Research

Collaborative Research Project List

The research unit of the UCSF-Stanford CERSI stimulates innovative and collaborative research in regulatory science among FDA scientists, academic scientists, and scientists in the biotechnology and pharmaceutical industries. Active and completed collaborative research projects are organized into categories as shown below. 

Project #32: Tissue Chips for Multipotent Stromal Cell Manufacturing

CERSI Principal Investigator: Ngan Huang, PhD (Stanford)
FDA Collaborators: Kyung Sung, PhD (CBER/FDA)
Status: Active

 

Completed Projects
Project #7: Single Cell Mass Cytometry Based Assessment of MSCs

CERSI Principal Investigator: Sean Bendall, PhD (Stanford)
FDA Collaborators: Steven Bauer, PhD (CBER/FDA)
Status: Completed

Project #22: Methods to Inactivate Pathogens in Blood

CERSI Principal Investigator: Eric Kool, PhD (Stanford)
FDA Collaborators: Jaroslav Vostal, MD, PhD (CBER/FDA), Chintamani Atreya,PhD (CBER/FDA)
Status: Completed

Project #27: An Unbiased Analysis of Identification and Assessment of Cas9/gRNA Potential Off-Target Sites in Clinical Development of Ex Vivo Manufactured Genome Edited Cell Products

CERSI Principal Investigator: Matthew Porteus, MD, PhD (Stanford)
FDA Collaborators: Zhaohui Ye, PhD (CBER/FDA)
Status: Completed

Project #33: Isolating Exosomes using a novel ExoTIC device from HIV-infected Patient Plasma and Saliva

CERSI Principal Investigator: Utkan Demirci, PhD (Stanford)
FDA Collaborators: Indira Hewlett, PhD (CBER/FDA), Mohan Haleyurgirisetty, PhD (CBER/FDA), Jiangqin Zhao, PhD (CBER/FDA)
Status: Completed

Project #38: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Biological Products

CERSI Principal Investigator: Tina Hernandez-Boussard, PhD, MPH, MS (Stanford)
FDA Collaborators: Barbee Whitaker, PhD (CBER/FDA), Steven Anderson, PhD, MPP (CBER/FDA), Artur Belov, PhD (CBER/FDA), Hui-Lee Wong, PhD (CBER/FDA)
Status: Completed

Project #39: Development of New Machine Learning Algorithms to Quantify Treatment Effectiveness and Adverse Outcomes

CERSI Principal Investigator: James Zou, PhD (Stanford)
FDA Collaborators: Steven Anderson, PhD, MPP (CBER/FDA), Barbee Whitaker, PhD (CBER/FDA), Alan Williams, PhD (CBER/FDA), Gregory Pappas, MD, PhD (CBER/FDA), Angela Moy (CBER/FDA)
Status: Completed

Project #41: Using the University of California Clinical Data Warehouse to Evaluate the Safety and Efficacy of Biologics, including Blood Transfusions, Vaccines, CAR-T cell Therapies, and other CBER Regulated Products

CERSI Principal Investigator: Atul Butte, MD, PhD (UCSF)
FDA Collaborators: Barbee Whitaker, PhD (CBER/FDA), Steven Anderson, PhD, MPP (CBER/FDA), Artur Belov, PhD (CBER/FDA), Hui-Lee Wong, PhD (CBER/FDA)
Status: Completed | Plain Language Summary

Project #60: Improving Adverse Event Detection Related to Biologic Immunosuppressant Use – A Pilot Study of the BERT Deep Learning Model Adapted to Real-world Clinical Notes

CERSI Principal Investigators: Vivek Rudrapatna, MD, PhD (UCSF), Atul Butte, MD, PhD (UCSF), Ludwig, Dana, MD (UCSF)
FDA Collaborators: Samer El-Kamary, MD, MPH (CDER/FDA), Jawahar Tiwari, PhD (CBER/FDA)
Status: Completed | Plain Language Summary

Project #44: OneSource Phase 2: Source Data Capture from Electronic Health Records using Standardized Clinical Research Data

CERSI Principal Investigator: Laura Esserman, MD, MBA (UCSF)
FDA Collaborators: Mitra Rocca, Dipl Inform Med (CDER/FDA), Jacqueline Corrigan-Curay, JD, MD (CDER/FDA), Dianne Paraoan (CDER/FDA), Frank Weichold, MD, PhD (ORSI/FDA), Paul Kluetz, MD (OCE/FDA), Gideon (Scott) Gordon, PhD (CDER/FDA)
Status: Active

