Manisha Sinha

Company: Expansion Therapeutics

Job title: Head Of Translational Sciences

Seminars:

De-Risking Small Molecule Safety through Understanding the Small Molecule Toxicity & Off-Target Profiling Strategies for Advancing Safe & Efficacious Therapeutics 9:00 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