2023
Neuroimaging to monitor worsening of multiple sclerosis: advances supported by the grant for multiple sclerosis innovation
Oh J, Airas L, Harrison D, Järvinen E, Livingston T, Lanker S, Malik R, Okuda D, Villoslada P, de Vries H. Neuroimaging to monitor worsening of multiple sclerosis: advances supported by the grant for multiple sclerosis innovation. Frontiers In Neurology 2023, 14: 1319869. PMID: 38107636, PMCID: PMC10722910, DOI: 10.3389/fneur.2023.1319869.Peer-Reviewed Original ResearchMultiple sclerosisClinical trialsMonitoring of MSMagnetic resonance imagingPositron emission tomographyDisability worseningKey unmetCentral pathologyEarly pathologyTreatment responseNew therapiesOcular imagingUnmet needResonance imagingEmission tomographyDisease pathologyNew therapeuticsPathologyNeuroimaging measuresTrialsLongitudinal studySclerosisClinicWorseningBiomarkersUS Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
Eadie A, MacGregor A, Wallach J, Ross J, Herder M. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics. BMJ Evidence-Based Medicine 2023, 28: 151-156. PMID: 36944478, DOI: 10.1136/bmjebm-2022-112005.Peer-Reviewed Original ResearchConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministrationThe Difficult Path to the Discovery of Novel Treatments in Psychiatric Disorders
Gribkoff V, Kaczmarek L. The Difficult Path to the Discovery of Novel Treatments in Psychiatric Disorders. Advances In Neurobiology 2023, 30: 255-285. PMID: 36928854, PMCID: PMC10599454, DOI: 10.1007/978-3-031-21054-9_11.Peer-Reviewed Original ResearchConceptsNervous system diseasesSystem diseasesPsychiatric disordersPsychiatric patientsNew drugsDetermination of efficacyDiseases/disordersNovel therapiesNovel treatmentsPsychiatric diseasesDiscovery effortsNew therapeuticsDisordersDiseaseDrugsPatientsFace validityPredictive validityTreatmentDiscoveryPresent particular challengesHuman healthRecent advancesTherapyClinicians
2022
New Therapeutics in Alzheimer’s Disease Longitudinal Cohort study (NTAD): study protocol
Lanskey J, Kocagoncu E, Quinn A, Cheng Y, Karadag M, Pitt J, Lowe S, Perkinton M, Raymont V, Singh K, Woolrich M, Nobre A, Henson R, Rowe J. New Therapeutics in Alzheimer’s Disease Longitudinal Cohort study (NTAD): study protocol. BMJ Open 2022, 12: e055135. PMID: 36521898, PMCID: PMC9756184, DOI: 10.1136/bmjopen-2021-055135.Peer-Reviewed Original ResearchConceptsMild cognitive impairmentEarly-stage Alzheimer's diseaseCognitive impairmentPeer-reviewed scientific journalsLongitudinal cohort studyResearch Ethics CommitteeAlzheimer's diseaseAmyloid-positive mild cognitive impairmentAlzheimer's disease studyConference presentationsCohort studyMeasures of diseaseCognitive AssessmentDisease StudyStudy protocolPrimary analysisEthics CommitteeLongitudinal changesParticipantsCognitive changesWebsite publicationClinical trial durationNew therapeuticsEast of England-Cambridge Central Research Ethics CommitteeProgression of Alzheimer's diseaseDendritic Spines and Pain Memory
Benson C, King J, Reimer M, Kauer S, Waxman S, Tan A. Dendritic Spines and Pain Memory. The Neuroscientist 2022, 30: 294-314. PMID: 36461773, DOI: 10.1177/10738584221138251.Peer-Reviewed Original ResearchNeuropathic painDendritic spinesSynaptic transmissionSpinal cord dorsal hornForm of painNew therapeutic approachesSurface of neuronsDorsal hornIntractable painDeep laminaePain memoryTherapeutic approachesPainNervous systemNew therapeuticsSpineMillions of peopleInjuryDiseaseRecent studiesReview articlePrevalenceNeuronsImportant roleSerological fingerprints link antiviral activity of therapeutic antibodies to affinity and concentration
