The US Food and Drug Administration (FDA) is founding a $3.3m (€2.4m) regulatory science centre jointly with the University of California San Francisco (UCSF) and Stanford University.
Located within UCSF’s School of Pharmacy, the site will house collaborative research into drug development to support the FDA’s abilities to evaluate safe and effective medications. The centre’s work will focus on improving preclinical safety and efficacy tests, improving clinical trials and harnessing data to accelerate and improve drug development.
Discoveries from the facility – the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation, or CERSI – will be used to “strengthen the knowledge base used in regulatory decision-making,” Stephen Ostroff, Acting Chief Scientist, FDA told in-Pharmatechnologist.com.
“Advancement in FDA’s data modelling and simulation science, done in collaboration with CERSI researchers, will hopefully contribute to the development, standardization, and qualification of tools to assess the safety, effectiveness, quality and performance of regulated products.
“Regulatory decision-making is a complicated process, and newly-developed methods or data used for decision-making need to be validated for their applicability and utility. The potential for CERSI outputs to improve regulatory processes and product development is a major goal of building the CERSI network.”
The FDA will combine its resources with those of UCSF and Stanford “to improve quantitative pharmacological and disease progression models in several areas,” said Ostroff. In this area, the universities’ informatics and data-driven quantitative pharmacology models will be particularly useful, he said, pointing to their “ability to model and simulate different disease populations and subgroups, and to examine gender and age differences using comprehensive databases.
“This can speed innovations that make products safer, more effective and more affordable. These types of efforts would help support the growing area of personalized medicine, especially if they enable us to recognize sub-group specific health and safety risks earlier.”
Kathy Giacomini, a professor in the UCSF School of Pharmacy and co-chair of the UCSF Center for Quantitative Pharmacology, added there are many ways quantitative pharmacologic methodologies that can be applied to drug development and approval.
“For early drug discovery, discovering drug targets and mechanisms of action can be greatly aided by computational methods. For example, the structures of potential drug targets can be modelled computationally, and potential drugs that interact with the modelled targets can be identified through molecular docking.
“Drug levels can be simulated quantitatively based on an understanding of the enzymes and transporters that are involved in the drug's absorption and metabolism.
“Drug effects can also be modelled and simulated based on the drug levels and the kinetics of interactions with the target proteins. Adverse drug reactions can be proposed by scanning social media and using statistical computation. Genetic data can be used to personalize drug therapy.”
Giacomini told in-Pharmatechnologist.com the project is “definitely a collaboration, so the research and insights will flow both ways between the Bay Area and Washington, DC.”
While the centre will be based at UCSF, Stanford will also host visiting FDA scientists and offer courses. “We envision some web-based courses, which will be available to everyone, for example, ‘What are the steps in obtaining an Investigational New Drug Application?’” said the professor. “A core course like that would be helpful to small start-up companies.”