using webex and webinar logistics · pre-application webinar for rfa -ca-20-038 and rfa -ca-20-039...
TRANSCRIPT
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Pre-application webinar for RFA-CA-20-038 and RFA-CA-20-039
Presentation will begin at 1:00pm ET.
Using Webex and Webinar Logistics
Everyone will be muted upon entry. Please remain on mute at all times.
Please keep your cameras off.
This webinar is being recorded and will be posted at a later date.
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Webinar Logistics—Questions
Submit questions at any time using the Chat. You may chat with “Everyone” or with “Samantha Finstad – Moderator.”
You may need to activate the appropriate box using the floating navigation panel found on the center of your screen.
A moderator will ask the question on your behalf during the Q & A portion at the end of the webinar.
The Serological Sciences Network (SeroNet)
Pre-application webinar for RFA-CA-20-038 and RFA-CA-20-039
June 18, 2020
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Presenters
Juli Klemm, PhD
Center for Strategic Scientific Initiatives, NCI
Samantha Finstad, PhD
Center for Strategic Scientific Initiatives, NCI
Crystal Wolfrey
Office of Grants Administration, NCI
Erik Stemmy, PhD
Respiratory Diseases Branch, NIAID
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Agenda
Overview on the Serological Sciences Network Request for Applications Details Questionso NOTE: Questions about specific aims will not be addressed today
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Structure of the Serological Sciences Network
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Congressional Appropriation
In April 2020, the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) provided the National Cancer Institute with appropriated funds “to develop, validate, improve, and implement serological testing and associated technologies.”
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Components of Serological Sciences Network (SeroNet) 4-8 CBCs: Serological Sciences
Capacity Building Centers 4-8 U54s: Serological Sciences
Centers of Excellence (RFA) 5-10 U01s: Serological Sciences
research projects (RFA) Frederick National Lab for Cancer
Research Serology Lab Network Coordinating Center at
Frederick National Lab
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FNLCR Serology Laboratory
Implement and qualify SARS-CoV-2 assays
Develop qualified assay standards, and generate novel reagents
Procure and characterize serum samples from SARS-CoV-2 patients and controls and establish serum panels
Share assays, reagents, and standards within SeroNet
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Serological Sciences Capacity Building Centers 4-8 CBCs: Serological Sciences
Capacity Building Centers (RFP)o Develop and expand serological
testing capacity and practice in the community
o Conduct serological standardization and assay development and scale up to screening capacity with FDA EUA assays
o Contact [email protected] to receive the RFP, S20-119.
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RFA-CA-20-038:SARS-CoV-2 Serological Sciences Centers of Excellence (U54 Clinical Trial Optional)
4-8 U54s: Serological Sciences Centers of Excellence (RFA)o 2-3 research projects
o Administrative core
o Optional shared resource core
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RFA-CA-20-039:Research Projects in SARS-CoV-2 Serological Sciences (U01 Clinical Trial Optional)
5-10 U01s: Serological Sciences research projects (RFA)
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Serological Sciences Network Coordinating Center (SSNCC) Managed by the FNLCR
SSNCC will work closely with NIH and SeroNet staff and investigators to manage all aspects of SeroNetcoordination including: o Organizing Steering Committee and
Investigator Meetings o Managing Network communication and
outreach o Coordinating reagent sharing and distribution o Facilitating and coordinating Network data
management
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Scientific Scope of the SeroNet RFAs
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Overall Goals of the Serological Sciences RFAs
Identify and advance research opportunities to characterize immune responses elicited by SARS-CoV-2 viral infection
Understand the mechanisms driving the serological, humoral, and cellular immune responses
Determine the host, genetic, and environmental modifiers of the immune response
Determine the serological correlates of disease pathogenesis and protection against future infection
Define access, communication, and implementation barriers related to SARS-CoV-2 serological testing
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Potential areas of investigation (1/3)
Developing novel assays, and preclinical and computational model systems to test adaptive and innate immune responses to SARS-CoV-2 infection that inform immune parameters and serological markers associated with asymptomatic vs symptomatic infection, disease severity, risk of re-infection or vaccine efficacy
Understanding the mechanisms underlying innate, cell-mediated, and humoral immune responses to SARS-CoV-2 – including macrophage activating syndrome and cytokine storm - as well as how disease severity differs as a function of immune health status
Determine if therapeutics (e.g. remdesivir, antivirals) and passive antibody therapies used to treat COVID-19 modulate serologic and immune responses to SARS-CoV-2 (e.g. antibody-dependent enhancement)
Characterizing the serologic differences resulting from natural infection vs. vaccination against SARS-CoV-2, and how they correlate with the persistence or longevity of the response
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Potential areas of investigation (2/3)
Identifying genetic and epigenetic determinants (e.g. HLA types) that modulate the development and durability of immune responses against SARS-CoV-2 infection and associated serological correlates
Understanding what factors affect the SARS-CoV-2 immune response or pathogenesis including SARS-CoV-2 viral load, health conditions (e.g., diabetes, obesity, cardiovascular disease, precancerous conditions), co-infection with other viruses (e.g., HIV, HPV, CMV), or the presence of endemic coronavirus antibodies
Understanding how precancerous conditions, cancer, and/or cancer therapies (i.e., chemotherapy, radiation, immunotherapy, hormonal therapy, combinations) affect serologic and immune responses to SARS-CoV-2 infection and the clinical course of infection, and conversely how the immune response to SARS-CoV-2 affects precancerous conditions, cancers, and responses to cancer therapies
