Introduction: In the traditional drug development paradigm, a cancer molecule can take up to 15 years to complete the journey from initial discovery to the US Food and Drug Administration (FDA) approval. While many oncology products are eligible for the FDA expedited pathways-Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval-the overall drug development process is still long and inefficient. In recent years, tremendous advances in the understanding of the molecular mechanisms underpinning cancer development have led to the development of many targeted therapies and immunotherapeutics, embarking on a new era of Precision/Personalized Medicine (PM). The PM model is centered on appropriate genotype or/and phenotype diagnostic testing to identify specific patient subpopulations that can respond well to a particular drug. It creates new opportunities for developing more flexible and efficient mechanisms to accelerate cancer drug development and support high-value care.

Our work: Inspired by the "21st Century Cures Act", we attempt to build up a de novo oncology drug development model. Our conceptual framework has integrated breakthrough emerging technologies such as point-of-care companion diagnostics, Next-Generation Sequencing (NGS), Artificial Intelligence (AI) modeling, patient-reported outcome(PRO) health Apps, wearable device, and real-world evidence (RWE), to remodel the traditional sequential drug development pathway into more integrated, faster, and patient-centered routes. As off-label use is common among cancer patients, post-marketing RWE will play an essential role in new oncology drug discovery. Every single patient who uses the drug outside of the first indication could be a single-patient intervention cohort of a hypothetical new indication. Many of these single-patient cohorts could be merged into new indications or new patient populations to gain FDA approval.

Conclusions:The Precision/Personized Medicine model will rapidly expedite oncology drug development and efficiently channel healthcare resources to unmet medical needs. “Me drug” will take the stage of oncology in the near future.