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2nd Excipient Workshop: Focus on Excipient Quality, Compendial Testing, and Regulatory Impact November 17-18, 2015 USP Meetings Center, Rockville, Maryland USA
2nd Excipient Workshop: Focus on Excipient Quality, Compendial Testing, and Regulatory Impact
November 17-18, 2015 USP Meetings Center, Rockville, MD USA
Preliminary Agenda (Updated November 15, 2015)
DAY ONE: Tuesday, November 17, 2015 8:00 – 8:30 a.m. Registration and Coffee 8:30 – 8:45 a.m. Welcome and Introductions SESSION I Strategy to Bring USP-NF Excipient Monograph Specifications Up to Date Moderator: Jeffrey Medwid, Ph.D., Government Liaison, USP Excipient Monographs 2 Expert Committee 8:45 – 9:15 a.m. Keynote Presentation
Joseph Kushner, IV, Ph.D., Pfizer Inc. Industry Perspective
9:15 – 9:45 a.m. Presentation 1: FDA /OPQ IID Issues and Potential Resolutions Katherine Ulman, DOW Corning
USP Perspective 9:45 – 10:10 a.m. Presentation 2: Challenges and Opportunities in Excipient Monograph
Development and Update Kate Houck, Ph.D., Chair, USP Excipient Monographs 2 Expert Committee
10:10 – 10:40 a.m. Break
Regulatory Perspective
10:40 – 11: 10 a.m. Presentation 3: FDA CDER Inactive Ingredient Database: Goals and Progress Susan Zuk, U.S. Food and Drug Administration (FDA)
Academic Perspective 11:10 – 11:40 p.m. Presentation 4: Global Excipient Databases – NIPTE Overview Stephen Hoag, Ph.D., Member, General Chapters Physical Analysis Expert
Committee. University of Maryland, School of Pharmacy 11:40 – 11:45 a.m. PQRI Survey Results on Excipient Variability (poster presentation) Lawrence H. Block, Ph.D., Vice-Chair, USP Excipient Monographs 2 and General Chapters Physical Analysis Expert Committees 11:45 – 12:00 p.m. Q & A (15 min) 12:00 – 1:00 p.m. Networking Lunch
2nd Excipient Workshop: Focus on Excipient Quality, Compendial Testing, and Regulatory Impact November 17-18, 2015 USP Meetings Center, Rockville, Maryland USA
SESSION II Challenges and Opportunities in Excipient Monograph Development and Update Moderators: Hong Wang, Ph.D., USP Senior Scientific Liaison, Excipients / Kevin Moore, Ph.D., USP Manager, Pharmacopeial Harmonization Topic 1: USP Up-to-Date for USP-NF monographs Regulatory Perspective 1:00 – 1:30 p.m. Presentation 5 (FDA): FDA Perspective on Excipient Monograph Up-to-Date
Steven Wolfgang, Ph.D., Government Liaison, USP Excipient Monographs 1 Expert Committee
USP Perspective
1:30 – 2:00 p.m. Presentation 6: What Does USP-NF Up-To-Date Mean for Excipients? R. Chris Moreton, Ph.D., Vice-Chair, USP Excipient Monographs 1 Expert
Committee
Industry Perspective 2:00 – 2:30 p.m. Presentation 7: Challenges and Opportunities in Development of Novel
Excipients and Monographs in USP Shaukat Ali, Ph.D., BASF
2:30 – 3:00 p.m. Break Topic 2: Global Harmonization Activities for Excipients 3:00 – 3:30 p.m. Presentation 8: USP Update on Pharmacopeial Harmonization Activities Lawrence H. Block, Ph.D., Vice-Chair, USP Excipient Monographs 2 and General Chapters Physical Analysis Expert Committees (USP)
3:30 – 4:00 p.m. Presentation 9: Pharmacopoeial Discussion Group (PDG) Update on Harmonization Activities – Japanese Pharmacopoeia (JP)
Hiroshi Tokunaga, Ph.D. (PMDA)
4:00 – 4:30 p.m. Presentation 10: EP Update on Harmonization Activities – European Pharmacopeia
Professor Anne Gayot (EDQM) 4:30 – 5:00 p.m. Roundtable Discussion / Q & A (30 min) – Challenges and Opportunities for
Harmonization, Update and Development of Excipient Specifications Moderator: Jiasheng Tu, Ph.D.
5:00 p.m. Adjourn
2nd Excipient Workshop: Focus on Excipient Quality, Compendial Testing, and Regulatory Impact November 17-18, 2015 USP Meetings Center, Rockville, Maryland USA
DAY TWO: Wednesday, November 18, 2015 8:00 – 8:30 a.m. Registration and Coffee SESSION III Challenges and Opportunities in Development and Update of Excipient Monographs Used for Biologics Drug Applications Moderator: R. Chris Moreton, Ph.D., Vice Chair, USP Excipient Monographs 1 Expert Committee / Catherine Sheehan, MS., MS., USP Senior Director, Excipients 8:30 – 9:00 a.m. Keynote Presentation: Integrity of Supply – Shifting Paradigms Marla Phillips, Ph.D., Xavier Health
USP Perspective
9:00 – 9:30 a.m. Presentation 1: Understanding USP’s Role with Excipients Used in Biologics: Identifying Gaps in Current Excipient Monographs and Developing Monographs for Missing Excipients
Thiago C Carvalho, Ph.D., Member, USP Excipient Monographs 1 Expert Committee
Regulatory Perspective
9:30 – 10:00 a.m. Presentation 2 (FDA): FDA Review of Excipient Submissions in BLA Laurie Graham, U.S. FDA
10:00 – 10:30 a.m. Break 10:30 – 11:00 a.m. Presentation 3 (FDA): The Scientific and Regulatory Basis for the Management
of Excipient Data During the Review of Biotechnology-Derived Drugs Ashutosh Rao, Ph.D., U.S. Food and Drug Administration (FDA)
11:00 – 11:30 a.m. Q &A (30 min)
Industry Perspective
11:30 – 12:00 p.m. Presentation 4: Ensuring an Excipient is Suitable for its Intended End Use; An Excipient Manufacturer’s Perspective Dora Meissner, M.S., BioSpectra
12:00 – 1:00 p.m. Networking Lunch
Industry Perspective (Cont’d.) 1:00 – 1:30 p.m. Presentation 5: Drug Product Manufacturer’s Perspective on the Use of
Pharmaceutical Excipients in Biologics Finished Final Product / Formulation; Focusing on the Characterization of Surfactants Y. John Wang, PhD., Genentech
1:30 – 2:00 p.m. Presentation 6: Impact of Raw Material Variability for Upstream Processes to Drug Substance Performance Attributes Colleen Alexander, Ph.D., BMS
2nd Excipient Workshop: Focus on Excipient Quality, Compendial Testing, and Regulatory Impact November 17-18, 2015 USP Meetings Center, Rockville, Maryland USA
2:00 – 3:30 p.m. Parallel Breakout Sessions: Rationalization of Terminology used in the
manufacturing of Biologics, including Drug Substance (upstream/downstream processing) and Drug Product (final formulations) aspects. To discuss / understand when compendial grade materials are necessary in the manufacture of Biologics. Parallel breakout sessions will explore and report back on learnings relating to the use of the current terminology and provide recommendations / path forward. Moderator: Jiasheng Tu, Ph.D.
