Sources Sought Notice SSN Number: W911QY-10-S-0003 INTEREST IN ABILITY TO CONDUCT A PHASE I CLINICAL HUMAN SAFETY STUDY WITH A RECOMBINANT HUMAN ENZYME This is a Qualified/Capable Business Sources Sought Notice (SSN). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified business sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The North American Industry Classification System (NAICS) Code(s) is/are 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for an appropriate Phase 1 Clinical Trial Plan. BACKGROUND: The mission of the Chemical Biological Medical Systems - Medical ldentification and Treatment Systems Joint Product Management Office (CBMS-MITS JPMO) is to rapidly provide the Warfighter with safe, robust, affordable medical countermeasures (MCMs) against a broad spectrum of chemical, biological, radiological and nuclear (CBRN) threats. Current CBMS-MITS JPMO products include Food and Drug Administration (FDA) approved drugs and diagnostic devices. CBMS-MITS JPMO is currently exploring the use of a large molecular weight recombinant human enzyme as a prophylactic bioscavenger that protects against the toxic effects of nerve agents. REQUIREMENT: The Department of Defense (DoD) through the CBMS-MITS JPMO is seeking information from entities with the capability and interest to perform a Phase I Clinical Human Safety Study of a soluble recombinant human enzyme. The actual dosage is yet to be determined, but will be selected to deliver from 100 mg to 500 mg of protein. The enzyme drug product will be supplied by the US Government in a form suitable for administration without additional processing. The enzyme will require storage at 2C to 8C. In addition to the typical safety observations and clinical chemistry assessments, pharmacokinetics will be assessed by shipping serum samples from each study subject to a location where enzyme assays will be performed to determine the amount of drug present over the course of the trial. It should be noted that based on the estimated frequency of sampling during the first 24 hours after the initial dose, it is preferable that the study subjects remain in a clinical facility for this period of observation and testing. Examples of previous clinical trials with Bioscavenger candidates can be referenced at www.clinicaltrials.gov at the following reference numbers: NCT00333515, NCT00333528, NCT00744146. PURPOSE AND OBJECTIVES: CBMS-MITS is seeking cost and schedule information from interested parties in order to facilitate programmatic planning for this effort. The following information is requested: " Description of clinical trial study design " The number of cohorts " The number of subjects per cohort " Number of blood draws following dosing/number of samples and associated testing " Timelines for completion (recruitment, in-life, follow-up, final report) " Costs associated with completing each arm of trial " Clinical monitoring strategy " Examples of previously completed clinical trials of similar nature Capability statements must specify the offerors business size and type, and demonstrate similar work that has been performed in the past five years and the dollar value of that work. Statements should also address the following personnel/management areas: 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. SUBMISSION INSTRUCTIONS: Sources having the capability and interest to meet these requirements are invited to respond to this SSN. Proprietary information should be identified as Company Proprietary. Submitted data and information will not be returned. The Government reserves the right to use any non-proprietary information in any resultant solicitation(s). Questions regarding this SSN should be forwarded to the CBMS e-mail address listed below within 10 days after SSN release. All written responses must be received by Friday, November 19, 2010. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Mr. Drake Russell, EMAIL ADDRESS:
contact@example.gov ; (3) be minimum 11 font on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this SSN; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 12 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the address below. Material that is advertisement only in nature is not desired. DISCLAIMER AND IMPORTANT NOTES: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose 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 organizations 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 the 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 which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO CBMS MITS Natick, RDE COM Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address:
contact@example.gov
