SSTD QAs_07Aug09v3

1. Q: What percentage of offerors who submit a proposal are awarded a contract?

A: There are no set percentages for award. Awards are made based on the overall need, responsiveness to the BAA, scientific and technical merits, capabilities of the Offeror, and overall costs. As with all contracts, awards are based on the availability of funding.

2. Q: If a company has a unique idea, but it is in early stage technology development, would BARDA have an interest in submission?

A: Early-stage technology development likely would be more appropriate for NIH/DoD funding as BARDA is focused on advanced research and development activities. BARDA may offer some flexibility according to the transition zones discussed, and in accordance to the stage of development in answer to question 3, but it may not fit into the Category 1 top-tier bucket if the technology is at an early-stage in development.

3. Q: If an Offeror is invited back for a full proposal submission, would the format of the proposal be similar (cost and a technical aspect) to those of other forms of solicitations?

A: Yes, and if you are invited back for full submission, you will receive full details as to what BARDA is looking for.

4. Q: Is there an advantage to submitting proposals early in the fiscal year versus late in the fiscal year?

A: There is no real advantage. If you miss the quarterly review deadline, your paper will be considered in the next round. Additionally, proposals are evaluated on their individual merit and not in comparison with other proposals submitted earlier or later in the fiscal year. Note also question 14.

5. Q: If a company has a technology used to produce drugs/therapeutics and it has advanced to Phase I, II or beyond, would the technology qualify for this BAA?

A: Yes, if you take the platform and apply it to a BARDA target of interest, then you would meet the intent of the BAA. For Area of Interest #3, bioprocess development and manufacturing, the technology should be at least TRL6 or higher.

7. Q: Does BARDA have any guidance for process development model systems to be used in product system performance?

A: Yes, although it is incumbent on the Offeror to identify how the platform technology can be integrated into the manufacturing process in accordance with the Areas of Interest outlined in the BAA.

8. Q: If we have process development, but it has never been used in a GMP process before, would BARDA be interested?

A: It is likely that BARDA would not have an interest in an early-stage process development technology. BARDA has set the guideline of at least TRL6 for this type of technology, i.e., qualified/validated assays, scale-up GMP process, Phase 1 clinical trial. There may be some flexibility depending on need, but this is the general guideline.

9. Q: If a company has a peptide-based flu vaccine platform, would it be able to submit to this BAA?

A: BARDA has an interest in manufacturing platforms that have produced GMP lot material used previously in clinical studies as applied to a BARDA target of interest. Development of a new molecular entity such as a peptide-based flu vaccine would not be responsive to this BAA.

10. Q: How are the Clinical Diagnostic Areas in the SSTD BAA different from those in the CBRN BAA?

A: The CBRN BAA is targeting specific applications focused on biodefense CBRN agents. The SSTD BAA is focused on diagnostic platforms to obtain broad, flexible, and robust operating systems that would enhance the diagnosis of disease caused by a broad range of bioagents, including Category A bioagents and emerging infectious disease agents such as pandemic flu strains. As indicated in the BAA, this includes integration of instrumentation and analysis algorithms, validating reference materials and analytical methods, and novel methods for collecting and processing human specimens.

11. Q: Is BARDA looking for comprehensive solutions or a specific individual portion of solutions? Additionally, if a comprehensive solution covers multiple Areas of Interest, should separate white papers be submitted?

A: BARDA is looking for either comprehensive solutions or solutions that can be incorporated into another process so long as it meets the intent of the BAA. The regulatory path to licensure must be fully considered. If more than one Area of Interest (AOI) is covered by a comprehensive solution, one white paper should be submitted to one Area of Interest. The Offeror is free to explain in the narrative how the solution affects multiple AOIs. Note also question 22 for when multiple solutions are not integrated.

12. Q: If a product fits the need, shows a believable pathway and shows the ability for implementation, will the product be considered?

A: It is likely, as long as TRL levels of the innovative platform are satisfied.

13. Q: If we have process development that has been used in a GMP process before, would BARDA recommend a specific product for us to apply our technology?

A: No, BARDA will not recommend a specific product although anthrax vaccines and anti-toxins and pandemic influenza vaccines and anti-virals are target areas of interest to BARDA.

14. Q: How will proposals submitted at different times be evaluated for an award – i.e., is a company disadvantaged by submitting a proposal late in the year, or alternatively will proposals for individual interest areas be evaluated together regardless of when they are submitted?

A: This is a “rolling BAA” and white papers can be submitted anytime during the published cycle periods. White papers will be reviewed on a quarterly basis beginning September 1, 2009. Notice for full proposal submission will be requested within 30 days after the start of the review cycle.

15. Q: Does BARDA intend to select awardees on a continuous chronological basis, or will awardees be selected on a periodic basis or some target date? (e.g. quarterly/semi-annual or specific date later in the year).

A: The number for awards will be dependent on the amount of funding available for the innovative science and technology program. BARDA expects awarding cycles on a quarterly basis.

16. Q: What will the mandatory stage of development (Technology Readiness Level) be for platforms for which an offeror seeks funding? For example, will platforms for the Areas of Interest need to have successfully completed a Phase 1 human clinical trial, or will in vivo preclinical efficacy data be adequate to be considered for funding?

