Serological Science For COVID-19 - NCI DEA

Serological Science forCOVID-19Dinah S. Singer, Ph.D.Deputy Director, Scientific Strategy andDevelopment4th Virtual Meeting of the Board of Scientific AdvisorsMay 12, 2020

Supplemental funding from Congress Enacted April 24th 306M for NCI todevelop, validate,improve, and implementserological testing andassociated technologies COVID-19 focused anddistinct from annualappropriation; not in RPG2

Proposed Serological Sciences Network ingCenterCBCU01FNL SerologyLabCBCU54CBC4-8 CBCs: SerologicalSciences CapacityBuilding Centers (RFP)4-8 U54s: SerologicalSciences Centers ofExcellence (RFA)5-10 U01s: Serologicalsciences projects (RFA)U54U54U54U54U543

FNLCR Serology Lab Implement and qualify SARS-CoV-2 ELISA assays for IgM, IgGand IgA Rapidly identify, procure, and characterize serum/plasmaspecimens from SARS-CoV-2 patients and necessary controls To allow comparison of negative, medium and high response levels Establish panels and produce novel reagents forqualification/validation of SARS-CoV-2 serological and otherrelevant immune assays and distribute to the network Develop qualified assay standards for the serology community4

Serological Sciences Capacity Building CentersGoalsRFP4-8 contracts withacademic and/or privatesector through FNLCRUp to 3M total costsper year, per site Develop and expand serological testing capacity and practice inthe community Implementation of serological standardization, assaydevelopment and availability of FDA-EUA authorizedSARS-CoV-2 testing to identify those who may have beenexposed to the virus. Scale up acquired serological testing to provide increasednational capacity by screening at least 10,000 patients perweek with FDA-EUA authorized assays Acquire convalescent sera from recovered COVID-19 patientswho are seropositive and conduct surveillance clinical trials inpatients who have recovered from COVID-19 and areseropositive Pursue focused serological science5

Serological Sciences Centers of Excellence (RFA)Goals Understand the mechanisms driving the serological, humoral andcellular immune responses to SARS-CoV-2 viral infection toinform the development of novel serological tests Determine the serological correlates with disease pathogenesisand protection against future infection Improve population-based models of outbreak and susceptibilitythrough serology-focused studies4-8 U54 awards Preference for cancer relevant componentUp to 2M totalcosts per year for upto 5 yearsEach Center will have 2-3 projects, administrative core and thepossibility of technical coreBudget set-aside for collaborative projects proposed post-award6

Serological sciences projects (RFA)Goals5-10 U01 awardsUp to 500K total Understand the mechanisms driving the serological, humoraland cellular immune responses to SARS-CoV-2 viral infectionto inform the development of novel serological tests Determine the serological correlates with diseasepathogenesis and protection against future infection Improve population-based models of outbreak andsusceptibility through serology-focused studies Preference for cancer relevant componentcosts per year, up to 5yearsBudget set-aside for collaborative projects proposed post-award7

Network Coordinating Center at Frederick National LabGoalsNetworkCoordinatingCenter Provide program management, coordination andcommunication across the Serological Sciences Network forSARS-CoV-2 Coordinate sharing of the data, reagent, sample, and assaysFNLCR TaskOrder Coordinate comparison of results among different centersand assays through inter-Center collaborative studies,leading to international serology standardization 750K totalcosts per year Coordinate partnerships with national and internationalassociates such as the FDA, CDC, WHO, National Institutefor Biological Standards and Control (NIBSC), and others Work in close collaboration with NCI program staff8

Request for Information:Strategy for Research in Coronavirus Serology Testingand Serological Sciences Seeking input from the researchcommunity on scope of SerologicalSciences Network RFI will be open to response for 10 days Responses will be reviewed andincorporated into the design of thetechnological and scientific scope of theNetwork9

The Serological Sciences NetworkWith Special Thanks DJim CherryKelly CrottySamantha FinstadSean HanlonSara HookJuli KlemmDoug LowyChris SiemonCrystal WolfreyCSSI staffNCI TACTICCarl DieffenbachEmily ErbeldingCristina Cassetti10

Serological Science for COVID-19 Dinah S. Singer, Ph.D. Deputy Director, Scientific Strategy and . serological testing and associated technologies COVID-19 focused and distinct from annual appropriation; not in RPG. 3 U01 U01 U01 U01 U01 U54 U54 U54 . Kelly Crotty Samantha Finstad Sean Hanlon Sara Hook Juli Klemm Doug Lowy Chris Siemon .