SSTD BAA Platform Technologies - Short

ASPR

Science and Technology Division

Science and Technology Platforms Applied to MCM Development

Broad Agency Announcement (BAA)

BARDA-BAA-09-100-SOL-0010

Solicitation Posted July 8, 2009 www.MedicalCounterMeasures.gov

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SSTD BAA: Contact Information

Michael Younkins Contracting Officer

DHHS, BARDA

Email: Michael.Younkins@hhs.gov Phone: 202-205-4709 Alternate Elizabeth Elmazahi Elizabeth.Elmazahi@hhs.gov

Purpose of SSTD BAA Promote Innovations in Product Development Improvements, Testing, and Manufacturing

SSTD BAA: Areas of Interest Technologies to Accelerate Evaluation of Candidate Vaccines and Therapeutics Formulation Chemistry, Protein Stabilization, and Vaccine Delivery Technologies Innovative Methods in Bioprocess Development and Manufacturing Methods and Technologies to Advance Development of Diagnostic Tests for Rapid Diagnosis of Human Infections

SSTD BAA: Targets of Interest Anthrax Vaccines and Anti-Toxins Pandemic Flu Vaccines and Antivirals Botulinum Anti-Toxins Diagnostic Platforms Applicable to a Range of Pathogens (Bacterial and Viral)

SSTD Broad Agency Announcement

Questions and Answers

Please hold questions until the open discussion section

Question and Answer # 1:

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?

This is a “rolling BAA” and white papers can be submitted anytime with a cut off date of July 7, 2010. White papers will be reviewed on a quarterly basis beginning September 1, 2009. Notice for full proposal submission will be made within 30 days after the start of the review cycle. Submissions after July 7, 2010 will be considered upon renewal of the BAA for 2010 calendar year pending availability of funds.

Question and Answer # 2:

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).

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.

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Question # 3:

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?

Answer to Question # 3:

Question and Answer # 4:

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?

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 a product procurement RFP utilizing Project BioShield or Panflu funds.

Question and Answer # 5:

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?

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Question and Answer # 6:

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

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.

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Question and Answer # 7:

What is the intended duration of funding under this BAA?

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.

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Question and Answer # 8:

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?

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.

Question and Answer # 9:

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

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.

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Question and Answer # 10:

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

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.

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Question and Answer # 11:

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?

Question and Answer # 12:

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Question and Answer # 13:

Will this BAA include development of broad-spectrum antibiotic or antiviral technology platforms?

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Question and Answer # 14:

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

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.

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Question and Answer # 15:

Can you tell us anything about the product characteristics you are interested in?

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.