Research
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Overview
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.
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. 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.
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.
We especially encourage UCSF investigators working with clinical trials to utilize the UCSF Research Action Group for Equity (RAGE) program, which provides support and infrastructure for UCSF researchers to diversify their study populations. RAGE provides consultations on how to partner directly with special populations to remove barriers and increase research participation, and can also help with recruitment support.
For Current Awardees - Acknowledgment of Funding Source(s). Please make sure to acknowledge the funding source(s) for your project by including the following statement:
This publication/poster was made possible by Grant Number U01 FD004979 / U01 FD005978 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.
In your statement also include: a. the percentage and dollar amount of the total costs of the program or project funded with federal money; and b. the percentage and dollar amount of the total costs of the project or program funded by non-governmental source.
Project List
UCSF-Stanford CERSI has supported 75 collaborative research projects between UCSF/Stanford faculty and FDA scientists.
Click on a category below to jump to those projects.
Biologics
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: Active
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: Active
CERSI Principal Investigator: Ngan Huang, PhD (Stanford)
FDA Collaborators: Kyung Sung, PhD (CBER/FDA)
Status: Active
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
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
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
CERSI Principal Investigator: Matthew Porteus, MD, PhD (Stanford)
FDA Collaborators: Zhaohui Ye, PhD (CBER/FDA)
Status: Completed
CERSI Principal Investigator: Eric Kool, PhD (Stanford)
FDA Collaborators: Jaroslav Vostal, MD, PhD (CBER/FDA), Chintamani Atreya,PhD (CBER/FDA)
Status: Completed
CERSI Principal Investigator: Sean Bendall, PhD (Stanford)
FDA Collaborators: Steven Bauer, PhD (CBER/FDA)
Status: Completed
Drugs
CERSI Principal Investigators: Russ Altman (Stanford)
FDA Collaborators: Liang Zhao (OGD), Meng Hu (OGD)
Status: Active
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: Active
CERSI Principal Investigator: Katherine Yang, PharmD, MPH (UCSF)
FDA Collaborators: Lei Zhang, PhD (CDER/FDA), Eleftheria Tsakalozou, PhD (CDER/FDA)
Status: Active
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: Active
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
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
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
CERSI Principal Investigator: Ida Sim, MD, PhD (UCSF)
FDA Collaborators: Elaine Johanson (OHI/FDA), Ameeta Parekh, PhD (CDER/FDA)
Status: Completed
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
CERSI Principal Investigator: Peter Turnbaugh, PhD (UCSF)
FDA Collaborators: Roselie Bright, ScD, MS, PMP (OHI/FDA), Elaine Johanson (OHI/FDA)
Status: Completed
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
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
Excipient Browser (a research tool to help investigate and improve these important substances)
Usage Statistics of Excipient Browser
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
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
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
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
Medical Devices
CERSI Principal Investigator: Manisha Desai (Stanford)
FDA Collaborators: Maria Matilde Kam (CDER), Andrew Potter (CDER), Paul Schuette (CDER), Lili Garrard (CDER)
Status: Active
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
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: Active
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: Active
CERSI Principal Investigator: Jean Feng, PhD (UCSF)
FDA Collaborators: Berkman Sahiner, PhD (CDRH/FDA), Alexej Gossmann, PhD, CDRH/FDA)
Status: Active
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: Active
