FINAL_Amendment_1.pdf

SOLICITATION: NHLBI-CSB-HV-2017-01-JS

AMENDMENT: One (1)

TITLE: Vascular Interventions/Innovations and Therapeutic Advances (VITA)

DATE OF ISSUANCE: July 28, 2015

ISSUED BY:

National Heart, Lung, and Blood Institute, NIH Office of Acquisitions, CSB, OM 6701 Rockledge Drive Bethesda, Maryland 20892-7902

The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged. All other terms and conditions of the solicitation remain unchanged. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by one of the following methods:

I. By acknowledging receipt of this amendment on each copy of the proposal submitted. Please note that this is the preferred method.

II. By separate letter or email which includes a reference to the solicitation and amendment number.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE

DESIGNATED FOR THE RECEIPT OF PROPOSALS PRIOR TO THE HOUR AND

DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR PROPOSAL. If by virtue of this amendment you desire to change a proposal already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

PURPOSE: The purpose of this amendment is to: (1) modify Section A – Solicitation/Contract Form, item 8. to extend the question submission date to August 14, 2015 as stated below, (2) include the slides presented during the pre-proposal webinar held on July 16, 2015 as an attachment to this amendment, and

(3) include questions from offerors and responses in reference to the solicitation as an attachment to this amendment.

Section A – Solicitation/Contract Form, item 8.

Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00p.m. local time on October 5, 2015.

Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH2043. Questions on this solicitation shall be submitted electronically by 3:00 PM EDT on August 14, 2015 at NHLBI_VITARound2@mail.nih.gov. If an offeror intends to submit a proposal, the Proposal Intent Response Sheet, Attachment 2, must be completed and submitted by 3:00 PM EDT August 6, 2015.

END OF AMENDMENT

7/27/2015

Pre-Proposal Conference – Webinar The audio is via a separate telephone line.

Call 1-888-989-9726 and enter pass-code: 2374140

Your phone is muted; you should hear us, but we cannot hear you.

You may submit questions during this webinar by sending an e-mail to NHLBI_VITAROUND2@MAIL.NIH.GOV We will review these questions, but may not have time to answer every question. However, after this webinar, we will provide questions and answers we believe are appropriate to all potential Offerors via amendments to the solicitation.

This webinar will be archived but there will be no audio. A PDF of the PowerPoint presentation will be posted. A link to view it will be included in a future solicitation amendment.

Instructions

VITA Webinar Purpose & Presenters

Webinar Purpose:

Provide an overview of the VITA Program and inform Offerors of the unique contract requirements

Assist Offerors in preparing technical and business proposals

List of Presenters:

Kelli Malkin, Contracting Officer, NHLBI

Jennifer Swift, Contract Specialist, NHLBI

Marc Charette, Ph.D., BAA Project Officer, NHLBI

Cheryl L. McDonald, M.D. PCC Project Officer, NHLBI

Overview of BAA - Development Project Proposals

Review of specific solicitation sections to assist Offerors in preparing contract proposals Section L of Solicitation Section M of Solicitation

Question and Answer Session

Webinar Agenda

Broad Agency Announcement (BAA) Development Project Proposals Solicitation #: NHLBI-CSB-HV-2017-01-JS

BAAs are:

Used by agencies to fulfill requirements for scientific study and experiments directed towards advancing the state-of-the-art, increasing knowledge, and/or understanding of a specific research area

BAA encourages creative and innovative approaches to specific research areas identified by the government

Offerors, as part of their proposal, shall develop a research plan (Statement of Work) based on the Required Objectives & Desired Results (Attachment 3) as indicated in the BAA solicitation.

VITA Program Broad Agency Announcement (BAA)

Development Project Proposals

Marc Charette, Ph.D.

Project Officer, NHLBI

The VITA Program is a translational initiative that provides funding for the development of biomedical product candidates in certain fields.

Overview

Product candidates must be within the fields of vascular disorders, thrombotic diseases, and pulmonary hypertension including:

peripheral arterial disease aortic aneurysms and dissections pulmonary vascular disorders venous and arterial thrombosis thromboembolic disorders and disorders of the lymphatic system

Specifically not included are diseases of the coronary and intracranial arteries

Eligible Projects

Definition:

New diagnostics New therapeutic agents Novel applications of existing agents and/or therapeutic interventions Can include, but are not limited to:

Small molecules, small peptides, proteins or antibodies Devices, diagnostic tests, or imaging agents Genetic markers and cell or gene agents

Product Candidates

Two types of development stages will be funded, Stage A and Stage B.

