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Building Global HIV/AIDS Clinical Pharmacology Research Capacity. Welcome Acknowledgement: NIH Fogarty International Center AIDS Training and Research Program. Gene D. Morse, PharmD, FCCP, BCPS Professor, University at Buffalo Associate Director

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building global hiv aids clinical pharmacology research capacity

Building Global HIV/AIDS Clinical Pharmacology Research Capacity

Welcome

Acknowledgement: NIH Fogarty International Center AIDS Training and Research Program

Gene D. Morse, PharmD, FCCP, BCPS

Professor, University at Buffalo

Associate Director

NYS Center of Excellence in Bioinformatics and Life Sciences

hiv clinical pharmacology in the news
HIV Clinical Pharmacology “in the News”

CNS Penetration Effectiveness (CPE)

Cytochrome P450, efflux transporters and miRNA

ARV Therapeutic Drug Monitoring

HIV and Nanomedicine

Inhibitory Quotient (IC50/Trough)

iPrEx demonstrates HIV prevention

Pediatric HIV dosing/formulations

Antiretroviral – TB Drug Interactions

Microbicide efficacy and tissue concentrations

Buprenorphine, Methadone for HIV-Infected SRD

Intracellular ARV Measurement

Pharmacogenomics and ARVs:

Abacavir, Efavirenz

biomedical and healthcare informatics facilitate a translational pharmacology model
Biomedical and Healthcare Informatics Facilitate a Translational Pharmacology Model

Therapeutics

Implementation Science Research

Healthcare Informatics

Prevention, Microbicides

TB, HCV Research

Biomedical Informatics

Post-approval Safety Research

Cure, End organ, Inflammation

hiv clinical pharmacology and quality assurance program cpqa
HIV Clinical Pharmacology and Quality Assurance Program (CPQA)
  • Current CPQA Components
    • Assay AVR/SOP Peer Review
    • Proficiency testing and lab compliance
    • Biomatrix assay guidelines
    • Pharmacology Laboratory Staff Training
    • International Pharmacology Laboratory sites
    • Clinical Pharmacology Research Site Training: tutorial/certificate
    • Laboratory Site Inspections and Audits
international clinical pharmacology capacity building
International Clinical Pharmacology Capacity Building
  • Identify sites planning to conduct clinical pharmacology protocols
  • Support sites to develop/expand a clinical pharmacology laboratory resource
  • Mentor researchers in pharmacokinetics and pharmacodynamics
  • Develop pharmacogenomics assay capacity
  • Pharmacovigilance and patient safety research
international clinical pharmacology capacity building1
International Clinical Pharmacology Capacity Building
  • CPQA website to develop a registration process for sites interested in conducting Clinical Pharmacology protocols and laboratory assays
  • Menu approach to include:
    • Clinical pharmacology protocol design
    • Drug interactions protocol design
    • Drug interactions: Precautionary and Prohibited Medications Database
    • Clinical pharmacology study conduct: Tutorial/certificate
    • Care Report Form development
    • Drug assays: Instrumentation, sample processing
    • Drug assays: AVR, SOP documentation
    • Rare biomatrices
    • Bioequivalence
    • Therapeutic drug monitoring
    • Pharmacokinetic data analysis
    • Pharmacodynamic analysis
    • Sample collection, labeling, processing, storage
    • Sample shipment
    • Pharmacogenomic assays and data analysis
    • Pharmacovigilance
    • Data management and Healthcare Informatics applications
summary
Summary
  • Clinical pharmacology is a key component of the HIV/AIDS drug development challenge
  • Clinical and translational pharmacology approach to address HIV and co-infection drug development research
  • Strategy to include community partnerships
  • In-country priorities and capacity building should guide approaches with implementation research
  • Coordinated effort among research programs may provide an efficient (time, $$) approach.
ias2012 visit buffalo niagara
IAS2012: Visit Buffalo-Niagara

Niagara Falls: Horseshoe Falls

Niagara Falls: American Falls