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
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
CERSI Principal Investigator: Jeffrey Lotz, PhD (UCSF)
FDA Collaborators: Anton Dmitriev, PhD (CDRH/FDA), Andrew Baumann, PhD (CDRH/FDA)
Status: Completed
CERSI Principal Investigator: Xiao Hu, PhD (UCSF)
FDA Collaborators: Christopher Scully, PhD (CDRH/FDA)
Status: Completed
CERSI Principal Investigator: Andrew Auerbach, MD (UCSF)
FDA Collaborators: Bakul Patel, MS, MBA (CDRH/FDA), Vinay Pai, PhD (CDRH/FDA)
Status: Completed
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
Patient Focused
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
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
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: Active
CERSI Principal Investigator: Kuldev Singh, MD, MBA (Stanford)
FDA Collaborators: Malvina Eydelman, MD (CDRH/FDA) Michelle Tarver, MD, PhD (CDRH/FDA)
Status: Active
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
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
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
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
Precision Medicine
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: Active
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
CERSI Principal Investigator: Joseph Wu, MD, PhD (Stanford)
FDA Collaborators: David Strauss (CDER/FDA), Kevin Ford (CDER/FDA), Dylan Bruckner (CDER/FDA)
Status: Active
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
CERSI Principal Investigator: Joseph Wu, MD, PhD (Stanford)
FDA Collaborators: Bridget Nugent, PhD (OWH/FDA), Alexandre Ribeiro, PhD (CDER/DARS/FDA)
Status: Active
CERSI Principal Investigator: Charles Chiu, MD, PhD (UCSF)
FDA Collaborators: Indira Hewlett, PhD (CBER/FDA)
Status: Active
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: Active
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: Active
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
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
CERSI Principal Investigator: Dmitri Petrov, PhD (Stanford)
FDA Collaborators: Elaine Johanson (OHI/FDA)
Status: Completed
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
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
CERSI Principal Investigator: Russ Altman, MD, PhD (Stanford)
FDA Collaborators: Elaine Johanson (OHI/FDA)
Status: Completed
Special Populations
CERSI Principal Investigator: Janice Schwartz, MD (UCSF)
FDA Collaborators: Christine Lee, PharmD, PhD (OMHHE/FDA), Qi Liu, PhD, MStat (CDER/OCP/FDA)
Status: Active
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: Active
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: Active
CERSI Principal Investigator: Christopher Almond, MD, MPH (Stanford)
FDA Collaborators: Vasum Peiris, MD, MPH (CDRH/FDA), Brittany Caldwell, PhD (CDRH/FDA)
Status: Active
CERSI Principal Investigator: Sook Wah Yee, PhD (UCSF)
FDA Collaborators: Shiew Mei Huang, PhD (CDER/FDA), Lei Zhang, PhD (CDER/FDA)
Status: Active
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: Active
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
CERSI Principal Investigator: Esteban Burchard, MD, MPH (UCSF)
FDA Collaborators: Richardae Araojo, PharmD (OMHHE/FDA)
Status: Completed
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
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
COVID-19
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: Active
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: Active
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: Active
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: Active
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: Active
CERSI Principal Investigator: Atul Butte, MD, PhD (UCSF)
FDA Collaborators: Amy Abernethy, MD, PhD (OC/FDA)
Status: Completed
Plain Language Summaries
Plain Language Summaries are available for the projects listed below.
Additional Plain Language Summaries from all CERSIs can also be found on the FDA CERSI Website
Project #1 (Altman): Improving the Efficiency and Rigor of Pharmacovigilance at FDA
Project #3 (Giacomini): Renal Impairment in New Drug Development
Project #8 (Lotz): Spinal Orthopedic Device Mechanics
Project #10 (Esserman): OneSource Phase I: Source Data Capture from Electronic Health Records (EHRs): Using Standardized Clinical Research Data
