Sunday, March 3, 2019
Grand Hyatt Seattle Hotel
SEATTLE
REGISTRATION:
Carl Dieffenbach, Director, Division of AIDS, NIH
Welcome!
Charles Flexner, Johns Hopkins University
Where Will We LEAP to Next?!
Workshop Overview
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PLENARY SESSION: Current Status of Existing Technologies:
Peter Williams, Janssen
Clinical Development of LA Rilpivirine
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William Spreen, ViiV Healthcare
Clinical Development of LA Cabotegravir
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Jay Grobler, Merck
Current Status of the Merck LA/ER Pipeline
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Jim Zheng, Gilead Sciences
Preclinical profile of a novel capsid inhibitor
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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
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Marco Siccardi, University of Liverpool
Update from the LEAP Modeling and Simulation Core: Using Physiologically-based Pharmacokinetic and Pharmacodynamic Modelling to Assess Drug Candidates
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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
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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
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Kimberly Struble, FDA
Getting to Phase 2 Without an Oral Partner Formulation: Regulatory Perspective
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Marc Baum, Oak Crest Institute
Tenofovir Alafenamide Subcutaneous Implant: Transition from Preclinical to Early Stage Clinical Evaluation
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Benson Edagwa, University of Nebraska Medical Center
Nanoformulation of Novel NRTI Prodrugs for LA Delivery
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Lut Van Damme, Bill & Melinda Gates Foundation
Nanoformulation of Novel NRTI Prodrugs for LA Delivery
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FOCUS GROUP REPORTS:
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?
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GROUP 2: Paul Domanico & Catherine Chappell Co-Chairs; Andy Kaytes, Rapporteur
Clinical Development of Antiretroviral Implants: Identifying Barriers & Knowledge Gaps
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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
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GROUP 4: Carmen Perez Casas & Meg Doherty, Co-Chairs; Polly Clayden, Rapporteur
Transitioning LA/ER Formulations to a Generic Marketplace for LMICs
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