Joshua J. Skydel, MD
Clinical FellowDownloadHi-Res Photo
Cards
Education
MD
Tufts University School of Medicine (2021)
Tufts University School of Medicine (2021)
BS (Hon)
University of Connecticut, Biological Sciences (2016)
University of Connecticut, Biological Sciences (2016)
Training
Clinical and Research Fellow
Yale-New Haven Hospital (2027)
Yale-New Haven Hospital (2027)
Resident
Dartmouth Hitchcock Medical Center (2024)
Dartmouth Hitchcock Medical Center (2024)
About
Copy Link
Titles
Clinical Fellow
Biography
Joshua Skydel, MD, attended Tufts University School of Medicine, earning his medical degree in 2021. He completed his residency in internal medicine at Dartmouth Hitchcock Medical Center before joining the Yale Rheumatology fellowship program in 2024. Dr. Skydel's research interests include US pharmaceutical policy and "meta-research" into the role of real-world evidence to support the use of new therapies, including disease-modifying antirheumatic drugs. With members of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), he has published on the US Food and Drug Administration's use of expedited review programs and postmarketing actions, enrollment patterns for clinical trials of new lupus therapies, and biosimilar policy.
Last Updated on December 16, 2025.
Departments & Organizations
Education & Training
- Clinical and Research Fellow
- Yale-New Haven Hospital (2027)
- Resident
- Dartmouth Hitchcock Medical Center (2024)
- MD
- Tufts University School of Medicine (2021)
- BS (Hon)
- University of Connecticut, Biological Sciences (2016)
Board Certifications
Internal Medicine
- Certification Organization
- American Board of Internal Medicine
- Original Certification Date
- 2024
Research
Copy Link
Overview
Medical Research Interests
Antirheumatic Agents; Evidence Gaps; Informatics; Price Transparency; Rheumatic Diseases; Rheumatology; United States Food and Drug Administration
Public Health Interests
Health Economics; Health Policy; Pharmaceuticals and Medical Devices; Regulatory Affairs
ORCID
0000-0002-3527-4277
Research at a Glance
Yale Co-Authors
Frequent collaborators of Joshua J. Skydel's published research.
Research Interests
Research topics Joshua J. Skydel is interested in exploring.
Joseph Ross, MD, MHS
Reshma Ramachandran, MD, MPP, MHS
Jennifer E Miller, PhD
Mallory Kathryn Ellingson, MPH
Michaela Dinan, PhD
Osman Moneer
United States Food and Drug Administration
Publications
Featured Publications
Regulatory change could improve biosimilar access in the US
Jiang T, Ramachandran R, Skydel J. Regulatory change could improve biosimilar access in the US. The BMJ 2025, 390: e084860. PMID: 40730379, DOI: 10.1136/bmj-2025-084860.Peer-Reviewed Original ResearchAltmetricGeographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies
Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.Peer-Reviewed Original ResearchCitationsAltmetricUS Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
2024
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study
Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.Peer-Reviewed Original ResearchCitationsAltmetricConceptsNational Comprehensive Cancer NetworkNational Comprehensive Cancer Network guidelinesComprehensive Cancer NetworkFood and Drug AdministrationCancer NetworkUS Food and Drug AdministrationCategories of evidenceAccelerated approvalCross sectional studyDrug treatmentConfirmatory trialsClinical benefitTrial resultsOncological indicationsTraditional approvalGuideline recommendationsOutcome measuresSectional studyApproval statusFDA decisionRecommended alignmentOncologyUpdate recommendationsPostapproval trialsGuidelines
2023
Want to make drugs, including insulin, affordable? End patent abuse.