Project #50: The Effect of Excipients on the Oral Absorption of Fexofenadine in Humans

CERSI Principal Investigator: Katherine Yang, PharmD, MPH (UCSF)
FDA Collaborators: Lei Zhang, PhD (CDER/FDA), Eleftheria Tsakalozou, PhD (CDER/FDA)
Status: Active

Project #77: Large Language Models to Support Bioequivalence Evaluation

CERSI Principal Investigators: Russ Altman (Stanford)
FDA Collaborators: Liang Zhao (OGD), Meng Hu (OGD)
Status: Active

Project #81: Comprehensive surfaceome target discovery in Osteosarcoma

CERSI Principal Investigators: Jim Wells, PhD (UCSF)
FDA Collaborators: Jeff Summers (CDER), Wenming Xiao (CDER), Martha Donoghue (CDER), Kristin Wessel (CDER), Mike Norcross (CDER), Li-Rong Yu (NCTR), Rebekah Zinn (OCE)
Status: Active

Project #82: Real-World Data to Improve Diversity and Inclusion of Participants in Randomized Controlled Trials and Evidence for Post-Market Safety and Effectiveness of Targeted Therapies in Oncology for Equitable Decision Making

CERSI Principal Investigators: Rohit Vashisht, PhD (UCSF)
Status: Active

 

Completed Projects
Project #1: Improving the Efficiency and Rigor of Pharmacovigilance at FDA

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Steve Anderson, PhD, MPP (CBER/FDA), Robert Ball, MD, MPH (CDER/FDA), Ruth Barratt, PhD, DVM (CDER/FDA), Mitra Rocca, Dipl Inform Med (CDER/FDA), Carol Pamer, RPh, MPH (CDER/FDA), Scott Proestel, MD (CDER/FDA)
Status: Completed | Plain Language Summary

Project #2: Improving the Diagnostic Accuracy of ADR Signal Detection by Combining Signals from Spontaneous Reports and Electronic Health Records

CERSI Principal Investigator: Nigam Shah, MBBS, PhD (Stanford)
FDA Collaborators: Ruth Barratt, PhD, DVM (CDER/FDA), Henry Francis, MD (CDER/FDA), Ana Szarfman, MD, PhD (CDER/FDA), Isaac Chang, MD, PhD (CDRH/FDA), Joseph Tonning, MD (CDER/FDA), Robert Ball, MD, MPH (CDER/FDA), Mitra Rocca, Dipl Inform Med (CDER/FDA
Status: Completed

Project #10: OneSource Phase I: Source Data Capture from Electronic Health Records (EHRs) - Using Standardized Clinical Research Data

CERSI Principal Investigator: Laura Esserman, MD, MBA (UCSF)
FDA Collaborators: Mitra Rocca, Dipl Inform Med (CDER/FDA), Ronald Fitzmartin, PhD, MBA (CDER/FDA), Fatima Frye (CDER/FDA), MaryAnne Slack (CDER/FDA)
Status: Completed | Plain Language Summary

Project #15A: Chemoinformatic Tools to Predict the Effects of Excipients in Generic Drugs

CERSI Principal Investigator: Brian Shoichet, PhD (UCSF)
FDA Collaborators: Andrew Babiskin, PhD (CDER/FDA), Robert Dorsam, PhD (CDER/FDA), Victoria Keck, MHA (CDER/FDA), Zhanglin Ni, PhD (CDER/FDA), Eleftheria Tsakalozou, PhD (CDER/FDA), Liang Zhao, PhD (CDER/FDA), Susan Zuk, MS (CDER/FDA)
Status: Completed | Excipient Browser | Usage Statistics of Excipient Browser | Plain Language Summary

Project #15B: Effects of Excipients in Generic Drugs on Intestinal Drug Transporters

CERSI Principal Investigator: Kathy Giacomini, PhD (UCSF)
FDA Collaborators: Andrew Babiskin, PhD (CDER/FDA), Sruthi King, PhD (CDER/FDA), Zhanglin Ni, PhD (CDER/FDA), Eleftheria Tsakalozou, PhD (CDER/FDA), Liang Zhao, PhD (CDER/FDA), Susan Zuk, MS (CDER/FDA)
Status: Completed | Plain Language Summary

