Saturday, March 8, 2025
InterContinental
San Francisco - Downtown
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 four Plenary Sessions and four Focus Groups. Below, you’ll find links to video recordings and of the Plenaries and Focus Group presentations.
• View PDF of the full workshop proceedings
Carl Dieffenbach, Director, DAIDS, NIH
Welcome
[Opening remarks]
Charles Flexner, Director, LEAP, Johns Hopkins University
Where are we LEAPing Next?!
Overview of Workshop
[Presentation]
PLENARY SESSION 1 – Current Status of Existing Technologies
Chair: Paul Domanico
Kenly Sikwese (for Imelda Mahaka, PZAT)
Community-Based Presentation
[Presentation]
William Spreen, ViiV Healthcare
Current Status of LA/ER Cabotegravir and Rilpivirine Including Pipeline Report on Novel CBT Formulations
[Presentation]
Luisa Stamm, Merck
Current Status of Merck LA/ER Pipeline
[Presentation]
Moupali Das, Gilead Sciences
Update on the Gilead Long-Acting HIV Treatment & Prevention Pipeline
[Presentation]
Vivian Cox, Gilead Sciences Johnson & Johnson
Update on J&J’s Long-Acting Formulations for Tuberculosis
[Presentation]
PLENARY SESSION 2 – Novel Approaches to LA/ER Drug Delivery
Chair: David Thomas
Andrew Owen, CELT, University of Liverpool
Charles Flexner, Johns Hopkins University
Summary of CHAI/BMGF/DAIDS/WHO Workshop on LAI
Summary of Liverpool Bioequivalence Workshop
[Presentation]
Rodney Ho & Simone Perazzolo, University of Washington
Development of Long-Acting TLD and Lopinavir and Ritonavir; Booster Role and Implications for Future Products
[Presentation]
Andrew Owen, CELT, University of Liverpool
Update from LONGEVITY
[Presentation]
Elizabeth Phillips, Vanderbilt
Hypersensitivity Reactions to Lipid-Based Excipients in Long-Acting Formulations
[Presentation]
Rahima Benhabbour, UNC - Chapel Hill
Preclinical Development of Ultra-Long-Acting Formulations
[Presentation]
Benson Edagwa, UNMC
Ultra-Long-Acting Prodrug Formulations for HIV/HBV Co-Infection
[Presentation]
Anil Gupta,The Scripps Research Institute, Calibr-Skaggs IFIM
LA-Entecavir for HBV
[Presentation]
Lobna Gaayeb, MPP | Adeniyi Olagunju, University of Liverpool
Unlocking Long-Acting Therapeutics: Digital Tools for Informed Decisions
[Presentation]
FOCUS GROUP SUMMARIES - Chair: Kim Scarsi
Chair: Raphael Landovitz | Co-Chair: Kenly Sikwese | Imelda Mahaka, Rapporteur
Group 1 - Unlocking Long-Acting Therapeutics: Digital Tools for Informed Decisions
[Presentation]
Chair: Cissy Kityo | Co-Chair: Melynda Watkins | Rapporteur: Ethel Weld
Group 2 - Developing Combinations for LAI Treatment: Good Partners or Bad Partners?
[Presentation]
Chair: Monica Gandhi | Co-Chair: Laura Waters | Rapporteur: Rachel Bender Ignacio
Group 3 - Management of Injection Site Reactions: Knowledge Gaps and Best Practices
[Presentation]
Paul Domanico, CHAI
Group 4 (part 1) - Update on WHO LA TPP
[Presentation]
Chair: Mike Reid | Co-Chair: Paul Domanico | Rapporteur: Raj Gandhi
Group 4 (part 2) - Target Product and Target Access Profiles of LAIs for Global Use
[Presentation]