HEAL Workshop: Target Validation for Non-Addictive Therapeutics Development for Pain (DAY 2)

Despite advances in the understanding of pain physiology there has been a paucity of novel analgesic medications developed to address the still high unmet need of pain patients especially those who rely on addictive opioid medicines for pain relief. The successful development of novel non-opioid, non-addictive therapeutics requires advances in preclinical target validation that demonstrate sufficient human disease relevance to trigger investment in non-clinical development and subsequent clinical trials to obtain proof of biology and early proof of efficacy before registrational studies. Translating novel target discoveries to the clinic depends on the quality of target validation and the rigorous implementation of research operating plans to provide compelling data supporting a causative link between the modulation of molecular target(s) and a disease phenotype associated with the disease state. The full target validation process covers target identification to proof-of concept efficacy in human subjects in clinical trials. This workshop will focus on the key preclinical experimental validation package components that de-risk and provide rigorous rationale for the pursuit of novel targets with minimal side effects and a reduced potential of abuse/addiction liability. The focus will be on the stage appropriate data required to justify further preclinical and clinical therapeutics development activities across the translational spectrum. Several perspectives will be presented ...
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