Fiedler S, Devenish S, Morgunov A, Ilsley A, Ricci F, Emmenegger M, Kosmoliaptsis V, Theel E, Mills J, Sholukh A, Aguzzi A, Iwasaki A, Lynn A, Knowles T. Serological fingerprints link antiviral activity of therapeutic antibodies to affinity and concentration. Scientific Reports 2022, 12: 19791. PMID: 36396691, PMCID: PMC9672333, DOI: 10.1038/s41598-022-22214-z.Peer-Reviewed Original ResearchConceptsSerum antibody responseAntiviral activityHigh antiviral activityAntibody responseTherapeutic mAbsReduced antiviral activityVirus neutralization assaysSARS-CoV-2 virusSARS-CoV-2Convalescent individualsNeutralization assaysTherapeutic monoclonal antibodiesSame mAbMonoclonal antibodiesNew therapeuticsTherapeutic antibodiesMAbsAntibodiesRBDSotrovimabWild typeActivitySerumModeling gene × environment interactions in PTSD using human neurons reveals diagnosis-specific glucocorticoid-induced gene expression
Seah C, Breen M, Rusielewicz T, Bader H, Xu C, Hunter C, McCarthy B, Deans P, Chattopadhyay M, Goldberg J, Dobariya S, Desarnaud F, Makotkine I, Flory J, Bierer L, Staniskyte M, Noggle S, Huckins L, Paull D, Brennand K, Yehuda R. Modeling gene × environment interactions in PTSD using human neurons reveals diagnosis-specific glucocorticoid-induced gene expression. Nature Neuroscience 2022, 25: 1434-1445. PMID: 36266471, PMCID: PMC9630117, DOI: 10.1038/s41593-022-01161-y.Peer-Reviewed Original ResearchConceptsPost-traumatic stress disorderPeripheral blood mononuclear cellsGlucocorticoid-induced changesGlucocorticoid-induced gene expressionBlood mononuclear cellsIndividual clinical outcomesEnvironmental risk factorsHuman postmortem brainGlucocorticoid hypersensitivityClinical outcomesGlutamatergic neuronsMononuclear cellsRisk factorsHydrocortisone exposureSevere traumaPostmortem brainsHuman neuronsGlucocorticoid responseInduced neuronsStress disorderNeuronsNew therapeuticsGene expressionGene × environment interactionsCombat veteransResponse of Human Toll–Like Receptor 2 During the Infection of Leptospirosis
Kappagoda C, Senavirathna I, Warnasekara J, Srimantha S, De Silva N, Agampodi S. Response of Human Toll–Like Receptor 2 During the Infection of Leptospirosis. International Journal Of Infectious Diseases 2022, 116: s71. DOI: 10.1016/j.ijid.2021.12.167.Peer-Reviewed Original ResearchToll-like receptor2Human TLR2 geneTLR2 geneMouse modelToll-like receptor 2Human Toll-like receptor 2Results 64 patientsInnate immune responsePathogenic Leptospira sppGene expression analysisImmune responseStudy populationReceptor 2Receptor responsesTLR2 regulationPatientsLeptospirosisLeptospira sppNew therapeuticsWhole bloodGene expression studiesGene amplificationReverse transcriptaseInfectionTotal RNAAMPK and Polycystic Kidney Disease Drug Development: An Interesting Off-Target Target
Caplan MJ. AMPK and Polycystic Kidney Disease Drug Development: An Interesting Off-Target Target. Frontiers In Medicine 2022, 9: 753418. PMID: 35174190, PMCID: PMC8841847, DOI: 10.3389/fmed.2022.753418.Peer-Reviewed Original ResearchCellular signaling pathwaysPolycystic kidney diseasePolycystic kidney disease mutationCellular energy useProtein kinaseMaster regulatorCellular metabolismSignaling pathwaysDisease mutationsGenetic diseasesTissue architectureEnzyme activityDramatic perturbationsAutosomal dominant polycystic kidney diseasePathwayDominant polycystic kidney diseaseNew therapeuticsMutationsRenal tissue architectureDrug developmentCellsKinaseAMPKGeneration pathwaysGenes
2021
Alpha power is associated with hippocampal volume in Alzheimer’s disease: A combined MEG and MRI study
