TOPIC RELEASE 1 Q and A.pdf

Question Answer

Q1: For Topic CBA-01, what is the cost limit for phase I? $150K?, $500K? $750K? etc.

A1. Phase I and II refer to the phases in which proposal submission is done for this BAA—and not to the phases of performance. Please refer to section 4.6 of HDTRA120S0001_BAA for this distinction.

The cost limit for phase I is therefore the same as the cost of your overall project.

As different performers will suggest different approaches, we are not specifying a cost limit at this time. We are interested in getting a sense of the estimates for this work from a broad cross section of performers.

Q2: For Topic CBA-01, what is the length of the period performance for Phase I? 6 months? 9 months? 12 months? Etc.

A2. Phase I and II refer to the phases in which proposal submission is done for this BAA—and not to the phases of performance. Please refer to section 4.6 of HDTRA120S0001_BAA for this distinction.

The period of performance for phase I is therefore the same as the period of performance for your entire project. We do not think this should exceed 3 years (page 2, item 10).

Q3: For Topic CBA-01, are there specific clinical indications or chem/bio agents the Sponsor requires be included in the biomarkers assay/algorithm?

A3. We do not have requirements for specific chem/bio agents.

We are partial to agents that present with an opportunity for differential diagnosis (e.g. differentiating whether undifferentiated fever symptoms will lead to severe outcomes) and are not looking for agents that produce quick lethal outcomes (e.g. no nerve agents).

Identifying the specific agent causing the symptoms is not a requirement of this topic. The developed assay needs to predict the severity of outcomes and the need for hospital based care.

Q4: For Topic CBA-01, is there a minimum number of clinical indications or chem/bio agents the assay/algorithm need to include for proposal consideration?

A4. There is no minimum number. A focused proposal that systematically tackles one or two conditions (e.g. undifferentiated fever, respiratory distress, or sepsis) may offer a greater chance of success than a proposal that seeks to identify severe outcomes from all symptoms. We will be looking for how systematically the approach is laid out, and how well the assay is validated.

Q5: For Topic CBA-01, does the biomarker assay need to be quantitative or is qualitative sufficient?

A5. The topic requires a “risk score indicative of severe clinical outcomes”; this risk score may be calculated from a variety of parameters, some of which may be qualitative.

Q6: For Topic CBA-01, is there a desired limit of detection for the biomarker assay?

A6: The biomarkers need to be detected with sufficient sensitivity to enable good prediction of severe outcomes.

Q7: For Topic CBA-01, are there assay run time/equipment/practitioner training level specifications for the proposal?

A7. The maximum assay run time ought to be within 30 minutes from sample to result; ideally within 15 minutes. The equipment should be portable enough to be utilized in the medical evacuation arena. The practitioners may be trained medical technicians, but the developed diagnostics tests would ideally require no specialized training.

Q8: For Topic CBA-01, what are proposal milestone requirements during Phase I?

A8: Phase I and II refer to the phases in which proposal submission is done for this BAA—and not to the phases of performance. Your milestones can be whatever you need them to be. We like clear, defined milestones that can serve as black and white go/no-go decision points.

Q9: For Topic CBA-01, is developing multiple separate assays (depending on cause of the mass casualty event) allowed?

A9. We are looking for one assay system. This may involve the measurement of several biomarkers. This assay system should be useable universally, and we are not looking to tailor the biomarker panels or algorithms to a given mass casualty event.

Q10: For Topic CBA-01, how complete is the algorithm expected to be by the end of Phase I? Put another way, if assays, algorithm, and validation steps are expected within 3 years, is the status of the project after the 6 months of Phase I supposed to be a method that doesn’t assay for every cause yet but is predictive and validated, or are all the biomarkers we plan to use for every type of trauma known, and later phases are for refining and validating the initial algorithm?

A10: Phase I and II refer to the phases in which proposal submission is done for this BAA—and not to the phases of performance.

Over the 3 year period, earlier milestones can involve development of a predictive model, while later milestones may involve validation and refinement.

Q11: For Topic CBA-01, roughly how long should the assay take to produce the needed information for the medical staff?

A11. The maximum assay run time ought to be within 30 minutes from sample to result; ideally within 15 minutes.

Q12: For Topic CBA-01, is an assay that would require a piece of large equipment (e.g. plate spectrophotometer) to allowed?

A12: Any equipment used should fit in the back of an ambulance or a MEDEVAC helicopter, i.e. it needs to be portable and field friendly. We are not asking for the development of instrumentation in this solicitation.

Q13: For Topic CBA-01, what are the specific metrics (i.e. how high of a correlation between predicted and real mortality rates and recovery times is needed) for determining that an algorithm is sufficiently valid?

A13. We are looking for a high correlation between conditions that generally requires hospitalization, and your test correctly predicting that need. This can be calculated in a number of ways and we are interested in your experimental design.

Q14: For Topic CBA-01, are there specific training and validation sets of clinical data that should be used?

A14: No, we do not have any specific recommended training or validation datasets.

Q15: For Topic CBS-02, objective #2 calls for researchers to “assess and evaluate the reaerosolization or resuspension properties for a specific chemical or biological aerosol particle…” Can DTRA clarify if the specific chemical or biological aerosol particle to be assessed is expected to be a live threat agent?

A15. Not necessarily. The intent here is knowing what is planned in order for reviewers to evaluate and make comments, etc., as needed when reviewing the proposed methods and the applicability of the expected results. Simulants and surrogates are acceptable.

Q16: For Topic CBS-02, are there specific surfaces of interest? A16: The intent of the topic is more for surface properties than specific materials (e.g., roughness, hydrophobicity or hydrophilicity, etc.). Common materials are acceptable, including soils if practical, as long as the surfaces are sufficiently characterized or characterizable to allow investigators to draw more generalized reaerosolization conclusions (vs. particle- or surface-specific conclusions).

Q17: For Topic CBS-02, can bacteria, viruses, or toxins of particular interest to DTRA for this topic be specified?

A17. Identifying specific bacteria, viruses or toxins could be too limiting for the objectives of the topic, which concerns chemical and physical properties of the aerosol particle in combination with properties of the surface upon which the particle has been deposited.

Also, staying non-specific for which ones should be used may open the topic to potential performers with facilities at lower BSL ratings.

As suggestions, though, Bacillus bacteria and either “small molecule” or proteinaceous toxins are of general interest.

Q18: For Topic CBS-04, the objective call for researchers to “Assess and evaluate the survivability and viability of a specific bacterial or viral biological aerosol to cause infection with respect to any physical and chemical property changes occurring once the aerosol has been disseminated.” Determination of infectivity would require the use of animal models. Can DTRA please clarify if evaluation of infectivity is required or if viability of the biological particle can be assessed?

A18: Viability of the agent is fine. Animal studies were not expected for the research intended to be performed under this topic.

Q19: For Topic CBS-04, can bacteria, viruses, or toxins of particular interest to DTRA for this topic be specified?

A19. Identifying specific bacteria, viruses or toxins could be too limiting for the objectives of the topic, which concerns chemical and physical properties of the aerosol particle in combination with properties of the surface upon which the particle has been deposited.

Also, staying non-specific for which ones should be used may open the topic to potential performers with facilities at lower BSL ratings.

As suggestions, though, Bacillus bacteria and either “small molecule” or proteinaceous toxins are of general interest.

HDTRA1-20-S-0001 BAA Q&A