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

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. 1

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. 2

The Serological Sciences Network (SeroNet) Pre-application webinar for RFA-CA-20-038 and RFA-CA-20-039 June 18, 2020

Presenters Juli Klemm, PhD Samantha Finstad, PhD Crystal Wolfrey Erik Stemmy, PhD Center for Strategic Center for Strategic Office of Grants Respiratory Diseases Scientific Initiatives, NCI Scientific Initiatives, NCI Administration, NCI Branch, NIAID klemmj@mail.nih.gov samantha.finstad@nih.gov wolfreyc@mail.nih.gov erik.stemmy@nih.gov 4

Agenda  Overview on the Serological Sciences Network  Request for Applications Details  Questions o NOTE: Questions about specific aims will not be addressed today 5

Structure of the Serological Sciences Network 6

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 .” 7

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 8

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 9

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 NCIFSSN@nih.gov to receive the RFP, S20-119. 10

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 11

RFA-CA-20-039: Research Projects in SARS-CoV-2 Serological Sciences (U01 Clinical Trial Optional)  5-10 U01s : Serological Sciences research projects (RFA) 12

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: 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 13

Scientific Scope of the SeroNet RFAs 14

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- 15 039

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- 16 039

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- 17 039

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 RFA-CA-20-038 and RFA-CA-20- 18 039

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 RFA-CA-20-038 and RFA-CA-20- 19 039

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- 20 039

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 RFA-CA-20-038 and RFA-CA-20- 21 039

SARS-CoV-2 Serological Sciences Centers of Excellence (U54) RFA-CA-20-038 22