Funding Opportunity #6
Beyond the Needle
What is Beyond The Needle?
Current vaccinations and therapeutics, involving injection of a liquid form via needle and syringe, place a tremendous burden on the healthcare system and supply chain, especially during a pandemic. Beyond the Needle is developing alternative technologies that aim to transform the paradigm making vaccines and therapeutics easier to administer and more widely available, without the need for needles, syringes, vials, and cold-chain distribution burdens.
Vision
A world in which needles are no longer the default choice for vaccination or drug delivery.
Mission
Transform vaccination and other drug delivery by helping bring new technologies into market that offer alternative routes of administration so that needles and syringes are no longer the default modality, making them easier to administer, in a broader range of settings, without the need for needles, syringes, vials, and cold-chain transport. Beyond the Needle specifically aims to:
- Overcome the logistics burdens associated with manufacturing, storing, shipping and distributing needles, syringes, and other ancillary supplies, and also with cold-chain storage and transportation
- Increase immunization compliance, with pain-free, easier (possibly self-) administration and dose sparing for single-dose efficacy (vs. multiple boosters)
- Make vaccine more widely available, especially in resource-constrained settings and during a pandemic or other public health emergency where qualified healthcare professionals are in high demand and short supply
Strategy
Help bring new technologies into the market that will replace the needle and syringe as the default modality. This includes technologies that:
- Use alternative delivery routes such as oral (swallowed, buccal, sublingual), inhaled (intranasal), transdermal, and implant (subcutaneous).
- Involve simplified logistics that facilitate easier deployment and uptake, and
- Enable administration without a trained healthcare professional.
Program FAQ
Learn more about the Beyond the Needle program by checking out our frequently asked questions
Is this Funding Opportunity open to academics or do only companies qualify?
It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions .
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Can companies/universities outside of the United States apply for DRIVe funding?
Yes. Applicants from outside of the United States are eligible to apply for funding.
Do academic institutions also need to provide a 30% cost share?
Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference).
Currently, none of the DRIVe partners under the DRIVe EZ-BAA have been awarded a contract that does not include a cost-share component below range, including all universities and non-profit organizations.
Cost-share may be in-kind or cash contributions. It may also come from a third-party investor/sponsor, however, it is up to you to ensure you receive their contribution toward the proposed project. Many organizations offer to cover Overhead or Fringe Benefits. Some also offer pro-bono labor hours or sponsored equipment, materials, or subcontractor costs.
A combination of all of the above could be acceptable. It would need to be indicated on a submission what is being cost-shared. To qualify for no cost-share under an EZ-BAA award, a respondent must show that there is “no probability that the respondent will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303.” Examples of present or future benefits include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market, and use of background knowledge in future contracts.
What are the data sharing requirements of this program?
Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.
The EZ-BAA application is so short. Can I include links to figures or references?
While you can include links to figures or references, it is not mandated that reviewers view that outside information. At this time, the abstract format does not accept any figures, only text.
Beyond the Needle Partners
Esperovax
Enesi Pharma
Vaxess Technologies Inc
MIT Langer Lab
University of Connecticut
Infectious Disease Research Institute (IDRI)
VxBiosciences
US Biologic
Verndari, Inc.
The Beyond the Needle program has or is currently supporting nine programs in different stages of development.
See our Portfolio of Partners
Submit your EZ BAA Abstract
For more information, please contact us at BeyondTheNeedle@hhs.gov
DRIVe (Division of Research, Innovation, and Ventures) was established by the Biomedical Advanced Research and Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS).
Aidar Health Inc
Evidation Health
Empatica
Biobeat
Dascena
Emory University
Current Health
Rizlab Health
Janus-I Sciences
Experovax
InnaMed
Sentien Biotechnologies
Qvella
Spire Health
President and Fellows of Harvard College
Enalare Therapeutics Inc.
Medicinova
Prenosis
Enesi Pharma
Inflammatix, Inc
Cytovale
Stanford Medicine
Partner Therapeutics
Vaxess Technologies Inc
MIT Langer Lab
END SEPSIS
University of Connecticut
Beckman Coulter
Trustees Of Columbia University
CVS Health Clinical Trials
Charles Stark Draper Laboratory, Inc.
Infectious Disease Research Institute (IDRI)
VxBiosciences
Clarivate
US Biologic
MIT Lincoln Laboratory
Advanced Animal Diagnostics
PeraHealth
BioAegis
EnLiSense
Sepsis Alliance
Immunexpress
Sonica Health
Sound Life Sciences
General Electric Research
University of California San Diego
Verndari, Inc.
Vital Connect, Inc.
FirstString Research, Inc.
https://drive.hhs.gov/beyondtheneedle.html
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