Dr. Anupama Kumar, MBBS PhD
Clinical and scientific expert with 15+ years of experience guiding CNS and neuroimmunology programs through complex clinical development and regulatory decision points.
Dr. Anupama Kumar brings deep expertise in FDA regulatory strategy, clinical trial design, and execution across neuroimmunology and psychiatry. She has led multidisciplinary teams in translating scientific innovation into structured development programs, advising on protocol design, endpoint strategy, regulatory alignment, and operational rigor; particularly for therapeutics targeting complex neurologic and psychiatric disorders.
Areas of Focus / Expertise
- Clinical trial design and execution in neuroimmunology and psychiatry
- IND-enabling strategy and regulatory alignment for CNS therapeutics
- FDA submission support and clinical documentation strategy
- Protocol development, implementation, and deviation mitigation
- Audit readiness and clinical quality systems oversight
- Translational medicine and evidence generation frameworks
- Research infrastructure development and operational scaling
Selected Experience & Impact
Over the course of her career, Dr. Kumar has managed multiple concurrent clinical trials at Johns Hopkins School of Medicine, achieving perfect audit outcomes and materially reducing protocol deviation rates. As Co-Director of an Esketamine Clinic, she developed standardized treatment protocols adopted by clinics nationwide. She later served as Vice President of Research at Miralogx, LLC, where she led drug development initiatives, built scalable research systems, and navigated complex regulatory requirements. Her work has contributed to 14 peer-reviewed publications, including in the New England Journal of Medicine.
Background & Credentials
Prior to FDA Partners, Dr. Kumar held academic and clinical research leadership roles at Johns Hopkins University in Psychiatry and Neuroimmunology. She completed dual post-doctoral fellowships in Psychiatry and Neuroimmunology at Johns Hopkins University following her medical training (MBBS), and has focused her career on advancing therapeutics for neurologic and psychiatric disease.
Dr. Kumar approaches clinical development with disciplined scientific rigor and operational precision, helping teams translate innovative science into regulatory-ready programs.