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Virtual | Virtual

Event Title
CERSI Program Showcase
October 5, 2023

Date:
October 5, 2023
Image
CERSI Program Showcase on October 5, 2023

CERSI Program Showcase

October 5, 2023
9:00 AM-4:30 PM (Eastern Standard Time)

This event will include:

  1. Presentation from new Research Triangle CERSI
  2. Updates from existing CERSIs
  3. Research project presentations from selected topics in the Regulatory Science Framework   
    • Charge 1 - Modernize Development & Evaluation of FDA Regulated Products
    • Charge 2 - Strengthen post-market surveillance and labeling of FDA-regulated products
    • Charge 3 - Invigorate public health preparedness and response of FDA, Patients & Consumers    

Recordings

Part 1   Part 2

Background

The Centers of Excellence in Regulatory Science and Innovation (CERSI) program led by the Office of Regulatory Science and Innovation (ORSI) promotes innovation in regulatory science through cutting-edge scientific research and information sharing opportunities that support FDA's regulatory science needs. The collaborations between CERSIs and FDA scientific experts target one or more of the focus areas in the Regulatory Science Framework. The current CERSIs were selected and awarded through a competitive process for a cooperative agreement. Renewal awards were made to University of Maryland, Johns Hopkins University, Yale University in joint effort with Mayo Clinic, and University of California at San Francisco (UCSF) in a joint effort with Stanford University (UCSF-Stanford). A new award was made to the University of North Carolina, Chapel Hill, in a partnership with Duke University, which will be called Research Triangle CERSI.  

Agenda

Time Topics Speakers/Moderators

9:00 am - 9:05 am

 Welcome and Agenda Overview Rebekah Zinn, PhD
ORSI CERSI Program Lead

9:05 am - 9:30 am

 Introduction Tina Morrison, PhD
ORSI Director
9:30 am - 9:40 am Opening Remarks Jacqueline O’Shaughnessy, Ph.D.
Deputy Director
Office of the Chief Scientist
 

CERSI Highlights

 Moderator: Tina Morrison, PhD
9:40 am - 10:15 am Research Triangle CERSI- University of North Carolina & Duke University Paul Watkins, MD; UNC
Susan Halabi, PhD; Duke Univ.
Robert Mentz, MD, Duke Univ.
Ehsan Samei, PhD, Duke Univ.
10:15 am - 10:25 am M-CERSI (University of Maryland) James Polli, PhD
William Bentley, PhD
10:25 am - 10:35 am JH-CERSI (Johns Hopkins University) Caleb Alexander, MD
10:35 am - 10:45 am Yale-Mayo Clinic CERSI Joseph Ross. MD; Yale University
Molly Jeffery, PhD: Mayo Clinic
10:45 am - 10:55 am UCSF-Stanford CERSI Russ Altman, MD, PhD; Stanford University
10:55 am - 11:15 am Q&A all CERSIs Moderator: Tina Morrison, PhD
  Break  
  Session 1
Charge 1- Modernize Development & Evaluation of FDA Regulated Products		 Moderator: Ruth Barratt, PhD; CDER
11:25 am - 11:45 am Development of a precision oncology decision support platform to enhance genotype-driven clinical trial recruitment and decentralized personalized medicine approaches Valsamo Anagnostou, MD, PhD; JHU
Preeti Narayan, MD; CDER
11:45 am - 12:05 pm Multi-organ microphysiological systems for modeling clinical drug effects Ishan Goswami, PhD; UC, Berkeley
 
12:05 pm - 12:25 pm Development, Implementation, and Evaluation of an Open Source Software to Support Patient-based Estimation of Clinically Meaningful Levels and Change Scores for Patient Reported Outcome Measures Karon F. Cook, PhD; Feral Scholars
Fraser Bocell, MEd, PhD; CDRH
12:25 pm - 12:45 pm Tissue Chips for Multipotent Stromal Cell Manufacturing Ngan Huang, PhD; Stanford University
Kyung Sung, PhD; CBER

12:45 pm - 1:45 pm

 Lunch  
  Session 2
Charge 2- Strengthen post-market surveillance and labeling of FDA-regulated products		 Moderator: Brittany Caldwell, PhD, MBA; CDRH

1:45 pm – 2:05 pm

 Patient and provider informed labeling of AI/ML-Based Software to enable transparency and trust for cardiac monitoring and diagnostics Barbara Barry, PhD; Mayo Clinic
Aubrey Shick, MS; CDRH

2:05 pm – 2:25 pm

 Assessment of Safety and Performance Issues with Extended Reality (XR) Tele-mentoring of an Image-Guided, Clinically Important Procedure Matthew Johnson; University of Maryland
Ryan Beams, PhD; CDRH

2:25 pm – 2:45 pm

 An Electronic Approach for Post-Market Surveillance for Antimicrobial-Associated Adverse Events Jerald Cherian, MD, MHS; JHU
Ramya Gopinath, MD; CDER

2:45 pm - 3:05 pm

 Evaluate the application of machine learning algorithms to the management of postpartum hemorrhage Management Moeun Son, MD; Yale University
Kevin Dysart, MD; Nemours
Kristie Baisden, DO; CDER

3:05 pm – 3:15 pm

 Break  

 

 Session 3
Charge 3- Invigorate public health preparedness and response of FDA, Patients & Consumers		 Moderator: Emily Braunstein, PhD; CBER

3:15 pm – 3:35 pm

 Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion Magali Fontaine, MD, PhD; Univ. of Maryland
Carlos Villa, MD, PhD; CBER

3:35 pm – 3:55 pm

 Integrating patient and consumer-generated discursive data to inform and enhance FDA One Health Initiative communication strategies Daniel Mullins, PhD; University of Maryland
Christine Lee, PharmD, PhD; OMHHE

3:55 pm – 4:15 pm

 Metabolism-based DDI and liver toxicity of drugs for COVID-19 treatment Hongbing Wang, PhD; University of Maryland

4:15 pm – 4:35 pm

 Trends in Opioid Use Among Patients with Cancer Henry Park, MD, PhD; Yale University
Catherine Lerro, MPH, PhD; OCE

4:35pm – 4:40 pm

 Closing Rebekah Zinn, PhD
ORSI CERSI Program Lead

 

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