Meet the Editors
Steven C. Schachter, M.D.
Professor of Neurology Harvard Medical School
Dr. Steven Schachter is Chief Academic Officer for CIMIT in Boston and a Professor of Neurology at Harvard Medical School. He is Past President of the American Epilepsy Society and has served on the Epilepsy Foundation of America Board of Directors and as Chair of its Professional Advisory Board. Dr. Schachter has published over 250 articles and chapters and edited or written 40 books. He is the founding editor and past editor-in-chief of the medical journals Epilepsy & Behavior and Epilepsy & Behavior Case Reports. He has extensive experience conducting, creating, and managing processes and teams that facilitate translational research and commercialization of medical technologies and the diagnosis and treatment of patients. His current focus is accelerating medical technologies from the bench to commercialization by engaging stakeholders, including government agencies and industry leaders. He led the extramural aspects of RADx Tech to support the development, commercialization, and production scale-up of accurate, rapid COVID-19 assays. His efforts have helped to establish a new model of translational research for medical technologies that is now widely applied across multiple funding agencies.
Wade E. Bolton, Ph.D.
Team Lead and Content Expert, NIBIB’s RADx Initiative
Dr. Bolton is a Team Lead and Content Expert federally contracted by VentureWell to support the National Institutes of Health’s Rapid of Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Previously, Dr. Bolton served as Vice President of the Program Management Office for Personal Genome Diagnostics located in Baltimore, MD. Prior to this, he held roles as the Divisional Vice President for Hematology Research and Development at Abbott Laboratories in Santa Clara, CA; President of the Institute for Immunology Research; Founder, President & CEO of ImmunoSite Technologies, LLC (IST); and Vice President of Beckman Coulter.
Meet the Authors
Managing Director, Health Catalysts Group and BlueStone Venture Partners
Co-Founder and Professor of Practice, Biomedical Diagnostics, Arizona State University College of Health Solutions
Advisor, The Rockefeller Foundation
Mara G. Aspinall is a healthcare leader and pioneer with nearly 40 years of experience in diagnostics, personalized medicine, and genomics. With seven publications and 130+ speeches about the COVID pandemic alone, Aspinall is a highly respected authority on diagnostic testing. She is Managing Director of Health Catalysts Group and BlueStone Venture Partners, Professor of Practice and Co-Founder of the Biomedical Diagnostics Program at Arizona State University, and an Advisor to the Rockefeller Foundation. Aspinall was formerly CEO of Ventana Medical Systems and President of Genzyme Genetics. She was named one of “100 Most Inspiring People in Life Sciences” by PharmaVOICE and holds an MBA from Harvard Business School.
Professor in Emergency Medicine, Internal Medicine, Icahn School of Medicine at Mount Sinai
Barbara Barnett is the Chief Medical Officer and Senior Vice President at Mount Sinai Beth Israel Medicine Center/Downtown. She spent most of her early career as the Residency Director of the Combined Emergency Medicine/Internal Medicine Residency Program at Long Island Jewish Medical Center. After becoming the Associate Chair of Internal Medicine for the NS-LIJ Healthcare System she developed a passion for hospital operations, Quality and Performance improvement. She completed the Greater New York Clinical Quality Fellowship. She was in the inaugural class of the Master of Health Care Delivery Science at Dartmouth. During the pandemic, Barbara focused on providing safe and efficient care to patients while maintaining morale and keeping her staff safe. She believes in strong leadership that is visible, reliable, and compassionate. Learning how to pivot has been crucial for her success.
Assistant Professor, Emory University School of Medicine
Leda Bassit is an Assistant Professor in the Department of Pediatrics at Emory University, with 35 years of experience in virology, antiviral drugs, and viral diagnosis. She serves as Co-PI on the RADx study of wastewater-based COVID-19 surveillance. She works extensively on the RADx Variant Task Force and significantly contributes to NIH program applications (ACME POCT Emergency COVID-19 Variant Testing & Independent Test Assessment Evaluation Program). In addition, she has been working extensively on building strategies to re-evaluate the sensitivity and accuracy of ~65 RADx and non-RADx tests in detecting SARS-CoV-2 and, most recently, Monkeypox, RSV, and Flu A&B viruses.
Expert Consultant, Rapid Acceleration of Diagnostics (RADx)
Grace Bendinger is an expert in digital and data-first strategy working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. She has held a diverse set of leadership roles in life sciences and health organizations with a demonstrated track record of implementing impactful and innovative technology solutions across industry functions for improved patient care. She has provided expert advice on new product innovation and strategic use of digital solutions to academic researchers, health care practitioners, health tech startups, and Fortune 500 companies.
