Fixing How FDA Regulates Diagnostic Lab Tests
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Diagnostic laboratory tests play a central role in the implementation of precision medicine. It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing. Read an original approach to FDA regulation that Professor David Hyman and I published in Investor’s Business Daily.
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Senior Judge, United States District Court for the Southern District of New York
Loretta A. Preska is a senior judge for the United States District Court for the Southern District of New York. She joined the court in 1992 after being nominated by President George H.W. Bush. Preska became the chief judge of the court in May of 2009 when Kimba Wood assumed senior status. She served as chief judge of the court for a seven-year term from 2009 to 2016, and took senior status in 2017.
Preska graduated from the College of St. Rose with her Bachelor's degree in 1970 and also graduated from Fordham Law with her Juris Doctor Degree in 1973. She graduated from NYU Law with her Master of Laws degree in 1978.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.