Project #14 (Singh): Patient Reported Outcomes for Minimally Invasive Glaucoma Surgery (MIGS)
Project #15A (Shoichet): Chemoinformatic Tools to Predict the Effects of Excipients in Generic Drugs
Project #15B (Giacomini): Effects of Excipients in Generic Drugs Products on Intestinal Drug Transporters
Project #16B (Altman): Next Generation Text Analytics for FDA - Relevant Text Mining
Project #17 (Wilson): Comparing Qualitative and Quantitative Approaches to Eliciting Patient Preferences: A Case Study on Innovative Upper Limb Prostheses
Project #25 (Roy): Development of Thrombogenicity Testing Methods for Medical Devices with Large Blood-Contacting Surfaces
Project #26 (Auerbach): Developing Frameworks and Tools for Integration of Digital Health Tools into Clinical Practice
Project #27 (Porteus): 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
Project #28 (Lyles, Sarkar): The Impact of Race and Ethnicity on Responses to Heart Failure Patient-Reported Outcome Measures
Project #29 (Almond): Adapting a Measure of Heart Failure to an Adolescent Population
Project #32 (Huang): Tissue Chips for Multipotent Stromal Cell Manufacturing
Project #37 (Altman): Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data
Project #41 (Butte): 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
Project #46 (Burchard): Characterizing Population-Specific Clinical Asthma Profiles
Project #50 (Yang): The Effect of Excipients on the Oral Absorption of Fexofenadine in Humans
Project #52 (Sarkar): Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients
Project #53 (Butte): A Rapid Query Model to Address Prioritized COVID-19 Questions Using EHR Data
Project #58 (Feng): Safe Algorithmic Change Protocols for Modifications to AI/ML-based Software as a Medical Device
Project #60 (Rudrapatna): Improving adverse event detection related to biologic immunosuppressant use – a pilot study of the BERT deep learning model adapted to real-world clinical notes
Project #61 (Vashisht): 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
Project #62 (Wu): Assessing the Potential for Patient-Specific and Genome Edited Induced Pluripotent Cell-Based Models to Streamline Clinical Drug Development for Rare Diseases
Project #64 (Schwartz): The MUM study: MUltimorbidity and Medications: The unheard perspective of older adults
Project #65 (Auerbach): The Digital Variome: Understanding the Implications of Digital Tools on Health
Project #66 (Shah, Turakhia): Post-Market Evaluation of Smartwatch Cardiovascular Notifications
Project #68 (Butte): Real-World Population Characteristics, Safety and Effectiveness of COVID-19 Vaccines
Project #69 (Yee): Effects of Antioxidants in Drug Products on Intestinal Drug Transporters
Project #70 (Bickler): Prospective Clinical Study of Pulse Oximeter Errors in Adult Hospitalized Patients with Varying Skin Pigmentation
Project #73 (Almond): Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children
Project #74 (Wu): Role of Genomic Ancestry in Tyrosine Kinase Inhibitor (TKI)-Induced Cardiotoxicity
Project #75 (Ziv): Whole exome sequencing to predict immune related adverse events and response to checkpoint inhibitors
Project #76 (Butte): The Real-World Effectiveness of COVID-19 Vaccines in the Pediatric Population Across the University of California Health System
Project #77 (Altman): Large Language Models to support Bioequivalence Evaluation
Publications
2024
2024 May 10
Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
Pharmaceutics
Authors: Kulkarni CP, Yang J, Koleske ML, Lara G, Alam K, Raw A, Rege B, Zhao L, Lu D, Zhang L, Yu LX, Lionberger RA, Giacomini KM, Kroetz DL, Yee SW
PMID 38794309
2024 Mar 14
Journal of the American Geriatrics Society
Authors: Schwartz JB, Liu RY, Boscardin J, Liu Q, Lau SWJ, Khatri S, Tarn D
PMID 38485469
2024 Mar 8
Clinical Pharmacology & Therapeutics
Authors: Silverman AL, Sushil M, Bhasuran B, Ludwig D, Buchanan J, Racz R, Parakala M, El-Kamary S, Ahima O, Belov A, Choi L, Billings M, Li Y, Habal N, Liu Q, Tiwari J, Butte AJ, Rudrapatna VA
PMID 38459719
2024 Mar
The Lancet Digital Health
Authors: Miao BY, Sushil M, Xu A, Wang M, Arneson D, Berkley E, Subash M, Vashisht R, Rudrapatna V, Butte AJ
PMID 38395542
2024 Feb 6
Research Square
