commonfund.nih.gov

Opportunity

The Common Fund's SPARC program seeks to acceleratedevelopment of therapeutic devices that precisely modulateelectrical activity in nerves to improve organ function. SPARCis generating maps and tools to identify and influence thera-peutic targets that exist within the neural circuitry of a widerange of organs and tissues. This therapeutic strategy, alsoknown as “bioelectronic medicine,” could offer new treat-ment options for diverse diseases and conditions such ashypertension, heart failure, gastrointestinal disorders, typeII diabetes, inflammatory disorders, and more.

Challenges

❯ The need to understand specific and diverse peripheralneural signals to/from end-organs and their functional re-lationships

❯ The development of tools, techniques, and translatableanimal models to accelerate research

❯ The need for ongoing partnerships between the NIH, U.S.Food and Drug Administration (FDA), and industry to drivestudies in humans

❯ The creation of predictive multiscale simulations inte-grating functional and anatomical data across varied ap-proaches, models, and organs

Stimulating Peripheral Activity to Relieve Conditions

Bridging the gap to make precision neuromodulation therapies a reality

Program Overview

The SPARC program includes five interdependent compo-nents (SPARC1-5) designed to elucidate the neurobiologyand neurophysiology underlying autonomic control of or-gans in health or disease. Ultimately, SPARC componentswill inform next-generation neuromodulation therapies bysharing the data generated and collected by the programwith the scientific community.

SPARC Components

SPARC1 supports studies in animal modelsand human tissues for mapping innervation ofmajor internal organs and developing compu-tational models that predict organ function withmodulation of a neural target.

SPARC2 supports development of next-gener-ation tools and technologies to improve modu-lation specificity, detection, and monitoring ofnerve activity, and organ function.

SPARC3 supports translational partnershipsbetween industry and SPARC investigators fo-cused on functional neuromodulation in humanclinical studies.

SPARC4 supports the creation of a multi-functional online hub for FA IR (Findable,Accessible, Interoperable, Reusable) data coor-dination, visualization of nerve-organ anatomyand function, online modeling, and predictivesimulations.

SPARC5 supports detailed mapping of the neural circuitry that mediates visceral pain.

commonfund.nih.gov

SPARC Portalsparc-science.org

Advancing bioelectronic medicine through open science

Scan to visit the SPARC Portal

Launched in July 2019, the SPARC Portal is an open-source Web application that provides access to a growing collection of interactive autonomic neuroscience resources.

DataA growing collection of curated SPARC data provides new insights intothe autonomic nervous system and neural control of organ function. Datasets are annotated with common standards, allowing users to performcross-data set comparisons and analyses.

MapsInteractive maps reveal anatomy and functional relationships of the au-tonomic nerves and organs that they innervate. 2D and 3D maps renderspatial dynamics, connectivity, and physiology across a range of speciesand nerve-organ systems.

Virtual StudiesA powerful computing platform called o2S2PARC enables modeling, sim-ulation, data analyses, and visualization directly within your Web brows-er. o2S2PARC supports simulations that predict the effects of autonomicneuromodulation on organ function. A growing list of curated computa-tional studies from various SPARC-funded teams is available for virtualexperimentation on o2S2PARC.

Listserv:NIH-SPARC-INFO@list.nih.gov

Scan to visit SPARC's website

Scan to visit the Common Fund

@GCivillicoNIH and #NIH_SPARC

www.facebook.com/ NIHCommonFund

Contact InformationTo learn more about thisprogram and futureFundingOpportunities, please contact SPARC programstaff: NIH-CF_SPARC@mail.nih.gov.

SPARC-VOX (cleared Jan 2021 counci l )

In phase 2 of SPARC, the program’s mapping focus will narrow tothe human vagus nerve. SPARC-V will create circuit-leveldescriptions of human vagal anatomy and physiology. SPARC-Owill begin pilot efforts toward development of a clinical-grade,modular Open-source neuromodulation platform, empoweringfuture researchers to prove out new therapeutic concepts. SPARC-X will support X-prize-like competitions to incentivizegroundbreaking proof-of-concept demonstrations meetingspecified benchmarks.

NINDS Translational Neural Devices

RFA-NS-18-011 — UG3/UH3 (Clinical Trial Required)• Advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or

neuromuscular systems• UG3 Phase supports non-clinical testing toward obtaining an Investigational Device Exemption (IDE) and/

or Institutional Review Board (IRB) approval for a clinical trial• UH3 Phase supports a small clinical trial to collect safety and effectiveness data required to support a

marketing application or to inform final device design

RFA-NS-18-012 — U44 Small Business Innovation Research (SBIR) Cooperative Agreement (Clinical TrialRequired)• SBIR Fast-Track to support the translation of devices on the verge of clinical trial• Phase I supports translational device activities toward obtaining an IDE and/or IRB approval for a clinical

trial• Phase II supports a small clinical trial

These funding opportunities will be reissued as they have cleared January 2021 council and application due dates will be announced soon.

