To promote consistently high quality clinical results, hVIVO challenge studies incorporate calibrated human models of disease. Our standardised approach to study processes and disease models enable us to demonstrate proof of concept for a new investigational drug in a much shorter timeframe and in fewer subjects than traditionally, and crucially before investing in large, expensive field-based studies.
The respiratory models available for our challenge studies include
Our disease models incorporate
- Standardised Components and Processes: Each model is calibrated specifically for the disease, challenge agent and patient population. Our studies are run within a controlled environment using a carefully dosed inoculum, administering the lowest possible dose to provide consistent disease
- Drug-Specific Study Designs: The study design, including end points and powering, is specifically tailored to the drug MOA (i.e. vaccine, immunomodulator, antiviral), study goals (i.e., POC dosing response) and objectives, guided by our challenge study know-how and knowledgebase.
- Qualified Challenge Agents: Depending upon the model, the agent can be a respiratory virus (GMP), for eliciting common self-limiting diseases (i.e., flu, cold, RSV) in otherwise healthy volunteers, or either viral or allergic agents in asthmatics (for studying viral exacerbations)
With cleaner information from the beginning, you’re empowered to make more informed decisions and move drugs through the development process more efficiently. Getting much more reliable results is the power of the disease models, enabled by the controlled setting.
“The advantages of a safe, reproducible human model are incalculable. This model permits the relatively quick and efficient study of new therapeutics in humans, and assists in making critical decisions.” American Journal of Respiratory and Critical Care Medicine, 2010
Looking for more proof? Companies that have used our challenge studies and disease models have experienced $2 billion in acquisitions.
For more information or to make a specific research or collaboration enquiry please use the Contact Us form.