The above slide shows the translation development pathway and where Stage A and Stage B will fall within the pathway.

The BAA is used for contracts, not grants. Therefore, offerors will need to submit their proposal as indicated in the BAA.

Each proposal will be evaluated using the evaluation criteria detailed on page 99.

This is actually the second round of solicitations for the VITA Program.

The current awards were made in 2013, and at that time in order to ensure continuity of the Program and its infrastructure, the Program Coordinating Center (PCC) was awarded a 6‐year contract. Thus, the PCC is up and running and will be ready to work with the Round 2 sites as soon as the new awards are made, but not before. The PCC staff can NOT help you with your proposals.

The contractor for the PCC is CCS Associates, Inc. and the PI is Donya Bagheri. There are several different Project Managers at the PCC who work directly with the VITA research sites.

Assisting the PCC with meeting logistics and the website it Capital Consulting Corporation. Susan Kerin in the logistics coordinator at CCC.

Again, please note that the PCC is only available to research sites AFTER award. They can NOT assist with your proposal development.

This slide illustrates the structure of the VITA Program. The Program Coordinating Center (PCC) provides overall coordination of the VITA Program and works with the NHLBI and the Stage A and Stage B product development research sites. The PCC is the linchpin of the VITA Program and serves several functions. The next few slides elaborate on some of those functions.

The main role of the PCC is to provide overall coordination of the VITA Program. Some specific tasks the fulfill are listed on this slide.

The PCC serves as a Liaison between the research sites and the NHLBI Project Officers.

The PCC also ensures efficient Project Management at the research sites with regular teleconferences with the site.

They coordinate all program meetings and teleconferences.

They also manage the External Advisory Committee (the EAC) that was empaneled to advise the NHLBI on the overall program and progress of each award.

The PCC developed and maintains the private internal VITA Program website where investigators, the NHLBI, and the PCC share many different kinds of information. The public VITA page is on the NHLBI website.

And an important facet of the PCC’s role is that they are available to assist the research sites with regulatory affairs matters.

This slide discussed the Project Management and Liaison Role that the PCC plays.

First, please note that all Offerors must plan to have a designated Project Manager at their site. Though it may be helpful, the Project Manager does not necessarily have to have a background in the biological sciences if they are skilled in Project Management.

The PCC Project Manager interacts with the research site Project Manager and the research site Steering Committee to facilitate timely progress on the work in order to meet the pre‐determined milestones.

The PCC Project Manager then keeps NHLBI apprised of the progress of the research and any issues of concern at the sites.

As in the slides above, there are annual organizational and performance meetings that the PCC coordinates.

These meetings are all held in the Bethesda, Maryland area. Please note, while the PCC coordinates these meetings, they do not cover the costs. You must put the travel funds in your budget.

The first meeting, the Kick‐Off meeting, will be held approximately 30‐60 days after the awards are made. At this meeting the awardees present their proposed research plans.

The second meeting in Year 1 is towards the end of the award period, at approximately 11 months post‐award. At this meeting the sites present the progress on their work and the External Advisory Committee assesses this and advises the NHLBI on how well the sites are achieving their milestones. Please note that it is very important that you set realistically achievable milestones. In the context of these contracts it is better to over‐perform than under‐achieve; but, ideally, you will strike just the right balance and hit your milestone targets.

And as previously mentioned, the PCC Project Managers have regular meetings, typically teleconferences, with the research sites. The PCC also has monthly and as needed teleconferences with the NHLBI Project Officers.

This slide shows some facets of the Regulatory Affairs Support Role of the PCC. Please note that the PCC can offer assistance, but they will not serve as your own private regulatory affairs department. First, the PCC can assist you in scheduling and preparing for meetings with oversight bodies such as the FDA, the IRB, etc.

The PCC can ASSIST you with the preparation of IND or IDE applications, But again, please note that the PCC will not do all of the regulatory work for you.

