Drug development has evolved over time from the examination of natural products and their potential ability to manage disease symptoms to the highly technological-based approaches of today.  Independently, the healthcare system, in developed countries, has evolved to incorporate a diverse and complex environment, the healthcare ecosystem, which includes the patient, physician, pharma company, payer, regulatory agency and underlying science.  The interaction of these elements yields systems-based behavior that impacts the potential for a molecule to become a drug and, more critically, a commercial product. The complexities include differences in clinical practice, clinical guidelines, formularies, co-morbid conditions and government regulations. The ability to model, analyze and evaluate such factors early in the drug development process can be used critically to optimize the probability for success in drug development.  A basis for such an approach and its application to specific drugs will be presented as has been studied with our colleagues at the National Research Council of Italy (CNR-Pisa).<br/>

Expanding the perspective of drug development: Understanding real world medicine and real world patients

254th National Meeting (2017)

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