Saturday, March 2, 2024
Denver, Colorado
The Long-Acting Extended Release Antiretroviral Research Resource Program (LEAP) virtually convened clinicians, investigators, developers, community advocacy groups, not-for-profit institutions and regulatory authorities. Attendees shared their diverse perspectives and discussed updates, challenges and future directions in the development of LA formulations. The meeting served as a forum to collectively advance the long-acting field. The Workshop consisted of two Plenary Sessions and four Focus Groups. Below, you’ll find links to video recordings and text summaries of the Plenary and Focus Group presentations.
• View PDF of the full workshop proceedings
• View key to abbreviations
Jeanne Marrazzo, M.D., M.P.H., Director of NIAID
Welcome
[Opening remarks] [text summary]
Carl Dieffenbach, Director, Division of AIDS, NIH
Welcome
[Opening remarks] [text summary]
Charles Flexner, Johns Hopkins University
Where are we LEAPing Next?!
Overview of Workshop
[Presentation] [text summary]
PLENARY SESSION 1 – Paul Domanico, Chair.
Current Status of Existing Technologies
William Spreen, ViiV
Current status of LA/ER Cabotegravir and Rilpivirine including pipeline report on novel CBT formulations
[Presentation] [text summary]
Ernest Asante-Appiah, Merck
Current status of the Merck LA/ER Pipeline
[Presentation] [text summary]
Martin Rhee, Gilead Sciences
Current status of the Gilead LA/ER Pipeline
[Presentation] [text summary]
Tom Quinci & Keith Henry, Celanese Corp
Overview of platform and expertise
[Presentation] [text summary]
Vivian Cox, J&J
Current Status of the Janssen LA/ER Pipeline
[Presentation] [text summary]
Richard Scranton, Lyndra Therapeutics
Advancement in Weekly Oral Drug Delivery
[Presentation] [text summary]
Imelda Mahaka, PZAT
Community-based presentation
[Presentation] [text summary]
PLENARY SESSION 2– David Thomas, Chair.
Novel approaches to LA/ER Drug Delivery
Rodney Ho, University of Washington
Update from the Targeted, Long-Acting and Combination Anti-Retroviral Therapy (TLC-ART) program
[Presentation] [text summary]
Andrew Owen, University of Liverpool
Update from LONGEVITY: Novel long-acting formulations for Tuberculosis, Malaria, and Hepatitis C Virus
[Presentation] [text summary]
Marc Baum, Oak Crest Institute of Science
TAF Implants – Phase 1 Studies
[Presentation] [text summary]
Tim Hallett
Cost-effectiveness Modeling for LA Formulations
[Presentation] [text summary]
Kirsten Lyke, University of Maryland (V)
Neutralizing Antibodies for Malaria
[Presentation] [text summary]
Leah Johnson, RTI International
IDevelopment and Acceptability of a Biodegradable Implant for Long-Acting Delivery of ARVs
[Presentation] [text summary]
Focus Group Summary Reports – Susan Swindells, Chair
The four 90-minute Focus Groups preceded the Workshop and were intended to foster informative and provocative discussion of strategically selected topics, listed below. The highlights and recommendations from each focus group were presented. Attendance for these sessions was limited.
Ethel Weld - Rapporteur
Co-Chairs: Mo Archary & Tim Cressey
Group 1: Progress in the develop of dosing strategies for pediatric populations
[Presentation] [text summary] [attendees]
Craig Hendrix - Rapporteur
Co-Chairs: Tim Hallett & Justin Earp
Group 2: Use of modeling and simulation in LA product development
[Presentation] [text summary] [attendees]
Polly Clayden - Rapporteur
Co-Chairs: Lobna Gaayeb & Carolyn Amole
Group 3: Global access to generic formulations: Progress and pitfalls
[Presentation] [text summary] [attendees]
Keith Crawford - Rapporteur
Co-Chairs: Dan Kuritzkes & Marina Caskey
Group 4: The Future of bnAbs in HIV Treatment and Prevention
[Presentation] [text summary] [attendees]