Pathways to timely, quality-assured, affordable and available long-acting formulations and delivery platforms at scale

The final session of the series Accelerating access to long-acting HIV prevention and treatment formulations and delivery platforms: Challenges and opportunities will discuss critical enablers that are needed to expedite access to at-scale manufacturing and supply of long-acting formulations and delivery platforms for HIV prevention and treatment, including the contribution of generic manufacturers. Lessons learned from scaling up access to HIV medicines and injectable contraceptives will be shared to inform how to prepare for roll out of long-acting formulations and delivery platforms at scale. Critical components that must be addressed in a timely and appropriate way will be discussed, including: affordability and the role and capacity of generic manufacturers; regulatory pathways and bioequivalence guidance; availability of clinical guidelines and their role to stimulate engagement from procurement agencies; demand creation and market size estimations and forecasts; and service delivery. Multiple stakeholders, including originator and generic manufacturers, procurement agencies, communities and civil society, will be invited to share their experiences. 

The aim of the session is to: 1) reach a common understanding of the most critical enablers required to expedite at-scale access to long-acting formulations and delivery platforms of HIV prevention and treatment; 2) provide an update on the status of these enablers; and 3) share perspectives for the development of a roadmap to collectively address the most critical enablers.

View session 1 of the series here and session 2 here

Chairs

Anton Pozniak

IAS Past-President and Consultant Physician in HIV Medicine

Chelsea and Westminster Hospital, UK

Helen McDowell

Head of Government Affairs & Global Public Health

ViiV Healthcare

Speakers

Rajesh Murthy

Head of Alliance Management and Indian Operations

Medicines Patent Pool

Lessons from scaling up access to ART and foreseen challenges with long-acting technologies

Lilian Mworeko

Executive Director and founding member

ICWEA, Uganda

Community and end-user expectations

Kate Rademacher

Senior Technical Advisor

FHI360, USA

Lessons learned from longer acting contraceptives scale-up and roll-out

Aditi Das

Business Development Manager, Technical and Regulatory Affairs

Medicines Patent Pool, India

Scaling-up manufacturing capacity of novel HIV therapeutics: Reality check

Ray Corrin

Clinical assessor

World Health Organization, Switzerland

Regulatory pathways enabling access to long-acting formulations

Wesley Kreft

APWG, Netherlands

Elements enabling predictable and successful procurement of long-acting technologies

Faez Ahmed

Assistant General Manager, Regulatory Affairs

Incepta Pharmaceuticals Ltd., Bangladesh

Michael Du Plooy

Associate Director

Cipla, South Africa

Rapid fire: perspectives from generic manufacturers
Panelists

Mitchell Warren

Executive Director

AVAC

Aditi Das

Business Development Manager, Technical and Regulatory Affairs

Medicines Patent Pool, India

Ray Corrin

Clinical assessor

World Health Organization, Switzerland

Wesley Kreft

APWG, Netherlands