Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

The commenter supports the FDA's draft guidance to reduce non-human primate testing but argues that the agency should go further by prioritizing non-animal methods (NAMs) over rodent studies. They urge the FDA to make weight-of-evidence assessments the default approach and require animal studies only when scientifically justified.

The commenter supports the proposed guidance to streamline nonclinical safety studies for oncology drugs by reducing unnecessary animal testing through weight-of-evidence (WoE) risk assessments. They provide specific recommendations for clarifying evidence requirements, the role of new approach methodologies (NAMs), and species relevance to ensure regulatory predictability.

PhRMA, a trade association representing biopharmaceutical research companies, supports the Draft Guidance for streamlining nonclinical safety studies for biologics and conjugated products. They advocate for greater regulatory predictability, clearer definitions for "well-characterized" payloads, and more explicit guidance on using Weight of Evidence (WoE) frameworks and New Approach Methodologies (NAMs) to reduce animal testing.

Laboratory Corporation of America Holdings (Labcorp) expresses general support for the draft guidance to streamline nonclinical safety studies for oncology pharmaceuticals, particularly in its goal to reduce unnecessary animal use. The company requests additional clarity on the definitions and requirements for "similar" pharmacological activity and weight of evidence risk assessments.

The commenter supports the FDA's draft guidance to reduce the use of non-human primates in oncology toxicology studies but argues that the agency should go further. They advocate for prioritizing human-relevant non-animal methods (NAMs) and integrated weight-of-evidence assessments over traditional animal testing as the default approach.

Alcyomics Ltd. supports the draft guidance, advocating for a weight-of-evidence approach that prioritizes human-relevant New Approach Methodologies (NAMs) over traditional animal studies. They emphasize the importance of context-of-use frameworks and validation strategies that correlate with clinical outcomes to improve the prediction of human safety in oncology products.

The commenter supports the guidance by advocating for the reduction of animal testing in favor of a "Weight of Evidence" approach. They request that the FDA clarify what constitutes a strong evidence package, promote consistent review, and reduce barriers to using existing scientific data.

Devin Diane Baker supports the draft guidance's goal of reducing non-human primate testing but argues that the FDA should go further by prioritizing non-animal methods (NAMs) over rodent studies. The commenter urges the FDA to adopt a weight-of-evidence approach that favors human-relevant science to improve drug development outcomes and animal welfare.

The American Association of Pharmaceutical Scientists (AAPS) supports the FDA's effort to streamline nonclinical safety studies for oncology biologics and conjugated products. They recommend providing more specific guidance on how to select alternative study designs, clarifying the role of new approach methodologies (NAMs), and ensuring the weight-of-evidence (WoE) framework is structured to improve predictability for sponsors.

The commenter supports the FDA's draft guidance to reduce the use of non-human primates in oncology toxicology studies but argues that the agency should go further by prioritizing non-animal methods (NAMs) over rodent studies. They advocate for a weight-of-evidence approach that requires animal studies only when human-relevant data cannot be obtained through other means.