LB Pharmaceuticals (NASDAQ: LBRX) has announced the appointment of James Rawls, PharmD, as senior vice president (SVP) of regulatory affairs.
With more than 25 years of regulatory leadership experience across global biopharmaceutical companies, Dr. Rawls has led or contributed to more than a dozen successful regulatory filings and product approvals in the U.S., Europe, and Japan, throughout his career. He has specific experience in neuropsychiatric diseases.
In a statement, Heather Turner, CEO of LB, commented, “Dr. Rawls has a remarkable depth of regulatory expertise that will be instrumental as we advance LB-102 into a Phase 3 clinical trial in schizophrenia and a Phase 2 clinical trial in bipolar depression in 2026. His experience leading successful FDA and global regulatory engagements, particularly in neuropsychiatry, will be invaluable as we continue to execute on our work to make LB-102 the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the U.S.”
Dr. Rawls added, “The complexity of neuropsychiatric drug development demands thoughtful, evidence-driven regulatory strategy that is bold but pragmatic. I’m energized by LB Pharmaceuticals’ mission and look forward to working with the highly skilled and experienced team at LB Pharmaceuticals as we advance LB-102 in the clinic with the goal of delivering a new treatment option for patients with neuropsychiatric disorders.”
