2024 CERSI Scientific Symposium

Date: 
Monday, January 8, 2024 - 9:00 am to 3:00 pm
Location: 
Mackenzie Room, Jen-Hsun Huang Engineering Center 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), University of Maryland CERSI (M-CERSI), Johns Hopkins University CERSI (JHU-CERSI), Yale-Mayo CERSI (Yale University, Mayo Clinic), and Research Triangle CERSI (University of North Carolina, Chapel Hill and Duke University) are pleased to present the inaugural CERSI Scientific Symposium. This event will feature exciting presentations by expert investigators from all CERSI sites on their cutting-edge, collaborative regulatory science research projects with FDA investigators.

 

Video Recording of the meeting.

 

Agenda

Time Title
8:30 - 9:00 am Sign-In
9:00 - 9:05 am

Welcome

  • Kathy Giacomini, PhD | Co-PI, UCSF-Stanford CERSI
9:05 - 9:10 am

Opening Remarks

  • Lloyd B. Minor, MD | Dean, Stanford University School of Medicine
9:10 - 9:20 am

Overview of CERSI Program

  • Tina Morrison, PhD | Director, Office of Regulatory Science and Innovation (ORSI), FDA
 

Session 1 - Advanced Manufacturing and Increasing Data Capacity

9:20 - 9:25 am

Session Overview
William Bentley, PhD, MEng | Co-PI, Maryland CERSI
James Polli, PhD | Co-PI, Maryland CERSI

9:25 - 9:40 am

Water Proton Nuclear Magnetic Resonance to Characterize Gene and Cell Therapy Products
Marc Taraban, PhD | Associate Research Professor of Pharmaceutical Sciences, University of Maryland, Baltimore

9:40 - 9:55 am Persistent In-Line Sensor for Real-World Loading Characterization of Osseointegrated Implants and Prosthetic Devices
Courtney Moran, CP, MS | Project Manager, Johns Hopkins University Applied Physics Laboratory
9:55 - 10:10 am

Optimizing and Assessing Safety of Homology Directed Repair Based Genome Editing
Matthew Porteus, MD, PhD | Professor of Pediatrics – Stem Cell Transplantation, Stanford University

10:10 - 10:20 am Session Panel Q&A
10:20 - 10:30 am Break
 

Session 2 - Clinical Outcome Assessment Surveys and Tools

10:30 - 10:35 am

Session Overview
Joseph Ross, MD, MHS | Co-PI, Yale-Mayo Clinic CERSI
Molly Jeffery, PhD, MPP | Co-PI, Yale-Mayo Clinic CERSI

10:35 - 10:50 am

Physical Function Assessments in Cancer Clinical Trials
Amylou C. Dueck, PhD | Associate Professor of Biostatistics, Mayo Clinic Arizona

10:50 - 11:05 am

Clinical Outcome Assessments (COAs) and Patient-Centricity
Eleanor Perfetto, PhD, MS | Professor of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore

11:05 - 11:20 am

Imaging as Intervention: Approaches to Estimating the Real-World Effectiveness of Novel Molecular Imaging Tools in Prostate Cancer
Michael Leapman, MD, MHS | Associate Professor of Urology, Yale School of Medicine

11:20 - 11:30 am Session Panel Q&A
 

Session 3 - Approaches to Incorporate Patient and Consumer Input

11:30 - 11:35 am

Session Overview
Meghan Moran, PhD, MA | Associate Professor of Health, Behavior, and Society, Johns Hopkins University

11:35 - 11:50 am

Techniques to Specify How Consumers Respond to Tobacco Marketing and FDA Educational Messaging
Meghan Moran, PhD, MA | Associate Professor of Health, Behavior, and Society, Johns Hopkins University

11:50 - 12:05 pm

Using Stated Preference Methods to Incorporate Patient Input for Benefit-Risk Decision-Making
Susan dosReis, PhD | Professor of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore
Julia Slejko, PhD | Associate Professor of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore

12:05 - 12:20 pm

Comparing Methods for Identifying Patients’ Preferences at Decision Making
Ian G. Hargraves, PhD | Assistant Professor of Medicine, Mayo Clinic Rochester

12:20 - 12:30 pm Session Panel Q&A

12:30 - 12:50 pm

Pick Up Boxed Lunches

 

Session 4 - Methods to Assess Viability of Real World Data

12:50 - 12:55 pm

Session Overview
Susan Halabi, PhD | Co-PI, Research Triangle (UNC-Duke) CERSI

12:55 - 1:10 pm

Understanding the Use of Existing Real-World Data for Medical Product Evaluation
Molly Jeffery, PhD, MPP | Co-PI, Yale-Mayo Clinic CERSI

1:10 - 1:25 pm

Utilizing UNC Clinical Data Warehouse for Dose-Response Relationships of Targeted Therapies in RWPs
Carter Cao, PhD | Associate Professor, University of North Carolina, Chapel Hill

1:25 - 1:40 pm

Epidemiologic Challenges to Using Real-World Large Claims Data to Study Opioid Use Disorder Treatment Cascades and Trajectories
Danya Qato, PharmD, MPH, PhD | Associate Professor of Practice, Sciences, and Health Outcomes Research, University of Maryland, Baltimore

1:40 - 1:50 pm Session Panel Q&A

1:50 - 1:55 pm

Closing Remarks
Russ Altman, MD, PhD | Co-PI, UCSF-Stanford CERSI
Kathy Giacomini, PhD | Co-PI, UCSF-Stanford CERSI

1:55 - 3:00 pm

Poster Reception