Skydel J, Ramachandran R. Want to make drugs, including insulin, affordable? End patent abuse. The Baltimore Sun. 03/03/2023. https://www.baltimoresun.com/opinion/op-ed/bs-ed-op-0306-pharmaceutical-patent-abuse-20230303-i5m23qxza5dkfd2oji5fv3v4ru-story.htmlPublications for non-academic audiences
2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
Skydel J, Ross J, Ramachandran R. Accelerated approval: unfulfilled promises for FDA’s expedited review program. The Hill. 05/27/2022. https://thehill.com/blogs/congress-blog/3504591-accelerated-approval-unfulfilled-promises-for-fdas-expedited-review-program/Publications for non-academic audiencesAgreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study
Moneer O, Daly G, Skydel JJ, Nyhan K, Lurie P, Ross JS, Wallach JD. Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study. The BMJ 2022, 377: e069400. PMID: 35537738, PMCID: PMC9086409, DOI: 10.1136/bmj-2021-069400.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsCOVID-19 treatmentObservational studyMeta-epidemiological studyEfficacy outcomesLopinavir-ritonavirLiving reviewTreatment effectsCOVID-19 treatment guidelinesSame interventionCOVID-19Continuous outcomesMeta-analyze evidenceTrial sequential analysisSummary treatment effectsDistribution of sexTreatment guidelinesIndividual RCTsSelection of studiesEvidence DatabasePlacebo comparatorClinical dataStudy demographicsRCTsDichotomous outcomesTherapeutic interventionsSpending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial results
2021
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, Ross JS. Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. JAMA Network Open 2021, 4: e2133667. PMID: 34751763, PMCID: PMC8579227, DOI: 10.1001/jamanetworkopen.2021.33667.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsReporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatients
Academic Achievements & Community Involvement
Copy Link
Featured
honor Student and Resident Research Award
10/01/2023National AwardRheumatology Research FoundationDetailsUnited States
Activities
activity Associations between Representation and Quality in Clinical Trials for Systemic Lupus Erythematosus
10/28/2025 - PresentPoster PresentationACR Convergence 2025DetailsChicago, IL, United StatesCollaborators- Joshua J. Skydel, MD
- Anna LelandEmory University, Rollins School of Public Health
- Reshma Ramachandran, MD, MPP, MHS
- Fotios Koumpouras, MD
- Joshua D. WallachEmory University, Rollins School of Public Health
activity Heterogeneous neutrophil subsets infiltrate glomeruli of lupus nephritis patients and are elevated in the kidneys and urine of sunlight-induced nephritis flares
11/18/2024 - PresentPoster PresentationACR Convergence 2024DetailsWashington, DC, United StatesCollaborators- Noelle KosarekGeisel School of Medicine at Dartmouth
- Joshua J. Skydel, MD
- Alecia RoyDartmouth College
- Fred KollingGeisel School of Medicine at Dartmouth
- Lucas SalasGeisel School of Medicine at Dartmouth
- Christopher BurnsDartmouth Hitchcock Medical Center
- Andrea FavaJohns Hopkins University
- Sladjana Skopelja-GardnerGeisel School of Medicine at Dartmouth
activity Geographic and demographic representation in industry-sponsored, US-based clinical trials of systemic lupus erythematosus therapies
11/13/2023 - PresentOral PresentationACR Convergence 2023DetailsSan Diego, CA, United StatesCollaborators- Joshua J. Skydel, MD
- Reshma Ramachandran, MD, MPP, MHS
- Sakinah Carter Suttiratana, PhD, MPH, MBA
- Joseph Ross, MD, MHS
- Joshua Wallach
- Christopher BurnsDartmouth Hitchcock Medical Center
activity Spatial transcriptomics reveals normal-density and low-density neutrophils are more prevalent than macrophages in lupus nephritis glomeruli, and urine DNA methylation analyses capture both myeloid populations
11/13/2023 - PresentPoster PresentationACR Convergence 2023DetailsSan Diego, CA, United StatesCollaborators- Sladjana Skopelja-GardnerGeisel School of Medicine at Dartmouth
- Joshua J. Skydel, MD
- Alecia RoyDartmouth College
- Brenna KerinGeisel School of Medicine at Dartmouth
- James WhitleyGeisel School of Medicine at Dartmouth
- Fred KollingGeisel School of Medicine at Dartmouth
- Noelle KosarekGeisel School of Medicine at Dartmouth
- Michelle PetriJohns Hopkins University
- Andrea FavaJohns Hopkins University
- Lucas SalaGeisel School of Medicine at Dartmouth
- Christopher BurnsDartmouth Hitchcock Medical Center
activity Exploring the clinical characteristics and correlation with corticosteroid dependence in polymyalgia rheumatica (PMR) patients: insights from an academic center
11/13/2023 - PresentPoster PresentationACR Convergence 2023DetailsSan Diego, CA, United StatesCollaborators- William RigbyDartmouth Hitchcock Medical Center
- Todd MackenzieDartmouth College
- Emily CampbellDartmouth Hitchcock Medical Center
- Joshua J. Skydel, MD
- Bryan SavageDartmouth Hitchcock Medical Center
- Monica DimambroDartmouth College
- Vivekanand TiwariDartmouth Hitchcock Medical Center
News
Copy Link
News
Get In Touch
Copy Link