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  1. Advancing Regulatory Science

CERSI Collaborative Research Projects

The CERSIs conduct cutting-edge regulatory science research with high public health impact aimed at development of new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Many of these research projects are conducted in collaboration with FDA.

The CERSIs promote innovation in regulatory science predominantly through cutting-edge scientific research that supports FDA's regulatory science needs. They may also provide regulatory science information sharing opportunities, such as lectures, workshops, courses, scholar awards, fellowships, and competitions. We aim for the collaborative activities to target one or more of the focus areas in the Regulatory Science Framework.

 

Project Title CERSI Fiscal Year (FY) Lead and / Funding Center CERSI Lead PI FDA Lead SME Charge/Topic Area
A Mixed Methods Research Design to Identify Factors Influencing Prescriber Decision-Making about Pain Management and Opioid Prescribing Yale-Mayo FY21 CDER Hooten, Michael Coleman, Blair Charge 2 Topic E
A positive deviance approach for representing women, older adults and patients identifying as racial and ethnic minorities in oncology research Yale-Mayo FY22 OCE Miller, Jennifer Fashoyin-Aje, Lola Charge 1 Topic F
A Rapid Query Model to Address Prioritized COVID-19 Questions Using EHR Data UCSF-Stanford FY20 OC Butte, Atul Abernethy, Amy Charge 1 Topic J
Active Surveillance of Medical Device Safety and Outcomes Using EHRs: Prostate Cancer Partial Gland Ablation Technologies JHU FY19 CDRH Gorin, Michael; Segal, Jodi Fisher, Benjamin Charge 2 Topic A
Adapting a Measure of Heart Failure to an Adolescent Population UCSF-Stanford, Yale-Mayo FY18 CDRH Stanford-Christopher Almond, Yale-Mayo Jennifer Ridgeway Bocell, Fraser Charge 1 Topic E
An integromic signature for distinguishing malignant from benign growths detected on screening CT scans UMD FY21 OCE Feng Jiang Schneider, Julie Charge 1 Topic D
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 UCSF-Stanford FY18 CBER Stanford- Matthew Porteus, Kyle Cromer Ye, Zhaohui  
An X-Ray Based Online Probe for Real-Time Process Monitoring of The Crystallization of Active Pharmaceutical Ingredients UMD FY23 OCET Lex Schultheis, MD, PhD Coburn, James  
Analysis and Strategy of Tools to Improve Remote Interactions and Document Management UMD FY23 CDER Kunpeng Zhang, PhD Jaiswal, Mihir Charge 1 Topic C
Applying Additive Manufacturing for Continuous Production of Extracellular Vesicle Products UMD FY23 OCET Steven Jay (PI) Sung, Kyung Charge 1 Topic B
Assessing Physiological, Neural, and Self-Reported Response to Tobacco Education Messages JHU FY18 CTP Moran, Meghan Navarro, Mario Charge 3 Topic C
Assessing real world use of pharmaceuticals among pregnant and lactating people JHU FY20 OWH Ladd-Acosta, Christine Vasisht, Kaveeta  
Assessing the Potential for Patient-Specific and Genome Edited Induced Pluripotent Cell-Based Models to Streamline Clinical Drug Development for Rare Diseases UCSF-Stanford FY21 CDER Joseph Wu (Stanford) Strauss, David  
Assessment of Patient Tolerance for Risk with High Intensity Focused Ultrasound (HIFU) that Destroys Prostate Tissue UMD FY20 CDRH Siddiqui, Minhaj Viviano, Charles Charge 1 Topic I
Assessment of Safety and Performance Issues with Extended Reality (XR) Tele-mentoring of an Image-Guided, Clinically Important Procedure UMD FY23 CDRH Sarah Murthi (Co-PI) Beams, Ryan Charge 1 Topic J
