Dr. Adam Kaplin, MD PhD
Industry and academic clinical strategy expert with 25+ years of experience guiding neuropsychiatric and CNS therapeutics through high-stakes FDA development and review decision points.
Dr. Adam Kaplin brings deep expertise in clinical development and translational neuroscience across biopharma and CNS drug programs. As a physician-scientist and former FDA medical reviewer, he has advised executive teams on regulatory pathway strategy, clinical trial design, endpoint selection, and Agency engagement; particularly for complex neuropsychiatric indications where evidentiary standards and safety considerations require careful alignment.
Areas of Focus / Expertise
- FDA regulatory pathway strategy for CNS and neuropsychiatric therapeutics
- IND strategy and clinical development planning
- NDA preparation and regulatory review strategy
- Clinical trial design, endpoint development, and safety assessment
- Translational medicine and biomarker integration
- Benefit-risk evaluation and regulatory positioning for novel mechanisms
- Lifecycle strategy from early development through post-approval
Selected Experience & Impact
Over the course of his career, Dr. Kaplin has contributed to regulatory review and development programs spanning mood disorders, neurodegenerative diseases, and other CNS conditions. He has supported programs advancing through IND and NDA stages and has advised emerging biotech companies on regulatory positioning, clinical evidence frameworks, and strategic FDA engagement.
Background & Credentials
Prior to FDA Partners, Dr. Kaplin served in a medical review capacity at the U.S. Food and Drug Administration and held academic and industry leadership roles in psychiatry and neuroscience. He holds an MD and a PhD in neuroscience and has led clinical and translational research programs focused on neuroimmune and neuropsychiatric disorders.
Dr. Kaplin integrates clinical insight and scientific rigor to help teams translate complex neuroscience into disciplined regulatory and development strategy.