Using Webex and Webinar Logistics Everyone will be muted upon entry. - - PowerPoint PPT Presentation

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Using Webex and Webinar Logistics Everyone will be muted upon entry. - - PowerPoint PPT Presentation

Mar 30, 2024 28 likes •469 views

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

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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.

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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 klemmj@mail.nih.gov Samantha Finstad, PhD Center for Strategic Scientific Initiatives, NCI samantha.finstad@nih.gov Crystal Wolfrey Office of Grants Administration, NCI wolfreyc@mail.nih.gov Erik Stemmy, PhD Respiratory Diseases Branch, NIAID erik.stemmy@nih.gov

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Agenda

  • Overview on the Serological Sciences Network
  • Request for Applications Details
  • Questions
  • 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)

  • Develop and expand serological

testing capacity and practice in the community

  • Conduct serological standardization

and assay development and scale up to screening capacity with FDA EUA assays

  • Contact NCIFSSN@nih.gov 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)

  • 2-3 research projects
  • Administrative core
  • 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 SeroNet coordination including:

  • Organizing Steering Committee and

Investigator Meetings

  • Managing Network communication and
  • utreach
  • Coordinating reagent sharing and distribution
  • 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

RFA-CA-20-038 and RFA-CA-20- 039

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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

RFA-CA-20-038 and RFA-CA-20- 039

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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

RFA-CA-20-038 and RFA-CA-20- 039

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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

  • utcomes
  • 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

RFA-CA-20-038 and RFA-CA-20- 039

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Out of scope

  • Topic areas considered non-responsive to these FOAs:
  • Interventional clinical trials of vaccines and other therapeutics
  • Fundamental virology studies
  • The long-term impact of SARS-CoV-2 infection on co-morbidities, unrelated to

cancer or precancers

RFA-CA-20-038 and RFA-CA-20- 039

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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

RFA-CA-20-038 and RFA-CA-20- 039

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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:

  • 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)

  • Investigators and staff must receive training in Good Clinical Practice
  • All sites participating in multi-site studies research will use a single IRB
  • 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 RFA-CA-20-038 and RFA-CA-20- 039

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SARS-CoV-2 Serological Sciences Centers of Excellence (U54)

RFA-CA-20-038

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Mechanism of Support & Funding: U54 Center of Excellence

U54

Mechanism of support: U54, Specialized Center-Cooperative Agreements

This 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

RFA-CA-20- 038

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Components of SeroNet U54 Centers of Excellence

RFA-CA-20-038

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Content of Application

Available Component Types Research Strategy/Program Plan Page Limits Overall 12 Admin Core (use for Administrative Core) 3 Shared Resource Core (optional; use for each Core) 3 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

RFA-CA-20-038

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U54 Overall Component

  • Research Strategy
  • Research Theme: brief background and rationale and outline the significance of

research in the selected area

  • Center Organization: concise description of the structure of the Center
  • 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

  • Center Expertise: demonstrate that the Center will include the necessary expertise and

support the team science environment need to complete proposed research

  • Research Projects: briefly describe each project, including its scientific integration with

the organizing framework

  • Shared Resource Cores: briefly describe any shared resource cores, including how the

core(s) will support the projects

RFA-CA-20-038

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U54 Overall Component

  • Resource Sharing Plan

The resource sharing plan for the Overall component should cover all the activities of the Center

  • Describe proposed process for making primary data and resulting publications

immediately and broadly available to the public

  • Describe approaches for making protocols, SOPs, and computational tools and other

software broadly available

  • Address sharing of data within the Center, across the Network, and with the broader

research community

  • 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

RFA-CA-20-038 and RFA-CA-20-039

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Administrative Core

  • Research Strategy

in lieu of standard sub-sections—Significance, Innovation, Approach—use sub-sections below

  • 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

  • SeroNet Meetings and Other Network Activities: Provide a brief description
  • f strategies for connecting and integrating the Center with the broader

SeroNet

  • 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 RFA-CA-20-038

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Administrative Core

  • Budget
  • Center Administrator: Administrative Core Leader is strongly encouraged

to propose and budget for a Center Administrator to manage day-to-day

  • perations
  • Travel Funds: Budget should include funds to support travel for Center and

Network activities, including participation in SeroNet Investigator Meetings

  • 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 SeroNet Steering Committee RFA-CA-20-038

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Shared Resource Core – Optional

  • Research Strategy
  • Each Shared Research Core is expected to support at least two Research Projects
  • 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)

RFA-CA-20-038

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Research Projects

  • Research Strategy
  • 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

  • If applicable, describe how the shared resource(s) will be used for the

proposed research RFA-CA-20-038

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Research Projects in SARS-CoV-2 Serological Sciences (U01)

RFA-CA-20-039

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Mechanism of Support & Funding: U01 Research Projects

U01

Mechanism of support: U01, Research Project-Cooperative Agreements

To 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.

RFA-CA-20-039

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Research Projects

  • Research Strategy – 6 pages
  • 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

  • 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

RFA-CA-20-039

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Research Projects

  • Budget
  • Travel Funds: budget should include funds to support travel for

Network activities

  • 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 Plan
  • Same requirements as RFA-CA-20-038

RFA-CA-20-039

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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

RFA-CA-20-038 and RFA-CA-20-039

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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

RFA-CA-20-038 and RFA-CA-20-039

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Summary U01 versus U54

U01 U54 Budget (Direct Costs/Year) $500k $1.5M Number of Awards (anticipated) 5-10 4-8 Research Projects 1 2-3 Administrative Core  Shared Resource Core

  • ptional

Resource 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 RFA-CA-20-038 and RFA-CA-20-039

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Resources

  • Read the FOA very carefully
  • https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-20-038.html
  • 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:
  • Juli Klemm juli.klemm@nih.gov
  • Samantha Finstad samantha.finstad@nih.gov
  • Erik Stemmy erik.stemmy@nih.gov
  • To receive the RFP for the Capacity Building Centers (S20-119), please send a

request to NCIFSSN@nih.gov

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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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www.cancer.gov www.cancer.gov/espanol