Spruce Biosciences announced the appointments of Daven Mody, Pharm.D., as Senior Vice President of Regulatory and Quality and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations.
“We are delighted to welcome both Daven and Bruno to the executive leadership team during a transformative time for Spruce,” said Javier Scwarzberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “Daven’s regulatory expertise is unparalleled across the industry, and his significant experience from successful filings and approvals of multiple NDAs and MAAs will be instrumental as we prepare for the BLA submission and seek potential U.S. FDA approval of our tralesinidase alfa enzyme replacement therapy (TA-ERT) program for the treatment of Sanfillipo Syndrome Type B (MPS IIIB). I believe that Bruno’s global leadership experience in rare disease drug development, including in MPS diseases, will drive the successful clinical execution of our planned confirmatory study of TA-ERT and other pipeline programs.”
Daven Mody, Pharm.D., brings over 25 years of regulatory affairs experience, guiding global development programs across multiple therapeutic areas including rare diseases. He most recently served as Senior Vice President, Regulatory Affairs and Quality at Lassen Therapeutics, Ocelot Bio, and Blade Therapeutics, working as team lead on investigational programs for multiple ophthalmologic, hepatic, pulmonary, hepatic, and oncology indications for which he helped secure several orphan drug and fast track designations. Earlier, he served as Head of Regulatory Affairs at Theravance Biopharma and Impax Laboratories where he led the efforts in the first-round approvals of YUPELRI® for COPD and RYTARY® for Parkinson’s Disease, respectively, by both the U.S. FDA and EMA. Dr. Mody began his career at ALZA Corporation and since held roles of increasing leadership responsibility within regulatory affairs at Matrix Pharmaceuticals, Genentech, CoTherix, Johnson & Johnson, and Medivation. He also founded AZURA Life Sciences, LLC, a regulatory and quality consultancy. He received a Pharm.D. from the University of the Pacific and an MBA from California State University, East Bay. Dr. Mody is certified by the Regulatory Affairs Certification Board.
Bruno Gagnon, B.Pharm., M.Sc., joins Spruce Biosciences with more than 30 years of experience leading clinical operations for global drug development programs. As Senior Vice President of Global Clinical Operations at Opthea, Mr. Gagnon oversaw clinical program execution for a Phase 3 pivotal wet age-related macular degeneration (wet AMD) program and took on interim responsibility for medical affairs and pharmacovigilance. Previously, he led development operations for BridgeBio Pharma’s affiliate, Eidos Therapeutics, where he oversaw strategic planning and operational execution of clinical trials for the company’s TTR amyloidosis program and played a key role in advancing ATTRUBY® (Acoramidis) towards regulatory approval. Earlier, he served as Vice President of Clinical Operations at BioMarin, directing rare disease clinical programs and global trial execution for six compounds across all stages of development. He earned his M.Sc. in pharmaceutical sciences and drug development from the University of Montreal and a B.S. in pharmacy from Laval University.