About FDA

Darrell R. Abernethy, M.D., Ph.D.

Picture of Darrell R. Abernethy, M.D., Ph.D.

Darrell R. Abernethy, M.D., Ph.D.
Associate Director for Drug Safety
Office of Clinical Pharmacology/OTS/CDER/FDA
White Oak Campus, Silver Spring, MD


  • M.D., Ph.D. (Pharmacology)
  • 4 years FDA experience
  • 8 years NIH experience
  • 18 years academic experience

Research Interests

  1. Mechanism based predictive drug safety
  2. Systems Pharmacology applied to drug safety
  3. Integration of bioinformatics tools for predictive drug safety

Proposed Research Project for an FDA Commissioner's Fellow:

A systems pharmacology based approach to predict cardiotoxicity (depression of left ventricular cardiac function) of tyrosine kinase inhibitor drugs is currently in development with the support of the Reagan Udall Foundation. The fellow will evaluate selected tyrosine kinase inhibitor drugs that have been marketed for some time and have known or suspected cardiotoxicity (eg, trastuzamab, imantinib) in the context of the integrated pharmacologic, chemical structure, and clinical phenotype system. Learnings from this will be applied to selected (2-3) tyrosine kinase inhibitor drug candidates for which there is not clinical information available, however which have as targets (intended or unintended) kinases that are predicted to be associated with cardiotoxicity. This latter activity will be also part of the regulatory review of these products as appropriate. We represent the predictive safety team which is often consulted in the course of regulatory review to do a predictive safety evaluation using the tools of bioinformatics and the published literature. The evaluations of drug candidates using the systems pharmacology analysis will be part of this consultative activity.

The FDA Regulatory Science Priority Area for the project is Modernize Toxicology to Enhance Product Safety.

Applicant Requirements:

M.D., Ph.D., or Pharm.D.

Training in bioinformatics and quantitative sciences very desireable

Capacity to collaborate with a wide range of disciplines including

  1. Pharmacologists
  2. Chemists
  3. Bioinformatics specialists
  4. Toxicologists
  5. Physicians/clinical medicine

Selected Recent Publications:

  1. Abernethy DR, Woodcock J, Lesko LJ: Pharmacological mechanism-based drug safety assessment and prediction. Clin Pharmacol Ther 2011;89:793-797.
  2. Abernethy DR, Bai JP, Burkhart K, Xie HG, Zhichkin P: Integration of diverse data sources for prediction of adverse drug events. Clin Pharmacol Ther 2011;90:645-646.
  3. He Y, Toldo L, Burns G, Tao C, Abernethy DR: A 2012 Workshop: Vaccine and drug ontology in the study of mechanism and effect (VDOSME 2012): J Biomed Semantics 2012;3:12.
  4. Zhichkin PE, Athey BD, Avigan MI, Abernethy DR: Needs for an expanded ontology-based classification of adverse drug reactions and related mechanisms. Clin Pharmacol Ther 2012;91:963-965.
  5. Bai JP, Abernethy DR: Systems pharmacology to predict drug toxicity: integration across levels of biological organization. Annu Rev Pharmacol Toxicol 2013;53:451-473.

Page Last Updated: 05/26/2015
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