hptn future directions january 22, 2003 bethesda, md
TRANSCRIPT
HPTN Future DirectionsHPTN Future Directions
January 22, 2003January 22, 2003
Bethesda, MDBethesda, MD
What’s NextWhat’s Next
Building on accomplishmentsBuilding on accomplishments
Short term goalsShort term goals• Science completion/implementationScience completion/implementation
Long term goalsLong term goals• Science generationScience generation
What Has WorkedWhat Has Worked
Science generationScience generation Including input from a variety of sources, concepts, Including input from a variety of sources, concepts,
review, quality of protocols, multidisciplinary inputsreview, quality of protocols, multidisciplinary inputs
Focus on international infrastructureFocus on international infrastructure Cooperative agreements as a funding Cooperative agreements as a funding
mechanismmechanism Multisdisciplinary integrationMultisdisciplinary integration GovernanceGovernance
Short Term GoalsShort Term Goals
Goal 1: Complete Science in Goal 1: Complete Science in Progress Progress
Goal 2: Capacity BuildingGoal 2: Capacity Building
Goal 3: Science GenerationGoal 3: Science Generation
Goal 4: Science ImplementationGoal 4: Science Implementation
Goal 1: Completing Science in Goal 1: Completing Science in ProgressProgress
012: Perinatal: Nevirapine012: Perinatal: Nevirapine
015: Behavioral: EXPLORE015: Behavioral: EXPLORE
016A: Microbicides/Behavioral: 016A: Microbicides/Behavioral: Couples CounselingCouples Counseling
024: Perinatal: Chorioamnionitis024: Perinatal: Chorioamnionitis
037: Substance use: Peer networks037: Substance use: Peer networks
032/049/050: Microbicides Phase I032/049/050: Microbicides Phase I
Goal 2: Capacity BuildingGoal 2: Capacity Building Working in places where incidence is highWorking in places where incidence is high We need to stay there and ensure that we can We need to stay there and ensure that we can
do the important trialsdo the important trials LaboratoryLaboratory GCPGCP GLPGLP EthicsEthics Community Community
• continuous improvement processcontinuous improvement process• network is ready for prevention clinical trialsnetwork is ready for prevention clinical trials
Goal 2: Capacity BuildingGoal 2: Capacity Building
Preparedness studiesPreparedness studies Cohort identification and follow-upCohort identification and follow-up 033: China, India, Russia033: China, India, Russia 034: India034: India 036: Peru036: Peru 055: South Africa, Tanzania, Zambia055: South Africa, Tanzania, Zambia 016a: Zimbabwe, Malawi (Lilongwe and 016a: Zimbabwe, Malawi (Lilongwe and
Blantyre)Blantyre)
Goal 3: Science GenerationGoal 3: Science Generation
Working GroupsWorking Groups• MetMet• AssessedAssessed• Identified gapsIdentified gaps• Matched gaps to HPTN strengths and Matched gaps to HPTN strengths and
missionmission• Stimulated and competed conceptsStimulated and competed concepts• Brought concepts to protocol stageBrought concepts to protocol stage• Spun off others into the R01 poolSpun off others into the R01 pool
Goal 4: Science ImplementationGoal 4: Science Implementation
035: Microbicides: BufferGel and Pro2000035: Microbicides: BufferGel and Pro2000 039: STDs (R01): Herpes039: STDs (R01): Herpes 040: Perinatal: Postnatal ART040: Perinatal: Postnatal ART 043: Behavioral (R01): Community VCT043: Behavioral (R01): Community VCT 046: Perinatal: Nevirapine during 046: Perinatal: Nevirapine during
BreastfeedingBreastfeeding 052: Antiretrovirals: Reducing 052: Antiretrovirals: Reducing
TransmissionTransmission 054: Perinatal: Access to NVP with and 054: Perinatal: Access to NVP with and
without HIV VCTwithout HIV VCT 056: Rectal Microbicides056: Rectal Microbicides
Long-Term: Science Long-Term: Science GenerationGeneration
Unmet needsUnmet needs MultidisciplinaryMultidisciplinary Array of epidemiological Array of epidemiological
environmentsenvironments Implemented and completed with Implemented and completed with
qualityquality Landmark trials: Phase III HIV Landmark trials: Phase III HIV
incidence endpointincidence endpoint
If Not in This Network, Then Where Will If Not in This Network, Then Where Will Phase III Prevention Trials Occur?Phase III Prevention Trials Occur?
The field needs Phase III prevention trialsThe field needs Phase III prevention trials
Industry not interestedIndustry not interested
Need to be multidisciplinaryNeed to be multidisciplinary
Beyond any one academic institutionBeyond any one academic institution
Beyond any one NIH instituteBeyond any one NIH institute
Beyond any one networkBeyond any one network
What Would We Change?What Would We Change?
New ‘rapid discovery’ regulatory model to New ‘rapid discovery’ regulatory model to facilitate protocols with FDAfacilitate protocols with FDA
Resources commensurate with the scope of Resources commensurate with the scope of responsibilities as Phase III non-vaccine networkresponsibilities as Phase III non-vaccine network
Product procurement contract to obtain study Product procurement contract to obtain study products more quicklyproducts more quickly
In ConclusionIn Conclusion
This is an excellent use of fundsThis is an excellent use of funds Important to preserve the triple trackImportant to preserve the triple track
• Treatment/ Vaccines/ PreventionTreatment/ Vaccines/ Prevention Focus on prevention is of vital significanceFocus on prevention is of vital significance The network is the right approachThe network is the right approach This network represents the best in the fieldThis network represents the best in the field HPTN has been productive, despite HPTN has been productive, despite
significant barriers and challengessignificant barriers and challenges
Are we in the ballpark?Are we in the ballpark?
High quality trialsHigh quality trials DefinitiveDefinitive Meeting FDA standardsMeeting FDA standards With HIV seroincidence endpointsWith HIV seroincidence endpoints Resources need to match expectations Resources need to match expectations
and breadth of the agendaand breadth of the agenda
Comparable Efforts?Comparable Efforts?
HSV Vaccine (GSK) : $200mHSV Vaccine (GSK) : $200m HIV Vaccines (VaxGen): $200mHIV Vaccines (VaxGen): $200m ID Prevention Trial: $45mID Prevention Trial: $45m HIV Interleukin-2 (Chiron): $160mHIV Interleukin-2 (Chiron): $160m
035: $60-100m (est)035: $60-100m (est) 052: $100m (est)052: $100m (est)