Program Contact: Nick Langhals, Ph.D., NINDS-Devices@nih.gov

NINDS Translational Devices

Additional NINDS Funding Opportunities for Small Businesses

The Small Business Technology Transfer (STTR) and Small Business Innovation Research (SBIR) programs fund smallbusinesses to perform research and development within the mission of NINDS, including development oftranslational devices. Many of our applications are investigator initiated and come in through the general NIH SBIR/STTR omnibus solicitations. Applicants are encouraged to speak with program staff in advance of applying.

Program Contact: Emily Caporello, Ph.D., emily.caporello@nih.gov

GOAL: Support development, optimization, and translational activities and small clinical studies involving therapeutic and diagnostic invasive or non-invasive devices for disorders that affect the nervous or neuromuscular systems

Next-Generation Invasive Devices

NIH BRAIN Initiative: Next-Gen Invasive Devices for Recording and Modulation in the Human Central Nervous SystemRFA-NS-18-021 — UG3/UH3 Cooperative Agreement (Clinical Trial Required)• UG3 Phase supports non-clinical testing toward filing of an IDE for an SR study or obtaining IRB approval for an NSR

clinical trial• UH3 Phase supports a small clinical trial to obtain critical information necessary to advance recording and/or

stimulating devices to treat CNS disorders and better understand the human brain

RFA-NS-18-022 — U44 SBIR Fast-Track and Direct-to-Phase II Cooperative Agreement (Clinical Trial Required)• Phase I supports non-clinical testing toward obtaining an IDE and/or IRB approval for a clinical trial• Phase II supports a small clinical trial to obtain critical information necessary to advance recording and/or

stimulating devices to treat CNS disorders and better understand the human brain

NIH BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation inthe Human Central Nervous SystemRFA-NS-18-023 — UH3 Cooperative Agreement (Clinical Trial Required)• Supports small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices

to treat CNS disorders and better understand the human brain

These funding opportunities will be reissued as they have cleared January 2021 council and application due dates will be announced soon.

Program Contact: Nick Langhals, Ph.D., NINDS-Devices@nih.gov

BRAIN Initiative Public Private Partnership (PPP) Program• Facilitate partnerships between UG3/UH3 or UH3 applicants and manufacturers• Companies provide technical support and/or devices• Pre-negotiated templates to facilitate collaborative research agreements• Currentlyparticipating companies: Abbott, Blackrock Microsystems, Boston Scientific, CorTec, Medtronic, NeuroNexus,

NeuroPace

GOAL: Support development, optimization, and translational activitiesand small clinical studies involving therapeutic and diagnostic invasivedevices for disorders that affect the central nervous system

Dissemination Support

BRAIN Initiative Research Resource Grants for Technology Integration and Dissemination (U24) RFA-NS-19-006• Milestone driven Award• Cooperative Agreement• Next due date: June 27, 2021• Contact: Natalie Trzcinski (natalie.trzcinski@nih.gov )

Administrative Supplements for BRAIN Initiative Awardees to Support Resource Dissemination NOT-NS-21-014• Supports small dissemination efforts for active BRAIN

awardees• Next due date: rolling submissions through Feb 28, 2022• Contact: Kari Ashmont (kari.ashmont@nih.gov )

Notice of Special Interest (NOSI): Translation of BRAIN Initiative Technologies to the Marketplace NOT-MH-21-125• SBIR/STTR Omnibus/Parent Clinical Trial Not Allowed• Next due date: September 05, 2021• Contact: Margaret Grabb (mgrabb@mail.nih.gov )

Key components :

Pace of disseminationReadiness of resource

for disseminationBroad dissemination

For more information, please contact: Nick Langhals, Ph.D., Blueprint-MedTech@nih.gov

This program has been cleared by NIBIB May 2020 council and application due dates will be announced soon.

Blueprint Neurotherapeutics Program for Medical Technologies

• MedTech is an NIH incubator that aims to bridge this gap by accelerating the development of cutting-edge medical devices to diagnose and treat nervous system and neuropsychiatric disorders.

• Mission: To catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies.

• Program Offerings: Non-dilutive funds and additional pre-clinical, clinical, regulatory, and business development resources and expertise.

