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.

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Project Title	CERSI	Fiscal Year (FY)	Lead/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 Electronic Approach for Post-Market Safety Monitoring for Antibiotic-Associated Adverse Events	JHU	FY21	CDER	Cosgrove, Sara	Gopinath, Ramya	Charge 2 Topic D
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	Charge 1 Topic G
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	Charge 1 Topic B
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 disparities in occurrence of type 2 diabetes adverse drug events in minority populations using real world administrative claims and electronic health records	JHU	FY20	CDER	Hadi Kharrazi	Liu, Qi (CDER)	Charge 2 Topic A
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	Charge 1 Topic
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	Charge 1 Topic J
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
Biokinetic modeling of hemolysis and renal injury in cardiopulmonary bypass patients: Establishing safety acceptance criteria for blood damage caused by medical devices	UMD	FY21	CDRH	Buehler, Paul	Saylor, David M	Charge 1 Topic D
Building Capacity for Research on Cancer and Aging: The UMGCCC-Medicare Database	UMD	FY21	OCE	Joanne Dorgan	Rivera, Donna	Charge 1 Topic J
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
Characterizing Benefit-Risk Tradeoffs in Opioid-Based Chronic Pain Treatment	UCSF-Stanford	FY19	CDRH	Stanford - Sean Mackey, Corinne Jung, Kate Lorig; Univ Houston - Partha Krishnamurthy, Ye Hu; Northwestern - Karon Cook	Tarver, Michelle	Charge 1 Topic I
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	Charge 1 Topic D
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
Community-Level Simulation of Opioid-Related Health Outcomes	Yale-Mayo, JHU	FY21	CDER	Taylor, Andrew (Yale); Ballreich, Jeromie (JHU)	Ahadpour, Mitra	Charge 2 Topic F
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	Charge 1 Topic D
Creating a Framework for a National Adaptive Platform Trial to Evaluate Pediatric Medical Devices	UCSF-Stanford	FY20	CDRH	Christopher Almond (Stanford)	Peiris, Vasum	Charge 1 Topic F
Data-informed Models to Identify Optimal Opioid Use Disorder Treatment Trajectories	UMD	FY20	CDER	Danya Qato	Coleman, Blair	Charge 3 Topic D
Defining SARS-CoV-2 vaccine-induced immunity in pregnant and lactating people	JHU	FY21	OWH	Klein, Sabra	Nugent, Bridget	Charge 1 Topic D
Developing Frameworks and Tools for Integration of Digital Health Tools into Clinical Practice	UCSF-Stanford	FY18	CDRH	Andrew Auerbach (UCSF)	Rashid, Leeda	Charge 3 Topic C
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 computational methods to inform public health decisions for newly emerging opioids	UMD	FY24	CDER	Shen, Jana	Stavitskaya, Lidiya	Charge 1 Topic C
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	Charge 1 Topic B
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 the Application of Machine Learning Algorithms to the Management of Postpartum Hemorrhage	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	Charge 1 Topic E
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	Charge 2 Topic E
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	JHU	FY17	CTP	Moran, Meghan; Kennedy, Ryan; Lagasse, Lisa	Trigger, Sarah	Charge 2 Topic E
Hyperspectral Interferometric Scattering Microscopy for Characterizing Nanoparticle-based Therapeutics	UMD	FY20	CDER	Woehl, Taylor	Qin, Bin	Charge 1 Topic C
Identification and Validation of Biomarkers for Breast Cancer Resistance Protein	UCSF-Stanford	FY20	CDER	Sook Wah Yee (UCSF)	Liu, Qi (CDER)	Charge 1 Topic D
Identify Genotype-Phenotype and Pharmacogenetic Association Using a Population-scale Cellular Platform	UCSF-Stanford	FY22	CDER	Joseph C. Wu	Strauss, David; Ford, Kevin	Charge 1 Topic G
Identifying, Selecting, and Utilizing Quantitative Bias Analysis Methods	Yale-Mayo	FY22	CDER	Wallach, Joshua	Hua, Wei; Zhang, Mingfeng	Charge 2 Topic B
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	Charge 1 Topic J
