MindPath Pharma Consulting Information

MindPath Pharma Consulting provides specialized strategic consulting for biotech, pharma, and digital health companies developing therapeutics in CNS, psychiatry, and addiction medicine. Founded by Bruce Imbert, MD, PhD — a physician-scientist with 20+ years spanning academic medicine, regulatory science, and executive drug development leadership — MindPath delivers the strategic depth of a senior CMO with the agility of a focused consulting engagement. Core capabilities: • Drug development strategy: IND-enabling through NDA/BLA submission • Clinical protocol design for CNS, psychiatric, and addiction indications • Addiction medicine programs: Opioid Use Disorders, Alcohol Use Disorders, Stimulant Use Disorder, Cannabis Use Disorder and Behavioral Addictions. • FDA regulatory strategy, Breakthrough Therapy and Fast Track designations • Prescription digital therapeutics (PDT/SaMD): regulatory pathways and clinical evidence generation • Real-world evidence integrated alongside RCT packages • Investor and board advisory: R&D narrative, due diligence, fundraising strategy Our approach is indication-specific and mechanism-grounded — never a generic template. Every strategy reflects the compound's MOA, patient population, and current regulatory landscape. Engagements span early feasibility through pivotal trial design and regulatory submission, across small molecules, biologics, and prescription digital therapeutics. 📧 contact@mindpathpharma.com | 🌐 www.mindpathpharma.com