The Phase-0/Microdosing Network
The Phase-0 Microdosing Network, a non-profit organization, is an international consortium of inter-and cross-disciplinary drug development stakeholders interested in the potential of Phase-0 including microdosing approaches to increase the efficiency and productivity of drug development. The Network was created to educate, disseminate information, and promote research and ideas relevant to microdosing and other Phase-0 approaches and their applications.
Network members include clinicians, scientists,
regulators, Pharma, Biotech, CROs, patient advocacy groups and other non-profit organizations with interest in the potential of these applications to provide safer, faster, and cheaper, live human data for drug development decision-making. The Network aims to use the collective inter-disciplinary knowledge and skills to establish a versatile and comprehensive appreciation of the potential of these approaches to address developmental needs. Specifically, the network considers AMS/PET/LC-MS/MS methodologies and the continuum of Phase-0 applications as complementary, synergistic, and cost-effective investigational tools for first-in-human, including first-in-patient studies.
The network welcomes and encourages discussion of the limitations of these approaches, aims to clarify their role in current and future drug development, and identifies criteria for their effective application.
The Phase-0 Microdosing Network was founded in 2012 by Tal Burt, M.D. while at Duke University. The Network twice won awards for inter-disciplinary work, initiated and supported research projects, led to presentations at professional meetings, publications, and dedicated Network meetings.