Authors: Sushil M, Zack T, Mandair D, Zheng Z, Wali A, Yu YN, Quan Y, Butte AJ
PMID 38405831
2024 Jan 5
Extracorporeal Life Support Organization (ELSO) Member Centers Group
Artificial Organ Research and Development ASAIO Journal
Authors: Tonna JE, Boonstra PS, MacLaren G, Paden M, Brodie D, Anders M, Hoskote A, Ramanathan K, Hyslop R, Fanning JJ, Rycus P, Stead C, Barrett NA, Mueller T, Gómez RD, Malhotra Kapoor P, Fraser JF, Bartlett RH, Alexander PMA, Barbaro RP
PMID 38181413
2023
2023 November 11
Trends in Influenza Vaccination Rates among a Medicaid Population from 2016 to 2021
Vaccines (Basel)
Authors: Naderalvojoud B, Shah ND, Mutanga JN, Belov A, Staiger R, Chen JH, Whitaker B, Hernandez-Boussard T
PMID 38006044
2023 October 26
eClinicalMedicine
Authors: Barsan V, Li Y, Prabhu S, Baggott C, Nguyen K, Pacenta H, Phillips CL, Rossoff J, Stefanski H, Talano JA, Moskop A, Baumeister S, Verneris MR, Myers GD, Karras NA, Cooper S, Qayed M, Hermiston M, Satwani P, Krupski C, Keating A, Fabrizio V, Chinnabhandar V, Kunicki M, Curran KJ, Mackall CL, Laetsch TW, Schultz LM
PMID 37954907
2023 July 29
Extracellular Matrix Bioactive Molecules and Cell Behavior Modeling
Handbook of the Extracellular Matrix
Authors: Khanna A, Oropeza BP, Jain I, Huang NF
(Project #32)
2023 June 27
Blood Advances
Authors: McNerney KO, Si Lim SJ, Ishikawa K, Dreyzin A, Vatsayan A, Chen JJ, Baggott C, Prabhu S, Pacenta HL, Philips C, Rossoff J, Stefanski HE, Talano JA, Moskop A, Verneris M, Myers D, Karras NA, Brown P, Bonifant CL, Qayed M, Hermiston M, Satwani P, Krupski C, Keating AK, Baumeister SHC, Fabrizio VA, Chinnabhandar V, Egeler E, Mavroukakis S, Curran KJ, Mackall CL, Laetsch TW, Schultz LM
PMID 36857419
(Project #43)
2023 June 6
Journal of Medical Internet Research
Authors: Dy M, Olazo K, Lisker S, Brown E, Saha A, Weinberg J, Sarkar U
PMID 37279039
(Project #52)
2023 June 1
Pediatric Critical Care Medicine
Authors: Alexander PMA, Habet V, Barbaro RP
PMID 37260339
2023 May 29
Transfusion (Online ahead of print)
Authors: Wang M, Goldgof GM, Patel A, Whitaker B, Belov A, Chan B, Phelps E, Rubin B, Anderson S, Butte AJ
PMID 37248741
(Project #41)
2023 February 10
PLoS One
Authors: Rodriguez-Watson CV, Sheils NE, Louder AM, Eldridge EH, Lin ND, Pollock BD, Gatz JL, Grannis SJ, Vashisht R, Ghauri K, Valo G, Chakravarty AG, Lasky T, Jung M, Lovell SL, Major JM, Kabelac C, Knepper C, Leonard S, Embi PJ, Jenkinson WG, Klesh R, Garner OB, Patel A, Dahm L, Barin A, Cooper DM, Andriola T, Byington CL, Crews BO, Butte AJ, Allen J
PMID 36763574
(Project #53)
2023 February 3
Real-world performance of SARS-Cov-2 serology tests in the United States, 2020
PLoS One
Authors: Rodriguez-Watson CV, Louder AM, Kabelac C, Frederick CM, Sheils NE, Eldridge EH, Lin ND, Pollock BD, Gatz JL, Grannis SJ, Vashisht R, Ghauri K, Knepper C, Leonard S, Embi PJ, Jenkinson G, Klesh R, Garner OB, Patel A, Dahm L, Barin A, Cooper DM, Andriola T, Byington CL, Crews BO, Butte AJ, Allen J
PMID 36735683
(Project #53)
2022
2022 December 28
Heart Rhythm
Authors: Caughron H, Bowman H, Raitt MH, Whooley MA, Tarasovsky G, Shen H, Matheny ME, Selzman KA, Wang L, Major J, Odobasic H, Dhruva SS
PMID 36586706
(Project #59)
2022 October 9
Biomolecules
Authors: Davidson J, Vashisht R, Butte AJ
PMID 36291658
(Project #53, #68)
2022 August 4
Journal of Visualized Experiments
Authors: Zhao SR, Mondéjar-Parreño G, Li D, Shen M, Wu JC
PMID 35993757
(Project #62)
2022 June 6
BMJ Open
Authors: Files DC, Matthay MA, Calfee CS, Aggarwal NR, Asare AL, Beitler JR, Berger PA, Burnham EL, Cimino G, Coleman MH, Crippa A, Discacciati A, Gandotra S, Gibbs KW, Henderson PT, Ittner CAG, Jauregui A, Khan KT, Koff JL, Lang J, LaRose M, Levitt J, Lu R, McKeehan JD, Meyer NJ, Russell DW, Thomas KW, Eklund M, Esserman LJ, Liu KD
PMID 35667714
(Project #55)
2022 April 19
Analyzing real world data of blood transfusion adverse events: Opportunities and challenges
Transfusion
Authors: Jhaveri P, Bozkurt S, Moyal A, Belov A, Anderson S, Shan H, Whitaker B, Hernandez-Boussard T
PMID 35437749
(Project #38)
2022 March 1
Preventive drugs for Huntington's disease: A choice-based conjoint survey of patient preferences
Journal of Clinical and Translational Science
Authors: Parrish MC, Hanson-Kahn A, Srinivasan V, Grimes KV