The PCC can provide some instruction or general education on regulatory processes to the research sites. For example, they could present an instructional webinar or provide helpful information to your site. For more detailed training in regulatory issues, sites can put travel and/or training funds in their own site budgets to take formal courses. If you put monies in your budget for training courses, the monies can be re‐budgeted for the research work, and vice‐versa BUT only within the same contract year. The money can not be carried over from one year to another. ALSO, we do not have extra funds to give your for training courses. Please see the BAA solicitation for more details on the training option.

The PCC can also assist you if you are conducting a clinical trial in your VITA project. They can assist with document preparation and other facets of trial preparation and management. The PCC can also help you identify and apply for other resources, including other NHLBI resources such as through the SMARTT program, the GTRP, BioLINCC, as well as outside resources.

For more details about the types of regulatory assistance the PCC can offer the awarded research sites, please read the Statement of Work of the PCC in the solicitation issued previously. You can find this by putting the entire solicitation number into Google or any of the usual search engines. That number is: RFP‐NHLBI‐CSB‐HV‐2013‐04‐JS.

Also, if you know now that you will likely ask the PCC for regulatory assistance, please mention in your proposal what type of assistance you will likely seek from the PCC. This is not binding and there is no charge to you for services from the PCC. It will just give us an idea of what sort of work might lie before the PCC in the coming years. Again, the PCC will only work with those who receive a VITA contract, AND only after it is awarded. They are not to be contacted prior to an award being issue to you.

VITA Program Contract Proposal Information

Ms. Kelli Malkin Contracting Officer, NHLBI

Ms. Jennifer Swift Contract Specialist, NHLBI

Distinction Between Contracts and Grants

Contracts Grants Definition A mutually binding legal relationship that is utilized to acquire research and development programs and products or services to meet a predetermined program need.

Mechanism used to extend financial assistance to organizations or individuals involved in programs related to the work of the Institute.

Solicitations RFP – Request for Proposals or BAA – Broad Agency Announcement

RFA – Request for Applications

Proposals Contract Proposal Grant Application

BAA Solicitation Mechanism - Section L

Instructions, Conditions, and Notices to Offerors (pages 45-98)

Instructions to Offerors General Instructions Technical Proposal Instructions Business Proposal Instructions

Instructions, Conditions, and Notices to Offerors General Instructions

(pages 56-65)

Information and Physical Access Security is applicable to this solicitation.

Information shall be addressed in a separate section of the Technical

Proposal entitled “Information Security.”

Additional Information on Information and Physical Access Security can be found in Sections C.2.b. Reporting Requirements pages 9-11 and Section

H.27. Information and Physical Access Security pages 25-32.

Please coordinate with your organization’s Information Security department.

BAA Solicitation Mechanism - Section L

Mandatory Qualification Criteria – Your proposal MUST meet the mandatory criteria. Any proposal that does not meet this criteria will NOT be reviewed or considered for award.

Technical Evaluation Factors – These are the scored evaluation criteria

Unscored Evaluation Factors – While these evaluation factors are unscored, ALL proposals will be reviewed in these areas and each proposal must contain the required elements.

It is NHLBI’s intent to award as many Stage A and Stage B awards as possible with the amount of funds allotted.

Offerors will receive contracts, not grants. Therefore, funds may NOT be carried over from one performance/funding period (project year) to the next. Please plan your budgets carefully and be sure to budget funds accordingly.

Proposals will not be accepted after 3pm EDT, on October 5, 2015. This is the absolute last date/time to submit your proposal. Please take traffic, mail delays, and proposal review time needed by your organization into consideration, as these delays will may cause your proposal to be late. Extensions will not be granted.

SAM registration may take several days/weeks to become active or to be updated when renewing certifications.

For more information regarding SAM registration, please refer to www.SAM.gov. For assistance with your SAM registration, please contact the SAM helpdesk. NHLBI contracting staff cannot assist you with your SAM registration.

Because the award dates are not firm, please put your milestone timelines in terms of post‐award periods, not by actual calendar dates or months. For example, a milestone goal could be that you will have a task completed by Post‐Award Month 3, not January 2017.

Because this is contract mechanism where Offerors are in competition with one another, NHLBI scientific Program staff are not allowed to speak directly to an Offeror. This could be seen as potentially providing an unfair advantage. But, please know that the NHLBI Contracting staff does get input from the scientific Program staff before responding to questions that are “scientific “in nature.

