UCSF

News

  • 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.