Antibody Society Meeting Report: Diagnostic Landscape for COVID-19

Bioinsider recently hosted a virtual meeting on Diagnostic Landscape for COVID-19. Some of the insights presented were reported by Dr. Simon Goodman, Science and Technology Program Manager of The Antibody Society. Examining COVID-19 testing is even more critical due to a large portion of unreviewed scientific publications as a result of the urgency in understanding the virus and its detection approaches to quickly contain it.

Read more about various diagnostic approaches such as molecular, serological, and rapid testing in this report. The meeting shed light on many important topics including practical and statistical considerations for diagnostic device comparisons, the critical role of antigen in serological test development, how to develop, implement, regulate and scale diagnostic tests. A clinician’s perspective on testing and how to properly handle the pandemic with the current testing capacity was presented along with a forward-looking content on a home collection of nasal specimens to lower the barrier to SARS-CoV-2 testing.

Read the full report here.

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James E. Crowe, Jr., MD,

Director, Vanderbilt Vaccine Center; Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair; Founder, IDBiologics

Dr. Crowe’s laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

Dr. Crowe received his MD degree from the University of North Carolina at Chapel Hill, where he also completed his pediatrics residency. Following his clinical training, Dr. Crowe received five years of post-doctoral training in the laboratory of Infectious Diseases at the NIH. He completed infectious diseases fellowship training in 1996 at Vanderbilt and has run an independent laboratory at Vanderbilt since that time. He is currently Professor of Pediatrics and of Pathology, Microbiology and Immunology, and the Ann Scott Carell Chair, Vanderbilt University Medical Center. The laboratory’s work has been published in over 300 publications in high-quality science journals including CellScience and Nature, and leading medical journals including the New England Journal of Medicine and JAMA. Dr. Crowe was elected to the National Academy of Medicine in 2014 and the National Academy of Inventors in 2017. He has been the recipient of investigator awards from the March of Dimes, American Society for Microbiology, Pediatric Infectious Diseases Society, and Society for Pediatric Research. He was awarded the Judson Infectious Daland Prize of the American Philosophical Society, the Oswald Avery Award of the IDSA, the E. Mead Johnson Award for Excellence in Pediatrics, the Outstanding Investigator Award of the American Federation for Medical Research, the Norman J. Siegel Award of the American Pediatric Society, the Samuel Rosenthal Prize for Excellence in Academic Pediatrics, the Stanley J. Korsmeyer Award of American Society for Clinical Investigation, the Distinguished Medical Alumnus Award from UNC School of Medicine, Chapel Hill, NC. He is an elected Fellow of AAM, AAAS, ASCI, and AAP, IDSA, APS, and others. His research team was selected as the Best Academic Research Team at the 11th Annual Vaccine Industry Excellence Awards. He was awarded the inaugural 2019 Merck Future Insight Prize, a 1M Euro prize shared with Pardis Sabeti. 

He is the Founder of IDBiologics, Inc., an early-stage biotech company developing human monoclonal antibodies for infectious diseases.

Daniel Chen, MD, PhD

CMO, IGM Bioscience

Daniel S. Chen, MD, PhD, is the Chief Medical Officer for IGM Biosciences, and former Vice President, Global Head of Cancer Immunotherapy Development at Genentech/Roche.  He received a BS degree in Biology from the Massachusetts Institute of Technology (1990), a PhD in Microbiology & Immunology (1996), and MD (1998) from the University of Southern California. His PhD work and publications focused on “Early Events in Coronavirus Infection.”

Daniel completed an Internal Medicine Residency and Medical Oncology Fellowship at Stanford University (2003). He went on to complete a Post-doctoral fellowship with Mark Davis in Immunology, where he was a Howard Hughes Medical Institute Associate. He also ran the metastatic melanoma clinic at the Stanford Cancer Center from 2003-2006. In that time, he studied human anti-cancer immune responses pre- and post-cancer vaccination and cytokine administration to determine why anti-tumor immune responses were not more clinically effective. He received a U19 grant to develop better immunologic tools to interrogate human immune responses and ultimately patented the MHC cellular microarray to detect and functionally characterize antigen-specific T cell states.

