SITIS Archives - Topic Details
Program:  SBIR
Topic Num:  CBD07-113 (CBD)
Title:  Development of novel therapeutic approaches for exposure to chemical agents
Research & Technical Areas:  Chemical/Bio Defense

Acquisition Program:  
  Objective:  Develop novel approaches to counteract the effects of exposure to chemical warfare agents taking full advantage of advancements medical technology. The primary purpose of the work will be to apply innovative techniques in the development of medical countermeasures against chemical warfare agents.
  Description:  Recent advancements in medical technology including, but not limited to, molecular modeling, drug design technology, molecular and recombinant technology suggest that novel approaches and opportunities exist in developing medical countermeasures to combat the effects of chemical warfare agents. Our warfighters are routinely called upon to conduct operations on a world-wide front with little prior warning or preparation. In these cases prophylaxis may not be possible or desirable. Also, development of multiple prophylactic materials may in itself result in problems in half-life, efficacy or toxicity when administered in combination within a short time frame. What is needed is fast acting, self or automated administration of therapeutic agents that prevent the soldier from becoming a casualty but only dose when there has been an exposure limiting the pharmaceutical burden on the unexposed soldier.

  PHASE I: Develop a concept or approach to one or more chemical agents and defend the hypothesis that this approach will work in vivo with no untoward events. Contractors will use their innovation and creativity to develop a detailed plan which articulates an effective strategy to formulate a therapeutic against one or more conventional chemical warfare agents (acetylcholinesterase inhibitor, vesicant, cyanide, pulmonary edemigenic) The plan must clearly describe why this approach is considered novel and yet has a potential for success. Feasibility, applicability, logical approach and cost are some of the key parameters that must be addressed in the detailed plan. Use of human cells and tissues and/or animals requires approval by the appropriate US Army Medical Research and Materiel Command regulatory office. Phase I should include approval of appropriate regulatory documents (human or animal use) necessary to execute Phase II.
  PHASE II: An approach will be developed that can demonstrate safety and efficacy of a medical countermeasure to one or more chemical warfare agent. Demonstrate efficacy in vitro and ex-vivo, if feasible. Computer modeling or other simulation approaches should be utilized as much as possible to minimize use of animals, time, cost and effort and expedite the program. Preliminary studies in animals is desirable. Evaluation of the approach for efficacy will be performed by USAMRICD.

  PHASE III: Dual use demonstrated in first responders, emergecy room personnel, as well as the military. This technology has dual use applications and thus could be used in a broad range of military and civilian settings. For example, this approach could be adopted by civilian medical treatment systems as a means of responding to a terrorist use of a chemical warfare agent.

  References:  1. Textbook of Military Medicine, Part I Warfare, Weaponry and the Casualty, Medical Aspects of Chemical and Biological Warfare, Office of the Surgeon General, Borden Institute, Walter Reed Army Medical Center, 1989 2. Briefing by the Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense at the National Defense University, Ft. McNair, VA, 2004.

Keywords:  chemical warfare, medical countermeasures, molecular modeling, drug design, WMD, therapeutics

Additional Information, Corrections, References, etc:
Ref #1: Document found through DTIC Accession Number: ADA278723
Ref #1: Document found through DTIC Accession Number: ADA278723

Questions and Answers:
Q: 1. Is the official collaboration between the Small Business and USAMRICD possible during Phase 2?
2. Is the direct communication between the Small Business and USAMRICD (Dr. Moore or Dr. Filbert) allowed, even before submitting a Phase 1 proposal in response to this topic CBD07-113 ?
A: 1. Phase II awardee/s are able to communicate with the Contracting Officer's Representative (COR) at USAMRICD.

2. During the open solicitation, potential offerors can only ask questions directly through SITIS. Small businesses may ask technical questions about the DoD SBIR and STTR solicitation topics by using SITIS which is an anonymous electronic forum between participant small businesses and the DoD scientists and engineers assigned to SBIR and STTR topics. SITIS should not be used to ask general questions about the program or solicitation, which should be directed to the DoD Help Desk, at 1-866-724-7457.
Q: 1. Is the official collaboration between the Small Business and USAMRICD possible during Phase 2?
2. Is the direct communication between the Small Business and USAMRICD (Dr. Moore or Dr. Filbert) allowed, even before submitting a Phase 1 proposal in response to this topic CBD07-113 ?
A: 1. Phase II awardee/s are able to communicate with the Contracting Officer's Representative (COR) at USAMRICD.