Bayesian adaptive trial designs for neoantigen based immunotherapy and borrowing strength across subpopulations within the trial and from external controls Yale-Mayo FY20 OCE Yin, Vivien Schneider, Julie; Sridhara, Rajeshwari Charge 1 Topic C
Building Capacity for Research on Cancer and Aging: The UMGCCC-Medicare Database UMD FY21 OCE Joanne Dorgan Rivera, Donna  
Bulk Drug Substances Used to Compound Drugs for Patients with Autism Spectrum Disorder (ASD) JHU FY18 CDER Robinson, Karen; Alexander, Caleb; Gilmore, Vi; Ladd-Acosta, Christine; Vasa, Roma; Volk, Heather Dohm, Julie Charge 2 Topic A
Characterization and analysis of high incidence of potentially unsafe prescribing of some Extended-Release opioid analgesics using Natural Language Processing of Electronic Health Records clinical notes Yale-Mayo FY17 CDER Jeffery, Molly Kornegay, Cynthia J; Liberatore, Mark Charge 2 Topic A
Characterization of the impact of xylazine and dexmedetomidine: pharmacological profile, addictive behaviors, and physiological effects, including wound development Triangle FY23 CDER McElligott, Zoe Varshneya, Neil Charge 3 Topic D
Characterizing Population-Specific Clinical Asthma Profiles UCSF-Stanford FY20 OMHHE Sook Wah Yee (UCSF) Araojo, Richardae  
Characterizing safety and efficacy of brand-name and generic drugs used to treat hypothyroidism among patients who switch therapy formulation Yale-Mayo FY19 CDER Brito, Juan; Lipska, Kasia Wang, Zhong Charge 2 Topic A
Characterizing use, safety and efficacy of brand-name and generic drugs used to treat hypothyroidism Yale-Mayo FY16 CDER Ross, Joseph; Shah, Nilay Choi, Lauren Charge 2 Topic A
Chemoinformatic Tools to Predict the Effects of Excipients in Generic Drugs UCSF-Stanford FY15 CDER UCSF- Brian Shoichet Zhao, Liang Charge 1 Topic C
Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities UMD FY18 CDER UMB- Ashlee Mattingly, James Polli, Steve Hoag Cosel, Gabrielle Charge 3 Topic F
Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities UMD FY18 CDER Mattingly, Ashlee Rothman, Sara Charge 3 Topic F
Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities UMD FY19 CDER Mattingly, Ashlee; Polli, James Lawson, Rosilend Charge 3 Topic F
Communicating about COVID-19 Testing to Underrepresented Populations (Spanish version) UMD FY21 CDRH, OMHHE Daniel Mullins Tarver, Michelle Charge 2 Topic A
Comparing Qualitative and Quantitative Approaches to Eliciting Patient Preferences: A Case Study on Innovative Upper Limb Prostheses UCSF-Stanford FY16 CDRH UCSF- Leslie Wilson Saha, Anindita Charge 1 Topic C
Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data UCSF-Stanford FY19 OWH Stanford - Russ Altman, Emily Flynn Nugent, Bridget  
Data-informed Models to Identify Optimal Opioid Use Disorder Treatment Trajectories UMD FY20 CDER Danya Qato Coleman, Blair  
Defining SARS-CoV-2 vaccine-induced immunity in pregnant and lactating people JHU FY21 OWH Klein, Sabra Nugent, Bridget  
Development of a precision oncology decision support platform to enhance genotype-driven clinical trial recruitment and decentralized personalized medicine approaches JHU FY22 OCE Valsamo Anagnostou Narayan, Preeti Charge 1 Topic D
Development of optical and digital microscopy hardware, software, and statistical methods to enable computational pathology in low resources Yale-Mayo FY22 CDRH Blenman, Kim Gallas, Brandon D. Charge 1 Topic D