Team Lead and Content Expert, VentureWell/ Rapid Acceleration of Diagnostics (RADx)
Wade Bolton is a Team Lead and Content Expert, contracted by VentureWell, a federal contractor for the National Institute of Health’s Rapid Accelerated Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Previously, Dr. Bolton served as Vice President of the Program Management Office for Personal Genome Diagnostics located in Baltimore, MD. Prior to this, he held roles as the Divisional Vice President for Hematology Research and Development at Abbott Laboratories in Santa Clara, CA; President of the Institute for Immunology Research; Founder, President & CEO of ImmunoSite Technologies, LLC (IST); and Vice President of Beckman Coulter.
Associate Director, Care Standardization, Population Health, Mount Sinai Health Partners
Saralynne Brown is an Associate Director of Care Standardization in Population Health at Mount Sinai Health Partners, focusing efforts on chronic disease management and integrating best practices into clinical workflows to drive impactful change. Previously, Ms. Brown served as the Project Manager for the Chief Medical Officer of the Mount Sinai Downtown campus, supporting multi-disciplinary projects driving quality, clinical process improvement, and hospital operations. During the height of the COVID-19 pandemic, she aided in operationalizing & staffing Inpatient Surge Units and the COVID-19 Vaccine POD at Mount Sinai Beth Israel. Ms. Brown completed her administrative residency at Women’s Health USA, and earned her master’s degree from the University of Scranton.
Professor of Emergency Medicine, Icahn School of Medicine at Mount Sinai
Yvette Calderon, MD, MS is currently a tenured Professor of Emergency Medicine at Icahn School of Medicine at Mount Sinai and Chair of the David B. Kriser Department of Emergency Medicine at Mount Sinai Beth Israel (MSBI), which includes oversight of Mount Sinai Union Square’s Urgent Care Center, and the Department of Emergency Medicine at Mount Sinai Brooklyn (MSB). Dr. Calderon is also Dean and Vice President for Equity in Clinical Care of the Icahn School of Medicine at Mount Sinai and Mount Sinai Health System. She is known for her clinical research that has focused on two major health disparities in the Bronx and the Lower East Side of Manhattan: HIV and Hepatitis C.
Atlanta Center for Microsystems-Engineered Point-of-Care Technologies
Ms. Cambria has over thirty years of experience in regulatory compliance and quality systems management and has successfully run her own consulting company for over two decades. Through her ongoing contact with different branches of the FDA, Cathy has completed multiple filings for Class I, II, and III 510(k) submissions and premarket approval (PMA) supplements, and real-time reviews to the FDA. In addition, she has successfully mentored many companies to establish their quality management system. Cathy is a member of the Atlanta Center for Microsystems-Engineered Point-of-Care Technologies (ACME POCT) team to support the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.
Managing Director of Prodct LLC
Devon C. Campbell, is the Founder and Managing Director of Prodct LLC; Chief Product Officer (CPO) and SVP of R&D/Quality at myBiometry; a Content Expert for the NIH RADx program; and serves on the Board of Directors or as an advisor to many early-stage medical device companies. He previously served as Director of Development at Ventana Medical Systems (acquired by Roche), Director of Engineering and Systems at Novartis (Companion Diagnostics division), and Sr. Director of Engineering at Quanterix. He has deep experience developing high quality, commercially successful diagnostic devices and biomarker detection research platforms. Devon holds dozens of patents worldwide and has exited three companies.
RADx Tech Deployment Core Project Facilitator
Mia Cirrincione is a Deployment Core Project Facilitator supporting the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative supporting the development, commercialization, and implementation of technologies for COVID-19 diagnostics. Her background is in Biomedical Engineering with an emphasis in Cell and Tissue engineering from the University of Minnesota. She is dedicated to accelerating innovation and targeting improvements in global health through medical device development.
Professor of Pathology, Johns Hopkins University School of Medicine
William Clarke is a Professor in the Department of Pathology, the Vice Chair of Pathology for Quality and Regulatory Affairs, as well as the Director of both Point-of-Care Testing and Reference Toxicology for the Johns Hopkins Hospital. His research interests include clinical mass spectrometry, method development and evaluation for therapeutic drug monitoring, clinical toxicology and point-of-care testing. Dr. Clarke has published over 170 peer-reviewed manuscripts or book chapters, is the Co-Editor of the textbook Contemporary Practice in Clinical Chemistry, and is an Editor-in-Chief of the journal Practical Laboratory Medicine.
Honorary Professor of Pediatric and Perinatal Pathology, Department of Bone and Metabolism; Sheffield University and Clinical Director at Sheffield Children’s Foundation Trust, UK
Marta C Cohen is an Honorary Professor of Pediatric and Perinatal Pathology at the University of Sheffield, Medical Director of Pharmacy, Diagnostics and Genetics and Consultant Histopathologist at Sheffield Children’s FT, Sheffield. She is Academic Lead of the Pediatric SAC Royal at the College of Pathologist; Council Member and Fellowship Program Director of the European Society of Pathology; Past President and Past Course Director of the International Pediatric Pathology Association (IPPA) and Executive Committee Member of the European Society of Microbiology and Infectious Diseases (ESCMID) Study Group for Forensic and Postmortem Microbiology. She is co-editor of several books and has published over 190 articles and chapters.
