Since the start of the COVID-19 outbreak clinical research has been impacted around the globe. Apart from the difficulties, the epidemic has also been a catalyst for positive change enabling faster uptake of new processes and technologies. This webinar aims to provide you with a unique perspective, bringing together first hand experiences from site and sponsor about opportunities and challenges.
The world has woken up to understand the disturbing impact of a global virus epidemic. Scientists have however been studying the risks for many years, trying to find novel ways to model and predict the spread of viruses.
An introduction to the current regulatory framework for advanced therapies, including the legislation on ATMPs, Tissues and Cells and some ethics specifics to consider in a do's and don'ts to reach an effective shortening of pharmaceutical development time.
10 November - Pioneering malaria challenge trials in Belgium: from theory to practice in a Phase I unit
13 November - Advanced therapies: the demise of alchemy and rise of pharmacology
16 November - “The scientific approach to a virus epidemic”
17 November - Online closing event: we look back on the past webinars and give the floor to a leading speaker in the field of healthcare.
TBC - "Collaboration between paediatric network sites in Belgium"
TBC - "Value based healthcare"
Human Challenge Trials (HCT) or Human Infection Models (HIM) are an extremely effective way of validating treatment efficacy using real-world symptomology studies. The challenge of infectious agents with vaccine (or drug) in vivo offers early access to mode of action (MOA) and proof of concept (POC) data prior to designing later, larger phase field trials. The last two decades have seen a surge in antimalarial drug development with product development partnerships taking a leading role. The development of resistance to the past and present anti-malarial drugs highlights the need for continued research to stay one step ahead. New drugs are needed, particularly those with new mechanisms of action. Malaria Volunteer Infection Studies (VIS) serve as a valuable tool in antimalarial drug development. Both for prophylactic and curative treatment, models have been developed in clinical trials by injection of infected red blood cells or direct inoculation with malaria sporozoites. Pioneer trials have already been performed in different countries such as Australia and the Netherlands. Last year, the first malaria-VIS trial has been performed in Belgium, aiming to investigate a prophylactic treatment. A second VIS-trial testing a curative treatment model will start in March 2020. This workshop offers unique insights about Belgium’s pioneer malaria-VIS trials from the scientific community, the sponsor’s and the investigator’s perspective.
Digital transformation of a research site is a complex, resource-intensive, and lengthy undertaking with many challenges, that can cover the entire process of clinical research allowing data to be used much more effectively and efficiently for patient-centered research.