UCSF

About

About

 

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is a joint effort among members of a world-class team of highly collaborative scientists at UC San Francisco, Stanford University, and the U.S. Food and Drug Administration (FDA).

The two academic institutions and the FDA work together on projects that promote regulatory science—including innovative research, education, and scientific exchange—in partnership with foundations and commercial entities interested in the development of FDA-approved medical products. The center collaborates, in particular, with the pharmaceutical, biotechnology, and high-tech industries of the San Francisco Bay Area and the West Coast.

Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

Aims

The center aims to meet scientific challenges in issues of critical importance in the development and evaluation of FDA-regulated products and at a time of rapid technological progress by:

  • Advancing regulatory science through the development and application of quantitative and systems-level methodologies.
  • Creating a West Coast presence of the FDA to enhance communication between academia and the pharmaceutical, biotechnology, and high–tech industries, with the FDA, about regulatory science.

Focus areas

The UCSF-Stanford CERSI builds on the enormous strengths of UCSF and Stanford University in the quantitative sciences and pharmacology to provide novel education, exchange, and collaborative research programs that focus on three key FDA priority areas as described in the FDA Strategic Plan for Regulatory Sciences:

  1. Improving preclinical safety and efficacy tests
  2. Improving clinical trials and evaluation
  3. Harnessing diverse data sets through information sciences to accelerate and improve new drug development

Collaboration: interdisciplinary and multidisciplinary

The UCSF-Stanford CERSI is the first regulatory science center on the West Coast. Due to its unique geographic location and proximity to the San Francisco Bay Area pharmaceutical, biotechnology, and high-tech industries it naturally creates a liaison among the FDA, academia, and industry, supporting a collaborative environment within—as well as beyond—the two institutions.

The center is uniquely positioned to foster strong interdisciplinary and multidisciplinary collaborations through its diverse array of schools, departments, and institutes. Both universities bring their individual academic and research strengths to the center.

UCSF

Stanford University

Both universities benefit from having their own medical centers and associated U.S. Veterans Affairs Medical Centers:

FDA CERSI Lecture Series

Lectures are presented by scientists from CERSI Academic Institutions

FDA CERSI Workshops

Workshops are held collaboratively between FDA and CERSI Academic Institutions

Related links

Beginnings

The UCSF-Stanford CERSI was launched in April 2014. See the public announcement.

 

People

Center leadership

Giacomini

Kathy M. Giacomini, PhD

Co-director, UCSF-Stanford CERSI
Professor, Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine

Russ Altman

Russ B. Altman, MD PhD

Co-director, UCSF-Stanford CERSI
Professor, Departments of Bioengineering, Genetics, Medicine and Computer Science
Stanford University, Schools of Engineering and Medicine

Maria Friciello

Program Director, UCSF-Stanford CERSI
Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine

Natalia Khuri photo

Natalia Khuri, PhD MBA

Educational Program Director, UCSF-Stanford CERSI
Lecturer, Department of Bioengineering
Stanford University, Schools of Engineering and Medicine
Adjunct Assistant Professor, Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine

Lawrence Lin, PhD

Director, External Relations and Outreach, UCSF-Stanford CERSI
Project Director, Pharmacogenomics Research Network (PGRN) Hub
UCSF Schools of Pharmacy and Medicine

Center members

UCSF

Stanford University

Center advisory board

News

 

  • FDA's Division of Non Prescription Drugs has a Fellowship opportunity (closes 3/31/20): PDF iconOTC Fellowship Details

  • FDA's Office of Clinical Pharmacology PDF iconSummer Internship announcement.

  • FDA's Center for Devices and Radiological Health (CDRH) has PDF iconFellowship and Internship Opportunities.

  • PhRMA Foundation announces Regulatory Science Fellowship (application deadline 04/01/18)

  • Jeff Bell from KCBS Radio interviews Russ Altman on UCSF-Stanford CERSI's 5-year grant renewal. Listen below:

    1. Transcript 1: On impacting millions of people around the world

      Jeff Bell: We’re talking about…

      Russ Altman: …the UCSF-Stanford Center for Excellence and Regulatory Science and Innovation.

      Jeff Bell: That’s Stanford professor Russ Altman who co-leads the collaboration, one of five such FDA-funded centers across the country.

      Altman: They’re funding these academic centers to do collaborative work for them and also training to create the future workforce for the FDA and for companies.

      Bell: The idea, says Altman, is to advance what’s known as regulatory science, or…

      Altman: …the study of science that needs to be understood in order to make better decisions by a regulatory agency.

      Bell: And when it comes to evaluating and approving new medical therapies, Altman says federal regulators face quite a challenge.

      Altman: They really want to get them out to the public as soon as possible, but it’s difficult for them to have all the expertise that they need in-house because things are rapidly changing.

      Bell: And that’s where academic collaborators can help, providing the FDA with new review methods and technologies. The work, says Altman, is especially rewarding for the scientists and the students involved.

      Altman: If we have a successful research project, it can literally impact millions of people around the world because it might accelerate the approval of a new drug or device.

      Bell: The UCSF-Stanford collaboration was launched in 2014. This new grant will help fund it for the next five years. Jeff Bell, KCBS.

    2. Transcript 2: On the value this work brings to students

      Jeff Bell: First, a definition.

      Russ Altman: Regulatory science is the study of science that needs to be understood in order to make better decisions by a regulatory agency.

      Bell: That’s Stanford professor Russ Altman, who co-leads the UCSF-Stanford Center for Excellence in Regulatory Science and Innovation, one of five such centers that the FDA has funded to help them keep up with emerging methods and technologies for evaluating medical therapies.

      Altman: They had the bright idea of bringing on academic collaborators who might be familiar with these areas…

      Bell: …because, says Altman, when it comes to regulating health care, there’s always a tricky balance in play.

      Altman: It’s a risk not to treat a disease, and it’s a risk to use the treatment.

      Bell: And, says Altman…

      Altman: This is exactly why they need to have help in the research to understand these new and emerging technologies so they can quickly make these decisions.

      Bell: While the FDA centers bring together some of the top experts in regulatory science, Altman says they also offer students some great opportunities.

      Altman: Students get exposed to these kinds of projects, get excited about this as a career option, and then either go to the FDA or go to business with a more profound understanding of how the FDA works.

      Bell: The UCSF-Stanford collaboration was launched in 2014. This new grant will help fund it for the next five years. Jeff Bell, KCBS.

 

Contact

 

For comments and questions, or to learn more about CERSI, contact us at:

UCSF-Stanford Center of Excellence in Regulatory Science and Innovation
Department of Bioengineering and Therapeutic Sciences
UCSF Box 0775
1700 4th St Rm 216D
San Francisco CA 94158
[email protected]

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Advertising Policy

In general, UCSF-Stanford CERSI will use its webpage and email distribution lists for the purpose of advertising its own events or events that the leadership suggests. Upon request, we will consider advertising events sponsored by other CERSIs, the FDA and organizations with which we work with to advance regulatory science. In general, we will not advertise events sponsored by other organizations.