Chinwe Okoro
Company: FDA
Job title: Medical Officer, Division of Clinical Evaluation & Pharmacology/Toxicology
Seminars:
Establishing Potential Endpoints in Clinical Trials to Innovate Treatment 12:00 pm
Establishing Potential Endpoints in Clinical Trials to Innovate Treatment Evaluating clinically meaningful endpoints and alternatives to invasive procedures to stimulate patient engagement in trials Assessing strategies for engaging regulatory authorities in discussions on redefining approvable endpoints Identifying easily measured and highly correlated surrogate endpoints to shorten studies and reduce sample sizeRead more
day: Conference Day 2
Regulatory Perspective on Navigating the Safety Vs Toxicity Hurdle to Achieve Success in Clinical Trials by Agreeing on a Standardized Approach for Dose Escalation & Endpoints 9:30 am
Addressing trial design concerns to ensure the risks and benefits are well balanced Coupling preclinical knowledge to find the right dose that’s both safe and efficacious in the clinical realm How to anticipate adverse events to propose a mitigating strategyRead more
day: Day Two
Establishing Potential Endpoints in Clinical Trials to Innovate Treatment 1:00 pm
Considering the significant debate surrounding the optimal endpoint for demonstrating efficacy of next generation cardiovascular therapeutics, an active discussion is essential to move forward. Attend this workshop to evaluate the current regulation on clinical endpoints to identify the windows of opportunity for the future of precise and targeted therapeutics within the cardiovascular industry. …Read more
day: Pre-Conference Workshop Day
Regulatory Perspective on Navigating the Safety Vs Toxicity Hurdle to Achieve Success in Clinical Trials by Agreeing on a Standardized Approach for Dose Escalation & Endpoints 11:30 am
Addressing trial design concerns to ensure the risks and benefits are well balanced Coupling preclinical knowledge to find the right dose that’s both safe and efficacious in the clinical realm How to anticipate adverse events to propose a mitigating strategyRead more
day: Conference Day 2