Please plan ahead and ensure that you have these required registrations.

While you do not have to have these before submitting a proposal, you must have them in place before an award can be issued to you. We suggest that you allow at least 6 weeks to secure all of these registrations.

Q5. I have a product candidate, but this is the first time I’ve heard of a BAA for a new program at NHLBI. Is there someone to whom I can send an application draft to get feedback on whether I am applying correctly?

A5. NHLBI Staff cannot proofread draft proposals for structure, or content. However, NHLBI staff may answer questions about the solicitation and whether your research topic area would be responsive. We recommend that you seek assistance from the Office of Sponsored Programs (or such equivalent) at your institution before submitting your question to the NHLBI mailbox.

Question 5 of 11

Q6. I see Information System Security (IT Security) is included in the solicitation. I do not believe this applies to my proposal or institution.

A6. Information System Security applies to the VITA program as a whole and therefore every proposal/contract.

You will need to address information system security in your proposal before submission.

As a side note, all offerors must comment/include all sections described in the solicitation, regardless of whether or not you believe they apply.

Question 6 of 11

Q7. Will the same VITA technical review panel be reviewing proposals for both Stage A & Stage B submissions, or will there be separate review panels for each stage? In addition, are the technical review panel(s) composed of outside scientific experts, or in-house NHLBI staff?

A7. There will be one peer review board which will review both stage A and stage B proposals. This peer review board will consist of subject matter experts from outside the federal government.

Question 7 of 11

Q8. How many total awards are anticipated to be awarded for each stage for VITA Round 2?

A8. The number of proposals awarded under VITA Round 2 depends upon the responsiveness, quality, and price of the proposals received.

Question 8 of 11

Q9. Stage B VITA awards are described as being able to be used for very early clinical testing of product candidates. Can you please elaborate on your definition of very early clinical testing?

A9. Early clinical testing is usually a Phase I study with a new drug/device or a Phase II study with an already approved drug/device but for a new indication.

Question 9 of 11

Q10. Can Stage B VITA awards be used primarily for safety pharmacology and toxicology studies that support an IND?

A10. Yes, pharmacology and toxicology studies which support an IND are included in a Stage B project.

Question 10 of 11

Q11. Is the aim of this contract more in assessing suitability of the technology or in applying the technology broadly?

A11. The primary aim of the VITA Program is to promote early stage biomedical product development and in that context assessing the suitability of a product technology is probably more applicable.

Question 11 of 11

Thank You

Vascular Inventions/Innovations and Therapeutic Advances (VITA) Round 2 Questions

Technical Proposal Questions:

Question 1 If the scope of proposed work overlaps Stage A and B, what should the Offeror do?

An Offeror should tease out the milestones that fit with the Stage they want to apply for. If they already have Proof of Concept (Principle) data and are ready to plan/conduct pivotal IND-enabling animal studies or early human testing they are Stage B. If they haven’t selected a lead compound, are still tweaking the formulation, have yet to prove efficacy in animal of the target disease, etc. they are Stage A and need to propose studies small enough in milestones/budget to get that proof of principle information.

Question 2 For a potential offeror who is a relatively new business that is starting to develop a technology, what kind of past performance is relevant to the BAA? In particular, for a business who began developing technology with federal funding at a university, but never competed for a federal contract under the new company name,is it relevant to discuss past performance on university grants and SBIR grants? What other information should be provided/discussed to demonstrate reliability?

Yes, past performance completed at the university and under an SBIR may be used when submitting a proposal in response to the VITA BAA. In addition, any other information that would convey to the reviewers that the team has the expertise to successfully complete the proposed project would be relevant past performance as well.

Question 3 Is the aim of the VITA project more in assessing suitability of the technology or in applying it broadly?

The VITA program is aimed at early stage product development. So, successful demonstration of the suitability of the product in a small, targeted population is more relevant.

Question 4 For the purpose of preclinical and eventually clinical trials, a potential offeror has set up a start-up company; however, a significant part of work will still be completed by a lab at a University. May a potential offer submit a proposal as a new start-up company and subcontract back to a university for a significant amount of work?

