Navigating NIH Funding During a Pandemic

Patrick SF Bellgowan, Ph.D.Program Director for TBI

Division of Neuroscience / NINDS / NIH

psfb@nih.gov

Linda Bambrick, Ph.D.Program Director for SCI

Division of Neuroscience / NINDS / NIH

Linda.bambrick@nih.gov

Thank you to the Organizers

Olga N. Kokiko-Cochran, Ph.D. - NNS Council MemberGrace Griesbach, Ph.D. - NNS PresidentSheilah Jewart - - NNS Exec DirectorNNS Leadership

Navigating NIH Funding During a Pandemic

Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH FundingThe NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

This is a rapidly evolving situation and we will provide updated guidance and information as it becomes available.

• There are excellent resources available online, we are here today to answer questions• Focus on NINDS• Links and resources will be made available• Questions welcome

• For general questions regarding COVID-19 flexibilities, contact NIH’s Office of Extramural Research at grantspolicy@nih.gov

• For questions specific to your NIH award, contact the grants management or program staff at the funding institute or center

3

FAQs frequently updated. Check back often!https://grants.nih.gov/policy/natural-disasters/corona-virus.htm

• Extramural staff are working remotely

• We continue to process applications and make awards

• We are conducting peer review meetings virtually

• We are offering administrative flexibilities in response to the effects of the pandemic on research

• We are working diligently to provide funding opportunities to support COVID-19 research

NIH is Open for Business

So you already have an award: progress reports, extensions, carry over requests, allowable expenses, milestones

• Progress report deadlines have not changed, do document any covid-19 pandemic impacts on resources and productivity as well as any foreseeable future challenges

• First year no-cost extensions can be still be automatically granted for awards that allow extensions

• It is possible more awardees will need to request approval for a second NCE—discuss with your program director and this is where documentation of impact in your progress reports may be helpful

• NIH is being flexible with carryover requests, discuss with your PD• NIH is being flexible about allowable expenses, e.g. salaries for staff—but some

administrative flexibilities expire at the end of September, consult your PD and https://grants.nih.gov/policy/natural-disasters/corona-virus/nih-omb-memo.htm

• Any award with milestones, e.g. IGNITE or SBIR will require negotiation with the PD

So you already have an award: and it has a built in timeline

• Fellowships (F-series), Career Development Awards (K-series)

• NIH will be flexible with extending time constraints for fellowship, career

development, and training awards, including phased awards

• Talk to your PD and the NINDS training office

Training officehttps://www.ninds.nih.gov/Funding/Training-Career-Development

So you already have an award: renewals

• PIs of awards, such as R01s, coming up for renewal need to consider whether their research project is best served by a NCE or a competitive renewal application

• For competitive renewals PIs should be aware that the following guidance has been provided to study section reviewers:

Reviewers should assume that problems arising from the COVID-19 pandemic will be resolved and complications related to COVID-19 should not affect their scores. Disregard temporary situations due to the COVID-19 pandemic, e.g. temporary declines in productivity, availability of key personnel, proposed patient populations, animal facility shutdowns, etc.

Guidance for peer reviewershttps://grants.nih.gov/sites/default/files/Coronavirus-update-Additional-Guidance-for-Peer-Reviewers.pdf

NIH has implemented a special exception to allow preliminary data as post submission materials beginning with due dates/on/after May 25, 2020:

• Preliminary data must be submitted 30 days before the study section meeting• AOR concurrence required• One page of preliminary data will be accepted for single component

applications or for each component of a multi-component application• Funding opportunity must allow preliminary data (i.e. does not explicitly

indicate preliminary data is not allowed)• Post-submission materials will not be accepted for applications for emergency

competitive revisions and urgent competitive revisions which undergo expedited review

• Check with your PD and SRO

Post-Submission Materials

Learn more: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-163.htmlInstructions for how to submit:https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-083.html

So you already have an award: and you are looking for funds to make good on pandemic losses

• Current status supplemental funds for “making good” losses to resources and productivity