PMID 35433035
2022 January 28
Pharmaceutical Research (Online ahead of print)
Authors: Chen EC, Matsson P, Azimi M, Zhou X, Handin N, Yee SW, Artursson P, Giacomini KM
PMID 35089508
(Project #23)
2022 January 25
Blood Advances, Volume 6, Issue 2, pp. 600-610
Authors: Fabrizio VA, Phillips CL, Lane A, Baggott C, Prabhu S, Egeler E, Mavroukakis S, Pacenta H, Rossoff J, Stefanski HE, Talano JA, Moskop A, Margossian SP, Verneris MR, Myers GD, Karras NA, Brown PA, Qayed M, Hermiston M, Satwani P, Krupski C, Keating AK, Wilcox R, Rabik CA, Chinnabhandar V, Kunicki M, Goksenin AY, Curran KJ, Mackall CL, Laetsch TW, Schultz LM
PMID 34794180
(Project #43)
2022 January 15
Journal of Patient-Reported Outcomes, Volume 6, Issue 1, Article 6 (pp. 1-12)
Authors: Davis J, Olazo K, Sierra M, Tarver ME, Caldwell B, Saha A, Lisker S, Lyles C, Sarkar U
PMID 35032226
(Project #28)
2022 January 11
Journal of the American Medical Informatics Association (Online ahead of print)
Authors: Feng J, Gossmann A, Sahiner B, Pirracchio R
PMID 35022756
(Project #58)
2021
2021 December 09
Journal of Clinical Oncology (Online ahead of print)
Authors: Schultz LM, Baggott C, Prabhu S, Pacenta HL, Phillips CL, Rossoff J, Stefanski HE, Talano JA, Moskop A, Margossian SP, Verneris MR, Myers GD, Karras NA, Brown PA, Qayed M, Hermiston M, Satwani P, Krupski C, Keating AK, Wilcox R, Rabik CA, Fabrizio VA, Rouce RH, Chinnabhandar V, Kunicki M, Barsan VV, Goksenin AY, Li Y, Mavroukakis S, Egeler E, Curran KJ, Mackall CL, Laetsch TW
PMID 34882493
(Project #43)
2021 November 25
Blood, Volume 138, Issue 21, pp. 2138-2142
Authors: Rossoff J, Baggott C, Prabhu S, Pacenta H, Phillips CL, Stefanski H, Talano JA, Moskop A, Margossian SP, Verneris MR, Myers GD, Karras N, Brown PA, Qayed M, Hermiston M, Satwani P, Krupski C, Keating AK, Wilcox R, Rabik CA, Fabrizio VA, Kunicki M, Chinnabhandar V, Goksenin AY, Curran KJ, Mackall CL, Laetsch TW, Schultz LM
PMID 34499715
(Project #43)
2021 November 17
Blood Advances (Online ahead of print)
Authors: Fabrizio VA, Boelens JJ, Mauguen A, Baggott C, Prabhu S, Egeler E, Mavroukakis S, Pacenta HL, Phillips CL, Rossoff J, Stefanski H, Talano JA, Moskop A, Margossian SP, Verneris MR, Myers GD, Karras NA, Brown PA, Qayed M, Hermiston ML, Satwani P, Krupski C, Keating AK, Wilcox R, Rabik CA, Chinnabhandar V, Kunicki M, Goksenin AY, Mackall CL, Laetsch TW, Schultz LM, Curran KJ
PMID 34788386
(Project #43)
2021 September 22
Journal of Medical Internet Research, Volume 23, Issue 9, Article 26623 (pp. 1-9)
Authors: Sarkar U, Lee JE, Nguyen KH, Lisker S, Lyles CR
PMID 34550074
(Project #52)
2021 September 21
Annals of Internal Medicine, Volume 174, Issue 11, pp. 1603-1611
Authors: Janiaud P, Irony T, Russek-Cohen E, Goodman SN
PMID 34543584
(Project #21)
2021 September 16
Racial/ethnic differences in eligibility for asthma biologics among pediatric populations
Journal of Allergy and Clinical Immunology, Volume 148, Issue 5, pp. 1324-1331.e12
Authors: Wohlford EM, Huang PF, Elhawary JR, Millette LA, Contreras MG, Witonsky J, Holweg CTJ, Oh SS, Lee C, Merenda C, Rabin RL, Araojo R, Mak ACY, Eng CS, Hu D, Huntsman S, LeNoir MA, Rodríguez-Santana JR, Borrell LN, Burchard EG
PMID 34536416
(Project #46)
2021 September 15
Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein
American Association of Pharmaceutical Scientists (AAPS) Journal, Volume 23, Issue 5, Article 106 (pp. 1-12)
Authors: Bajaj R, Chong LB, Zou L, Tsakalozou E, Ni Z, Giacomini KM, Kroetz DL
PMID 34528148
(Project #15B)
2021 July 24
Bone, Volume 153, Article 116129 (pp. 1-15)
Authors: Matsuo K, Lepinski A, Chavez RD, Barruet E, Pereira A, Moody TA, Ton AN, Sharma A, Hellman J, Tomoda K, Nakamura MC, Hsiao EC
PMID 34311122
(Project #31)
2021 July 18
Genomewide Association Studies in Pharmacogenomics
Clinical Pharmacology & Therapeutics, Volume 110, Issue 3, pp. 637-648
Authors: McInnes G, Yee SW, Pershad Y, Altman RB
PMID 34185318
(Project #36)
2021 June 17
Physiological Measurement, Volume 42, Issue 5, Article 055005 (pp. 1-17)
Authors: Gadhoumi K, Beltran A, Scully CG, Xiao R, Nahmias DO, Hu X
PMID 33902012
(Project #34)
2021 May 03
Clinical Pharmacology & Therapeutics, Volume 110, Issue 1, pp. 108-122
Authors: Yee SW, Vora B, Oskotsky T, Zou L, Jakobsen S, Enogieru OJ, Koleske ML, Kosti I, Rödin M, Sirota M, Giacomini KM