Potential offerors may submit a proposal with subcontract costs (whether to a university or other entity) provided at least 30% of budget funds remain with the offeror (no more than 70% of funds may be passed through to other entities). In addition both organizations (start-up and University) must have the required registrations, etc. to participate in VITA as outlined in the solicitation.

Question 5 If a Stage A project is going to be a preclinical animal study for a product:

1) Are there cost limits on subcontracts? In particular for animal studies, subcontracts may be necessary.

All budget costs, including subcontracted costs must stay within the costs limits stated within the solicitation. In addition, no more than 70% of budget funds may be passed through to another entity.

As a side note, if you already have proof of principle and the animal study is an IND-enabling animal study (e.g., pharm/tox) that should be stage B.

2) At the end of Stage A, is it expected that the product be at a certain stage of development?

By the end of a Stage A award, there should be convincing demonstration of Proof of Principle for the product candidate.

3) In terms of bridging from Stage A to Stage B, is it reasonable to anticipate a need for additional funds to carry the project from Stage A to Stage B -possible SBIR or investor funds?

These awards are for distinct Stages and the budgets allowable would not usually be sufficient for all of the work for both stages. Therefore, only work that can be completed under the 3-year VITA award should be proposed.

Question 6 Are biomarker studies for PAD fundable through VITA?

Yes. Biomarker studies for PAD are fundable through VITA.

Question 7 The last round of funded contracts had two “anti-thrombotic with minimal bleeding profile”. Would there be any more interest in that segment to seek a novel technology with a unique target offering better efficacy or would a potential offeror need to position the proposal for a different and specific indication?

VITA projects will be evaluated on the merits of each proposal. NHLBI will not limit the categories of potential product candidates other than the broad categories of vascular disorders, thrombotic disorders, and pulmonary hypertension as in the solicitation.

Question 8 What does “Proof-of Principle” mean? Does “Proof –of-Principle” mean first-in-human studies and data or does it mean “proof –of concept” animal studies?

Within the VITA Program “proof of concept” means demonstration of efficacy within animal studies for drug candidates.

Question 9 Would a completed SBIR Phase I funded project with bench test results qualify for a Stage A or Stage B designation?

The distinction between Stage A and Stage B in the VITA program is determined by “proof of concept” status. In the case of a new product candidate, proof of concept is considered to be convincing demonstration of efficacy in a model of the target disease or disorder (such as an animal model).

Business Questions:

Question 1 May foreign partners be included?

There are no restrictions on foreign collaborators; however, should your proposal be awarded, clearance must be obtained from the State Department prior to entering into an agreement with a foreign entity.

Question 2 Will there be other solicitations beyond round 2?

At this time, future solicitations are not being considered.

Question 3 Can academic institute apply for the program?

This BAA is being competed full and open solicitation. As such, all vendors who believe they have a study/device which is responsive to the solicitation may submit a proposal.

Question 4 Is this program ONLY for small businesses?

This BAA is being competed full and open and not set aside for small businesses.

Small businesses may still submit a proposal.

Question 5 Do we need to submit a technical letter of intent addressing the technical merits and gaps in knowledge along with the “Proposal Intent Response Sheet, Attachment 2” by August 6 deadline OR is it just the “Proposal Intent Response Sheet, Attachment 2” by that deadline?

Only the Proposal Intent Response Sheet needs to be submitted. There is no need to submit a technical letter.

Question 6 What rate do you allow for indirects? The institution’s negotiated F&A rate?

Offerors should use their federally negotiated indirect cost rate agreement when including indirect costs. For offerors who do not have a federally negotiated indirect cost rate agreement, indirect costs may be negotiated for a period of time while a federally negotiated indirect cost rate agreement is negotiated.

Question 7 Is a letter of intent required or recommended?

A Proposal Intent Response Sheet is requested by August 6, 2015.

Question 8 Can one investigator be involved in more than one proposal?

An investigator may be involved with multiple proposals, provided the statements of work are different and there will be no overlap of work.

Question 9 If applying from an academic center, are we required to partner with company? If so, is the size of company limited, like SBIR? Essentially, how similar to an SBIR is this?

No. There is no requirement for academic institutions (or any other type of entity) to partner with a company in order to submit a proposal in response to the BAA.

VITA Questions-Answered & Amended