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Davis KD, Aghaeepour N, Ahn AH, et al. Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities. Nat Rev Neurol. 2020;16(7):381-400doi: 10.1038/s41582-020-0362-2.
Davis, K. D., Aghaeepour, N., Ahn, A. H., Angst, M. S., Borsook, D., Brenton, A., Burczynski, M. E., Crean, C., Edwards, R., Gaudilliere, B., Hergenroeder, G. W., Iadarola, M. J., Iyengar, S., Jiang, Y., Kong, J. T., Mackey, S., Saab, C. Y., Sang, C. N., Scholz, J., Segerdahl, M., Tracey, I., Veasley, C., Wang, J., Wager, T. D., Wasan, A. D., & Pelleymounter, M. A. (2020). Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities. Nature reviews. Neurology, 16(7), 381-400. https://doi.org/10.1038/s41582-020-0362-2
Davis, Karen D, et al. "Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities." Nature reviews. Neurology vol. 16,7 (2020): 381-400. doi: https://doi.org/10.1038/s41582-020-0362-2
Davis KD, Aghaeepour N, Ahn AH, Angst MS, Borsook D, Brenton A, Burczynski ME, Crean C, Edwards R, Gaudilliere B, Hergenroeder GW, Iadarola MJ, Iyengar S, Jiang Y, Kong JT, Mackey S, Saab CY, Sang CN, Scholz J, Segerdahl M, Tracey I, Veasley C, Wang J, Wager TD, Wasan AD, Pelleymounter MA. Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities. Nat Rev Neurol. 2020 Jul;16(7):381-400. doi: 10.1038/s41582-020-0362-2. Epub 2020 Jun 15. PMID: 32541893; PMCID: PMC7326705.
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Nat Rev Neurol. 2020 Jul;16(7):381-400. doi: 10.1038/s41582-020-0362-2. Epub 2020 Jun 15.

Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities.

Nature reviews. Neurology

Karen D Davis, Nima Aghaeepour, Andrew H Ahn, Martin S Angst, David Borsook, Ashley Brenton, Michael E Burczynski, Christopher Crean, Robert Edwards, Brice Gaudilliere, Georgene W Hergenroeder, Michael J Iadarola, Smriti Iyengar, Yunyun Jiang, Jiang-Ti Kong, Sean Mackey, Carl Y Saab, Christine N Sang, Joachim Scholz, Marta Segerdahl, Irene Tracey, Christin Veasley, Jing Wang, Tor D Wager, Ajay D Wasan, Mary Ann Pelleymounter

Affiliations

  1. Department of Surgery and Institute of Medical Science, University of Toronto, Toronto, ON, Canada. [email protected].
  2. Division of Brain, Imaging and Behaviour, Krembil Brain Institute, Toronto Western Hospital, University Health Network, Toronto, ON, Canada. [email protected].
  3. Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.
  4. Teva Pharmaceuticals, Frazer, PA, USA.
  5. Center for Pain and the Brain, Harvard Medical School, Boston, MA, USA.
  6. Mycroft Bioanalytics, Salt Lake City, UT, USA.
  7. Teva Pharmaceutical Industries, Frazer, PA, USA.
  8. Xyzagen, Pittsboro, NC, USA.
  9. Pain Management Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
  10. The Vivian L. Smith Department of Neurosurgery, The University of Texas Health Science Center at Houston, McGovern Medical School, Houston, TX, USA.
  11. Department of Perioperative Medicine, Clinical Center, NIH, Rockville, MD, USA.
  12. Division of Translational Research, National Institute of Neurological Disorders and Stroke, NIH, Rockville, MD, USA.
  13. The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
  14. Department of Neuroscience and Department of Neurosurgery, Carney Institute for Brain Science, Brown University, Providence, RI, USA.
  15. Department of Anesthesiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
  16. Neurocognitive Disorders, Pain and New Indications, Biogen, Cambridge, MA, USA.
  17. Asarina Pharma, Copenhagen, Denmark.
  18. Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
  19. Chronic Pain Research Alliance, Bethesda, MD, USA.
  20. Department of Anesthesiology, Perioperative Care and Pain Medicine, NYU School of Medicine, New York, NY, USA.
  21. Department of Psychological and Brain Sciences, Dartmouth College, Hanover, NH, USA.
  22. Anesthesiology and Perioperative Medicine and Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.

PMID: 32541893 PMCID: PMC7326705 DOI: 10.1038/s41582-020-0362-2

Abstract

Pain medication plays an important role in the treatment of acute and chronic pain conditions, but some drugs, opioids in particular, have been overprescribed or prescribed without adequate safeguards, leading to an alarming rise in medication-related overdose deaths. The NIH Helping to End Addiction Long-term (HEAL) Initiative is a trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to support biomarker discovery and rigorous validation in collaboration with industry leaders to accelerate high-quality clinical research into neurotherapeutics and pain. The use of objective biomarkers and clinical trial end points throughout the drug discovery and development process is crucial to help define pathophysiological subsets of pain, evaluate target engagement of new drugs and predict the analgesic efficacy of new drugs. In 2018, the NIH-led Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened scientific leaders from academia, industry, government and patient advocacy groups to discuss progress, challenges, gaps and ideas to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.

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