Developing a risk prediction engine for relapse in opioid use disorder Triangle FY23 CDRH Dunn, Jessilyn Saha, Anindita Charge 3 Topic D
Development of Thrombogenicity Testing Methods for Medical Devices with Large Blood-Contacting Surfaces UCSF-Stanford FY18 CDRH UCSF- Shuvo Roy Lu, Qijin  
Effects of Antioxidants in Drug Products on Intestinal Drug Transporters UCSF-Stanford FY22 CDER Sook Wah Yee (UCSF) Lu, Dongmei Charge 2 Topic A
Effects of Excipients in Generic Drugs Products on Intestinal Drug Transporters UCSF-Stanford FY15 CDER UCSF- Kathy Giacomini Zhao, Liang Charge 1 Topic C
Engineering quality control into biomanufacturing of extracellular vesicle-based products UMD FY20 CBER Steven Jay Bauer, Steven Charge 1 Topic B
Enhancing the role of pharmacies in reducing opioid misuse and abuse in racial and ethnic minority and rural communities Triangle FY23 CDER Hughes, Tamera; Ferreri, Stefanie Rass, Olga Charge 3 Topic D
Evaluate Application of Artificial Intelligence to Adaptive Enrichment Clinical Trials Yale-Mayo FY21 CDER Yin, Vivien Brodsky, Boris Charge 2 Topic B
Evaluate Application of Artificial Intelligence to Adaptive Enrichment Clinical Trials Yale-Mayo FY22 OWH Son, Mouen Bersoff-Matcha, Susan Charge 2 Topic A
Evaluating mobile health tool use for capturing patient-centered outcome measures in heart failure patients Yale-Mayo FY18 CDER McLeod, Chris Sacks, Leonard V Charge 2 Topic A
Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products UMD FY22 OWH Audra Stinchcomb South, Erin  
Evaluating the utility of negative controls in drug safety and effectiveness studies using real-world data UMD FY20 CDER Zafar Zafari Tian, Fang Charge 2 Topic A
Evaluation of the REMS Programs for Psychiatric Medications UMD FY20 CDER Catherine Cooke Bergquist, Barbara  
Histology, Pathology and Histopathology of Humanized Mice JHU FY18 CDER Gabrielson, Kathleen; Howard, Kristina Charge 1 Topic D
How consumers use flavors to make inferences about Electronic Nicotine Delivery System (ENDS) product qualities and intentions to use? (Phases I) JHU FY17 CTP Moran, Meghan; Kennedy, Ryan; Lagasse, Lisa Zandberg, Izabella Charge 1 Topic I
How consumers use flavors to make inferences about Electronic Nicotine Delivery System (ENDS) product qualities and intentions to use? (Phases II) JHU FY18 CTP Moran, Meghan; Kennedy, Ryan; Lagasse, Lisa Perreras, Lexie Zandberg, Izabella Charge 2 Topic E
Hyperspectral Interferometric Scattering Microscopy for Characterizing Nanoparticle-based Therapeutics UMD FY20 CDER Woehl, Taylor Qin, Bin  
Identifying, Selecting, and Utilizing Quantitative Bias Analysis Methods Yale-Mayo FY22 CDER Wallach, Joshua Hua, Wei; Zhang, Mingfeng Charge 2 Topic F
Implementation of a stakeholder survey to facilitate enhanced pediatric medical device innovation Yale-Mayo FY18 ORSI, CDRH Schlesinger, Mark Peiris, Vasum Charge 1 Topic H
Improving adverse event detection related to biologic immunosuppressant use – a pilot study of the BERT deep learning model adapted to real-world clinical notes UCSF-Stanford FY21 CDER Vivek Rudrapatna Habal, Nadia  
Improving efficacy and safety of pathogen inactivation strategies for platelet transfusion UMD FY19 CBER Fontaine, Magali Atreya, Chintamani Charge 1 Topic B
Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products UMD FY19 OWH Mullins, Daniel Ju, Jing (Julia) Charge 2 Topic E
