Research

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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. Particular attention is paid to research involving computational methods to integrate vast and multiple data sets in the evaluation of therapies that will lead to better quality and safer medical products for the health of the public.

Funding for collaborative science

The UCSF-Stanford CERSI will fund collaborative research projects that focus on “unmet needs” in regulatory science. A broad net will be cast to define the most critical problems in regulatory science that can be solved through collaborative research efforts; the center will fund research that addresses the most critical problems. Complementing the research program funded by the FDA is an Innovation in Regulatory Sciences Award from the Burroughs Wellcome Fund. This award is focused on using systems pharmacology approaches to identify the targets and mechanisms for drug-induced obesity, a major adverse event for many drugs including many neuropsychiatric agents.

A copy of our Procedures for Initiating Collaborative Research Projects can be found here: PDF iconResearchGuidelines.pdf

Research Pilot Project Name Lead Scientist AT UCSF & Stanford University                    

FDA Collaborators                                                                                             

1. Improving Efficiency and Rigor of Pharmacovigilance at FDA

Russ Altman, MD, PhD (Stanford)

Ruth Barratt, PhD, DVM, CDER/FDA

Robert Ball, MD, MPH, CDER/FDA

Steve Anderson, PhD, MPP, CBER/FDA

Mitra Rocca, PhD, CDER/FDA

Carol Pamer, RPh, MPH, CDER/FDA

Scott Prostel, MD, CDER/FDA

     
2. Precision Medicine Initiative Russ Altman, MD, PhD (Stanford)

Taha Kass-Hout, MD, MS, OITI, OIMT/FDA

Elaine Johanson, OHI/FDA

     
3. Role of Ancestry in Genetic Diagnostics Snehit Prabhu, PhD (Stanford)

Taha Kass-Hout, MD, MS, OITI, OIMT/FDA

Elaine Johanson, OHI/FDA

Roselie Bright, ScD, OHI/FDA

Zivana Tezak, PhD, CDRH/FDA

David Litwack, PhD, CDRH/FDA

Adam Berger, PhD, CDRH/FDA

Samir Lababidi, PhD, OHI/FDA

     
4. Causes of Real-Life NGS Variability Dmitri Petrov, PhD (Stanford) Taha Kass-Hout, MD, MS, OITI, OIMT/FDA
     
5. Next Generation Text Analytics for FDA-Relevant Text Mining Russ Altman, MD, PhD (Stanford)

Taha Kass-Hout, MD, MS, OITI, OIMT/FDA

Elaine Johanson, OHI/FDA

     
6. Renal Impairment in New Drug Development

Kathy Giacomini, PhD (UCSF)

Timothy Meyer, MD (Stanford)

Ruth Barratt, PhD, DVM, CDER/FDA

Lei Zhang, PhD, CDER/FDA

Shiew Mei Huang, PhD, CDER/FDA

Issam Zineh, PharmD, MPH, CDER/FDA

Kenta Yoshida, PhD, CDER/FDA

     
7. Effects of Excipients in Generic Drugs Products on Intestinal Drug Transporters

Kathy Giacomini, PhD (UCSF)

Robert Lionberger, PhD, CDER/FDA

Liang Zhao, PhD, CDER/FDA

Susan Zuk, PhD, CDER/FDA

Ni Zhanglin, PhD, CDER/FDA

Stephanie Choi, PhD, CDER/FDA

Eleftheria Tsakalozou, PhD, CDER/FDA

   

 

(Link takes you to the Excipient Browser, a new research tool to help investigate and improve these important substances. URL is http://excipients.ucsf.bkslab.org)

Brian Shoichet, PhD (UCSF)

