Amendment Three - HHS-NIH-NIAID-BAA2020-1.pdf

HHS-NIH-NIAID-BAA2020-1 Page 1 of 9 Amendment Three (3)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT THREE (3)

OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D38, MSC 9821 Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2020-1

Date of Solicitation Issuance: January 3, 2020

Date of Amendment Three (3) Issuance: February 4, 2020

Number of Pages: 9

Proposal Due Dates:

The hour and date specified for receipt of offers for each Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE RECEIPT DATE AND

TIME

001 DAIT Development of Radiation/Nuclear Medical Countermeasures (MCMs)

3:00 PM Eastern Time, 04/09/2020

002 DMID Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68

3:00 PM Eastern Time, 02/28/2020

003 DMID Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

004 DMID Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

005 DMID Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

Points of Contact:

Division of Allergy, Immunology, and Transplantation (DAIT) Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Liem Nguyen, Contracting Officer Email: liem.nguyen@nih.gov Phone: 240-669-5144 mailto:liem.nguyen@nih.gov

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Division of Microbiology and Infectious Diseases (DMID) Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68 Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases Research Area 005: Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

Primary Contact:

Swee L. Teo, Contracting Officer Email: teosl@niaid.nih.gov Phone: 240-669-5173

Secondary Contact:

Brian Madgey, Contracting Officer Email: brian.madgey@nih.gov Phone: 240-627-3712

Offerors MUST acknowledge receipt of the amendment by Amendment number (s) and date of the amendment. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE OF SOLICITATION AMENDMENT

The purpose of Amendment Three is to:

I) Revise Section 3.2.2.2.3 – Technical Approach (Page 20 and 21) and Section 3.2.2.2.4. –

Additional Requirements (Page 21) of Research Area 003.

II) Revise Section 3.2.2.3.2 – Technical Objectives (Page 22 -24) and Section 3.2.2.3.3 – Technical

Approach (Page 24) of Research Area 004.

III) Revision Section 3.2.2.4.3 – Technical Approach (Page 36) of Research Area 005.

IV) Provide responses to questions received regarding the solicitation.

The responses are offered for information only and do not modify or become part of this solicitation.

Additional amendments may be provided as needed to address further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

mailto:teosl@niaid.nih.gov mailto:brian.madgey@nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 3 of 9

I.) REVISIONS TO HHS-NIH-NIAID-BAA2020-1 Research Area 003 (highlighted in red):

3.2. – DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID), NIAID

Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Section 3.2.2.2.3 – Technical Approach (page 21 of the BAA) – Vaccines for Pandemic Preparedness is hereby revised to add paragraph two and shall read as follows:

Vaccines for Pandemic Preparedness

Multiple organizations are funding vaccines and vaccine platforms to expedite responses to pandemic outbreaks. This Broad Agency Announcement seeks to support vaccine development for pandemics that have not been funded by other governmental and non-governmental funding agencies. Based on an internal landscape analysis, this Broad Agency Announcement seeks to support unfunded and/or under-funded vaccine development for disease such as Rift Valley Fever and Candida auris. Vaccines for the following diseases may be supported in future Broad Agency Announcements but the following vaccine candidates will be excluded from this Broad Agency Announcement: Filoviruses, Lassa, MERS, and Nipah.

Vaccine candidates for the 2019 novel coronavirus (2019-nCoV) outbreak in Wuhan are included in this Omnibus BAA. Since the 2019 coronavirus involves a novel viral strain, proposals are not expected to have proof of concept data for the vaccine candidate or supporting well characterized assays. As a result, proposals for the 2019 novel coronavirus will not be subjected to these additional requirements as described in Section 3.2.2.2.4.(I). However, the vaccine platform utilized should be well developed with clinical experience, and a defined and scalable manufacturing process that is suitable for use in a global pandemic.

Section 3.2.2.2.4 – Additional Requirements (page 21 of BAA) – this section is hereby revised to add paragraph III. and shall read as follows:

I.) This Research Area focuses on the development of promising lead vaccine candidates/products. Lead candidates should have the following requirements provided in order of preference:

a. lead vaccine candidates identified and optimized

b. proof of concept data that includes immunogenicity and preferably efficacy data

c. completion of upstream and downstream manufacturing processes

d. lead vaccine candidate characterized by well controlled assays including potency assay(s)

II.) Organizations responding to this Research Area, collectively with the proposed subcontractors and consultants where applicable, must have documented expertise in vaccine discovery and development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against emerging infectious diseases and/or biological threats identified in the Technical Objectives.