Improving the diagnosis and treatment of women with myocardial ischemia and no obstructive coronary artery disease (INOCA) Yale-Mayo FY22 OWH Shah, Sumit; Spatz, Erica Bersoff-Matcha, Susan; Reasner, David Charge 1 Topic E
Improving the Efficiency and Rigor of Pharmacovigilance at FDA UCSF-Stanford FY15 CDER Russ Altman (Stanford) Rocca, Mitra Charge 1 Topic A
Improving the Efficiency and Rigor of Pharmacovigilance at FDA: visualization of multi-source information and unsupervised learning to support causal inference JHU FY18 ORSI, CDER Botsis, Taxiarchis; Rosner, Gary; Lehmann, Harold; Naidoo, Jaruska Ball, Robert; Dang, Oanh Charge 2 Topic A
Informatics driven real world analysis of SARS-CoV-2 serologic response and in vitro diagnostic accuracy Yale-Mayo FY20 CDRH Schulz, Wade Canos, Daniel Charge 2 Topic A
Investigation of potential mutagenicity of Molnupiravir in COVID-19 patients UMD FY22 NCTR James Polli Dobrovolsky, Vasily  
Large Language Models to support Bioequivalence Evaluation UCSF-Stanford FY23 CDER Russ Altman (Stanford) Zhao, Liang Charge 1 Topic C
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 UCSF-Stanford FY21 OWH Rohit Vashisht (UCSF) Doamekpor, Lauren; Bersoff-Matcha, Susan  
Leveraging human brain organoids for mixture neurotoxicity and the understanding of individual susceptibilities – BrainMixTox JHU FY21 CFSAN Hartung, Thomas Fitzpatrick, Suzanne Charge 1 Topic A
Linking data sources to elucidate non-fatal and fatal opioid-related overdose epidemiology and the role of FDA-regulated products Yale-Mayo FY17 ORSI, CDER Becker, William; Howell, Ben Dormitzer, Catherine; Greene, Christina Charge 2 Topic A
Longitudinal analysis & visualization of patient-reported physical function & symptom data Yale-Mayo FY22 OCE Thanarajasingam, Gita Bhatnagar, Vishal Charge 1 Topic E
Measurement of Metal Ions and HPHCs in Electronic Nicotine Delivery Systems (ENDS) and Their Physio-pathological Impact on Cells of the Oral Cavity and Upper Respiratory Tract UMD FY20 CTP Sarah Michel Patel, Vyomesh Charge 1 Topic C
Metabolism-based drug-drug interactions (DDI) and liver toxicity of drugs for COVID-19 treatment UMD FY20 CDER Hongbing Wang Huang, Shiew Mei  
Next Generation Text Analytics for FDA - Relevant Text Mining UCSF-Stanford FY15 OHI Stanford- Russ Altman Johanson, Elaine Charge 1 Topic C
Non-invasive Integrative Liquid Biopsy Approaches for Precision Immuno-oncology JHU FY22 OCE Valsamo Anagnostou Vellanki, Paz  
Noninvasive Process Analytical Technology (PAT) for Manufacturing Automation UMD FY23 OCET Bruce Yu, Ph.D. Coburn, James  
Orthopedic Device Mechanics UCSF-Stanford FY15 CDRH UCSF- Jeffrey Lotz Dmitriev, Anton Charge 1 Topic E
Patient and Caregiver Diversity in FDA Patient Engagement Activities and CBER-regulated Therapeutics UMD FY21 CBER Mattingly, Joey Jackler, Karen Charge 3 Topic C
Patient and provider informed labeling of Artificial Intelligence/Machine Learning-Based Software to enable transparency and trust for cardiac monitoring and diagnostics Yale-Mayo FY21 CDRH Barry, Barbara Saha, Anindita; Weinberg, Jessica Charge 1 Topic I
Patient and Provider Views on Clinical Endpoints: A Qualitative Preference Study of Minimally Invasive Glaucoma Surgical (MIGS) Devices JHU FY16 ORSI, CDRH Li, Tianjing Li; Le, Jimmy; Bridges, John; Bicket, Amanda Kiely Eydelman, Malvina B.; Tarver, Michelle Charge 1 Topic I
