Karen D. Davis 1 , 2 , , Nima Aghaeepour 3 , Andrew H. Ahn 4 , Martin S. Angst 3 , David Borsook 5 , Ashley Brenton 6 , Michael E. Burczynski 7 , Christopher Crean 8 , Robert Edwards 9 , Brice Gaudilliere 3 , Georgene W. Hergenroeder 10 , Michael J. Iadarola 11 , Smriti Iyengar 12 , Yunyun Jiang 13 , Jiang-Ti Kong 3 , Sean Mackey 3 , Carl Y. Saab 14 , Christine N. Sang 15 , Joachim Scholz 16 , Marta Segerdahl 17 , Irene Tracey 18 , Christin Veasley 19 , Jing Wang 20 , Tor D. Wager 21 , Ajay D. Wasan 22 , Mary Ann Pelleymounter 12
15 June 2020
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.
In 2018, the Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened to discuss strategies to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.