3:30 – 4:00 p.m. Break Closing Summary 4:00 – 4:15 p.m. Session I 4:15 – 4:30 p.m. Session II 4:30 – 4:45 p.m. Session III 4:45 p.m. Workshop Concludes
2ndExcipientWorkshop:FocusonExcipientQuality,
CompendialTesting,andRegulatoryImpact
SpeakerandModeratorInformation(alphaorder)
U . S . P H A R M A C O P E I A L C O N V E N T I O N
ColleenM.Alexander,Ph.D.ScientistBristol‐MyersSquibbEastSyracuse,NY,USAColleenAlexanderisaScientistintheMaterialSciencegroupwithinManufacturingSciencesandTechnology(MS&T)atBristol‐MyersSquibb(BMS)inEastSyracuse,NY.ColleenfocusesprimarilyontheRawMaterialssub‐functionwithinMaterialScience.Inthisrole,sheprovidesrawmaterialssupporttobiologicsdrugsubstancemanufacturing,aswellassupportintheauthoringofregulatoryfilingsandinternaldocuments.ColleenjoinedBMSin2014andhasmostrecentlyworkedasaPostdoctoralResearchAssociateintheChemistryDepartmentattheUniversityofMassachusettsatAmherst.ColleenholdsaPh.D.inChemistryfromSyracuseUniversity,aB.S.inBiochemistryfromStateUniversityofNYatOswego,andaB.A.inPsychologyfromMcGillUniversity.
PresentationAbstractPresentation6:ImpactofRawMaterialVariabilityforUpstreamProcessestoDrugSubstancePerformanceAttributesWednesday,November18,2015,1:30–2:00p.m.Theimpactofrawmaterialvariabilityontheupstreammanufacturingofabiologicsdrugsubstance(DS)processisdiscussedinthispresentation.Rawmaterialvariabilityisexploredwithin‐lot,lot‐to‐lot,andasafunctionoftime.TheimpacttoDSmanufacturingismeasuredforrelevantparameters,includingseveralprocessperformanceattributes(PAs).Inthefirststudy,metalswerequantifiedusingICP‐MSinupstreamrawmaterials,demonstratingbothwithin‐lotandlot‐to‐lotvariabilityofcoppercontent.Tofurtherexploretheimpactofcoppercontentvariability,apilotscaleupstreammanufacturingstudythatincluded7xand20xcoppersupplementationrelativetothecoppercontentofthecontrolconditionwascompleted.Viablecelldensity(VCD)ofthecellculturewasenhanced1.4foldand1.9‐foldrelativetothecontrolforthe7xand20xcopperconditions,respectively.Percentviabilitywasenhancedforbothhighcopperconditions.Thepercentviabilityremained>80%forbothhighcopperconditionscomparedto<40%forthecontrol.Titerwasalsoenhancedsignificantlyforbothhighcopperconditions.Furthermore,titerforthe7xcopperconditionwascomparabletomanufacturingscaledatawhichutilizedahighcopperrawmateriallot.Inaseparatestudy,vitaminsandaminoacidswerequantifiedincellculturemediausingHPLC‐MS.Variabilityofselectvitaminsandaminoacidswasdemonstratedasafunctionofmediaage.Forexample,folicacidconcentrationdeclinedoverthe12monthmediashelflife,ultimatelyreaching<12%ofitstheoreticalconcentration.Inasmallscalefollowupstudy,mediaageandfolicacidcontentwereevaluatedfortheirresponsetowardspecificPAs:VCD,percentviability,titer,and
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
glycosylation.Atsmallscale,newermedia(1month)increasedVCD,percentviability,titer,andglycosylationrelativetooldmedia(11months).Increasedfolicacidcontent(folicacidspikedintooldmedia)increasedglycosylationrelativetocontrol(agedmedia).Manufacturingscaledatawasconsistentwiththesmallscalestudy,anddemonstrateda>15%increaseintiterusingnewmediacomparedtoagedmedia.Inanotherretrospectiveanalysisofmanufacturingdata,theimpactofmediaageandcomponentvariabilitywasexploredforadifferentcellculturemedium.Lot‐to‐lotvariabilityofasinglemediacomponentwasidentifiedandwasfoundtocorrelatewithreducedtiter.Mediaageat≥6monthscorrelatedwithreducedtiter.Theresultsfromthesestudiesenhancetheknowledgeofhowrawmaterialsimpactmanufacturingandareusefulforidentifyingstrategicmaterial‐relatedchangestosupportprocessimprovements.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
ShaukatAli,Ph.D.TechnicalSupportManagerBASFCorporationFlorhamPark,NJ,USAShaukatAlihasover21yearsofexperienceinthepharmaceuticalindustriesincluding11yearsatBASF,wherehesupportssolubilization,instantandmodifiedreleaseplatforms,andAPIs.Dr.Ali’sareasofexpertiseincludesoliddispersions,liposomedrugdelivery,controlledrelease,transdermal,andfilmdevelopmenttechnologies.Dr.Aliisamemberoftheeditorialadvisoryboardsof,AmericanPharmaceuticalreviews,BiopharmaAsia,ContractPharma,DrugDelivery&Development,InternationalJournalofPharmaceuticalInvestigation,JournalofPharmaceuticalSciencesandPharmacology,andJournalofAnalytical&PharmaceuticalResearch.HeisalsoamemberofUSPpanelofexpertsforGeneralChapters‐PhysicalAnalysis.HereceivedhisPh.D.inChemistryfromtheCityUniversityofNewYorkandpursuedhispostdoctoraltrainingattheUniversityofMinnesotaandCornellUniversity.Hehasauthoredover37scientificarticlesandistheinventorin14USpatents.
PresentationAbstractChallengesandOpportunitiesinDevelopmentofNovelExcipientsandMonographsinUSPTuesday,November17,2015,2:00–2:30p.m.Compendialrequirementsofnovelexcipientsandtheir“firsttouse”informulationhavebeensubjectofcontinuedinterestbyboththeexcipientanddrugmanufacturers.Suchchallengeshavebeenunderestimated,andthusfindingthecommonsolutionsatbothsides,stemmingfromexcipient’ssafetyoracceptancebytheindustry,havebeenunsettled.CoupledwithregulatoryandFDArequirements,thoseissuesfurtherdiscouragedinnovationbyexcipientmanufacturers,whichinturnhassloweddowntheindustryinaddressingthechallengeseitherwithcontinuedsurgeinnumberofpoorlysolublecompounds,inareasoftaste‐maskingofbitterAPIsorfindingtheappropriateexcipientsforimprovingtheperformanceofadesireddosage.Notably,thesechallengesmaynotbeaddressedwiththestandardexcipientsandtherefore,thepharmaindustrywillcontinuetodependuponthenovelexcipientsthatmeetdesiredsafetyandperformance,andtechnologicaladaptablefordevelopingbetterandsmartermedicinesfortomorrow.Thatwillinevitablychallengetheregulatoryagencies.BASFcontinuestotakeasteeperpathandinnovatenewexcipients,knowingthattheapprovalofdrugswithnovelexcipientswilltakemuchlongerthanthosedevelopedwiththestandardexcipients.Itischallengingbutimportanttoaddresstheindustry’sneedswheremostdesirable.Soluplus®andKollicoat®Smartseal
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
weredevelopedtomeetexactlythoseneedsinaddressingsolubilityandbioavailabilitychallengesanddesigningbetterdosageswithtastemaskedAPI’s,respectively.Bothhaveyetnotbeenapprovedindrugproducts.ThispresentationwillfocusontechnicalunderstandingofselectedinnovativeexcipientsandtheirperformancesinthedesiredformulationdosagesThechallengesindevelopmentofdosagewithnon‐compendialexcipientssuchasSoluplus®andKollicoat®Smartseal,andtheiracceptancenotonlybytheindustrybutalsobyregulatoryagencies,willbediscussedwithcommoninterestsandhowtoembracethenovelexcipientsindrugproductswithoutbeinglistedinFDA’sinactiveingredientdatabase.ThepresentationwillhighlightchallengesandopportunitieswithdevelopingNFmonographsinUSP.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
