Comment from Wood Michelle

To the Food and Drug Administration, I am writing to share my support for the FDA's new draft guidance, "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products." I really appreciate the agency’s effort to modernize drug development and find ways to reduce unnecessary animal testing. It is heartening to see the FDA moving toward more efficient pathways, like reducing the reliance on multiple animal species and focusing on weight-of-evidence risk assessments. However, as you finalize this guidance, I strongly urge you to prioritize the use of modern, non-animal alternatives—often called "New Approach Methodologies" (NAMs)—whenever possible. We now have incredible tools available, like organ-on-a-chip systems and advanced computer modeling, that can look at how human biology reacts to drugs far more accurately than animal models can. Using these human-centric tools is not just the right thing to do for animal welfare; it’s simply better science. It can help us get a clearer picture of drug safety, reduce the number of promising cancer treatments that fail once they reach human trials, and speed up the process of getting life-saving therapies to patients. Please make sure this guidance gives researchers and companies clear, encouraging signals to move away from outdated animal testing in favor of these more innovative, humane technologies. Thank you for the work you are doing to make drug testing both more efficient and more ethical. Sincerely, Michelle Wood