About

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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.

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

• School of Pharmacy, which is ranked top nationwide in National Institutes of Health (NIH) research funding among pharmacy schools since 1979 and for its Doctor of Pharmacy degree program
• School of Medicine
• School of Dentistry
• School of Nursing
• Novel Department of Bioengineering and Therapeutic Sciences, which is a joint department between the School of Pharmacy and the School of Medicine.
• Well-established Clinical and Translational Science Institute funded by the NIH
• California Institute for Quantitative Biosciences-UCSF (QB3-UCSF)

Stanford University

• Large efforts in medical devices and quantitative sciences through its School of Medicine and School of Engineering
• Law School
• School of Business
• Strong Department of Bioengineering
• NIH-funded Clinical and Translational Science Award

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

• UCSF Medical Center and Veterans Affairs Medical Center, San Francisco
• Stanford University Medical Center and Veterans Affairs Medical Center, Palo Alto

FDA CERSI Lecture Series

Lectures are presented by scientists from CERSI Academic Institutions

• FDA CERSI Lecture Series Schedule

FDA CERSI Workshops

Workshops are held collaboratively between FDA and CERSI Academic Institutions

• FDA CERSI Workshop Schedule

Related links

• University of Maryland CERSI
  
• Johns Hopkins University CERSI
  
• Yale University-Mayo Clinic CERSI
  
• UCSF-Tobacco Center of Regulatory Science
• FDA CERSI

Beginnings

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

Center leadership

	Kathy M. Giacomini, PhD Codirector, UCSF-Stanford CERSI Professor, Department of Bioengineering and Therapeutic Sciences UCSF Schools of Pharmacy and Medicine
	Russ B. Altman, MD, PhD Codirector, UCSF-Stanford CERSI Professor, Departments of Bioengineering, Genetics, Medicine and Computer Science Stanford University, Schools of Engineering and Medicine
	Lawrence Lin, PhD Executive Director, UCSF-Stanford CERSI Department of Bioengineering and Therapeutic Sciences UCSF Schools of Pharmacy and Medicine
	Maria Friciello Program Director, UCSF-Stanford CERSI Department of Bioengineering and Therapeutic Sciences UCSF Schools of Pharmacy and Medicine
	Mark Dresser, PhD Educational Program Director, UCSF-Stanford CERSI UCSF Schools of Pharmacy and Medicine

Center members

UCSF

• Sourav Bandyopadhyay, PhD
• Leslie Benet, PhD
• Esteban G. Burchard, MD, MPH
• Atul Butte, MD, PhD
• Tejal Desai, PhD
• Michael Fischbach, PhD
• Su Guo, PhD
• Richard Guy, PhD
• Michael Keiser, PhD
• Deanna Kroetz, PhD
• Geoffrey Manley, MD, PhD
• Shuvo Roy, PhD
• Minnie Sarwal, MD, PhD
• Rada Savic, PhD
• Brian Shoichet, PhD
• Laura Van't Veer, PhD
• Leslie Wilson, PhD

Stanford University

• Terry Blaschke, MD
• Phil Lavori, PhD
• Timothy Meyer, MD
• Vijay Pande, PhD
• Nigam Shah, MBBS, PhD
• Arend Sidow, PhD
• Kuldev Singh, MD, MPH
• Joe Wu, MD, PhD

Center advisory board

• David Agard, PhD - UCSF
• Robert Califf, MD - Duke University
• Jennifer Cochran, PhD - Stanford University
• Andrew Conrad, PhD - Verily
• Tejal Desai, PhD - UCSF
• Laura Esserman, MD, MBA - UCSF
• B. Joseph Guglielmo, PharmD - UCSF
• Robert Harrington, MD - Stanford University
• Vijay Pande, PhD - Stanford University
• Carl Peck, MD - NDA Partners
• Michelle Rohrer, PhD - Genentech Roche
• Marc Salit, PhD - NIST
• George Scangos, PhD - Vir Biotechnology
• Sharon Terry - Genetic Alliance
• Anne Wojcicki - 23andMe

• 8/15/2021: UCSF-Stanford CERSI has been renewed by the FDA for two more years!

• 3/3/2021: 2021-2022 FDA OCP ORISE Fellowship Program for Training in Policy Development and Regulatory Science - FDA/Office of Clinical Pharmacology

• 2/4/2021: 2021 FDA Summer Internship Program - FDA/Office of Clinical Pharmacology/Office of Translational Science

• 1/4/2021: The FDA has cleared a new pain management technique for children based on pioneering work by researchers at the UCSF-Stanford Pediatric Device Consortium in the emerging field of real-world evidence (RWE). This is the first time ever that RWE has been used to clear or approve a medical device for children

• 12/16/2020: Verana Health, FDA, Center of Excellence in Regulatory Science and Innovation (CERSI) at UCSF and Stanford University, American Academy of Ophthalmology and American Glaucoma Society announce start of new patient-reported outcomes validation study

• 1/12/2020: UCSF-Stanford CERSI hosts its first Innovations in Regulatory Sciences Summit

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

• FDA's Office of Clinical Pharmacology Summer Internship announcement.

• FDA's Center for Devices and Radiological Health (CDRH) has Fellowship 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.

• FDA Funds UCSF-Stanford Center on Regulatory Science

• JIMB is hiring Principal Investigators (selection begins 12/18/2016)

• FDA is hiring Chief Scientist (closes Thursday 9/29/2016) [link defunct]

• Our CERSI Advisory Board Member, Laura Esserman, MD, MBA, has been named to the 2016 TIME 100 list of most influential people in the world!

• FDA collaborates with academia to pursue patient-centric endpoints in glaucoma

• Russ Altman's TEDMED talk on machine learning to understand adverse drug effects is now available online.

• Our CERSI Board Chair, George Scangos, has been named the #10 Businessperson of the Year by Fortune Magazine.

• UCSF-Stanford CERSI announced $5000 CERSI Scholars award for excellence in regulatory science

• 2016 CDRH Regulatory Science Priorities are published

• Applications for the 2016-17 MTM Cohort are now being accepted. Application deadline: January 6, 2016

• Research Participation Programs at the U.S. FDA

• FDA Science Moving Forward published (progress report to the FDA Science Board)

• The Food & Drug Administration is hiring Biologist, Chemist, Consumer Safety Officers, Entomologist and Microbiologist

• FDA-TRACK OC Office of the Chief Scientist Dashboard

• FDA Broad Agency Announcement for the Advanced Research and Development of Regulatory Science

• FDA Launches Center of Excellence for Drug Development at UCSF

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]

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.