James Cassella, Ph.D., serves as Chief Development Officer at Trevi Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine HCl), an investigational therapy for chronic pruritus associated with prurigo nodularis and notalgia paresthetica. In this role, Dr. Cassella leads the company’s clinical development, regulatory strategy, and medical affairs efforts, guiding Haduvio through Phase 2b and Phase 3 clinical trials, including the PRISM and PACE studies. His leadership has been instrumental in advancing Trevi’s pipeline toward potential regulatory submissions, leveraging his deep expertise in central nervous system (CNS) disorders and pruritus pathophysiology. With over 30 years of experience in the pharmaceutical industry, Dr. Cassella has held senior leadership positions at several prominent biotech and pharma companies. Most recently, he was Executive Vice President and Chief Scientific Officer at Xenon Pharmaceuticals, where he oversaw neurology and psychiatry programs. Prior to that, as Senior Vice President of Research and Development at XenoPort (acquired by Arbor Pharmaceuticals), he directed the development of gabapentin enacarbil (Horizant®), approved by the FDA for restless legs syndrome and postherpetic neuralgia. Earlier roles include Vice President of R&D at Adolor Corporation (acquired by Cubist Pharmaceuticals), where he contributed to the approval of alvimopan (Entereg®) for postoperative ileus, as well as positions at Purdue Pharma and Marion Merrell Dow in CNS discovery and development. Dr. Cassella holds a Ph.D. in Pharmacology from the University of Michigan and completed a postdoctoral fellowship in Neuropsychiatry at the National Institute of Mental Health. His career is marked by a proven track record of successfully advancing therapies from preclinical stages to FDA approval, with a focus on innovative treatments for debilitating neurological and pruritic conditions. Under his guidance at Trevi, the company continues to pioneer kappa opioid modulation for unmet needs in dermatology and neurology.