BAA-NIAID-DMID-NIH-AI-2014007_-_Amendment_2___7-24-2014.pdf

AMENDMENT No. 002

BAA-NIAID-DMID-NIH-AI-2014007

TARGETING THERAPEUTICS DEVELOPMENT TO RELIEVE BOTTLENECKS:

OPTIMIZING LEAD THERAPEUTIC COMPOUNDS AGAINST INFECTIOUS

PATHOGENS

Solicitation Number: BAA-NIAID-DMID-NIH-AI-2014007

Amendment Number: Two (002)

Amendment Issue Date: July 24, 2014

Proposal Due Date: Wednesday, August 13, 2014 3:30 PM EST

(UNCHANGED)

Issued By: Sevag Kasparian Contracting Officer Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive Room 3212, MSC 7612 Bethesda, MD 20892-7612

Point of Contact: Mr. Sevag Kasparian, Contracting Officer Email: Sevag.Kasparian@nih.gov

The purpose of this amendment is as follows:

NOTICE:

Deadline for receipt of solicitation questions was Wednesday, July 16, 2014. No additional questions will be considered.

CLARIFICATION, QUESTION AND RESPONSE regarding this BAA is 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 unchanged at Wednesday, August 13, 2014, at 3:30 PM EST.

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:Sevag.Kasparian@nih.gov

BAA-NIAID-DMID-NIH-AI-2014007

TARGETING THERAPEUTICS DEVELOPMENT TO RELIEVE BOTTLENECKS:

OPTIMIZING LEAD THERAPEUTIC COMPOUNDS AGAINST INFECTIOUS

PATHOGENS

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

1) Drug-resistant strains of a pathogen are not considered a different pathogen. For example, a drug that acts on B. anthracis and drug-resistant strains of B. anthracis is not ‘broad spectrum’ under the BAA definition. The drug must also be active against another Category A, B or C bacterial species to meet the criteria.

2) Natural products and modified natural products may be lead compounds. Analogs must be chemically synthesized, so there must be sufficient core starting material to produce sufficient amounts of a set number of analogs to develop a structure-activity relationship and to improve drug-like properties.

3) As a lead compound, a peptide must be chemically synthesized and amenable to generation of analogs via similar synthetic routes in order to develop a structure-activity relationship and improve drug-like properties. The BAA supports development of a structure-activity relationship and improvement in drug-like properties of lead compound, as denoted on page 3.

4) Activity against emerging disease bacterial pathogens (such as drug resistant bacterial pathogens) and a biodefense pathogen, such as B. anthracis, is sufficient to meet the broad spectrum criteria.

5) A lead compound must be active against more than one pathogen as described in the announcement. Multiple, albeit similar, drug candidates, each active against discreet pathogens do not fit the criteria for ‘broad spectrum’ as defined in the BAA.

6) In a partnership of two companies, one company can be the applicant and the other company can be the subcontractor.

7) In FY 2015 NIAID plans to award a total of $4 million to fund base period activities for three to five contracts. Offerors can propose options that are necessary to complete the work and are subject to negotiation. The amount of funding available for proposed option periods are subject to the availability of funds and programmatic needs for future fiscal years. The number of awards will be determined following peer review, negotiations and allocation of funds

8) The goal of the BAA is to support development of therapeutics that are active against at least one of the biodefense pathogens plus another Category A, B or C pathogen.

9) Support under NIAID preclinical development services is determined on a case-by-case basis and cannot be guaranteed.

10) Since immunity to discreet strains of influenza do not confer cross-protective immunity against other strains of influenza, each strain is considered a discreet viral pathogen.

11) Proposed lead antibacterial compounds must target at least one of the listed bacterial pathogens; compounds targeting resistant mechanisms that do not include activity against a listed bacterial pathogen do not meet the criteria of broad-spectrum as defined in the BAA.

12) Reimbursement for equipment purchase is not allowable under this BAA award.

13) This solicitation is intended to lead to the award of federal contracts under the regulations for Broad Agency Announcements (BAA). It is not a federal grant nor is it a contract to be awarded under the Request for Proposal mechanism (RFP).

14) Under a BAA award, base and option periods are not tied to fiscal years but to discreet deliverables. Offerors may propose the amount of time necessary to carry out non-severable activities within the base or an option period. Options can be exercised at appropriate intervals and are not tied fiscal years, for example, two options may be exercised within the same fiscal year as long as pre-set milestones are met and funding is available. Offerors are to propose reasonable costs to complete the required work to meet the objectives within 3 years from the award date. Final Statements of Work, period of performance, milestones and costs for the base and each option will be negotiated before award.

