MTEC-23-12-Blood RPI.pdf

Request for Project Information

Solicitation Number: MTEC‐23‐12‐Blood

“Blood and Blood Products State of the Technology Meeting”

Issued by:

Advanced Technology International (ATI), MTEC Consortium Manager (CM)

315 Sigma Drive

Summerville, SC 29486 for the

Medical Technology Enterprise Consortium (MTEC)

Request Issue Date: September 7, 2023

Project Information Paper Due Date: October 23, 2023

Noon Eastern Time

The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Information (RPI) focused on Blood and Blood Products in support of an upcoming State of the Technology Meeting.

BACKGROUND ON UPCOMING STATE OF THE TECHNOLOGY MEETING:

Through MTEC, the DoD Combat Casualty Care Research Program (CCCRP), in conjunction with the

Biomedical Advanced Research and Development Authority (BARDA) Radiation/Nuclear Medical

Countermeasures Branch, intends to host a Blood and Blood Products State of the Technology Meeting in order to inform current processes and future research, development and acquisition strategies. This meeting is expected to be held in Washington D.C. on November 29, 2023. MTEC will notify membership when registration information related to this State of the Technology meeting is available and it will also be posted on the MTEC website. The government will review and approve registrations to this meeting.

The purpose of this meeting is to inform the US Government and the greater scientific community of innovative research for blood and blood products, in support of current and future military and civilian blood needs for future large scale combat operations, as well as domestic mass casualty and disaster response. Additionally, the meeting will assist the US Government in identifying capability gaps and prioritizing efforts toward blood product development within DoD and across the inter‐agency enterprise. The meeting will give an opportunity for a dynamic exchange of ideas among all participants and provide support to identify and overcome challenges.

Examples of specific areas of interest to be addressed at the State of Technology meeting include, but are not limited to, the following items. These areas of interest are not listed in order of importance:

a) ex vivo manufacturing of blood products (synthetic, chemical isolation, or recombinant biochemical technologies)

b) Infrastructure required to support military and civilian needs including supply chain limitations and surge capabilities

c) Synthetic products that have blood capabilities (oxygen carriers, hemostatics, nanoparticles)

d) Extended shelf‐life blood products

e) Rapid donor screening technologies (blood typing and pathogen detection)

f) Lyophilized blood products

Attendees of the State of Technology meeting are expected to bring an understanding of blood, blood products, and synthetic blood. Attendees of the meeting will also gain exposure to government agencies, their respective portfolios, and potential funding opportunities relevant to blood and blood products.

The intended impact of the State of the Technology meeting is to better inform possible future investments by the United States Government to advance specific technologies poised to address unmet needs in the blood products field and enhance the standard of care for military and civilian populations.

The meeting organizers will develop a State of the Technology Report with the intent for publication following the meeting.

PURPOSE OF THE PROJECT INFORMATION PAPER:

MTEC is seeking input from both MTEC members and the general public (non‐member companies) that are developing solutions for synthetic blood. We seek input to gauge interest in attendance/technology presentations and to frame the agenda on areas of concerns, unmet needs, products/technology advancements and limitations, and regulatory challenges from all interested parties, including but not limited to, healthcare providers, scientists, product developers, regulatory experts, and reimbursement strategists.

This RPI contains background material and guidance for the preparation of Project Information Papers to be submitted to MTEC. MTEC membership is not required for submission of Project Information

Paper.

REQUIREMENTS OF THE PROJECT INFORMATION PAPER:

The intent of this RPI is to understand respondents’ interest and technology capabilities in support of the State of the Technology Meeting’s area of interest. MTEC is seeking input from both MTEC members and non‐members via a project information paper to be considered by the panel. Project information papers will be shared with the reviewers under non‐disclosure agreements. The MTEC may invite one or more of those who submit project information papers to participate in, or present to, the organizing panel during their convening.

Project Information Papers may be submitted at any time during the submission period but no later than the due date and time specified on the first page of this RPI using BIDS:

https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm. See Addendum 2 of this RPI for further information regarding BIDS registration.

Project Information Papers should NOT include proprietary or classified information. Information obtained through this RPI may be used to develop the State of the Technology meeting’s agenda as well as be included as a component of the final State of the Technology report.

Submission Document(s): Submitted via BIDS (5MB or lower per document)

[Required] Project Information Paper: one Word document (See Addendum 1 of this RPI)

[Optional] Quad Chart: one Word document (See Appendix A of this RPI)

MTEC:

The MTEC mission is to assist the USAMRDC by providing cutting‐edge technologies and effective materiel life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10‐year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH‐15‐9‐0001, with the U.S.

Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “non‐traditional” government contractors, academic research institutions and not‐for‐ profit organizations.

POINTS OF CONTACT:

For inquiries, please direct your correspondence to the following contacts:

Technical and membership questions should be directed to the MTEC Research Project Analyst, Dr.

Seth Tomblyn, Ph.D., Seth.Tomblyn@ati.org

All other questions should be directed to the MTEC Chief of Consortium Operations, Ms. Kathy

Zolman, Kathy.Zolman@ati.org

Addendum 1 – Information Paper Template

Military Technology Enterprise Consortium (MTEC)

Synthetic Blood State of Technology Meeting

Project Information Template

[2‐page limit. 12‐point Arial font, smaller font may be used in figures and tables, but must be clearly legible. Single‐spaced, single‐sided, 8.5 inches x 11 inches. Margins on all sides (top, bottom, left, and right) should be at least 0.5 inch. These project information submissions will be shared with the Sponsor;

therefore, all information must be nonproprietary. Project Information Paper should be submitted as a

Word (*.doc or *.docx) document using the template provided in this RPI.]