LawrenceH.Block,Ph.D.USPAffiliation:Vice‐Chair,USPExcipientMonographs2andGeneralChaptersPhysicalAnalysisExpertCommitteesProfessor Emeritus of Pharmaceutics DuquesneUniversity Pittsburgh,PA,USALawrenceH.Block,Ph.D.,isProfessorEmeritusofPharmaceuticsattheMylanSchoolofPharmacyandGraduateSchoolofPharmaceuticalSciencesatDuquesneUniversity.Dr.BlockwaseducatedattheUniversityofMarylandwhereheearnedhisB.S.inPharmacy,M.S.,andPh.D.degrees.Dr.BlockisaFellowofboththeAmericanAssociationofPharmaceuticalScientists(AAPS)andtheAmericanPharmacistsAssociation‐AcademyforPharmaceuticalResearchandScience(APhA‐APRS).HeisamemberofAAPS,APhA‐APRS,theControlledReleaseSociety,theNewYorkAcademyofSciences,andtheSocietyofRheology.Dr.BlockisaPastChairofboththeTeachersofPharmaceuticsSectionoftheAmericanAssociationofCollegesofPharmacyandtheBasicPharmaceuticalSciencesSectionoftheAPhA‐APRS.HecurrentlyservesasCo‐ChairoftheExcipientMonographs2ExpertCommitteeoftheUSPandisalsoamemberoftheUSPGeneralChapters‐PhysicalAnalysis(GC‐PA)ExpertCommittee.Inaddition,Dr.BlockservesasChairoftheRheologySubcommitteeoftheGC‐PA.Arecipientin2000oftheDuquesneUniversityPresident'sAwardforExcellenceinScholarship,Dr.Blockhasauthoredmorethan100publicationsandmentoredmorethan70post‐baccalaureatePharm.D.,M.S.,andPh.D.researchstudentsinthecourseofhisprofessionalcareer.Hisresearchinterestsembraceexcipienttechnology,rheology,drugandcosmeticdeliverysystems,pharmaceuticalengineering,biopharmaceutics,andpharmacokinetics.HehasservedasaVisitingScholaratKobeGakuinUniversityinKobe,JapanandVisitingProfessorofPharmaceuticalSciencesattheCenterforPharmacogeneticsattheUniversityofPittsburghSchoolofPharmacy.SteeringCommitteeMemberPresentationAbstractPQRISurveyResultsonExcipientVariability(posterpresentation)Tuesday,November17,2015,11:40–11:45a.m.Excipientvariabilityhaslongbeenatopicofconcernamongpharmaceuticalmanufacturersandformulators.But,liketheweather,"…everybodytalksaboutit,butnobodydoesanythingaboutit".Butisexcipientvariabilityinevitableandirremediable?Toexploreandunderstandexcipientvariabilitybetter,PQRIrecentlyinitiatedasurveyofthepharmaceuticalindustryintendedtoassesstheextentoftheproblemanditsimpactonpharmaceuticalmanufacturingandproductperformance.Althoughsurveyparticipationwasmorelimitedthanhadbeenhopedfor(n=49),theresultscorroboratetheexpectationsofmanyexcipient
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
experts:Excipientvariabilityissuesonacommercialscalehavebeenexperiencedbymanyexcipientusers:Inmanyinstancestherewasaneedtoreformulateorreengineertheaffectedproduct(s).AnextensivereviewoftheliteratureonexcipientvariabilitywillbethesubjectofaforthcomingPQRIpublication.Subsequently,aPQRIworkshoporwebinarwillprovideforumsforfurtherdiscussionandexplorationofexcipientvariabilityanditsramifications.Ultimately,theseactivitieswillfacilitatetheprovisionofrecommendationsforbestpracticesforthepharmaceuticalindustry,pharmaceuticalexcipientmanufacturers,andregulatoryauthorities.Presentation8:USPUpdateonPharmacopeialHarmonizationActivitiesTuesday,November17,2015,3:00–3:30p.m.ThistalkwillprovideanoverviewofthecurrentofinternationalharmonizationfromaUSPperspective.Globalharmonizationofpharmacopeialspecificationsofexcipientshasbeenagoalofpharmacopeias,inresponsetorequestsfromindustrytoeliminateredundanttestingacrossmultipleregions.TheseeffortsbeganwiththePharmacopeialDiscussionGroup(PDG),whichworkonharmonizingselectedstandardsforgeneralchaptersandexcipientmonographswiththeUSP,EuropeanPharmacopeia,andJapanesePharmacopeia.USP'scurrenteffortstothisendareexemplifiedinthispresentationnotonlybytheformalPDGprocessbutalsobycollaborationsthroughWHOonthedevelopmentoftheGoodPharmacopeialPractices(GPhP),aswellasadditionalinformalprospectiveharmonizationactivitieswithotherpharmacopieas
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
ThiagoCarvalho,Ph.D.USPAffiliation:Member,USPExcipientMonographs1ExpertCommitteeResearchInvestigatorBristol‐MyersSquibbNewBrunswick,NJ,USAThiagoCarvalho,Ph.D.,iscurrentlyaResearchInvestigatorinDrugProductScience&TechnologyatBristol‐MyersSquibb.Hehasover6yearsofexperienceinthepharmaceuticalindustry,workingwithdevelopment,techtransferandmanufacturingofproteintherapeuticsaswellasinthedrugproductdevelopmentofsmallmolecules.HeholdsaB.Pharm.DegreefromFederalUniversityofMinasGerais,Brazil,andaPh.D.degreeinPharmaceuticsfromtheUniversityofTexasatAustin.Dr.Carvalhohaspublishedseveralpeer‐reviewedmanuscriptsandorganizedmultiplescientificsymposiaandwebinars.Heisthe2015PastChairoftheAAPSExcipientsFocusGroupandcurrentlyservesatthe2015‐2020USPExcipientMonographsExpertCommittee.SteeringCommitteeMemberPresentationAbstractPresentation1:UnderstandingUSP’sRolewithExcipientsUsedinBiologics:IdentifyingGapsinCurrentExcipientMonographsandDevelopingMonographsforMissingExcipientsWednesday,November18,2015,9:00–9:30a.m.Forthe2015‐2020USPCouncilofExpertsrevisioncycle,theUSPisinvestingtobringtheUSP‐NFUptoDate.Aspartofthiseffort,theUSP‐NFmonographswillberevisedtobecurrent,relevantandsuitablefortheirintendeduse.ThegreatmajorityofBiologicsproductsaredeliveredviainjectionandthusrequirebioburdenandendotoxincontrolswithappropriateacceptancelimits.MonographsforexcipientsusedinBiologicsformulationsshouldthuscomplywithrequirementsforparenteralproducts.Currently,therearemonographsforexcipientsusedinparenteralformulationswithconsiderablegaps.Someexamplesformonographsrequiringmodernizationare:inconsistencieswithregardstobioburdenandendotoxinlimits;existingexcipientsbeingrecentlyusedininjectabledosageforms;obsoletetechnologiestodetectimpurities;andneedtoaddtestsfornewlyfoundimpuritiesthatmayaffectdataanalysisand/orproductquality.Inaddition,someexcipientsusedinBiologicsformulationsaremissingmonographs.Theobjectiveofthistalkistobringsomeofthesegapstolightandtoinitiatea
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
discussiononhowtoapproachmodernizingthesemonographs.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
AnneGayot,Ph.D.ProfessorUniversityofLille2FacultyofPharmacyEuropeanPharmacopoeiaLille,FranceProfessorAnneGayotisinco‐chargeofthePharmaceuticalIndustryLaboratoryattheUniversityofLILLE‐France.
