Check: https://rdcu.be/b61rf; https://talburtmd.com/; https://phase-0microdosing.org/ORCID: http://orcid.org/0000-0002-5853-6110 Tal Burt MD is drug development and clinical development specialist, founder and CEO of Burt Consultancy LLC, a drug development consultancy, and Phase-0/Microdosing Network, an international consortium of stakeholders invested in increasing the efficiency and productivity of drug development through the application of Phase-0 including Microdosing approaches. Dr. Burt is a board-certified psychiatrist with more than 20 years experience in all phases of clinical development with specific expertise in CNS drug development, early-phase, proof-of-concept (POC), and microdosing stages of clinical development.Consultancy Philosophy:The test article is the center of the strategic philosophy and is driving development through its characteristics, healthcare benefits, and competitive environment, making creative use of the flexibility in developmental disciplines to optimize signal detection, maximize the likelihood of obtaining accurate results, and drive correct developmental decisions.Areas of expertise:• Early-Phase Clinical Development: Matching developmental scenarios with Exploratory IND (Phase-0, microdosing) approaches and proof-of-concept (POC) methodologies. Strategic and logistic planning, study design, interpretation of results, regulatory consultations, and go-no-go decisions. • Drug Development Leadership: Shaping the future of the field as board member, advisory board member, and consultant by identifying clinical development solutions to translational challenges. Strategic assessment of developmental priorities and contingency plans. Integration of ‘omics’ approaches and novel technologies with marketing and regulatory realities. Assembly of subject-matter experts. • Neuroscience Therapeutics Development: Design and conduct of drug and device trials across all phases of clinical development. Antidepressants, mood-stabilizers, antipsychotics, neurodegenerative agents, Transcranial Magnetic Stimulation (TMS) and Vagus Nerve Stimulation (VNS).• Clinical Research Administration: Integrating clinical research operations within parent organizations, establishing operational readiness including network of collaborators and expert advisors. Ensuring consistency with business plans, and compliance with training programs, national and international regulatory frameworks.• Clinical Research Education. Establishing clinical research education programs with skills assessment, training, and monitoring.