The INTREPID Alliance is a not-for-profit consortium of innovative biopharmaceutical companies dedicated to accelerating the development of new treatments (particularly antivirals) for emerging pandemic threats, as discussed by the WHO R&D Blueprint for Epidemics.

With a global, patient-centred perspective, the objective of the INTREPID Antiviral TCP is to highlight categories and key attributes for antiviral compounds with utility against viruses with pandemic potential. In addition to the experience across the INTREPID member companies, external experts with antiviral drug discovery experience were also invited to review the TCP. The integrated feedback resulted in the current version of the INTREPID Antiviral TCP and provides a view of essential industry-standard preclinical molecular, pharmacological and manufacturing attributes that impact clinical development.

Six key attributes for the antiviral TCP are highlighted in Table 1, as well as the associated key preclinical activities for identifying and prioritizing compounds. A more detailed description of the key attributes and activities, including additional references, is provided in the Supplementary information.

In the process of evaluating these key attributes, the in vitro and preclinical methodologies and approaches used may include ones that are well characterized and named in regulatory guidance as best practices, such as the in vitro IKr/hERG assay8,9,10. It is also important to note that methods may evolve with technological advances. The key takeaway is that the data generation and analysis approaches used are consistent with regulatory guidance/requirements and with state-of-the-art in vitro and in vivo scientific methods that have undergone robust standardization and/or validation.

It is important to note that these key attributes should be used in close association with the respective TPPs, as the preclinical profile of a potential antiviral clinical candidate is connected to its intended use: prevention versus treatment of active disease, in combination with other antiviral drugs, how it is administered, or what the target patient population(s) is (for example, general population, adults, children, women of childbearing potential or pregnant women). These and other considerations may require preclinical and/or clinical-phase testing beyond what is listed above and can be further informed by interactions with regulatory authorities. This also includes taking into consideration the preventative and therapeutic use for patient populations in resource-constrained settings and the local/regional standard of care.