Thislaboratory,beyonditsteachingactivitiesinthefieldofthedevelopmentandproductionofpharmaceuticalproducts,studiesthesolidstatepropertiesandpropertiesoftheparticulatesolidoftherawmaterialsusedintheformulationofdrugs.
Itstudiesthephysicalpropertiesofexcipientsandactivesubstanceswithrespecttothefunctionalitycharacteristics.
ProfessorAnneGayotwasuntilreorganizationoftheFrenchagencymemberandvice‐presidentoftheFrenchMarketingauthorizationcommitteeSheisnowmemberoftheFrenchPharmaceuticalandGenericworkinggroupattheFrenchAgency.SheparticipatestothewritingoftheguidelineonPharmaceuticalDevelopmentofMedicinesforPediatricuse.ProfessorAnneGayothasbeeninvolvedintheFrenchPharmacopoeiathentheEuropeanPharmacopoeiasince1980.AsanexpertofpowdertechnologyattheEuropeanPharmacopeia,shewasveryactiveintheelaborationofmonographsconcerningtheparticle–size,thesurfaceareadeterminations.ShewasnominatedasamemberoftheFrenchPharmacopoeiaCommissionandbelongsnowtothePharmaceuticalpreparations–IndustrialPharmacygroup.ShewasamemberofthecellulosegroupandamemberoftheP.A.T.GroupoftheEuropeanPharmacopoeiafrom2008–2012.Since2005,shehasbeenamemberofthefunctionalityrelatedcharacteristicsgroup.Shehasbeenchairmanofthisgroupsince2007.ShepreparedherPh.D.attheUniversityofLille(1981).Itconcernsmicrocapsulesofactivatedcharcoalforrenalpatients.Herscientificworkconcernscauterizationofsolidparticles,extrusion‐spheronisation,powderforinhalation.Sheusesasaninvitedspeakertogiveconferencesonthepharmaceuticaldevelopment,theprocessvalidation,thepowdersforinhalation.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
SheisinchargeofthemasterinindustrialpharmaceuticsattheUniv.ofLille2.
PresentationAbstractPresentation10:UpdateonHarmonizationActivities–EuropeanPharmacopeiaTuesday,November17,2015,4:00–4:30p.m.TheauthorpresentstheEuropeanDirectorateforthequalityofMedicinesandHealthcare(EDQM)oftheCouncilofEurope.ItsupportstheCommissionintheelaborationandrevisionoftextsoftheEuropeanPharmacopoeia.ThePharmacopoeiaEuropeanisengagedinaprocessofharmonizationwiththeJapanesePharmacopoeiaandtheUnitedStatesPharmacopoeiawithinaninformalstructurereferredtoasthePharmacopoeialDiscussionGroup(PDG).Thecellulosederivativesarepartoftheprogramofharmonization.Thepolymershavecomplexrheologicalproperties.Theviscositycanbedeterminatedwithdifferentapparatus,givinganabsoluteorrelativevalue.Theharmonizationofthedeterminationoftheviscosity,especiallyofcellulosederivatives,isanimportantsubject.Veryoften,theviscosityisrelevantasF.R.C.forsomefunctionsofthesepolymers.TheinterestsoftheF.R.C.inaqualitybydesignpharmaceuticaldevelopmentareoutlined.ThepresentworkoftheF.R.C.groupofthePharmacopoeiaEuropeanrelativetosurfactantsispresented.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
LaurieGrahamLeadBiologistU.S.FoodandDrugAdministration(FDA)SilverSpring,MD,USABiographyforthcoming.
PresentationAbstractPresentation2(FDA):FDAReviewofExcipientSubmissionsinBLAWednesday,November18,2015,9:30–10:00a.m.Abstractforthcoming.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
StephenW.Hoag,Ph.D.USPAffiliation:Member,GeneralChaptersPhysicalAnalysisExpertCommitteeProfessorUniversityofMaryland,SchoolofPharmacyBaltimore,MD,USAStephenW.HoagisaprofessorattheUniversityofMaryland,BaltimoreSchoolofPharmacy.Hisprimaryresearchinterestsaretabletcompaction,dosageformdevelopment,controlledreleasepolymers,excipientfunctionality,excipienttesting,formulationofnutritionalsupplements,botanicalproductsandNIRspectroscopyapplicationsinPAT.WorkingwiththeFDA,NIPTEhewasaco‐principleinvestigatoroftheteamthatcreatedtheexcipientdatabaseonpharmahub.org.Dr.HoagisamemberofNIPTE,USPCounselofExperts,SteeringCommitteefortheHandbookofPharmaceuticalExcipients,theeditorialboardofthejournalofPharmaceuticalDevelopmentTechnologyandanAAPSFellow. PresentationAbstractPresentation4:GlobalExcipientDatabases–NIPTEOverviewTuesday,November17,2015,11:10–11:40a.m.Successfulmanufacturingofpharmaceuticaldosageformsandtheresultanttherapeuticefficacydependsonthephysical,chemicalandmechanicalpropertiesofthedrugsubstanceandexcipients.Physicalpropertiesarelinkedtofinalproductqualityattributessuchaspurity,uniformity,dissolution,stability,appearanceandmechanicaldurability.Despiteawarenessoftheimportanceofphysicalandmechanicalproperties,manyfundamentalquestionsaboutexcipientfunctionalitystillneedtobeanswered.Tobeginansweringthesequestions,anexcipientdatabasewascreatedtoconsistentlycatalogandorganizeexcipientproperties.Databasesofmaterialpropertiesareverycommoninotherfieldsofengineering,andthesestandardizedandreliablematerialpropertiesareindispensabletoengineerswhoaredesigningproductsandindustrialprocesses.Inaddition,excipientscanbevariable,becausetheyarederivedfromnaturalproductsorsyntheticallymodifiednaturalproductsandareavailablefrommultiplevendors;asaresult,theirphysicalpropertiesmayvaryfromlot‐to‐lotandvendor‐to‐vendor,andifthisnaturalvariabilityifnotaccountedfor,itcancausemanufacturingproblemsthatseeminglyappearunpredictablythroughoutthelifecycleofadrugproduct.Thus,anothergoalofthedatabaseistocatalogtheintrinsicvariabilityofexcipientsfromvendor‐to‐vendorandlot‐to‐lot.Thiswillmakeiteasierforformulationstodeterminetheintrinsicvariablyintheirexcipientsandhowthisvariabilitycouldimpactproductquality.Theoverallgoaloftheexcipientdatabaseistocatalogmaterialpropertiesandusageinformationthatwouldbeusefulforformulationdevelopmentandtheevaluationof
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
formulationsbyregulators.Inthispresentationthestructureandfeaturesofthedatabasewillbediscussed.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
KateHouck,Ph.D.USPAffiliation:Chair,USPExcipientMonographs2ExpertCommitteeAssociateDirector,AnalysisandTechnologyAstellasPharmaTechnologyNorman,OK,USADr.KateHouckisthechairoftheExcipientMonograph2committeeandtheAssociateDirectorofAnalysisandTechnologyatAstellasPharmaTechnologiesinNormanOklahomawhereshedirectstheAnalyticalDevelopment,QualityControl,StabilityandMicrobiologygroups.Shehasover25yearsofexperienceinthepharmaceuticalindustrywithexperienceinawiderangeofpharmaceuticaldosageformsaswellasdrugsubstancesandexcipients.Dr.HouckhasalsoworkedatTheDowChemicalCompany,SyntexChemicals(nowRocheColorado),CellTherapeutics,ScheinPharmaceutical,AlkermesandPPD.ShehasworkedasavolunteerfortheUnitedStatesPharmacopeiaontheexpertcommitteeforexcipientmonographsforthelast10yearsandhasvolunteeredforanumberoflocalandnationalorganizations.Dr.HouckearnedaB.S.inChemistryfromCreightonUniversityandaPh.D.inAnalyticalChemistryfromtheUniversityofArizona.