PMID 33759449
2021 April 30
Engineering Hydrogel-Based Biomedical Photonics: Design, Fabrication, and Applications
Advanced Materials, Volume 33, Issue 23, Article 2006582 (pp. 1-25)
Authors: Guimarães CF, Ahmed R, Marques AP, Reis RL, Demirci U
PMID 33929771
(Project #33)
2021 April 20
Engineering Cardiovascular Tissue Chips for Disease Modeling and Drug Screening Applications
Frontiers in Bioengineering and Biotechnology
Authors: Chan AHP, Huang NF
PMID 33959600
(Project #32)
2021 April 11
American Journal of Ophthalmology, Volume 229, pp. 145-151
Authors: Cui QN, Hays RD, Tarver ME, Spaeth GL, Paz SH, Weidmer B, Fellman RL, Vold SD, Eydelman M, Singh K
PMID 33852908
(Project #14)
2021 April
Nature Medicine, Volume 27, Issue 4, pp. 582-584
Authors: Wu E, Wu K, Daneshjou R, Ouyang D, Ho DE, Zou J
PMID 33820998
(Project #39)
2021 February 28
A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring
Journal of the American Medical Informatics Association, Volume 109, Issue 5, 1197-1202
Authors: Han L, Ball R, Pamer CA, Altman RB, Proestel S
PMID 33492663
(Project #1)
2020
2020 September 07
Drug Metabolites Potently Inhibit Renal Organic Anion Transporters, OAT1 and OAT3
Journal of Pharmaceutical Sciences, Volume 110, Issue 1, pp. 347-353
Authors: Zou L, Matsson P, Stecula A, Ngo HX, Zur AA, Giacomini KM
PMID 32910949
(Project #3)
2020 July 29
Scientific Considerations for Global Drug Development
Science Translational Medicine, Vol 12, Issue 554, Article eaax2550 (pp. 1-5)
Authors: Ling Zou, Jennifer L Wilson, Kit Wun Kathy Cheung, Lawrence Lin, Elizabeth A E Green, Analia I Porras, Ling Zou, David Mukanga, Paul A Akpa, Delese Mimi Darko, Rae Yuan, Sheng Ding, Wiltshire C N Johnson, Howard A Lee, Emer Cooke, Carl C Peck, Steven E Kern, Dan Hartman, Yoshikazu Hayashi, Peter W Marks, Russ B Altman, Murray M Lumpkin, Kathleen M Giacomini, Terrence F Blaschke
PMID 32727913
2020 July 24
The Activities of Drug Inactive Ingredients on Biological Targets
Science, Vol. 369, Issue 6502, pp. 403-413
Authors: Joshua Pottel, Duncan Armstrong, Ling Zou, Alexander Fekete, Xi-Ping Huang, Hayarpi Torosyan, Dallas Bednarczyk, Steven Whitebread, Barun Bhhatarai, Guiqing Liang, Hong Jin, Nassir Ghaemi, Samuel Slocum, Katalin V. Lukacs, John J. Irwin, Ellen L. Berg, Kathleen M. Giacomini, Bryan L. Roth, Brian K. Shoichet, Laszlo Urban
PMID 32703874
(Project #15A)
2020 July 03
Effects of Nicotine on the Translation of Stem Cell Therapy
Regenerative Medicine, Volume 15, Issue 5, pp. 1679-1688
Authors: Chan AH, Huang NF
PMID 32618492
(Project #32)
2020 June 22
Bacterial Metabolism Rescues the Inhibition of Intestinal Drug Absorption by Food and Drug Additives
Proceedings of the National Academy of Sciences, Volume 117, Issue 27, pp. 16009-16018
Authors: Ling Zou, Peter Spanogiannopoulos, Lindsey M Pieper, Huan-Chieh Chien, Wenlong Cai, Natalia Khuri, Joshua Pottel, Bianca Vora, Zhanglin Ni, Eleftheria Tsakalozou, Wenjun Zhang, Brian K Shoichet, Kathleen M Giacomini, Peter J Turnbaugh
PMID 32571913
(Project #15B)
2020 May 27
Extracting Chemical Reactions from Text using Snorkel
BMC (BioMed Central) Bioinformatics 2020, Volume 21, Issue 1, Article 217 (pp. 1-15)
Authors: Mallory EK, de Rochemonteix M, Ratner A, Acharya A, Re C, Bright RA, Altman RB
PMID 32460703
(Project #16B)
2020 February 10
Interactions of Oral Molecular Excipients with Breast Cancer Resistance Protein, BCRP
Molecular Pharmaceutics, Volume 17, Issue 3, pp. 748-756
Authors: Zou L, Pottel J, Khuri N, Ngo HX, Ni Z, Tsakalozou E, Warren MS, Huang Y, Shoichet BK, Giacomini KM
PMID 31990564
(Project #15B)
2019
2019 December
Patient, Volume 12, Issue 6, pp. 553-557
Authors: Benz HL, Lee TJ, Tsai JH, Bridges JFP, Eggers S, Moncur M, Shaya FT, Shoulson I, Spatz ES, Wilson L, Saha A
PMID 31696436
(Project #17)
2019 November 26
Eye, Volume 34, Issue 1, pp. 205-210
Authors: Tianjing Li, T. Le, Ronald D. Hays, Qi N. Cui, Malvina Eydelman, George Spaeth, Michelle E. Tarver & Kuldev Singh
PMID 31772384
(Project #14)
2019 November 23
The Patient Perspective: Putting the Patient at the Center of the Translational Innovation Process
Clinical Pharmacology & Therapeutics, Volume 107, Issue 1, pp. 82-84
Authors: Wilson L, Lin L, Singh K.
