2024 CERSI Scientific Symposium

Date: 
Monday, January 8, 2024 - 9:00 am to 3:00 pm
Location: 
Mackenzie Room at Stanford University

475 Via Ortega 3rd Floor, Stanford, CA 94305

Overview

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI), in partnership with University of Maryland CERSI (M-CERSI), Johns Hopkins University CERSI (JH-CERSI), Yale-Mayo Clinic CERSI, and Research Triangle (University of North Carolina, Chapel Hill and Duke University) CERSI, is pleased to present the inaugural CERSI Scientific Symposium. This event will feature exciting presentations and short research talks by expert CERSI investigators on cutting-edge, collaborative regulatory science research projects with FDA investigators.

Submit poster abstracts

Event registration link coming soon

Agenda

Time Title
9:00 - 9:05 am

Opening Remarks

  • Kathy Giacomini, PhD · Co-PI, UCSF-Stanford CERSI
9:05 - 9:15 am

Overview of CERSI Program

  • Tina Morrison, PhD · Director, Office of Regulatory Science and Innovation (ORSI), FDA
9:15 - 10:15 am

Session 1 - Advanced Manufacturing

  • Session Overview

    • William Bentley, PhD · Co-PI, M-CERSI

    • James Polli, PhD · Co-PI, M-CERSI

  • Presentations

  • Panel Q&A

10:15 - 10:25 am Break
10:25 - 11:25 am

Session 2 - Clinical Outcome Assessment Surveys/Tools

  • Session Overview

    • Joseph Ross, MD, MHS · Co-PI, Yale-Mayo Clinic CERSI

    • Molly Jeffery, PhD, MPP · Co-PI, Yale-Mayo Clinic CERSI

  • Presentations

  • Panel Q&A

11:25 - 12:25 pm

Session 3 - Approaches to Incorporate Patient and Consumer Input

  • Session Overview

    • Caleb Alexander, MD, MS · PI, JH-CERSI

  • Presentations

  • Panel Q&A

12:25 - 12:45 pm

Pick Up Boxed Lunches

12:45 - 1:45 pm

Session 4 - Methods to Assess Viability of Real World Data

  • Session Overview

    • Paul Watkins, MD · Co-PI, Research Triangle CERSI

    • Kathy Giacomini, PhD · Co-PI, UCSF-Stanford CERSI

    • Russ Altman, MD, PhD · Co-PI, UCSF-Stanford CERSI

  • Presentations

  • Panel Q&A

1:45 - 1:50 pm

Closing Remarks

  • Kathy Giacomini, PhD · Co-PI, UCSF-Stanford CERSI

  • Russ Altman, MD, PhD · Co-PI, UCSF-Stanford CERSI

1:50 - 3:00 pm Poster Reception