CIMIT
John is based at CIMIT and has led the effort to codify its innovation methodology through the CoLab and GAITS web platforms as well as the CRAASH program to scale its impact. Before CIMIT, John was president of TIAX, a technology development company. Before that he was at the international consulting firm Arthur D Little, Inc., where he was senior vice president of its Technology & Innovation business and before that its business across Asia Pacific. He received a B.S. from Rensselaer Polytechnic Institute and an M.S. and Ph.D. in Mechanical Engineering from the Massachusetts Institute of Technology. He is a frequent speaker and holds over 20 US patents.
Entrepreneur in Residence, CIMIT
Mike Dempsey has worked in the field of medical devices for more than 35 years. During this time, he founded three medical device companies and holds over a dozen patents on various medical devices. Mike is currently the EIR at the Center for the Integration of Medicine and Innovative Technology (CIMIT), the Director of the CIMIT Accelerator Program, and a lecturer at MIT. Mike has received a special citation from the Commissioner of the FDA for “exceptional initiative and leadership to protect the public health.” During the COVID-19 pandemic, Mike and the CIMIT team were leaders in the NIH-NIBIB RADxTech initiative.
Project Facilitator, Rapid Acceleration of Diagnostics (RADx)
Sam Dolphin is a Project Facilitator contracted by VentureWell to support the National Institutes of Health’s RADx initiative across a number of areas including direct project consulting, Variant Task Force activities, Commercialization and Deployment Cores, Accessibility program development and operations, and VentureWell contract negotiations. He holds a Bachelor of Science in Engineering for Biomedical Engineering, summa cum laude, from the University of Michigan (2020) where he researched 3D printing applications in surgical planning and training, as well as superficial prosthetics, and is co-author on two associated papers. He is a RADx Distinguished Fellow and prolific reader of books.
Project Facilitator – RADx
Maren Downing is a federally contracted Project Facilitator by VentureWell supporting the National Institutes of Health Rapid Acceleration of Diagnostics Initiative (RADx). She carries bachelor’s and master’s degrees in biomedical engineering and is now pursuing her Medical Doctor degree. She works across functions, including regulatory, quality, project management, and clinical studies to ensure the required collaboration to bring products to market. Her dedication to innovation is shown through scientific publications and involvement with various start-ups. She is also a Project Facilitator in the NIH Blueprint MedTech program. In her professional career, she seeks to combine her problem-solving mindset with clinical knowledge to improve patient outcomes.
Associate Professor of Emergency Medicine, Icahn School of Medicine at Mount Sinai
Erick Eiting is an Associate Professor of Emergency Medicine at the Icahn School of Medicine at Mount Sinai, New York; Vice Chair of Operations for Emergency Medicine at Mount Sinai Downtown; Medical Director for Quality for the Center for Transgender Medicine and Surgery in the Mount Sinai Health System, New York; and Program Director for the LGBTQ Medicine Fellowship at the Icahn School of Medicine at Mount Sinai, New York. Dr. Eiting is President of the New York County Medical Society and is Co-Chair of the Committee on Health Equity for the Medical Society of the State of New York. He is a member of the AMA Council on Medical Service and the National LGBTQ Fellowship Commission. His research focuses on sexual and gender minorities, clinical operations, and reducing structural barrier to healthcare for vulnerable patient populations.
Founder and CEO, DreamCatcher Ventures
Tania Fernandez is the founder and CEO of DreamCatcher Ventures, a strategic advisory services firm in San Francisco, CA with domain expertise in the life science industry and specializes in working with entrepreneurs and investors to create, and scale successful ventures. She is a senior Life Sciences Industry Executive with more than 25 years of experience across therapeutics, medtech, diagnostics, digital health and healthcare delivery and over 18 years of experience as a venture capitalist in biotech financing. She serves as a Team Lead and Content Expert federally contracted by VentureWell to support the National Institutes of Health’s RADx initiative to accelerate the development and commercialization of innovative technologies for COVID-19 testing. She has frequently authored articles on the biotech landscape and has been a data contributor to the Biotech industry reports. Tania also serves on the Board of the US-India Science and Technology Endowment Fund.