15) The awarded contracts will not reimburse the contractor for costs incurred prior to the award date.

16) The use of consultants and subcontractors is acceptable. For instance, regulatory expertise may be provided from within or from outside a company or academic institution.

17) The BAA is open to all institutions and companies.

18) As identified in the BAA, viruses of interest are Ebola virus, Marburg virus, Variola major, Dengue virus, Chikungunya virus and human influenza virus as well as other Category A, B and C viruses. Please refer to the Broad Agency Announcement on page 4.

19) The activities to be supported are for preclinical development of a lead candidate therapeutic drug. Activities and associated costs necessary for filing of an Investigational New Drug Application (IND) will not be supported by these awards.

Examples of activities not supported include, but are not limited to, GMP manufacturing and GLP toxicology studies.

20) Contracts awarded under this BAA will support:

• Chemical synthesis of analogs to develop structure-activity relationship profiles

• Chemical optimization of core molecular scaffolds to improve physiochemical properties to produce more drug-like molecules

• Synthetic route-scouting towards process development

• Formulation studies to optimize dosing, pharmacodynamics, product stability andother drug properties

• In vitro and non-GLP in vivo testing for toxicity, activity, ADME (absorption, distribution, metabolism, and excretion) properties

• Preclinical non-GLP efficacy testing for biodefense and emerging infectious diseases

Question 1: In accordance with item 2c on page 19; proposals are to include the Section 508 template. Please confirm that this 10 page form is excluded from the page count limit.

Response 1: Yes, Section 508 is excluded from the technical proposal 50 pages limit. Section 508 should be included in the business proposal.

Question 2: P. 21-22 of BAA; VI Technical Proposal Instructions: STATEMENT OF WORK- There are 15 items listed in the section that must be included in the SOW, but then on page 24-25, the BAA details the Outline and Headings that should be used in the SOW. I'm struggling on how to connect the 2 pieces of information.

Do you have an example to share with me?

Response 2: No sample SOW is provided.

Question 3: The BAA shows the format needed for the Technical Proposal but I am not clear where the "OTHER CONSIDERATIONS" header fits in on page. 26-27. These sections look more like statements that the grantee must be made aware of and approve, rather than providing information. Do I add those headers into the Technical proposal and just indicate that the "applicant understands those items listed on page. 26-27?"

Response 3: Please note this is not a grant. Each offeror must state: how they plan to meet the Other Considerations identified.

Question 4: On page 7 of the BAA, III.B.5.a.2) says “Font size must be 10 to 12 point.” May we use a smaller font size for graphics and tables, as long as they are readable?

Response 4: No, font size must be 10 to 12 point as stated in the BAA.

Question 5: One of our Faculty plans to respond to this BAA. His proposal would include a scientist at USAMRIID as subcontractor (CRADA).Our experience with NIH grant awards, is that NIH policy has precluded NIH from awarding any F&A, IDC, Overhead, etc for USAMRIID. Does NIH Contract awards deal with overhead for USAMRIID any differently than grants. Can USAMRIID request F&A, IDC, Overhead, etc on their section, and will NIH Contracts award it?

USAMRIID overhead recovery has been a recurring complication, so I need to provide our scientist with accurate information on this topic before they devote time to this response.

Response 5: If an offeror is selected for negotiations, all costs will be reviewed to determine allowability, allocability and cost reasonableness. We will also review offerors proposals to determine if the proposed costs are reasonable for the proposed labor mix.

Question 6: Items B. 2, 3 and 4 on pages 25 and 26 in the SOW section are also duplicated on pages 23 and 24, although they do not appear to be part of Item C. SOW.

Should items D. Quality Requirements and Data Management, E. Facilities, Equipment and Other Resources, and F. Project Management be a part of the SOW or be shown separately in the technical proposal?

Response 6: Refer to Pages 20 – 24, items A – H for technical proposal format (item C is the SOW). Item 5 on Page 24 is the synopsis for the technical proposal format.

Question 7: [BAA] Section 5, Statement of Work Format, states on page 25, “Offerors are strongly advised to use the headings provided below in preparing the proposed SOW, and to incorporate aspects of the “SOW for the Implementation of the Lead Compound Development Plan” as appropriate.” Does the term ““SOW for the Implementation of the Lead Compound Development Plan” refer to the information in [BAA] Section 4.C, Statement of Work, pages 21-23? If not, can you please clarify to what this term refers?

