Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program (LEAP) Investigator Meeting and Annual Workshop - 2018

Saturday, March 3, 2018
Marriott Copley Place

    Plenary Session 1; Current Status of Existing Technologies:

    Charles Flexner, Johns Hopkins University
    Welcome!  Where will we LEAP to next?!  Overview of Workshop

    Peter Williams (Janssen)
    Current Status of Clinical Development of LA-Rilpivirine?

    William Spreen, (ViiV Healthcare)
    Current Status of Clinical Development of LA-Cabotegravir

    Jay Grobler, Merck
    Current Status of the Merck LA/ER Pipeline
    Question and Answer for Jay, William, and Bill
    Susan Swindells, University of Nebraska Medical Center
    LEAP TB – Update from the LEAP Working Group on Development of Long-Acting Approaches to the Treatment of Tuberculosis
    Marco Siccardi, University of Liverpool (being presented by Andrew Owen)
    Update from the LEAP Modeling and Simulation Core: The use of Physiologicallybased Pharmacokinetic and Pharmacodynamic Modelling to
     Assess Drug Candidates

    Polly Clayden, iBase
    Summary of the November, 2017 Workshop on Long Acting/Extended Release Antiretroviral Formulations for HIV Treatment and Prevention
     in Children, Adolescents, and PregnantWomen: Knowledge Gaps and Approaches for Development


    Plenary Session 2; Novel approaches to LA/ER Drug Delivery: 10-Minute Presentations followed by Five-Minute Q & A:

    Leah Johnson, RTI International (presented by Ariane van der Straten)
    Biodegradable Implants for PreP

    Ryan Donnelly, University of Belfast
    LA ART Transdermal Delivery Using Microneedle Technology

    Rodney Ho, University of Washington
    Phase 0 Development of Combination LA ART Delivered Subcutaneously

    Andrew Owen, University of Liverpool
    Nanoformulation of novel NRTI prodrugs

    David Thomas, Johns Hopkins University
    LA Drugs for HCV Eradication: Time to Reconsider?

    GROUP 1:  Craig Hendrix, Rapporteur
    Phase 0 and microdosing as a strategy for efficient development of LA-ER formulations

    GROUP 2:  Polly Clayden, Rapporteur
    Managing drug toxicities, co-morbidities, and drug-drug interactions in the context of LA/ER

    GROUP 3:  Paul Domanico, Rapporteur (being presented by Trip Gulick)
    Streamlining development of investigational drugs and novel prodrugs for LA-ER formulation and clinical development

    GROUP 4:  Charles Boucher, Rapporteur
     Monitoring and Managing Drug Resistance: What kind of monitoring needs to be done in the real world setting?

    GROUP 5:  Marco Siccardi, Rapporteur (being presented by Andrew Owen)
     LA/ER Development for Tuberculosis