Long Acting/Extended Release Antiretroviral Formulations for HIV Treatment & Prevention in Children, Adolescents, & Pregnant Women: Knowledge Gaps & Approaches for Development

Monday-Tuesday, November 6-7, 2017
National Institute of Allergy and Infectious Diseases
Rockville, Maryland

    
PLENARY SESSION

Sharon Nachman, SUNY Stony Brook; Charles Flexner, Johns Hopkins University    
Introduction

Carl Dieffenbach; Director, Division of AIDS, NIH    
Welcome

Sharon Nachman, SUNY Stony Brook
State of the Science & Meeting Overview

Charles Flexner, Johns Hopkins University
State of the Science & Meeting Overview

Magali Hickey, Alkermes
Industry Perspective

Kimberly Struble, FDA
Regulatory Perspective

Edmund Capparelli, UC San Diego
Role of PK Modeling
 
Bethany Stewart, Clinton Health Access Initiative
Global Operations & Implementation
    
Heather Watts, US President’s Emergency Plan for AIDS Relief (PEPFAR)
Challenges in Drug Development in Women Who Become Pregnant
    
Linda-Gail Bekker, University of Cape Town
Challenges in Drug Development in Adolescents

Allison Agwu, Johns Hopkins
Challenges in Drug Development in Adolescents
    
BREAKOUT REPORTS
    
Marco Siccardi, Rapporteur
LA/ER Formulations for Children: Should They Be the Same as Formulations for Adults?
    
Polly Clayden, Rapporteur
What to Do When a Woman Becomes Pregnant?
    
Jen Cohen, Rapporteur
Challenges in Enrolling & Retaining Adolescents in Clinical Trials for HIV Treatment & Prevention 
    
Jeff Jacobson, Rapporteur
Regulatory & Formulation Approval Challenges Related to These Three Key Populations 
 

Sponsored by LEAP  |  NIH/DAIDS  |  Bill & Melinda Gates Foundation  |  IMPAACT