Patient Reported Outcomes for Minimally Invasive Glaucoma Surgery (MIGS) UCSF-Stanford FY19 CDRH Kuldev Singh (Stanford) Tarver, Michelle Charge 1 Topic I
Persistent In-Line Sensor for Real-World Loading Characterization of Osseointegrated Implants and Prosthetic Devices JHU FY22 CDRH Jonathon Thornhill Kontson, Kimberly Charge 1 Topic I
PET Evaluation of Adoptive Cancer Cellular Immunotherapy JHU FY18 CBER Nimmagadda, Sridhar Puri, Raj  
Phase 1: Development of diagnostic biomarkers for determination of traumatic brain injury UMD FY19 CDER Kane, Maureen A. Bandukwala, Abbas Charge 1 Topic D
Physiologically based pharmacokinetic model informed framework to prioritize drugs to be studied in pregnant population UMD FY23 CDER Mathangi Gopalakrishnan, M.Pharm, PhD, FCP (PI) Liu, Qi Charge 1 Topic C
Post-Market Evaluation of Smartwatch Cardiovascular Notifications UCSF-Stanford FY21 CDRH Nigam Shah (Co-PI) Saha, Anindita  
Postmarket surveillance with a novel mHealth platform Yale-Mayo FY16 ORSI, CDRH Ross, Joseph; Shah, Nilay Dong, Jun; Long, Cynthia Charge 2 Topic A
Precision Medicine Utilizing Bacillus Calmette–Guérin (BCG) Vaccine in Non-Muscle Invasive Bladder Cancer UMD FY22 OCE Mohummad Minhaj Siddiqui Lee, Daniel Charge 1 Topic D
Principal stratification methods and software for intercurrent events in clinical trials Triangle FY23 CDRH Li, Fan Shen, Yuan Li Charge 1 Topic C
Prospective Clinical Study of Pulse Oximeter Errors in Adult Hospitalized Patients with Varying Skin Pigmentation UCSF-Stanford FY22 CDRH Philip Bickler (UCSF) Torguson, Rebecca Charge 1 Topic J
Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children UCSF-Stanford FY22 CDRH Christopher Almond Tarver, Michelle  
Qualitative analysis of gender differences in heart failure Patient Reported Outcomes (PROs) Yale-Mayo FY18 CDRH Dunlay; Shannon Saha, Anindita; Caldwell, Brittany Charge 1 Topic E
Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients Yale-Mayo FY22 OCE Lee, Minji; Yost, Kathleen Bhatnagar, Vishal Charge 1 Topic E
Quantifying physical function in cancer patients undergoing chemotherapy using clinician-reported, patient-reported, and wearable device data sources Yale-Mayo FY20 OCE Thanarajasingam, Gita; Gross, Cary Kluetz, Paul Charge 1 Topic E
Quantifying the relationship between inappropriate prescribing of opioid-tolerant-only medications to patients without prior opioid tolerance and opioid-related harms Yale-Mayo FY19 CDER Jeffery, Milly Kornegay, Cynthia J; Liberatore, Mark Charge 2 Topic A
Real world short and intermediate-term safety outcomes following atrial fibrillation ablation Yale-Mayo FY17 ORSI, CDRH Akar, Joe Dong, Jun; Ward, Rebecca Charge 2 Topic A
Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations Yale-Mayo FY19 CDER Jeffery, Molly Ahadpour, Mitra Charge 2 Topic A
Real-World Population Characteristics, Safety and Effectiveness of COVID-19 Vaccines UCSF-Stanford FY21 CBER Atul Butte (PI) Whitaker, Barbee Charge 2 Topic A
Recall of patient-reported symptoms and function in episodic disease/conditions, specifically temporomandibular disorders Triangle FY23 CDRH Bennett, Antonia; Coles, Theresa Zhang, Caiyan Charge 1 Topic E
Renal Impairment in New Drug Development UCSF-Stanford FY15 CDER Kathy Giacomini (UCSF) Barratt, Ruth Charge 1 Topic C
Role of Genomic Ancestry in Tyrosine Kinase Inhibitor (TKI)-Induced Cardiotoxicity UCSF-Stanford FY22 OCE Joseph C. Wu Amiri Kordestani, Laleh Charge 2 Topic C
