Tal Burt MD is drug development and clinical development specialist. 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 more than 45 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).
Burt Consultancy expertise is in Clinical Development. The core expertise is in Early-Phase Development, CNS drug development, and Life-Cycle Management. In addition, through its network of subject-matter experts, the scope of Burt Consultancy expertise covers most developmental scenarios, most therapeutic areas, drug classes, and targets, and all phases of development. The developmental philosophy is applied to any developmental scenario through customized multidisciplinary team assembled to match test article characteristics and developmental challenges. Such challenges and associated team expertise may include a changing competitive environment, validation of process-specific modeling, or training clinical research team on the use of a novel procedure or outcome measurement. The team proposes informed solutions prior to program initiation and monitors their status throughout program execution.
The test article is at the center of the strategic approach. Through its chemical properties, target characteristics, healthcare needs, and competitive environment dynamics, it drives and guides development. In addition, the developmental approach makes creative use of the versatility of developmental disciplines to maximizes signal detection and arrive at optimal developmental decisions.
The Burt Consultancy expertise, through its collaborative network, covers most drug development scenarios, therapeutic areas, and major drug classes. The core expertise includes the following areas:
- 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 a leading consultant, KOL, board member, advisory board member, 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, antianxiety, analgesics, 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.
- Global Clinical Research: Hardware and administrative infrastructure. Bridging regulatory and cultural divides. Assembly of customized teams of experts to match project requirements. Access to local clinical research, regulatory, and legal experts in Europe, Asia, North America and South America.
- Clinical Research Education: Establishing clinical research education programs with skills assessment, training, and monitoring. Development of public awareness initiatives. Individual mentoring and program oversight.