The UCSF-Stanford Center of Excellence in Regulatory Science Innovation or CERSI is known for offering yearly summits focused on academia, biomedical industry, and regulatory affairs. Their third summit on the topic took place on January 9, 2022, and became a groundbreaking summit in many ways. (1)
What is the CERSI? The U.S. Food and Drug Administration (FDA) Center of Excellence in Regulatory Science and Innovation (CERSI) is composed of the University of Maryland, the University of California at San Francisco (UCSF) in a joint effort with Stanford University (UCSF-Stanford), Johns Hopkins University, and Yale University in joint effort with Mayo Clinic. (2) The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation, is a world-class collaborative center founded by scientists from the University of California San Francisco, Stanford University, and the FDA. These institutions work together to promote regulatory science across all dimensions and build partnerships with foundations and organizations, commercial and non-commercial, that are hoping to develop medical products that can earn the FDA’s approval, in particular pharmaceutical biotechnology. (3) Each summit is a gathering of leaders from academic, regulatory, and industry backgrounds to discuss regulatory science and its role in the development of medical products.
In 2020, the first CERSI summit took place. The panels focused more on accelerating medical product development, artificial intelligence (AI), and the relationship between regulatory science and other disciplines and organizations. (2) In 2021, the focus of the second summit was on the COVID-19 pandemic and infectious disease. Panels considered pandemic preparedness and the continued impact of the coronavirus on medical product development and approval. Another goal was to consider the development of cancer-focused medical products. (4)
What were the new insights from this summit? The main topics of the 2022 summit involved considering the issues and the opportunities provided by faster drug development, biomarkers and surrogate endpoints in Alzheimer’s, and the present and future in the FDA. It also considered the changes brought forth by the COVID-19 pandemic on the FDA. The event took place virtually to accommodate for ongoing pandemic restrictions, although the original intent was to make it a hybrid event, showcasing the continued impact of the pandemic on the industry. (1)
Furthermore, the 2022 annual summit hosted former FDA Commissioners discussing pandemic-related changes in the organization, lessons learned, and scientific issues that must be addressed to advance the safe development and release of medical products. (1)
In regards to the FDA, one particular issue that has been pointed out is the polarization and even the fracturing of the society after the pandemic, with community considerations, costs, staff burnout, and more. There are emerging challenges and negative attitudes on the behalf of the public that can impact the FDA, but also opportunities to make changes on the level of community healthcare. The pandemic has left significant and long-lasting consequences, opening up new possibilities but also leaving negative impacts that might be felt for a long time still within the organization and with its work. In society, some people have been speaking out against regulations as a general concept. (5)
With regard to Alzheimer’s disease (AD), a novel proposal is that some of the existing biomarkers like amyloid plaques might not have as much clinical significance on all stages of disease. A particularly important point is the idea that what is known as Alzheimer’s might not be in fact a single condition, but a series of different diseases that are classified or identified under the same name, which points to the existence of a lot of conditions and the need for exhaustive and continued research. (5) If you want to get more information about FDA, DA and medical surgical supplies, Pharmasources would be a great choice.
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