NCL Lessons Learned Workshop NCI’s Nanotechnology Characterization Lab (NCL) is providing an intensive one-day workshop on the science of preclinical characterization of nanomaterials. This workshop will cover some of the “lessons learned” from the NCL’s testing of more than 240 nanotechnology-based candidate cancer treatments and diagnostics. The NCL performs physiochemical characterization, in vitro experiments and in vivo testing for collaborators, to support regulatory filings with the FDA. The morning session will cover methods for nanomaterial characterization, including strategies for determining appropriate tests for batch-to-batch consistency, surface characterization, etc., nanomaterial ADME/Tox and PK, sterility and endotoxin contamination, immunotoxicity, and linking physicochemical characterization to safety and efficacy. This session will highlight methods from the NCL’s three-phase Assay Cascade. The afternoon will be devoted to case studies from NCL preclinical characterization, with details on specific nanomaterials, issues/problems encountered during NCL testing (e.g. impurities, agglomeration, unexpected toxicities, immune reactions, etc.), and how these were overcome. Featuring sessions by: Scott McNeil, NCL Director Anil Patri, NCL Chemist Stephan Stern, NCL Toxicologist Marina Dobrovolskaia, NCL Immunologist Jeff Clogston, NCL Chemist More information about the NCL is available at http://ncl.cancer.gov. NCL Lessons Learned Workshop Agenda 9:00-9:30am Opening Remarks – Scott McNeil 9:30-10:15am Physiochemical Characterization – Anil Patri 10:15-10:30am Break 10:30-11:15am Nanotox and Pharmacology – Steve Stern 11:15-12pm Nanoimmunology – Marina Dobrovolskaia 12-1pm Lunch Break 1:00-3:00pm Case Studies – NCL Scientists 3:00-3:15pm Break 3:15-4:15pm Focus Topics: e.g., Sterility, Autophagy, Light Scattering, Microscopy – NCL Scientists 4:15-4:45pm Panel Discussion – NCL Scientists 4:45-5:00pm Meeting Wrap Up and Concluding Remarks – Scott McNeil