Project #19: Use of natural language processing/machine learning to analyze medication error reports and improve the quality of data submitted to the FDA Adverse Event Reporting System (FAERS)

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Sonja Brajovic, MD (CDER/FDA), Todd Bridges, RPh (CDER/FDA), Carol Pamer, RPh, MPH (CDER/FDA), Jim Schlick, RPh, MBA (CDER/FDA), Jo Wyeth, PharmD (CDER/FDA)
Status: Completed

Project #20: Gut Microbiome: Knowledge Synthesis

CERSI Principal Investigator: Peter Turnbaugh, PhD (UCSF)
FDA Collaborators: Roselie Bright, ScD, MS, PMP (OHI/FDA), Elaine Johanson (OHI/FDA)
Status: Completed

Project #21: Developing an Operational Framework for Defining the Strength of Evidence in Therapeutic Development

CERSI Principal Investigator: Steve Goodman, MD, MHS, PhD (Stanford)
FDA Collaborators: Telba Irony, PhD (CBER/FDA), Tom Permutt, PhD (CDER/FDA), Estelle Russek-Cohen, PhD (CDER/FDA)
Status: Completed

Project #30: Healthy Citizen Hospital Pilot

CERSI Principal Investigator: Ida Sim, MD, PhD (UCSF)
FDA Collaborators: Elaine Johanson (OHI/FDA), Ameeta Parekh, PhD (CDER/FDA)
Status: Completed

Project #31: Multi-organ Microphysiological Systems for Modeling Clinical Drug Effects

CERSI Principal Investigators: Kevin Healy, PhD (UC Berkeley), Edward Hsiao, MD, PhD (UCSF)
FDA Collaborators: Alexandre Ribeiro, PhD (CDER/FDA), David Strauss, MD, PhD (CDER/FDA)
Status: Completed

Project #47: Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

CERSI Principal Investigator: Sook Wah Yee, PhD (UCSF)
FDA Collaborators: Shiew Mei Huang, PhD (CDER/FDA), Qi Liu, PhD (CDER/FDA), Lei Zhang, PhD (CDER/FDA)
Status: Completed

Project #48: Data Science Methods for Post-Marketing Surveillance of AI Diagnostic Tools and Algorithm-Based Therapeutics

CERSI Principal Investigator: Daniel Rubin, MD, MS (Stanford)
FDA Collaborators: Qi Liu, PhD, MStat, FCP (CDER/FDA), Yaning Wang, PhD, MStat (CDER/FDA), Hao Zhu, PhD, MStat (CDER/FDA), M. Khair ElZarrad PHD, MPH (CDER/FDA), Matthew Diamond, MD, PhD (CDRH/FDA)
Status: Completed

Project #69: Effects of Antioxidants in Drugs Products on Intestinal Drug Transporters
CERSI Principal Investigators: Sook Wah Yee, PhD (UCSF), Deanna Kroetz, PhD (UCSF) (Co-PI)
FDA Collaborators: Liang Zhao, PhD (CDER/OGD/FDA), Lei Zhang, PhD (CDER/OGD/FDA), Khondoker Alam, PhD (CDER/OGD/FDA)
Status: Completed

Project #73: Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Pediatric Patients with Increased Skin Pigmentation

CERSI Principal Investigator: Christopher Almond (Stanford), Chandra Ramamoorthy (Stanford)
FDA Collaborators: Nilsa Loyo-Berrios, PhD (CDRH/FDA), Malvina Eydelman, MD (CDRH/FDA), Rebecca Torguson, MPH (CDRH/FDA), Christine Merenda (OMHHE/FDA), Allison O'Neill, PhD (CDRH/FDA), Gene Pennello, PhD (CDRH/FDA), Rebecca Ward, PhD (CDRH/FDA), Vasum Peiris, MD, (CDRH/FDA), Michelle Tarver, MD, PhD (CDRH/FDA), Damia Jackson (CDRH/FDA)
Status: Active | Plain Language Summary

Project #78: Improving the Integrity of Novel Digital Health Technology-Derived Endpoints Through Rigorous Simulation Studies of Multiple Imputation

CERSI Principal Investigator: Manisha Desai (Stanford)
FDA Collaborators: Maria Matilde Kam (CDER), Andrew Potter (CDER), Paul Schuette (CDER), Lili Garrard (CDER)
Status: Active

Project #83: Pathogen reduction of whole blood using silicon nanopore membrane-based filtration system (SNM-FS)

