Revolutionizing the Clinical Research for Long-Acting Injectables: What to Expect Globally?

Session Description

Long-acting injectables (LAIs) are considered as an important alternative to oral medications for patients with chronic conditions such as schizophrenia because they decrease the dosing frequency and improve patient adherence. However, LAIs still remain underutilized and only a few drug products are approved globally, for both new and generic drug products. Development of LAIs is a lengthy, complex and costly process. Due to the nature of LAIs, conventional clinical studies can last for one or several years. With the increasing length of clinical studies, recruiting and managing patients become difficult and multiple clinical centers are often needed to ensure sufficient sample size. With all the challenges above, the introduction of an LAI may take more than a decade after the initial approval of its oral product, and even longer to have the first generic product. Revolutionizing the clinical research for LAIs is in demand to improve access to LAI medications globally.

This session will discuss alternative approaches such as model-based methods to revolutionize the clinical research for LAIs that can shorten the study duration, reduce the sample size, and increase the effectiveness of clinical studies. The session will also discuss the potential global harmonization efforts to support a single global generic drug development program, which plays an important role in helping to address rising development costs and in promoting access to essential LAIs worldwide.

Learning Objectives

1. Learn the future of modeling approach in revolutionizing clinical research for LAI drug development, and increasing the effectiveness of clinical studies.
2. Learn the regulatory considerations when model-based approaches are applied in drug development.
3. Understand the potential efforts in global harmonization for generic LAIs.

Session Schedule

3:00 PM - 3:05 PM MT
Introduction
Navin Goyal, PhD

3:05 PM - 3:20 PM MT
Model Informed Development of Long-Acting injectables – Traversing from Preclinical to Clinical Settings
Rajendra Singh, PhD

3:20 PM - 3:35 PM MT
Strategic Development of Generic Long-Acting Injectables: From a Regulatory Science Perspective
Yuqing Gong, PhD

3:35 PM - 3:55 PM MT
Panel Discussion and Q&A

3:55 PM - 4:00 PM MT
Closing Remarks