LEAP Program a Resource for Investigators of New Antiretrovirals

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February 3, 2016—Baltimore, MD—The Johns Hopkins Center for Clinical Global Health Education, the Johns Hopkins Departments of Medicine and Pharmacology and Molecular Sciences, and the University of Liverpool launched a new website for an NIH-funded drug development resource called the Long-Acting/Extended Release Antiretroviral Resource Program, or LEAP.

LEAP is designed to advance the development of long-lasting therapies for illnesses that require taking medications long-term. Life-long adherence to daily antiretroviral treatment regimens is challenging for patients who have diseases such as HIV and tuberculosis. Clinical researchers are conducting studies that will ultimately lead to the development of antiretroviral therapies that can be administered less frequently, increasing the odds of adherence.

Drug development is risky and expensive, with estimates ranging from hundreds of millions to well into the billions of dollars. Many scientists working outside of the commercial drug industry lack access to technical, clinical, regulatory affairs, and pharmaceutical experts who can help advance development of long-acting/extended release antiretrovirals. The mission of LEAP is to: 

  • Support scientific innovation through investigator access to broad-based scientific expertise, including the pharmaceutical industry>
  • Develop a communications and data hub to support investigators in this field
  • Provide a Modeling and Simulation Core Service that helps investigators identify the most promising approaches to the development of new products.

Led by Dr. Charles Flexner, Professor of Medicine in the Divisions of Clinical Pharmacology and Infectious Diseases, and Professor of Pharmacology and Molecular Sciences in the Johns Hopkins University School of Medicine, LEAP activities are governed by an Executive Committee and a Pharmaceutical Advisory Board comprising experts that represent basic and applied research,  global health, patient advocacy, and regulatory affairs. The role of these experts is to identify promising approaches and provide expertise on promoting development. A separate TB Working Group will focus specifically on identifying priorities and providing guidance for development of long acting drugs that improve outcomes in tuberculosis treatment.

Flexner, a leading pharmacologist and HIV expert, sees great potential for a network that encourages, nurtures, and advances novel ideas: “Development of long-acting/extended release drugs would effectively eliminate burdensome daily treatment regimens for people living with life-long diseases, and innovators need to be able to communicate, seek advice, and collaborate on ways to advance promising discoveries,” he noted. “We believe the LEAP program can help bring scientific innovation to patients more quickly and, in turn, more cost effectively.”

The LEAP website and portal (www.longactinghiv.org) are central to supporting investigators and facilitating communication. Senior Program Officer Jane McKenzie-White oversees design, implementation, and management of LEAP communications and the website and portal, “The portal is designed to provide resources for investigators, as well as a means to create a community of support for their work.”

A core component of LEAP offers investigators who are working on preclinical and clinical development access to physiologically-based pharmacokinetic predictive modeling services on their projects. Using the Modelling and Simulation Core, directed by Drs. Marco Siccardi and Andrew Owen of the University of Liverpool, several projects per year will be selected for support based on their promise for moving development forward.