What evidence do we need for biomarker qualification?

Affiliations

• ¹ Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
• ² Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA.
• ³ Takeda Pharmaceuticals International Co., Cambridge, MA 02139, USA.
• ⁴ Pfizer Inc., Groton, CT 06340, USA.
• ⁵ National Institute of Mental Health, NIH, Bethesda, MD 20892, USA.
• ⁶ Critical Path Institute, Tucson, AZ 85718, USA.
• ⁷ Pharmaceutical Research and Manufacturers of America, Washington, DC 20004, USA.
• ⁸ National Cancer Institute, NIH, Rockville, MD 20850, USA.
• ⁹ Biocerna LLC, Maple Lawn, MD 20759, USA.
• ¹⁰ Massachusetts General Hospital, Boston, MA 02114, USA.
• ¹¹ Merck and Co. Inc., West Point, PA 19486, USA.
• ¹² Genentech Inc., South San Francisco, CA 94080, USA.
• ¹³ Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA. [email protected].