2. During the open solicitation, potential offerors can only ask questions directly through SITIS. Small businesses may ask technical questions about the DoD SBIR and STTR solicitation topics by using SITIS which is an anonymous electronic forum between participant small businesses and the DoD scientists and engineers assigned to SBIR and STTR topics. SITIS should not be used to ask general questions about the program or solicitation, which should be directed to the DoD Help Desk, at 1-866-724-7457.
Q: How would you characterize the main-single-focus of this topic?
To (A) Develop a DEVICE to release/deliver countermeasures to CW agents;
(B) Develop a VACCINE against CW agents;
(C) Develop an ASSAY to detect/alert against CW agents.

A: I do not mean to be elusive but both A and B would qualify.
First - this is strictly a medical program so unless the detection is in bodily fluids as more of a diagnostic, it would not qualify.
Second - the topic was designed purposely vague to allow for a broad spectrum of respondents. I am looking for innovative ideas to either develop, or provide a tool to help our in house scientists develop, medical countermeasures to chemical warfare agents. Many new technologies have either been developed or have been enhanced that can now be focused on our mission. Such things as limiting use of animals through modeling, mol biol tech, bioinformatics, methods of ascertaining mechanism of action, are all concerns and unanswered questions.
Q: 1. The call states: “What is needed is fast acting, self or automated administration of therapeutic agents that prevent the soldier from becoming a casualty but only dose when there has been an exposure limiting the pharmaceutical burden on the unexposed soldier.” Please amplify the highlighted phrase. It is not clear to me.

2. In a previous answer, you imply that only “bodily fluids” should be sampled and wish to “provide a tool to help our in house scientists develop, medical countermeasures to chemical warfare agents.” Would external detection not be preferable to monitoring body fluids?
A: 1. Therapy as opposed to prophylaxis is only administered when an exposure has occurred and is targeted against the affects of that agent. Pretreating soldiers against the spectrum of possible agents results in a polypharmaceutical approach that could be detrimental when administered in combination.
2. External detection is not in the scope of this SBIR unless it is an approach that is on or in the skin as a warning of exposure to indicate treatment.
Q: How would you characterize the main-single-focus of this topic?
To (A) Develop a DEVICE to release/deliver countermeasures to CW agents;
(B) Develop a VACCINE against CW agents;
(C) Develop an ASSAY to detect/alert against CW agents.

A: I do not mean to be elusive but both A and B would qualify.
First - this is strictly a medical program so unless the detection is in bodily fluids as more of a diagnostic, it would not qualify.
Second - the topic was designed purposely vague to allow for a broad spectrum of respondents. I am looking for innovative ideas to either develop, or provide a tool to help our in house scientists develop, medical countermeasures to chemical warfare agents. Many new technologies have either been developed or have been enhanced that can now be focused on our mission. Such things as limiting use of animals through modeling, mol biol tech, bioinformatics, methods of ascertaining mechanism of action, are all concerns and unanswered questions.
Q: 1. The call states: “What is needed is fast acting, self or automated administration of therapeutic agents that prevent the soldier from becoming a casualty but only dose when there has been an exposure limiting the pharmaceutical burden on the unexposed soldier.” Please amplify the highlighted phrase. It is not clear to me.

2. In a previous answer, you imply that only “bodily fluids” should be sampled and wish to “provide a tool to help our in house scientists develop, medical countermeasures to chemical warfare agents.” Would external detection not be preferable to monitoring body fluids?
A: 1. Therapy as opposed to prophylaxis is only administered when an exposure has occurred and is targeted against the affects of that agent. Pretreating soldiers against the spectrum of possible agents results in a polypharmaceutical approach that could be detrimental when administered in combination.
2. External detection is not in the scope of this SBIR unless it is an approach that is on or in the skin as a warning of exposure to indicate treatment.

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