CAMBRIDGE, Mass.—Two leaders in the field of treatinginflammatory bowel diseases (IBDs), Janssen Biotech Inc. and the Icahn Schoolof Medicine at Mt. Sinai Hospital, have teamed up to advance the scientificunderstanding of these diseases, identify biomarkers that enable therapies tobe tailored to individual patients and explore next-generation therapeuticsolutions.
Scientists from the Janssen Immunology Therapeutic Area andresearchers from Mt. Sinai will investigate disease triggers, identify newopportunities for therapeutic interventions and establish diagnostics tofacilitate "precision medicine" and predictive biomarkers. Thefirst-of-its-kind industry and academic partnership brings together Janssen'sR&D capabilities with an early-stage life science investment through theJohnson & Johnson Innovation center in Boston and Mount Sinai's expertisein 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 UnitedStates. But neither condition has a cure, and they are also very difficult totreat, as they affect individual patients in different ways.
Janssen has proven to be a leader in the treatment of IBDsfor at least the last two decades. In 1998, the U.S. Food and DrugAdministration (FDA) approved Remicade (Infliximab), a monoclonal antibody forthe treatment of Crohn's disease. Remicade is now the company's top-sellingdrug, reaching about $5.5 billion in annual sales in 2011, and Janssen hasexpanded the market for Remicade by seeking and winning approval for additionalautoimmune indications, including UC. Janssen also recently won FDA approvalfor the use of the Simponi (golimumab) injection to treat adults with moderateto severe ulcerative colitis.
"We have a longstanding legacy in the treatment of Crohn'sdisease and ulcerative colitis, and we also have a long-term strategy andvision for continuing to address unmet medical needs in IBD—all the way to apotential cure and prevention of this disease," says Dr. Miguel S. Barbosa,head of Immunology Research and Scientific Partnership Strategy at JanssenResearch & Development.
Janssen has a longstanding relationship with Dr. BruceSands, a professor of medicine and gastroenterology at Mt. Sinai Hospital whois heralded as an expert in the management of IBDs and participated in thedevelopment of Remicade; as well as Dr. Eric Schadt, a visionary in the use ofcomputational biology in genomics, Barbosa points out.
"That's what really sparked our interest, the ability towork with two leading clinical scientists who have an understanding of how totreat patients with IBD and how best to interact with patients in a clinicalsetting," he says. "That, and the ability to extract a deeper understanding ofthe complex biology involved in these diseases, and to develop computational tools."
As in many industry/institutional partnerships, this onewill combine Janssen's drug discovery and development expertise with Mt.Sinai's clinical resources, but it's unique in one respect: The Mt. Sinai teamwill be contributing a data set that provides insight into advances diseasestages, and combined with Janssen's database of patient information, thepartners will create a computational infrastructure that allows them to minethe joint database. The partners will then use this information to evaluatepotential therapeutic candidates.
"One additional component that makes this collaboration ofinterest to us in the long term is that just as Janssen R&D is committed totransforming the way patients are treated in the future—not just fortherapeutics, but the actual decision process a clinician uses to decide on themost appropriate therapy for a patient—Mt. Sinai has also expressed an interestin developing broader, more integrated solutions to enable more informeddiscussions between patients and clinicians, which will create a moreintegrated healthcare solution," Barbosa says.
As computational methodologies evolve and are optimized,Janssen feels that it is placing itself at the leading edge of that effortthrough its partnerships with leading academic labs, says Barbosa. And whilethe term "personalized medicine" has become familiar vocabulary, Janssenprefers the term "precision medicine," which Barbosa defines as "the approachby which you match the appropriate therapeutic molecule or drug to a patient bymeasuring how they will respond to a specific therapy."
"This therefore removes some of the empirical approachesthat are more standard today, where you take one therapeutic, test it and if itdoesn't work, you move on to the next one. Biomarkers for these diseases willbecome fundamentally important as we select a drug candidate to progress intomore advanced studies and examine the mechanism by which that drug correlatesto disease benefit. In those cases where the correlation is high, and theassociation with disease is strong, we can recognize the biomarkers that willplay a role in developing companion diagnostics—and thus, precision medicine,"he concludes.