Tal Burt, M.D.

Tal Burt MD is drug development and clinical development consultant. He is the founder and CEO of Burt Consultancy LLC, a drug development consultancy, and of the Phase-0/Microdosing Network, an international consortium of drug development stakeholders invested in increasing the efficiency and productivity of the drug development process 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. He has led clinical research and development programs of drugs and devices in academia and industry. He held Senior Medical Director positions at Pfizer Inc. and Eisai Inc. where he led early-and late-phase developmental programs. He was part of the Pfizer team that led the global antidepressant market with Zoloft (sertraline) from 2000 to 2006.. Dr. Burt was the founding Medical Director of two state-of-the-art POC research units, part of Duke’s Global POC Research Network, the first global academic CRO, and was the Scientific Director of the network. These experiences were formative to his appreciation of the challenges of novel treatment development, including the considerable expenses, waste, uncertainties, and risks involved, and the considerable burden on public health, and R&D, that ineffective translational and clinical research lead to. He has worked with regulators (FDA, Japan PMDA, Singapore HAS, India DFA), industry, academic, non-profit organizations, and patient advocacy stakeholders to address these challenges to accelerate development of novel therapeutics. He has authored 47 manuscripts in clinical research and drug development. These include original drug development methodologies such as Intra-Target Microdosing (ITM), the first randomized-withdrawal designs in psychiatry, the first comprehensive assessment of the impact of false-negatives on the productivity of drug development, and the first global public awareness program of clinical research (PARTAKE). He is also the author of the first publications of Vagus Nerve Stimulation (VNS) in major depression, the first meta-analysis and comprehensive review of Transcranial Magnetic Stimulation (TMS), and a textbook on outcomes measurement in clinical psychiatry. He has established the microdosing program and infrastructure at Duke University and the affiliated Investigational Medicine Unit (IMU) in Singapore General Hospital (SGH), presented data and chaired symposia and workshops on Phase-0/Microdosing in meetings of the relevant professional organizations (e.g., ASCPT, AAPS, AACP, DIA).