Keep followinghttps://grants.nih.gov/policy/natural-disasters/corona-virus.htm

NINDS Is Investing Across the Research Spectrum

Basic

Fundamental NeuroscienceDisease-Focused Research

Translational

Pipeline through toFDA IND/IDE

Clinical

Phase I, II, III TrialsFDA Review

psfb@nih.gov

Division of Neuroscience

psfb@nih.gov

Primary Funding Mechanisms in DON (focus on Investigator-Initiated Research):

https://grants.nih.gov/grants/guide/pa-files/PA-20-185.html

https://grants.nih.gov/grants/guide/pa-files/pa-18-358.html

NINDS Funding Philosophy is to Fund Investigator-Initiated Research based on a Percentile Pay line

Rely on Peer Review

Most Awards through the Parent Funding Opportunity Announcements (FOA) ESI – 10 percentile benefit (R01 Only)

NINDS Funding Strategy

psfb@nih.gov

NIH Sample Applications and SS

to facilitate the preclinical discovery and development of new therapeutic interventions for neurological disorders

The Mission of NINDS DTR

Blueprint NeurotherapeuticsNetwork (BPN) for small molecules

Development of small moleculesProvides investigators with access to consultants and contracts that provide discovery, preclinical development, and clinical trial support

Cooperative Research to Enable and Advance Translational Enterprises (CREATE) Bio and Devices

Development of biologics or Devices (including proteins, peptides, nucleic acids, gene and cell therapies)

Assay Development and Therapeutic Agent Identification and Characterization^ Pharmacodynamics and In vivo Efficacy Studies^ Development and Validation of Translational Model Systems for Drug Discovery*

NINDS Division of Translational Research (DTR)

https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research

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

NINDS Funding Strategy: Biomarkers

Discovery Identification Sample source Bioinformatics Technology

development

PAR-18-550: Analytical Validation of aCandidate Biomarker for Neurological Disorders

Validation Context of use Analytical validationMulti-site clinical

validation studies

ClinicalMulti-site clinical

evaluation Preparation for

regulatory consideration

PAR-18-664: Clinical Validation of aCandidate Biomarker for Neurological Disorders

PAR-19-315: Discovery of Biomarkers and Biomarker Signatures for Neurological and Neuromuscular

Disorders (R61/R33 Clinical Trial Optional)

https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinical-Research

Division of Clinical Research (DCR)

Exploratory

PAR-18-422: NINDS Efficacy Clinical Trials (U01 Clinical Trial Required)Interventional

Clinical TrialsPhase 2 & 3

Comparative Effectiveness

Trials

PAR-19-171: Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3

Clinical Trial Not Allowed)

PAR-18-420: NINDS Exploratory Clinical Trials (U01 Clinical Trial Required)

NINDS

Career Development Programs

https://www.ninds.nih.gov/Funding/Training-Career-Development

Workforce Diversity Funding

https://www.ninds.nih.gov/About-NINDS/Workforce-Diversity/Diversity-Resources

NIH Sample Applications and SSCOVID-19 Opportunities and Notices

psfb@nih.gov

• Opportunities for neuroscience research relevant to Covid-19• Administrative Supplements & Competitive Revisions

• https://grants.nih.gov/grants/guide/notice-files/NOT-NS-20-051.html• https://grants.nih.gov/grants/guide/notice-files/NOT-NS-20-074.html

• Resources for non-neurotrauma Covid-19 research•Notices of Special Interest from NINDS

• Chemosensory Testing screening tool -• https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-152.html

• Diversity K22 Advanced Postdoctoral Career Transition Award K22 eligibility extended• https://grants.nih.gov/grants/guide/notice-files/not-ns-20-076.html

• NIH-wide COVID Funding Opportunities:• https://grants.nih.gov/grants/guide/COVID-Related.cfm

Watch NINDS Open Session(https://videocast.nih.gov/)

https://videocast.nih.gov/summary.asp?Live=18981&bhcp=1psfb@nih.gov

Know the NINDS Funding Environment

Use Social Media to Stay in TouchStay in Informed using Social Media & Listservs

https://www.nih.gov/news-events/social-media-outreach

NINDS Podcast

Navigating NIH Funding During a Pandemic

Patrick SF Bellgowan, Ph.D.Program Director for TBI

Division of Neuroscience / NINDS / NIH

psfb@nih.gov

Linda Bambrick, Ph.D.Program Director for SCI

Division of Neuroscience / NINDS / NIH

Linda.bambrick@nih.gov

Question and Answer Session

&

Listening and Prioritization