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 Francome 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
Join this one-hour webinar to 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.
Speakers
Dr. Simon Hutchings, Director of Pharmacology, Simbec-Orion
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.
Message Presenter
Dr. Danielle Francombe, Senior Pharmacologist, Simbec-Orion
Dr. Danielle Francome 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).
Message PresenterWho Should Attend?
This webinar will appeal to those working in biotech or mid-size pharma companies developing rare disease treatments or orphan drugs, including:
- Clinical Teams
- Head/Director of Clinical Operations
- CMOs
- CEOs
- CSOs
What You Will Learn
In this webinar, participants will learn about:
- 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
Xtalks Partner
Simbec-Orion
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Simbec-Orion offers clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post-marketing studies. With a focus on tailormade and scalable solutions, Simbec-Orion adapt delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives.
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