build this basis for clinical trials, a lot of investment is required. And, this investment is not just getting a product or manufacturing a product, it is for building an ecosystem for testing the product.
Pharma Now: How is IAVI planning to tackle these challenges? As you mentioned, you have to create plans and make sure they are implemented properly in rural regions. What are your plans to achieve this?
Ms. Aggarwal: So, we're right now, at a very early stage of R&D. We have an antibody in the early stages that's discovered. We intend to first answer the question, “What should the product look like? What are the needs of your early-stage candidate to get a product? What should be that pathway?” We intend to hold a couple of consultations this and next year to help identify these exact gaps. Understand the people who are in the field and who have the right information so that once the gap identification and the product design are complete, we can think about where we are and how we get there. I think we're missing both right now: where we are and what needs to happen. We plan to hold a series of consultations to first identify the problem and then build a roadmap towards that.
Pharma Now: In rural areas, when we are talking about the Snakebite disease, IAVI is currently in the R&D phase of developing antibodies to minimize the effect or cure snake bites. Can we also develop a vaccine for any of such diseases so that we can prevent the concentration of the disease?
Ms. Aggarwal: So theoretically, the answer is yes. Dr. Mahesh Bhalgat spoke about one of the innovations, and he used the phrase “reverse vaccinology”. The whole concept of reverse vaccinology is that I know the bases on my epitope or the antigen for the ones that I have the antibody for. I know that if there is an antigen, the antibody will act accordingly, and it will try to neutralize it. Now, if I know that, I've figured out the structure of the antigen. Then, I reverse-engineer the antigen and make something exactly like the antigen in the body, it can be used as a vaccine. That's the entire concept behind reverse vaccinology. Like a puzzle. If I know a piece of the puzzle, I can map out this and use that as a vaccine. Theoretically, yes, if I have an antibody that can be broadly neutralized, I can use the reverse vaccinology concept to design an antigen that can be used as a vaccine. If someone is thinking about the viability and feasibility of the vaccine, I don’t think that we have got into a stage where there’s a broadly neutralizing antibody for the snakebite disease.
Pharma Now: This is a new concept coming up, and your explanation was very simple to understand. You also mentioned that you're focusing on TB and HIV. What plans does IAVI have for the diseases, and what therapies are you coming up with?
Ms. Aggarwal: For HIV, we have multiple products in our pipeline. For HIV, we are working in two areas, namely, HIV vaccines and HIV broadly neutralizing antibodies. Within the HIV vaccine, we are developing a number of antigens and leveraging different platforms, using the mRNA platform, to quickly get the antigens into clinical trials, and to get them manufactured quickly and across different pipelines. We can then see which one has the most impact.
We are conducting G001 and G003 trials in Africa. In addition to that, we have the concept of HIV broadly neutralizing antibodies. These are a cocktail of various antibodies that target different epitopes within a virus, so cumulatively, they can neutralize the antibody. We plan to start Phase 1 clinical trials in 2025. We have just manufactured the pilot lot for Phase 1 and soon we’ll be doing the clinical trials in collaboration with the National Institute of Health (NIH).
Pharma Now: That’s great. How long do you estimate the clinical trials will take?
Ms. Aggarwal: A typical clinical trial takes a lot of time. There are three stages: Phase 1, Phase 2, and Phase 3. I think with HIV, it’s very complex because for Phase 3, we need to understand the product’s effects and efficacy in a large population. New interventions are changing the field of HIV. For example, we have a drug called Pre-exposure prophylaxis (PrEP), which helps in the prevention of HIV. We also have a policy that is, Test and Treat. Here, as soon as the patient tests positive for HIV, they are treated on the spot. To design the vaccine trial, you need a population prone to HIV.
But with these interventions, finding a population prone to HIV is hard and it is also hard to figure out whether a population is already on any preventive drug to be able to test something which is for prevention. So designing a trial requires a larger chunk of the population. Going back to your question on how long it takes: All of these design elements contribute to the timeline of the trial. So unless we come up with an innovative vaccine trial design or assays without an endpoint, the clinical trials will require a lot of time. This time will not decrease unless we create new ways of doing clinical trials, adaptive clinical trials, or experimental medicine trials.
Pharma Now: Understandable, I hope to see some innovations in this effect soon so that the clinical trial period is reduced. Speaking of time, people talk about work-life balance. I’m sure you must’ve gone through phases where you have to prioritize your family and at other times, your job, your corporate role, comes first. Do you believe in work-life balance? How have you managed to maintain a work-life balance?
Ms. Aggarwal: I have a love-hate relationship with this terminology because I don’t think it exists. Somebody told me that everybody has boxes in their life–like the work box, partner’s box, children’s box, parents’ box, and friends’ box–and you have to give enough time to each box to have a sustained life. Ultimately, it depends on you which box to prioritize at which time. To me, work-life balance doesn’t count as 24 hours. I look at it from a bigger lens. For example, rather than maintaining a work-life balance of a single day, it should be a work-life balance of a particular week or a month. If I’m hustling for the past four years to get to a point in my career, maybe I’ll take a year off to understand myself or allow myself to grow mentally or emotionally. That's work-life balance for me.
Pharma Now: This concept is certainly intriguing because I’m sure most believe define it in 24-hour terms rather than weeks, months, or years. However, do you think this is practically possible?
Ms. Aggarwal: It may or may not be possible because it’s very personal. It isn’t possible to tell a person to take 10 minutes every day to exercise for the sake of work-life balance. There is no written prescription for everyone. When thinking of the work-life balance, don’t give up on yourself, never limit yourself to something, and never think there is no escape from doing something. Even if it’s a small activity–like taking some time every Sunday for painting–that’s your piece of you. It may not work for everybody.
Taking time out for yourself in one way or the other is a continuous exercise. It may work for you right now, but it won’t work 6 months later. As long as you don’t give up on yourself and you think, “I will be bigger than this”, you’ll be fine. As long as you don’t give up or stop thinking about ways to improve yourself, you’ll be fine. For example, for me, it could be a simple thing like coming back home or deciding what I’ll be cooking that day. If I planned a week–thought of the dish, bought ingredients–I could take some personal time and get it done. Even if it means that after cooking and eating, I still have to work for an hour, it’s fine, and this is what gives me happiness. So that’s how I manage my work-life balance. It’s not like working for 8 hours and coming back. This concept of work-life balance is very misaligned. Work-life balance is answering the question, “Can you have a life beyond the definition of work?”
Pharma Now: Yes, I think this is the perfect definition of work-life balance. You said, “It may work for you right now, but it won’t work 6 months later. As long as you don’t give up on yourself, you’ll be fine.” I think that’s the perfect way to put it. It was amazing speaking with you today, Ms. Aggarwal. Thank you for joining us on Pharma Now.
Ms. Aggarwal: Thank you!
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