For the biopharma industry, 2020 was many things, but for Samit Hirawat, M.D., chief medical officer of Bristol Myers Squibb, three things stand out: collaboration, adaptation and evolution.
“It’s been a bittersweet moment in the sense that we got hit by the pandemic, but how humanity evolved, how we evolved and how we got new things into play—it’s been absolutely exciting,” Hirawat said.
He highlighted how quickly biopharma companies and governments teamed up to develop treatments and vaccines for COVID-19, as well as the many thousands of people who volunteered to participate in clinical trials of those medicines. We’re already starting to see the results of those efforts, with the emergency authorization of the first two COVID-19 vaccines from tandem Pfizer-BioNTech and Moderna.
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As we start a new year, Hirawat looks forward to the continued evolution of the biopharma sector, but not just from a COVID-19 perspective. Whatever disease area they were working in, every drug developer has had to contend with the pandemic and everything that came with it, including social distancing rules.
Many clinical trials were paused, while others had to start later than anticipated. To get development programs back on track, companies got creative. And some of those solutions turned out to be even better than what had been the status quo.
“If you think about how we were able to incorporate telemedicine in protecting patients from visiting the hospitals but rather can be seen at home," Hirawat said. "How medicines were provided at home so patients don’t have to come to the site. How we collected the data, monitored the data, analyzed the data and reported the data."
“More of the remote nature of that work, I think, is here to stay," he added. "The simplification in the conduct of our clinical trials, I think, is here to stay.”
Beyond COVID-19, Hirawat thinks 2021 will be a big year for oncology. Bristol Myers itself is working on two CAR-T therapies picked up in its $74 billion Celgene acquisition and pushing its other immuno-oncology meds into earlier lines of therapy, but the cancer field will see progress on multiple fronts.
“If we think about the oncology space, it’s ripe right now because of the multitude of platforms that are being investigated in a very large setting in terms of the types of tumors,” Hirawat said.
He’s looking forward to new data from those platforms, which include antibody-drug conjugates, anti-TIGIT approaches, protein degraders and targeted therapies, such as those for KRAS mutations. Of course, cell therapy will be a big one, too.
“Cell-therapy-wise, we have the evolution ongoing—not just moving them up front (into earlier lines of treatment), but I think everybody’s working on improving the manufacturing of autologous CAR-Ts,” Hirawat said, referring to CAR-T treatments made from a patient’s own T cells. Such treatments can be complex and time-consuming to make, which isn’t ideal for very sick patients who may not have long to live.
“We’re all working toward the various ways of shortening that (manufacturing) time frame,” he added.
That said, there are other ways to speed up the manufacturing of cell therapies, including making them from donor cells in an allogeneic approach. Finally, Hirawat hopes to see new data that indicate where cell therapy can go beyond the blood cancers where it has shown success to date.
“We’ve also started to see data now being generated for cell therapies beyond hematology and oncology, so I think 2021 is going to be very important from that perspective, to see where the evolution can truly be triggered and accelerated to go beyond where we are today, just focused on the autologous CAR-Ts only focused on parts of lymphoma and parts of multiple myeloma,” he said.