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 |