June 20, 2024
Joining colleagues from the pharmaceutical industry, Dr. McDonald kicked off a session on the FDA Modernization ACT as part of a career development session at the annual STP symposium. The presentation provided an overview of that updates to the ACT that went into law in late 2022 as well as the new updates that are currently under review. This presentation set the stage for the remaining talks of the session, which provided critical reviews and updates on the use of virtual controls and alternative non-animal testing strategies.
Overall, the session helped to educate the community on the need for scientific considerations in the use of any new tool that is intended to help protect human health. Dr. McDonalds presentation postured that there are many non-animal tools that have existed for many years, and many novel methods are being developed that can hopefully streamline the drug development process, as the ACT intends. Regulatory, scientific and other frameworks should consider a strong balanced approach of animal use, with the appropriate animal model and scientific designs, with other methods.
About the Presentation
The presentation suggested that “while the breadth of additional scientifically validated tools will help with the efficiency of drug development, and hopefully its accuracy; It will not replace the need for animal nonclinical testing for the foreseeable future”. The additional approaches available will, however, help to reduce and refine the need for animal use now and in the future.
About Dr Jake McDonald
Dr. McDonald is CEO of Envol Biomedical, a laboratory that conducts research for the pharmaceutical industry with non-human primates. Envol Biomedical, as part of their 3R strategy, applies study designs that efficiently use animals and works with sister companies to help make biological matrices available to partner innovators that enable in vitro and ex vivo assays.