President, Gordon and Betty Moore Foundation
Harvey V. Fineberg, president of the Gordon and Betty Moore Foundation, champions groundbreaking scientific discovery, environmental conservation, and improved patient care. As interim chief program officer, he oversees the foundation’s patient care initiatives. Formerly president of the Institute of Medicine and Harvard University provost, Fineberg has focused his academic career on health policy and medical decision-making. He chaired the Carnegie Endowment for International Peace, served on the boards of the William and Flora Hewlett Foundation and the China Medical Board, and co-founded the Society for Medical Decision Making. An accomplished author, he co-authored books on clinical decision analysis, physician education, and the 1976 swine flu immunization program.
Professor of Pathology, Icahn School of Medicine at Mount Sinai
Adolfo Firpo-Betancourt is Professor and Vice Chair at the Department of Pathology, Molecular and Cell-based Medicine at Icahn School of Medicine at Mount Sinai; Vice Chair for Clinical Pathology & Clinical Services Integration, and Medical Director of Clinical Laboratories & the Center for Clinical Laboratories at Mount Sinai Hospital, New York City. A recognized leader at the intersection of clinical laboratory sciences and innovation in high complexity clinical laboratory testing and clinical laboratory science, he led MSH efforts to obtain the first FDA and NYSDOH EUA-approved serological assays for detection and measurement of Spike and RBD antigens of SARS-CoV-2, by ELISA. The MSH assay served as the standard serological assay employed for the assessment of serum titers of samples in the national repository of convalescent plasma for the Biomedical Advanced Research and Development Authority (BARDA) in 2020 and samples from the MSH clinical and research laboratories were provided to support NIH-NCI efforts in the assessment of serological kits produced in other countries seeking access to the US Market.
Assistant Professor, Nell Hodgson Woodruff School of Nursing, Emory University
Jennifer Frediani is a PhD-trained registered dietitian, exercise physiologist, researcher, and educator at the Nell Hodgson Woodruff School of Nursing at Emory University. She is a co-investigator and the Director of Adult Clinical Research and Operations for Rapid Acceleration of Diagnostics (RADx) at Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) at Emory University. This center serves as the verification core for the RADx Initiative of the National Institutes of Health. Her part in the Center’s activities is to direct the clinical studies in adults and to date has managed over 60 individual device studies and led several investigator-initiated research studies.
Associate Professor, University of Massachusetts Chan Medical School
Dr. Gibson is an Associate Professor at the University of Massachusetts Chan Medical School and specializes in Adult and Pediatric Infectious Diseases and Immunology. She served as Co-Lead for the NIH RADx Tech Clinical Studies Core managing its comprehensive activities, including design and implementation of studies related to SARS-CoV-2 testing, regulatory activities, collaboration with other RADx cores and the FDA, and communications with NIH leadership. She cares for patients of all ages, focusing on immunocompromised individuals, pregnant women, and children. Her research focuses on the immunopathogenesis of cytomegalovirus and other herpesviruses in populations at risk for severe disease, particularly infants with congenital infections.
Director of Variant Operations, Emory University/ACME-POCT/Rapid Acceleration of Diagnostics (RADx)
Morgan Greenleaf is the Director of Variant Operations at the Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT), a center that spans Emory University, Georgia Tech and Children’s Healthcare of Atlanta supporting the National Institute of Health’s Rapid Acceleration of Diagnostics (RADx) and Independent Test Assessment Program (ITAP).
Neil and Jane Pappalardo Professor of Mechanical Engineering, MIT
Anette “Peko” Hosoi is the Neil and Jane Pappalardo Professor of Mechanical Engineering, Professor of Mathematics, and a core faculty member of the Institute for Data, Systems and Society at MIT. She previously served as the Associate Dean of the MIT School of Engineering. Prof. Hosoi has published over 250 articles and she has received numerous awards including the American Physical Society Stanley Corrsin Award, the SIAM I. E. Block Community Lectureship, and the Jacob P. Den Hartog Distinguished Educator Award. She is a Fellow of the American Physical Society, a Radcliffe Institute Fellow, and a MacVicar Faculty Fellow.
Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai
Waleed Javaid is a Professor of Medicine at Icahn School of Medicine at Mount Sinai. As a Hospital Epidemiologist and Director of Infection Prevention and Control, he works to reduce healthcare-associated infections with a focus on patient safety. He is a national expert in infection control. He participates in many national organizations and committees. He is a member of the Infectious disease society of America (IDSA) guidelines committee and a voting member of the Council for Outbreak Response: HAI and Antibiotic resistance (CORHA). He has authored several publications on antimicrobial resistance and infectious diseases and is a regular guest expert in the media.
Partner, Prodct LLC.
Christie Johnson is a Partner at Prodct LLC, providing customized advisory and infrastructure development for early-stage startups, and serves as Director of Quality at myBiometry, a digital health company focused on asthma management. With a strong background in product risk management and quality systems, Christie is a content expert for the NIH’s RADx program which accelerates COVID-19 diagnostics. Previously, as the founder of Kasota Engineering, she helped startups and small medtech companies establish tailored quality management systems and risk management files. Her diverse experience includes engineering roles at industry-leading companies such as GE Aviation, Hologic, and Sonablate Corp.
