The unprecedented collaboration among biopharmaceutical companies in developing new vaccines and therapies for COVID-19 portends lasting changes to drug development that could benefit patients living with chronic disease and other hard-to-treat conditions. That was one key takeaway from Amgen CEO Bob Bradway's fireside chat at the USA-India Chamber of Commerce's annual BioPharma and Healthcare Summit, held online last month. Bradway spoke with Kiran Mazumdar-Shaw, Executive Chair of Biocon Ltd.
Bradway highlighted a number of learnings from the biopharmaceutical industry's "extraordinary accomplishment" in bringing to market not one, but several, COVID-19 vaccines in less than one year, and from how industry, regulators, governments, and the academic community worked together to make this happen in such short time. "We demonstrated that the power of biotechnology is extraordinary when the ecosystem is working together to try to make a difference," he noted. "So, is there an opportunity to increase the tempo of drug discovery and drug development? Absolutely. Are some of the things that we learned over the past 18 months applicable to diseases going forward or to the drug discovery development process? I think, absolutely."
"The speed at which we agreed to collaborate and the extent to which we threw in together reflected the urgency," Bradway observed. "That kind of cooperation points the way forward, when it comes to some of the big challenges that we still face as an industry," he added, citing Amgen's partnership with Eli Lilly to manufacture Lilly's antibody therapies for COVID-19.
Bradway expressed confidence that many of the innovations used to develop new interventions for COVID-19 – such as adaptive clinical trial designs and expanded use of big data – can be maintained and applied to biopharmaceutical research and development aimed at other conditions. "I think there are opportunities and hopefully we will seize them… There are pathways that will enable us to move more quickly than we have in the past. So the question would be, how can we and regulators work together in the future in the way that we were able to for COVID-19 and capture some of the benefits of speed and efficiency coming from collaborations, especially when the regulators are engaged."
For example, COVID-19 has prompted Amgen to accelerate its own use of new digital technologies. "In ten months," Bradway observed, "we've probably accelerated ten years in terms of our adoption of digital tools and technologies." He added that Amgen sees opportunities to improve its use of digital across its business, starting with human genetics. "We are the world's largest player when it comes to using human genetics for drug discovery and development. We have a very considerable effort in that regard based in our subsidiary in Iceland, and that is, at its core, a data business. Trying to extract insight from that larger repository of genetic information is a digital challenge. In addition to human genetic data, we have massive proteomic experiments running and other ‘omic' data that we're combining with our genetic information to try to understand what causes disease and what we can do to compete against the disease process. We're also looking at digital as a way to think better about the kind of molecules we discover. We're really encouraged about how rapidly the field of protein structure and function is evolving and how machine learning might be able to break some of the important roadblocks that exist in that area."
Bradway noted that Amgen still "feels like a small, tiny biotechnology firm in some ways," despite having invested some $4 billion annually in R&D, all of which is aimed at developing novel medicines with large effect sizes and targeting serious disease. He cited Amgen's rapid development of LUMAKRASTM as the latest evidence that "we're living in the biocentury."
Turning to gastric cancer, which is the fourth leading cause of cancer death globally and is particularly widespread in Asia, Bradway highlighted bemarituzumab, which came to Amgen via its recent acquisition of Five Prime Therapeutics and is being developed as a targeted therapy for gastric and gastroesophageal cancer. Reflecting the urgent need for new treatments for this form of cancer, the U.S. Food and Drug Administration has granted breakthrough therapy designation to bemarituzumab. "We are working to move quickly into Phase 3 clinical development," Bradway said. "So again, first-in-class and a novel way to try to bring help to patients who are suffering from gastric cancer."