Amend 2 BAA-NIAID-DMID-NIHAI2012149 final 090712.pdf

AMENDMENT # 002, BAA-NIAID-DMID-NIHAI2012149 Page 1 of 3

AMENDMENT No. 002

BAA-NIAID-DMID-NIHAI2012149

“Development of Therapeutic Medical Countermeasures for Biodefense and Emerging Infectious ‘Diseases”

Solicitation Number: BAA-NIAID-DMID-NIHAI2012149

Amendment Number: Two (002)

Amendment Issue Date: September 7, 2012

Proposal Due Date: Monday October 22, 2012 3:30 PM Local Time

(CHANGED)

Issued By:

Kathy M. Fetterman Contract Specialist Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institute of Health 6700-B Rockledge Drive Room

3214, MSC 7612

Bethesda, Maryland 20892-7612

Point of Contact:

Kathy M. Fetterman, Contract Specialist Email: fettermanka@niaid.nih.gov

The purpose of this amendment is as follows:

NOTICE:

Deadline for receipt of Solicitation questions is Friday, September 21, 2012. Questions received after this date will not be considered.

QUESTIONS AND ANSWERS regarding this BAA are attached below. Questions will not be responded to individually but will only be responded to via periodic published amendments.

The date specified for receipt of proposals is changed to October 22, 2012 at 3:30 PM Local Time.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

mailto:fettermanka@niaid.nih.gov

AMENDMENT # 002, BAA-NIAID-DMID-NIHAI2012149 Page 2 of 3

BAA- NIAID-DMID- NIHAI2012149

Development of Therapeutic Medical Countermeasures for Biodefense and Emerging Diseases

In response to inquiries received, the following clarifications are provided:

• For the purposes of this BAA, eligible therapeutic products are those that are effective as stand-alone treatment in the post-event setting, when signs of disease can be detected. Products that are to be used only as prophylactics or as post-exposure prophylactics are not eligible. Products that must be used in conjunction with other parenterally-administered therapeutics in order to be effective are also not eligible.

• Antitoxin candidates must be active in therapeutic settings against one of the toxins listed and must be effective as a stand-alone therapy and not in conjunction with other drugs.

• A single agent is defined as a unique drug product being evaluated non-clinically and clinically, manufactured, and marketed as one entity. Alternatively, a combination of products or entities that are administered together would qualify as long as the combination is supported by efficacy data and is manufactured and administered as a single formulation.

• An antiviral therapeutic agent that is active as a treatment against the 4 serotypes of Dengue would be eligible under the broad spectrum criteria since natural infection with one serotype of Dengue virus does not confer immunity to other serotypes.

• An antiviral therapeutic agent that is active as a treatment against Ebola and Marburg would be eligible under the broad spectrum criteria.

• If significant chemical modifications are needed to improve the properties of a proposed therapeutic candidate, then the candidate would not have met the criteria for eligibility as activities involving “Refinement of a lead series to identify a lead candidate”, are excluded.

• There is no specification for formulation or route of administration of a candidate therapeutic. The formulation of the candidate, including pro-drugs should be suitable for the treatment indication being pursued. If significant modifications are needed to improve a candidate’s properties, then the candidate would not meet the criteria regarding the exclusion of work that encompasses “Refinement of a lead series to identify a lead candidate”.

• The BAA will not support the development of candidate products that do not have any in vivo efficacy data to support their therapeutic value in a relevant diseased animal model. The strength of any in vivo data that supports the proposed therapeutic candidate will be determined as part of peer review.

Question 1: NIAID has expressed interest in broad spectrum therapeutic activity against viruses or bacterial pathogens. To what extent does the availability of advanced therapeutics for a specific biothreat agent diminish NIAID’s prioritization of broad spectrum therapeutics that incorporate that same biothreat agent?

Response: There is no predetermined priority order for pathogens against which advanced therapeutics are already available. Each proposal will be peer-reviewed on its own merit and programmatic priority will be determined when the results of peer review are provided to DMID.

Question 2: What level of detail regarding future clinical plans and protocols are you expecting for this solicitation? It looks like clinical protocols are post-award requirements. Is this the case? Do you have an example document for guidance?

Response: Regarding how to prepare clinical trial portion of the application, please refer to the “Format for Technical

Proposal” section of the BAA (page 24), under Item #4 “Scientific and Technical Approaches”, sub section C. “Clinical Trial Protocol Development and Implementation” for guidance. The clinical trial protocol synopsis provided in the BAA application will serve as the basis for future full development of the protocol.

Question 4: Will this BAA also support subsequent animal efficacy studies under the animal rule and/or scale up of manufacturing to commercial scale if phase 1 clinical testing has been completed during the BAA?

AMENDMENT # 002, BAA-NIAID-DMID-NIHAI2012149 Page 3 of 3

Response: Depending on the stage of product development at the entry point for this BAA, certain post-Phase 1 activities such as animal efficacy studies under the animal rule and scale-up manufacturing can be supported by the BAA.

Question 5: How critical would be the lack of clinical trials for the evaluation of a proposal?

Response: If a Phase 1 clinical trial can’t be completed within the specified 5 year period, then the candidate product is still in its early development stage and will not meet the criteria/definitions cited for this BAA.

Question 6: In the BAA, the following is stated: "Influenza antiviral agents: Therapeutics active against multiple influenza A subtypes directed at either viral or host targets." Can you please define multiple subtypes?

Response: The candidate agent should be active against more than one of the subtypes in influenza A viruses, the most common subtypes are H1N1, H3N2, H5N1.

Question 7: Are there any restrictions/limitations on the proportion of the award that can be directed to sub-contractors for drug development activities for GLP, cGMP, and GCP studies?

Response: No

Question 8: Is there a maximum limit to the amount of the award?

Response: There is no maximum limit set for an award.

END OF AMENDMENT NO. 002, BAA-NIAID-DMID-NIHAI2012149