Understanding NIH: Drinking from the Fire-hose Rosemarie Hunziker, - - PowerPoint PPT Presentation

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Understanding NIH: Drinking from the Fire-hose Rosemarie Hunziker, - - PowerPoint PPT Presentation

Understanding NIH: Drinking from the Fire-hose Rosemarie Hunziker, PhD Tissue Engineering/Regenerative Medicine and Biomaterials Program Director National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institutes of


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Understanding NIH:

Drinking from the Fire-hose

Rosemarie Hunziker, PhD

Tissue Engineering/Regenerative Medicine and Biomaterials Program Director National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institutes of Health (NIH) hunzikerr@mail.nih.gov 301-451-1609

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  • What New in the Zoo:

− NIH − NIBIB

  • Finding your NIH Niche

− Each IC has a unique character − Get help from the inside

  • Writing Competitive Grants

− Organize your team and plan − Specific Aims are the bedrock − Make reviewers your advocates

TODAY’S AGENDA:

HOW TO SUCCEED AT NIH

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  • What New in the Zoo

− NIH

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NIH “hot topics”

Source: http://www.nih.gov/about/director/budgetrequest/fy2016_directorsbudgetrequest_slides.pdf

  • Precision Medicine Initiative
  • Discovery Science

− BRAIN Initiative − Microbiome and health − Stem Cell Technology (tissue chips, regenerative medicine) − New Vaccines (Ebola, Flu, HIV…)

  • Translating discovery into health

− Antimicrobial Resistance

  • national database of germ genomes
  • prize for better diagnostics (w/BARDA)
  • antibiotics and vaccines

− Alzheimer’s Disease

  • basic research
  • epidemiology for risk/protective genes
  • early diagnosis and progression

− Accelerating Medicine Partnership (Alzheimer’s, type 2 diabetes, lupus, rheumatoid arthritis)

  • Preparing a diverse and talented biomedical research

workforce

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http://www.nih.gov/precisionmedicine/

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The human brain has 1011 neurons, each connected to 104 other neurons. Sitting on your shoulders is the most complicated object in the known universe. http://braininitiative.nih.gov/

NIH and the BRAIN Initiative

  • Goal: revolutionary new dynamic picture of the brain

showing individual cells and complex circuits

  • Foundations: genome sequenced, CLARITY, fMRI, other high

resolution tools

  • Planning: BRAIN 2025: A Scientific Vision
  • Funding: $46M (FY14), $85M (FY15), $135M+ (FY16) (requested)

through targeted initiatives (basic neuroscience, classification of

circuits, recording and modulating—non-invasively)

  • Others: DARPA, NSF, FDA, IARPA
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Stimulating Peripheral Activity to Relieve Conditions (SPARC)

First Call:

RFA-RM-15-002: Exploratory Technologies to Understand the Control of Organ Function by the Peripheral Nervous System for SPARC (U18)

12 awards

  • Urinary tract, spleen, cardiovascular, upper

airway, gastrointestinal tract

  • Approaches
  • Electrical interfaces
  • Viral and optogenetics
  • 3D imaging tools
  • Transgenic/animal models
  • Organoids
  • Ultrasound/infrared modulation
  • Microfluidic/wireless devices
  • elucidating autonomic and sensory control of internal organ

function for effective, minimally invasive neuromodulation therapy

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Trans-NIH Programs

http://commonfund.nih.gov/

Health Economics Single Cell Analysis Gulf Oil Spill Human Microbiome Protein Capture

Early Independence New innovators Pioneers Transformative R01s

Bioinformatics and Computational Biology Genotype- Tissue Expression Library of Integrated Network- Based Cellular Signatures (LINCS) Science of Behavior Change Global Health HCS Research Collaboratory Epigenomics 4D Nucleome Gabrielle Miller Kids First Illuminating the Drugable Genome Molecular Transducers of Physical Activity Stimulating Peripheral Activity to Relieve Conditions (SPARC) Biomedical Workforce NIH Workforce Diversity Big Data to Knowledge Metabolomics Undiagnosed Diseases

Common Fund

Transformative – Catalytic Synergistic – Unique Cross-cutting

Glycoscience Regulatory Science Nanomedicine Knockout Mouse Phenotyping High-risk Research

* * * * *

= watch for new initiatives

*

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NIBIB

(46 = 4.2%)

NIDCR

(35 = 3.5%)

NIAMS

(33 = 1.7%)

NHLBI

(65 = 1.2%)

NIDDK

(32 = 1.1%)

NINDS

(23 = 0.7%)

NEI

(11 = 0.7%)

NHGRI

(1 = 0.5%)

