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FBO DAILY ISSUE OF JULY 15, 2005 FBO #1327
SOLICITATION NOTICE

A -- Process Development, Assay Development, and Small Scale Manufacturing of Bioscavenger, Increment II product for use in Preclinical and Clinical Trials.

Notice Date

7/13/2005
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

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-05-R-0022
 

Response Due

7/27/2005
 

Archive Date

9/25/2005
 

Small Business Set-Aside

N/A
 

Description

The Department of Defense (DoD) through the Chemical, Biological Medical Systems (CBMS) Joint Project Management Office and the Medical Identification and Treatment Systems Joint Product Management Office (MITS-JPMO) has a requirement to develop and license a second generation prophylactic product, Bioscavenger Increment II, to be used in humans against organophosphorus nerve agents. The product should be capable of strongly binding or degrading organophosphorus nerve agents before they can exhibit t heir toxic effects. Potential candidates might include human butyrylcholinesterase (other than plasma-derived) or acetylcholinesterase, other proteins, or compounds that have the property of binding or degrading nerve agents and/or preventing inhibition o f acetylcholinesterase. Development of the nerve agent prophylactic product shall require a Contractor to coordinate and manage the activities associated with advanced development of the product. The Contractor will be responsible for conducting the various activities associated with drug/biologic development in a manner that is consistent with eventual approval or licensure by the FDA, to include management of any subcontractors. Activities will include manufacturing process development and related tasks, current Good Manufactu ring Practices (cGMP)-compliant small-scale manufacturing and testing of the Bioscavenger product, Good Laboratory Practices (GLP)-compliant acute toxicology testing filing of an Investigational New Drug (IND) application, and conducting a Phase 1 clinica l trial in accordance with FDA regulations and guidelines. There will be an option for continuing advanced development through FDA approval (or licensure) of the product following the successful completion of the Phase 1 clinical trial and Government reviews. These follow-on advanced development activities may in clude, but are not necessarily limited to, large-scale manufacturing, process validation, definitive animal efficacy and expanded safety studies, conduct of Phase 2 and/or 3 clinical trials, and filing of a New Drug Application/Biologics License Applicatio n. There will be a 2nd option for the production of 90,000 doses of the product, to be exercised following the successful licensure or approval of the product and successful government reviews. The initial advanced development activities, from award of contract through completion of the Phase 1 clinical trial, are expected to require 2.5 to 3 years to complete. The post-Phase 1 development through approval of the Bioscavenger product by the FDA i s expected to take about 4 to 4.5 years. The DoD will only consider those Bioscavenger Increment II candidates for which preliminary in vivo safety and efficacy data already exist. Due to urgent need and a stringent timeline, consideration cannot be given to chemicals or proteins for which there are no proof of concept data in relevant animal models. These preliminary studies should be substantial but do not need to be GLP compliant. Offerors will be requested to submit technical and cost proposal that clearly represents technical and regulato ry approaches. Participants must demonstrate the ability to provide GLP, cGMP, and Good Clinical Practices (GCP) compliance related to the development of the product for use in pre-clinical and clinical studies. The purpose of this synopsis is to give advanced notice of a Request for Proposal (RFP) that will be issued on or about July 29, 2005 and interested firms to indentify themselves to the Government to receive a copy of the solicitation when issued. General requirements of the solicitation and its options are mentioned in this synopsis. The solicitation will contain detailed instructions for response to the near-term requirement of developing a nerve agent prophylaxis through a Phase 1 clinical trial and the longer-term requirements that include approval or licensure and production of doses. The requirements for succes sful execution of the contract encompass a broad range of capabilities. Offerors are encouraged to partner or subcontract with contract manufacturers, clinical research organizations, etc. as necessary to span these capabilities. All responsible sources may participate in this acquisition, which shall be considered by the agency. These sources must be registered in the Central Contractor Registration (CCR) to be considered for award. All firms that desire to be considered must iden tify themselves no later than 4:30PM, 27 July 2005 to the Contract Specialist listed below to receive the solicitation when issued by the Government. This acquisition is open to participation by foreign firms at both the prime contract and subcontract level, subject to FAR/DFARS Part 25 limitations. The following numbered notes are applicable to this acquisiton: 12, 25, and 26. Point of Contact is Greg Florey, Contract Specialist. Email adress is greg.florey@det.amedd.army.mil, telephone number is 301.619.8427.
 

Place of Performance

Address: US Army Space and Missile Defense Command, Deputy Commander 64 Thomas Johnson Drive Frederick MD

Zip Code: 21702

Country: US
 

Record

SN00846472-W 20050715/050713212500 (fbodaily.com)
 

Source

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

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