IQ DruSafe members met jointly with BioSafe leadership and FDA Pharm Tox
September 5, 2014
IQ DruSafe (Preclinical Safety Leadership Group) members met jointly with BioSafe leadership and FDA Pharm Tox supervisors on July 31, 2014. Multiple topics were discussed. The day-long meeting concluded with FDA Pharm Tox supervisors, DruSafe, and BioSafe all agreeing to hold the next annual meeting in approximately June or July of 2015.
Adversity and the NOAEL in toxicology studies: FDA reviewers agreed that a comprehensive and integrated assessment of study findings is key to risk assessment and that draft recommendations being prepared by Society of Toxicologic Pathology appear to be reasonable.
Starting Dose for Ph1 Clinical studies: It was determined that, in IND-enabling toxicology studies, reviewers prefer that Sponsors not intervene with prophylactic treatments. Intervention should only be undertaken as a last resort, in order to maintain animals on study, in cases where it is expected to enhance the overall risk assessment.
Emerging New Science: A special lunch-time topic allowed industry attendees to highlight perceived upcoming emerging science issues and opportunities that will likely be coming forward in future new drug programs.
Non clinical requirements to support orphan drug development: A review of past programs was conducted, using both disease-model and normal animals. Requirements have varied significantly among approved drugs and is perhaps influenced by the relative number of patients who will be candidates to receive treatment, post marketing.
New Pregnancy and Lactation Labeling: FDA expert, Melissa Tassinari, gave an informational overview of the new pregnancy and lactation labeling. Implementation of the new labeling is expected to include workshops and training sessions.