He continued as Adjunct Clinical Faculty at Stanford from 2006-2016, where he cared for melanoma patients. At Genentech from 2006-2018, Daniel focused on the clinical development of anti-angiogenic and immune-modulatory targeted therapies in both early and late development, as well as the diagnostic tools to aid their development. This included leading the clinical development for atezolizumab, a PD-L1 inhibitor, from the time the program was in research through IND, Phase I, Phase II, Phase III, to filing and approvals in multiple indications worldwide. At IGM, Daniel focuses on the development of novel engineered multivalent and multispecific therapeutics. He is a reviewer for Nature, Immunity, and Clinical Cancer Research, serves on the Board of Directors for SITC, co-chair of the CRI cancer Immunotherapy consortium, gave the keynote presentation at the AACR NCI EORTC Annual Meeting 2014 and presented at the US Congressional Briefing on Immuno Oncology in 2017. He has continued to publish with academic and industry collaborators in the field of cancer immunotherapy, including the often-referenced Chen and Mellman manuscripts, “Elements of cancer immunity and the cancer-immune set point” and “Oncology meets Immunology: The Cancer-Immunity Cycle.”

Imre Berger

Founding Director, Max Planck Bristol Centre; Chair in Biochemistry and Chemistry; University of Bristol UK

Imre Berger was trained as a biochemist and synthetic biologist at Leibniz University and Medical School (MHH) in Hannover (Germany), at MIT (Cambridge, USA), and at ETH Zurich (Switzerland). Imre’s team develops enabling methods for DNA delivery and genome engineering, engineers synthetic vaccines and nanosensors and researches the structure and mechanism of multiprotein complexes in human health and disease. After Group Leader posts at ETH (2005) and EMBL (2007), Berger joined Bristol as Full Professor of Biochemistry (2014) with a joint appointment in Chemistry (2019). He is Founding Director of the Max Planck Centre for Minimal Biology in Bristol, Director of the BBSRC/EPSRC research center for synthetic biology BrisSynBio and Co-director of the Bristol Biodesign Institute BBI.

Imre Berger holds international patents for DNA and protein technologies, co-founded three biotech companies, and received numerous distinctions, notably the Swiss Technology Award, the W.A. DeVigier Foundation Award, and a Wellcome Trust Senior Investigator Award for his innovative research. Since 2019, he is an Investigator of the European Research Council (ERC).

Prof. Berger has participated in leading roles in numerous European Commission (EC) projects, including the pan-European structural biology infrastructure INSTRUCT. He has been Coordinator of the EC FP7 HEALTH ComplexINC project enhancing production tools for complex biologics in academic and industrial R&D (2011-2016) and is partner in the EPSRC funded Innovative Future Vaccine Manufacturing Research Hub.

Sina Bavari, PhD

CSO, Edge BioInnovation Consulting and Management; former CSO, Scientific Director US Army Medical Research Institute of Infectious Diseases (USAMRIID)

Dr. Sina Bavari received his Ph.D. in Immunotoxicology and Pharmaceutical Science at the University of Nebraska Medical Center in Omaha, Nebraska.  He is the former Chief Scientific Officer, Scientific Director at US Army Research Institute of Infectious Diseases (USAMRIID) and has held numerous leadership roles at USAMRIID, including Chief, Molecular and Translational Sciences Division and Therapeutic Discovery Center; Chief, Target Discovery & Experimental Microbiology, Integrated Toxicology Division; and Chief, Immunology, Target Identification, and Translational Research, Bacteriology Division.  He has produced approximately 30 patents, and out-licensed many products.