SteeringCommitteeMemberPresentationAbstractPresentation2:ChallengesandOpportunitiesinExcipientMonographDevelopmentandUpdateTuesday,November17,2015,9:45–10:10a.m.Aswenearthecelebrationof200yearsoftheUSP,itisimportantthatwearelookingnotonlyatthepastbutalsoatthepresentandfutureneedsofthehealthcareindustry.Bringingtheexistingexcipientmonographstoup‐to‐date,inadditiontothedevelopmentofmonographsfornewexcipientsisimportanttoprovidingastablesupplyofqualitypharmaceuticalproductstoaglobalmarketplace.Changesinthepharmaceuticalindustrysuchasincreasedgenerics,shifttowardbiologics,andincreasedoutsourcingdemandthattheUSP‐NFstandardsaremaintainedtocurrentstateoftechnology.Asthepharmaceuticalindustryfindsnewusesforexistingexcipients,theup‐to‐dateexcipientsmonographsmustcontaincertaincriticalqualityattributesthatsupportthenewuses.Newmonographsshouldbedevelopedfornovelexcipientsthatareneededtosupportemergingtechnologies.Inthischangingenvironment,theroleoftheinactiveingredientdatabase(IID)indeterminingwhatmonographsrequirechangesandwhatnewmonographsshouldbedevelopediscrucialtomaintaining
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
theUSP‐NFstandards.Additionally,theIIDhasthepotentialtobeagreatresourceofinformationhelpingusersdetermineswhetheranewlyaddedexcipientorachangetoanexistingexcipientimpactsdosageforms/routesofadministrationordosageamounts.Thistalkwillcoverabackgroundoftherequirementsfordevelopingnewmonographsandupdatingexistingmonographs,theimpactoftheIIDnomenclature,functionality,andcompletenessonexcipientsmonographdevelopmentandupdate,andfinallydiscussthechangesrequiredfromtheIIDtobettersupportthemaintenanceofUSP‐NFcompendialstandards.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
JosephKushner,IV,Ph.D.SeniorPrincipalScientistPfizer,Inc.Groton,CT,USADr.KushnerreceivedaB.S.inChemicalEngineeringfromArizonaStateUniversityandcompletedaM.S.andPh.D.inChemicalEngineeringfromtheMassachusettsInstituteofTechnology,conductingresearchinthefieldofultrasound‐mediatedtransdermaldrugdelivery.SincejoiningPfizerin2006asaresearchscientistintheDrugProductDesigngroup,Dr.Kushnerhasledresearcheffortstobetterunderstandtheroleofexcipientvariabilityonsmallmoleculedrugproductrobustness,aswellastoprogressmodelingofthelubricationblendingprocess.Theseresearcheffortshaveledtonovelmethodsforassessingexcipientlot‐to‐lotvariabilityandthedevelopmentofalubricantblendingprocessscale‐upmodel,bothofwhichhavebeenusedtosupportthedevelopmentofPfizerdrugproducts.Dr.Kushnerhasauthoredseveralpublicationsandpresentationsinthefieldsoftransdermaldrugdeliveryandsolidoraldosageformdesignanddevelopment,includinglubricationunderstandingandexcipientvariability.Previously,hehasgiveninvitedtalksonexcipientvariabilityconceptsatworkshopshostedbyNIPTE,Patheon,andtheAAPSChicagolandRegionalGroup.HeisalsocurrentlyinvolvedwiththeInternationalPharmaceuticalExcipientCouncil(IPEC)QbDandExcipientCompositioncommittees.Throughthisinvolvement,hehasprovidedperspectivesonexcipientvariabilityindrugproductmanufacturingfromanexcipientuserperspectiveduringIPEC‐ledtrainingsessionswiththeFDAOfficeofGenericDrugsandanIPEC‐sponsoredWebinarseriesonExcipientVariabilityandQuality‐by‐Designdrugproductdevelopment.Dr.KushnerisamemberofbothAIChEandAAPS,andalsoservesasaScientificAdvisorfortheJournalofPharmaceuticalSciences.PresentationAbstractKeynotePresentationTuesday,November17,2015,8:45–9:15a.m.Excipientsareanessentialcomponentofrobust,commercialpharmaceuticaldrugproducts.Therefore,understandingthepotentialimpactofvariabilityinexcipientmaterialattributesondrugproductmanufactureandperformanceisanintegralpartofdrugproductdesignanddevelopment.Casestudiesincorporatingexcipientvariabilityunderstandingintothedrugproductdesignanddevelopmentprocesswillbereviewed.Thesecasestudiesareintendedtohighlightthechallengesdrugproductdevelopersmayencounterwhileevaluatingtheimpactthatexcipientvariabilitymayplayintheperformanceofdrugproductsandjustifyingexcipient‐relatedaspectsofthedrugproductcontrolstrategy.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
JeffreyMedwid,Ph.D.USPAffiliation:GovernmentLiaison,USPExcipientMonographs2ExpertCommitteeSeniorCMCReviewChemistU.S.FoodandDrugAdministration(FDA)SilverSpring,MD,USAJeffreyB.Medwid,Ph.D.,hasover35years’experienceinthepharmaceuticalIndustry.JeffmovedtoNewYorkin1980tojoinAmericanCyanamid(Lederle),whichbecameWyethandisnowpartofPfizerwherehemadehiscareerinpharmaceuticaldevelopmentthereforovertwenty‐sevenyears.Dr.MedwidretiredfromWyeth(nowPfizer)asaDirectorinAnalyticalR&DinMarch2007toformCMCPharmaceuticalConsultants,LLC.Aspresident,heconsultedforanumberofpharmaceuticalcompanies,includinganotabletriptoChinaforon‐sitefacilityevaluationsin2008.JeffjoinedtheFDAinOctober2008.InhiscurrentpositionasaSeniorCMCQualityReviewer,Jeff’sprimaryroleisreviewingtheCMCsectionsforNewDrugs.HeisalsoveryinvolvedwithAAPS,IPEC,andUSP(FDALiaisontoUSP)inlearningandhelpingtopresenttheFDAperspectiveontheroleofExcipientsfromaQbDpointofview.
SteeringCommitteeMemberModeratorSession1:StrategytoBringUSP‐NFExcipientMonographSpecificationsUptoDateTuesday,November17,2015,8:45a.m.–12:00p.m.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
DoraMeissner,M.S.DirectorofRegulatoryAffairsBioSpectraBangor,MS,USADoraMeissneristheDirectorofRegulatoryAffairsforBioSpectrawhichisheadquarteredinBangor,PA.ShereceivedherB.S.inChemistryfromtheUniversityofPittsburghandiscurrentlypursuingaMaster’sDegreeinQualityAssuranceandRegulatoryAffairsfromTempleUniversity.DorabeganworkingatBioSpectraasaQualityControlAnalystin2004.ShehasdedicatedherprofessionalcareertounderstandingandadvancingthequalityandregulatorystandardsofBioSpectra,aleadingmanufacturerofExcipientsandActivePharmaceuticalIngredients.DuringherelevenyearsatBioSpectra,DorahasbeenresponsiblefortheQuality,SafetyandRegulatoryaspectsofthecompany’soperationsatthreedifferentmanufacturingfacilities.InhercurrentroleasDirectorofRegulatoryAffairs,DoraisresponsibleformanagingQualityControl,QualityAssurance,EnvironmentalHealthandSafety,InformationTechnologyandInformationSystems.Additionally,DoraisresponsibleforthemanagementofBioSpectra’sglobalrawmaterialsupplychain.
