Friday, September 20, 2024
Liverpool, UK
Long acting/extended release antiretroviral drug formulations have tremendous potential to revolutionize the prevention and treatment of HIV infection. However, these formulations are likely to have their greatest global impact in low- and middle-income countries. This, in turn, will require the efficient development and approval of generic or near-equivalent formulations of these agents to gain accelerated approval from global regulatory authorities. To date, the clinical development of such formulations has been painfully slow, with the first generics not expected to be available until 2027/2028.
This workshop aims to catalyze coordinated activity to identify the most efficient pathways for development and approval of generic antiretroviral LA/ER products and recommend appropriate ways to maximize the benefit these formulations will bring to these important and vulnerable populations. This is a multi-disciplinary workshop that includes experts from academia, the pharmaceutical and generics industries, NIH, regulatory agencies, NGO’s, and community representatives.
Welcome
Andrew Owen, PhD, University of Liverpool; Director, CELT
[Opening remarks]
Welcome
Keith Crawford, RPh, PhD, Division of AIDS, NIH
[Opening remarks]
Welcome and Overview of Workshop
Charles Flexner, Johns Hopkins University - Director, LEAP
[Opening remarks]
PLENARY SESSION 1 - Adeniyi Olagunju, Chair
Precedent for development of generic LAI formulations:
Kimberly Struble, FDA
Regulatory Experience with Development and Approval of Generic or Equivalent Formulations for LAI Drugs
[Presentation]
Melynda Watkins, CHAI
Hormonal Contraceptive Implants and Injectables: What have we learned to apply to LAI ARVs?
[Presentation]
Parag Nimbolkar & Lobna Gaayeb, MPP
Landscape Analysis of Approvals and Market Uptake of Generic or Equivalent Formulations for LAI Drugs
[Parag Presentation] [Lobna Presentation]
PLENARY SESSION 2– Kimberly Struble, Chair
Regulatory and IP issues in generic development and approval of LAI formulations for HIV treatment and prevention
Kimberly Struble, FDA
Bioequivalence of New Formulations of Approved Antiretroviral LAI Drugs: What are the Regulatory Considerations
[Presentation]
Simone Perazzolo, University of Washington
Role of Modelling and Simulation as a Tool for Assessment of BE of LAI Formulations
[Presentation]
Bharat Pagi, Uddipak Consultancy (rec)
IP issues for consideration in development of generic formulations for LMICs
[Presentation]
Chairs and Speakers, Plenary Sessions 1 & 2
Open Discussion on Barriers to Generic LAI Development and BE assessment
[Discussion]
PLENARY SESSION 3– Kim Scarsi, Chair
Clinical development of generic LAI for HIV treatment and prevention: What are the issues?
Annemarie Wensing, UMC Utrecht (rec)
Pharmacodynamics of HIV Drug Resistance and How This Might Affect BE Study Design for LAI formulations
[Presentation not added as requested by presenter]
Saye Khoo, Univ of Liverpool?
Patients Versus Healthy Volunteers
[Presentation]
Marta Boffito, Chelsea and Westminster
Managing the PK Tail in BE Studies
[Presentation]
Charles Flexner, Johns Hopkins University
How Long Does a BE Study Need to Be for an Antiretroviral LAI?
[Presentation]
Chair and Speakers
Open Discussion on Clinical Considerations
[Presentation]
PLENARY SESSION 4– Paul Domanico, Chair
Manufacturing and Implementation
Paul Domanico, CHAI
The Importance of Partnerships Across the Continuum of Care
[Presentation]
René Holm, Univ of Southern Denmark
How Difficult Is It to Manufacture an LAI Formulation, Really?
[Presentation]
Zack Panos, CHAI
The Adoption and Business Case for LA Antiretrovirals: HIV as a Case Study
[Presentation]
Imelda Mahaka, PZAT
The Community’s Perspective
[Presentation]
Francois Venter, Univ of the Witwatersrand
The Clinician’s Perspective
[Presentation]
Benny Kottiri, USAID/PEPFAR
The Payer’s Perspective
[Presentation]
Polly Clayden, Andrew Owen, and Charles Flexner
Workshop Summary and Adjournment
[Presentation]