PHASE I CLINICAL TRIAL UNIT FOR THERAPEUTICS AGAINST INFECTIOUS DISEASES
Added: Oct 31, 2013 11:39 am Type of Requirement: Re-competition Contracts/Numbers: 1.HHSN2722008000242.HHSN272200800026Expansion of (Contract/RFP No.:______________)Duration of contract: __7_ Year Ordering PeriodAnticipated award date: 12/01/2014IntroductionThe 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 to support a Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases in order to move promising therapeutic candidates into the clinical pipeline; such studies are often on the critical path for product development. Description Research supported and conducted by the NIAID, NIH, DHHS, strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that teaten millions of human lives. The DMID supports extramural research to control and prevent diseases caused by virtually all infectious agents other than human immunodeficiency virus (HIV). This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded tough a variety of research grants and contracts.The evaluation of new and improved vaccine and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Tough an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase I, Phase II, Phase III, and Phase IV clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, including: targeted surveillance for pathogens of interest; reevaluation of current vaccine formulations, schedules and modes of delivery; and evaluations of novel investigational product delivery systems.DMID also supports substantial preclinical research efforts to develop new therapeutics or find additional uses for already approved therapies. These efforts, as well as efforts by many other organizations, produce promising therapeutic candidates that are appropriate for testing in humans in Phase I clinical trials. First-in-human Phase I clinical trial data of new therapeutic agents provides important safety, pharmacokinetic (PK) and pharmacodynamic (PD) information needed to determine how best to proceed with product development. Other Phase I clinical trials provide important data on drug-drug interactions and food effects. In addition, pharmacokinetic analysis of already licensed therapeutics in new populations, or in combination with other compounds, can help better define treatment guidelines.Since Phase I studies are often on the critical path for product development, the ability to prepare protocols and execute trials in a timely manner is important. To help meet these goals and move promising candidates into the clinical pipeline in a timely manner, NIAID awarded contracts for the Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases (Phase I Unit) in 2008 under contracts HHSN272200800024C and HHSN272200800026C.NIAID is conducting an acquisition to recompete the Phase I Unit research program requirements to continue to provide DMID with the infrastructure necessary for the design and conduct of Phase I clinical trials for therapeutics. The scope of activities to be performed by the Contractor shall encompass all aspects of the design, development, implementation, and conduct of Phase I clinical trials to assess safety, pharmacokinetics and/or pharmacodynamics, of licensed and investigational therapeutic products, including immunomodulatory agents and monoclonal antibodies, against infectious diseases, including viral, bacterial, parasitic, and fungal pathogens and toxins. The types of trials conducted, or planned, include first-in-human small molecule and monoclonal antibody trials, corrected QT interval (QTc) trials, and drug-drug interaction trials.DMID anticipates awarding Indefinite Delivery Indefinite Quantity (IDIQ) contracts with an ordering period of seven (7) years. The anticipated start date is on/or about December 1, 2014. It is anticipated that Task Orders for specific tasks within each of the following Task Areas will be issued after award of the IDIQ contracts:Task Area A: Administrative and Overall Clinical Operations Support and Concept Development.Task Area B: Protocol Development, Implementation, Conduct, Data Analysis, Completion, and Laboratory Analysis.This information is furnished to potential offerors for information purposes only and is not to be considered restrictive for proposal purposes.Any responsible offeror may submit a proposal to be considered by NIAID in response to the posting of an Request for Proposals (RFP). The RFP will be available electronically on/about November 15th 2013, and may be accessed tough FedBizOpps http://www.fedbizopps.gov/. Directions for proposal submission will be included in the RFP.This notice does not commit the Government to actually posting an RFP nor to the award of a contract. Contact with Government personnel, other than the following points of contact, by a potential offeror or its employees' regarding this acquisition is strictly prohibited. Questions regarding this notice should be directed to the following:Primary Point of ContactMr. Chase A. LucasContract SpecialistPhone: (301) 402-0641lucasca@niaid.nih.govSecondary Point of ContactAileene Mitchell FordContracting OfficerPhone: (301) 496-7288aileene.mitchellford@nih.govNo collect calls will be accepted. RFP-NIAID-DMID-NIHAI2013178 Department of Health and Human Services National Institutes of Health
10/31/13, 11:39 AM