PresentationAbstractPresentation4:EnsuringanExcipientisSuitableforitsIntendedEndUse;AnExcipientManufacturer’sPerspectiveWednesday,November18,2015,11:30a.m.–12:00p.m.Anunderstandingofthequality,identity,purityandgradeofanexcipientisessentialtoassureitssuitabilityfortheintendedenduse.Therearemanyparameters,controlsandanalyticaltestsnecessarytoverifyandprovethatanexcipientismanufacturedinaccordancewithdesiredquality,uniformityandcompliance.Theseparametersallowaningredienttoconsistentlymeetthedefiningspecificationsforuseinthemanufactureofadrugproduct.Informationprovidedthroughresourcesisavailabletomanufacturersandenduserstoaidinharmonizingexpectations,testingcriteriaandcompliancerequirements.Resources,suchastheUSPMonograph,areusedtoprovideguidelinesforqualifyingandapprovingthequalityandenduseofaningredient.Thispresentationwilldiscusstheinformationandtoolsthatanexcipientmanufacturershouldusetosupporttheintendedenduseofanexcipient.Thispresentationwillalsoprovideabroadoverviewofhowanexcipientmanufacturercanensureitsproductsaresuppliedwiththenecessaryattributesfortheirintendeduse.Specificcasestudieswillalsobediscussedduringthispresentation.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
KevinMoore,Ph.D.Manager,PharmacopeialHarmonizationUSPRockville,MD,USAKevinistheManager,PharmacopeialHarmonizationwithresponsibilitiesastheUSPtechnicalleadforallofUSP’sglobalharmonizationactivities.ThisincludesleadingtheUSdelegationtothePharmacopeialDiscussionGroup,whichworkstoharmonizeGeneralChaptersandExcipientMonographswithrepresentativesfromtheUnitedStatesPharmacopeia,theEuropeanPharmacopeia,andtheJapanesePharmacopeia.Inaddition,KevinworkstocoordinatethetechnicalactivitieswithinUSPforUSP’sprospectiveharmonizationinitiativesfordrugsubstance,drugproduct,andexcipientmonographs,aswellassupportUSPactivitiesincollaborationwithWHOinthedevelopmentoftheGoodPharmacopeialPractices(GPhP).KevinholdsaPh.D.inInorganicChemistryfromtheUniversityofPennsylvaniaandaB.S.inChemistryandBiologyfromLeMoyneCollege.ModeratorSession2:ChallengesandOpportunitiesinExcipientMonographDevelopmentandUpdateTuesday,November17,2015,1:00–2:30p.m.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
R.ChrisMoreton,Ph.D.USPAffiliation:Vice‐Chair,USPExcipientMonographs1ExpertCommitteePartnerFinnBritConsultingWaltham,MA,USADr.Moretonisaformulationscientistwithover30yearspharmaceuticalindustryexperience.Hehasformulatedawiderangeofdifferentdrugproducts,bothforclinicalandcommercialuse,includingtablets,capsules,injections,creams,ointments,suppositoriesandpessariesandhastakenproductsfrompreformulationthroughtocommercialmanufacture.InadditionhehasworkedinQA,QCandRegulatoryAffairsforanexcipientanddrugdeliverycompany.Dr.MoretonhasworkedwithIPECovermanyyears,initiallyinEuropeandlaterintheUS.HewasamemberoftheIPECTeamthatpreparedtheinitialIPECGuideonGoodManufacturingPracticesforBulkPharmaceuticalExcipients,andhasalsohelpeddraftseveralotherIPECGuides.HeisapastChairofIPEC‐Americas.Dr.MoretonisamemberoftheEditorialAdvisoryBoardforPharmaceuticalTechnologyandalsofortheJournalofExcipientsandFoodChemicals.Hehasauthoredandco‐authoredscientificpapers,articlesandbookchapters,andlecturedextensivelyintheareasofexcipients,drugdelivery,preformulationandformulationatuniversities,trainingcoursesandsymposiaintheU.S.,EuropeandJapan.SteeringCommitteeMemberPresentationAbstractPresentation6:WhatDoesUSP‐NFUp‐To‐DateMeanforExcipients?Tuesday,November17,2015,1:30–2:00p.m.Underthe‘USP‐NFuptodate’initiativetheEM1Expertcommitteewillbeworkingtoensurethatnewandexistingmonographsarecurrent,relevantandsuitablefortheirintendeduse.Thispresentationwillreviewhowthisimpactsexcipientmonographsandthenfocusonmonographupdatingactivities,andhowtheCommitteewillbelookingtoupdatemonographs.Inadditionthelikelyimpactofnewanalyticaltechnologieswillalsobediscussed.ModeratorSession3:ChallengesandOpportunitiesinDevelopmentandUpdateofExcipientMonographsUsedforBiologicsDrugApplicationsWednesday,November18,2015,8:30–3:30p.m.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
MarlaPhillips,Ph.D.Director,XavierHealthXavierUniversityCincinnati,OH,USA
Marla joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 as a Senior Project Chemist in the Analytical Methods Development group, became Manager of the Quality Control Laboratory for the Philadelphia plant site, and ultimately served as the Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.
PresentationAbstractKeynotePresentation:IntegrityofSupply–ShiftingParadigmsWednesday,November18,2015,8:30–9:00a.m.XavierUniversityhasbeenleadingtheIntegrityofSupplyinitiativesince2012withrepresentationfromFDA,pharmaceuticalandmedicaldevicemanufacturers,andsuppliers.Thegoalofthisworkistoincreasethereliabilityofthesupplychainandtoincreaseproductconfidence.Majorparadigmshiftshavebeendiscoveredthroughtheseinitiativesthatareresultinginthedevelopmentofimpactfulsolutions.Attendeeswillunderstandhowtheparadigmshiftscanaltercurrentpracticesintheircompaniestoday.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
AshutoshRao,Ph.D.Chief,LaboratoryofAppliedBiochemistryU.S.FoodandDrugAdministration(FDA)SilverSpring,MD,USADr.AshutoshRaoistheActingChiefoftheLaboratoryofAppliedBiochemistryandSupervisoryDrugQualityReviewerintheDivisionofBiotechnologyReviewandResearch,OfficeofBiotechnologyProductsatOPQ/CDER/FDA.Dr.RaoreceivedhisB.PharmfromtheUniversityofBombayandPh.D.inmolecularpharmacologyfromtheUniversityofTexasM.D.AndersonCancerCenterinHouston,TX.PriortojoiningtheFDAin2006,Dr.Raocompletedpost‐doctoralfellowshipsinbiochemistryandmolecularbiologyattheNationalCancerInstituteinBethesda,MD.Dr.Raoiscurrentlyresponsiblefortheregulationoftherapeuticproteinssuchasenzymes,monoclonalantibodies,andcytokines,andservesasanexpertreviewerforbiomarkersrelatedtooncologyorneuromuscularindications.HealsoservesonFDAworkinggroupstodevelopregulatorypolicyonthedevelopmentandvalidationofanalyticalmethodsduringmanufacture,novelexcipients,referencestandards,andonsurrogatemarkersforacceleratedapproval.Dr.Raoalsodirectsalaboratoryresearchprogramthatinvestigatesthestructure‐activityrelationshipbetweenproteinoxidationanddrugsafetyandefficacy.Hehasauthoredseveralpeer‐reviewedarticlesondrugdevelopment,metal‐catalyzedoxidationoftherapeuticproteins,biomarkersofcancerchemotherapy,andFDAregulatoryguidances.
