stimulating peripheral activity to relieve conditions (sparc) foa... · 2017-04-04 · stimulating...
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Stimulating Peripheral Activity to Relieve Conditions (SPARC)
Informational Webinar for RFA-RM-17-009
Technologies to Understand the Control of Organ Function by the Peripheral Nervous System
March 27, 2017
Features of NIH Common Fund Programs
Address important challenges/obstacles in biomedical research, and/or capitalize on emerging scientific opportunities where strategic investment can have an impact
Are catalytic: Programs must achieve a defined set of high impact goals within 5-10 years
Are goal-driven, with progress measured against concrete milestones
Promote the missions of multiple NIH Institutes and Centers (ICs)
Can require a high level of coordination
Each Common Fund program addresses unique scientific needs and opportunities, and so each program has a unique implementation plan driven by the science.
NIH Common Fund Programs
New Types of Clinical PartnershipsData/Tools/Methods
New ParadigmsTransformative Workforce Support
Illuminating the Druggable Genome
Glycoscience
Enhancing the Diversity of the NIH-Funded
Workforce
RegulatoryScience
Human Microbiome
Pioneer AwardsNew Innovator AwardsTransformative Research AwardsEarly Independence Awards
Genotype-Tissue
Expression
Library of Integrated Network-
Based Cellular Signatures
(LINCS)
Science ofBehaviorChange
Global Health
Big Data to Knowledge
(BD2K)
HCS ResearchCollaboratory
High-RiskResearch Common Fund
Health Economics
Epigenomics
Undiagnosed Diseases Network
Extracellular RNACommunication
Strengthening the Biomedical Research
Workforce 4D Nucleome
Gabriella Miller Kids First
Molecular Transducers of
Physical Activity in Humans
Metabolomics
SingleCell
Analysis
Knockout Mouse
Phenotyping
NIHCenter for
RegenerativeMedicine
Protein Capture
Stimulating PeripheralActivity to Relieve
Conditions (SPARC)
Recent FDA Market Approvals
Inspire EnteroMedics -Maestro
Medtronic - InterStim
BioControls - CardioFit MetaCure - Diamond
Boston Scientific - Vessix
Many randomized controlled trials miss their prespecified primary efficacy endpoints
Boston Scientific NECTAR Trial (Vagal Nerve Stimulation, Heart Failure)BioControls INOVATE Trial (Vagal Nerve Stimulation, Heart Failure)Medtronic SYMPLICITY (Renal Denervation, Hypertension) CVRx® Rheos (Baroreflex Activation Therapy)Apnex (Hypoglossal Nerve Stimulation, Sleep Apnea)St. Jude BROADEN Trial (DBS Area 25, Depression)Medtronic RECLAIM Trial (DBS Ventral Capsule/Ventral Striatum, Depression)Medtronic SANTE Trial (DBS ANT, Epilepsy)
Common Themes:followed successful open label studieslarge sham arm effectremarkable response in some patients
Autonomic Nervous System
Furness 2006
SPARC - Stimulating Peripheral Activity to Relieve Conditions
Opportunity: Neuromodulation of organ function holds promise in treating many diseases.
Challenge: The mechanisms of action for neuromodulation therapies remain poorly understood.
Program Goals: Provide a scientific foundation that enables better understanding of the neural control of organ function, spurring development of the next-generation of therapeutic closed-loop neuromodulation devices.
