IMPAACT Laboratories

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IMPAACT Laboratories
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IMPAACT Lab Organizational Chart
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NL Specific Aims

• Perform assays and interpret results in support
  of IMPAACT protocols Core and Specialized
• Provide scientific leadership - All
• Develop and evaluate protocols All
• Train, build capacity and transfer technology
  All
• Coordinate QA and QC Central
• Evaluate new assays to elucidate pathogenesis
  Specialized
• Harmonize procedures across networks - Central

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IMPAACT Lab Steering Committee

• Coordinate laboratory scientific priorities
• Assess laboratory issues for open and closed
  protocols for which laboratory testing is still
  ongoing
• Biannual review of laboratory performance
• Mechanisms for restricting protocol testing based
  on poor proficiency testing performance
• Review repository activities

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Lab Technologists Committee

• Multi-network membership
• Standardize laboratory procedures such as
  specimen processing, labeling, storage, shipping
  across the network and in collaboration with the
  other networks to insure harmonization of these
  processes.
• Participate in protocol development and review,
  especially with the development of Laboratory
  Processing Charts or Manual of Procedures

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SSS Lab Support

• Sue Sepelak, the IMPAACT Lab Group Senior
  Coordinator will supervise SSS Lab Group staff
  and be responsible for supporting the Laboratory
  PI, the operational aspects of cross-network
  laboratory activities, be a member of the lab
  steering committee, and manage repository
  activities
• Celine Husbands will support all IMPAACT
  Laboratory Committees and their working groups.
• Kim Banks will coordinate international lab
  assessments, proficiencies and training
  activities as well as maintain the international
  laboratory database at SSS

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Central Lab

• The IMPAACT Central Lab will be responsible for
• Scientific leadership and participation in
  network leadership
• Overseeing quality assurance/quality control
  (QA/QC) of all labs in conjunction with SSS
• Providing training and infrastructure
• Monitoring the Repository in conjunction with SSS
• Facilitating capacity building and technology
  transfer
• Collaborating with other networks laboratories

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Core Labs

• Core labs will perform standard testing on a fee
  for service basis that will be paid from protocol
  implementation funds (PIF)
• 3 Core Labs
• Virology UNC
• Immunology CHOP
• Pharmacology - UCSD

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Virology Core Lab

• Standard HIV RNA
• Ultra-sensitive HIV RNA
• HIV DNA
• HIV culture
• HIV resistance genotyping
• Studies includes ATN 015, 382, 390, 1021, 1025,
  1030, 1034, 1036B, 1038, 1029, 1053, 1059, 1061S

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SUMMARY OF WORKLOAD EFFECTIVE 6/19/06 FOR
EXISTING PACTG PROTOCOLS

• Immunophenotyping
• LPA
• ELISA
• Cell processing and cryopreservation for TREC
• Processing and cryopreservation
• Cell processing and
• cryopreservation for ELISPOT
• TREC
• ELISPOT
• On saliva samples stored at UCSF

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Core Lab Performance

• Result reporting
• Accuracy
• Completeness
• Turn-around time
• Queries
• EQA
• Other considerations
• Fee for service structure assay costs and
  process for reimbursement

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Specialty Labs
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Specialty Labs
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Specialty Labs

• IMPAACTs domestic lab directors are
  international leaders and have made significant
  contributions to our understanding of HIV/AIDS in
  pregnant women, children and adolescents
• If we are to get new drugs approved, to
  understand the response of infants and children
  to HIV vaccines, or to understand the
  pathogenesis and prevention of breast milk
  transmission, we need the lab scientists proposed
  in IMPAACT
• They will conduct assays on non-standard
  specimens (breast milk, genital secretions,
  amniotic fluid, etc) or develop new highly
  specialized assays to advance the scientific
  agenda and improve diagnosis and monitoring for
  all IMPAACT studies, not just domestic trials

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Specialty Labs

• Based on projected workloads and extrapolating
  from current network experience, it was
  determined that the Network would need 4
  immunology, pharmacology, and virology
  laboratories, 1 microbiology lab and 1 DNA
  repository
• Specimens from IMPAACT protocols will provide a
  rich and unique source of material to address the
  many specific aims and questions described in the
  application as well as new hypotheses
• IMPAACT scientists will have sources of funding
  outside the network and IMPAACT will encourage
  and support independent lab investigations that
  support the scientific agenda
• This balance will foster creativity, intellectual
  development, and provide value added to all
  investigations

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Specialty Labs

• Specific lab activities will be discussed and
  approved by the Lab Steering Committee and SOC
• Laboratory performance and future funding will be
  tied to the approved projects
• Comparison, optimization, standardization, and
  validation of new assays will be performed in
  collaboration with other Network labs , as needed
• Specialty labs will provide training for
  international sites and lab scientists
• Training and trouble shooting at the
  international labs will be coordinated by the
  Central Lab and SSS in collaboration with the
  other networks

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Specialty Lab Performance

• Annual plan/project by each lab
• Determine if the activities of the lab are
• Integrated into the network agenda
• Advance scientific knowledge in the field
• Non-standard protocol work, if applicable
• Cognitive contributions
• Protocol and NWCS membership and participation
• Committee membership and participation
• IMPAACT presentations, abstracts and publications

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Focus Labs

• Potential for other scientists with novel methods
  not available within the network to perform assays

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International Labs

• New international labs will be established in
  collaboration with other networks, when possible
• Send questionnaire to site to assess capacity,
  equipment, personnel, training, shipping
• Site visit and assessment
• Provide a list of what is required before going
  further, e.g. SOPs, QA/QC program, specific
  assays, etc.
• Capitalize on existing training programs
• Certification of lab readiness as part of site
  approval (SOPs, QA/QC, GCLP, LDMS, EQA, specific
  assays)
• May have to put a person in place for a while
  during establishment process
• On-going monitoring, trouble shooting and
  performance evaluation

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Lab Projects

• Protocol related
• Use specimens from existing studies secondary
  objectives and NWCS
• Validate new assays needed for studies
• Repository samples from old studies NWCS

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What was Discussed Mon/Tues

• NVP resistance
• Breast milk virology and immunology
• Vaccine immunology in infants, children, and
  adolescents
• PK in breast milk and amniotic fluid
• New drug PK in infants, children, adolescents,
  pregnant women (integrase, tibotec)
• Simpler, cheaper diagnostics and monitoring
  (DBS?, other)
• Using rapid Ab tests early to rule out infection

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What was Discussed Mon/Tues

• Diarrheal diseases
• Pneumonia
• Malaria in pregnancy
• Drug resistance in TB
• Adherence to weaning
• Acute HIV infection in pregancy or lactation
• How to distinguish vaccinees from infected
  quickly and inexpensively
• Genetics of transmission host and viral
• PK interactions in pregnancy with TB/HIV or
  malaria/HIV drugs
• PK and virology of integrase inhibitors

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Working Groups

• DBS working group

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Where are the holes?
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Whats Next?

• 2-4 page CS outlining several projects
• Submit to ILSC for the next call (August)
• Sent to SOC/NEC early September

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Potential Projects