PresentationAbstractPresentation3:TheScientificandRegulatoryBasisfortheManagementofExcipientDataDuringtheReviewofBiotechnology‐DerivedDrugsWednesday,November18,2015,10:30–11:00a.m.Abstractforthcoming.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
CatherineM.Sheehan,M.S.,M.S.SeniorDirector,Science‐ExcipientsUSPRockville,MD,USAMs.SheehanjoinedUSPin2001.SheiscurrentlytheSeniorDirector,Science‐Excipients,UnitedStatesPharmacopeiaConvention,Rockville,MD.Inhercurrentrole,shesupportsexcipientsstandardsettingactivitiesoftheUSPCouncilofExpertsfortwoExcipientMonographExpertCommittees.HerresponsibilitiesincludeworkingwithstakeholdersonthedevelopmentandupdateofexcipientmonographsandrelatedgeneralchaptersincludingtheupdateofhighpriorityexcipientsaspartofUSPscollaborationwiththeFDAMonographModernizationTaskGroup.SheisalsoresponsiblefortheharmonizationactivitiesofexcipientmonographsandgeneralchaptersthroughthePharmacopeialDiscussionGroupandispartoftheUSPdelegationtothePharmacopeialDiscussionGroup.Ms.SheehanholdsbothanM.S.RegulatorySciencedegreeandM.S.MolecularBiotechnologydegreefromTheJohnsHopkinsUniversity,Baltimore,USA.
ModeratorSession3:ChallengesandOpportunitiesinDevelopmentandUpdateofExcipientMonographsUsedforBiologicsDrugApplicationsWednesday,November18,2015,8:30a.m.–3:30p.m.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
HiroshiTokunaga,Ph.D.TechnicalExpertPharmaceuticalsandMedicalDevicesAgencyTokyo,JapanHehadthirty‐sixyears’experienceintheNationalInstituteofHealthSciencesandworkedatqualitycontrolofpharmaceuticalsandexcipients.Afterretiring,hestartstoworkinPharmaceuticalsandMedicalDevicesAgency.HeisoneofJPExpertCommitteeonExcipientandoneoftherepresentativesofJPinPDG.HeleadsactivelythequalitycontrolofexcipientsandtheInternationalharmonization.
PresentationAbstractPresentation9:PharmacopoeialDiscussionGroup(PDG)UpdateonHarmonizationActivities–JapanesePharmacopoeia(JP)Tuesday,November17,2015,3:30–4:00p.m.Inthispresentation,theactivitiesofPDGarereportedfromthepasttothenearfuture.PDGhasthreePharmacopoeialbodiesasEP,USP,andJPandWHOasobserver.PDGhasbeenestablishedin1989andcontinuestoworkfor26years.Thefirstsign‐offoftheharmonizeddocumentwasSDS‐PAGE.ICHapprovedtheICHQ6AAgreementfortheSpecificationsfornewdrugson1999andalsoestablishedtheICHQ4Bforevaluatingforinter‐regionalregulatoryacceptanceon2003.ICHQ4Bactivitiesstoppedtoworkon2011.PDGhastheWorkingProceduresfromStage1toStage6;Stage1istheIdentificationofmonograph,Stage2isitsInvestigation,Stage3istheProposalforExpertCommitteeReview,Stage4isitsofficialInquiry,Stage5isitsconsensusofsign‐off,andStage6isitsregionaladoptionandimplementation.ICHnominated15generalchaptersontheprogramofICHQ6A.WhenhavingdiscontinuedtheICHQ4Bon2011,ICHadopted14generalchaptersexcept“color”onPharmacopoeia.PDGTokyomeetingwashostedbyJPinTokyo,Japan,30June–1July,2015.PDGselected36generalchaptersand62excipient’smonographs.Atpresent,29ofthe36GeneralChaptersand48ofthe62excipientmonographsonthecurrentworkprogrammehavebeenharmonised.Sign‐offsatthismeetingincludedarevisedmonographon“Povidone”inordertorefineconditionsforimpuritytestingofmonomers(1‐vinyl‐2‐pyrrolidoneand2‐pyrrolidone)andtoaddidentitytestingbyinfraredspectroscopyasaharmonisedattribute.In‐depthdiscussionsonanumberofadditionalitemscurrentlyontheworkprogrammetookplacewithaviewtoresolvingoutstandingissuesandadvancingtheitemstowardsign‐off.Withregardto“Chromatographychapter”,asafollow‐upfromrecentPDGdecisionsonPDGprocessimprovement,ateleconferencewithexpertsfromthe3regionshadtakenplaceinMayandallowingsignificantprogresstobemadeintheresolutionofmajorstickingpoints.ThecoordinatingpharmacopoeiawillworkontheresolutionofanumberofotheritemswiththeaimoffinalisingaStage4draftfor
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
publicinquiryforthenextPDGmeeting.Withregardto“Copovidone”,thecoordinatingpharmacopoeiawillsendoutadraftforpublicconsultationinJulyforthethreepharmacopoeiastopublishaccordingtotheirrespectiveschedules.ThethreepharmacopoeiasexchangedinformationontheirrespectiveapproachesfortheimplementationoftheICHQ3Dguideline.Inaddition,PDGconfirmedtheircommitmenttoharmonisethegeneralchapterontestingproceduresforelementalimpurities.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
JiashengTu,Ph.D.USPAffiliation:Member,USPExcipientMonographs2ExpertCommitteeProfessorChinaPharmaceuticalUniversityNanjing,ChinaJiashengTuistheprofessorofpharmaceuticsofChinaPharmaceuticalUniversity,asupervisorofdoctoratestudents.Dr.TuhasalsoservedasthedeputychairofCHPpharmaceuticalexcipientcommittee,anexpertcommitteememberofCHP,anexpertcommitteememberofpharmaceuticalexcipientofUSP,consultantofCDEofCFDA,areviewerofnationalawardofChina,co‐editorofPharmaceuticalBiotechnologies.Dr.TugraduatedfromBeijingMedicalUniversity.HewasawardedPh.D.ofpharmaceuticsinChinaPharmaceuticalUniversityat1992anddidpostdoctoralresearchesinUniversityofthePacific,CA,during2001‐2003.Dr.Tualsoservedasjoint‐professorinUniversityoftheUniversityandJiangnanUnivesityinWuxi,China.SteeringCommitteeMemberModeratorRoundtableDiscussion/Q&A(30min)–ChallengesandOpportunitiesforHarmonization,UpdateandDevelopmentofExcipientSpecificationsTuesday,November17,2015,4:30–5:00p.m.ParallelBreakoutSessions:RationalizationofTerminologyusedinthemanufacturingofBiologics,includingDrugSubstance(upstream/downstreamprocessing)andDrugProduct(finalformulations)aspects.Todiscuss/understandwhencompendialgradematerialsarenecessaryinthemanufactureofBiologics.Parallelbreakoutsessionswillexploreandreportbackonlearningsrelatingtotheuseofthecurrentterminologyandproviderecommendations/pathforward.Wednesday,November18,2015,2:00–3:30p.m.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
KatherineUlmanAssociateScientistGlobalRegulatoryComplianceManagerDowCorningHealthcareMidland,MI,USAKatherineUlmanhasbeenemployedwithDowCorningCorporationfor40years.SheiscurrentlyaglobalregulatorycompliancemanagerforDowCorningHealthcare,aswellasaDowCorningassociatescientist.Shehasworkedinthedevelopmentandcharacterizationofpharmaceuticalexcipientandmedicaldevicerawmaterials/componentsfornearly27years.SheisamemberoftheACS,AAPS,andCRSandvicechairofScienceandRegulatoryPolicyforIPEC‐Americas.ShehaspublishedandpresentedseveralpapersinherfieldaswellasdevelopedandtaughtcoursesinOrganosiliconPolymerChemistryandTechnology.UlmanearnedherBachelorofSciencedegreeinchemistryfromtheSouthDakotaSchoolofMinesandTechnologyin1976.
