News & Perspectives
Addressing barriers to clinical trial participation and clinical trial diversity during COVID-19 and beyond

A conversation with: Chief Medical Officer, Global Drug Development, Samit Hirawat, M.D.

August 27, 2020     

As chief medical officer, Global Drug Development, Samit Hirawat, M.D., oversees late-stage drug development across all therapeutic areas at Bristol Myers Squibb (BMS), including the design and operation of clinical trials. A physician by training, Hirawat specialized in oncology and clinical research before transitioning to drug development. He joined BMS in 2019 after serving as executive vice president and head of Oncology Global Development for Novartis.

Hirawat recently reflected on the progress of the company’s R&D pipeline, the impact COVID-19 has had on clinical trials,  and the completion of his first year at BMS.  

Chief Medical Officer, Global Drug Development, Samit Hirawat, M.D.

Chief Medical Officer, Global Drug Development, Samit Hirawat, M.D.

Your first year at BMS was eventful to say the least, with the acquisition and integration of Celgene and the global outbreak of COVID-19. What stands out for you as you look back?

It’s been a fascinating journey. I joined BMS knowing it was a time of change but none of us anticipated a year such as 2020. We are delighted with the progress of the ongoing integration and the multiple milestones achieved, but the pandemic will always be the way I will remember this time – there is no way not to. While some of the unknowns were unpredictable, they also offered opportunities to work closely with a phenomenal team of individuals to chart a path that was completely new. To be in a position where we can impact so many lives with our work is a great honor and I never lose sight of that. I’m grateful for the guidance and support that I have received from my colleagues and friends. 

How has COVID-19 impacted the company’s drug development program, and clinical trials specifically?

Our attitude at the outset was, pandemic or no pandemic, the diseases we’re fighting are still here. If anything, our commitment to continue this fight had to be intensified because many patients in the therapeutic areas we work in are living with autoimmune diseases or malignancies that impact the immune system, making them even more vulnerable. We were determined to do everything we could to continue our work, while also protecting the health and safety of our patients, our colleagues and our partners.  

Of course there were limitations, and the situation is still evolving, but thanks to the tenacity of our colleagues to quickly assess the situation and identify solutions, we have been able to continue the work of our clinical trials and development programs. You see this reflected in the number of product approvals, regulatory submissions and data read-outs in the last six months – as well as clinical trial enrollments. All of this speaks loudly to the dedication of the team and the passion they have for delivering on our commitment and transforming the lives of patients through science. It’s been an incredibly productive first half of 2020 despite these unprecedented challenges.

What were some of the challenges you encountered, and the solutions that overcame them?

Challenges came from every direction, and we had to manage a great deal of anxiety and fear of the unknown.  As for the solutions, it starts with having an open mindset: listening more, saying less and trying to understand the needs of the community. 

We did a lot of listening – to the physicians, to clinical trial site coordinators and monitors, and to patient advocacy groups. When we learned that patients couldn’t come to clinical trial sites, we utilized telemedicine so they could still talk to their doctors. When we saw patients couldn’t go to central lab locations for tests, we identified a way for them to use labs in their communities. We also evaluated if medicines could be sent to the patient rather than the patient coming to the hospital or pharmacy to collect them.

We pivoted as the situation evolved. Some of the cell therapy clinical trials that required some on-call hospital services had to pause enrollment when hospitals were being overwhelmed with the number of COVID-19 patients. When we saw the situation reversing in some countries, we were able to re-initiate these studies and now these trials are advancing science for patients in need.  

Everything comes back to listening carefully and keeping your finger on the pulse as the situation evolves. I am a type of person who is calm in difficult situations; I like to think creatively and focus on what can be done and how can we do it.  

Are there practices or lessons that you think will carry into a post-COVID world and change clinical trials in the future?

Overall, our industry needs to do a better job of listening to patients to understand the challenges they are going through, and to reflect this understanding into clinical trial design and conduct. I think you’re going to see that dialogue become more important. 

In fact, BMS recently worked with patient advocacy groups to launch the Patient Expert Engagement Resource (PEER), which will incorporate patient input at every step of the product development and commercialization process. 

Additionally, we recently partnered with GRYT Health to create the COVID Advocacy Exchange, a virtual platform to foster dialogue among global and local advocacy organizations. The advocacy organizations are currently navigating the challenge of COVID-19, but the Exchange, which takes the form of a virtual, 24/7 medical congress with weekly live sessions, is envisioned as a long-term resource. 

I think we will also see the pandemic accelerate the adoption of technologies, such as telemedicine. We are just scratching the surface in terms of leveraging technology to collect and monitor data. For example, during the pandemic many hospitals were strictly limiting outside visitors, which included our clinical trial monitors. So we had to find a different way. Wherever legislation and our contracts allowed for it, we utilized the ability to access electronic medical record systems so that we could continue compliant data verification activities. Clinical trial integrity cannot be compromised.  

There are many learnings from this time of crisis that can help us when we come back to whatever the new normal will look like, but the greatest one is that perhaps we are more resilient and agile than we think. I would like to see this mentality of strength and flexibility stay as a key organizational and individual attribute.

COVID-19 has also exposed the severity of social and health disparities in the U.S. Recently, BMS and the Bristol Myers Squibb Foundation announced a combined investment of 300 million to accelerate and expand health equity and diversity and inclusion efforts, including efforts to increase clinical trial diversity. What’s your perspective on the need to accelerate diversity in clinical trials? 

This is an area I’m extremely passionate about. Since joining BMS, I’ve been the executive sponsor of an R&D working group dedicated to increasing diversity in our clinical trials. This group has made great progress, but we recognize that we need to do more. Blacks, Latinx, Asians and other minorities are significantly underrepresented in clinical research. To deliver on our mission, we must conduct trials that reflect the population impacted by the disease.

To do this, we need to reach patients who normally may not encounter the opportunity to participate in clinical research or who face barriers to clinical trial participation. It means bringing new clinical trial sites into our network and ensuring our trials include a diverse slate of investigators.

Where a person lives should not define whether or not they have an opportunity to participate in a trial. We are working towards real systemic change. For clinical trials, driving this kind of change will mean broader representation which leads to better science; and better science leads to safer and more appropriate medical practice and care for all of us.  We need to continue to discover, develop and deliver effective medicines for all patients and not some.

Like many people you’ve been working from home during the pandemic. What has the experience taught you?

I’ve been amazed at the resilience of my young daughter in navigating all these changes.  Kids are incredible and they teach us so much!  It has also been a time where mutual support and kindness are front and center, which is wonderful.  I am privileged to have a strong support system.  And this experience highlighted for me how much I enjoy being around people – it is something I miss.  But most of all I think the great awakening is broader than about the home – it is about the world.  It is about those who do not have the resources, the opportunities or access to even basic care. Strangely, despite the physical distance, I feel more connected than ever to the world as a whole and to the importance of striving to make a positive impact.

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Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. As global citizens, we work sustainably and responsibly to create a positive impact in the communities where we live and work.