Program and Project Facilitator, VentureWell / Rapid Acceleration of Diagnostics (RADx)
Emily Kennedy is a Program and Project Facilitator contracted by VentureWell, a federal contractor for the National Institute of Health’s Rapid Accelerated Diagnostics (RADx) initiative. Previously, she served as Co-founder and CEO of Hedgemon; Director of External Relations for The University of Akron Biomimicry Research and Innovation Center; Senior Consultant / Collaborator for Great Lakes Biomimicry; Visiting Industrial Design Faculty at Rhode Island School of Design; Biomimicry Fellow for GOJO Industries; and Marketing Apprentice / Scientist for EA Engineering, Science, and Technology. Dr. Kennedy is an inventor on multiple patents, and has authored research articles, opinion pieces, and invited columns with hundreds of collective citations.
Team Lead and Content Expert
Manuel Kingsley is Team Lead and Content Expert contracted by VentureWell to support the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in developing, commercializing, and implementing technologies for COVID-19 testing. Manuel focuses on evaluating, developing, and commercializing medical technology, helping organizations and physician/academic inventors commercialize novel medical technologies. With over 20 years of experience in the medical technology space, including roles in corporate business development (executing mergers and acquisitions), guiding product development, and developing growth strategies. Manuel worked for CR Bard, McKinsey & Co., Baxter Healthcare, Edwards Lifesciences, and IDEXX Labs during his corporate career.
Associate Professor of Medicine, Division of Hospital Medicine, The Ohio State University Wexner Medical Center
Bethany Kranitzky is currently an Associate Professor of Medicine and the Division Director of Operations, Division of Hospital Medicine, at The Ohio State University Wexner Medical Center and is formerly an Associate Professor of Medicine at Icahn School of Medicine at Mount Sinai and Deputy Chief Medical Officer at Mount Sinai Beth Israel. She completed the Greater New York Clinical Quality Fellowship and is a member of the Society of Hospital Medicine and the American College of Physicians. She is passionate that it is the responsibility and work of leadership to make it easier for frontline staff to do the right thing.
Professor of Pediatrics and Biomedical Engineering at Emory University and Georgia Tech
Wilbur A. Lam, MD, PhD is Professor of Pediatrics and Biomedical Engineering at Emory University and Georgia Tech as well as a clinical pediatric hematologist/oncologist at Children’s Healthcare of Atlanta. His overall research interests involve developing micro/nanosystems and microfluidic technologies to advance biomedical research with a focus on the biophysics of hematologic processes and diseases. With an interest in patient-operated diagnostics, his laboratory is also dedicated to translating their technologies as novel and inexpensive solutions to enable and empower patients to more easily monitor their own diseases at home and in the global health and rural settings. Dr. Lam is also Chief Innovation Officer of the Pediatric Technology Center at Children’s and a principal investigator of the NIH-funded Atlanta Center for Microsystems Engineered Point-of-Care Technologies, which is part of the NIBIB Point-of-Care Technologies Research Network and currently serves as the Test Verification Center of the NIH RADx initiative.
Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Icahn School of Medicine at Mount Sinai
Young Im Lee is an Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine at Icahn School of Medicine at Mount Sinai. She is the site director of Institute for Critical Care Medicine of Mount Sinai Health System and the Director of Medical and Surgical Intensive Care Unit at Mount Sinai Beth Israel. Dr. Lee is Chair of Critical Care Committee and Rapid Response and Cardiac Arrest Committee at Mount Sinai Beth Israel. She is the 2021 recipient of Excellence in Health Care Award for Quality Improvement Champions from United Hospital Fund for her response to COVID 19. She is an active member of American College of Chest Physicians, American Thoracic Society, and Society of Critical Care Medicine. Her research has focused on sepsis, point of care ultrasound on critically ill patients and diaphragm ultrasound on vented patients.
Director of Commercialization Support, RADx
Kevin Leite is Director of Commercialization Support, federally contracted to support the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in development, commercialization, and implementation of technologies for COVID-19 testing. Previously, Kevin was VP Operations at Alievio Inc., supporting development of a long-term implantable glaucoma shunt device, and Novocor Medical Systems, supporting development of an EMS assistive cardiac arrest device. Prior to this, he held roles of Business Unit Manager, with Ethicon Inc., Director of Operations, with Closure Medical Corporation, and Manager of Engineering, with Fresenius Kabi. He holds degrees from North Carolina State University (BSEE) and from the University of North Carolina Chapel Hill (MBA).