HHS-NIH-NIAID-BAA2020-1 Page 4 of 9

III.) Please note that the Additional Requirements stated above in Section 3.2.2.2.4.(I) apply to all proposals that do not seek to develop a coronavirus vaccine.

II.) REVISIONS TO HHS-NIH-NIAID-BAA2020-1 Research Area 004 (highlighted in red):

3.2. – DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID), NIAID

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

Section 3.2.2.3.2 – Technical Objectives (page 22 of BAA) – paragraph three is hereby revised to read as follows:

Research Area 004 will support lead optimization, pre-clinical (IND enabling) and clinical trials that include Phase 1 and Phase 2 studies or confirmatory trials no greater than 120 subjects. The scope of support differs depending on the stage of the project being proposed, as outlined below.

Section 3.2.2.3.2 – Technical Objectives (page 23 and 24 of BAA) – Preliminary Data Requirements is hereby revised to read as follows:

Preliminary Data Requirements: Regardless of the proposed entry point, therapeutic lead series/lead/product candidate must show demonstrated, phase-appropriate evidence of all the following characteristics:

• Synthesis/manufacturing feasibility;

• Appropriate in vitro AND in vivo efficacy; and

• Appropriate in vitro AND in vivo pharmacokinetic and toxicology.

These characteristics must be reflected in the draft Target Product Profile (TPP).

For this BAA, product candidate against the 2019-nCoV, data generated on relevant SARS or MERS coronavirus for efficacy would be considered appropriate.

Section 3.2.2.3.3 – Technical Approach (page 24 of BAA) – Solicited Products 2. Antiviral Therapeutics is hereby revised to read as follows:

2. Antiviral Therapeutics

a. Must display activity against viruses that are classified as NIAID Category A, B, or C viral threat agents; AND/OR

b. Display activity against infection caused by one of the following viral families:

i. Flaviviruses (esp. Zika, Dengue, and Yellow Fever virus)

ii. Filoviruses (esp. Ebola, Sudan, and Marburg virus)

HHS-NIH-NIAID-BAA2020-1 Page 5 of 9

iii. Orthopox viruses representative of Variola major

iv. Pathogenic Coronaviruses (e.g. MERS, SARS CoV, and 2019-nCoV)

v. Alphaviruses (esp. EEEV)

vi. Influenza (e.g., H1N1, H3N2)

vii. Other hemorrhagic fever viruses (e.g. Lassa fever)

III.) REVISIONS TO HHS-NIH-NIAID-BAA2020-1 Research Area 005 (highlighted in red):

3.3. – DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID), NIAID

Research Area 005: Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

Section 3.2.2.4.3 – Technical Approach (page 36 of the BAA) – paragraph one is hereby revised to read as follows:

Solicited product:

Early through late-stage diagnostics to address biodefense and pandemic preparedness Diagnostic must detect one of the following agents:

o Bacillus anthracis and must phenotypically determine its antibiotic susceptibility o Yersinia pestis and must phenotypically determine its antibiotic susceptibility o Francisella tularemia and must phenotypically determine its antibiotic susceptibility o Burkholderia sp. and must phenotypically determine its antibiotic susceptibility o Botulinum toxin and must identify and distinguish relevant serotypes o Lassa virus o Nipah virus o Rift Valley Fever virus o Enterovirus D68 virus o Zika virus o Candida auris o Coccidioides sp.

o 2019-nCoV

IV.) The Government’s responses to questions received regarding this solicitation are as follows:

GENERAL QUESTIONS

Question 1: Can an applicant organization submit more than one proposal (for separate PIs) per specific research area?

Response: Applicant organization can submit more than one proposal (for separate PIs) per specific research area. However, a PIs effort may not exceed 100% if more than one of the proposals is selected for negotiations.

HHS-NIH-NIAID-BAA2020-1 Page 6 of 9

Question 2: Can a PI submit more than one proposal per research area?

Response: A PI can submit more than one proposal per research area. However, a PIs effort may not exceed 100% if more than one of the proposals is selected for negotiations.

Question 3: Are application documents kept confidential, for example if they contain proprietary information?