CERSI Principal Investigator: Shuvo Roy (UCSF)
FDA Collaborators: Carlos Villa (CBER), David McGivern (CBER)
Status: Active

 

Completed Projects
Project #8: Spinal Orthopedic Device Mechanics

CERSI Principal Investigator: Jeffrey Lotz, PhD (UCSF)
FDA Collaborators: Anton Dmitriev, PhD (CDRH/FDA), Srinidhi Nagaraja, PhD (CDRH/FDA), Jonathan Peck, MS (CDRH/FDA)
Status: Completed | Plain Language Summary

Project #26: Developing Frameworks and Tools for Integration of Digital Health Tools into Clinical Practice

CERSI Principal Investigator: Andrew Auerbach, MD (UCSF)
FDA Collaborators: Bakul Patel, MS, MBA (CDRH/FDA), Vinay Pai, PhD (CDRH/FDA)
Status: Completed

Project #34: Development and Evaluation of Computational Test Methods Leveraging Real-world and Simulated Datasets for Predictive Medical Device Alarm Algorithms

CERSI Principal Investigator: Xiao Hu, PhD (UCSF)
FDA Collaborators: Christopher Scully, PhD (CDRH/FDA)
Status: Completed

Project #35: Advancing Computational Modeling in the Regulatory Evaluation of Spinal Fusion Cages

CERSI Principal Investigator: Jeffrey Lotz, PhD (UCSF)
FDA Collaborators: Anton Dmitriev, PhD (CDRH/FDA), Andrew Baumann, PhD (CDRH/FDA)
Status: Completed

Project #25: Development of Thrombogenicity Testing Methods for Medical Devices with Large Blood-Contacting Surfaces

CERSI Principal Investigator: Shuvo Roy, PhD (UCSF)
FDA Collaborators: Qijin Lu, PhD (CDRH/FDA), Megan Jamiolkowski, PhD (CDRH/FDA), Richard Malinauskas, PhD (CDRH/FDA)
Status: Completed

Project #58: Safe Algorithmic Change Protocols for Modifications to AI/ML-Based Software as a Medical Device

CERSI Principal Investigator: Jean Feng, PhD (UCSF)
FDA Collaborators: Berkman Sahiner, PhD (CDRH/FDA), Alexej Gossmann, PhD, CDRH/FDA)
Status: Completed

Project #59: Identification of Pacemaker and Implantable Cardioverter-Defibrillator Lead Failure Using Remote Monitoring Data

CERSI Principal Investigator: Sanket Dhruva, MD, MHS (UCSF)
FDA Collaborators: Hetal Odobasic, MS (CDRH/FDA), Li Wang, PhD, MBA, MS (CDRH/FDA), Jacqueline M. Major, PhD (CDRH/FDA)
Status: Completed

Project #65: The Digital Variome: Understanding the Implications of Digital Tools on Health

CERSI Principal Investigator: Andrew Auerbach, MD (UCSF)
FDA Collaborators: Leeda Rashid, MD, MPH (CDRH/FDA), Anindita Saha, (CDRH/FDA), Bakul Patel, MS, MBA (CDRH/FDA), Cathy Bahr (CDRH/FDA), Vinay Pai, PhD (CDRH/FDA), Arti Tandon, PhD (CDRH/FDA), JiPing Chen, MD, PhD (CDRH/FDA), Charles Yongpravat (CDRH/FDA), Aubrey Shick, MS (CDRH/FDA)
Status: Completed

Project #66: Post-Market Evaluation of Smartwatch Cardiovascular Notifications

CERSI Principal Investigator: Nigam Shah, MBBS, PhD (Stanford)
FDA Collaborators: Anindita Saha (CDRH/FDA), Bakul Patel, MS, MBA (CDRH/FDA), MiRa Jacobs, PhD (CDRH/FDA), Vinay Pai, PhD (CDRH/FDA), Aubrey Shick, MS (CDRH/FDA), Gloria Nyankima, PhD, (CDRH/FDA), Jessica Paulsen (CDRH/FDA), Kan Fang, MD (CDRH/FDA),,Charlie Yongpravat (CDRH/FDA)
Status: Completed

