The first regulatory science and innovation center on the West Coast
News
2024
- Mar 15: "UCSF-Stanford CERSI Hosts 2024 Summit of Regulatory Science Leaders" - UCSF-Stanford CERSI hosts its fifth annual Innovations in Regulatory Science Summit - UCSF School of Pharmacy News
- Jan 08: UCSF-Stanford CERSI hosts the inaugural CERSI Scientific Symposium at Stanford University, organized with the CERSI Network (M-CERSI, JHU-CERSI, Yale-Mayo CERSI, and Research Triangle CERSI) and the Office of Regulatory Science and Innovation at FDA.
- Jan 07: UCSF-Stanford CERSI hosts its fifth annual Innovations in Regulatory Science Summit.
2023
- Sep 01: "A budding partnership with Korean regulatory science pharmacists" - UCSF School of Pharmacy signs MOU with Korea Regulatory Science Center (K-RSC) - UCSF School of Pharmacy News
- Jul 18: "Regulatory science at UCSF gets major boost with FDA CERSI renewal" - UCSF-Stanford CERSI is renewed by FDA with up to $50 million in funding through 2028 - UCSF School of Pharmacy News
- Feb 03: "As trial diversity becomes a must, so does a change in how to recruit" - BioCentury publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 30: "How FDA should get ahead of an ever-bending curve of innovation" - BioCentury publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 25: "UCSF-Stanford CERSI hosts summit of regulatory science leaders" - UCSF-Stanford CERSI hosts its fourth annual Innovations in Regulatory Science Summit - UCSF School of Pharmacy News
- Jan 20: "Ex-FDA chiefs see distrust in science rising, offer Califf starting solutions" - BioCentury publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 11: "Strong regulatory system guarantees access to safe medicines – NAFDAC" - The Sun publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 11: "CERSI Summit: Wider use of real-world evidence continues to face hurdles" - Regulatory Focus publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 10: "CDER director calls for simplifying clinical trials to boost diversity" - Regulatory Focus publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 09: "Califf, past FDA chiefs look for partners to curb misinformation" - Regulatory Focus publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 09: "Clinical trial diversity, long an issue in drug development, gets legislative mandate" - San Francisco Business Times publishes a story on our 2023 Innovations in Regulatory Science Summit.
- Jan 08: UCSF-Stanford CERSI hosts its fourth annual Innovations in Regulatory Science Summit, the first in-person Summit since 2020.
2022
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May 05: "Real-World Evidence - Where Are We Now?" - Dr. Laura Esserman's OneSource project is highlighted in an FDA commentary on real-world evidence published in the New England Journal of Medicine.
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May 04: "UCSF Names Kathy Giacomini Dean of Pharmacy School" - UCSF-Stanford CERSI Co-PI Kathy Giacomini is appointed dean of the UCSF School of Pharmacy - UCSF News
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Apr 22: "Dr. Hacker: With ‘no carrot,’ healthcare can’t overcome cybersecurity failures" - SC Media publishes a story on our Cybersecurity seminar by Christian Dameff.
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Apr 08: "Arm Your Biomed Company Against Cyberattacks" - Healthcare Packaging publishes a story on our Cybersecurity seminar by Kevin T. Kornegay.
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Jan 09: Our third annual Innovations in Regulatory Science Summit is covered by Bioworld, BioCentury, Pink Sheet, RAPS (story 1 and story 2), and Endpoints News.
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Jan 09: UCSF-Stanford CERSI hosts its third Innovations in Regulatory Science Summit (virtually).
2021
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Aug 15: UCSF-Stanford CERSI has been renewed by the FDA for two more years!
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Mar 03:
2021-2022 FDA OCP ORISE Fellowship Program for Training in Policy Development and Regulatory Science - FDA/Office of Clinical Pharmacology -
Feb 04:
2021 FDA Summer Internship Program - FDA/Office of Clinical Pharmacology/Office of Translational Science -
Jan 11: UCSF-Stanford CERSI hosts its second Innovations in Regulatory Science Summit (virtually).
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Jan 04: "AtriCure Announces Labeling Expansion for Cryo Nerve Block Therapy" - Business Wire publishes a story on how 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.
2020
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Dec 16: 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 - EurekAlert/AAAS News Release
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Jan 23: "FDA, academia, and industry join forces to shepherd new therapies to patients" - UCSF School of Pharmacy publishes a story about our first Innovations in Regulatory Sciences Summit.
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Jan 12: UCSF-Stanford CERSI hosts its first Innovations in Regulatory Sciences Summit.
2019
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Aug 09: FDA's Division of Non-Prescription Drugs has a Fellowship opportunity (closes 3/31/20):
OTC Fellowship Details.
2018
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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).
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Jeff Bell from KCBS interviews Russ Altman on UCSF-Stanford CERSI's 5-year grant renewal. Listen below:
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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.
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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.
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2016
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Nov 15: "FDA Funds UCSF-Stanford Center on Regulatory Science" - UCSF News
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JIMB is hiring Principal Investigators (selection begins 12/18/2016)
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FDA is hiring Chief Scientist (closes Thursday 9/29/2016) [link defunct]
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Apr 21: "Laura Esserman Named to TIME 100 List of Most Influential People in the World" - UCSF News publishes a story about how 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!
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Mar 10: "FDA collaborates with academia to pursue patient-centric endpoints in glaucoma" - Healio News
2015
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Nov 20: "What really happens when you mix medications?" - UCSF-Stanford CERSI Co-PI Russ Altman gives a TEDMED talk on machine learning to understand adverse drug effects (Made available online 03/02/16).
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UCSF-Stanford CERSI announces $5000 CERSI Scholars award for excellence in regulatory science.
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Oct 20: The FDA Center for Devices and Radiological Health (CDRH) publishes its 2016 Regulatory Science Priorities.
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Applications for the 2016-17 MTM Cohort are now being accepted. Application deadline: January 6, 2016.
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FDA's Science Moving Forward is published (progress report to the FDA Science Board).
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FDA Broad Agency Announcement for the Advanced Research and Development of Regulatory Science. [link defunct]
2014
- May 05: "Stanford, UCSF target better drug development in new FDA partnership" - San Francisco Business Times
- May 05: "FDA Launches Center of Excellence for Drug Development at UCSF" - UCSF News