Helen Crehan
Company: Expansion Therapeutics
Job title: Principal Scientist, Pharmacology
Seminars:
Evaluating Safety & Toxicity Packages for Marketed & Late-Stage Clinical Investigational Drugs 9:15 am
Highlighting the safety and toxicity packages which are made to advance safe small molecules targeting RNA towards the patients in need Evaluating the safety window which is required for regulatory approval to fast-track RNA-targeting therapeutics towards the clinic Uncovering reliable preclinical models used to represent RNA targets and analyse small molecule safetyRead more
day: Focus Day
Roundtable Discussion: Evaluating Regulators’ Views on Safety & Toxicity Testing to Streamline Preclinical Testing & Fast-Track RNA-Targeting Drug Approval 9:30 am
What are regulators' thoughts on using animal models to showcase off-target effects and toxicity given their limited RNA conservation? What safety and toxicity tests are required to gain FDA approval for advancing into human clinical trials? Highlight specifications which are required to be met by RNA-targeting drugs to ensure regulatory approvalRead more
day: Focus Day