PresentationAbstractPresentation1:FDA/OPQIIDIssuesandPotentialResolutionsTuesday,November17,2015,9:15–9:45a.m.TheInternationalPharmaceuticalExcipientsCounciloftheAmericas(IPEC‐Americas)isanindustryassociationthatdevelops,implements,andpromotesglobaluseofappropriatequality,safety,andfunctionalitystandardsforpharmaceuticalexcipientsanddeliverysystems.FDAcreatedaworkinggroupwithIPEC‐Americas,includingarepresentativefromGPhAtoaddressIIDissues.ThisgrouphasbeenmeetingquarterlywithmembersoftheFDAIIDExcipientWorkingGroup(EWG)sincetheyfirstformedinthefallof2011.AlthoughtheAgencyhasresolvedseveralhistoricalconcerns/issuesraisedbyIPEC‐AmericasandGPhA,includingbutnotlimitedtoIIDcontentanduse,theteamcontinuestoworkwiththeAgencyastheystrivetore‐designandmaintainIIDinformationwhileenhancingtheutilityandusabilityofthedatabase.Thistalkisintendedtoprovideanoverviewofdiscussiontopicscoveredbytheteam,aswellashighlighttheircurrentstatusandongoingactivities.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
HongWang,Ph.D.SeniorScientificLiaison,ExcipientsUSPRockville,MD,USADr.HongWangisaSeniorScientificLiaisoninScience—ExcipientsatU.S.PharmacopeialConvention.ShehasovertenyearsofexperienceindevelopingandupdatingUSP‐NFpublicstandards.ShereceivedherPh.D.inphysicalchemistryfromtheUniversityofBasel,Switzerland.PriortojoiningUSP,sheworkedatBioprocessandBioanalyticalResearchdepartmentinMerckResearchLaboratories,WestPoint,PAforsevenyears.BeforestartinganindustrialcareeratMerck,Dr.WangworkedasapostdoctoralresearchfellowatBrandeisUniversity,Waltham,MA,forabouttwoyears.
ModeratorSession2:ChallengesandOpportunitiesinExcipientMonographDevelopmentandUpdateTuesday,November17,2015,1:00–2:30p.m.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
Y.JohnWang,Ph.D.PrincipalScientistGenentechSanFrancisco,CA,USADr.Y.JohnWangisaFellowofAmericanAssociationofPharmaceuticalScientists(AAPS).Hehasbeenworkingover11yearsintheLateStagePharmaceuticalDevelopmentatGenentech,amemberoftheRocheGroup.HereceivedhisB.S.Pharmacyand,fromtheUniversityofMichigan,Ph.D.inPharmaceuticalChemistry.PriortoGenentech,heworkedintheformulationdepartmentatSquibb,Ortho,SciosandBayer.Hisareasofexpertisearestabilityofdrugproduct,autoclavecycledevelopment,proteinformulationandstabilizers,deamidation,oxidationofpeptidesandproteins.Heauthoredorcoauthoredover60peer‐reviewedarticles,anumberofbookchaptersandtwoPDATechnicalReportsandco‐editedtwobookstitledFormulation,CharacterizationandStabilityofProteinDrugs.HewasamemberoftheBoardofDirectorsoftheParenteralDrugAssociationand,in1992,ChairofAAPSBiotecSection.PresentationAbstractPresentation5:DrugProductManufacturer’sPerspectiveontheUseofPharmaceuticalExcipientsinBiologicsFinishedFinalProduct/Formulation;FocusingontheCharacterizationofSurfactantsWednesday,November18,2015,1:00–1:30p.m.Polysorbate20and80,andpoloxamber188areusedextensivelyindrugproductsofbiologics.Recentlytheinstabilityofpolysorbatehasbeennoticedindevelopmentormarketproducts.Insomeoccasions,insolubleparticleswereobserved.ThecompositionsofpolysorbatearemuchmorecomplexthanwhataredefinedbypharmacopeiawhichincludesonlyhydrocarbonchainlengthandnumberofPOE.Variationinheadgroup,sorbitol,sorbitan,orisosorbide,inorderofesterification,mono,di‐,tri‐,ortetra‐esters,andthepresenceofun‐esterifiedheadgroup(non‐surfactant),werenotdescribednorcontrolled.Forpolysorbate,newassaymethodmaybedeveloped.Byusinglipasetogeneratehydrolyzedpolysorbate,alllauratepolysorbate20wasfoundnottoproduceinsolubleparticles.Basedonthisobservation,compositionoffattyacidsinpolysorbate20mayberevised.Wealsoproposetoreducetheunsaturationspecificationtozeroforpoloxamer.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
StevenWolfgang,Ph.D.USPAffiliation:GovernmentLiaison,USPExcipientMonographs1ExpertCommitteeChemistU.S.FoodandDrugAdministration(FDA)SilverSpring,MD,USADr.WolfgangreceivedhisPh.D.inInorganicChemistryfromtheCityUniversityofNewYorkin1983.HejoinedFDAin2005afterspending15yearsasatechnicalsupportchemistforamanufacturerofAPIsandexcipients.Dr.WolfgangstartedasaCMCreviewerfornewdrugsandmovedovertotheOfficeofCompliancein2007.Dr.WolfgangisanFDAliaisontotheUSPExcipientExpertCommitteeandtoexpertpanelsforthemodernizationofthePovidoneandTalcmonographsandremainsactiveinresearchatFDA.
SteeringCommitteeMemberPresentationAbstractPresentation5:FDAPerspectiveonExcipientMonographUp‐to‐DateTuesday,November17,2015,1:00–1:30p.m.Abstractforthcoming.
2ndUSPExcipientWorkshop:FocusonExcipientQuality,CompendialTesting,andRegulatoryImpactNovember17‐18,2015,USPMeetingsCenter,Rockville,Maryland,USA
SusanZuk,M.S.LeadChemistU.S.FoodandDrugAdministration(FDA)SilverSpring,MD,USASusanholdsaBSinChemistryfromSyracuseUniversityandaMSinBiotechnologyfromJohnsHopkinsUniversity.Duringher15yearswiththeFDA,shehasservedasChemistryReviewer,TeamLeaderandActingDeputyDirectorintheOfficeofGenericDrugsandasActingBranchChiefoftheDivisionofInternalPoliciesandProcedures(DIPAP)intheOPQOfficeofPolicyforPharmaceuticalQuality(OPPQ).SheisthecurrentleaderoftheFDACDERExcipientWorkingGroup.Inthisrole,sheisresponsibleforoverseeingtheIIDproject.SusanhasservedonmanyFDAcommitteesandworkinggroupsrelatedtoproductsafetyandquality.
PresentationAbstractPresentation3:FDACDERInactiveIngredientDatabase:GoalsandProgressTuesday,November17,2015,10:40–11:10a.m.TheFDAInactiveIngredientDatabase(IID)playsacentralroleindailydecisionsmadebyFDAandthepharmaceuticalindustry.ForFDA,theIIDisreferencedduringallstagesoftheapplicationprocess,fromfilingthroughchemistry,bioequivalence,toxicology,andclinicalreviewsofbothgenericandnewdrugproductapplications.Itisusedasthebasisforacceptanceofinactiveingredientsingenericdrugproductformulations.Forindustry,theIIDguidesmanyproductdevelopmentdecisions.Thislist,whichprovidesthemaximumapprovedlevelofeachinactiveingredientperunitdose,dosageformandrouteofadministration,isperiodicallyupdatedastheFDAapprovesproductscontainingnewingredientsandhigherlevelsofexistingingredients.ButtheIIDinitspresentformhaslimitations.Inthispresentation,theprogressofFDA’seffortstodevelopabetter,morefunctionalIIDwillbediscussed.ThepresentationwillalsodescribeFDA’svisionforthefutureoftheIID.