rPASpecialInstructions 6.doc

Part VI: Special Instructions

NEW REQUIREMENT FOR RECOMBINANT PROTECTIVE ANTIGEN (rPA)

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED DEVELOPMENT OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

Broad Agency Announcement Number:

BAA-BARDA-09-34

Amendment Number:

Six (6)

Amendment Posting Date:

7 December 2009

Issued By:

Biomedical Advanced Research and Development Authority (BARDA)

330 Independence Ave., SW, Room G640

Washington, D.C. 20201

Point of Contact:

Primary: Ethan J. Mueller, Contracting Officer, Ethan.Mueller@hhs.gov Alternate: Jeannett Jackman, Contract Specialist, jeannett.jackman@hhs.gov

SUMMARY OF CHANGES

A. PURPOSE: The following are special instructions for offerors submitting White Papers and Quad Charts for Area of Interest #1: Vaccines: Advanced Development of Recombinant Protective Antigen (rPA) Anthrax Vaccines. The purpose of these special instructions is to specifically solicit solutions for developing Recombinant Protective Antigen (rPA) anthrax vaccines. This special instruction also extends the end date for BAA-BARDA-09-34 from 31 December 2009 to 1 February 2010.

(1) White Papers and Quad Charts will be accepted for funding consideration in fiscal year 2010 and must be submitted electronically only and titled Advanced Development of Recombinant Protective Antigen (rPA) Anthrax Vaccine to the following e-mail address: CBRN-BAA@hhs.gov. The date for receipt of Quad Charts and White Papers under these special instructions is open for the duration of BAA-BARDA-09-34.

(2) The page limit is increased as follows for Part IV: Proposal Preparation and Submission, Section 2: Stage 1 Quad Chart and White Paper Preparation, Initial submission is limited to a one-page Quad Chart; a one-page integrated product development timeline/ task overview; a cover page; a White Paper not to exceed ten (10) pages and an addendum (not to exceed three (3) pages).

(3) Pre-Proposal Conference

Date: January 11, 2010 at 1 PM until 3PM.

330 C- Street Switzer Building 3rd floor, Room 3005

Washington, DC 20201 Metro: Federal Center SW (Blue and Orange Lines) Please note the following regarding the pre-proposal conference:

1. Questions to be posed for clarification during the pre-proposal conference should be submitted in advance. Email questions titled Advanced Development of Recombinant Protective Antigen (rPA) Anthrax Vaccine to CBRN-BAA@hhs.gov by close of business on December 21, 2009.

2. Enter the Switzer Building at the C Street entrance.

3. Arrive 15 minutes early to allow time to clear security.

4. Each attendee must present a government-issued picture identification to enter the Switzer Building.

5. The closest metro stop is Federal Center SW on Blue and Orange Line.

6. There is a limit of three (3) attendees per organization.

7. All recording devices are prohibited.

8. A teleconference line will be available for people who are unable to attend in person.

Please register the names and contact information of people participating via teleconference and titled Advanced Development of Recombinant Protective Antigen (rPA) Anthrax Vaccine to CBRN-BAA@hhs.gov by close of business on December 21, 2009.

The teleconference number is 1-866-917-6472 and the participant code will be provided by email upon registration.

(4) Questions from industry regarding the special instructions may be emailed and titled Advanced Development of Recombinant Protective Antigen (rPA) Anthrax Vaccine to CBRN-BAA@hhs.gov by close of business on December 21, 2009.

(5) Except as provided herein, all other terms and conditions of the BAA remain unchanged.

Special Instructions – Advanced Development of Recombinant Protective Antigen (rPA) Anthrax Vaccine The purpose of these special instructions is to specifically solicit solutions for advanced development of rPA anthrax vaccines.

Under Area of Interest #1: Vaccines: Recombinant Protective Antigen (rPA) Anthrax Vaccines, the following are the special instructions for Offerors submitting Quad Charts and White Papers (Stage 1). This area of interest will have priority consideration for funding in fiscal year 2010. Please note that Responses in the form of Quad Charts and White Papers for Stage 1 called for under this Special Instruction must also fulfill the requirements outlined in the original BAA-BARDA-09-34.

A. Objective

Offerors developing rPA anthrax vaccines are invited to submit a White Paper and a Quad Chart outlining plans for advanced development of candidate products for both general-use prophylaxis and post-exposure prophylaxis. Offerors are required to provide an integrated product development program which reflects realistic timelines across typical product development areas allowing sufficient time for contingencies. Offerors are strongly encouraged to include risk mitigation strategies that clearly address potential points of failure in the product development process.

B. Scope

Procurement of the candidate product developed shall not be considered under this contract.

Minimum Eligibility Criteria

· Offerors shall propose a Statement of Work (SOW) consistent with activities for vaccine candidate product development at Integrated Technology Readiness Levels (TRLs) 6 or higher. Under the BAA, see Solicitation 1 and Amendment 3 in the following link:

· https://www.fbo.gov/spg/H/OOS/OASPHEP/BAA-BARDA-09-34/listing.html

· https://www.medicalcountermeasures.gov/Integrated_TRLs.aspx

· Clinical safety data based on an earlier formulation or product dosage form may be considered if sufficient supporting evidence is provided to justify the change in formulation or dosage form. Ongoing or planned studies will be considered depending on the available information and supporting data.

· Nonclinical: Offerors should have completed non-clinical studies demonstrating proof-of concept efficacy using anthrax spore aerosol challenge in relevant animal models. Ongoing or planned studies will be considered depending on the available information and supporting data.

Ideal characteristics of desired rPA anthrax vaccine candidates are listed below:

· Rapid onset of immunity for maximum efficacy in a post-exposure prophylaxis regimen that includes antibiotics.

· Reduced dosing schedule for general-use prophylaxis (<5 doses) and post-exposure prophylaxis use (<3 doses).

· Improved storage conditions (4°C or above).

· Product shelf life of at least 3 years (demonstrated over the contract period of performance).

· Packaging as single dose or multi-dose units, with consideration for life-cycle costs and ease of distribution.

· Ease of administration during a mass vaccination program (allowing for non-professional staff to perform inoculations; incorporation of novel delivery methods or systems).

Offerors are encouraged to partner with other companies and/or organizations that specialize in pharmaceutical product innovation in order to address the characteristics outlined above and/or to address their deficiencies or weaknesses in their core competencies to take a product to licensure (e.g. US regulatory expertise, vaccine development expertise, etc).

All White Paper and Quad Chart submissions must be UNCLASSIFIED.

All Offerors will receive a letter and/or e-mail acknowledging receipt of their White Paper and Quad Chart submission. Offerors will receive either a Rejection Letter or a Letter inviting the submission of a Full Proposal based on the evaluation of the White Paper and Quad Chart.

Debriefings for White Papers and Quad Charts will not be provided.

Evaluation Criteria: Please refer to the BAA and Amendments at the following link:

· https://www.fbo.gov/spg/HHS/OOS/OASPHEP/BAA-BARDA-09-34/listing.html