SBIR Contract Topic 125 - Development of Long-Acting Treatments for HCV Cure
The purpose of this Notice of Funding Opportunity (NOFO) is to support the development of a comprehensive and well-defined product development strategy for next-generation treatments for HIV and HIV-associated comorbidities, coinfections and complications and preventive strategies for HIV, as well as facilitating the translation of research findings into drug products that enables submission of an Investigational New Drug (IND) application to the FDA.
The purpose of this FOA is to provide investigators working on the development of novel therapeutic products for HIV and HIV-associated co-infections (hepatitis B virus, hepatitis C virus, and Mycobacterium tuberculosis) with a mechanism to request NIAID DAIDS preclinical services to fill gaps in their product development efforts and facilitate the advancement of promising therapeutics from bench to clinics.
Clinical experience for HIV treatment and prevention has demonstrated that adherence to a drug regimen schedule is a significant factor in the success of the HIV treatment regime and/or prevention strategies. Effective treatment of HIV-infected individuals requires strict adherence to a multi-component regimen of antiretroviral agents taken at least daily for the remainder of a patient’s life. Non-adherence can lead to emergence of drug-resistance and loss of therapeutic effectiveness. Among people living with HIV, morbidity and mortality is increasingly driven by co-infections, such as tuberculosis (TB) and hepatitis B, where the compliance and completion of prolonged multidrug regimens are significant factors in treatment success.
Effective prevention requires that the inhibitor be present at the right time, place, and concentration to stop HIV transmission and acquisition. Although many factors (social, behavioral, and individual preference) can influence adherence, the use of drug delivery systems to provide for a longer therapeutic exposure or window of protection and/or less frequent administration may improve their consistent use, reduce dosing intervals, and potentially improve adherence to the drug regimens.
Development of safe, effective, and well-tolerated sustained release (SR)/long acting (LA) products and strategies that maintain consistent and effective drug levels in plasma and target tissues for longer periods of time is critical for successful treatment and prevention of HIV and HIV-associated co-infections.
The purpose of this Funding Opportunity is to stimulate new and innovative multidisciplinary research in the area of long acting therapeutics for HIV and HIV-associated tuberculosis (TB) and viral hepatitis B and C.
The purpose of this Funding Opportunity Announcement (FOA) is to stimulate the high-risk research needed to develop new and innovative sustained release antiviral strategies for treatment of HIV disease or the prevention of HIV transmission and acquisition. Adherence to dosing regimens is a shared critical issue for both HIV treatment and prevention.
The purpose of this Funding Opportunity Announcement (FOA) is to stimulate the development of new and innovative sustained/extended release (SER) drug delivery systems (DDS) that can achieve extended durations (months to years) and provide systemic protection from all routes of HIV infection/transmission in at-risk individuals.
Application Deadline: December 4, 2019, by 5:00 PM local time of applicant organization
The purpose of this Funding Opportunity Announcement (FOA) is to accelerate development of safe and effective long-acting drug delivery systems (LA-DDS) for improved, simplified treatment of HIV-1 in children. This FOA invites applicants engaged in the development of existing LA-DDS platforms at early product development stages to perform specific preclinical activities that enable product optimization and accelerated translation to HIV-1 infected children. Collaborative research partnerships with industry are required.
Application Deadline: March 13, 2019 - 5:00 PM local time of applicant