Broad Agency Announcement (BAA): Targeted Clinical Research to Address Select Viral Infections, NIAID-DMID-NIH-AI-2014028


Notice Number:

NOT-AI-15-014

Key Dates

Release Date: December 18, 2014

Related Announcements

None

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Division of Microbiology and Infectious Diseases (DMID) has a requirement for the support/advancement of the development of therapeutic strategies for select rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations.

Description:

Rare and/or emerging viral diseases typically are associated with significant morbidity and mortality and economic costs worldwide. A rare (or orphan) disease is generally considered to have a prevalence of fewer than 200,000 affected individuals in the United States. 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.

Although many of the disease syndromes (conditions and manifestations) caused by viruses in general are relatively benign and self-limited in the normal host, they are often much more severe in a variety of special populations of patients, e.g., immunocompromised individuals, the elderly, pregnant women, or children and neonates. The study of serious rare or emerging viral infections in these populations provides unique and special challenges and treatment options are frequently sparse. Consequently, the development of effective therapies or therapeutic strategies for rare viral diseases or viral diseases in special populations remains a significant unmet medical need. The pharmaceutical industry is focused primarily on the development of therapies for chronic viral infections, such as HIV, hepatitis B, hepatitis C or therapies for acute viral illnesses that are usually self-limited, but may affect large numbers of people, such as influenza or the common cold. Whereas, the development of therapies for rare and/or emerging viral diseases has not been an industry priority due to potentially limited markets, high development costs and/or because knowledge on the natural history of the illness is limited. Natural history studies that focus on understanding the range of manifestations, disease progression, disease presentation in various populations and the establishment of biomarkers of clinical progression and correlates of clinical outcome are being recognized as critical to facilitate effective product development programs and overcome issues that have led to stalled or failed product development strategies.

Objective:

The overall objective of this solicitation is to support/advance the development of therapeutic strategies for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations. The NIAID is aware that many of these diseases, and the patient populations that are most affected, may not be amenable to traditional product development/common clinical trial methodologies. Thus, the evaluation of the natural history, as well as the use of alternative and innovative research methods and clinical trial design strategies, is encouraged, where appropriate and valid. A variety of clinical study approaches will be considered responsive including natural history studies, retrospective analysis of existing data (either in patient records or other patient data registries), and interventional clinical trials. Adaptive clinical trial designs (http://www.fda.gov/downloads/Drugs/.../Guidances/ucm201790.pdf) or other alternative clinical trial designs with adaptive features are encouraged, when appropriate. The assessment of laboratory surrogate markers for clinical response, enhanced use of existing therapies, evaluation of new therapeutic drugs and the development of resistance to important antiviral drugs are important aspects, and may be included in any study proposed.

For the purposes of this BAA, the targeted patient populations are those for which there is a significant unmet medical need for therapeutic options for rare/emerging viral diseases that are not being addressed by the pharmaceutical industry or other significant clinical initiatives. Targeted populations include children (neonates through adolescents); the elderly, transplant recipients, and pregnant women. Studies in the general population may be considered for select rare and/or emerging diseases (see below).

Natural history studies are defined as those that evaluate the contemporary clinical course of the viral disease in a target patient population, with the goal of providing data to design interventional clinical trials. Important aspects include evaluation of a disease’s incidence, variability in patients, causes of morbidity and mortality, and response to standard of care. Studies that focus primarily on immunologic changes associated with disease progression will not be considered.

The following are some examples of research areas of interest:

In pediatric subjects, viral diseases that are considered to be rare would include, but are not limited to: congenital cytomegalovirus (CMV), serious enteroviral diseases, Epstein-Barr virus (EBV) infections, neonatal herpes virus infections, and serious flavivirus or filovirus infections. However, diseases such as influenza in pediatric patients would not be considered rare.

Viral infections are increasing in incidence in transplant patients, as immunosuppressive therapies improve in potency. Epstein Barr virus (EBV), human herpesvirus-6 (HHV-6) and adenovirus infections are a few examples of infections following transplantation. Norovirus infections are posing an increased risk for serious outcomes in vulnerable populations, such as the elderly and transplant recipients. Viral infections of the nervous system, specifically viral encephalitis (various viral etiologies), are examples of rare diseases with significant morbidity in the general population. Finally emerging diseases such as serious flavivirus, lassa fever virus, and chikungunya virus infections, remain, to date, rare in the US, but have the potential to cause significant morbidity/mortality. In these cases, international studies may be necessary.

For the purposes of this BAA, eligible clinical trials/studies include:

  • 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.

Contracts awarded under this BAA will NOT support:

  • Surveillance studies;
  • Transmission studies;
  • Studies of vaccines;
  • Studies designed primarily 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.

NOTE: Organizations responding to this BAA must have documented expertise in clinical research and clinical research in the patient population proposed or in the type of study proposed, and demonstrated knowledge of applicable regulatory guidelines.

This BAA acquisition will include phases. The timing and quantity of phases shall be determined by the work proposed and subsequently awarded in the negotiated Statement of Work, and shall be incorporated under the contract as options.

It is anticipated that multiple cost reimbursement, completion type contracts will be awarded on or about May 1, 2016. The total period of performance comprised of a base period and options should not exceed five (5) years.

NIAID estimates that three to five contracts may be issued for a total cost (direct and indirect costs combined) of up to $6.3 million in Fiscal Year 2016 for all awards during the first non-severable phase. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed five (5) years.

The NAICS Code is 541712 with a size standard of 500 employees.

The anticipated period of performance is May 1, 2016 through April 30, 2021.

Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA is available electronically and can be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

Inquiries

Please direct all inquiries to:

Primary Contact:

Swee L. Teo
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5173
Email: teosl@niaid.nih.gov

Secondary Contact:

George Kennedy, J.D.
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5170
Email: kennedyg@mail.nih.gov