Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 08, 2009 FBO #2814
MODIFICATION

A -- Filovirus Vaccine

Notice Date

8/6/2009
 

Notice Type

Modification/Amendment
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of the Army, U.S. Army Space and Missile Defense Command, U.S. Army Space and Missile Defense Command, Deputy Commander, US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
 

ZIP Code

35807-3801
 

Solicitation Number

W9113M-09-R-0009
 

Response Due

12/31/2009
 

Archive Date

3/1/2010
 

Point of Contact

Cynthia Gnam, 301-619-8453<br />
 

E-Mail Address

US Army Space and Missile Defense Command, Deputy Commander
(cynthia.gnam@us.army.mil)
 

Small Business Set-Aside

Total Small Business
 

Description

Pre-Solicitation Notice and Pre-Solicitation Conference Announcement PRE-SOLICITATION NOTICE The U.S. Army Space and Missile Defense Command (SMDC), on behalf of the Joint Program Manager (JPM) for Chemical Biological Medical Systems - Joint Vaccine Acquisition Program (CBMS-JVAP), intends to solicit and award one or more competitive cost-plus-incentive-fee (CPIF) contracts for the development of filovirus vaccine(s) through a Phase 1 clinical trial. This is a 100% set-aside for small business. The North American Industry Classification System (NAICS) code is 541711, Research and Development in Biotechnology (500 employees). The purpose of the contract(s) is to develop a filovirus vaccine containing components for Ebola (Sudan and Zaire) and Marburg viruses, to perform the necessary manufacturing and non-clinical studies to submit an Investigational New Drug application, and to complete Phase I clinical trials in a manner consistent with a regulatory approach for Food and Drug Administration (FDA) licensure. Favorable candidates will have all filovirus vaccine components in a single vial, however, a separate vaccine for Ebola viruses and one for Marburg viruses will still be considered for this program. The anticipated date for the release of the final Request for Proposal (RFP), number W9113M-09-R-0009, is on or about 21 September 2009. The final RFP, and any associated information will be published on two websites: the Federal Business Opportunities (FBO) website at http://www.fbo.gov and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD) website at http://www.jpeocbd.osd.mil (link to Working with JPEO-CBD then Current Opportunities). A DRAFT Request for Proposal (RFP) is available for review and comment by potential offerors. The DRAFT RFP can be obtained at the JPEO-CBD website at http://www.jpeocbd.osd.mil (link to Working with JPEO-CBD then Current Opportunities). The anticipated solicitation described herein is, in part, a result of the responses received from interested parties to the Request for Information (RFI) W9113M-RFI-090001, titled Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures Prime Systems, published 2 October 2008 on the FBO website. PRE-SOLICITATION CONFERENCE (Industry Day) CBMS-JVAP will host a Pre-Solicitation Conference for the Filovirus Vaccine on 19 August 2009, 8:00 a.m. (Eastern Time), at the Hampton Inn & Suites Frederick Fort Detrick, located at 1565 Opossumtown Pike, Frederick, MD 21702. (Website: http://hamptoninn.hilton.com/en/hp/hotels/index.jhtml?ctyhocn=FDRHSHX ) The purpose of this Conference is to expand market research, to provide additional information to industry on the filovirus vaccine program, to solicit industry input into the resultant final RFP, and to provide an opportunity for interested parties to network with each other. Government representatives will provide preliminary information on business/contract considerations and anticipated technical requirements. Attendance/participation at the Conference is encouraged, but is not required for submission of a proposal to the final RFP. CBMS-JVAP will not be responsible for any cost incurred for attending the Conference. The Pre-solicitation Conference is held for information and planning purposes only and is not to be construed as a commitment by the Government. To ensure adequate seating at the Conference, companies interested in attending should register by emailing cbms.FiloRFP@amedd.army.mil with the name of the individual(s) attending, company name, telephone number(s), and email address(es). Please Note: there is a three person maximum per company if more than three names are submitted, only the first three will be placed on the registration list. RSVPs to Filovirus Vaccine Pre-Solicitation Conference are required by 12:00 p.m. (Eastern Time) on 10 August 2009. If