Lena Biosciences reposted this
Independent, Previous Senior Vice President and Head of Translational Sciences at Bayer Pharmaceuticals
This is a nice local newspaper article which is pointing to a general dilemma when talking about non-animal methods in regulatory processes. For understandable ethical and humane reasons animal rights groups have petioned the FDA to move faster in approving non-animal testing. On the other side the FDA, while supporting industry efforts to develop and use alternative methods, needs evidence that their regulatory decisions, i.e. the benefit-risk assessment for new drug candidates, can in fact be based on such novel methods. In this context, it is important to note that the FDA Modernization Act 2.0, passed in 2022, freed the FDA from requiring animal tests, i.e. it gave the FDA the option to accept non-animal tests, but didn’t explicitly require FDA to give them priority. To speed up the process, an updated version, the FDA Modernization Act 3.0, is now going further by requiring FDA to establish a process to qualify the new testing methods and expedite drug applications that incorporate non-animal approaches. The updated bill is expected to facilitate the development, qualification, and adoption of testing methods that could reduce or possibly even replace the use of animals in nonclinical testing. From my perspective it is important to note that the FDA Modernization Act 3.0 makes it clear from the very beginning that the reduction and replacement of animals must not be seen as an isolated or independent target in nonclinical research but that there is in fact a high need to improve the predictivity of nonclinical testing methods and to reduce the development time for a biological product or other drug. The low likelyhood of technical success remains the biggest challenge for all R&D organizations in pharmaceutical industry but there is hope that novel (non-animal) technologies along with artificial intelligence/machine learning approaches may lead to better predictions and thereby better outcomes for patients which must be the most important and ultimate goal of any activity. A full alignment and full support from all stakeholders is needed to make this happen. While it is clear that it may still take some time and huge efforts before novel alternative methodologies can be used to fully replace an intact organism, the use of such models to answer a particular question can already be justified now. I am convinced that regulators are open for such discussions. In this context it is encouraging to see that small companies like Lena Biosciences with their power to innovate are offering already now solutions to particular questions and on the long run they may play an important role in the transformation process. Jelena Vukasinovic James T Shoemaker Lena Biosciences