Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program (LEAP) Investigator Meeting & Annual Workshop - 2021


Friday March 5, 2021


Carl Dieffenbach, Directo, Division of AIDS, NIH

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

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

Jay Grobler, Merck
Current status of the Merck LA/ER pipeline

Martin Rhee, Gilead Sciences
Current status of the Gilead LA/ER pipeline

Marco Siccardi, University of Liverpool
Update from the LEAP Modeling and Simulation Core

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

Plenary Session II: Novel technologies and approaches:

Erika Englund, Food and Drug Administration
Chemistry, Manufacturing and Controls (CMC): Considerations for Extended-Release Injectable Formulations

Nicole Ammerman, Johns Hopkins University
Injection volumes: possible role of recombinant hyaluronidase and other approaches

Edmund Capparelli, University of California, San Diego
Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery

Andrew Owen, University of Liverpool
Update from LONGEVITY

Rodney Ho, University of Washington
Update from the Targeted, Long-acting and Combination Anti-Retroviral Therapy (TLC-ART) program
Lobna Gaayeb, Medicine Patent Pool
Medicines Patent Pool Long Acting Initiatives

Focus Group Summary Reports:

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?

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?

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?

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?