Two-part webinar series: Navigating the Regulatory Journey From Nonclinical To Early Phase Clinical Trials
Now available on demand
Being first to market with an innovator drug remains the ultimate goal for all and most organisations are constantly reviewing timelines in order to achieve efficiencies through trial design, conduct and the reduction of down time between phases of their drug development. As a small biotech, how can you ensure that your asset is ahead of your competitors without the weight, or budget, of a larger organisation to support the process?
Over the course of these two presentations we will be examining the transition from nonclinical to early clinical from a regulatory perspective and highlighting the key areas where your program can benefit from some forward thinking and planning for your next steps.
Over both sessions you will learn:
▪ Why nonclinical studies are conducted
▪ Important aspects of the nonclinical findings to support Phase I Clinical Trials
▪ How to determine starting and maximum doses based on nonclinical data
▪ Mitigate issues with your CTA application
▪ Risk vs benefit plus novel trial design
▪ Dosing considerations for your FiH study
For our session covering non-clinical considerations, you can access the recording now.
The slides are also available as a PDF Nonclinical considerations for early phase clinical trials_2023
For our session covering clinical considerations, access the recording now.
The slides are also available as a PDF Clinical considerations for early phase clinical trials_2023
Should you have questions for any of our presenters following the presentation please contact us and we will connect you.