Date: [Insert Date of Submission]

Point of Contact: [Insert name, role, organization, email address, phone number]

Answers to the following questions are required:

1) Are you interested in attending the State of Technology meeting [Tentative Dates: November 29‐

30]? Yes or No

2) Describe any suggestions on specific areas of interest that align with the overall topic of this State of the Technology meeting.

3) If you have a specific technology that you would like us to consider for presentation at the meeting, please indicate what type of presentation you wish to be considered for in the table below and include a brief narrative on the technology, its state of development, and how it aligns to the objectives.

Technology Objective Areas of Interest Poster

Presentation

(Yes/No)

Technology

Demonstration

(Yes/No) ex vivo manufacturing of blood products (synthetic, chemical isolation, or recombinant biochemical technologies)

Infrastructure support required to support military and surge needs

Synthetic products that have blood capabilities (oxygen carriers, injectable hemostatics, nanoparticles)

Lyophilized blood products

Extended shelf‐life blood products

Rapid blood donor screening technologies (blood typing and pathogen detection

Other blood related technologies

4) The meeting organizers intend to attach an addendum to their final post‐meeting report that includes quad charts of technologies related to the topics outlined above in item #4. If you have a specific technology that you would like us to consider for inclusion in a final report detailing the breadth of technologies available within this focus area, then please use the attached quad chart template. Quad charts should be marked as either public release or confidential. Confidential submissions will be included in a separate addendum for government use only and will not be published publicly. See Appendix A of this RPI for template.

Appendix A: Quad Chart Template

PRODUCT OR TECHNOLOGY:

COMPANY NAME & ADDRESS

TECHNICAL/ADMINISTRATIVE POINT OF CONTACT (NAME, EMAIL, PHONE)

Description of technology: A bullet list (2‐3) of the primary scientific challenges being addressed, suggested use for technology and mechanism of action.

Picture or Graphic that Illustrates the research or concept (e.g., data figures, molecule illustrations or processes)

Benefits of proposed technology:

Any significant technology development challenges:

Anticipated storage or cold chain requirements:

Current maturity of Technology (TRL):

Timeline of previous accomplishments and future anticipated major goals/milestones

Please check one box only:

Confidential information for government use only

Publicly release information

Addendum 2 BIDS Instructions

THIS PAGE IS INTENTIONALLY LEFT BLANK. PLEASE SEE THE PRESENTATION BELOW.

Medical Technology Enterprise Consortium

MTEC BIDS REGISTRATION

MTEC BIDS URL:

HTTPS://ATI2.ACQCENTER.COM/ATI2/PORTAL.NSF/START?REA

DFORM

https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm

BIDS New Registration

Select “New Registration” from the home screen.

Select “Submitter”.

BIDS Registration: Complete the registration form. Be sure to select how you want to receive the dual factor verification code (SMS text message is recommended).

Select “Submit Registration” to complete BIDS registration.

BIDS registration is instantaneous. It does not require any verification by the MTEC team. After successfully registering, you can submit proposals to any open MTEC RPP.

• MTEC Membership will be verified once a proposal is received and after the proposal deadline.

• Updates to submitted documents can be made anytime prior to the due date and time.

• MTEC RPP links will be opened, within BIDS, at least two weeks prior to the submission deadline.

Please note: For RPPs that are two stages (i.e. White Paper to Full Proposal) only the account that submitted the stage 1 proposal (the White Paper) will be allowed to submit for stage 2 (the Full Proposal), if selected.

ALL PROPOSALS MUST BE SUBMITTED BEFORE THE SUBMISSION

DUE DATE AND TIME. LATE PROPOSALS CAN NOT BE ACCEPTED.

MTEC BIDS PROPOSAL

SUBMISSION

MTEC BIDS URL:

HTTPS://ATI2.ACQCENTER.COM/ATI2/PORTAL.NSF/START?REA

DFORM

Proposal Submission BIDS

Navigate to the MTEC BIDS site and login. After login select the “MTEC BIDS Home” link.

Login to your BIDS Account.

Then select the

“MTEC BIDS

Home” link

Select the “Respond to RPP” link under the submitter tools

Click the link to respond to an RPP.

RPP information is provided in this section. This includes status updates.

Once logged in, your username will appear here.

Select which RPP you will be responding to.

Select which RPP to respond

to. If multiple RPPs are open, they will be listed here.

Complete the submission form.

Shows remaining time before submission close.

Select the technical area your submitting to as identified in the RPP.

Complete the submission form by uploading the required documents and click submit.

Upload documents in this section.

Once the submission form is completed select submit.

Once you have successfully submitted a proposal, you will receive a notification with your submission number (ex.

MTEC-23-24-Everest- 045).

Please note: For RPPs that are two stages (i.e. White Paper to Full Proposal) only the account that submitted the stage 1 proposal (the White Paper) will be allowed to submit for stage 2 (the Full Proposal), if selected.

ALL PROPOSALS MUST BE SUBMITTED BEFORE THE SUBMISSION

DUE DATE AND TIME. LATE PROPOSALS CAN NOT BE ACCEPTED.