Since 2012, the US Food and Drug Administration (FDA) has engaged with universities across the country on dedicated research projects targeting the agency’s public health priorities.
Frank Weichold of FDA’s Office of the Chief Scientist recently explained in Clinical Pharmacology & Therapeutics
how the work at the four Centers for Regulatory Science and Innovation (CERSI) supported by cooperative agreement grants from FDA is going. The four CERSIs currently are the University of Maryland, Baltimore and College Park (Schools of Pharmacy and Engineering), University of California, San Francisco in a joint effort with Stanford University, Johns Hopkins University and Yale University in a joint effort with the Mayo Clinic.
And CERSI priority research projects, of which there have been 90 as of December 2018, have ranged from enhancing pediatric medical device innovation to improving health literacy and cultural competency in FDA risk communications.
“46 workshops and over 7300 attendees later at just Maryland alone, FDA scientists view the CERSI network as a facile way to interact with the broad biomedical community,” James Polli of the University of Maryland School of Pharmacy explained.
As far as research, last February, FDA laid out
three priority areas that include reducing health care-associated infections, creating methods to improve predictive value in nonclinical evaluations, and developing methods and tools to improve and streamline the clinical and postmarket evaluation of FDA-regulated products.
Weichold notes that moving forward, CERSI research will continue to focus on clinical trial innovation, patient‐reported outcomes and modernizing the way data is collected and assessed.
“Due to the explosion in health data, the FDA has never had greater need for the collaborative and responsive platform that the CERSI program offers. The data complexity and potential impact forces us to change how we interact with stakeholders to be more timely and scalable. Examples of modernization initiatives include the advancement of data standards to interoperability, smart templates for postmarket safety data and for new medical product applications, and near‐real‐time review tools,” he writes.
FDA’s Center for Drug Evaluation and Research recently funded studies with the University of Maryland and Johns Hopkins CERSIs that will provide information to inform the agency's policies and increase public understanding regarding compounded products.
“CERSIs can also help provide access to real‐world evidence for the improvement of risk‐based approaches and technologies to assess biosimilarity. They can aid our reviewers in gaining more clinical data on generic products to better understand their relative performance and safety. They can help us extrapolate adult data to pediatric populations. They can help us create training sets to validate artificial intelligence in text mining of medical records. They can help solve the opioid crisis while still providing adequate treatment for pain,” Weichold adds.
Stanford’s Russ Altman also noted working with the FDA Adverse Event Reporting System scientists to try to use machine learning to identify the most useful reports that should be prioritized for review.
“There is some question about whether the CERSI program is unfair because it creates special relationships with a subset of universities. I think that as long as it is peer-reviewed every 5 years, this is a non-issue. Academics are always used to competing for limited resources and then being evaluated for success.
Moreover, the importance of having embedded staff at the universities is a huge value to the FDA,” Altman said.
The US Food and Drug Administration Centers for Regulatory Science and Innovation: Current Activities and Future Promise to Accelerate Innovations
Centers of Excellence in Regulatory Science and Innovation (CERSIs)