Diversity of Thought in Action

Samit Hirawat

Samit Hirawat, MD, gained his Bachelor of Medicine and Bachelor of Surgery degrees at Sawai Man Singh Medical College in Jaipur, India, and stayed on for the college’s general surgery residence program. In 1996, he came to enroll in the internal medicine residency program and finish his oncology training at the North Shore University Hospital in New York. In early 2002, he switched over to the pharma industry, becoming an associate director at the Pharmacia Corporation in Bedminster, NJ. In 2007, he joined Novartis Oncology in Florham Park, NJ, where he would move through positions of increasing seniority, before becoming Novartis’ head of oncology global development in 2017. In June 2019, he took up his present position as chief medical officer, global drug development, at Bristol Myers Squibb.

A major reason Hirawat moved from practicing medicine to working in the industry, he says, was that he struggled with “having to say to a patient, ‘There is no further treatment available,’ or ‘There is nothing more we can do.’” He explains, “I was dissatisfied with this status quo; I wanted to further my understanding of what else we could do. Also, I didn’t want to work in an environment that inhibits me or prohibits me from thinking broadly.”

He would find that the pharma industry provided the environment he wanted, an environment “where drug development has one purpose only, and that is make the best use of science for the best outcome for the patient.” This is what continues to drive Hirawat in his career.

“When we think about science, we are not looking to be simply additive,” he explains. “We want to be transformative. As we continue to learn more about the science and biology of drug development, we bring in diversity of thought and a diversity of leaders who have the insight of then thinking around how to utilize the data in a different way.”

At Novartis and for the last 18 months at BMS, Hirawat has spent his time cultivating this diversity of thought, encouraging and empowering the people he works with “to bring that change and transform and accelerate the process of drug development by utilizing the machinery of clinical trials, data collection, and novelty of execution.”

Clinical trial diversity

In August, BMS and the Bristol Myers Squibb Foundation announced a five-year, $300 million plan to address health disparities, vowing to increase clinical trial diversity, increase Black/African American and Hispanic/Latino representation at all levels of the company, and “strengthening health equity work across the business.”

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The commitment to clinical trial diversity will see BMS extend the reach of its trials into underserved patient communities in urban and rural US geographies. The Foundation will also help to train and develop 250 new racially and ethnically diverse clinical investigators and work to enroll underserved patients into clinical trials.

As part of the leadership of this initiative, Hirawat told Pharm Exec, “When we look at where clinical trials are conducted and the people who participate in them, there is a paucity of representation from, especially, the black and Latinx communities.”

One approach BMS will be taking to increase the participation of these communities is to expand the number of clinical trial centers in metropolitan areas where they are concentrated. BMS has made it “a goal and a mandate” to seek patient input into its pivotal trials to understand, Hirawat says, “first, if the data we are going to be collecting is appropriate, and, second, if participation in the trial is an extra burden for the patient. That level of engagement will give us a better sense of the work that we’re doing and how it will ultimately impact the patient.”

This endeavor goes beyond the patient and the healthcare provider, however. BMS also announced in August that it would be increasing its spend with diverse suppliers. By 2025, the company will spend $1 billion globally with Black/African-American and other diverse-owned businesses “to help create jobs and generate positive economic impact in diverse communities.” Hirawat explains, “Because we are only a company of around 30,000 people, we use a large number of third-party services. So we have plenty of opportunity to seek partnerships and collaborations with a diversity of external vendors and suppliers, with companies from the Black, Latinx, or Asian communities, and with other businesses that are underrepresented.”

BMS currently works, for example, with an organization that provides employees who fall within in the spectrum of autism. “They contribute some absolutely critical work for us on the IT side of things,” says Hirawat.

Pursuing and maintaining diversity of thought in an organization cannot be achieved with an ad hoc approach, says Hirawat, “rather, it has to be ingrained and then cultivated. It has to be a mandate.” For example, he explains, “I made it a standing mandate that for pivotal trials, if we don’t have that patient insight at the start, then I will not be signing off on the protocol.” Gaining that patient insight requires trust, he says. “Historically, certain sectors of society have not had the trust in pharma companies to participate in clinical trials. How do we gain that trust back?”

Hirawat believes that pharma needs to continue cultivating a dialogue amongst patient communities. “It is important to build community connections where patients can talk to other patients about their experiences. And things like avoiding clinical jargon, which we as healthcare workers can become very used to, might be helpful for patients to understand the clinical trial process.”

COVID-19: change accelerant

BMS made its recent diversity and inclusion announcement several months into the COVID-19 pandemic. Inevitably, translating these commitments into results has required a new way thinking and acting. COVID has served as an “accelerant,” says Hirawat, forcing the industry to think more outside the box as it relates to drug development. “We took action very early on, when the pandemic curve was going up around the world,” he explains. “We followed three basic principles. We wanted to be absolutely sure that we protect the safety of the patients, that we protect the safety of the workers in the company, and that we protect the safety of those working at the clinical trial sites.” It was with those priorities in mind that BMS constructed its plan and made it public. “We started acting back in April on the new principles that clinical trial sites will need follow to enroll new patients or start new trials,” he says.

Certain trials were put on the back burner; they were issued with voluntary goals and stopped enrolling new patients to avoid overburdening the healthcare system, which had become focused on taking care of COVID patients. “Then, as we started to see the curve change in many parts of the world, we released guidance on how to reopen those studies and reinitiate the enrollment of new patients,” says Hirawat. For example, BMS tasked local labs with drawing patients’ blood, rather than have patients travel 50 miles to have the procedure done at a clinical trial site. Also, in the US especially, “wherever the institutional policies and legislative policies allowed it, we were able to utilize electronic health records to do some of the data cleaning,” says Hirawat.

With or without COVID in the background, he points out, these learnings will be used to continue to evolve clinical trials in the long term. Hirawat notes, “These were ideas that we were still mulling over prior to COVID-19. The pandemic provided the impetus to go faster and validate them, and start instituting them as practices.”

Medicines for all

Hirawat is proud to be part of a team “that is diverse in their thought processes, is very resilient, and have patients at the center of their attention.” But while BMS has had a “long history of addressing health disparities as part of its overall mission,” he says that the company now recognizes “the urgent need to do more to address these serious gaps that have become even more apparent during the pandemic.”

Hirawat adds, “We are working toward real systemic change. 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, not for some patients but for all.”

Julian Upton is Pharm Exec’s European and Online Editor. He can be reached at jupton@mjhlifesciences.com.