Dr. Bavari has published nearly 200 manuscripts in high impact journals, contributed to 15 development candidates, as well as numerous IND filings.  He has managed complex programs by galvanizing strong collaborations with key internal and external partners which includes other government agencies; academic Institutions and small to large pharmaceutical organizations. Dr. Bavari’s group has developed, standardized, and successfully finished multiple large screens, using authentic highly pathogenic viruses including filoviruses.  He has an extensive understanding of therapeutic countermeasures against filoviruses including; polymerase inhibitors and nucleic acid based targeted approaches.  Dr. Bavari is very familiar with animal models for filoviruses.  He has been deeply involved with many clinical studies and currently oversees or participates in 28 discoveries, 11 preclinical, and 3 clinical stage candidate antivirals against Ebola virus.

Currently, Dr. Bavari is the CSO of the Edge BioInnovation Consulting and Management. He is a lead decision maker and leader in global research and development of vaccines and therapeutics for deadly infectious diseases. Well-experienced in using and providing management on new and complex technologies, Dr. Bavari is adept at effectively translating scientific discovery into products, and has discovered and developed vaccines and therapeutics for multiple infectious diseases. Dr. Bavari has initiated and led programs at all stages of discovery and guided programs through critical decision points and into advanced development. Dr. Bavari has substantial experience in providing technical leadership and communicating policies and strategies to dynamic and highly matrixed environments. He has provided representation in both national and international settings and organizations.

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Ralph Rogers, MD

Assistant Professor of Medicine, Clinician Educator, Infectious Diseases, Warren Alpert Medical School of Brown University

Ralph Rogers, MD is an infectious disease specialist at the Lifespan Cancer Institute. He earned his medical degree from The Warren Alpert Medical School of Brown University where he also completed his residency and fellowship in infectious diseases. Dr. Rogers is Assistant Professor of Medicine, Clinician Educator Division of Infectious Diseases Warren Alpert Medical School of Brown University. He is a member of the Infectious Diseases Society of America (IDSA), the American Society for Microbiology (ASM) and the American Society of Transplantation (AST).

John Sninsky, PhD

Consultant, Translational Sciences

John J. Sninsky, PhD is a translational medicine consultant with deep understanding of diagnostics and diagnostics paired with medicine intervention. John has served in senior management positions in small and large CLIA service laboratories and in vitro diagnostic kit companies including Cetus, Roche Molecular Systems, Celera, Quest and CareDx. He was a member of the pioneering Cetus team that developed and optimized PCR technology for research and diagnostic use; specifically, the virology team developed the HIV, HTLV, HPV, HCV and HBV PCR assays. John put in place a surveillance initiative for viral variants and presented at the first FDA PMA advisory meeting for HIV PCR approval.

Timothy J. O’Leary, MD, PhD

Adjunct Professor, Pathology, University of Maryland School of Medicine; Former Chief Research and Development Officer, Veterans Affairs

Timothy O’Leary, MD, is Adjunct Professor of Pathology at the University of Maryland and served as Chief Research and Development Officer (CRADO) of the Department of Veterans Affairs from 2013-2015. He holds a doctorate in physical chemistry from Stanford University and a medical degree from the University of Michigan.

He is certified in anatomic pathology by the American Board of Pathology and in molecular genetic pathology by the American Board of Pathology and the American Board of Medical Genetics. Prior to his VA service, O’Leary chaired the Department of Cellular Pathology and Genetics at the Armed Forces Institute of Pathology for more than 15 years. He joined VA in 2004 and served as Director of Biomedical Laboratory Research and Development, Director of Clinical Sciences Research and Development, and Deputy CRADO prior to his appointment as CRADO. O’Leary also served as a reserve member of the Public Health Service Commissioned Corps from 1979 to 2010, serving two tours on active duty. His research interests include genomics, proteomics, and ultrasensitive detection of biological toxins. He has served on numerous federal panels and advisory committees, including the Health and Human Services Clinical Laboratory Improvement Advisory Committee and the Food and Drug Administration Hematology and Devices Panel. O’Leary, the holder of four patents, has authored or co-authored more than 190 journal articles and numerous book chapters and technical reports. He is a past president of the Association for Molecular Pathology and served as editor-in-chief for the Journal of Molecular Diagnostics.