The Impact of the Regulatory Science Summit 2022

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.

In regards to the accelerated FDA approval, one particular point is the need for greater international collaboration and a less U.S.-centric point of view, allowing for better and faster export process and other advantages that can contribute to a greater efficacy on a global scale. (5)

The summit was over last month, but the recordings are freely available on the summit website and YouTube. The summit might be especially interesting for students and researchers in the biomedical industry, anyone involved in the process of developing and getting approval for their medical products, as well as any party with interest in engaging more with the FDA and receiving up-to-date information. The summit is also open to a wider audience but does use more specialized language and offers a formal presentation style that might make it more difficult for individuals with no prior understanding to engage with all the materials equally.

The summit is only having its third edition, but it is establishing itself as an industry reference point. It features participation from main players in academia and the regulatory industry. It is freely available and offers a quick update on the current state of things directly from the people involved, presenting the central challenges, achievements, and future directions concerning the intersection of regulation, scientific research, and product development. Throughout the past three years, the summit has offered insightful and effectively presented information. It has the backing and sponsorship of global pharmaceutical giants like Merck, Lilly, Johnson & Johnson, and many others.

The CERSI summit is likely to continue and showcase the importance for interdisciplinary cooperation, as is the mission of the CERSI itself. The event offers a point of reference for those involved in research and the industry, creating an excellent opportunity for new direction and the sharing of information.

As the COVID-19 pandemic has highlighted, it is very important to share information, especially in a field with such high stakes as medical development. On the other hand, it is also essential to create safe processes that can serve to provide effective products, medications, and technological advancements. To accomplish both, events like the summit can offer a good space for sharing important data and build collaborations between people participating in different industries and academic pursuits.

The CERSI summit in 2022 has been successful in addressing some of the most relevant issues in medical development and regulatory science with input from the FDA and leading researchers in various areas. It remains to be seen which topics will be especially relevant next year, but the CERSI summit is shaping up to be a long-running event.

References

1.CERSI. (2022). Movers and Shapers: The Future of Drug and Device Development. https://cersisummit.com/

2. https://www.fda.gov/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis

3. CERSI. (2020). 2020 Innovations in Regulatory Science Summit. https://pharm.ucsf.edu/cersi/events/2020-innovations-regulatory-science-summit

4. CERSI. (2021). 2021 Innovations in Regulatory Science Summit. https://cersisummit.com/2021summit/

5. CERSI. (2022). 2022 Innovations in Regulatory Science Summit. https://cersisummit.com/2022recording/.

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.