Navigating NIH Funding During a Pandemic€¦ · Blueprint Neurotherapeutics Network (BPN) for...
Transcript of Navigating NIH Funding During a Pandemic€¦ · Blueprint Neurotherapeutics Network (BPN) for...
Navigating NIH Funding During a Pandemic
Patrick SF Bellgowan, Ph.D.Program Director for TBI
Division of Neuroscience / NINDS / NIH
Linda Bambrick, Ph.D.Program Director for SCI
Division of Neuroscience / NINDS / NIH
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 [email protected]
• For questions specific to your NIH award, contact the grants management or program staff at the funding institute or center
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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
Division of Neuroscience
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
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
• 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&[email protected]
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
Linda Bambrick, Ph.D.Program Director for SCI
Division of Neuroscience / NINDS / NIH
Question and Answer Session
&
Listening and Prioritization