Friday March 5, 2021
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, Directo, Division of AIDS, NIH
Welcome
[video-only]
Charles Flexner, Johns Hopkins University
Where are we LEAPing Next?!
[video/slides] [text summary]
PLENARY 1: Current Status of Existing Programs:
William Spreen, ViiV Healthcare
Current status of LA/ER Cabotegravir and Rilpivirine including pipeline report on novel CBT formulations
[video/slides] [text summary]
Jay Grobler, Merck
Current status of the Merck LA/ER pipeline
[video/slides] [text summary]
Martin Rhee, Gilead Sciences
Current status of the Gilead LA/ER pipeline
[video/slides [text summary]
Marco Siccardi, University of Liverpool
Update from the LEAP Modeling and Simulation Core
[video/slides] [text summary]
Susan Swindells, University of Nebraska Medical Center
LEAP TB: Update from the LEAP Working Group on Development of Long-Acting Approaches to the Treatment of Tuberculosis
[video/slides] [text summary]
Plenary Session II: Novel technologies and approaches:
Erika Englund, Food and Drug Administration
Chemistry, Manufacturing and Controls (CMC): Considerations for Extended-Release Injectable Formulations
[video/slides] [text summary]
Nicole Ammerman, Johns Hopkins University
Injection volumes: possible role of recombinant hyaluronidase and other approaches
[video/slides] [text summary]
Edmund Capparelli, University of California, San Diego
Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery
[video/slides] [text summary]
Andrew Owen, University of Liverpool
Update from LONGEVITY
[video/slides] [text summary]
Rodney Ho, University of Washington
Update from the Targeted, Long-acting and Combination Anti-Retroviral Therapy (TLC-ART) program
[video/slides] [text summary]
Lobna Gaayeb, Medicine Patent Pool
Medicines Patent Pool Long Acting Initiatives
[video/slides] [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.
Dave Thomas, Johns Hopkins University, Andrew Owen, Liverpool; Craig McClure as Rapporteur
Group 1: What should the agenda be in coming year for the LEAP Viral Hepatitis Working Group?
[video/slides] [text summary] [attendees]
Raphael Landovitz, UCLA, and Beatriz Grinsztejn, Fiocruz; Andy Kaytes as Rapporteur
Group 2: What HPTN 083 and 084 teaches us about Injectable LA ARV’s: What have we learned, and what do we need to learn next? What to do about the tail? How to avoid oral formulations at the end of LA PrEP strategies?
[video/slides] [text summary] [attendees]
Katie Bar, U Penn, and Marina Caskey, Rockefeller University; Roy (Trip) Gulick, Cornell University, as Rapporteur
Group 3: Designing and implementing clinical studies of monoclonal antibodies for HIV and SARS-CoV-2: What have we learned to date?
[video/slides] [text summary] [attendees]
Elaine Abrams, Columbia University and Mark Mirochnick, Boston University; Polly Clayden Rapporteur
Group 4: Infants, children, and pregnant women: How to make better progress in clinical studies of LA formulations?
[video/slides] [text summary] [attendees]