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Kibur Science Spotlight: A discussion with Dr. Tal Burt, Founder of the Phase 0 Microdosing Network.

 A discussion with Dr. Tal Burt, Founder of the Phase 0 Microdosing Network.                           

Tell me about Phase 0 Microdosing, the Network and your impetus for launching it.

Phase 0 Microdosing evaluates small doses of new drugs in first-in-human studies known as exploratory clinical trials with the potential to enable safer, cheaper, quicker and better decisions during the drug development process.  The Phase 0 Microdosing Network is a non-profit organization focused on education and research to increase Phase 0 (Ph0) methodologies. The Network aims to increase the validity of the Ph0 microdosing approach to increase the efficiency and effectiveness of the drug development process.  I started the network in 2008 while doing research at Duke and the National University of Singapore, two years post guidance from the FDA for microdosing in exploratory IND studies in humans.

What are some of the scenarios where Ph0 microdosing can be particularly beneficial?

When drug developers are trying to select among multiple preclinical drug candidates, many may be of a similar class and ‘look the same’.  In order to identify lead candidates, human subjects may be required, especially when animal models are unable to differentiate between the candidates.  However, this is extremely expensive when it occurs later in the drug development process, when significant money has already been spent on the drug.  Utilization of a Ph0 microdosing approach allows the use of human subjects earlier in the process to guide selection of promising candidates.  

Secondly, preclinical data can sometime be contradictory, such as due to differences between mice, rats, and other species and then extrapolating the data to humans.  For example, only 8% of psychiatry drugs tested in animals actually end up being used in humans.

Ph0 microdosing can also reduce toxicity and other tolerance issues.  Many drugs are targeted to those in vulnerable populations or those with serious conditions, which often don’t mimic the characterization of the healthy volunteers in typical Phase 1 trials.  The small doses used in Phase 0 enable the use of a broader subject population, and importantly, the target patients themselves, earlier in the process and give us an insight into the safety profile and mechanism of action.

How is the Network addressing any concerns and advancing the use of Ph0 microdosing?

The Network aims to pull together all stakeholders: Regulators, Industry, Academics and Contract Research Organizations as well as engaging patient advocates.  Also, Ph0 microdosing decreases the use of animals in drug development which is also important to many stakeholders.  We hold a stakeholder meeting and engage in discussions to advance and grow the research and application of Phase 0 in drug development.  You can join here.

For additional information, please see the articles below.

FDA. Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies. (2006).

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