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.

List of Poster Submissions

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

Overview

Agenda

Session 1 - Advanced Manufacturing and Increasing Data Capacity

Session 2 - Clinical Outcome Assessment Surveys and Tools

Session 3 - Approaches to Incorporate Patient and Consumer Input

Session 4 - Methods to Assess Viability of Real World Data