SOURCES_SOUGHT_NOTICE.pdf

SOURCES SOUGHT NOTICE

PHASE I CLINICAL TRIAL UNIT FOR THERAPEUTICS AGAINST INFECTIOUS DISEASES

RFP-NIAID-DMID-NIHAI2013178

Type of Requirement

New Requirement

Re-competition – Contracts/Numbers:

1. HHSN272200800024

2. HHSN272200800026

Expansion of (Contract/RFP No.:______________)

Place of Performance

Place of performance is unknown at this time

Place of performance is known. Address or general location:__________________

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National

Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B

Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612

Introduction

THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT

A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO

ISSUING AN RFP OR TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO

SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS

RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT NOTICE THE ACQUISITION

MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL

BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE

ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS

MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS

ADMINISTRATION. ALL SMALL BUSINESSES ARE ENCOURAGED TO RESPOND. THE

NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 Employees.

Description

Research supported and conducted by the National Institute of Allergy and Infectious

Diseases (NIAID), National Institutes of Health (NIH), Department of Health and

Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (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 through 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. Through 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 Contract

HHSN272200800024C and Contract HHSN272200800026C.

NIAID intends to issue a solicitation 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. 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.

All projects carried out under the anticipated contract must be conducted in a manner consistent with all applicable Federal regulations and the DMID, NIAID, NIH and DHHS policies and guidelines for the conduct and oversight of research involving human subjects.

Capability Statement/Information Sought:

NIAID anticipates awarding one or more Indefinite Delivery Indefinite Quantity

(IDIQ) contracts to fulfill the technical requirements of the contract with an ordering period of seven (7) years. The anticipated start date of the contract is on/or about

December 1, 2014. Task Orders for specific tasks within each of the following Task

Areas may be issued after award of the IDIQ Contract:

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.

Sources are expected to have the expertise, personnel, and facilities to meet requirements stated herein. Tailored Capability Statements submitted as a result of this notice should demonstrate and document the organization’s qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following technical areas:

1. relevant experience in design and preparation of clinical protocols and associated documents for Phase 1 clinical trials to assess safety, pharmacokinetics and phamacodynamics (PK/PD) of novel therapeutics in humans;

2. relevant experience in execution, in compliance with current Good Clinical

Practices and FDA regulations, of Phase I in-patient and out-patient clinical trials to assess safety and PK/PD of novel therapeutics;

3. relevant experience in statistical analysis of safety and PK/PD data from

Phase I clinical trials;

4. relevant experience in assay development, validation, and sample analysis to drug concentration in humans following exposure;

5. ability to recruit the needed patient populations, including enrolling at least

200 volunteers per year;

6. ability to conduct all necessary statistical analysis;

7. capacity and facilities to perform inpatient Phase I clinical trials;

8. ability to provide personnel who have the training, expertise, and experience necessary to accomplish the work related to design of protocols and associated documents for, and conduct and analysis of, Phase 1 clinical trials to determine PK/PD and safety of novel therapeutics in humans under GCP;

and

9. ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities.

In addition, capability statements should address the following:

I. Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. The appropriateness and adequacy of the education, training, experience, expertise, and qualifications of the proposed Principal Investigator with respect to:

1. designing, implementing, conducting, analyzing, and completing inpatient and outpatient Phase I clinical trials to assess safety (including corrected QT interval (QTc)), pharmacokinetics, and pharmacodynamics of therapeutics, including monoclonal antibodies;

2. conducting assay development, validation, and sample analysis to determine drug concentration in humans following exposure;

3. providing oversight and ensuring adherence and compliance with all applicable clinical trial regulations and policies; and

4. providing managerial experience in identifying issues and performance problems, and implementing remedial actions.

II. Facilities/Resources/IT Security: adequacy and appropriateness of the facilities and resources dedicated to the project.

III. Past Performance: Past performance is considered essential. In addition to demonstrating that your company has met the above qualifications, interested parties must identify at least eight (8) other clinical trials of similar size and complexity conducted in the last three (3) years.

The list below represents the average number of specific tasks orders offerors should assume will be awarded each year under the contract. This list is provided to indicate the general scope of work of the contract.

Assume that the period of performance of Task orders may range from less than one year to multiple years. The quantities identified in the table below are estimates only and are provided for informational purposes. The actual quantities may be higher or lower.

Task

Area Title

Estimated # of Task

Order

Awards

A Administrative, Management, and Technical Support 1

B

Protocol Development, Implementation, Conduct, Analysis, Completion and Final Reporting*

First-in-Human Intravenous Multiple Ascending Dose Phase I 2

Phase I Oral Multiple Ascending Dose 2

Phase I QTc Study 1

How to Submit a Response:

1. Page Limitations:

Interested qualified small business organizations should submit a tailored capability statement for the requirement stated herein not to exceed five (5) pages, excluding resumes, describing the company’s experience and ability to perform this effort, which includes the following: 1) a summary list of similar work previously performed or being performed within the last three (3) years; 2) demonstrated scientific and technical ability to carry out the work; 3) the professional qualifications and specific experience of staff who may be assigned to the requirement; 4) the capability to provide the required level of effort on a continuing and emerging needs basis; 5) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; and 6) a general description of the facilities and other resources needed to perform the work. All proprietary information should be marked as such. Tailored capability statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address).

Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

Responsible contractors who have proven experience and meet the capabilities cited to perform the technical requirements stated herein, may submit your experience, capabilities and qualifications as outlined above which will be considered by the NIH. This Sources Sought Notice is not a request for competitive proposals. However, all information received within fifteen (15) days after date of publication of this Sources Sought Notice will be considered by the

Government for small business set aside.

2. Required Business Information:

DUNS.

Company Name.

Company Address.

Company Point of Contact, Phone and Email address

Current GSA Schedules appropriate to this Sources Sought Notice.

Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration

(CCR). All offerors must register on the CCR located at www.sam.gov

3. Number of Copies and Delivery Point:

Please submit one (1) electronic copy of your response to the following e-mail address:

Mr. Chase Lucas, Contract Specialist, lucasca@niaid.nih.gov

All capability statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to Mr. Chase Lucas, Contracts

Specialist, at lucasca@niaid.nih.gov in MS Word, WordPerfect or Adobe Portable

Document Format (PDF). The e-mail subject line must specify RFP-NIAID-DMID-

NIHAI2013178.

4. Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 2:00PM

(Eastern Prevailing Time) on October 4, 2013.

CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE

CONSIDERED.

All responses must be received at NIAID by the specified due date and time in order to be considered.

Facsimile responses will not be accepted.

In conclusion, this notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose http://www.sam.gov/ mailto:lucasca@niaid.nih.gov deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Points of Contact:

Inquiries concerning this Notice may be directed to:

Mr. Chase Lucas, Contract Specialist

Ph: 301-402-0641

Email: lucasca@niaid.nih.gov