“Biomaterials” in the NIH Portfolio

(by percent of total investment, FY14) Total Awards

< 0.5% = NIDCD(4), NIGMS(21), NCI(32), OD(1), NIEHS(3), NCATS(3), NIMH(11), NIAID(11), NIA(5), NICHD(3), FIC(1), NIAAA(0), NIDA(0), NLM(0), NIMHD(0), NINR(0), NCCAM(0)

NIH average 0.5%

** *** **** ** * * = > 2% (NIH average) in

Regenerative Medicine

* = 341

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integrating the physical and engineering sciences with the life sciences to advance basic research and medical care support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, training of basic and clinical scientists for this improve oral, dental and craniofacial health through research, training, and dissemination of health information

Sample IC Mission Statements

NHLBI NIDDK NIBIB NIDCR NIAMS

medical research, training and dissemination of science- based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases

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  • What New in the Zoo

− NIBIB

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There are two kinds of scientific revolutions, those driven by new tools and those driven by new concepts… The effect of a concept- driven revolution is to explain old things in new ways. The effect

  • f a tool-driven revolution is to discover new things that have to

be explained.

  • Freeman Dyson, 1997
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the NIBIB distinction…

  • Technology development
  • Enabling tools/approaches

It’s not enough to be UNIQUE… you must also be USEFUL.

Featured Mechanisms

  • Bioengineering grants (EBRG, BRG, BRP)
  • Biomedical Technology Resource Centers (P41)
  • Quantum grants

Featured Programs

  • Pediatric Research using Integrated Sensor

Monitoring Systems (PRISMS)

  • Multiscale Modeling Consortium
  • Point-of-Care Technologies Research Network
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  • Biomaterials
  • Biomedical Informatics
  • Delivery Systems & Devices for Drugs

and Biologics

  • Image-Guided Interventions
  • Image Processing, Visual Perception and

Display

  • Integration of Implantable Medical

Devices

  • Magnetic, Biomagnetic and Bioelectric

Devices

  • Magnetic Resonance Imaging and

Spectroscopy

  • Mathematical Modeling, Simulation and

Analysis

  • Micro-Biomechanics
  • Micro-/Nanosystems & Platforms
  • Molecular Imaging
  • Nuclear Medicine
  • Optical Imaging and Spectroscopy
  • Rehabilitation Engineering
  • Sensors
  • Surgical Tools, Techniques & Systems
  • Synthetic Biology for Technology Development
  • Telehealth
  • Tissue Engineering
  • Ultrasound: Diagnostic & Interventional
  • X-ray, Electron, and Ion Beam

Scientific Program Areas

Creating Biomedical Technologies to Improve Health

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NIH Bioengineering Program Announcements

  • PA-12-284: Exploratory/Developmental Bioengineering

Research Grants (EBRG) (R21) early and conceptual stages of new exploratory and developmental research that may involve considerable risk but may lead to a breakthrough

  • PA-13-137: Bioengineering Research Grants (BRG) (R01)

integrated, systems approach to basic and applied multi- disciplinary research that addresses important biological, clinical or biomedical research problems

  • PAR-14-092: Bioengineering Research Partnerships (BRP)

(R01) team approach to basic, applied, and translational multi- disciplinary research to establish a robust engineering solution to a biomedical problem

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BioTechnology Resource Centers (P41)

  • Strong foundation of Technology Research & Development (TR&D) Projects

− national/international impact − innovative, cutting-edge − complex, multidisciplinary − high-risk test beds leading to practical tools

  • Driven by needs of the field through robust Collaborative Projects (CP)

− dynamic, push-pull relationships

  • Deploying results via Service Projects (SP)

− geographically diverse − technology push − exploit more mature capabilities of the Center

  • Committed to training practitioners
  • Aggressive dissemination

– research papers, reviews – patents – presentations, workshops – website(s)

  • Seamless Oversight

– senior scientist to “herd cats” – experienced TR&D Leaders – Scientific Advisory Board – institutional Support

TR&D project TR&D project TR&D project CP SP A D M I N I S T R A T I O N CP CP CP CP CP CP CP SP SP SP SP SP

P41 Components & Structure

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NIBIB’s Quantum Grants: Medical Moonshots

  • profound impact
  • prevent/diagnose/treat a major disease
  • technology development
  • 12 years (4 year grant, twice renewable)
  • deliverable-focused, milestone-driven
  • $1M direct costs per year
  • due dates: January 26, 2016 and 2017

(PAR-15-031)

Current projects:

