Saturday, February 12, 2022
ZOOM VIRTUAL WEBCAST
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
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 1: Current Status of Existing Programs:
Ryan Donnelly, Queens University Belfast
Update on Transcutaneous Microneedles for Antiretroviral Drug Delivery”
[Presentation] [text summary]
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]
Andrew Owen, University of Liverpool
Update from the LEAP Modeling and Simulation Core
[Presentation] [text summary]
Lynn Bertagnolli, Johns Hopkins University
LEAP Systematic Reviews of LA formulation use in pediatrics and pregnancy”
[Presentation] [text summary]
Keith Crawford, Division of AIDS, NIH
DAIDS/NIH resources to support preclinical and clinical development of ARVs and related anti-infective drugs
[Presentation] [text summary]
Plenary Session II: Novel technologies and approaches:
Marc Baum, Oak Crest Institute
Tenofovir implants and local toxicity: What have we learned to date?
[Presentation] [text summary]
A. Chatterjee, Calibr, Scripps Institute, San Diego
Developing a long-acting formulation for Hepatitis B virus treatment and prevention”
[Presentation] [text summary]
Benson Edagwa, University of Nebraska
Novel long-acting protides of approved ARVs
[Presentation] [text summary]
Andrew Owen, University of Liverpool
Update from LONGEVITY: Novel long-acting formulations for Tuberculosis
[Presentation] [text summary]
Rodney Ho, University of Washington
Update from the Targeted, Long-acting and Combination Anti-Retroviral Therapy
[Presentation] [text summary]
David Ripin, Clinton Health Access Initiative
CADO 4/PADO 5: Approach to delivery of LA ARVs for HIV Treatment and Prevention in LMICs, report from a WHO-sponsored meeting
[Presentation] [text summary]
Focus Group Summary Reports:
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.
Andy Kaytes, UCSD - Rapporteur
Group 1: Developing LA formulations for treatment and prevention of HBV and HDV: Where are we now and where do we need to go?
[Presentation] [text summary] [attendees]
Polly Clayden, iBase - Rapporteur
Group 2: Long-acting oral drugs and formulations: how do they stack up compared to other routes of drug delivery?
[Presentation] [text summary] [attendees]
Paul Domanico, CHAI - Rapporteur
Group 3: Best practices for conversion of immediate release approved ARVs: To prodrug or not to prodrug?
[Presentation] [text summary] [attendees]
Bob Bollinger, JHU - Rapporteur
Group 4: Challenges in developing combination LA products and regimens.
[Presentation] [text summary] [attendees]