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SUMMARY:“Paradigm changes produced by targeted agents in Phase I trials 
 in Oncology. Case studies of a TFbeta inhibitor and a Sonic Hedgehog inhib
 itor” - Dr Jordi Rodon\, Head of Research Unit for Molecular Therapy of 
 Cancer Oncology Department. Vall D’Hebron University Hospital\, Barcelon
 a\, Spain
DTSTART:20140909T110000Z
DTEND:20140909T120000Z
UID:TALK49443@talks.cam.ac.uk
CONTACT:Mala Jayasundera
DESCRIPTION:The development of cytotoxic agents is based on the paradigm o
 f a single direct dose–response relationship\, i.e. the greater the dose
 \, the greater the effect. The effect of decreasing tumour burden is\, how
 ever\, accompanied by a greater degree of toxicity. Targeted agents\, in c
 ontrast\, are framed differently. The specificity of a given effect may\, 
 in fact\, be lost at high doses while not achieving greater benefit after 
 a given biologically effective dose.  Although contemporary early drug dev
 elopment has shifted away from cytotoxics and it is primarily focused upon
  molecularly targeted agents\, the paradigm of drug development has only b
 een partially modified.  \n\nIn this talk we will first address how target
 ed therapies have transformed phase I trials in an arena for hypothesis te
 sting (proof of concept)\, and how this has changed not only the objective
 s and methods of these trials\, but also the patient population and expect
 ations of efficacy. This raises some practical\, logistical and ethical co
 ncerns. We will\, then\, use three scenarios (molecularly selected patient
  populations\, the development of a TGFbeta inhibitor and of a Sonic Hedge
 hog inhibitor) to depict how modern phase I trials\, molecular biology and
  translational medicine are connected.  \n
LOCATION:CRI Lecture Theatre\, Cambridge Research Institute
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