Safe Algorithmic Change Protocols for Modifications to AI/ML-based Software as a Medical Device UCSF-Stanford FY21 CDRH Jean Feng (UCSF) Sahiner, Berkman; Gossmann, Alexej  
Sex differences in immune profiles of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) before and after vaccination Yale-Mayo FY21 OWH Iwasaki, Akiko Bersoff-Matcha, Susan Charge 2 Topic A
Source Data Capture from Electronic Health Records (EHRs): Using Standardized Clinical Research Data (OneSource Phase I) UCSF-Stanford FY15 CDER UCSF- Laura Esserman Rocca, Mitra Charge 1 Topic J
Standardizing multi-model data for the diagnosis and prognosis of coccidioidomycosis as a model for establishing harmonized core data for additional infectious diseases Yale-Mayo FY23 CDRH Grys, Thomas Sheikh, Sarah; Jani, Pooja Charge 2 Topic E
Statistical methods to improve precision and reduce the required sample size in many phase 2 and 3 clinical trials, including COVID-19 trials, by covariate adjustment JHU FY20 CDER Michael Rosenblum Pennello, Gene Charge 1 Topic C
The impact of novel positron emission tomography (PET) imaging tracers on real-world outcomes for patients with prostate cancer Yale-Mayo FY22 OCE Leapman, Michael Fallah, Jaleh Charge 1 Topic D
The MUM study: MUltimorbidity and Medications: The unheard perspective of older adults UCSF-Stanford FY21 CDER Janice B. Schwartz (UCSF) Liu, Qi Charge 1 Topic I
The Real-World Effectiveness of COVID-19 Vaccines in the Pediatric Population Across the University of California Health System UCSF-Stanford FY22 CBER Atul Butte (UCSF) Anderson, Steven Charge 1 Topic J
Tissue Chips for Multipotent Stromal Cell Manufacturing UCSF-Stanford FY20 CBER Ngan Huang (Stanford) Sung, Kyung Charge 1 Topic B
Trace metals and their impact on protein quality, safety, and efficacy UMD FY19 CDER Michel, Sarah Rao, Ashutosh Charge 1 Topic C
Trends in Opioid Use Among Patients with Cancer Yale-Mayo FY22 ORSI, CDER Park, Henry Lerro, Catherine Charge 2 Topic A
Understanding Safety Concerns with Intravenous (IV) Misuse and Abuse of Opioids in Deterrent Formulations UMD FY20 CDER Paul Buehler Pinto, Julia Charge 1 Topic B
Understanding the contribution of laboratory data linked to administrative claims: a case study looking at renal function and oral anticoagulant performance in patients with atrial fibrillation Yale-Mayo FY17 ORSI, CDER Yao, Xaoxi; Noseworthy, Peter Graham, David J Charge 2 Topic A
Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients UCSF-Stanford FY20 OMHHE Urmimala Sarkar (UCSF) Lee, Christine  
Using Social Media for Tobacco Regulatory Intelligence JHU FY20 CTP Mark Dredze Navarro, Mario Charge 3 Topic C
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 UCSF-Stanford FY19 CBER UCSF- Atul Butte, Ayan Patel, Michelle Wang Whitaker, Barbee Charge 2 Topic A
Utilizing the UNC Clinical Data Warehouse for Assessing Efficacy, Toxicity, and Dose-Response Relationships of Molecularly Targeted Therapies in Real-World Patients Triangle FY23 OCE Cao, Yanguang (Carter); Benyam, Muluneh Shah, Mirat Charge 1 Topic J
Whole exome sequencing to predict immune related adverse events and response to checkpoint inhibitors UCSF-Stanford FY22 OCE Elad Ziv Theoret, Marc Charge 1 Topic D
Project Title CERSI Fiscal Year (FY) Lead/Funding Center CERSI Lead PI FDA Lead SME Charge/Topic Area
 
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