Long-Acting/Extended Release (LA/ER) Antiretroviral Drugs Workshop - 2016

    Sunday, February 21, 2016
    Westin Copley Plaza Hotel

    Carl Dieffenbach; Director, Division of AIDS, NIH    
    [video]  [audio-only/slide]

    Charles Flexner, Johns Hopkins University; Susan Swindells, University of Nebraska Medical Center
    Welcome to LEAP! and Overview of Worshop
    [video]  [audio-only/slide]
    Marco Siccardi, University of Liverpool (WILL BE UPLOADED SOON)
    The Use of Physiologically-based Pharmacokinetic and Pharmacodynamic
    Modelling to Assess Drug Candidates

    [video/slides]  [audio-only/slide]
    Peter Williams (Janssen)
    Current Status of Clinical Development of LA-Rilpivirine?
    [video/slides]  [audio-only/slide]
    Kimberly Smith and William Spreen, ViiV Healthcare
    Current Status of Clinical Development of LA-Cabotegravir
    [video/slides]  [audio-only/slide]
    Kimberly Struble, FDA Antivirals Division
    Regulatory Perspective on Developing Long Acting ARVs for HIV Treatment
    [video/slides]  [audio-only/slide]
    Marc Baum, Oak Crest Institute
    Implantable LA/ER Tenofovir Alafenamide
    [video/slides]  [audio-only/slide]
    Thomas Hope, Northwestern University
    Sexual Transmission and Topical LA/ER ART Delivery
    [video/slides]  [audio-only/slide]
    Rodney Ho, University of Washington
    Lymphatic Targeting – TLC ART
    [video/slides]  [audio-only/slide]
    Patrick Sinko, Rutgers University
    BRIEF UPDATE: Nanotechnology Approaches for Mucosal HIV
    PreExposure Prophylaxis (mPrEP)

    [video/slides]  [audio-only/slide]

    Andrew Bellinger, Lyndra Corporation
    A Novel Approach to LA/ER Oral Drug Delivery
    [Presentation withheld at speaker's request]
    Focus Groups’ Feedback: Ten-Minute Reports
    Daria Hazuda, PhD, and Andrew Owen, PhD, Co-Chairs, and Patrick Sinko, PhD, Rapporteur
    Molecular Discovery — How best to access existing molecules that were already
    screened, are highly potent and promising for LA/ER formulation, but were shelved
    because they did not meet criteria for oral delivery. How can NIH/DAIDS best help
    to promote these interactions?

    [video/slides]  [audio-only/slide]
    Susan Swindells, MD, and Paul Domanico, PhD, Co-Chairs, and Polly Clayden, Rapporteur
    Facilitating collaboration between the pharmaceutical industry and
    non-pharmaceutical drug and formulation discovery efforts

    [video/slides]  [audio-only/slide]
    Kimberly Struble, PharmD, Chair, and Jeff Jacobson, MD, Rapporteur
    Regulatory Guidance -- Regulatory issues in LA/ER ARV development, and what options
    exist for developing an injectable LA/ER formulation without an oral partner formulation.
    [video/slides]  [audio-only/slide]