LB Pharmaceuticals Strengthens Leadership Team With Appointment Of James Rawls, Pharm.D., As Senior Vice President Of Regulatory Affairs

LB Pharmaceuticals Inc., a biopharmaceutical company focused on developing novel treatments for neuropsychiatric disorders, has announced the appointment of James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs. Dr. Rawls brings more than 25 years of regulatory leadership experience in the global biopharmaceutical industry, with a strong record of successful regulatory submissions, approvals, and interactions with health authorities across the United States, Europe, and Japan. Over the course of his career, he has contributed to or led more than a dozen successful regulatory filings and product approvals, particularly in the field of neuropsychiatric diseases.

Before joining LB Pharmaceuticals, Dr. Rawls served as Executive Vice President and Chief Regulatory Officer at Boston Biodevelopment, LLC, where he led regulatory strategy and execution for multiple small and mid-sized biopharma companies. He previously held senior regulatory leadership roles at Sumitomo Pharma America, where he managed a regulatory team of more than 60 professionals after integrating seven subsidiaries, including Sunovion. 

During his 15-year tenure at Sunovion, he led the Global Regulatory Affairs function and played a key role in securing multiple global product approvals and lifecycle extensions across various therapeutic areas. Earlier in his career, he spent over a decade in progressively senior regulatory roles at Novartis. Dr. Rawls earned his Doctor of Pharmacy degree from the University of Michigan and completed a postdoctoral fellowship in Regulatory Affairs and Clinical Research at Novartis and Rutgers University.

Commenting on the appointment, Heather Turner, Chief Executive Officer of LB Pharmaceuticals, said that Dr. Rawls’ deep regulatory expertise will be critical as the company advances LB-102 into a Phase 3 clinical trial for schizophrenia and a Phase 2 trial for bipolar depression in 2026. She noted that his extensive experience in managing FDA and global regulatory engagements, especially in neuropsychiatry will play an essential role in LB Pharmaceuticals’ efforts to make LB-102 the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.

In response to his appointment, Dr. Rawls stated that the development of neuropsychiatric drugs requires a careful balance of scientific innovation and strategic regulatory planning. He expressed enthusiasm for joining LB Pharmaceuticals, highlighting the company’s strong commitment to advancing meaningful therapies. Dr. Rawls said he looks forward to working with the team to move LB-102 through clinical development and ultimately bring a new treatment option to patients with neuropsychiatric disorders.