SOURCES SOUGHT
A -- Biostatistical Consultant Support for vaccine potency assays
- Notice Date
- 8/17/2009
- Notice Type
- Sources Sought
- 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
- DVC0087-PLAG-09
- Response Due
- 8/24/2009
- Archive Date
- 10/23/2009
- Point of Contact
- Sandra OConnell, 301-619-2895<br />
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(sandra.oconnell@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Biostatistical Consultant Support for vaccine potency assays Set Side - Preference given to Small Businesses, SD-VO, Hub-Zone but it is not considered a set-aside. DynPort Vaccine Company LLC, a CSC company (DVC) is the prime systems contractor for the U.S. Department of Defense Joint Vaccine Acquisition Program (JVAP) and is responsible for the advanced development and licensure with the Food and Drug Administration (FDA) of vaccines and other biological products designed to protect against a variety of biological agents. As part of this program, a recombinant vaccine (rF1V) for protection against pneumonic plague is undergoing advanced development by DVC. DVC plans to license rF1V vaccine as a prophylactic for pneumonic plague in accordance with the Animal Rule. The efficacy of rF1V cannot be determined directly because pneumonic plague challenge studies in humans are unethical. In addition, the incidence of pneumonic plague in the general population is extremely low making field studies not practical. Statistical input is needed in planning vaccine potency assays for lot release of the vaccine. In addition, statistical input is needed in planning and analyzing data from efficacy studies with a goal of predicting clinical benefit. The objective of this work scope is to provide statistical input in the design and optimization of the relative potency assay and nonclinical vaccine efficacy studies. We are looking for an organization or consulting firm who would be responsible for the following activities associated with nonclinical studies: FDA Animal Rule - Understanding the use of the Animal Rule in conducting nonclinical studies supporting vaccine licensure. We will provide the document, FDA Guidance Elements to Address Efficacy Under the Animal Rule (Jan 2009). Relative Potency Model Development to include statistical evaluation and interpretation of data obtained during assay optimization studies. Statistical input in evaluating test variables, such as group size and gender and statistical input in planning future qualification and validation studies. Efficacy Studies (active vaccination/challenge and passive transfer/challenge) to include - statistical analysis plan for efficacy studies. Statistical input regarding appropriate group size to meet study objectives and ensure appropriate statistical power. Statistical analysis of survival data and statistical input in the development of a mouse protective index for use in evaluation of passive transfer data. DVC is seeking the technical services for a biostatistical consultant in the biotechnology research field. If you are interested in receiving a copy of the RFI, please contact Jo Ann Brown, Principal Subcontract Administrator, DVC, a CSC company at jbrown253@csc.com Please only contact the person noted above and not the USASMDC office listed in this announcement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/DVC0087-PLAG-09/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 />
- Zip Code: 35807-3801<br />
- Record
- SN01914434-W 20090819/090818001145-77cbaf5e7640ba9d5484d9f19ba3928f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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