Project #70: Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients

CERSI Principal Investigator: Philip Bickler, MD (UCSF), Michael Lipnick, MD (UCSF)
FDA Collaborators: Nilsa Loyo-Berrios, PhD (CDRH/OPEQ/OCEA/FDA), Malvina Eydelman, MD (CDRH/OPEQ/OHT1/FDA), Rebecca Torguson, MPH (CDRH/OPEQ/OHT1/FDA), Christine Merenda (OMHHE/FDA)
Status: Completed | Plain Language Summary

Project #40: Characterizing Risk-Benefit Tradeoff in Opioid-based Chronic Pain Treatment

CERSI Principal Investigator: Sean Mackey, MD, PhD (Stanford)
FDA Collaborators: Michelle Tarver, MD, PhD (CDRH/FDA), Anindita Saha (CDRH/FDA), David Gebben, PhD (CDRH/FDA), Heather Benz, PhD (CDRH/FDA)
Status: Active

Project #63: Development, Implementation, and Evaluation of an Open Source Software Program to Support Patient-based Estimation of Clinically Meaningful Levels and Change Scores for Patient Reported Outcome Measures

CERSI Principal Investigator: Sean Mackey, MD, PhD (Stanford)
FDA Collaborators: Fraser Bocell, PhD (CDRH/OST/FDA), Michelle Tarver, MD, PhD (CDRH/FDA), Allen Chen, PhD (CDRH/FDA)
Status: Active

 
Completed Projects
Project #14: Patient Reported Outcomes for Minimally Invasive Glaucoma Surgery (MIGS)

CERSI Principal Investigator: Kuldev Singh, MD, MBA (Stanford)
FDA Collaborators: Malvina Eydelman, MD (CDRH/FDA) Michelle Tarver, MD, PhD (CDRH/FDA)
Status: Completed | Plain Language Summary

Project #17: Comparing Qualitative and Quantitative Approaches for Eliciting Patient Preference on Upper Limb Prostheses: A Case Study on Innovative Upper Limb Prostheses

CERSI Principal Investigator: Leslie Wilson, PhD (UCSF)
FDA Collaborators: Eugene Civillico, PhD (CDRH/FDA), Telba Irony, PhD (CBER/FDA), Xuefeng Li, PhD (CDRH/FDA), Anindita Saha (CDRH/FDA)
Status: Complete | Plain Language Summary

Project #18: Mapping a Better Approach to Obtaining Pediatric Patient Preferences

CERSI Principal Investigator: Korey Hood, PhD (Stanford)
FDA Collaborators: Heather Benz, PhD (CDRH/FDA), Martin Ho, MSc (CDRH/FDA), Vasum Peiris, MD, MPH (CDRH/FDA), Anindita Saha (CDRH/FDA)
Status: Complete

Project #28: The Impact of Race and Ethnicity on Responses to Heart Failure Patient-Reported Outcome Measures

CERSI Principal Investigator: Courtney Lyles, PhD (UCSF), Urmimala Sarkar, MD, MPH (UCSF)
FDA Collaborators: Fraser Bocell, PhD (CDRH/FDA), Michelle Tarver, MD PhD (CDRH/FDA), Brittany Caldwell, PhD (CDRH/FDA), Annie Saha (CDRH/FDA), Martin Ho, MSc (CDRH/FDA)
Status: Complete

Project #29: Adapting a Measure of Heart Failure to an Adolescent Population

CERSI Principal Investigator: Christopher Almond, MD, MPH (Stanford)
FDA Collaborators: Fraser Bocell, PhD (CDRH/FDA), Vasum Peiris, MD, MPH (CDRH/FDA), Michelle Tarver, MD, PhD (CDRH/FDA), Brittany Caldwell, PhD (CDRH/FDA), Anindita Saha (CDRH/FDA), Martin Ho, MSc (CDRH/FDA)
Status: Completed

Project #51: Assessment of Patient Tolerance for Risk Associated with High Intensity Focused Ultrasound (HIFU) for the Ablation of Prostate Tissue

CERSI Principal Investigator: Geoffrey Sonn, MD (Stanford)
FDA Collaborators: Charles Viviano, MD, PhD (CDRH/FDA), David Gebben, PhD (CDRH/FDA), Olufemi Babalola, MSc, MHS (CDRH/FDA)
Status: Complete

Project #45: HIV Genomic Surveillance in Cameroon by Next-Generation Sequencing

CERSI Principal Investigator: Charles Chiu, MD, PhD (UCSF)
FDA Collaborators: Indira Hewlett, PhD (CBER/FDA)
Status: Active

