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FDA/PhUSE Collaboration
Computational Sciences Symposium 2016 Outcomes
Nonclinical Working Group Co-Leads: Susan DeHaven, Sanofi & Robert Dorsam, FDA
Webinar 27 April 2016
CSS2016: Nonclinical Working Group Outcomes • BreakoutA+endanceandAc/onbe+erthanever
– over60a+endeesrepresen/ngFDA,PMDA,Pharma,CROsandsoAwarevendors.
– Nineprojectteamswillgoforwardintothecoming“PhUSEYear”toanswertheirhighestprioritydatachallenges
• Highlights– Collabora/onPosterAwardfortheNonclinicalSDRGposter!– AssessmentofcurrentstateofSEND-readinessinIndustry
• Teamconclusion:Industryprogressbutroomforimprovement• NewProjectTeamsformedtotackleemergingimplementa/onissues
– ExtensivestakeholderdiscussionsonDataVisualiza/onandAnalysis• Mul/pleneedsiden/fiedresul/ngonseveralkeyprojects:oneforvisualiza/on,oneforanalysisandoneforscriptdevelopment
Nine Nonclinical Projects for the Coming Year
1. SENDImplementa/onUserGroup–Newcollabora/onwithSDTM/ADAMFAQ!– SENDexpertadviceonFAQ+noncompe77ve
discussionforumonques7onsaboutSENDimplementa7on
– Co-Leads:TroySmyrnios,Zoe7s&DebraOetzman,Instem
2. NonclinicalStudyDataReviewer’sGuide– FDAFederalRegisterNo7ceforIntenttoReview,
issuedjustpriortoCSS–s7ll7metocomment!
• FivededicatedtoSENDImplementa/on;FourtoAnalysis&Visualiza/on
• Contactco-leadstocontribute!
– Co-Leads:SusanDeHaven,Sanofi&LauraKaufman,PDS&DebraOetzman,Instem
Nine Nonclinical Projects for the Coming Year
3. AnnualSENDImplementa/onStatusSurvey– 2016SurveyResults:Fullresult.pdfonPhUSEWIKI.– Outcome:Manyareinearlystagesofimplementa7on,allhavewaytogo.– Co-Leads:GeorgeKahlbaugh,Boehringer-Ingelheim&LouAnnKramer,Instem
Nine Nonclinical Projects for the Coming Year
4. New!DataConsistency:SENDDatasetsandtheStudyReport– Objec7ve:Iden7fyandaddressinconsistenciesbetweenthestudyreportandthe
SENDdatasets.Developsolu7onsforhowcompaniesgoaboutfixingtheonesthatarenotdeemedacceptable
– Callforpar7cipants!– Co-Leads:MariaFrancomacaro,Merck&FredWood,Accenture
5. New!TestSubmissionForum– Objec7ve:Iden7fybarriersassociatedwithcomple7ngtestsubmissionsand
determinewaystodemys7fytheprocess.Getfeedbackfromorganiza7onsthathaveorwillsubmittestsubmissions
– ProjectconductedwiththeSENDImplementa7onUserGroup– Callforpar7cipants!– Co-Leads:DaveEpstein,FDA&KathyBrown,Sanofi
Nine Nonclinical Projects for the Coming Year
6. Applica/onofSENDDataforAnalysis– DetermineSENDdatafitforanalysis.Iden7fyrepor7ngtables(e.g.,LIMS,FDA
ReviewTemplate),createtablelibrary,andpriori7zeworkonadomainbydomainlevel.
– TocollaboratewithNonclinicalScriptsAssessmentproject– Leader:GibeFrausing,DataStandardsDecisions
7. New!NonclinicalScriptsAssessment– ExploredevelopmentofanalysisscriptstoquerySENDdata.Evaluateexis7ng
clinicalscriptsfornonclinicaluse.Iden7fyprocessforpriori7zing,developing,andreleasinganalysisscripts
– Co-Leads:WilliamHouser,BMS&KevinSnyder,FDA
Nine Nonclinical Projects for the Coming Year 8. Visualiza/onofGroupDifferencesinHistopathologyData
– Ini7alObjec7venearcomple7on:Explorehowtographicallydisplayhistopathdatatoiden7fy/communicategroupdifferences,pabernsinresponse,andphenotypicexpression.FurtherObjec7veunderway:Explorecross-domainandmul7-studyanalyses(includingorganweights,clinicalpathology,histopathologyandin-lifedata).
– Collabora7onspossiblewithNonclinicalScriptsAssessmentandClinicalDataVisualiza7ongroups
– Co-Leads:WilliamHouser,BMS&PhilDrew,PDSConsultantsPhilDrew(PDS)&SreeRayavarapu,FDA
9. Inves/ga/ngEndpointModeling-Biomarkers,ADAdataandImmunophenotyping– Objec7vesnearcomple7on:ExploremodelingBiomarkers,ADA(An7-DrugAn7bodies),and
Immunophenotypingdata.ResearchClinicalexperiencewiththeseendpointstoensurealignmentwherepossible.Provideguidelinewhencustomdomainsareneededorwhenexisi7ngdomainscanorshouldbeused.
– Co-Leads:MikeWasko,PDS&DebraOetzman,Instem
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