Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program (LEAP) Investigator Meeting and Annual Workshop 2023


Saturday, February 18, 2023
Seattle, Washington

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      

Carl Dieffenbach, Director, Division of AIDS, NIH
[Opening remarks]  [text summary]

Charles Flexner, Johns Hopkins University
Where are we LEAPing Next?!
Overview of Workshop

[Presentation]  [text summary]

PLENARY SESSION 1 – Charles Flexner, 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]

Jay Grobler, 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]

David Margolis, Brii Biosciences
Novel LA antiretrovirals from Brii Biosciences
[Presentation]  [text summary]

Simone Perazzolo, University of Washington
Modelling and simulation in support of a novel LA ARV formulation
[Presentation]  [text summary]

Ryan Donnelly, Queens University Belfast
Update on the status of microarray patches for LA delivery of ARVs
[Presentation]  [text summary]

Imelda Mahaka, Pangaea Zimbabwe AIDS Trust
How can we increase access to LA formulations? A community perspective
[Presentation]  [text summary]

PLENARY SESSION 2– David Thomas, Chair: Novel technologies and approaches:

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]

Vikram Arya, FDA
Conversion of an approved oral ARV to an LA formulation: regulatory issues
[Presentation]  [text summary]

Kim Struble, FDA
When is an oral lead-in needed for a novel LA formulation?
[Presentation]  [text summary]

Lasse Leino, DelSiTech
A novel silicon-based platform for Drug Delivery
[Presentation]  [text summary]

Martina Kovarova, UNC Chapel Hill
In-Situ Implant Formation for TB and other infectious diseases
[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.

Polly Clayden - Rapporteur
Group 1: Lessons learned from Islatravir Toxicology
[Presentation]  [text summary]  [attendees]

Ashwin Balagopal - Rapporteur
Group 2: The needs and challenges developing long-acting treatments for hepatitis C?
[Presentation]  [text summary]  [attendees]

Ethel Weld - Rapporteur
Group 3: Tuberculosis long-acting formulations: status and prospects for future clinical development
[Presentation]  [text summary]  [attendees]

Paul Domanico - Rapporteur
Group 4: Barriers to commercial manufacturing of generic LA formulations.
[Presentation]  [text summary]  [attendees]