A Panel Discussion on Research, Development, Regulation, and Commercialization Efforts to Address COVID-19

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COVID-19 is clearly a defining moment for all of us. Short of eradication of Sars-Cov-2, all of our lives will undoubtably be different going forward from what they were at the end of 2019. Major disruptions lead to major changes. For the first time in history governments are going to partner with industry to make hundreds of millions of dose of vaccines months before we know the vaccines will work. Therapeutic solutions are being devised in “real time” with immediate regulatory approvals in countries around the world. Partnerships that took a decade to build to make HIV treatment available worldwide have been accomplished in three weeks. This presents opportunities for all of us to impact the new “normal."    

The University of Maryland's Fischell Department of Bioengineering (BIOE) has an Advisory Board with representatives from industry, government research institutions, government regulatory agencies and other leading universities. One of the roles of the Advisory Board is to help BIOE define where to focus both our research efforts and curriculum to best meet future needs. Given the importance of COVID-19, several Advisory Board members shared their perspectives on current activities across research, development, regulation and commercialization of COVID-19 efforts globally. This included covering how 1) regulatory agencies are thinking about fast track and emergency use authorizations of diagnostic, therapeutic and vaccine solutions, 2) government labs are driving research and partnering with industry, 3) overall economic impacts, 4) vaccine development and 5) therapeutics solutions.

The recorded webinar is now available online. The presentations featured in this webinar can be downloaded via the corresponding topics below.


Featured Topics:

Sara Brenner, M.D., MPH, is a preventive medicine and public health physician currently serving as the Chief Medical Officer for In Vitro Diagnostics and Associate Director for Medical Affairs in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA). Prior to joining FDA, Dr. Brenner served as a Senior Policy Advisor in the White House Office of Science and Technology Policy (OSTP) with a broad portfolio in biomedical science, technology, and human health. From within the Executive Office of the President (EOP), Dr. Brenner worked with U.S. Departments and Agencies, the Office of Management and Budget, the National Security Council, the Domestic Policy Council, and other White House components to develop national policy relevant to health care, medical technology, biomedical science, innovative early-stage research, and workforce training and education. Her portfolio included focus areas in health data interoperability, privacy, and national security, interagency coordination in biological and health sciences, research business models and reducing burdens on the national research enterprise, open science/open data initiatives, translational science and commercialization, promotion and protection of the U.S. bioeconomy, biomedical research in microgravity (space), national public health response to combat the opioid crisis, Veterans’ suicide prevention (PREVENTS), and risk assessment and mitigation related to human exposures to contaminants of emerging concern.
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Jonathan S. Bromberg, M.D., Ph.D., is Professor of Surgery and Microbiology and Immunology, and Vice Chair for Research with the University of Maryland School of Medicine. Dr. Bromberg has been involved continuously in basic cellular and molecular transplant immunology for over 25 years. His basic research has always focused on T cell immunobiology, and for more than 15 years, has also focused on issues of migration, trafficking, secondary lymphoid organ structure and function, and lymphatic structure and function, and how these processes and structures influence T cell immunity and T cell tolerance in models of cardiac transplantation and pancreatic islet transplantation. Dr. Bromberg has also maintained an active clinical practice in solid organ transplantation and he is thus constantly exposed to the problems of patients and their immune systems, including cellular and humoral rejection, opportunistic infections, chronic viral disease, autoimmune organ failure, and immunosuppression
medication side effects. 
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Claudio Knizek, Managing Director and Partner at the Boston Consulting Group (BCG), joined BCG in January 2006 and works in the Washington, D.C. office. Claudio supports clients on a variety of operational and strategic issues, and currently co-leads the Manufacturing and Supply Chain Business Line globally for BCG.  He has a B.S. and M.S. from Stanford University and an M.B.A. from Harvard Business School.
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Steven Lehrer brings over 30 years of experience starting, growing and running life science-based businesses focused on commercializing new technology and expanding businesses globally. Steve has extensive experience  in pharmaceutical, biopharmaceutical and biosimilar  R&D, regulatory, operations and commercialization. In addition, he had led the development and commercialization of several molecular genetic diagnostic tests and developed outcomes databases for bioinformatics and healthcare econometric modeling. 
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David Lindsay, Ph.D., is Director, Vaccine Clinical Materials Program (VCMP) at Leidos Biomedical Research/Frederick National Lab (FNL). Dr. Lindsay provides scientific/ technical and administrative oversight of a multi-product, vaccine pilot plant located in Frederick, Maryland, operated under NIH /NCI contract to the National Institute of Allergy and Infectious Disease’s Vaccine Research Center (VRC). The VCMP engages in subcontract research and pre-clinical support, process development support, tech transfer, cGMP pilot scale manufacture, testing, formulation/filling and supply of drug products (e.g. monoclonal antibody therapies, plasmid DNA and structure-based subunit vaccines, including nanoparticles) intended for Phase I/II investigational studies in humans. The VCMP partners closely with VRC to address existing and emerging/re-emerging infectious diseases of global significance including HIV, Ebola, Influenza, Malaria, RSV and Tuberculosis.  
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