Announcing Regulatory Science Competition Winners
The results are in for the Fifth Annual “America’s Got Regulatory Science Talent” competition, a UR CTSI Regulatory Science program. Eight student teams proposed novel solutions to regulatory science issues related to nine FDA priority areas. The first place winner will present her proposal in person at the FDA in April.
Dr. Data: An Integrated Drug Repurposing Database for Identifying New Indications of FDA Approved Drugs
Xiaowen (Cindy) Wang, M.S.
Drug repurposing, the process of finding new uses for previously approved drugs, could speed up drug development and reduce cost, but drug repurposing data sets are not easy to access. This proposal aims to develop a collaborative drug repurposing database to promote new research directions, novel clinical trial designs and biomarker identifications.
The drug-repurposing database (Dr. Data) would house molecular and clinical data mined from public sources, including all FDA approved drugs plus those under investigation for new uses. A self-report portal will enable investigators from academia and industry to submit ongoing drug repurposing studies. Analytical tools will allow chemical structure processing and signaling pathway analysis. Drugs will be classified based on suggested new uses, fostering identification of common chemical characteristics and protein targets. Predictive analytics will suggest promising repurposing candidates for a given use based on structural similarities and/or common signaling pathways.
Rochester Regulators: Ensuring FDA’s Readiness to Evaluate Additive Manufacturing
Eric Ravinal, Justin Schumacher, Vladimir Tokarchuk, Rebecca Amorese
Additive manufacturing, including 3D printing, is an emerging medical technology for creating drugs and devices. Limited guidance exists to evaluate this evolving technology and many factors influence the performance and quality of printed products. We propose an evaluation toolkit to address key issues in additive manufacturing. The toolkit would provide quantitative imaging biomarkers and real-time monitoring to identify printing defects, while quantifying realistic printer performance, resolution metrics, and material property integrity. This would help evaluate emerging technologies going through FDA review by assessing the build and post-processing validation steps in the FDA Guidance document.
FDA ALERT: Approved Listings & Explanations of Regulated Technology
Amanda Smith, Meghann Meyer, Emily Newman, Evan Sosnow
FDA ALERT is a smartphone-based mobile app that streamlines the process of accessing and reporting warnings, complications, and recalls associated with FDA-regulated products. Through the app, users are able to scan a QR code on the label of an FDA-regulated product to get reliable, FDA-approved, information to help them decide whether or not to purchase the product. FDA ALERT allows users to subscribe to the products they have purchased and receive recall and warning alerts on their phone in real time. The app also enables users to report any adverse effects they've experienced with FDA-regulated products through this portal.
For more information on programs like this, visit the UR CTSI Regulatory Science Training Programs website, or contact Scott Steele, Ph.D., director of Regulatory Science Programs or Joan Adamo, Ph.D., director of Regulatory Support Services at the UR CTSI.
The America’s Got Regulatory Science Talent student competition is part of the UR CSTI Regulatory Science program, which is supported by the University of Rochester CTSA award number UL1 TR002001 from the National Center for Advancing Translational Sciences of the National Institutes of Health.
Susanne Pritchard Pallo |