the information required for RSVP is not received by 10 August 2009 you may not be able to secure seating arrangements at the conference site. Interested parties are encouraged to review and provide questions and comments on the draft RFP, located at http://www.jpeocbd.osd.mil (link to Working with JPEO-CBD then Current Opportunities). Questions and comments must be submitted in writing by 12:00 p.m. (Eastern Time) 14 August 2009. Only those questions and comments submitted to cbms.FiloRFP@amedd.army.mil in writing will be accepted and receive a response. Answers to the questions received will be addressed during the Filovirus Vaccine Pre-Solicitation Conference. Upon completion of the government presentations at the Conference, industry representatives will have an opportunity to meet aside with CBMS-JVAP program and science representatives, in addition to SMDC contracting representatives, for not more than fifteen (15) minutes each to discuss questions on the requirements of the RFP. The 15-minute sessions will be scheduled on a first-come first-serve basis for all small businesses interested in meeting with government representatives. Large businesses will be scheduled as time permits. These meetings may not be used as an opportunity for marketing. Attendees are advised to arrive for registration beginning at 8:00 a.m. EST. Pre-Solicitation Conference Schedule of Events, 19 August 2009: (All times are Eastern Time zone) Registration: 8:00 a.m. CBMS-JVAP Overview: 8:30 a.m. Filovirus RFP Overview: 9:30 a.m. Responses to Comments and Questions from Draft RFP: 10:00 a.m. Face-to-Face Meetings with JVAP Program and Contracting personnel: 1:00 p.m. End of Conference: 4:30 p.m. DRAFT REQUEST FOR PROPOSAL (RFP) The overall Department of Defense (DoD) objective of the Filovirus Vaccine Program is the development of a pre- and post-exposure filovirus vaccine which provides broad spectrum protection against aerosol exposure to multiple species of the Ebola and Marburg viruses from initiation of Advanced Development (DoD Acquisition Milestone A) through FDA licensure in accordance with the DoD Acquisition System, FDA regulations and guidelines, and industry best practices. Candidate vaccines must utilize a platform technology such that the same basic development and manufacturing processes can be used to develop each component of the final desired multivalent vaccine. If a multivalent Ebola/Marburg is not available as a single product, a separate Ebola vaccine providing protection against Zaire and Sudan species along with a separate Marburg vaccine maybe acceptable. To support this overall acquisition strategy, CBMS-JVAP will first award a contract to develop a filovirus vaccine containing components for Ebola (Sudan and Zaire) and Marburg viruses. Contractor will provide the necessary manufacturing and non-clinical studies for submission of an Investigational New Drug application, and will complete Phase I clinical trials in a manner consistent with a regulatory approach for FDA guidelines for licensure of a vaccine. Favorable vaccine candidates will contain all filovirus vaccine components in a single vial; however, a separate vaccine for Ebola viruses and one for Marburg viruses will still be considered for this program. Before completion of the first contract(s), and prior to Milestone B, CBMS-JVAP will competitively solicit and award another contract(s) for further filovirus vaccine development through FDA licensure. The draft RFP is composed of: 1) Statement of Objectives (SOO); 2) Instructions, Conditions, & Notices to Offerors or Quoters (Section L); and 3) Evaluation Factors for Award (Section M). The DRAFT RFP can be obtained at the JPEO-CBD website at http://www.jpeocbd.osd.mil (link to Working with JPEO-CBD then Current Opportunities). This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. The anticipated date for the release of the final RFP number W9113M-09-R-0009 is on or about 21 September 2009. If your company is interested in this procurement it is advised that you monitor the FBO website at http://www.fbo.gov and the JPEO CBD website at http://www.jpeocbd.osd.mil (link to Working with JPEO CBD then Current Opportunities).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-09-R-0009/listing.html)
 

Place of Performance

Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL<br />

Zip Code: 35807-3801<br />
 

Record

SN01902404-W 20090808/090807001000-b96a7bad3a8451a6531934ce628aa098 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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