PhD Candidate, Georgia Institute of Technology and Emory University
Jessica Lin is a PhD candidate in the Walter H. Coulter Department of Biomedical Engineering at Georgia Institute of Technology and Emory University. She has received the NSF Graduate Research Fellowship, and works in the laboratory of Dr. Wilbur Lam. She has worked with the Rapid Acceleration of Diagnostics (RADx) initiative to publish research on COVID-19 diagnostic test performance against variants of concern and has been involved in developing COVID-19 surveillance testing for students on the Georgia Tech campus in 2020-2021.
Graduate Student at Icahn School of Medicine at Mount Sinai
Yang Lu is a PhD student at Icahn School of Medicine at Mount Sinai, focusing on research on high resolution genomic analysis on host and viral genomes. Previously, he earned his bachelor’s degree from Emory University.
Johns Hopkins University School of Medicine
Dr. Manabe is a Professor of Medicine, Department of Medicine, Division of Infectious Diseases within the Johns Hopkins University School of Medicine and Director of the Center for Innovative Diagnostics for Infectious Diseases. She also holds joint appointments in the Johns Hopkins Bloomberg School of Public Health Departments of International Health and Molecular Microbiology and Immunology and is the Associate Director of Global Health Research and Innovation within the Johns Hopkins Center for Global Health. Her research has focused on infectious disease diagnostics for STI’s, HIV, TB, and respiratory viruses (COVID-19, influenza) and their impact on patient-centered outcomes. She is dedicated to accelerating infectious disease diagnostic development, innovation, and access to increase diagnostic certainty and targeted treatment to improve global health.
Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine at Icahn School of Medicine at Mount Sinai
Lina Miyakawa is an Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine at Icahn School of Medicine at Mount Sinai; Associate Director of the Intensive Care Unit at Mount Sinai Beth Israel, Director of Quality for the Division of PCCM at Mount Sinai Beth Israel, and also the Associate Director of Quality for Institute of Critical Care Medicine at Mount Sinai Health System. She is board certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine. She has a LEAN Bronze Belt Certification and is currently enrolled in the Greater New York Hospital Association and United Hospital Fund Clinical Quality Fellowship Program. She is an active member of American College of Chest Physicians, American Thoracic Society, and Society of Critical Care Medicine and is invited annually to lecture and teach at regional and international conferences.
Commercialization Team Content Expert, VentureWell/ Rapid Acceleration of Diagnostics (RADx)
Sunshine Moore is a member of the Commercialization Team and content expert for contracted by VentureWell, a federal contractor for the National Institute of Health’s Rapid Accelerated Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. She has consulted for digital health startups, Medicaid managed care organizations, nonprofit advocacy groups, and commercial and Medicare health plans on business development, procurement, communications, and regulatory affairs. Previously, she was Senior Vice President of Strategy for Primary.Health, a software platform for public health agencies and school-based health care initiatives. She has worked in government relations and health policy for more than 15 years, representing CVS Health/Aetna and other health plans on issues related to health care reform and implementation, delivery system transformation, and cost containment.
Clinical Studies Coordinator, Rapid Acceleration of Diagnostics (RADx)
Emily Muth is a Clinical Studies Coordinator contracted by VentureWell, a federal contractor for the National Institute of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Emily works under the Commercialization Team. In this roll, she manages all working relationships between RADx, Clinical Research Organizations (CRO) and Analytical Testing Labs. Previously, Emily worked for Personal Genome Diagnostics in Baltimore, MD as a Project Coordinator assisting in managing multiple programs.
Vice President, Government and Capital Engagement, University City Science Center
Heath Naquin is Vice President of Government and Capital Engagement at the University City Science Center in Philadelphia, PA where he oversees a number of government innovation programs, commercialization activities across the tri-state region as well as acting as a principal for the $25M Science Center Health Fund. Previously. Mr. Naquin has worked for a number of non-profit and academic institutions and has served as PI and lead on more than $100 Million in federal innovation related programs and interventions.
Assistant Professor, Emory University School of Medicine
Anne Piantadosi MD, PhD is an Assistant Professor in the Emory University School of Medicine, Department of Pathology and Laboratory Medicine and Department of Medicine, Division of Infectious Diseases. Her research is focused on the emergence and evolution of viruses of clinical and public health importance, and her group uses a combination of translational, laboratory, and computational approaches.
MedScience Services
Enrique Rabellino is a Consultant and Content Expert contracted by VentureWell to support the National Institutes of Health’s RADx initiative. Previously, Dr. Rabellino served as consultant for Abbott Laboratories in Haematology and as Corporate Medical Director of Beckman Coulter. Prior to this, he held roles in academia as Associate Professor at the Division of Haematology-Oncology at Cornell University Medical Centre in New York City, National Jewish Hospital in Denver, and Scripps Clinic at La Jolla. He has extensive experience in clinical and laboratory medicine, applied research and medical diagnostic device industries. Dr Rabellino is recognized as an international leader in biomedical research in the space of biomarkers and companion diagnostics. Pioneered publications in the fields of hematology-oncology and cellular immunology and published over 50 articles and chapters
Assistant Professor, Division of Pediatric Gastroenterology, Hepatology and Nutrition, Emory University School of Medicine.
