Risk‐based preclinical safety requirements
The global support for drug and vaccine development, including streamlining nonclinical requirements, has allowed candidates, such as severe acute respiratory syndrome coronavirus 2 (SARS‐CoV2) antibodies, to move quickly into the clinic to most efficiently determine if the experimental treatment is effective for patients. The practice of deferring or eliminating certain preclinical studies while there is a degree of uncertainty in the experimental candidate for specific life‐threatening illnesses with no effective treatment is not new. ICH S9 Guideline “Nonclinical Evaluation for Anticancer Pharmaceuticals” provides for such regulatory flexibility for advanced oncology indications. We encourage regulators to apply this approach to other life‐threatening illnesses across therapeutic areas, and to model a global harmonized approach as ICH. The benefits to society could be significant—by reducing the need to use animals, modernize drug development, and potentially make new therapies available to patients faster.