Pitt J, Quinn A, Kocagoncu E, Karadag‐Assem M, Lanskey J, Klimovich‐Gray A, Cheng Y, Raymont V, Rowe J, Nobre A, Woolrich M. Alpha power is associated with hippocampal volume in Alzheimer’s disease: A combined MEG and MRI study. Alzheimer's & Dementia 2021, 17 DOI: 10.1002/alz.052308.Peer-Reviewed Original ResearchMild cognitive impairmentAssociated with MMSE scoreHippocampal volumeAlpha frequencyEyes closed conditionsCognitive impairmentAlpha peak frequencyAssociated with hippocampal volumeClinical benefitDementia researchAlzheimer's diseaseAmyloid-positive mild cognitive impairmentHealthy controlsIncreasing cognitive impairmentClinical trialsProgressive atrophyMulti-centreMMSE scorePatientsStage of mild cognitive impairmentCalculate hippocampal volumeMRI studiesAlpha rhythmNew therapeuticsAD patientsUS 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 ResearchConceptsClinical 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 approvalGenetic contributions to anxiety disorders: where we are and where we are heading
Ask H, Cheesman R, Jami ES, Levey DF, Purves KL, Weber H. Genetic contributions to anxiety disorders: where we are and where we are heading. Psychological Medicine 2021, 51: 2231-2246. PMID: 33557968, DOI: 10.1017/s0033291720005486.Peer-Reviewed Original ResearchConceptsLarge-scale genome-wide association studiesGenome-wide association studiesGenetics of anxietyGenome-wide studiesRelated traitsAssociation studiesGeneticsGenetic contributionSpecific gene-environment interactionsGene-environment interactionsCurrent knowledgeTraitsNew therapeuticsSuch discoveriesDiscoveryNew research possibilitiesLifespanTherapeuticsCircuit mechanismsTranslation
2019
Metabolism: A Burning Opioid Issue in Obesity Therapeutics
da Silva Catarino J, Horvath TL. Metabolism: A Burning Opioid Issue in Obesity Therapeutics. Current Biology 2019, 29: r1323-r1325. PMID: 31846684, DOI: 10.1016/j.cub.2019.10.055.Peer-Reviewed Original ResearchChallenges and approaches to implementing master/basket trials in oncology
Burd A, Schilsky RL, Byrd JC, Levine RL, Papadimitrakopoulou VA, Herbst RS, Redman MW, Druker BJ, Gandara DR. Challenges and approaches to implementing master/basket trials in oncology. Blood Advances 2019, 3: 2237-2243. PMID: 31337605, PMCID: PMC6650731, DOI: 10.1182/bloodadvances.2019031229.Peer-Reviewed Original ResearchConceptsBasket trialsClinical trial designHealth care providersDifferent tumor typesTherapeutic optionsImmunologic reactionsCare providersDrug development effortsTrial designTumor typesPatientsMost cancersClinical researchNew therapeuticsCancer communityTherapy todayMedical institutionsCancerCancer researchTrialsRare mutationsEpigenetic changesHistologyOncologyAppetite
2017
Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open 2017, 7: e014582. PMID: 28179418, PMCID: PMC5306516, DOI: 10.1136/bmjopen-2016-014582.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyCohort studyClinical impactRare diseaseHealth CanadaNew therapeuticsLikely clinical impactPotential clinical impactUS patientsAvailable therapiesNovel mechanismDrug AdministrationMedicines AgencyNovel therapeuticsUS approvalNew drugsDrugsFDA submissionsReview outcomesTherapeuticsSafety concernsDiseaseFDAMechanistic noveltyAffected population
2015
Immunotherapy and targeted therapy for cervical cancer: an update
Menderes G, Black J, Schwab CL, Santin AD. Immunotherapy and targeted therapy for cervical cancer: an update. Expert Review Of Anticancer Therapy 2015, 16: 83-98. PMID: 26568261, DOI: 10.1586/14737140.2016.1121108.Peer-Reviewed Original ResearchConceptsCervical cancer patientsCervical cancerCancer patientsImmune check pointsUse of immunotherapyMetastatic cervical cancerPrognosis of patientsActionable driver mutationsTyrosine kinase inhibitorsImmune system interactionsImmunotherapy studiesMedian survivalAngiogenesis inhibitorsChemotherapeutic drugsPatientsDriver mutationsKinase inhibitorsNew therapeuticsCancerNext-generation sequencingImmunotherapyTherapyGeneration sequencingInhibitorsPrognosisThe Genetic Basis of Mendelian Phenotypes: Discoveries, Challenges, and Opportunities
