15 May 2026
The Biotech’s Case for Programmatic Oncology Development
THE ONCOLOGY CENTER OF EXCELLENCE (COE) THAT DELIVERS
Oncology isn’t just another therapeutic area. It is its own world with its own rules, especially in drug development. Oncology clinical trials follow different regulatory pathways, involve complex classes of drugs, and demand a level of urgency and precision rarely seen in other indications. Sponsors need to decide on line of treatment, stage of disease, and the patient subpopulation, which in many cases is defined by molecular or genetic predisposition, design for RECISTbased objective response rates, and how to adapt protocols in real time. And they need to do it at pace, because delays in early oncology development can directly impact patients’ access to promising therapies. Placebo-only arms must be used judicially in later phase trials, and there’s little tolerance for inefficiency.
For U.S.-based biotechs running Early Phase oncology trials, these difficulties are magnified by limited internal resources, intense financing pressures, and evolving U.S. regulatory expectations.