National Institute of Neurological Disorders and Stroke (NINDS) Small Business Program

List of Resources

• NINDS SBP homepage and entrepreneurial resources page

• NIH Small Business homepageand resources page

• Confirm small business eligibility and begin required registrations

• Review NIH SBIR/STTR processes and policies

• Determine target application date

• NIH SBIR/STTR timelines

• The NINDS mission space encompasses hundreds of neurological disorders

• NIH RePORTER can show you what has been funded in your technology space, and bywhich IC

• Detailed NINDS Small Business Program Budget Guidance

• NIH Clinical Trial Guidance

• See small business cooperative agreement funding opportunities: NINDS TranslationalPrograms

• NINDS has several resources on rigor available

• Review guidance for scoring and for the overall review process

• View the Center for Scientific Review (CSR) presentation on Advice for SBIR/STTRApplicants

• For guidance on use of hyperlinks see notice NOT-OD-20-174.

• Open Mike blog

• SF424 SBIR/STTR (R&R) Application Guide contains registration and applicationinstructions

• The SBIR/STTR Annotated Form Set provides step-by-step instructions to fill out theapplication

• View sample SBIR and STTR applications

• use the PHS Assignment form to request IC assignment, reviewer expertise, and studysection (optional)

• The eRA Service Desk should be contacted for question related to the application process

• Applicant Assistance Program AAP Webpage

• NINDS Small Business Program priority statement

• NIH SBIR/STTR funding rates are published by year and mechanism

Applicant Assistance Program (AAP)AAP is aimed at helping small businesses apply for Phase I SBIR/STTR funding

AAP provides: Knowledgeablecoaching support for application preparationat no cost

AAP does not provide:A grant writer, smallbusiness registration,technical consulting

•Open to companies that have never received NIHSBIR/STTR funding

•Intended for applicants with little NIH grant writingexperience, limited networks, and sparse access to support

•Diverse applicants highly encouraged to apply

Each participating NIH Institute and Center has afinite number of slots for applicants

Participating institutes:NINDS, NCI, NIA, NHLBI, NCCIH, NCATS, NIEHS,

NINR

For eligible companies developing a Phase I application forSeptember 5th

Submission Portal Opens: April 26, 2021NIH AAP outreach webinar: May 4, 2021 at 12:30 PM ET -register hereNIH AAP Q&A webinar: May 12, 2021 at 2:00 PM ET - registerhereApplications Due: May 20, 2021 at 5:00 PM ET

AAP Webpage

18

National Institute of Biomedical Imaging and Bioengineering National Institutes of Health

SMALL BUSINESS PROGRAM

NIBIB ContactIlana Goldberg 301-402-3465NIBIB-SBIR@mail.nih.gov

Todd Merchak 301-496-8592NIBIB-SBIR@mail.nih.gov

IntroductionThe mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve human health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care.

The NIH Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs award federal research grants and contracts to small businesses conducting biomedical research. These programs invest over $1 billion into health and life science companies that are creating innovative technologies that align with NIH’s mission to improve health and save lives. A key objective is to translate promising technologies to the private sector and enable life-saving innovations to reach consumer markets.

Program StructureBoth the SBIR and STTR are divided into three phases listed below. NIH offersaFast-trackOptionthat allows small businesses to submit one application for Phase I and Phase II; a Direct SBIR Phase II solicitation, which permits small businesses to bypass a Phase I award if they have already proved the feasibility of their technology; and a Commercial Readiness Pilot Program solicitation that can help support commercialization activities. For more information about which solicitation is best suited for your small business, please visit the NIH SBIR/STTR website (https://sbir.nih.gov/funding) and speak to the appropriate SBIR/STTR program manager (https://sbir.nih.gov/engage/ic-contacts).

NIH Review Process Timeline

www.nibib.nih.gov

SMALL BUSINESS PROGRAM

NIBIB Mission: Technology and InnovationResearchAreas of Interest

C3i ProgramThe C3i program is designed to provide medical device innovators with the specialized business frameworks and essential toolsfor successful translation of biomedical technologies from lab to market. NIH-supported researchers are eligible for thisentrepreneurial training program. The curriculum and customized mentoring enhanced preparations for SBIR and STTR applications and position the companies for commercialization success. For more information, please visit the NIBIB websiteat http://www.nibib.nih.gov/research-program/c3i.

Bioanalytical Sensors Image-Guided InterventionsMagneticResonance Imaging

Bio-Electromagnetic Technologies Molecular Probesand ImagingAgentsNuclearMedicineOptical ImagingandSpectroscopy Ultrasound: Diagnostic andInterventional X-ray, electron, andIon Beam

Funding OpportunitiesNIBIB Participates in the following SBIR/STTR omnibus solicitations:

PA-20-260: SBIR [R43/R44] Clinical Trial Not Allowed PA-20-261: STTR [R41/R42] Clinical Trial Required PA-20-262: SBIR [R43/R44] Clinical Trial Required PA-20-265: STTR [R41/R42] Clinical Trial Not Allowed

Information on current SBIR and STTR funding opportunities is available online at https://sbir.nih.gov/funding.

