Business
Spruce Biosciences Adds Regulatory and Clinical Development Expertise to Leadership Team
Daven Mody, Pharm.D., Appointed as Senior Vice President, Regulatory and Quality Bruno Gagnon, B.Pharm., M.Sc., Appointed as Senior Vice President, Clinical
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nDaven Mody, Pharm.D., Appointed as Senior Vice President, Regulatory and Quality\n\n\nBruno Gagnon, B.Pharm., M.Sc., Appointed as Senior Vice President, Clinical Development Operations\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nSpruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today 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.\n\n\n“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.”\n\n\nDaven 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 withi...