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Potential areas of investigation (3/3)
Understanding how patient demographic factors (e.g., age, sex, ethnicity), behavioral (e.g., smoking, physical activity), and environmental factors affect immune or serological responses to SARS-CoV-2 infection
Researching the clinical and public health implementation of validated serologic assays, their interpretation, and follow-up for health outcomes
Approaches to promoting and ensuring equitable access to serologic testing, identification of contextual factors associated with the uptake of SARS-CoV-2 serologic testing, and whether differential access further exacerbates health disparities and health outcomes
Determining the ethical, legal and social implications of serologic testing for SARS-CoV-2 in diverse populations and the best methods for appropriate communication of results and interpretation at the individual, provider, and population level; for example, the impact of serologic testing on employment, housing, health insurance, access to federal benefits
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Out of scope
Topic areas considered non-responsive to these FOAs:o Interventional clinical trials of vaccines and other therapeutics
o Fundamental virology studies
o The long-term impact of SARS-CoV-2 infection on co-morbidities, unrelated to cancer or precancers
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Clinical Trials Optional
Intervention trials addressing behavioral, health care delivery, or implementation research related to serologic testing and serologic outcomes are appropriate for this RFA
These research efforts should include a broad and diverse population, including consideration of age, sex, gender, race, socioeconomic status, rural populations, ethnicity, as well as specific vulnerable populations (e.g., individuals with comorbidities such as autoimmune disease, immunosuppression, and obesity, medically underserved, and cancer populations – across all age groups – childhood, adolescent and young adult, and older populations)
Leveraging ongoing cohort studies and registry data is encouraged
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Clinical Trials Requirements (if applicable) NIH requirements for clinical trials research applications were updated in
January 2018. Please be sure to learn about and understand the following policies:o Application form now consolidates all Human Subjects and Clinical Trial related
information into one place and also expands the information required for applications that include a clinical trial (FORMS-E)
o Investigators and staff must receive training in Good Clinical Practice
o All sites participating in multi-site studies research will use a single IRB
o All NIH-funded clinical trials are expected to register and submit results to Clinicaltrials.gov
Information about the NIH Clinical Trial Requirements: https://grants.nih.gov/policy/clinical-trials.htm
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SARS-CoV-2 Serological Sciences Centers of Excellence (U54)
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Mechanism of Support & Funding: U54 Center of Excellence U54
Mechanism of support: U54, Specialized Center-Cooperative AgreementsThis mechanism can support any part of the full range of research and development from very basic to clinical; the spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These differ from a program project in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff.
Budget: $1.5M per year (direct costs) per Center
Project Period: 5 years
Foreign Institutions: Non-domestic entities are not eligible to apply, though foreign components are allowed
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Components of SeroNet U54 Centers of Excellence
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Content of Application
Available Component Types Research Strategy/Program Plan Page Limits
Overall 12Admin Core (use for Administrative Core) 3Shared Resource Core (optional; use for each Core)
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Projects (use for each Research Project) 6
This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application
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U54 Overall Component
Research Strategyo Research Theme: brief background and rationale and outline the significance of
research in the selected areao Center Organization: concise description of the structure of the Centero Center Integration: explicitly discuss integration of work proposed and cross-cutting
elements. Applications should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities, and research resources that a research Center can uniquely provide
o Center Expertise: demonstrate that the Center will include the necessary expertise and support the team science environment need to complete proposed research
o Research Projects: briefly describe each project, including its scientific integration with the organizing framework
o Shared Resource Cores: briefly describe any shared resource cores, including how the core(s) will support the projects
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U54 Overall Component
Resource Sharing PlanThe resource sharing plan for the Overall component should cover all the activities of the Centero Describe proposed process for making primary data and resulting publications
immediately and broadly available to the public
o Describe approaches for making protocols, SOPs, and computational tools and other software broadly available
o Address sharing of data within the Center, across the Network, and with the broader research community
o If a clinical trial is planned, address participants’ Study Consents and include (whenever possible) the option to use data and/or biospecimens for future research studies
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Administrative Core
Research Strategy in lieu of standard sub-sections—Significance, Innovation, Approach—use sub-sections below
o Management and Communication Plan: describe the leadership and communication strategies to manage and track progress of the multiple projects and sites that make up the Center
o SeroNet Meetings and Other Network Activities: Provide a brief description of strategies for connecting and integrating the Center with the broader SeroNet
o Center and Program Evaluation: The Administrative Core should coordinate participation in Center program evaluation activities, including progress reports, site visits, and providing additional communication and materials to NIH as needed
