Background & Problem
In March 2014, the World Health Organization reported a major Ebola outbreak in West Africa. In September of that year, the first Ebola case was confirmed in the United States. Ebola outbreaks continue in the World to this day and the need for pharmaceutical intervention is urgent.
There is no FDA-approved antiviral drug to treat Ebola. Instead, the current standard-of-care intervention relies upon symptomatic relief and supportive care to give the patient’s immune system the best chance to overcome the infection.
Nuventra assisted with devising a drug development strategy to quickly and efficiently respond to this unmet medical need and the associated ethical challenges for developing an anti-Ebola intervention.
The “Animal Rule” is a product development strategy that allows efficacy studies in animals to be used in place of human clinical studies. For Ebola, nonhuman primate studies can be used to reasonably approximate human safety and efficacy endpoints in development of novel drugs inhibiting the Ebola virus. This approach involves the use of pharmacokinetic (PK) and pharmacodynamic (PD) modeling of data between species (inter-species PK/PD modeling) to define an optimally safe and effective dose in humans.
Ebola intervention and prevention is a critical world health need. The FDA and other regulatory agencies have provided the regulatory and clinical framework to approve new Ebola therapies. Nuventra’s experience with clinical pharmacology/PK/PD and modeling can be applied to this regulatory and clinical framework to speed new therapies to patients in need.
Contact our experienced consultants for help on your unique drug development issues today.