Response: The NIH and its institutes follow strict rules to protect confidentiality for unfunded applications. Responsible NIH staff must ensure that reviews provide for the most competent advice to guide decisions on selection and award of contracts. Throughout the process, staff must avoid actual or apparent conflicts of interest, maintain confidentiality of information, and comply with procurement integrity requirements.

SPECIFIC RESEARCH AREA QUESTIONS

Division of Allergy, Immunology and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Question 1: Is NIAID looking to fund non-NHP model development.?

Response: 1: Please refer to Section 3.1.2.1.3 – Technical Approach, under paragraph “This contract will support the following activities:”, page 9/142 of the solicitation, where you can find the information for your questions, specifically from items a. and c.

Question 2: Does this BAA also allow drug development companies (biotechs) to respond with a white paper? Or, is the BAA soliciting white papers from labs (or CROs) that are testing the animal models?

Response 2: The above referenced solicitation, Research Area 001 is open to the public. Any business entity who has the capability to provide the requirements as stated in the Solicitation is encouraged to submit a proposal in response to the solicitation.

Please carefully review the requirements specifically related to the subject Research Area 001, starting from page 5 of the announcement to prepare your proposal.

Question 3: Is a focused irradiation model that does not include full body exposure appropriate for this Research Area 001 Solicitation.

Response 3: There is no language in the solicitation that would exclude the model of focused radiation.

Question 4: What is the level of preliminary/feasibility data that is expected for this application. Would this funding mechanism allow for further animal testing and validation in an appropriate animal model or do you expect the applicants to be further along in their development of the MCM?

Response 4: Please refer to page 8/142 of the BAA, section 3.1.2.1.3 – Technical Approach and

HHS-NIH-NIAID-BAA2020-1 Page 7 of 9 thoroughly review the requirements described in that section. The BAA does support nonclinical research and developing including efficacy studies in animal models of radiation exposure. Proposals will be evaluated according to Scientific Merit, including the “soundness of the supporting research”.

Question 5: Where in the solicitation is the template for writing and submitting a proposal? Are there page limits and what is the website to submit the proposal?

Response 5: Please refer to Section 4 – Instructions, Conditions, and Notices to Offerors, starting from page 49/142 of the solicitation.

Division of Microbiology and Infectious Diseases (DMID)

Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Question 1: For a platform technology that has existing efficacy and safety data in non-human primates, does the nonclinical proof of concept require use of an alphavirus or bunyavirus? Is it sufficient to have the nonclinical proof of the vaccine platform in a different system with multiple other types of viruses?

Response: The 2020 Omnibus BAA states that a prerequisite for acceptable proposals is an existing vaccine candidate with nonclinical data supporting additional development as defined in the two sections below:

Section 3.2.2.2.4 – Additional Requirements states:

I) This Research Area focuses on the development of promising lead vaccine candidate/products.

Lead candidates should have the following requirements provided in order of preference:

a. lead vaccine candidates identified and optimized

b. proof of concept data that includes immunogenicity and preferably efficacy data

c. completion of upstream and downstream manufacturing processes

d. lead vaccine candidate characterized by well controlled assays including potency assay(s)

Section 3.2.2.2.5 – Contracts awarded under this Research Area will NOT support:

• Basic research and discovery of new series/candidates/products

Question 2: Is this solicitation targeting only those organisms enumerated in the description of the two technical objectives (3.2.2.2.2.) or could programs for vaccine candidates for other NIAID Category A-C organisms also be considered for funding?

Response: Section 3.2.1 – Background states “ Through a variety of research grants and contracts, NIAID’s DMID supports basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics targeting multiple pathogens, including NIAID Category A, B, and C priority pathogens.

Section 3.2.2.2.2 – Technical Objective states “ A second objective is to support development of vaccines for emerging viruses and pandemic preparedness that includes but is not limited to alphaviruses….”

HHS-NIH-NIAID-BAA2020-1 Page 8 of 9

Section 3.2.2.2.3 – Vaccines for Alphaviruses and Other Emerging Infectious Diseases states “ This BAA seeks to support vaccine development focused on EEE virus but may support other alphaviruses or emerging pathogens.”

Question 3: African Swine Fever, a hemorrhagic arbovirus and pandemic disease in swine, is closely related to other hemorrhagic viruses of concern. Would NIAID accept a proposal that use ASFV as a model for development of a platform to create protective vaccines for Arboviridae? The platform includes an adjuvant that elicits potent cellular immunity and has no cold chain requirements.