Project #62: Assessing the Potential for Patient-Specific and Genome Edited Induced Pluripotent Cell-Based Models to Streamline Clinical Drug Development for Rare Diseases

CERSI Principal Investigator: Joseph Wu, PhD (Stanford)
FDA Collaborators: David Strauss, MD, PhD (CDER/OTS/OCP/FDA), Alexandre Ribeiro, PhD (CDER/FDA), Rodney Rouse, DVM (CDER/OTS/OCP/FDA), Kevin Ford, PhD (CDER/FDA)
Status: Active

Project #72: Identify Genotype-Phenotype and Pharmacogenetic Association Using a Population-scale Cellular Platform

CERSI Principal Investigator: Joseph Wu, MD, PhD (Stanford)
FDA Collaborators: David Strauss (CDER/FDA), Kevin Ford (CDER/FDA), Dylan Bruckner (CDER/FDA)
Status: Active

Project #74: Role of Genomic Ancestry in Tyrosine Kinase Inhibitor-Induced Cardiotoxicity

CERSI Principal Investigator: Joseph Wu, MD, PhD (Stanford)
FDA Collaborators: Laleh Amiri-Kordestani (CDER/FDA), Kevin Ford (CDER/FDA), Margret Merino (CDER/FDA) , Julie Schneider (OCE/FDA)
Status: Active

Project #80: Utilizing neomer signatures in circulating tumor DNA to detect early stage epithelial ovarian cancer

CERSI Principal Investigator: Nadav Ahitiv, PhD (UCSF)
Status: Active

 

Completed Projects
Project #16A: Precision Medicine Initiative

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Elaine Johanson (OHI/FDA)
Status: Completed | Plain Language Summary

Project #16B: Next Generation Text Analytics for FDA-Relevant Text Mining

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Roselie Bright, ScD (OHI/FDA), Larry Callahan, PhD (OHI/FDA), Elaine Johanson (OHI/FDA), Frank Switzer, PhD (OHI/FDA)
Status: Completed | Plain Language Summary

Project #16E: Role of Ancestry in Genetic Diagnostics

CERSI Principal Investigator: Snehit Prabhu, PhD (Stanford)
FDA Collaborators: Adam Berger, PhD (CDRH/FDA), Roselie Bright, ScD, MS, PMP (OHI/FDA), Elaine Johanson (OHI/FDA), Samir Lababidi, PhD (OHI/FDA), David Litwack, PhD (CDRH/FDA), Zivana Tezak, PhD (CDRH/FDA)
Status: Completed

Project #16F: Causes of Real-Life NGS Variability

CERSI Principal Investigator: Dmitri Petrov, PhD (Stanford)
FDA Collaborators: Elaine Johanson (OHI/FDA)
Status: Completed

Project #24: Network Integration for Precision Medicine Drug Models

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Michael Pacanowski, PharmD, MPH (CDER/FDA), Anuradha Ramamoorthy, PhD (CDER/FDA), Oluseyi Adeniyi, PhD (CDER/FDA)
Status: Completed

Project #36: Evaluation of the impact of Genetic Variability on Drug Target Interactions using Structural Bioinformatics

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Michael Pacanowski, PharmD, MPH (CDER/FDA), Oluseyi Adeniyi, PhD (CDER/FDA), Paula Hyland, PhD (CDER/FDA), Ellis Christopher, PhD (CDER/FDA), Rosane Charlab Orbach, PhD (CDER/FDA), Robert Schuck, PhD (CDER/FDA)
Status: Completed

Project #42: TOBIAS – A Clinical Decision Support tool to Personalize NGS Diagnostic Test Results based on Genetic Ancestry

CERSI Principal Investigator: Snehit Prabhu, PhD (Stanford)
FDA Collaborators: Elaine Johanson (OHI/FDA), Zivana Tezak, PhD (CDRH/FDA), Richardae Araojo, PharmD (OMHHE/FDA), Christine Lee, PharmD, PhD (OMHHE/FDA)
Status: Completed

Project #43: HYDRA – A Federated Computational Infrastructure to Enable Inclusive, Large-scale Precision Medicine Studies

CERSI Principal Investigator: Snehit Prabhu, PhD (Stanford)
FDA Collaborators: Elaine Johanson (OHI/FDA), Zivana Tezak, PhD (CDRH/FDA), Richardae Araojo, PharmD (OMHHE/FDA), Christine Lee, PharmD, PhD (OMHHE/FDA)
Status: Completed

