Sunday, February 21, 2016
Westin Copley Plaza Hotel
BOSTON
Carl Dieffenbach; Director, Division of AIDS, NIH
Welcome
[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]