Amendment_1_-_Questions_and_Responses_(BAANIAIDNIHAI2016064).pdf

BAA_NIAID_NIHAI2016064

Amendment 1

Amendment 1: BAA_NIAID_NIHAI2016064

GENERAL COMMENTS

***The page numbers provided below refer to the page number of the PDF of the Solicitation.***

The hyperlink for Attachment 15: Small Business Subcontracting Plan in Section J – List of Attachments doesn’t work. Therefore, we are attaching the document to this amendment.

1. Please see the Table on pages 2‐4 of this amendment for other revisions to

BAA_NIAID_DMID_NIHAI2016064.

TABLE: REVISIONS TO BAA‐NIAID‐NIHAI2016064

Solicitation location (Page/Section/Paragraph)

Current language Amended language

SECTION A/10. Primary Point of Contact:

Primary Point of Contact:

Courtney Markey; phone:

(301) 761-5141; email:

courtney.markey@nih.gov

Secondary Point of Contact: Michael Finn;

phone: (240) 669-5125;

email:

finnm@niaid.nih.gov

Primary Point of Contact:

Chase Sullivan; phone:

(240) 669-5141; email:

chase.sullivan@nih.gov

Secondary Point of Contact: Aileene Lewis;

phone: (240) 669-5133;

email:

Aileene.Lewis@nih.gov

Alternate Point of Contact: Michael Finn;

phone: (240) 669-5125;

email:

finnm@niaid.nih.gov

Pg91/Sec M – EVALUATION FACTORS

FOR AWARD/8. TECHNICAL

EVALUATION FACTORS/Criterion

2/PARAGRAPH B.

“…B. Soundness, adequacy, feasibility, completeness, suitability, and quality of the clinical trial Protocol Synopsis in performing human subjects research in accordance with Federal regulations for the conduct of clinical trials.

The feasibility of attaining a safety profile that meets all existing FDA requirements, completion of cGMP manufacturing, and initiation of a Phase 1 or Phase 2 (if a Phase 1 trial has already been completed) clinical trial within 5 years of award as well as safety and immunogenicity results that support further clinical development. The adequacy and appropriateness of the regulatory plan for entering Phase 1 (or if appropriate, Phase

2) testing and eventual licensure by the FDA.”

“…B. Soundness, adequacy, feasibility, completeness, suitability, and quality of the clinical trial Protocol Synopsis in performing human subjects research in accordance with Federal regulations for the conduct of clinical trials.

The feasibility of attaining a safety profile that meets all existing FDA requirements, completion of cGMP manufacturing, and initiation of a Phase 1, Phase 1/2 or Phase 2 (if a Phase 1 trial has already been completed) clinical trial within 5 years of award as well as safety and immunogenicity results that support further clinical development. The adequacy and appropriateness of the regulatory plan for entering Phase 1, Phase 1/2 (or if appropriate, Phase

2) testing and eventual licensure by the FDA.

Pg102/Attachment 5 RESEARCH AND TECHNICAL OBJECTIVES/The scope of activities may include the following:/ 8.

“…8. The design, conduct, and completion of a Phase 1 or Phase 2 (if a Phase 1 trial has already been completed) clinical trial for the vaccine candidate.”

“…8. The design, conduct, and completion of a Phase 1, Phase 1/2 or Phase 2 (if a Phase 1 trial has already been completed) clinical trial for the vaccine candidate. The conduct of more than one clinical trial could be supported but will depend on the availability of funds and programmatic balance.”

Pg102/Attachment 5 RESEARCH AND TECHNICAL OBJECTIVES/Contracts awarded under this BAA will not support:

“ Early stage discovery of vaccine candidates;

� The development and evaluation of the safety and efficacy of individual vaccine components (see above definition of vaccine components);

� The design and conduct of Phase 3 clinical trials;

� The design, conduct, and/or completion of a clinical trial for individual vaccine components.

� Proposals that do not provide proof of concept efficacy data in Nonhuman Primates (NHP) or in ferrets for at least one of the three filovirus components (Ebola virus, Sudan virus, or Marburg virus) using wild type (non-animal adapted) minimally passaged virus challenge material.

Proposals that seek to advance more than one multivalent vaccine candidate into a Phase 1 or Phase 2 clinical trial. A single multivalent vaccine candidate may consist of a mixture of individual monovalent vaccines, or more than one vaccine to be used in the context of a heterologous prime-boost immunization.

“ Early stage discovery of vaccine candidates;

� The development and evaluation of the safety and efficacy of individual vaccine components (see above definition of vaccine components) however, contracts could support evaluation of monovalent vaccine components of a multivalent vaccine if the monovalent vaccine components are part of a larger multivalent vaccine program;

� The design and conduct of Phase 3 clinical trials;

� The design, conduct, and/or completion of a clinical trial for individual vaccine components.

However, contracts could support clinical testing of a monovalent vaccine component of a multivalent vaccine if the monovalent vaccine is part of a larger multivalent program. For example a clinical trial mainly focused on the multivalent product could have arm(s) for a monovalent vaccine if inclusion of the monovalent vaccine arms addresses relevant questions.

� Proposals that do not provide proof of concept efficacy data in Nonhuman Primates (NHP) or in ferrets for at least one of the three filovirus components (Ebola virus, Sudan virus, or Marburg virus) using wild type (non-animal adapted) minimally passaged virus challenge material.

Proposals that seek to advance more than one multivalent vaccine candidate into a Phase 1 or Phase 2 clinical trial. A single multivalent vaccine candidate may consist of a mixture of individual monovalent vaccines, or more than one vaccine to be used in the context of a heterologous prime-boost immunization.

P104/Attachment 5 RESEARCH AND

TECHNICAL OBJECTIVES/C.

MANUFACTURE OF cGMP MATERIAL/a.1

“ 1. Completion of the proposed Phase 1 or Phase 2 clinical trial, “ 1. Completion of the proposed Phase 1, Phase 1/2 or Phase 2 clinical trial, P106/Attachment 5 RESEARCH AND

TECHNICAL OBJECTIVES/D. CLINICAL

DEVELOPMENT AND INVESTIGATIONAL

NEW DRUG (IND) SPONSORSHIP AND

SUBMISSION/paragraph d.3

“ 3. Proposed clinical sites to participate in the conduct of the Phase 1 or Phase 2 clinical trial and documentation of access to and experience in the recruitment and retention of the types of subjects required for the proposed clinical trial.”

“ 3. Proposed clinical sites to participate in the conduct of the Phase 1, Phase 1/2 or Phase 2 clinical trial and documentation of access to and experience in the recruitment and retention of the types of subjects required for the proposed clinical trial.