Chong JX, Buckingham KJ, Jhangiani SN, Boehm C, Sobreira N, Smith JD, Harrell TM, McMillin MJ, Wiszniewski W, Gambin T, Akdemir Z, Doheny K, Scott AF, Avramopoulos D, Chakravarti A, Hoover-Fong J, Mathews D, Witmer PD, Ling H, Hetrick K, Watkins L, Patterson KE, Reinier F, Blue E, Muzny D, Kircher M, Bilguvar K, López-Giráldez F, Sutton VR, Tabor HK, Leal SM, Gunel M, Mane S, Gibbs RA, Boerwinkle E, Hamosh A, Shendure J, Lupski JR, Lifton RP, Valle D, Nickerson DA, Genomics C, Bamshad MJ. The Genetic Basis of Mendelian Phenotypes: Discoveries, Challenges, and Opportunities. American Journal Of Human Genetics 2015, 97: 199-215. PMID: 26166479, PMCID: PMC4573249, DOI: 10.1016/j.ajhg.2015.06.009.Peer-Reviewed Original ResearchConceptsMendelian phenotypesGenetic basisLarge-scale whole-exome sequencingMendelian conditionsGene functionGene regulationGenomic dataWhole-exome sequencingMendelian GenomicsGenesPhenotypic characterizationNovel mechanismExtensive clinical variabilityGenetic variantsPhenotypePervasive sharingBiological mechanismsSequencingNew therapeuticsSuch discoveriesFamilyDiscoveryHuman healthGenomicsClinical variability
2014
Crystallographic and Receptor Binding Characterization of Plasmodium falciparum Macrophage Migration Inhibitory Factor Complexed to Two Potent Inhibitors
Pantouris G, Rajasekaran D, Garcia AB, Ruiz VG, Leng L, Jorgensen WL, Bucala R, Lolis EJ. Crystallographic and Receptor Binding Characterization of Plasmodium falciparum Macrophage Migration Inhibitory Factor Complexed to Two Potent Inhibitors. Journal Of Medicinal Chemistry 2014, 57: 8652-8656. PMID: 25268646, PMCID: PMC4207548, DOI: 10.1021/jm501168q.Peer-Reviewed Original ResearchAdult Cancer Clinical Trials That Fail to Complete: An Epidemic?
Stensland K, McBride R, Latif A, Wisnivesky J, Hendricks R, Roper N, Boffetta P, Hall S, Oh W, Galsky M. Adult Cancer Clinical Trials That Fail to Complete: An Epidemic? Journal Of The National Cancer Institute 2014, 106: dju229. PMID: 25190726, DOI: 10.1093/jnci/dju229.Peer-Reviewed Original ResearchConceptsClinical trialsCancer clinical trialsNational Cancer InstituteCumulative incidence of failureCooperative group trialsStandard therapeutic approachClinical drug developmentIncidence of failureCumulative incidenceEligible patientsPreclinical discoveryTherapeutic approachesCancer therapeuticsCancer InstituteCancer biologyCancerPatientsNew therapeuticsTherapeutic targetGroup trialClinical trial enterpriseTrialsDrug to marketDrug developmentClinical trial system
2011
Glutamate abnormalities in obsessive compulsive disorder: Neurobiology, pathophysiology, and treatment
Pittenger C, Bloch MH, Williams K. Glutamate abnormalities in obsessive compulsive disorder: Neurobiology, pathophysiology, and treatment. Pharmacology & Therapeutics 2011, 132: 314-332. PMID: 21963369, PMCID: PMC3205262, DOI: 10.1016/j.pharmthera.2011.09.006.Peer-Reviewed Original ResearchConceptsObsessive-compulsive disorderTreatment-refractory OCDGlutamate-modulating agentsSmall clinical trialsNew treatment strategiesCompulsive disorderExcitatory neurotransmitter glutamatePathophysiology of OCDGlutamate abnormalitiesGlutamate dysregulationMonoaminergic neurotransmissionCurrent therapiesClinical trialsDopaminergic neurotransmissionTreatment strategiesCognitive-behavioral psychotherapyTherapeutic benefitAnimal modelsNeurotransmitter glutamateNeurochemical investigationsPathophysiologyNew therapeuticsDisordersRecent evidenceMedications
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