Infectious Disease & Vaccines
Antiviral Products in the pre-IND Phase
Productive pre-IND interactions with FDA are important to the success of any drug development program, including infectious disease product development. The Pre-IND Consultation Program through the Office of Infectious Disease (OID), one of 27 review divisions within the Office of New Drugs, provides opportunities for makers of infectious disease products to engage with FDA by facilitating early communications between the Division of Antivirals or the Division of Anti-Infectives within OID and sponsors/investigators of potential new therapeutics – these products include drugs and therapeutic biologics for the treatment of bacterial, fungal, and viral infections (including SARS-CoV-2 infection).
Considerations When Starting a Vaccine Study
For over 10 years, Rho has worked in vaccine research and is currently 1 of 5 contract research organizations in the BARDA Medical Countermeasures Clinical Studies Network (MCM-CSN) that designs and conducts clinical studies needed to develop drugs, vaccines, and diagnostic tests that help protect public health. Based on our experience, we understand the risks, challenges, and solutions needed to operationalize a vaccine trial.
Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD
Generating Antibiotic Incentives Now (GAIN) and the Qualified Infectious Disease Product (QIDP) designation and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), described below, were designed by the FDA to streamline development and encourage investment into targeting infections that lack effective therapies.