Building Global HIV/AIDS Clinical Pharmacology Research Capacity

1. 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

2. 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

3. 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

4. Developing Partnerships in a Global HIV-TB Translational Pharmacology Program

5. Integrated HIV-Infectious Diseases and Biomatrix Analysis Strategy

6. 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

7. 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

8. 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

9. 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.

10. IAS2012: Visit Buffalo-Niagara Niagara Falls: Horseshoe Falls Niagara Falls: American Falls