Drugs

Edits Suggested for BEST Taxonomy

Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds FDA for the BEST (Biomarkers, EndpointS, and other Tools) resource taxonomy that serves as a point of consensus for all stakeholders and provides clarity needed to drive programs in biomedical research and clinical care. In a comment letter, PhRMA says it believes the resource “will help ensure a consistent use of terms and, therefore, a common understanding of the issues between industry and FDA. PhRMA appreciates that the BEST resource has embedded links to relevant FDA guidances and recommends FDA continue to update the glossary in this manner. The oncology examples that are included in the glossary are very helpful and as FDA updates the document, PhRMA recommends including examples in every section.”

The Critical Path Institute says it routinely uses the BEST resource when facilitating discussions around biomarkers and endpoints with consortia stakeholders from diverse settings. “Defining frequently used terms related to biomarkers and endpoints is foundational to advancing the evaluation and adoption of these tools into the drug development process,” it says. “The many examples and references provided throughout the BEST document ae extremely useful in illustrating complex topics; we encourage the use of examples at any opportunity in the glossary.” The organization provides suggested edits focused on three concepts that it finds are often points of significant confusion: (1) understanding that the “category” of biomarker is not inherent to that marker, but rather dependent on how it is being used; (2) surrogate endpoints; and (3) validation (distinguishing clinical versus analytical; use of the word in different settings to mean different things).

Merck commented that the glossary “seems very useful to assure appropriate usage of these terms in regulatory documents and publications. We did notice that vaccine examples were not included, and we provide an example for inclusion…. In several areas we observed a need for clarification or elaboration of definitions and explanations….”

Finally, Genentech says BEST “will continue to ensure a consistent use of terms and promote better dialog between academia, industry, and FDA.” It also provides specific recommendations and edits.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome