In early clinical development, making changes to a study design after regulatory approval can cause significant delays. These can be avoided by incorporating additional/optional study parts into the original protocol. Proactively planning for additional study elements gives greater flexibility, allowing you to make decisions based on emerging data, without requiring additional regulatory approval.
With extensive practical experience and scientific knowledge of the design, management, analysis and reporting of early clinical development projects, including first-in-human pharmacology, phase I pharmacology and pharmacokinetic (PK) studies, join Dr. Simon Hutchings and Dr. Danielle Francombe on this webinar to get insights on:
- How to work with your CRO to create an adaptive, multi-part FiH study which suits your needs
- Adding maximum value to your FiH protocol by answering key human pharmacology questions via flexible and optional study parts (e.g. food effect, DDI, formulation, posology, target engagement, gender/age effect, TQT assessment, Proof of Concept)
- Additional considerations for FiH to patient multi-part studies
- Theoretical and case study examples
- Considerations for budgeting
During this one hour presentation, you will discover how an adaptive, multi-part, First-in-Human (FiH) study can accelerate your early clinical development and inform key go/no-go decisions earlier in your clinical development program.
Our Presenters
Dr. Simon Hutchings
Dr. Simon Hutchings has over 15 years of experience in the drug development process, including pre-clinical pharmacology/toxicology, phase I (including first-in-human) pharmacology/PK studies and investigator-led phase II and phase III trials. In addition to undergraduate and postgraduate qualifications in pharmacology, Simon also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine (Royal College of Physicians) and a Certificate in Regulatory Affairs, University of Hertfordshire.
Dr. Danielle Francombe, Senior Pharmacologist, Simbec-Orion
Dr. Danielle Francombe has over 7 years of experience in clinical research, having joined Simbec-Orion in September 2013. Danielle has a PhD from the Welsh School of Pharmacy and has previous pre-clinical experience in pulmonary pharmacology and pharmacokinetic modelling. Danielle also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine (Royal College of Physicians).
Connect with Danielle on Linkedin
Explore our related webinar: Effective Implementation of the Revised EMA First-into-Human (FiH) Guidance to Accelerate Your Early Clinical Development.