PMID 31758800
(Project #14, 17)
2019 November 01
PathFXweb: A Web Application for Identifying Drug Safety and Efficacy Phenotypes
Bioinformatics, Volume 35, Issue 21, pp. 4504–4506
Authors: Jennifer L Wilson, Mike Wong, Ajinkya Chalke, Nicholas Stepanov, Dragutin Petkovic, Russ B Altman
PMID 31114840
(Project #24)
2019 September
The Journal of Clinical Pharmacology, Volume 59, Issue S1, pp. S56-S69
Authors: Cheung KWK, van Groen BD, Burckart GJ, Zhang L, de Wildt SN, Huang SM
PMID 31502692
(Project #23)
2019 July 03
Clinical Pharmacology & Therapeutics, Volume 106, Issue 5, pp. 1083-1092
Authors: Cheung KWK, van Groen BD, Spaans E, van Borselen MD, de Bruijn ACJM, Simons-Oosterhuis Y, Tibboel D, Samsom JN, Verdijk RM, Smeets B, Zhang L, Huang SM, Giacomini KM, de Wildt SN
PMID 31127606
(Project #23)
2019 June 20
An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials
Clinical Pharmacology & Therapeutics, Volume 106, Issue 4, pp. 841-846
Authors: Adeniyi O, Ramamoorthy A, Schuck R, Sun J, Wilson J, Zineh I, Pacanowski M
PMID 31002380
(Project #24)
2019 June 10
In Vitro Models for Thrombogenicity Testing of Blood-Recirculating Medical Devices
Expert Review of Medical Devices, Volume 16, Issue 7, pp. 603-616
Authors: Sarode DN, Roy S
PMID 31154869
(Project #25)
2019 February 17
Clinical Pharmacology & Therapeutics, Volume 105, Issue 4, pp. 815-818
Authors: Kathleen M. Giacomini, Lawrence Lin, Russ B. Altman
PMID 30773618
2019 January 20
Impact of Pharmaceutical Excipients on Oral Drug Absorption: A Focus on Intestinal Drug Transporters
Clinical Pharmacology & Therapeutics, Volume 105, Issue 2, pp. 323-325
Authors: Ling Zou, Zhanglin Ni, Eleftheria Tsakalozou, Kathleen M. Giacomini
PMID 30663035
(Project #15B)
2018
2018 December 07
PLOS (Public Library of Science) Computational Biology, Volume 14, Issue 12, Article e1006614 (pp. 1-27)
Authors: Jennifer L. Wilson, Rebecca Racz, Tianyun Liu, Oluseyi Adeniyi, Jielin Sun, Anuradha Ramamoorthy, Michael Pacanowski, Russ Altman
PMID 30532240
(Project #24)
2018 September 27
BMC (BioMed Central) Cancer, Volume 18, Issue 1, Article 933 (pp. 1-10)
Authors: López-Pineda A, Rodríguez-Moran MF, Álvarez-Aguilar C, Fuentes Valle SM, Acosta-Rosales R, Bhatt AS, Sheth SN, Bustamante CD
PMID 30261931
(Project #16E)
2018 September 12
Annual Review of Pharmacology and Toxicology, Volume 59, pp. 405-421
Authors: Parrish MC, Tan YJ, Grimes KV, Mochly-Rosen D
PMID 30208282
2018 August 06
Network Enhancement as a General Method to Denoise Weighted Biological Networks
Nature Communications, Volume 9, Issue 1, Article 3108 (pp. 1-8)
Authors: Wang B, Pourshafeie A, Zitnik M, Zhu J, Bustamante CD, Batzoglou S, Leskovec J
PMID 30082777
(Project #16E)
2018 May 08
Machine Learning in Chemoinformatics and Drug Discovery
Drug Discovery Today, Volume 23, Issue 8, pp. 1538-1546
Authors: Lo YC, Rensi SE, Torng W, Altman RB
PMID 29750902
2018 May 01
Pharmacogenomics and big genomic data: from lab to clinic and back again
Human Molecular Genetics, Volume 27, Issue R1, pp. R72-R78
Authors: Lavertu A, McInnes G, Daneshjou R, Whirl-Carrillo M, Klein TE, Altman RB
PMID 29635477
2018 January 27
Chemical Reaction Vector Embeddings: Towards Predicting Drug Metabolism in the Human Gut Microbiome
Pacific Symposium of Biocomputing, Volume 23, pp. 56-67
Authors: Mallory EK, Acharya A, Rensi SE, Turnbaugh PJ, Bright RA, Altman RB
PMID 29218869
(Project #16B, 20)
2017
2017 December 03
Biomarkers: Delivering on the Expectation of Molecularly Driven, Quantitative Health
Experimental Biology Medicine, Volume 243, Issue 3, pp. 313-322
Authors: Wilson JL, Altman RB
PMID 29199461
(Project #24)
2017 November 01
Toward Multimodal Signal Detection of Adverse Drug Reactions
Journal of Biomedical Informatics, Volume 76, pp. 41-49