~$238 million investment over 7 years
SPARC Components
SPARC1 Anatomical and Functional Mapping of the Innervation of Major Internal OrgansAnatomical and functional neural circuit maps for multiple major organsNovel electrode designs, surgical procedures, and stimulation protocols
SPARC2 Next Generation Tools and Technologies Novel and adapted technologies to define PNS control of organ functionNext generation neuromodulation therapies
SPARC3 Use of Existing Market-Approved Technology for New Market Indications New indications for existing, approved devicesNew therapeutic opportunities and methodologies
SPARC4 Data Resource Center (Data Coordination, Mapping, and Modeling)Public data resource containing SPARC dataIntegrated, predictive, anatomical, and functional neural circuit maps
SPARC Components
ANATOMICAL & FUNCTIONAL
MAPPING
NIDDKTRANSLATIONAL PARTNERSHIPS
NCATSDATA & RESOURCE
CENTER
NIBIB
TECHNOLOGY DEVELOPMENT
NIBIB/NINDS
SPARC Program Manager and Staff set overall vision and make adjustments
Other Transactionshttps://commonfund.nih.gov/sparc/OtherTransactions
Unique funding mechanism that is neither a grant, cooperative agreement, nor a contract
Funding Announcement
• Publication on the SPARC website and/or Grants.gov• Encourages nontraditional partners
Review
• Interactive discussion with Program staff• New reviewer voices• Selection of pieces of a proposal• Reviewer input considered by the SPARC Program Manager in
award selection
Award Management
Awarded activity can be:• Expanded• Modified• Partnered• Not supported• Discontinued
Based on: • Program needs• Emerging methods• Technologies or approaches• Availability of funds
SPARC TimelineM
APPI
NG
TOO
LSTR
ANSL
ATIO
NDA
TA
2015
3
New Tools (exploratory)
2016
22
Build public-private partnerships
2017
Maps 1.0
42
New tools (specific, need-driven)
“Next gen sharing”
2018
Leverage public-private partnerships for human functional mapping
47
2019
46
Maps 2.0
2020
42
2021
38
SPARC Snapshot, March 2017M
appi
ngTr
ansla
tion
Comprehensive (Shivkumar/UCLA)Auricular branch of vagus (Napadow/MGH)
Comprehensive (Bolser/U FL)Pulmonary neuroepithelial cells (Sun/UCSD)
Superior Cervical Ganglion(Lewis/Case Western)
Canning (Hopkins)/NuviantSynapse VNS for asthma
Comprehensive (Powley/Purdue)
Chen (Hopkins)/Boston SciSCS for gastric motility
Comprehensive (Howard/Toledo)Transcriptome (Southard-Smith/Vanderbilt)
Enteroendocrine cells (Shen/Duke)
Foundational maps (Keast/Melbourne)
ETC
Pancreas (Campbell-Thompson/U FL)Spleen (Campbell-Thompson/U FL)
Adipose tissue (Muenzberg-Gruening/Pennington; Zeltser/Columbia)
Yin (Transtimulation)/CVRxVNS for diabetes
Tool
s
Cardioneural mapping Electrodes (Ardell/UCLA)
Intrafascicular nanowire(Durand/Case)
Rabbit OSA model(Strohl/CWRU)
Ephys/IR mapping(Horn/Pitt)
Implantable gastric platform(Farajidavar/NYIT)
Ultrasound modulation(Okusa/UVA)
Mouse lines for ENS study(Howard/Toledo)
Human GI organoids(Wells/Cinncinnati)
Conformal bladder electronics(Gereau/WashU)
Bladder monitoring(Damaser/Cleveland Clinic)
Spinal root interface (Bruns/U Mich)
Viral bladder tools(Davis/Pitt)
Optical prove(Weir/U Colorado)
Viral tools(Vulchanova/UMN)
Data TBD TBD TBD TBD – APPLY!
SPARC1 – Neurocardiac CircuitryShivkumar – UCLA
Shivkumar group, UCLA Ardell et al 2016 J Physiol
SPARC2 – Miniature Multiphoton MicroscopeWeir – U Colorado
http://dx.doi.org/10.1364/OL.40.002553
Preliminary device
Cells in volume: > 200
Cells in volume: > 20049
0 μm
250 μm
Current design
Collaboration with Prof. Diego Restrepo, Department of Cell and Developmental Biology, Director Center of Neuroscience
SPARC2 – Funding Opportunities
Technologies to Understand the Control of Organ Function by the Peripheral Nervous System
• RFA-RM-17-009 (OT1, a.k.a. ”pre-application”)
• RFA-RM-17-010 (OT2, a.k.a. “application”)
• Quarterly OT1 receipt dates – first date is May 1, 2017
• Applicants whose OT1 pre-applications are found to be meritorious and programmatically relevant will be invited to submit a full OT2 application
• OT2 applications are invitation-only
Priorities
https://commonfund.nih.gov/sparc/FOAprioritiesVary for each OT1 receipt date
Posted online two months before each OT1 receipt date
May 1, 2017 PrioritiesImaging & Targeting
• Example: Fascicular tracing/targeting (biochemical, surgical, and/or viral)
Modeling & Simulation
• Example: Computational models to assess safety limits of stimulation and/or blocking of neural activity
Surgical • Example: Real-time in-vivo methods to determine if the PNS is damaged during surgery
Neural Interfacing
• Example: Biosensors to detect end-organ function biomarkers
Application Process
Discuss
• Optional, but encouraged discussion with SPARC program staff
OT1 application
• Email six-page OT1 application by receipt date in RFA-RM-17-009
• Must propose to address a Priority listed for this receipt date
Feedback
• We will provide feedback on your OT1 application
• Some applications will be invited to submit an OT2 application
Discuss
•Required discussion of feedback with SPARC program staff
OT2 app
•Invitation specifies deadline and other requirements
•Follow RFA-RM-17-010 to submit OT2 application to Grants.gov
Negotiate
•SPARC will negotiate budget, benchmarks, and deliverables with selected applicants
Award
•NIH will award an Other Transaction Award (OT2) after successful negotiation
OT1 Pre-application
This is not a typical NIH grant application
Cover Page (up to one page)Project Summary (up to one page)• Not a traditional Specific Aims page• Outline of project including objective, major tasks, milestones/benchmarks, timeline,
and deliverables. How do deliverable(s) address current SPARC Priorities?
