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t m c » p u l s e | s e p t e m b e r 2 0 1 5 31 "Aggressive hematologic malig- nancies represent significant areas of unmet need," said Laura Bessen, M.D., head of U.S. Medical at Bristol-Myers Squibb. "Cooperation between industry and academia offers a tremendous opportunity to strengthen our scien- tific and clinical understanding of the role of the immune system in treating cancer. This collaboration will provide an efficient and compre- hensive landscape of the potential of immunologic approaches to evaluate treatment options for leukemia and pre-leukemic conditions." Launching up to 10 clinical studies to evaluate the utility of immune-based approaches, as well as identifying optimal treatment approaches, the two organizations are leveraging their own unique strengths. MD Anderson will be leading the operational aspects of the studies, while a joint development committee will oversee any collabora- tive efforts. "Our partnership with Bristol-Myers Squibb involves us taking their five immune-oncology drugs—what I call checkpoint inhibitors—and we pro- posed to investigate them across all leukemia and not just one particular disease," said Kantarjian. "In fact, it allows us to combine investigations in these drugs because they all come from the same pipeline. You're looking at many more tumors rather than one, so the chance of success will be higher, and the process is much faster. It's a win-win situation where the cancer experts develop the concepts and propose the protocols." The traditional methodology that companies use to test out new drugs, which involves testing each compound one at a time, is frustratingly labor intensive and mired in bureaucracy. Driven by contract research organiza- tions, which pharmaceutical, biotech- nology, and medical device industries use to outsource their research, the opportunities to shine a light on suc- cessful therapies are slim. "What we realized over time is that research has shifted from the experts— those at the academic and research cancer centers—to the companies," noted Kantarjian. "It became not a partnership but a business model where people from the companies would say, 'We have a drug, X, we want to test it out in a single cancer, Y, and that's going to be our goal.' "That form of company-driven research has drawbacks," he added. "It's a longer process. It's much more expen- sive, because they use clinical research organizations with intermediaries and a lot of bureaucracy; it shortens the pat- ent time; and it reduces their chance of success because they're looking at one particular tumor rather than a spectrum of tumors." For researchers like Kantarjian, there had to be a different way of doing things. Through their approach, MD Anderson and Bristol-Myers Squibb have created a model that brings research back into the steady hands of cancer experts. "In this partnership, we're the ones actually driving those studies," said Prat. "We're really defining the best modalities of immunotherapy for a very underserved segment of the patient population. We just started enrolling patients, but we're conducting all 10 of our clinical trials simultane- ously. This is something that under the old model would have taken us three years just to get started, much less to get clinical results. "By setting up this alliance, we're going to learn a tremendous amount," he added. "It's a process that's over ten times faster and over a much broader scope. Because you're really boiling the ocean, the chances that you're going to achieve a positive response are maximized. For the study modalities that don't work, they merely get closed and substituted within the setting of the alliance—we actually have a much better chance of finding better com- binations for particular segments of patient populations." With the studies ongoing, Kantarjian and his colleagues have already gained valuable insights on the mechanisms of how checkpoint inhib- itors kill leukemia cells. Pending the success of these trials, MD Anderson is looking to other companies with a similar partnership model in mind—an approach with the potential to reinvigo- rate research throughout the country. "I think cancer research in the United States has led cancer research throughout the world," said Kantarjian. "There's no way that we will be ced- ing this leadership because we have great minds in the United States, we have great resources, we conduct high quality research, and we have a need to help patients with cancer. We have to disrupt the existing cancer research model, because it's dying by thousands of bureaucratic paper cuts, high costs and a low success rate. The only way to move forward is by shifting the current model into something similar to what's being attempted here—one that's research driven and patient-centric." Ranked as the nation's leading can- cer hospital for 11 of the past 14 years, MD Anderson is distinguished, in large part, by the sheer scope of their ambi- tion. With their Moon Shots program, a celebration of the drive and dedication necessary to put a man on the moon, they are seeking a similarly lofty goal with the same level of conviction— a dramatic 50 percent reduction of mortality across several major cancers. It's a good thing they don't have to do it alone. "Cancer is a very, very complex problem," said Prat. "It would be slightly arrogant to think that we can do it all by ourselves. We need a lot of help. And we fundamentally believe that industry partnerships are not a necessary evil, but an essential part of achieving our mission. They have a lot of smart people—many of whom come from academia—a lot of resources, and our goals are aligned. At a basic level, we all want to help cure patients." This really conveys the great strides that MD Anderson has made as an institution. […] We want to create a virtuous cycle where we conduct all types of research of different magnitudes, which will enable us to have a lot more significance. — FERRAN PRAT, PH.D. Vice President of Strategic Industry Ventures for MD Anderson