Publications by authors named "Michelle Martin-Pozo"
Model-informed approaches provide a quantitative framework to integrate all available nonclinical and clinical data, thus furnishing a totality of evidence approach to drug development and regulatory evaluation. Maximizing the use of all available data and information about the drug enables a more robust characterization of the risk-benefit profile and reduces uncertainty in both technical and regulatory success. This offers the potential to transform rare diseases drug development, where conducting large well-controlled clinical trials is impractical and/or unethical due to a small patient population, a significant portion of which could be children.
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- - SJS/TEN is a severe, drug-induced skin condition with a high mortality rate of 15-20% and requires multidisciplinary expertise for effective treatment; it's rare, with an incidence of 1-5 cases per million annually in the U.S., but more common globally.
- - The SJS/TEN 2021 research meeting, held virtually, aimed to build an international research network involving 428 scientists and 140 survivors and family members to enhance collaboration between science and the community.
- - The workshop covered vital themes such as mental health, pediatric cases, long-term complications, skin care for diverse populations, and the impact of COVID-19 vaccines, identifying key areas for future research and clinical focus.