Development Strategy (up to three pages)• Impact and Significance• Preliminary Data (not required)• Risk Analysis (optional for OT1)• Tasks, Benchmarks, Timeline, and Deliverables (go/no-go)• Key Personnel & Experience• Budget (high level)• Resource Sharing Plan
Bibliography (up to one page)
Evaluation
Innovation is not a scored criterion
SPARC uses objective review
Relevance and Justification
Benchmarks and Deliverables
Expertise
Resource Sharing Plans
NOT Responsive
Major deliverables which are not new technologies
Development of tools solely justified by a treatment or therapeutic strategy
Deliverables which are outside the SPARC Priorities for the receipt date
Study of organs in a diseased state
Tools and techniques to neuromodulate sensory organs of the head, named voluntary muscles, and the central nervous system above the spine
Data and Resource Sharing
Before applying, read the Material Sharing Policyhttps://go.usa.gov/xX8Hh
Funded projects will be required to make SPARC-developed technologies available to other projects in the consortium, and more broadly to the research community
Read the Funding Opportunity Announcements
SPARC is mission-drivenTools must facilitate mapping of peripheral nerve circuits
“Proposals must” vs. “proposals should”Ambiguity may be intentionalIs your concept in scope?Don’t work around restrictions
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≠en.wikipedia.org/wiki/Halter#/media/File:Horse_h
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Advice
Read the funding opportunityBe thorough
Analytical modelsExpected performanceCorner cases
Be specificBe quantitativeJustify
BudgetPeriod of PerformanceMission-relevance
Apis dorsata107.4 ± 13.2 mg unloaded5.4 m/s (from Apis mellifera)
17 mm ± 1 mm
hal.archives-ouvertes.fr/hal-00892251/document
Advice
Be clearWhat has been doneWhat will be doneWhat might be done
Deliverables & benchmarksDon’t distort realityDon’t whitewash risksDon’t waste pagesDon’t be late
Teaming
Multiple investigators are not a TeamIntegratePlan aheadFind weaknessesDebate tradeoffs
www.flickr.com/photos/124961070@N02/14485059353
ASK!
Talk to NIH staff before applying• Use proper channels• Visit http://nihsparc.setmore.com to sign up for virtual office hours• We strongly encourage applicants to discuss concepts with the SPARC team• We will provide feedback on program fit and suggestions on your concepts
aspiringmormonwomen.org/get-involved/
Office of the NIH Director TeamDr. Gene Civillico – Program Manager [email protected] (301) 351-4180Dr. Felicia Qashu – Program Officer, OT Project Manager [email protected] (301) 451-7222Ms. Kristina Faulk – Communications Lead, OT Policy Analyst [email protected] (301) 402-9185
Project Team LeadersBiology Dr. David Saslowsky: [email protected] (301) 594-8876
Dr. Patricia Greenwel: [email protected] (301) 435-1169
Technology Dr. Mike Wolfson: [email protected] (301) 451-4778Dr. Andrew Weitz: [email protected] (301) 451-4778
Translation Dr. Danilo Tagle: [email protected] (301) 594-8064Dr. Siavash Vaziri: [email protected] (301) 594-8921
Data Dr. Vinay Pai: [email protected] (301) 451-4781Dr. Andrew Weitz: [email protected] (301) 451-4778
SPARC Contacts and Resources
[email protected] Questions:
http://nihsparc.setmore.comVirtual Office Hours: