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COMMERCE BUSINESS DAILY ISSUE OF APRIL 6,1995 PSA#1319National Heart, Lung, and Blood Institute, BDR Contracts Section,
Contracts Operations Branch, Federal Building, Room 610, National
Institutes of Health, Bethesda, MD 20892 A -- MEDICAL COORDINATING CENTER FOR CORD BLOOD STEM CELL
TRANSPLANTATION STUDY SOL NHLBI-HB-95-07 POC Lynda A. Bindseil,
Contracting Officer, (301) 496-3513. The National Heart, Lung, and
Blood Institute (NHLBI) is conducting a market survey to assess the
availability and potential technical capability of small business firms
as defined by Standard Industrial Classification Code (SIC) 7379, $18.0
million, Computer Related Services, N.E.C. to perform as a Medical
Coordinating Center (MCC) for a phase I-II clinical trial (estimated
2-4 umbilical cord blood banks and 6-8 transplant centers) designed to
determine if stem and progenitor cells (CBSPC) from umbilical cord
blood are a clinically acceptable alternative to those from marrow or
peripheral blood for unrelated donor allogeneic transplantation. It is
anticipated that four groups of 75 patients each (total 300), will be
transplanted for this four- year study. In addition, the initial goal
for the number of cord blood units in multiple cord blood banks will
be 20,000. The MCC will establish a centralized electronic database
registry of banked cord blood units that will include information on
each unit that is stored in a participating blood bank. The MCC must
have, or must create within 4 months of contract award, an electronic
search algorithm to permit checking the database rapidly for the best
available HLA matches. The MCC will manage donor searches, facilitate
the provision of cord blood units for transplantation, and collect and
analyze data from these transplants. The database management
capability must be sophisticated and flexible enough to accommodate
class I and class II HLA typing (both serological and DNA-based) and
changes in interpretation, as the state of science evolves. The search
algorithm must be able to detect and describe the degrees of matches
within the database and be flexible enough to accommodate modifications
of match criteria, as science dictates. The ability to recognize
cross-reacting antigens and those with similar molecular structures
must be available when needed. As knowledge in the field of tissue
antigen typing and matching expands, the search algorithms may need to
be modified to improve the definition of suitable donors and the
outcome of the transplants. The MCC must also collect data on the
outcome of the CBSPC transplants, analyze the recipient data, including
survival, disease status, complications and other aspects of the
transplant follow-up. Working under the auspices and with the
concurrence of the NHLBI, the MCC in conjunction with the participating
organizations, will establish standards for the collection, testing,
storage, shipping and use of CBSPC for transplantation. Should there be
a need to add contractors to accomplish the number and type of
transplants performed, the MCC will assist in the gathering of data
necessary for the NHLBI to determine how and when the number involved
must be expanded. The MCC will have responsibility for the overall
coordination, monitoring, and central management of all activities
required by the study protocol, manual of operations, data collection,
and data analysis. Small business firms having demonstrated research
and development capabilities for ongoing design, coordination and
analysis of long-term, multicenter studies related to marrow
transplantation, or other clinical trials of similar complexity are
invited to submit capability statements. Information furnished should
establish (1) qualification of medical, scientific, technical, and
administrative staff with experience pertinent to the operation of a
medical coordinating center for a multicenter phase I-II clinical trial
to accomplish the above mentioned activities, (2) the ability to
create, within 4 months of contract award, an electronic data-base and
search algorithm, (3) the ability to coordinate, monitor, and manage
study activities, including those related to data collection,
management, and analysis, (4) evidence of administrative and scientific
leadership, including biostatistics, in medical coordinating center
activities, (5) the availability of facilities, space, and equipment
necessary for the conduct of this study, and (6) the firm's status as
a small business under SIC code 7379. This is not a Request for
Proposal (RFP). The RFP release date is pending. Three copies of the
capability statement must be submitted within thirty (30) calendar days
including the date of publication of this announcement in the Commerce
Business Daily (CBD). (0094) Loren Data Corp. http://www.ld.com (SYN# 0008 19950405\A-0008.SOL)
A - Research and Development Index Page
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