Dr. Rao is co-lead for Analytical Studies in the Verification and Validation Core at ACME-POCT. The Analytical Studies Team is responsible for laboratory testing of COVID-19 diagnostic tests and analysis to determine whether assays recognize SARS-CoV-2 variants as effectively as the wild type. Almost all assays that arrive at Emory University as part of RADx and the Independent Test Assessment Program undergo analytical testing. She is also involved in BSL3 studies using lab-propagated SARS-CoV-2. Prior to joining RADx, Dr. Rao’s research was focused on identifying novel small-molecule therapeutic agents to treat nonalcoholic fatty liver disease and pediatric cholestatic liver disease.
Assistant Professor, Johns Hopkins School of Medicine, Division of Infectious Diseases
Matthew Robinson is an Assistant Professor at the Johns Hopkins School of Medicine, Division of Infectious Diseases. His interests are in leveraging diagnostic innovation and precision medicine to reduce diagnostic and prognostic uncertainty for infectious diseases. He has developed analysis pipelines for novel highly multiplex nucleic acid tests and immunoassays for SARS-CoV-2 and co-chaired the RADx Clinical Review Committee to guide companies developing more rapid and usable SARS-CoV-2 tests. His work with the Johns Hopkins Precision Medicine Center of Excellence for COVID-19 has examined the individual contributions of specific therapeutics for COVID-19 and used novel machine learning techniques to predict the probability of developing severe disease among patients admitted with COVID-19
Content Expert and Lead Writer, WhenToTest.org; Co-Editor, Sensitive and Specific: The Testing Newsletter
Liz Ruark is Content Expert and Lead Writer for WhenToTest.org, an educational website devoted to diagnostic testing and COVID-19 prevention, developed as a partnership between the Consortia for Improving Medicine with Innovation and Technology at Massachusetts General Hospital; the MIT Institute for Data, Systems, and Society; and NIH’s RADx Initiative. With Mara Aspinall, she co-edits Sensitive and Specific: The Testing Newsletter, a weekly publication of news and commentary on diagnostic testing, infectious disease, and public health.
Program Facilitator, RADx Deployment Core – Commercialization Team
Adam Samuta is a Program Facilitator for the RADx Deployment Core; a federal contractor, contracted through VentureWell to support the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative. A recipient of the RADx Fellow Award; he is a member of multiple cross-functional teams supporting the RADx program awardees, including the RADx Deployment Core’s Commercialization Team, Procurement Team, Variant Task Force, Accessibility Team, and the Independent Test Assessment Program (ITAP). He helps manage resource implementation, and the relationship between multiple government agencies including the Department of Defence (DOD) and Food and Drug Administration (FDA) to contribute to the success of the RADx program.
Professor of Neurology, Harvard Medical School
Dr. Steven Schachter is Chief Academic Officer for CIMIT in Boston and a Professor of Neurology at Harvard Medical School. He is Past President of the American Epilepsy Society and has served on the Epilepsy Foundation of America Board of Directors and as Chair of its Professional Advisory Board. Dr. Schachter has published over 250 articles and chapters and edited or written 40 books. He is the founding editor and past editor-in-chief of the medical journals Epilepsy & Behavior and Epilepsy & Behavior Case Reports. He has extensive experience conducting, creating, and managing processes and teams that facilitate translational research and commercialization of medical technologies and the diagnosis and treatment of patients. His current focus is accelerating medical technologies from the bench to commercialization by engaging stakeholders, including government agencies and industry leaders. He led the extramural aspects of RADx Tech to support the development, commercialization, and production scale-up of accurate, rapid COVID-19 assays. His efforts have helped to establish a new model of translational research for medical technologies that is now widely applied across multiple funding agencies.
Project Facilitator, VentureWell / Rapid Acceleration of Diagnostics (RADx)
Alexandra Smith is a Project Facilitator, contracted by VentureWell, a federal contractor for the National Institute of Health’s Rapid Accelerated Diagnostics (RADx) initiative. She earned her Bachelor and Masters in Biomedical Engineering from Clemson University. While at Clemson, she was awarded the South Carolina Medical Device Alliance Fellowship and the R. Larry Dooley Entrepreneurship Award. In parallel to her work at RADx, Alexandra is studying to earn her Medical Degree from the University of South Carolina School of Medicine Greenville.