Project #49: Identifying Genetic Mechanisms of Doxorubicin-Induced Cardiotoxicity

CERSI Principal Investigator: Joseph Wu, MD, PhD (Stanford)
FDA Collaborators: Bridget Nugent, PhD (OWH/FDA), Alexandre Ribeiro, PhD (CDER/DARS/FDA)
Status: Completed

Project #75: Whole exome sequencing in patients on immune checkpoint inhibitors to risk stratify for treatment response and immune related adverse events

CERSI Principal Investigator: Elad Ziv, MD (UCSF)
FDA Collaborators: Marc Theoret (OCE/FDA), Julie Schneider (OCE/FDA), Wenming Xiao (CDER/FDA), Maitreyee Hazarika (CDER/FDA)
Status: Completed

Project #54: Creating a Framework for a National Adaptive Platform Trial to Evaluate Pediatric Medical Devices

CERSI Principal Investigator: Christopher Almond, MD, MPH (Stanford)
FDA Collaborators: Vasum Peiris, MD, MPH (CDRH/FDA), Brittany Caldwell, PhD (CDRH/FDA)
Status: Active

Project #79: Understanding Female-Specific Treatment Outcomes of Inflammatory Bowel Disease Using Novel Artificial Intelligence Tools

CERSI Principal Investigator: Vivek Rudrapatna, MD (UCSF)
FDA Collaborators: Artur Belov (CBER), Melissa Shapiro (CDER), Zhihua Li (CDER), Laurén Doamekpor (OWH), Susan Bersoff-Matcha (OWH), Kaveeta Vasisht (OWH), Joyce Obidi (OWH)
Status: Active

 

Completed Projects
Project #3: Renal Impairment in New Drug Development

CERSI Principal Investigator: Kathy Giacomini, PhD (UCSF), Timothy Meyer, MD (Stanford)
FDA Collaborators: Ruth Barratt, PhD, DVM (CDER/FDA), Lei Zhang, PhD (CDER/FDA), Shiew Mei Huang, PhD (CDER/FDA), Issam Zineh, PharmD, MPH (CDER/FDA), Ming-Liang Tan, PhD (CDER/FDA)
Status: Completed | Plain Language Summary

Project #13: Safer Labeling of Pediatric Medications: Reducing Literacy-related Health Disparities among Chronically Ill Adolescents

CERSI Principal Investigator: Lee Sanders, MD (Stanford), Bonnie Halpern-Felsher, PhD (Stanford)
FDA Collaborators: Christine Lee, PharmD, PhD (OMHHE/FDA), Richardae Araojo, PharmD, MS (OMHHE/FDA), Shelly Harris, MPH (CDER/FDA), Grace Jones, PharmD (CDER/FDA), Martin Mendoza, PhD (OMHHE/FDA), Amanda Pike-McCrudden, MAA (CDER/FDA), Lee Zwanziger (OC/FDA)
Status: Completed

Project #23: Predicting Pediatric Dosing for Medical Countermeasures

CERSI Principal Investigator: Sook Wah Yee, PhD (UCSF)
FDA Collaborators: Shiew Mei Huang, PhD (CDER/FDA), Lei Zhang, PhD (CDER/FDA)
Status: Completed

Project #37: Comprehensive Assessment of Sex Differential Smoking-related Effects in Publicly Available Gene Expression Data

CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Bridget Nugent, PhD (OWH/FDA), Susan Bersoff-Matcha, MD (OWH/FDA), Patricia Bradfield (OWH/FDA), Kaveeta Vasisht, MD, PharmD (OWH/FDA), Ryan Conville (OWH/FDA), Jonathan Kwan, MS (OTP/FDA)
Status: Completed | Plain Language Summary

Project #46: Characterizing Population-Specific Clinical Asthma Profiles

CERSI Principal Investigator: Esteban Burchard, MD, MPH (UCSF)
FDA Collaborators: Richardae Araojo, PharmD (OMHHE/FDA)
Status: Completed

Project #52: Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients

CERSI Principal Investigator: Urmimala Sarkar, MD, MPH (UCSF), Courtney Lyles, PhD (UCSF)
FDA Collaborators: Richardae Araojo, PharmD, MS (OMHHE/FDA), Christine Lee, PharmD, PhD (OMHHE/FDA), Michelle Tarver, MD, PhD (CDRH/FDA)
Status: Completed

