Models of Excellence: Improving Oncology Drug Development

Models of Excellence: Improving Oncology Drug Development

Simulations based on disease-progression models and phase II trial results can predict phase III results and have the potential to improve oncology drug development by informing end-of-phase II decisions (EOP2Ds). Many barriers impede effective use of modeling and simulation (M&S) for EOP2Ds in oncology: concerns about model validity, lack of access to M&S results and patient-level data, limite...

Biomarkers in oncology drug development.

Biomarker measurements have become an essential component of oncology drug development, particularly so in this era of targeted therapies. Such measurements ensure that clinical studies are testing our biological hypotheses and can help make the difficult decisions required to choose which drugs to stop developing or de-prioritise. For those drugs taken forward, biomarker measurements may also ...

Economics of new oncology drug development.

PURPOSE Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estim...

Model-based drug development applied to oncology.

Model-based drug development (MBDD) is an approach that is used to organize the vast and complex data streams that feed the drug development pipelines of small molecule and biotechnology sponsors. Such data streams are ultimately reviewed by the global regulatory community as evidence of a drug's potential to treat and/or harm patients. Some of this information is captured in the scientific lit...

Oncology drug development: what is changing?