BiochemicalEngineering Bioeletromagnetic Engineering BiomechanicalEngineering Biphotonic Engineering AdaptiveBiomaterial Systems

Bionic SystemsMathematical Modeling, Simulation andAnalysis Robotic SystemsSynthetic Biological Systems

Artificial Intelligence, Machine Learning , and Deep Learning ConnectedHealth-Mobile Health andTelehealth Biomedical InformaticsPoint of CareTechnologies – DiagnosticsImage Processing, Visual Perception andDisplay

For a more detailed description of the NIBIB scientific program areas, please visit the NIBIB website: http://www.nibib.nih.gov/research-funding.

Notices of Special InterestNOT-EB-19-023: Small Business Research in Biomedical Imaging and Bioengneering

www.nibib.nih.gov

NOT-EB-21-001: Small Business Initiatives for Innovative Diagnostic Technology for Improving Outcomes for Maternal Health

NIBIB Resources for Small BusinessesEntrepreneurial Finance for Biomedical Innovators (Video Course): This free video series provides biomedical entrepreneurs with a detailed framework for building a step-wise, validated financial plan. Move beyond the short-term perspective of immediate financing needs to a comprehensive, long-term financial plan to help you increase the probability of success for your venture!

Technical and Business Assistance - Needs Assessment: The TABA Needs Assessment Report provides a third party, unbiased assessment of your program in 10 technical and business areas that are critical to success in the competitive healthcare marketplace.

NIH Innovator Support: The SEED Innovator Support Team is a FREE business resource for small business awardees seeking assistance with commercializing their technology and ensuring success in the market. There are no fixed time commitments or funding required - support is on an "as needed" basis to assist you in your commercialization objectives.

SBIR/STTR Application Process Infographic: Interactive chart that contains helpful information to guide you through the NIH SBIR/STTR application process.

NIBIB ContactsApplicants are strongly encouraged to contact NIBIB sta ff before

submitting an SBIR or STTR application. Additional information can be obtained by sending an e-mail toNIBIB-SBIR@mail.nih.gov.

A biomarker is a defined characteristic that is used as an indicator of normal biologicalprocesses, pathogenic processes or responses to a therapeutic intervention. Biomarkers are recognized as essential tools for the development of therapeutics, allowing improved andbetter-informed clinical trial design through indicators of target engagement and those thatenable patient stratification. In addition, biomarkers can facilitate the evaluation oftherapeutic intervention on disease progression or recurrence.

Current Funding Opportunities:

PAR-19-315 – Discovery of Biomarkers and Biomarker Signatures for Neurological andNeuromuscular Disorders

• Identification and initial clinical validation of biomarker/biomarker signatures;may include development/optimization of the associated detection method

• Phased R61/R33 Research Project

PAR-21-056 (U01) & PAR-21-057 (U44) – Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders

• Establish the detection method performance characteristics and technicalprotocols for measuring a biomarker/biomarker signature for a specifiedclinical Context of Use

• Cooperative Agreement U01 & U44 (Fast-Track SBIR)

PAR-21-058 (U01) & PAR-21-059 (U44) – Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders

• Establish the biomarker/biomarker signature acceptably identifies, measures, or predicts the concept of interest within a defined clinical Context of Use

• Cooperative Agreement U01 & U44 (Fast-Track SBIR)

Program Contact: Carol Taylor-Burds, PhD – carol.taylor-burds@nih.gov

https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Biomarkers

NINDS Biomarker ProgramMission: To facilitate the validation of biomarkers and biomarker signaturesready for use in clinical trials to accelerate therapeutic development and advance patient care.

C-Clinician-scientist

F30C K08/K23C

NINDS K12sC,I

K02C

G-General

F31G

JSPTPN & NINDS T32sG,I

BRAIN F32G

NINDS F32*G

*Eligibility measured from date joined lab

Postdoc K01G

K99/R00G

D-Diversity

F31D

BRAIN K99/R00D

MOSAIC K99/R00D

BP F99/K00D Faculty K01D

Loan Repayment ProgramG

I-Institutional

Re-Entry SupplementsG

Diversity Research Supplements (AD/ADRD, BRAIN, SBIR/STTR, HEAL)D

Diversity, Clinician-Scientist, and General R25 ProgramsC,D,G,I

High School Student Undergraduate Student

Graduate/ Medical Student Postdoc New Faculty

NINDS Extramural Training and Career Development Programs

National Institute of Neurological Disorders and Stroke (NINDS)