Targeted Clinical Research to Address Select Viral Infections

Purpose This is a Request for Information (RFI) only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this RFI is to obtain knowledge and information to assess the current state of the science. Further, neither DHHS/NIH/NIAID nor the government will be responsible for any cost incurred in furnishing this information. The NIAID is seeking information from organizations interested in the support/advancement of the development of therapeutic strategies for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations. The purpose of this RFI is to gather information about the current state of the natural history studies that evaluate the contemporary clinical course of the viral disease in a target patient population as well as the use of alternative and innovative research methods and clinical trial design strategies. Targeted patient populations include children (neonates through adolescents), the elderly, transplant recipients, and pregnant women. A rare (or orphan) disease is generally considered to have a prevalence of fewer than 200,000 affected individuals in the United States. Examples include congenital cytomegalovirus (CMV), Epstein-Barr virus (EBV), and neonatal herpes virus. Emerging viral diseases can be defined as infections that have newly appeared in a population, or have existed but are rapidly increasing in incidence in that population or geographic range. Examples include lassa fever virus and chikungunya virus. Background Research supported and conducted by the NIAID, NIH, DHHS, strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten the health and lives of millions of humans. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, with the exception of the human immunodeficiency virus (HIV). This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. Information Requested Organizations are invited to submit a white paper describing their research efforts in the evaluation of the natural history as well as the use of alternative and innovative research methods and clinical trial design strategies in the support/advancement of the development of therapeutic strategies for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations. The paper can include but is not limited to: - Interventional trials of safety and effectiveness for treatments for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations and under-served by the pharmaceutical industry (Phase I [except first in human studies], Phase II or Phase IV are allowable); - Natural history studies of the rare and/or emerging viral diseases to assist in the design of treatment trials with useful endpoints; - Validation of biomarkers or surrogate markers of clinical responses and safety in antiviral therapy for the purposes of designing future clinical therapeutic studies; - Validation of diagnostic tests for predicting clinical response to therapy; - Proof of principle studies to further product development; - Exposure/exposure-response studies (using pharmacokinetic and pharmacokinetic /pharmacodynamic approaches) to optimize therapies; - Assessment of the emergence of resistance to antiviral therapies; or - Analysis of existing databases or patient charts. Studies that will not be supported include: - Surveillance studies; - Transmission studies; - Studies designed to evaluate the immunologic changes associated with the viral disease; - Studies designed to evaluate immunosuppressive regimens in transplant patients; - First in human (FIH) interventional trials; - Phase III studies; - HIV studies or studies of other infections in HIV patients; - Studies for viral illnesses for which there are effective marketed therapeutics or substantial pharmaceutical industry investment in development of therapies, such as influenza, hepatitis C, or hepatitis B. Responses should be limited to 10 pages, not including cover page, cover letter and table of contents. Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law. Submitted data and information will not be returned. RFI response must include: 1) Name and title of the primary point of contact for the response; 2) Name and address of the Institution or Company; 3) Email address and phone number of the primary point of contact. Responses are due by October 8, 2014. Inquiries Inquiries and RFI responses should be directed to the NIAID Division of Microbiology and Infectious Diseases, Office of Acquisitions, Point of Contact (POC): Swee Teo, at teosl@niaid.nih.gov. Alternate POC is George Kennedy, at kennedyg@niaid.nih.gov.