Welcome to the elderbrook solutions Academy!
As the independent training institute of elderbrook solutions, after our succesful first lunch webinar, we are thrilled to host the subsequent session.
elderbrook solutions brings deep, real-world expertise in clinical data management, biostatistics, and statistical programming. Our Academy is the vital channel through which we share this knowledge, driving meaningful impact and professional excellence across the industry.
Join us for this exclusive session to enhance your skill set and leverage our proven experience in digital solutions and specialized clinical research services.
Upcoming Event: Maximising Value from your First-in-Human Study
Transitioning an experimental drug from preclinical animal models to the clinic is a critical milestone in bringing new medications to the market. The primary goals of First-in-Human (FIH) studies are to evaluate the safety and tolerability of a new investigational product and to assess its pharmacokinetic (PK) profile in humans.
In addition, FIH studies nowadays often aim to explore the relationship between exposure to a drug and changes in biomarkers of safety and efficacy. These early-phase clinical studies have evolved since the 1970s from a basic “feed-and-bleed” model to more complex and comprehensive study designs. By taking advantage of sophisticated technologies, adaptive designs, and the application of biomarkers, such enrichment of FIH trials allows Sponsors to obtain early signals of efficacy sooner — helping to shape and shorten the route of clinical drug development.
The presentation will be followed by an interactive Panel Discussion, where you will have the opportunity to engage directly with our experts on these pressing industry topics.
Speaker Spotlight: Aernout van Haarst, PhD, Celerion
We are honored to welcome Aernout van Haarst to our Lunch Webinar as a speaker.
Aernout van Haarst has over 30 years of drug development experience at biotechnology companies as well as CROs and joined Celerion in 2015. As Senior Director of Scientific Affairs at Celerion, he provides scientific, operational, and strategic support for clinical pharmacology studies. He also provides input to clinical drug development programs across a broad range of therapeutic areas. Aernout received his PhD from the School of Medicine at Leiden University and qualified as a Clinical Pharmacologist in The Netherlands.
What to Expect? Our Agenda
Lunch Webinar – Maximising Value from your First-in-Human Study
11:30 – Welcome and short introduction
11:35 – Maximising Value from your First-in-Human Study – Dr. Aernout van Haarst
- Evolution of First-in-Human studies
- Obtaining early signs of effect
- Cardiac safety assessments to de-risk drug development
- Food effect and drug interactions
11:55 – Expert Discussion
12:15 – Farewell
