Innovative, advanced therapies have enormous promise, but also come with a host of logistical problems that innovators underestimate at their own peril.
Validating the regulatory expectations on evidential requirements for predictive biomarkers is not a trivial process, but quite conceptually challenging.
Innovation was the watchword at CAR-TCR in Boston last month, but one of the limitations of innovation is that it can be challenging for an industry to transition from the rapid iteration s