Response 7: See response 6. Yes. The SOW for Implementation of Lead Compound Development Plan on page 25 does refer to the Statement of Work in Section 4C.

Question 8: What is meant by "a short description of the scientific fields encompassed by the response” when stating interest in the grant?

Response 8: Please note this is not a grant. Provide a 250 words or less description of the scientific fields encompassed by your proposed project.

Question 9: Are subcontractors limited to fully US companies or can work be done in other countries? How about in the case that the only provider of the service is overseas?

Response 9: The offeror may propose International companies, however they are subject to Department of State approval. Supporting information is required as described by FAR Part 44 for rationale for determining use of an international company or any other company.

Question 10: Do we need to show competitive bids for subcontracted services? In some cases foreign providers are much more competitive in price. In the latter case should we use foreign contractors?

Response 10: Yes, supporting documentation is required to be submitted for determination of cost reasonableness for using a subcontractor. Refer to “Business Proposal Instructions” on page 27 of the BAA.

Question 11: ITEM 1: Decision Points/Gates

BAA References:

• BAA Page 21 VI. TECHNICAL PROPOSAL INSTRUCTIONS 4.B LEAD COMPOUND DEVELOPMENT PLAN: BAA states that “Technical Proposals shall include a Lead Compound Development Plan that describes the critical path for the optimization of the proposed lead compound to eventual selection of a candidate compound for further clinical development and identifies the decision points/gates for progress”.

• BAA Page 22 VI TECHNICAL PROPOSAL INSTRUCTIONS C.

STATEMENT OF WORK: BAA states “For each decision point proposed, provide a description of the specific qualitative and quantitative criteria and associated data elements and the process for making decisions to proceed or not proceed (Go/No-Go), for advancement of product candidates through each stage of the product development process”.

Question: The information requirements in the above referenced highlighted areas appear to be redundant on the information to be supplied by the offeror; can you either clarify the difference in the information or explain if it is redundant which of these topical areas that the information needs to be included in and which it can be excluded from?

Response 11: The SOW identifies the general activities and requirements of the proposed project. The Development Plan is the specific activities to carry out the SOW.

Question 12: ITEM 2: Curriculum Vitae

• BAA page 6 III GENERAL PROPOSAL INSTRUCTIONS AND INFORMATION B. Proposal Submission 5.b.1) Formatting, Number of Copies and Page Limitations: The BAA states Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section.

Question: Curriculum Vitae are not listed as being excluded from page count.

Can the CV’s be excluded from the page count in the Technical Proposal?

Response 12: Refer to “Scientific and Technical Team” on page 24 of the BAA. CV’s are included in the technical proposal page count.

Question 13: ITEM 3: Summary of Related Activities

• BAA page 5 II. BACKGROUND AND TECHNICAL OBJECTIVES. B Technical Objectives

• BAA page 6 III GENERAL PROPOSAL INSTRUCTIONS AND INFORMATION B. Proposal Submission 5.b.1) Formatting, Number of Copies and Page Limitations: The BAA states Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section

Question: Summary of Related Activities are not listed as being excluded from page count. Can the Summary of Related Activities be excluded from the page count in the Technical Proposal?

Response 13: Summary of Related Activities will be included in the technical proposal page count.

Question 14: ITEM 4: 508 Product Assessment Template

BAA References: BAA page 19V. REPORTING F.POST-AWARD REQUIREMENTS 2. Electronic and Information Technology (SECTION 508) c:

The BAA states that “Offerors must prepare an HHS Section 508 Product Assessment Template, in accordance with its completion instructions, and provide a binding statement of conformance”.

Question: If you place the 508 Product Assessment Template into Microsoft Word it takes up 11 pages without any of the information even being filled out.

Once information is included this would increase the page count. Therefore, can the 508 Product Assessment Template be excluded from the page count in the Technical Proposal?

Response 14: The 508 Product Assessment should be included in the business proposal.

Question 15: Is it possible to have Multiple Program Director(s)/Principal Investigator(s) (PD/PI) similar to what is allowed on many NIH grant mechanisms.

Response 15: Offerors should propose Key Personnel under the prime contract as appropriate to accomplish the proposed work. If other institutions are to participate in carrying out the proposed work, they may be listed as subcontractors or consultants.