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Partners in precision--not just personalized--medicine
CAMBRIDGE, Mass.—Two leaders in the field of treating inflammatory bowel diseases (IBDs), Janssen Biotech Inc. and the Icahn School of Medicine at Mt. Sinai Hospital, have teamed up to advance the scientific understanding of these diseases, identify biomarkers that enable therapies to be tailored to individual patients and explore next-generation therapeutic solutions.
Scientists from the Janssen Immunology Therapeutic Area and researchers from Mt. Sinai will investigate disease triggers, identify new opportunities for therapeutic interventions and establish diagnostics to facilitate "precision medicine" and predictive biomarkers. The first-of-its-kind industry and academic partnership brings together Janssen's R&D capabilities with an early-stage life science investment through the Johnson & Johnson Innovation center in Boston and Mount Sinai's expertise in computational biology and clinical and translational research in IBD.
IBD includes Crohn's disease and ulcerative colitis (UC), two chronic diseases that affect as many as 1.4 million people in the United States. But neither condition has a cure, and they are also very difficult to treat, as they affect individual patients in different ways.
Janssen has proven to be a leader in the treatment of IBDs for at least the last two decades. In 1998, the U.S. Food and Drug Administration (FDA) approved Remicade (Infliximab), a monoclonal antibody for the treatment of Crohn's disease. Remicade is now the company's top-selling drug, reaching about $5.5 billion in annual sales in 2011, and Janssen has expanded the market for Remicade by seeking and winning approval for additional autoimmune indications, including UC. Janssen also recently won FDA approval for the use of the Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
"We have a longstanding legacy in the treatment of Crohn's disease and ulcerative colitis, and we also have a long-term strategy and vision for continuing to address unmet medical needs in IBD—all the way to a potential cure and prevention of this disease," says Dr. Miguel S. Barbosa, head of Immunology Research and Scientific Partnership Strategy at Janssen Research & Development.
Janssen has a longstanding relationship with Dr. Bruce Sands, a professor of medicine and gastroenterology at Mt. Sinai Hospital who is heralded as an expert in the management of IBDs and participated in the development of Remicade; as well as Dr. Eric Schadt, a visionary in the use of computational biology in genomics, Barbosa points out.
"That's what really sparked our interest, the ability to work with two leading clinical scientists who have an understanding of how to treat patients with IBD and how best to interact with patients in a clinical setting," he says. "That, and the ability to extract a deeper understanding of the complex biology involved in these diseases, and to develop computational tools. "
As in many industry/institutional partnerships, this one will combine Janssen's drug discovery and development expertise with Mt. Sinai's clinical resources, but it's unique in one respect: The Mt. Sinai team will be contributing a data set that provides insight into advances disease stages, and combined with Janssen's database of patient information, the partners will create a computational infrastructure that allows them to mine the joint database. The partners will then use this information to evaluate potential therapeutic candidates.
"One additional component that makes this collaboration of interest to us in the long term is that just as Janssen R&D is committed to transforming the way patients are treated in the future—not just for therapeutics, but the actual decision process a clinician uses to decide on the most appropriate therapy for a patient—Mt. Sinai has also expressed an interest in developing broader, more integrated solutions to enable more informed discussions between patients and clinicians, which will create a more integrated healthcare solution," Barbosa says.
As computational methodologies evolve and are optimized, Janssen feels that it is placing itself at the leading edge of that effort through its partnerships with leading academic labs, says Barbosa. And while the term "personalized medicine" has become familiar vocabulary, Janssen prefers the term "precision medicine," which Barbosa defines as "the approach by which you match the appropriate therapeutic molecule or drug to a patient by measuring how they will respond to a specific therapy."
"This therefore removes some of the empirical approaches that are more standard today, where you take one therapeutic, test it and if it doesn't work, you move on to the next one. Biomarkers for these diseases will become fundamentally important as we select a drug candidate to progress into more advanced studies and examine the mechanism by which that drug correlates to disease benefit. In those cases where the correlation is high, and the association with disease is strong, we can recognize the biomarkers that will play a role in developing companion diagnostics—and thus, precision medicine," he concludes.