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BUSINESS STORIES

OPERATIONAL REVIEW


TRANSLATIONAL MEDICINE AT NIBR: THE BRIDGE FROM BASIC SCIENCE TO NEW DRUGS

 

Professor Mark Fishman, M.D., moves easily between two worlds – the laboratory bench, as a researcher specializing in devel-opmental genetics, and the bedside of patients, as a practicing car-diologist and former Chief of Cardiology at Massachusetts General Hospital.

As President of the Novartis Institutes for Biomedical Research (NIBR) since 2002, Dr. Fishman has fostered the perspective of a physician-scientist in the company’s labs around the world. “The whole drug discovery process at Novartis today is permeated with medical thinking – our focus is the individual patient with true unmet medical need,” he says.
To sharpen that patient focus, NIBR and colleagues from Development have established a Translational Medicine team – experienced physician-scientists recruited from academia as well as industry. Each member of the Translational Medicine group represents one of NIBR’s disease areas – and helps to bridge the gap between basic science
and clinical medicine in that field, with the goal of delivering more new medicines.
The increasing emphasis on translational medicine underscores a broader trend at Novartis, where the traditional segregation of research and development is giving way to integrated “exploratory research,” spanning from the most fundamental biological knowledge, to early clinical trials. The push for integration has led to a new immersion in patient-centric concerns for research scientists. “Today at NIBR the exploratory phase of research doesn’t end when a compound enters development – we have to show that it actually works in some patients,” says Trevor Mundel, M.D., Head of Exploratory Clinical Development.
It seems to be paying off. Graeme Bilbe, head of NIBR’s Neuroscience Disease Area, says there is intense interaction between research, development and translational medicine staff today. “Physicians working in early clinical development get involved in a project much sooner than they used to. And we talk with them all the time to take advantage of their knowledge of disease and clinical practice,” Dr. Bilbe adds.
The focal point of this interaction is the “proof-of-concept” clinical trial. The hallowed, sequential model of drug development is being reshuffled, moving toxicology and other tests of a new compound earlier in the process. This sets the stage for studies in a small number of patients.
“It forces our scientists to work in a new way,” Dr. Fishman says. “From the very beginning, as they do fundamental biology, scientists must think carefully about which patients most likely will benefit from the new medicine, and how we

 

NOVARTIS GROUP BUSINESS REVIEW 2005