Proceedings of the meeting - Department of Physics - University of ...

O25Imaging in drug development: lessons from therapeutics and targeted molecularimaging agents.Andy Dzik-Jurasz, VP of Clinical Development, Point Therapeutics, Inc., Boston, MA,USA. adzikjurasz@pther.comPrecise quantitative knowledge of clinical drug pharmacology, in normal and diseasedstates is essential to the successful development of drugs. Several biomarker strategies,including imaging, are currently under development and have had success in supportingidentification of the mechanisms of action of drugs, and developing early read-outs ofresponse and prognosis for the purpose of patient stratification. Imaging has the greatbenefit over other biomarkers in providing functional and anatomical data. Usingexamples from the field of oncology the role of imaging in supporting the development ofoncology drugs in early clinical trials will be discussed. Many of these techniques are farfrom being accepted as outcome measures for regulatory submission of new chemicalentities (putative drugs that have not yet been approved for commercialization). On theother hand, conventional anatomical imaging represents the main body of imaging usedin late phase drug development (phase 3 and 4) and differs substantially in its role to thenewer functional techniques in development. The manner in which imaging is used forregulatory and exploratory research purposes will also be discussed.Many drugs currently under development are characterized by their unique moleculartargeting which is as a result of the increased understanding of key molecular targetscontrolling disease behavior i.e. apoptosis, angiogenesis. The importance of molecularevents in disease has led to an attempt to image those events in man in the hope ofaltering disease management to the patient’s advantage compared with the standard ofcare. The development of such agents is no less demanding than the development of atherapeutic and presents certain unique problems for those hoping to bring a targetedimaging agent to market. Not least of these is the regulatory hurdle to approval. Examplesof recent experience with targeted magnetic resonance agents will be used to illustrate theissues faced in bringing a targeted imaging agent to the clinic.