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, Samit	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
Improving the Integrity of Novel Digital Health Technology-derived Endpoints through Rigorous Simulation Studies of Multiple Imputation Techniques	UCSF-Stanford	FY23	CDER	Manisha Desai	Kam, Maria Matilde	Charge 1 Topic J
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	Charge 1 Topic G
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	Charge 1 Topic A
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	Charge 1 Topic G
Methods to capture post-market patient preference information	Yale-Mayo	FY19	OWH	Hargraves, Ian	Bersoff-Matcha, Susan	Charge 2 Topic E
Microphysiological Systems for the Evaluation of Drug-induced Liver Injury	UMD	FY24	CDER	Hongbing Wang	Sadrieh, Nakissa	Charge 1 Topic A
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	Charge 1 Topic D
Noninvasive Process Analytical Technology (PAT) for Manufacturing Automation	UMD	FY23	OCET	Bruce Yu, Ph.D.	Coburn, James	Charge 1 Topic B
Novel DHT-centric statistical methods for subject-level fingerprinting and handling missingness	JHU	FY23	CDER	Vadim Zipunnikov	Kam, Maria Matilde	Charge 1 Topic J
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	Charge 1 Topic G
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	Charge 2 Topic A
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
Predicting Pediatric Dosing for Medical Countermeasures	UCSF-Stanford	FY16	CDER	Sook Wah Yee (UCSF)	Huang, Shiew Mei	Charge 1 Topic F
Prescription Stimulants for Attention-Deficit/Hyperactivity Disorder (ADHD): Prescribing Patterns and Associated Consequences in the Veterans Health Administration	Yale-Mayo	FY24	CDER	Jennifer Edelman	PerezVilar, Silvia	Charge 2 Topic A
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	Charge 1 Topic J
Qualitative analysis of sex 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, Molly	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
Redefining the paradigm for Lyme disease diagnosis and therapeutics	Yale-Mayo	FY24	CDRH	Thomas Grys	Honey, Kristen	Charge 2 Topic G
Renal Impairment in New Drug Development	UCSF-Stanford	FY15	CDER	Kathy Giacomini (UCSF)	Barratt, Ruth	Charge 1 Topic C
Renal Impairment in New Drug Development	UCSF-Stanford	FY20	CDER	Timothy Meyer (Stanford)	Huang, Shiew Mei	Charge 1 Topic D
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	Charge 2 Topic B
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 Assessment of Commercially Available In-Home Drug Disposal Products	UMD	FY24	CDER	Stephen W. Hoag, Ph.D.	Nguyen, Bic (CDER)	Charge 3 Topic D
The Digital Variome: Understanding the Implications of Digital Tools on Health	UCSF-Stanford	FY21	CDRH	Andy Auerbach (UCSF)	Rashid, Leeda	Charge 1 Topic J
The Effect of Excipients on the Oral Absorption of Fexofenadine in Humans	UCSF-Stanford	FY20	CDER	Katherine Yang (UCSF)	Al-Ghabeish, Manar	Charge 1 Topic G
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 MUM-URMA1 study: Multimorbidity and Medications: the unheard perspective of older Under-Represented Racial and Ethnic Minority Adults: Phase 1	UCSF-Stanford	FY22	CDER	Janice B. Schwartz (UCSF)	Lee, Christine (OC); Liu, Qi (CDER)	Charge 3 Topic C
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
The Regulatory Effect of Substrate Mechanical Properties on the Production and Immunomodulation Efficacy of Mesenchymal Stem Stromal Cells	JHU	FY21	CBER	Gu, Luo	Sung, Kyung	Charge 1 Topic B
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 How Flavors and Nicotine are Used in Electronic Nicotine Delivery Systems Advertising (Phases 1 and 2)	JHU	FY20	CTP	Kennedy, Ryan; Moran Meghan; Welding, Kevin; Czaplicki, Lauren	Kelley, Dannielle	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
Understanding the use of existing real-world data for medical product evaluation	Yale-Mayo	FY19	CDER	Wallach, Joshua	Quinto, Kenneth; Gandotra, Charu; Bradley, Marie	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	Charge 1 Topic E
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