Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program Investigator Meeting & Annual Workshop - 2019


Sunday, March 3, 2019
Grand Hyatt Seattle Hotel



Carl Dieffenbach, Director, Division of AIDS, NIH
Charles Flexner, Johns Hopkins University
Where Will We LEAP to Next?!
Workshop Overview  

PLENARY SESSION: Current Status of Existing Technologies:

Peter Williams, Janssen
Clinical Development of LA Rilpivirine

William Spreen, ViiV Healthcare
Clinical Development of LA Cabotegravir
Jay Grobler, Merck
Current Status of the Merck LA/ER Pipeline
Jim Zheng, Gilead Sciences
Preclinical profile of a novel capsid inhibitor
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

Marco Siccardi, University of Liverpool
Update from the LEAP Modeling and Simulation Core: Using Physiologically-based Pharmacokinetic and Pharmacodynamic Modelling to Assess Drug Candidates

Melissa Davey-Rothwell, Johns Hopkins University, LEAP Systematic Reviews Core
Use of Systematic Reviews to Inform the Development of LA-ER Drug Delivery Products for Children, Adolescents, and Pregnant Women

PLENARY SESSION: Novel Approaches to LA/ER Drug Delivery:

Babafemi Taiwo, Northwestern University
Combining Cabotegravir-LA and VRC01-LS for Viral Suppression in HIV-1-infected Adults

Kimberly Struble, FDA
Getting to Phase 2 Without an Oral Partner Formulation: Regulatory Perspective

Marc Baum, Oak Crest Institute
Tenofovir Alafenamide Subcutaneous Implant: Transition from Preclinical to Early Stage Clinical Evaluation

Benson Edagwa, University of Nebraska Medical Center
Nanoformulation of Novel NRTI Prodrugs for LA Delivery

Lut Van Damme, Bill & Melinda Gates Foundation
Nanoformulation of Novel NRTI Prodrugs for LA Delivery

GROUP 1:  Raphael Landovitz & Richard Koup, Co-Chairs; Jeff Jacobson, Rapporteur
Partnering Long-acting Broadly Neutralizing Antibodies with Small Molecule Formulations: What Are the Issues?

GROUP 2:  Paul Domanico & Catherine Chappell Co-Chairs; Andy Kaytes, Rapporteur
Clinical Development of Antiretroviral Implants: Identifying Barriers & Knowledge Gaps

GROUP 3:  Terrance Blaschke & Elaine Abrams, Co-Chairs; Craig Hendrix, Rapporteur
Best Practices in the Management of Non-adherent Patients: Defining ‘Forgiveness’ for LA Regimens

GROUP 4:  Carmen Perez Casas & Meg Doherty, Co-Chairs; Polly Clayden, Rapporteur
Transitioning LA/ER Formulations to a Generic Marketplace for LMICs