  • Point-of-care Microfluidics for Early Detection of Cancer (Mehmet Toner)
  • Influenza vaccine using a microneedle patch (Mark Prausnitz)
  • Optimizing Cardiovascular Device Thromboresistance for Eliminating Anticoagulants (Danny Bluestein)
  • Neurovascular Regeneration (Karen Hirschi)
  • Building an Implantable Artificial Kidney (Shuvo Roy)
  • One Stop Shop Imaging for Acute Ischemic Stroke Treatment (Guang-Hong Chen)
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Pediatric Research using Integrated Sensor Monitoring Systems

  • wearable, non-invasive sensors to detect/monitor

(U01) − environmental exposures − physiological signals − activity − behavior in a natural environment

  • wireless, plug-and-play interface to informatics

platforms (U24) − processing − visualization − secure uploading

  • coordination and integration Center (U54)
  • Sensor-based, integrated monitoring

to empower epidemiological studies

  • f asthma in the pediatric population
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Multiscale Modeling

  • Spanning scales from molecular to population
  • Mechanistic integration of biological processes
  • Predictive in biological, biomedical and environmental systems
  • Encompasses concepts of space, time and state

Thanks to Peter Hunter

Genes, mRNA Cell Tissue Organism Organ Proteins, Lipids, Carbohydrates Population

30,000+ genes 100,000+ proteins 12 organ systems 1 body 200+ cell types 4 tissue types 102 - 106 people

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IMAG Funding Opportunity - PAR 15-085:

Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental and Clinical Research (U01)

  • next generation cutting edge multiscale models – think out of

the box

  • 7 Participating Agencies: NIH, ARO, DOE, FDA, NASA, NSF, and

ONR

  • 9 receipt dates until: September 29, 2017
  • Cooperative Agreement allows investigators to contribute

funded efforts to the MSM Consortium

Interagency Modeling and Analysis Group

Greater than the sum of its parts

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  • Finding your NIH Niche

− Each IC has a unique character − Get help from the inside

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Different Agencies: Different Cultures

Research Development

Spectrum of support

Entrepreneurial Experienced

PI/Team Qualifications

High Risk High Feasibility

Probability of success NSF NIH DARPA

basic applied

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NIH FY15 Budget

NIH Divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers), with <4% allocated to trans-NIH initiatives. About 85% distributed via Extramural grants, contracts, cooperative agreements

Total = $30.4 B

NCI NIAID NHLBI

NIGMS NIDDK NINDS NIMH OD NICHD NIA NIDA

NIEHS NEI NIAMS NHGRI NCATS NIDCR NIAAA NIDCD NIBIB NLM NIMHD NINR

NCCAM FIC

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Targeting IC Priorities: an example

accelerating the application of biomedical technologies… [via] integrating the physical and engineering sciences with the life sciences to advance basic research and medical care.

NIBIB mission NINDS mission

seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Novel polymer scaffold for tissue regeneration Pivotal large animal studies for stroke therapy Neural progenitor cells in biomimetic matrix in rat brain

???

Imaging cells transplanted to the brain

???

Neural differentiation

  • f stem cells
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Need Help with Your Proposal… Who Ya’ Gonna’ Call?

 about the scientific and technical aspects of your application… Program Director  for questions during the review… Scientific Review Officer  for help with the business aspects of a proposal… Grants Specialist

  • Find them on the solicitation
  • See also the IC’s programmatic descriptions

(http://www.nih.gov/icd/index.html).

  • Listed on the eRA Commons link to your

submitted proposal

  • See also the review group rosters at the

CSR web site

  • Listed on the eRA Commons link to your

submitted proposal

  • See also the IC’s programmatic descriptions

(http://www.nih.gov/icd/index.html).

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NIH Program Officials: your primary

contact

Pre-Application

  • Assess the “fit” to the IC, Program(s)
  • Start the conversation early: develop

your ideas together

  • Choose the right activity/mechanism
  • Brief on Review Issues: Dos/Don’ts

Application Award Review Post Review

  • Analyze the Summary Statement:

deeper insights from the Review

  • Understand the rating and assess the

likelihood of funding

  • BEWARE! Nothing is certain until you

have it in writing

During the Award

  • Discuss problems in execution

(rebudgeting, re-scoping, extensions…)

  • Find an administrator to address

unusual issues

  • Brag about important discoveries

Anytime

  • Arrange introductions so you can

serve on advisory boards, workshop panels, etc.