Project #57: Renal Impairment in New Drug Development: Phase II

CERSI Principal Investigator: Timothy Meyer, MD (Stanford)
FDA Collaborators: Shiew Mei Huang, PhD (CDER/FDA), Lei Zhang, PhD (CDER/FDA), Qi Liu, PhD (CDER/FDA)
Status: Completed

Project #64: The MUM study: MUltimorbidity and Medications: The Unheard Perspective of Older Adults

CERSI Principal Investigator: Janice Schwartz, MD (UCSF)
FDA Collaborators: Qi Liu, PhD, MStat (CDER/OCP/FDA), Shiew-Mei Huang, PhD (CDER/OCP/OTS/FDA)
Status: Completed

Project #71: The MUM-URMA1 study: Multimorbidity and Medications: The Unheard Perspective of Older Under-Represented Racial and Ethnic Minority Adults - Phase 1

CERSI Principal Investigator: Janice Schwartz, MD (UCSF)
FDA Collaborators: Christine Lee, PharmD, PhD (OMHHE/FDA), Qi Liu, PhD, MStat (CDER/OCP/FDA)
Status: Completed

Completed Projects
 
Project #53: A Rapid Query Model to Address Prioritized COVID-19 Questions Using EHR Data

CERSI Principal Investigator: Atul Butte, MD, PhD (UCSF)
FDA Collaborators: Amy Abernethy, MD, PhD (OC/FDA)
Status: Completed

Project #55: OneSource: SMART on FHIR for I-SPY COVID-19 Trial

CERSI Principal Investigator: Laura Esserman, MD, MBA (UCSF)
FDA Collaborators: Mitra Rocca, Dipl. Inform. Med. (CDER/FDA), Jacqueline Corrigan-Curay, JD, MD (CDER/FDA), Dianne Paraoan (CDER/FDA), Vishal Bhatnagar, MD (OCE/FDA), Frank Weichold, MD, PhD (ORSI/FDA)
Status: Completed

Project #56: OneSource Phase III: Demonstration of EHR/eCRF Integration in the COVID-19 Critical Care Environment

CERSI Principal Investigator: Laura Esserman, MD, MBA (UCSF)
FDA Collaborators: Mitra Rocca, Dipl. Inform. Med. (CDER/FDA), Jacqueline Corrigan-Curay, JD, MD (CDER/FDA), Dianne Paraoan (CDER/FDA), Vishal Bhatnagar, MD (OCE/FDA), Frank Weichold, MD, PhD (ORSI/FDA)
Status: Completed

Project #61: Learning Real-World Sex-Specific Clinical Factors Influencing the Susceptibility to Infection, Immune Response, Treatment Utilization and Outcomes Among Individuals Infected with SARS-CoV-2 Infection

CERSI Principal Investigator: Rohit Vashisht, PhD (UCSF)
FDA Collaborators: Bridget Nugent, PhD (OWH/FDA), Kaveeta Vasisht, MD, PharmD (OWH/FDA), Susan Bersoff-Matcha, MD (OWH/FDA), Osman Yogurtcu, PhD (CBER/FDA), Yong Ma, PhD (CDER/FDA), Andrew Giffin, PhD (CDER/FDA) , Shuang (Sarah) Zhou, PhD (CDER/FDA)
Status: Completed | Plain Language Summary

Project #76: The Real-World Effectiveness of COVID-19 Vaccines in the Pediatric Population Across the University of California Health System

CERSI Principal Investigator: Atul Butte, MD, PhD (UCSF), Kendra Radtke, PharmD, PhD (UCSF)
FDA Collaborators: Steven Anderson (CBER/FDA), Yun Lu (CBER/FDA), Artur Belov (CBER/FDA), Barbee Whitaker (CBER/FDA), Richard Forshee (CBER/FDA), Angela Moy (CBER/FDA), Chartrina Andrell (CBER/FDA)
Status: Completed

Project #68: Real-World Population Characteristics, Safety and Effectiveness of COVID-19 Vaccines

CERSI Principal Investigator: Atul Butte, MD, PhD (UCSF)
FDA Collaborators: Barbee Whitaker, PhD (CBER/OBE/FDA), Artur Belov, PhD (CBER/OBE/FDA), Hussein Ezzeldin, PhD (CBER/OBE/FDA), Steve Anderson, PhD (CBER/OBE/FDA), Jane Mutanga, PhD (CBER/FDA)
Status: Completed