Authors: Harpaz R, DuMouchel W, Schuemie M, Bodenreider O, Friedman C, Horvitz E, Ripple A, Sorbello A, White RW, Winnenburg R, Shah NH
PMID 29081385
(Project #2)
2017 September 01
Journal of the American Medical Informatics Association, Volume 25, Issue 5, pp. 913-920
Authors: Han L, Ball R, Pamer CA, Altman RB, Proestel S
PMID 28371826
(Project #1)
2017 June 15
Journal of Chemical Information and Modeling, Volume 57, Issue 6, pp. 1402-1413
Authors: Khuri N, Zur AA, Wittwer MB, Lin L, Yee SW, Sali A, Giacomini KM
PMID 28562037
(Project #3)
2017 May 05
The Effect of Uremic Solutes on the Organic Cation Transporter 2
Journal of Pharmaceutical Sciences, Volume 106, Issue 9, pp. 2551-2557
Authors: Cheung KWK, Hsueh CH, Zhao P, Meyer TW, Zhang L, Huang SM, Giacomini KM
PMID 28483424
(Project #3)
2017 February 01
Journal of Biomechanics, Volume 54, pp. 26-32
Authors: Peck JH, Sing DC, Nagaraja S, Peck DG, Lotz JC, Dmitriev AE
PMID 28256243
(Project #8)
2016
2016 September 20
Metabolomic and Genome-wide Association Studies Reveal Potential Endogenous Biomarkers for OATP1B1
Clinical Pharmacology & Therapeutics, Volume 100, Issue 5, pp. 524-536
Authors: Yee SW, Giacomini MM, Hsueh CH, Weitz D, Liang X, Goswami S, Kinchen JM, Coelho A, Zur AA, Mertsch K, Brian W, Kroetz DL, Giacomini KM
PMID 27447836
(Project #3)
2016 October 27
From the Patient's Point of View, How Should Minimally Invasive Glaucoma Surgeries be Evaluated?
American Journal of Ophthalmology, Volume 172, pp. xii-xiv
Authors: Qui N. Cui, Kuldev Singh, George L. Spaeth
PMID 28327295
(Project #14)
2016 September 28
A Molecular Basis for Innovation in Drug Excipients
Clinical Pharmacology & Therapeutics, Volume101, Issue 3, pp. 320-323
Authors: John J. Irwin, Joshua Pottel, Ling Zou, Hong Wen, Susan Zuk, Xinyuan Zhang, Teague Sterling, Brian K., Shoichet, Robert Lionberger, Kathleen M. Giacomini
PMID 27557422
(Project #15A, 15B)
2016 August 09
Molecular Pharmaceutics, Volume 12, Issue 9, pp. 3130-40
Authors: Chia-Hsiang Hsueh, Kenta Yoshida, Ping Zhao, Timothy W Meyer, Lei Zhang, Shiew-Mei Huang, Kathleen M Giacomini
PMID 27467266
(Project #3)
2016 June 14
Pharmacometabolomic Assessment of Metformin in Non-diabetic, African Americans
Frontiers in Pharmacology, Volume 7, Article 135 (pp. 1-12)
Authors: Rotroff DM, Oki NO, Liang X, Yee SW, Stocker SL, Corum DG, Meisner M, Fiehn O, Motsinger-Reif AA, Giacomini KM, Kaddurah-Daouk R
PMID 27378919
(Project #)
2016 June 14
Clinical Pharmacokinetics, Volume 55, Issue 6, pp. 711-21
Authors: Hibma JE, Zur AA, Castro RA, Wittwer MB, Keizer RJ, Yee SW, Goswami S, Stocker SL, Zhang X, Huang Y, Brett CM, Savic RM, Giacomini KM
PMID 26597253
(Project #)
2016 April 20
A Research Roadmap for Next Generation Sequencing Informatics
Science Translational Medicine, Volume 8, Issue 335, Article 335ps10 (pp. 1-4)
Authors: Altman RB, Prabhu S, Sidow A, Zook JM, Goldfeder R, Litwack D, Ashley E, Asimenos G, Bustamante DC, Donigan K, Giacomini KM, Johansen E, Khuri N, Lee E, Liang XS, Salit M, Serang O, Tezak Z, Wall DP, Mansfield E, Kass-Hout T
PMID 27099173
(Project #16A)
2015
2015 November 25
Unmet Needs: Research Helps Regulators do their Jobs
Science Translational Medicine, Volume 7, Issue 315, Article 315ps22 (pp. 1-7)
Authors: Altman RB, Khuri N, Salit M, Giacomini KM
PMID 26606966
2015 November 16
Metformin Is a Substrate and Inhibitor of the Human Thiamine Transporter, THTR-2 (SLC19A3)
Molecular Pharmaceutics, Volume 12, Issue 12, pp. 4301-10
Authors: Liang X, Chien HC, Yee SW, Giacomini MM, Chen EC, Piao M, Hao J, Twelves J, Lepist EI, Ray AS, Giacomini KM
PMID 26528626
(Project #)
2015 July 31
A Method for Systematic Discovery of Adverse Drug Events from Clinical Notes
Journal of the American Medical Informatics Association, Volume 22, Issue 6, pp. 1196-204
Authors: Wang G, Jung K, Winnenberg R, Shah NH
PMID 26232442
(Project #2)