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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CSS2016Outcome:NonclinicalWGRocked!