The First-in-human (FIH) clinical trial is a pivotal milestone in the drug development process and is the stage-gate before molecules can proceed to Phase II/proof of concept trials.
Since 80% of drug candidates fail in Phase II or before, drug developers are increasingly looking at ways to increase the size of the data package collected in the FIH trial to improve their understanding of the drug candidate, mitigate development risks and shorten project timelines.
This webinar will present a set of case studies that will illustrate:
- How to design and conduct complex multi-part adaptive FIH studies
- Benefits of a single integrated protocol and IRB considerations
- Strategies for starting doses, interim decisions and dose escalations
- Real-time drug product manufacturing (GMP) and pharmacy compounding in early clinical studies
- Reduced timelines and API requirements
- Maximising data output to robustly transition into Phase II patient trials
- Inclusion of biomarkers for proof of concept/mechanism
- Building the clinical pharmacology data package
Presented by
Dr Stuart Harris, MD, PhD.,
Medical Director
Dr Harris is the Executive Medical Director at Quotient Sciences, USA. As a Board Certified Internist he received his MD and PhD (Physiology/Pharmacology) degrees at Duke University. Dr Harris is the co-founder of SeaView Research and has been a Clinical Investigator specializing in Phase I and early Phase II trials since 1988.
Dr Alyson Connor, PhD.,
Executive Director, Exploratory Clinical Pharmacology
Alyson is the Executive Director, Exploratory Clinical Pharmacology at Quotient Sciences, with responsibility for the global portfolio of First-in-Human (FIH) and Proof-of-Concept (POC) studies. She has 20 years’ experience in the design and conduct of clinical programs, with particular emphasis on the use of adaptive and umbrella protocols to streamline the transition to POC.