  • Discover what’s New and Coming

Soon in Funding Opportunities

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Does NIH Already Support My Interest Area?

http://report.nih.gov/quicklinks.aspx

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NIH Searchable Databases Contain Abstracts of All Funded Projects

Search by

  • MESH terms
  • Key words
  • Organizations
  • States
  • Investigators
  • Mechanisms
  • Solicitations
  • Institutes
  • Investigators
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https://loop.nigms.nih.gov/index.php/2012/12/03/how-to-use- reporter-when-preparing-new-grant-applications/

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Grants: A to Z

http://grants.nih.gov/grants/oer.htm

Grant Basics Funding Initiatives Due Dates, Templates

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  • Writing Competitive Grants

− Organize your team and plan − Specific Aims are the bedrock − Make reviewers your advocates

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Planning Meeting Output: Blueprint for Successful Research

Project Title: really a quick summary Principal Investigator(s) and Key Personnel: defines role, commitment Overall goal: resolve an important issue in a timely manner Specific goal: best stated as a hypothesis (a boastful claim, substantiated by data) Impact: 2-3 sentences, define success, distill innovation and significance RESEARCH Responsibilities, Costs, Milestones and Timeline

  • 1. Validate the … (THIS AIM MUST WORK—i.e. no/low risk here!)
  • 1a. Compare… confirm…
  • 1b. Optimize the dose/time course…

Overseer Cost Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8

  • 2. Elucidate the mechanism… (May omit for high risk (e.g. R21) grants.)

2a. 2b. 2c.

  • 3. Assess the biocompatibility of … in a …

* * High-risk element. Propose and discuss alternatives. Decision point.

(Transition to next grant.)

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SPECIFIC AIMS Page: Formula for Success

  • 1. Outline an important medical problem and your timely,

innovative solution. Describe the big picture quantitatively. How can

science/engineering help?

  • 2. Define the challenge for this application. What is your specific

target and hypothesis? How will you get there? How do you know?

  • 3. State each of your (three) Specific Aims in a single sentence in

bold face. Then, identify strategies, methods, assays to be used, and data expected.

  • 4. Overview the competencies of the team and the resources.

Why is this the right group at the right place and time? Outline your specific skill sets.

  • 5. What happens when you succeed? What are the next steps?

How will paradigms shift or treatment change, and what will this project contribute?

Significance – Innovation – Investigator(s) – Approach – Environment

Tell your story in five compelling, concise, plain-language paragraphs!

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"Simple can be harder than complex. You have to work hard to get your thinking clean to make it simple. But it's worth it in the end, because once you get there, you can move mountains."

“Everything should be made as simple le as possib ible, le, but not simpler.”

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How to Win Over the Peer Reviewers

  • Own impact: tackle an important and difficult problem

− engineers beware: lead with an urgent issue, NOT your cool tools/technologies − discovery (basic) science plus technology development (non-hypothesis driven)

  • Hit all Review Criteria on the “Specific Aims” page
  • Balance “the possible” with “the exciting”

− feasibility = most relevant preliminary data + sound, logical pathway − defend assertions with publications (citing reviewers a plus) − inspiration << invention = innovation − short term objectives inform long term goals − milestones > bold, general ideas − experience, expertise count

  • Define success and point to the next grant/activity
  • Good grantsmanship

− limit jargon/acronyms − reinforce (don’t repeat) important ideas − use legible/sensible figures − strategically place an overview as “eye candy” − proofread!

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If you want something in your life you’ve never had, you’ll have to do something you’ve never done.

  • JD Houston
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Take Home Messages

  • Monitor Institute websites and the NIH

Guide (http://grants.nih.gov/grants/guide/)

  • Get to know the Program Director(s) for

your scientific area and discuss your ideas

− Fit with institute mission and priorities − Best grant mechanism or program − Best study section for review

  • Participate in workshops and symposia

− Get fresh ideas and directions for your research − Become known to your peers (i.e. reviewers)

  • Participate in review of grant applications

(serve on study sections)

Lots of directions and opportunities at the NIH

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Step #1: Do your homework; learn a bit about the grant process and the

  • ptions.

Step #2: Contact us because… We’re from the Government, we’re here to help you!

Path to Success at NIH

Office of Extramural Research: Basics - http://grants.nih.gov/grants/grant_basics.htm Overview - http://grants.nih.gov/grants/grants_process.htm IC priorities: http://www.nih.gov/icd/index.html NIH Guide Provides Weekly Updates on Funding Opportunities: http://grants.nih.gov/grants/guide/ NIH RePORTer – lots of statistics and abstracts of funded grants http://report.nih.gov/

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Do science because you can’t imagine doing anything else, and enjoy the ride. No one said it would be easy, only wild.

  • Doug Green
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Rosemarie Hunziker, PhD

Program Director Tissue Engineering/Regenerative Medicine Biomaterials National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institutes of Health (NIH) 301-451-1609 Rosemarie.Hunziker@nih.gov www.nibib.nih.gov

Creating Biomedical Technologies to Improve Health