Response: Section 3.2.2.2.3 states: “Research Area 003 seeks to identify promising candidate vaccines that have sufficient proof of concept data and/or clinical data to support vaccine development through manufacturing, toxicology testing, and testing in phase I/II clinical trials.”

Section 3.2.2.2.4 states the following Additional Requirements: II) Organizations responding to this Research Area, collectively with the proposed subcontractors and consultants where applicable, must have documented expertise in vaccine discovery and development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against emerging infectious diseases and/or biological threats identified in the Technical Objectives.

Therefore, proposals are required to define expertise in human vaccine discovery and development along with demonstrated knowledge of FDA regulatory guidelines and submission processes. Proposals should describe a clear path to regulatory approval, need to initiate a Phase I clinical trial, and clearly identify the requisite contractor expertise, subcontractor expertise, and/or vendor expertise.

Note: The NIAID/DMID provides other pre-clinical services and funding opportunities for organizations that may be used to advance candidates that do not meet the requirements of this BAA.

https://www.niaid.nih.gov/about/dmid-preclinical-clinical-services-contacts

Question 4: If the participating institutions are not able to sponsor a human clinical trial, can the applicants propose that DMID sponsor the clinical trials with products developed from an award under this BAA?

Response: Section 3.2.2.2.3 – Technical Approach states “Research Area 003 seeks to identify promising candidate vaccines that have sufficient proof concept data and/or clinical data to support vaccine development through manufacturing, toxicology testing, and testing in Phase I/II clinical trials.

Proposals are expected to provide: 11.) Design, conduct, completion, and analysis of a Phase 1, Phase ½ or Phase 2 clinical trial of the candidate product in normal healthy volunteers may be included.

Question 5: If DMID agrees to sponsor the trial, does this require any transfer of ownership of the product or underlying IP from the innovator or licensee to DMID?

Response: DMID does not agree to sponsor a trial.

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases https://www.niaid.nih.gov/about/dmid-preclinical-clinical-services-contacts

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Question 1: According to the BAA (Section 3.2.2.3.1), contracts are not expected to be awarded until May 2021 and advances in our program are likely to be made during that time. Will offerors have an opportunity to update proposals as the program progresses, and new data becomes available?

Response: Offerors will be unable to revise their proposal after the closing date and time specified in the BAA. Your technical proposal will be evaluated by a peer review group against the evaluation criteria identified in Section 6.3 of the BAA.

As stated in Section 6.1. of the BAA, following the proposal evaluation, the Government will conduct negotiations with selected offerors to address identified weaknesses, questions, and areas for clarification, as well as to refine the proposed SOW and deliverables.

Question 2: It is not entirely clear to us that there is a distinction between fee-for-service vendors who we would subcontract to perform work for us, and subcontractors who might be considered “collaborators” due to having a scientific role. Do fee-for-service vendors fall under the definition of “subcontractor” in Section 4.3.3.1.16 and are these vendors required to supply all of the information listed in Section 4.3.3.1.16? Additionally, will they be required at the Post Award Contract Initiation Meeting and subsequent Annual Contract Review Meetings?

Response: Page 97 of the BAA defines a “subcontract” to mean any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

Based on the definition provided above and as defined in FAR Part 44.101, both would be categorized as a subcontract.

Section 3.1.3.7 – Uniform Cost Assumptions - 2.) Travel - allows for key personnel of subcontractors to attend the Contract Initiation Meeting, Annual Site Visits , and Annual Programmatic Meetings.

Question 3: For the budget, we will be soliciting quotes from the fee-for-service vendors and will include these costs in our proposal. Is any additional information required to support these vendor costs?

Response: Please refer to the Section 4.3.3. – Business Proposal Instruction of the BAA which starts on page 90 of the BAA. This section specifies the minimum documentation requirements for cost data and all cost related support.

Question 4: Is your scope limitation for the BAA of pre-clinical to Phase 2 based on defined phase of study or is it based on cost?

Response: See clarification to Section 3.2.2.3.2 above in Section II of this Amendment. The scope of support for the therapeutics contracts ranges from preclinical lead optimization through early clinical trials (Ph 1 – Ph 2) and small confirmatory trials. This scope is based primarily on budget limitations and the high costs of typical Ph 3 trials.

PLEASE NOTE: In the questions/responses above, specific organizational names have been removed or replaced where possible as well as other minor adjustments.