As the executive vice president, chief medical officer and head of development at Bristol Myers Squibb, Samit Hirawat oversees early-stage and late-stage product development across therapeutic areas for the biopharmaceutical major. In an exclusive chat with The Hindu, on a recent visit to Hyderabad, he discussed India’s growing significance as a site for clinical trials, innovations in drug development, and how technology is poised to help bring new products to market faster.
BMS announced a $100 million development centre in Hyderabad in 2023, adding to its India operations comprising the two decade old commercial activities from Mumbai as well as the R&D centre established in 2008 with Syngene in Bengaluru. Could you provide an overview of work in Hyderabad?
When I joined BMS about five and a half years ago, we didn’t have a drug development presence in India. After COVID, as we were reinventing ourselves and our portfolio was growing at BMS, one of the ideologies I carried was we need to build talent pool not just in the New Jersey area or the United States, but how do we grow our presence and then utilise the talent wherever it is in the world?
We did look at a few other cities, but homed in into Hyderabad as talent exists here. At the time of MoU in February of last year, we committed to have 1,500 people over three years, that’s by end of 2026. We are past that number already…
As opposed to many other companies that came, used Hyderabad and India to build capability and capacity for say ancillary activities, back office functions, we came in with the mentality that talent in India has grown quite a bit… got experience in the process of drug development.
So we brought in here not only IT capabilities, but also capabilities in development operations, conduct of clinical trials, regulatory capabilities, medical writing capabilities, biostatistics capabilities, data management capabilities, patient safety, pharmacovigilance capabilities. We have all of those functions contributing from here. India is the largest hub for us now in drug development operations, even bigger than all combined spaces that we have in the U.S.
What would that be in terms of employees focused on drug development?
Overall drug development [globally for BMS] is about 5,300 people, spread in about 50 countries. Hyderabad houses close to 2,000 employees across functions, including drug development and business insights and technology. The drug development team is about 800-strong in Hyderabad and likely to grow 20-25% by next year. BMS in India is participating in more than 20 clinical trials across indications and we target to double that number in two years.
As Hyderabad emerges as a key centre for you, would it see more investment?
It’s not in terms of money anymore, it’s about using best talent for the best innovation. We only had seven clinical trials running in India 3-4 years ago… now have 23 clinical trials. Next year or by 2026, I want to have at least 50 clinical trials running in India. We used to run only oncology clinical trials in India before 2019. Now we are running immunology clinical trials, bringing in psychiatry clinical trials. We’re bringing in haematological malignancies. And we are bringing drugs not yet registered in the U.S. So we are not doing life cycle management of drugs. We’re actually doing true innovation. India is becoming a part of our global drug development operation. Money is secondary… if more investment is needed we’ll do that.
On clinical trials, is there a need for a review of regulations in India?
Regulations are there for safety of people and that appropriateness and transparency is there in terms of conduct of clinical trials. Indian regulations have evolved. Drug development is getting faster, better with regulations. Should some things be changed? Probably yes. Right now India doesn’t allow first-in-human trials for drug products discovered outside of India. Is that the right thing to do or not? And that is a conversation we need to have and continue to have with the regulators in India, that if you allow that in an appropriate setting at the right centres to do those first-in-human trials, I think it’s the right time to do it because we’ve never seen innovation coming through at a speed that we are seeing today. I remember the stories of the past, but times have changed. More transparency has come through, people are more educated and we have better systems to monitor.
In what way is Artificial Intelligence contributing to accelerating clinical trials?
We looked deeper into the process of clinical trial and what we can do to do drug development at a faster pace. We found spaces where technology can help. For example, writing of a protocol, using more and more of Artificial Intelligence, Machine Learning… Let’s say there are 17 sections to a protocol, maybe 12 can be automatically written because of prior knowledge. So we don’t have to have human hands typing those and we can focus only 30% of our time in writing the rest of the sections. We can increase productivity.
In terms of startup activities, how we can use [technology for] clinical trial site selection and startup packaging in terms of how to get the sites up and running in shortest period of time. In terms of enrolment, how do we identify patients? A lot of technology is going behind it… writing of documents or database lock, visualization of data, making sense of data in the shortest format
Each of the components is using some sort of technology and that is shortening our period of drug development. Our aim is that in our pipeline, from first-in-human trial to [drug] approval, a median of about six and a half years is what we want to get to and then continue to shorten that. We know that not all drugs will meet that timeline.
With use of emerging technologies, there are also reservations on their deployment? Your comments?
One is the job perspective, that when AI and ML come in will my job go away? If I’m working 10 hours a day on a certain thing, if I can get machines to work for me for say, four hours of that because that’s automated now I can still work 10 hours. So it’s not the job going away, but becoming more productive using the machines.
The second element is quality and transparency. Am I cutting corners by using machines? And I think that’s all human dependent. That’s why we’ll need to have the quality checks, QC and QA. We can’t close our eyes because ultimately, algorithms for these are written by humans. And if we make an error in one place, it will be transmitted all along. And that’s why we’ll have to put these edit checks everywhere… so that we are able to audit trail it backwards… we will have to remain accountable and responsible for the product delivery.
You mentioned a target of 6.5 years, what is the median now?
If we get to the six and a half, we’ll be in the top quartile in the pharma industry, that in the top 25% or so, the norm of the top performing companies. That’s where we want to get to. We’re not there yet.
Oncology, haematology, cardiovascular, and immunology are core therapeutic areas of BMS are and the company is eyeing to increase presence in neuroscience. How important India is from a diversified pool perspective as BMS consider bringing more trials here?
If you think about the therapeutic areas we are in today, we are in solid tumours as in oncology, in liquid tumours or blood cancers and haematology. We do clinical trials in immunology. So systemic lupus erythematosus, for example, or if you think about lung fibrosis, we’re doing clinical trials there. We’re doing clinical trials in cardiovascular medicine. We’re doing clinical trials in neuropsychiatry right now, for Alzheimer’s disease, dementia, or cognition impairment, or psychosis, or bipolar disorder. We are talking about clinical trials for Alzheimer’s disease itself. All of those have possibilities to come to India.
In fact, we are in the process of starting trials in lymphoma… opening centres in Hyderabad itself. Across all of our therapeutic areas, we have opportunities to engage India.
Do you see a role for startups in accelerating the drug development of Big pharma?
If you look at any big pharma, a lot of pipeline actually comes from biotech companies. Because large pharma has a large footprint where we focus on execution of large clinical trials. We do do research, but our research is facilitated by using the talent and the mind of smaller companies that have a more focused approach to a single product, single modality. If you look at our pipeline today, 60% is something we got from outside, as an external pipeline. From 2019 to 2024, BMS acquired a number of companies [globally]… our mindset is we want the best drugs in the company. We don’t care where they come from.