Chief Operating Officer, RADx at ACME POCT
Julie Sullivan serves as Chief Operating Officer for RADx at the Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT), an NIH-funded center that spans Emory University, Georgia Tech and Children’s Healthcare of Atlanta. Ms. Sullivan oversees the Center’s operations as the Test Verification Core, which serves to evaluate, validate and verify the various projects in the RADx funnels, including the Independent Test Assessment Program (ITAP).
COO, CIMIT
Paul Tessier is the Chief Operating Officer for the Center for Integration of Medicine and Innovative Technology (CIMIT). He is an experienced medical product developer, manager, and entrepreneur who for over 40 years has been dedicated to commercializing innovative medical products to improve patient care and healthcare delivery. While at CIMIT, Mr. Tessier has provided coaching and facilitation on translation of medical research and medical product development for organizations worldwide. He has been a central force in establishing the “assess, improve, select, and mentor” process that is key to CIMIT operations and the RADx programs that CIMIT coordinates.
Regulatory Core Lead, Rapid Acceleration of Diagnostics (RADx); CEO, Sanguina, Inc.
Erika Tyburski leads the regulatory core for the National Institutes of Health-funded Rapid Acceleration of Diagnostics (RADx) initiative for translation of diagnostics, where she has assisted over 20 project teams in obtaining Emergency Use Authorizations for COVID-19 tests. She is also the Regulatory co-lead for the Atlanta Center for Microsystems-Engineered Point-of-Care Technologies (ACME POCT), part of the NIH-funded Point-of-Care Technologies Research Network (POCTRN). Finally, Erika is the CEO of Sanguina, a biotech company developing and commercializing health and wellness tools including smartphone apps and single-use diagnostics. She holds a degree in biomedical engineering and has 12 years of experience in translating technologies from academic concept to commercialization.
Director of Procurement, RADx Deployment Core – Procurement Team
Jose Valdesuso is the Director of Procurement and a federal contractor for the NIH on the Rapid Acceleration of Diagnostics (RADx) initiative for COVID-19 testing. Previously he worked as a Director of Strategic Sourcing for Contec Americas, in Melbourne, Fl., a small medical technology company and senior manager in various roles in Procurement for Beckman Coulter, a large Medical Diagnostic company in Brea, CA. He has over 40 years in Procurement management in the commercial, government, and health care industry. Jose’s current responsibilities include helping RADx awardees in sourcing of material, expediting long-lead items, negotiating pricing, contract terms and risk analysis.
CEO, Capital Stack Investors
Eli Velasquez is founder & CEO of Capital Stack Investors, a global innovation and venture capital advisory firm. He is also founder & Managing Partner of the Investors of Color, a U.S. network of Black, Latinx and Asian accredited investors syndicating investments into early-stage companies and emerging funds. He also serves as a Principal and Capital Advisor to the University City Science Center Health Fund, investing in healthcare innovation with global impact. He is an angel investor and serves on the Board of the Angel Capital Association, Hispanics in Philanthropy, and Capital Advisor to the Stanford Latino Business Action Network.
Deployment Core Team Lead, Accessibility Program Manager, Rapid Acceleration of Diagnostics (RADx)
Brian Walsh is the Deployment Core Team Lead and the Accessibility Program Manager contracted by VentureWell to support the National Institutes of Health’s RADx initiative supporting the development, commercialization, and implementation of technologies for COVID-19 testing. Previously, he was President and General Manager of Dornier MedTech America located in Atlanta, Georgia responsible for North and South America. Prior to this, he held roles as Director of Strategy and General Manager of Radiation Therapy Products for ACAC Laboratories in Milpitas, California. He is past Treasurer of the American Foundation of Urologic Disease.
CMO, Rosalind
Cassandra is an impassioned advocate for patient-centered care and bridging clinical practice and genomic discovery. She currently is the Chief Marketing Officer at Rosalind Bio and is a founding member of the Council of Corporate Leadership with the Rosalind Franklin Society. Cassandra is responsible for the launch of the Rosalind Clinical Solutions business unit to focus on the “bench-to-bedside” benefits of translational research and was Project Lead on the Diagnostic Monitoring platform (Rosalind DxM) for the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative for COVID-19 testing. She holds an M.B.A from Pepperdine and is a graduate from UCLA with a focus on Neuroscience.
Adam Samuta
Program Facilitator, RADx Deployment Core – Commercialization Team
Adam Samuta is a Program Facilitator for the RADx Deployment Core; a federal contractor, contracted through VentureWell to support the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative. A recipient of the RADx Fellow Award; he is a member of multiple cross-functional teams supporting the RADx program awardees, including the RADx Deployment Core’s Commercialization Team, Procurement Team, Variant Task Force, Accessibility Team, and the Independent Test Assessment Program (ITAP). He helps manage resource implementation, and the relationship between multiple government agencies including the Department of Defence (DOD) and Food and Drug Administration (FDA) to contribute to the success of the RADx program.

