There was no template.
In 2018 nobody in Russia had written a clinical trial protocol for CAR-T cell therapy. In 2020, there was none for HER2 bispecific antibodies.
So I wrote the first ones. From scratch.
Notes. BIOCAD, Russia’s leading biotech company. The oncology portfolio: 14 trials, phases I–III, for the EAEU, EMA, FDA and other regulators.
