Precision medicine in oncology drug development: a pharma perspective

• Select the trial for the patient, not the patient for the trial.
• A new paradigm of patient-centric drug development, as precision medicine continues to shape the oncology drug development landscape.
• Success will require continued innovation, and collaboration and co-operation between and across all parties and sectors involved in development and delivery of cancer therapeutics and care.

A rapid expansion in precision medicine founded on the potential for durable clinical benefit through matching a drug to a predictive marker used to select patients has driven the development of targeted drugs with accompanied companion diagnostics for patient selection. Oncology has been at the forefront, with the improvements in patient survival notable. Increasing numbers of molecular subgroups require an equally increasing number (and new generation) of highly selective agents targeting inevitably lower incidence molecular segments, posing significant challenges for drug development. Innovative trial designs (umbrella or basket studies) are emerging as patient-centric approaches and public–private partnerships, cross-industry, government and non-profit sector collaborations are enabling implementation. Success will require continued innovation, new paradigms in oncology drug development and market approval and continued collaboration.