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Administrative Core
Budgeto Center Administrator: Administrative Core Leader is strongly encouraged
to propose and budget for a Center Administrator to manage day-to-day operations
o Travel Funds: Budget should include funds to support travel for Center and Network activities, including participation in SeroNet Investigator Meetings
o Funds for Trans-Network Projects: Beginning in Budget Period 2, applicants must allocate 10% of their annual budget (within the Direct Costs cap) to a restricted fund to support collaborative activities with other components of SeroNet. Final decisions for the release of set-aside funds will be made by NIH staff based on recommendations of the SeroNetSteering Committee
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Shared Resource Core – Optional
Research Strategyo Each Shared Research Core is expected to support at least two Research Projects o Issues to be addressed include, but are not limited to:
• Value of the Core services to the Research Center and Research Projects• Interactions between the Core and Research Projects• Procedures for how the core prioritizes services to the proposed projects in the U54
Center, including allocating resources, cost effectiveness, and increased efficiency• Quality control measures
These proposed new shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested)
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Research Projects
Research Strategyo Clearly describe the SARS-CoV-2 serological science research addressed
by each Project. Explain how the proposed research will accelerate understanding the immune response to SARS-CoV-2 and inform the development of novel serological tests to further define the characteristics of COVID-19
o If applicable, describe how the shared resource(s) will be used for the proposed research
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Research Projects in SARS-CoV-2 Serological Sciences (U01)
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Mechanism of Support & Funding: U01 Research Projects
U01
Mechanism of support: U01, Research Project-Cooperative AgreementsTo support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies; subsequently receive continuous attention from funding Institute or Division staff.
Budget: $500k per year (direct costs)
Project Period: 5 years
Foreign Institutions: Non-domestic entities are not eligible to apply, though foreign components are allowed.
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Research Projects
Research Strategy – 6 pageso This is an emergency FOA due to the SARS-CoV-2 global pandemic;
therefore, applicants do not need to provide extensive background information or preliminary data in this application
o Clearly describe the SARS-CoV-2 serological science research addressed by each Project. Explain how the proposed research will accelerate understanding the immune response to SARS-CoV-2 and inform the development of novel serological tests to further define the characteristics of COVID-19
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Research Projects
Budgeto Travel Funds: budget should include funds to support travel for
Network activities
o Funds for Trans-Network Projects: Beginning in Budget Period 2, applicants must allocate 10% of their annual budget to a restricted fund to support collaborative activities with other components of SeroNet
Resource Sharing Plano Same requirements as RFA-CA-20-038
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Specifics of Both RFAs
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Cooperative Agreement Terms and Conditions
Participate in a cooperative, interactive, and collaborative manner with NIH staff, FNLCR Serology Lab staff, other SeroNet investigators, Capacity Building Centers (CBCs), and the Coordinating Center, to maximize impact of the SeroNet and meet Program goals and objectives
One PD/PI from each of the SeroNet U01/U54 awards, CBCs, Serology Lab, and Coordinating Center will comprise the SeroNet Steering Committee (SeroNet SC)
Participate in additional collaborative research activities identified post-award by the SeroNet SC
Awardees must adhere to a Network Communications Plan which will be drafted by the SeroNet SC
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Application Review Information Special Emphasis Panel convened by NCI
This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application
Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Applications with a cancer component will be given preference
Consider the FOA-specific review criteria for each criterion defined in Part 2, Section V of each FOA
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Summary U01 versus U54U01 U54
Budget (Direct Costs/Year) $500k $1.5MNumber of Awards (anticipated) 5-10 4-8Research Projects 1 2-3Administrative Core
Shared Resource Core optionalResource Sharing Plan
Cooperative Agreement
Collaborative set-aside
Participation in SeroNet SC
Special Emphasis Panel Review
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Key Dates
Pre-Application Webinar June 18, 2020
Application Due Dates July 22, 2020
Review Dates August 2020
Earliest Anticipated Start Dates September 2020
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Resources Read the FOA very carefully
o https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-20-038.html
o https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-20-039.html
Today’s webinar and slides will be posted on the SeroNet webpage:cancer.gov/research/key-initiatives/covid-19/coronavirus-research-initiatives/serological-sciences-network
For questions specific to your application:
o Juli Klemm [email protected]
o Samantha Finstad [email protected]
o Erik Stemmy [email protected]
To receive the RFP for the Capacity Building Centers (S20-119), please send a request to [email protected]
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Current NIAID COVID-19 Funding Opportunities
Expedited Review R21/R01 (PAR-20-177/PAR-20-278)Broad objectives: COVID-19 pathogenesis, diagnostics, therapeutics, vaccines.
Parent NIH Grant Mechanisms R03, SBIR, STTR: NOT-AI-20-051
R01: PA-19-056
R21: PA-19-053
https://grants.nih.gov/policy/natural-disasters/corona-virus.htm
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Questions?Submit questions using the Chat
You may need to activate the appropriate box using the floating navigation panel found on the center of your screen
A moderator will ask the question on your behalf
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