Robert Lionberger, PhD, CDER/FDA

Ni Zhanglin, PhD, CDER/FDA

Andrew Babiskin, PhD, CDER/FDA

Stephanie Choi, PhD, CDER/FDA

Eleftheria Tsakalozou, PhD, CDER/FDA

     
9. Spinal Orthopedic Device Mechanics Jeff Lotz, PhD (UCSF)

Anton Dmitriev, PhD, CDRH/FDA

Srinidhi Nagaraja, PhD, CDRH/FDA

Jonathan Peck, MS, CDRH/FDA

     
10. OneSource Laura Esserman, MD, MBA (UCSF)

MaryAnne Slack, CDER/FDA

Ronald Fitzmartin, PhD, MBA, CDER/FDA

Mitra Rocca, PhD, CDER/FDA

     
11. Improving the Diagnostic Accuracy of ADR Signal Detection Nigam Shah, MBBS, PhD (Stanford)

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, PhD, CDER/FDA

     
12. Single Cell Mass Cytometry Based Assessment of MSCs Sean Bendall, PhD (Stanford) Steven Bauer, PhD, CBER/FDA
     
13. Safer Labeling of Pediatric Medications

Lee Sanders, MD (Stanford)

Bonnie Halpern-Felsher, PhD (Stanford)

Amanda Pike-McCrudden, MAA, CDER/FDA

Jonca Bull, MD, OMH/FDA

Martin Mendoza, PhD, OMH/FDA

     
14. Patient Reported Outcomes for Minimally Invasive Glaucoma Surgery

Kuldev Singh, MD (Stanford)

Tianjing Li, MD, PhD (JHU)

Kay Dickerson, PhD (JHU)

Malvina Eydelman, MD, CDRH/FDA

Michelle Tarver, MD, PhD, CDRH/FDA

     

15. Comparing Qualitative and Quantitative Approaches to Eliciting Patient Preferences on Upper Limb Prostheses

Leslie Wilson, PhD (UCSF)

Heather Benz, PhD, CDRH/FDA

Eugene Civilico, PhD, CDRH/FDA

Martin Ho, MSc, CDRH/FDA

Telba Irony, PhD, CBER/FDA

Xuefeng Li, PhD, CDRH/FDA

Anindita Saha, CDRH/FDA

     
16. Mapping a Better Approach to Obtaining Pediatric Patient Preferences Korey Hood, PhD (Stanford)

Vasum Peiris, MD, MPH, CDRH/FDA

Heather Benz, PhD, CDRH/FDA

Martin Ho, MSc, CDRH/FDA

Anindita Saha, CDRH/FDA

     
17. Use of NLP/Machine Learning to Analyze Medication Error Reports Russ Altman, MD, PhD (Stanford)

Jo Wyeth, PharmD, CDER/FDA

Jim Schlick, RPh, MBA, CDER/FDA

Todd Bridges, RPh, CDER/FDA

Sonja Brajovic, MD, CDER/FDA

Carol Pamer, RPh, MPH, CDER/FDA

Research environment of UCSF and Stanford

The center’s collaborative research unit engages top-tier researchers at UCSF and Stanford University to apply modern methods to problems in regulatory science.

Historically, UCSF has been the premier institution in quantitative pharmacology as it relates to drug discovery and development. UCSF pioneered pharmacokinetics and pharmacodynamics and computational drug discovery, which are used commonly in regulatory science. UCSF has continued to lead the pharmacological sciences with internationally renowned faculty members in pharmacogenomics, chemoinformatics, disease modeling, imaging and high throughput methodologies, and by forging strong research programs relevant to the discovery and development of therapeutics. The California Institute for Quantitative Biosciences-UCSF (QB3-UCSF) provides a home and resources for the recruitment of exceptional new faculty with quantitative skills.

Stanford University features a world-class Stanford Center for Biomedical Informatics Research, which recently pioneered the use of internet query logs, population health databases (e.g., FDA AERS Database), and electronic medical records from hospitals to identify adverse drug events and drug interactions.

Collaborations among Stanford University and UCSF scientists and the FDA are already under way for using new informatics methods for data fusion to construct safety profiles of drugs and for developing quantitative models to predict drug levels in the central nervous system. The collaborative research projects include a pilot project funding mechanism.

Current Awardees

Please make sure to acknowledge the funding source for your project by including the following statement: "This publication/poster was made possible by Grant Number U01FD004979 from the FDA, which supports the UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA."