The ACTIV Tracking Resistance and Coronavirus Evolution (TRACE) Working Group

The Problem
Mutations in SARS-CoV-2 are occurring, and some that are reaching high frequency could reduce therapeutic or vaccine efficacy. As the virus continues to circulate, additional mutations may emerge that lead to resistance to treatment.
The Solution
The TRACE Working Group will provide actionable information on emerging SARS-CoV-2 variants through genomic surveillance, data sharing and standardized assessments of treatment response to these new virus strains.

Overview

The Tracking Resistance and Coronavirus Evolution (TRACE) team are developing processes and infrastructure for monitoring and testing emerging SARS-CoV-2 variants as well as for gathering and sharing variant sequencing and phenotypic data. This work is being done in collaboration with other U.S. government agencies (e.g., CDC, BARDA, FDA, DoD), academic experts and private partners. The team is following a five-step approach to variant monitoring and data sharing:

  • Monitor global emergence and circulation of SARS-CoV-2 mutations
  • Cross-reference initial sequence data against database of experimentally or clinically phenotyped mutants
  • Characterize prioritized mutants in vitro through critical-path assays
  • Characterize prioritized mutants in vivo through critical-path assays
  • Rapidly share activity data with ACTIV and scientific community

Currently available information on viral variant surveillance can be found on the NCBI FTP site. Information on viral variant phenotypic characteristics and overviews of preclinical assays used to test them can be found on the Variant Therapeutic Data Summary within the NCATS OpenData Portal.

Resources

Goals

  • TRACE Report—Publish a weekly report that summarizes shifting trends in emerging SARS-CoV-2 variants based on sequence data deposition to GenBank/SRA. The complete record of TRACE Reports can be found here.
  • Data Collection and Curation—Leverage the private-public partnership framework of ACTIV to facilitate rapid data sharing from industry and government agencies to characterize the impact of variants on vaccines and therapeutics. This data is collated and shared publicly on the OpenData Portal and actively managed by the National Center for Advancing Translational Sciences (NCATS).
  • In Vitro Assessments of Therapeutic Efficacy—Generate datasets using standardized protocols and common reference reagents to better understand the impact of variants on the efficacy of vaccines and therapeutics. These data sets will be generated in close collaboration with industry partners, and all data will be made publicly available.

Contact

Joe Menetski, Ph.D, Vice President, Research Partnerships, [email protected]

TRACE Working Group Members

Michael Abram, Ph.D.
Translational Medicine Lead, Infectious Diseases & Head, Clinical Virology
AstraZeneca

Andrew Charles Adams, Ph.D.
Chief Scientific Officer
Eli Lilly and Company

James Anderson, M.D., Ph.D.
Director
Division of Program Coordination, Planning, and Strategic Initiatives, NIH

Matthew Arnegard, Ph.D.
Health Scientist Administrator
Office of Research Infrastructure Programs, NIH

Ralph Baric, Ph.D.
Professor, Department of Epidemiology and Dept. of Microbiology and Immunology
University of North Carolina, Chapel Hill

Dipanwita Basu, Ph.D.
Program Manager
Small Business Innovation Research and Small Business Technology Transfer, NIH

Lisa Bentley, M.S.
Data Scientist, Statistician
Biomedical Advanced Research and Development Authority, HHS

David Blazes, M.D., M.P.H.
Senior Program Officer, Surveillance and Epidemiology
Bill and Melinda Gates Foundation

Kyle Brimacombe, M.S.
Biochemist, NIH Chemical Genomics Center
National Center for Advancing Translational Sciences, NIH

Rodney Brister, Ph.D.
Coordinator, National Center for Biotechnology Information
National Library of Medicine, NIH

Liliana Brown, Ph.D.
Director, Office of Genomics and Advanced Technologies
National Institute of Allergy and Infectious Diseases, NIH

Patricia Brown-Augsburger, Ph.D.
Research Fellow
Eli Lilly and Company

Paula Bryant, Ph.D.
Acting Director, Office of Biodefense, Research Resources, and Translational Resources
National Institute of Allergy and Infectious Diseases, NIH

Rhonda Cardin, Ph.D.
Senior Director of Anti-infectives
Pfizer

Kara Carter, Ph.D.
Senior Vice President Discovery Biology
Dewpoint Therapeutics

Cristina Cassetti, Ph.D.
Deputy Director, Division of Microbiology and Infectious
National Institute of Allergy and Infectious Diseases, NIH

Patrick Chain, Ph.D.
Lead, Metagenomics Applications, Bioinformatics and Analytics Team, Genome Programs
Los Alamos National Laboratory

Marc Charette, Ph.D.
Program Director
National Heart, Lung, and Blood Institute, NIH

Tomas Cihlar, Ph.D.
VP, Head of Virology
Gilead

Christine Colvis, Ph.D. (Co-chair)
Director, Drug Development Partnership Programs
National Center for Advancing Translational Sciences, NIH

Ryan Connor, Ph.D.
Product Owner, COVID-19 SRA Cloud Analysis Tools, SME Viral Genomes, National Center for Biotechnology Information
National Library of Medicine, NIH

Michael Diamond, M.D., Ph.D.
Professor, Departments of Medicine, Molecular Microbiology, Pathology & Immunology
Washington University St Louis

Groves Dixon, Ph.D
Scientist, Bioinformatics
Moderna

Philip Dormitzer, M.D., Ph.D.
Vice President, Chief Scientific Officer of Viral Vaccines
Pfizer

Ken Duncan, Ph.D.
Deputy Director, Drugs, Discovery & Translational Sciences
Bill and Melinda Gates Foundation

Ann Eakin, Ph.D.
Therapeutic Concept Accelerator, Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases, NIH

Richard Eastman, Ph.D.
Scientist
National Center for Advancing Translational Sciences, NIH

Philip Ebert, Ph.D.
Principal Research Scientist
Eli Lilly and Company

Darin Edwards, Ph.D.
Director of Immunology, Infectious Disease Group
Moderna

Emily Erbelding M.D., M.P.H.
Director, Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases, NIH

Karl Erlandson, Ph.D.
Interdisciplinary Scientist
Biomedical Advanced Research and Development Authority, HHS

Ravinder Pannu Eskandary, Ph.D., CSP-PO
Staff Scientist, Program Product Manager
National Center for Biotechnology Information
National Library of Medicine, NIH

Mark Esser, Ph.D., M.B.A.
Vice President, Head of Microbial Science
AstraZeneca

Clint Florence, Ph.D.
Program Officer, Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases, NIH

Barney Graham, M.D., Ph.D.
Deputy Director, Dale and Betty Bumpers Vaccine Research Center
National Institute of Allergy and Infectious Diseases, NIH

Jay Grobler, Ph.D.
Director, Infectious Disease Biology
Merck

Rajesh Gupta, M.D., M.P.H.
Vice President, Global Health Portfolio and Public-Private Partnerships
Vir Biotechnology

Nancy Haigwood, Ph.D.
Director
Oregon National Primate Research Center

Matthew Hall, Ph.D.
Acting Director, Early Translation Branch
National Center for Advancing Translational Sciences, NIH

Christy Hebner, Ph.D.
VP, Virology and COO of Research
Vir Biotechnology

Judith Hewitt, Ph.D.
Deputy Director, Office of Biodefense, Research Resources and Translational Research
National Institute of Allergy and Infectious Diseases, NIH

Lorraine Horgan, P.M.P.
Vice President, Program Management
Brii Biosciences

Bin Hu, Ph.D.
Staff Scientist, Bioinformatics, Data Analytics, Computing Infrastructure
Los Alamos National Laboratory

Bolyn Hubby, Ph.D.
Chief Corporate Affairs Officer
Vir Biotechnology

Kathrin Jansen, Ph.D.
Head, Vaccine Research and Development
Pfizer

Daniel Jernigan, M.D., M.P.H.
Director, Influenza Division
National Center for Immunization and Respiratory Diseases, CDC

Samantha Jonson, M.S.
Dissemination and Implementation Strategy Lead
National Center for Advancing Translational Sciences, NIH

Nicole Kallewaard, Ph.D.
Research Advisor, Immunology-Translational Sciences
Eli Lilly and Company

Isis Kanevsky, Ph.D.
Director, Vaccine Research Department, Bacterial Vaccines
Pfizer

Jacqueline Kirchner, Ph.D.
Senior Program Officer
Bill and Melinda Gates Foundation

Bette Korber, Ph.D.
Laboratory Fellow|
Los Alamos National Laboratory

Emily Lee, Ph.D.
Staff Scientist
National Center for Advancing Translational Sciences, NIH

Jiani Li, Ph.D.
Research Scientist, Bioinformatics
Gilead Sciences

Po-E Li, M.S.
Research Technologist
Los Alamos National Laboratory

Kent Lloyd, DVM, Ph.D.
Professor, Surgery, Director Mouse Biology Program
University of California, Davis School of Medicine

Chien-Chi Lo, M.S.
Research Technologist
Los Alamos National Laboratory

Yueh-Ming Loo, Ph.D.
Senior Scientist
AstraZeneca

Cat Lutz, Ph.D.
Senior Director, In Vivo Pharmacology and Mouse Resources
The Jackson Laboratory

Duncan MacCannell, Ph.D.
Director, Influenza Division, National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention

Aron Marchler-Bauer, Ph.D.
Lead Scientist, National Center for Biotechnology Information
National Library of Medicine, NIH

David Margolis, M.D., M.P.H.
Vice President, Head of Infectious Diseases Therapy Area
Brii Biosciences

Ross Martin, M.S.
Bioinformatic Team Leader
Gilead Sciences

John Misasi, M.D.
Chief, Yeast Engineering Technology and Immunobiology Core, Dale and Betty Bumpers Vaccine Research Center
National Institute of Allergy and Infectious Diseases, NIH

Michiel Niesen, Ph.D.
Head of Biomedical Research
nference

Ajay Nirula, M.D., Ph.D.
Vice President, Immunology
Eli Lilly and Company

Steve Oberste, Ph.D.
Chief, Polio and Picornavirus Laboratory Branch, Division of Viral Diseases
Centers for Disease Control and Prevention

Rolando Pajon, Ph.D.
Director Clinical Biomarkers
Moderna

L Revell Phillips, Ph.D.
CIV Defense Threat Reduction Agency (DTRA) RD (USA)
Department of Defense

Danielle Porter, Ph.D.
Director of Clinical Virology, Emerging and Respiratory Viruses
Gilead Sciences

Diane Post, Ph.D.
Section Chief
National Institute of Allergy and Infectious Diseases, NIH

Kim Pruitt, Ph.D.
Chief, Information Engineering Branch, National Center for Biotechnology Information
National Library of Medicine, NIH

Lisa Purcell, Ph.D.
Vice President, Microbiology and Virology
Vir Biotechnology

Jay Rappaport, Ph.D.
Director, Chief Academic Officer
Tulane National Primate Center

Sujatha Rashid, Ph.D.
Program Manager, BEI Resources
American Type Culture Collection

Joni Rutter, Ph.D.
Acting Director
National Center for Advancing Translational Sciences, NIH

Erica Ollmann Saphire, Ph.D.
Professor, Center for Infectious Disease and Vaccine Research
La Jolla Institute for Immunology

Migun Shakya, Ph.D.
Scientist
Los Alamos National Laboratory

Steve Sherry, Ph.D.
Director, National Center for Biotechnology Information
National Library of Medicine, NIH

Venky Soundararajan, Ph.D. 
Co-founder & Chief Scientific Officer
nference

Jack Stapleton, M.D.
Professor, University of Iowa
Veterans Affairs Hospital

Kimberly Stemple, M.P.H.
Research Resources Project Officer Biodefense Vaccine and Other Biological Products
National Institute of Allergy and Infectious Diseases, NIH

Timothy Stenzel, M.D., Ph.D.
Director, Office of In Vitro Diagnostics and Radiological Health
Food and Drug Administration

Katie Streicher, Ph.D.
Director, Head of Translational Medicine
AstraZeneca

Nancy Sullivan, Ph.D.
Senior Investigator, Chief, Biodefense Research Section, Dale and Betty Bumpers Vaccine Research Center
National Institute of Allergy and Infectious Diseases, NIH

Jenny Svarovskaia, Ph.D.
Senior Director, Clinical Virology
Gilead Sciences

Carla Talarico, Ph.D., M.P.H.
Senior Director, Lead Epidemiologist, COVID-19 Vaccines
Moderna

AJ Venkatakrishnan. Ph.D.
Vice President of Scientific Research
nference

Kanny Wan, Ph.D.
Research Scientist, Division of Preclinical Innovation
National Center for Advancing Translational Sciences, NIH

David Wentworth, Ph.D.
Virology Surveillance and Diagnosis Branch Chief, Influenza Division
Centers for Disease Control and Prevention

Chunlin Xiao, Ph.D.
Staff Scientist, National Center for Biotechnology Information
National Library of Medicine, NIH

Li Yan, M.D., Ph.D.
Chief Medical Officer
Brii Biosciences

David Yarmosh, M.S.
Senior Bioinformatician
American Type Culture Collection

John Young, Ph.D. (Co-chair)
Global Head Infectious Diseases, Vice President
Roche

Roland Zahn, Ph.D.
Senior Scientific Director, Preclinical Immunology, Viral Vaccines
Janssen/Johnson & Johnson

Theo Zainal, M.S., Ph.D.
Commander, AC, M.S.C, Deputy Joint Product Lead Joint Rapid Acquisition Cell (JRAC) Screening and Diagnostics Capability (SDC) Team
US Navy

Qing Zhu, Ph.D.
Senior Vice President
Brii Biosciences

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