A: The BAA states that the specific application of platform technologies should be applied to candidate products (CBRN, panflu) in late stages of product development, i.e., at least TRL 6 (qualified assays, GMP lots, Phase 1 clinical trial). The stage of the platform can be generally viewed as follows as applied to a late-stage candidate product:

AOI #1 – In vitro/Ex vivo systems. At least TRL5 (establish correlates of protection for use in GLP studies, in-process assays for product characterization and release amenable to GMP, etc.)

AOI #2 – Adjuvant/Formulation/Protein Stability/Delivery technologies. At least TRL 6 (qualified assays, GMP lots, Phase 1 clinical trial)

AOI #3 – Bioprocess development/Manufacturing. At least TRL 6/7 (qualified/validated assays, scale-up GMP process, Phase 1 clinical)

AOI #4 – Diagnostics platforms. Established and applied to clinical evaluations, or minimally pre-clinical feasibility with capability for increased automation or reduced complexity for clinical application

17. Q: Will contracts under this solicitation include an option for procurement? If not, will companies with late stage products -- defined as ready for consistency lot manufacture and conduct of pivotal studies – be expected to go through a separate competition for a procurement contract?

A: This BAA is not intended to be used for procurement of products; it is intended to support innovative platform technologies as applied to late-stage products of interest in terms of product improvements and/or reduction in the time of cost of research, development, and manufacturing of products. Procurement of products would be under product procurement RFP utilizing Project BioShield or Panflu funds.

18. Q: What is the difference between the CBRN BAA that was posted in March 2009 and the Science and Technology Platform BAA posted in June 2009?

A: The CBRN BAA is focused on advanced research and development funding of product-specific biodefense countermeasures addressing defined requirements. The SSTD BAA is focused on process-oriented platform technologies that can be applied to late-stage products for biodefense, panflu, and emerging infectious diseases.

19. Q: Will there be an EVM requirement? Our understanding is that HHS requires any award over $25M to use EVMS. Please confirm.

A: The requirements for EVM or an EVMS vary based on several factors. If required for contract performance, the information will be provided to the Offeror when asked to submit a proposal.

20. Q: What is the intended duration of funding under this BAA?

A: Contracts awarded will be constructed in accordance with applicable fiscal and contract laws. Duration is largely dependent upon the proposed effort, performance and available funding. It is anticipated that awards will be constructed with a one year base and subsequent one year option periods (as necessary) up to 5 full years total performance. The possibility exists for any period of performance to be incrementally funded.

21. Q: Will DHHS consider firm fixed contracts for research related work and/or clinical trials? How will the mechanism of funding (Cooperative agreement, contract) be determined for each project that is given an award?

A: BARDA reserves the right to award the contract type best suited to the nature of the work proposed and may award any appropriate contract type under the Federal Acquisition Regulation. BARDA may, in the future, also elect to make awards in the form of cooperative agreements, or other transactional agreements (OTAs) as appropriate.

22. Q: Can potential offerors submit multiple proposals for differing targets/projects under this funding mechanism?

A: Yes, offerors can submit multiple white papers of differing science and technology to the same or different Areas of Interest. However, each white paper must stand-alone. Do not combine multiple ideas on any single white paper submission.

23. Q: At which point will BARDA consider funding platform technologies further as applied to the development of new and/or improved countermeasures?

A: Under this BAA, the platform technology should be applied to a maturity of product that correlates with at least TRL 6. It is expected that additional funding will be available in the out-years but not yet committed for continued advance research and development activities.

24. Q: Will BARDA provide or assist the Offeror in gaining access to late-stage product bulk drug substance or manufacturing process from which to test the platform technology of interest?

A: BARDA will either provide materials to the Offeror(s) for testing purposes or will review requests for product from the Offeror(s) and evaluate it on a case-by-case basis.

25. Q: On page 4, it states that the “utility of these novel platforms should generate validated data suitable for comparability analysis with candidate products … and development activities are to be fully integrated with regulatory activities associated with product development efforts.” What precisely does this mean? Does this mean that all activities should facilitate submission of an EUA package or development toward licensure?

A: Offerors should have a clear understanding of the regulatory path to obtain licensure utilizing their platform technology as applied to a candidate product(s) for the proposed indication at a very early stage of development. This includes comparability analyses with candidate product(s) to demonstrate improved safety, efficacy, and/or delivery of the products or efficiencies and costs savings in the manufacturing process. A full understanding of regulatory requirements will be essential, particularly as it relates to fulfilling the required data sets for potential use under an EUA or subsequent licensure.

26. Q: Will this BAA include development of broad-spectrum antibiotic or antiviral technology platforms?

A: No, these product areas are covered under the CBRN BAA posted in March 2009.

27. Q: What classes of therapeutics are BARDA interested in (i.e. small molecule, polyclonal antibody, etc.)?

A: All classes of therapeutics would be considered if they are relevant to BARDA’s program. Albeit, BARDA’s preference would be for MCMs that are less expensive and have a broad spectrum of activities.

28. Q: Can you tell us anything about the product characteristics you are interested in?

A: Products should have the typical desirable characteristics for any biologic or drug including but not limited to safety and efficacy. BARDA is also interested in developing products that are easy to administer, have a relatively long shelf-life and can be stored and deployed under conditions that minimize the risk to the cold chain, if needed. . Specific guidance on the product can only be discussed with the Offeror in context of how it aligns with BARDA program relevance, when invited to submit a Full Proposal.