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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Appendix C

Biographical Sketches of Workshop Speakers and Moderators

Stacey J. Arnesen, M.S., is the chief of the Disaster Information Management Research Center in the Specialized Information Services Division of the NLM, NIH. She has worked at NLM for 30 years, the past 15 years in the area of disaster information management. Her work includes the coordination of tools and resources to improve access to disaster medicine and public health information including disaster health literature, tools and apps for hazmat and CBRN incidents, and disaster information management research. Ms. Arnesen oversees the development of a gray literature database on disaster medicine and public health (http://disasterlit.nlm.nih.gov). Ms. Arnesen received her M.S. in neurobiology and behavior from Cornell University and her A.B. from Smith College.

Quazi Ataher, M.B.B.S., M.H.S., Ph.D., is a senior director of epidemiology in Worldwide Safety Strategy at Pfizer Inc. He is the epidemiology group lead for the Pfizer Essential Health and Pfizer Consumer Health businesses. He leads a group of epidemiologists responsible for developing pharmacoepidemiology programs to support drug development and safety assessment. He has more than 10 years of experience in designing and conducting epidemiology studies for multiple products in various therapeutic areas. Additionally, he is involved in the study and use of quantitative methods of product benefit–risk assessment at Pfizer. Prior to joining the pharmaceutical industry, Dr. Ataher practiced medicine in Bangladesh. He received his medical degree from Chittagong Medical College in Bangladesh, an M.H.S. in molecular microbiology and immunology from the Johns Hopkins Uni-

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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versity School of Hygiene and Public Health, and a Ph.D. in epidemiology from Emory University.

Suzanne Bakken, RN, Ph.D., FAAN, FACMI, is the alumni professor of nursing and professor of biomedical informatics at Columbia University. Following doctoral study in nursing at the University of California, San Francisco, she completed an NLM postdoctoral fellowship in medical informatics at Stanford University. She currently directs the Precision in Symptom Self-Management Center. In 2010, she received the Pathfinder Award from the Friends of the National Institute of Nursing Research. She is the past president of the American College of Medical Informatics, a fellow of the American Academy of Nursing, and a member of the National Academy of Medicine.

Raphael Barishansky, M.P.H., M.S., CPM, is the deputy secretary for health planning and assessment at the Pennsylvania Department of Health. He is a nationally recognized EMS and PHE preparedness leader, author, speaker, and advocate. From 2012 to 2015, he served as the director of the Office of Emergency Medical Services for the Connecticut Department of Public Health. Prior to that, he served as the chief of Public Health Emergency Preparedness and Response for the Prince George’s County (Maryland) Health Department from 2008 to 2012. Mr. Barishansky holds a B.A. from Touro College, an M.P.H. from New York Medical College, and an M.S. in homeland security studies from Long Island University. He is a graduate of the Senior Executives in State and Local Government program held at the John F. Kennedy School of Government at Harvard University (2006) and the Healthcare Leadership and Administrative Decision Making class held at the Center for Domestic Preparedness in Anniston, Alabama (2009). He has also earned a certified public manager (CPM) certification through Arizona State University. Mr. Barishansky has authored more than 300 articles in such publications as EMS Magazine, Journal of Emergency Medical Services, EMS Insider, Domestic Preparedness Journal, Journal of Homeland Security and Emergency Management, Emergency Management Magazine, Public Safety Communications, and Crisis Response Journal (UK). He is a nationally known speaker and has made more than 100 public presentations at various EMS and public health conferences.

Jeffrey Brown, Ph.D., is an associate professor in the Department of Population Medicine (DPM) at Harvard Medical School and the Harvard Pilgrim Healthcare Institute. He is research director of the Therapeutics Research and Infectious Disease program at DPM and chief operating officer and a member of the executive committee of the FDA Sentinel project. Dr. Brown is a health services researcher with expertise in pharmacoepidemiology

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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and medical product safety, with primary research interests in the development of approaches to facilitate multi-institutional medical product safety surveillance and research using electronic health data. He is co-lead of the PCORnet Distributed Research Network Operations Center, co-chair of the Informatics Core of the NCI Cancer Research Network, and co-lead of the EHR Core of the NIH Healthcare System Research Collaboratory. Dr. Brown is the lead architect and inventor of PopMedNet, an open-source software platform that facilitates the creation and operation of large-scale distributed health data networks. He holds a master’s degree in economics from Tufts University and a Ph.D. in social policy from Brandeis University.

Greg Burel, currently serves as the director of the Division of Strategic National Stockpile (DSNS), Office of Public Health Preparedness and Response, CDC. Prior to his leadership at DSNS, Mr. Burel developed an extensive background in supply chain management in the federal government beginning in 1982. In addition to CDC, his service includes management roles with increasing responsibility with the Internal Revenue Service, General Services Administration, and the Federal Emergency Management Agency. Mr. Burel was selected as a member of the Senior Executive Service and joined CDC in April 2005. In March 2007, he assumed his current position. In this role, Mr. Burel directs the nation’s premier medical materiel preparedness and response organization charged with supply chain management delivering critical medical assets to the site of a national emergency. Mr. Burel holds a bachelor’s of business administration degree from Georgia State University. He is a graduate of the Federal Executive Institute’s Leadership for a Democratic Society and Harvard University’s Kennedy School of Government National Preparedness Leadership Initiative. In 2016, Mr. Burel was awarded the Samuel J. Heyman Service to America Medal for Management Excellence. He is an elected Fellow of the National Academy of Public Administration.

Redonna Chandler, Ph.D., joined NCATS as the deputy director of the Division of Clinical Innovation (DCI) in April 2015. She brings extensive scientific and organizational leadership and supports coordination, collaboration, and communication for DCI and the CTSA Program. Dr. Chandler earned her Ph.D. in psychology from the University of Kentucky and is a licensed psychologist. As a clinician, she has treated those struggling with addiction, serious mental health issues, and infertility. She has been at NIH since 2002, serving in positions of increasing responsibility and leadership at the National Institute on Drug Abuse. Prior to joining NCATS, Dr. Chandler served as the acting deputy director for the Division of Epidemiology, Services and Prevention Research and as the chief of the Services Research Branch at the National Institute on Drug Abuse. She worked for the U.S.

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Department of Justice from 1996 to 2002, directing large drug treatment programs.

Perren Cobb, M.D., FACS, FCCM, is the director of Surgical Critical Care at Keck Medicine of the University of Southern California. At the Keck School of Medicine, he holds the rank of clinical professor of surgery and of anesthesiology. Dr. Cobb is founding director of the U.S. Critical Illness and Injury Trials Group, which fosters investigator-initiated hypothesis testing and strategic planning at the national level for critical illness and injury research. His academic interest is systems approaches to clinical quality improvement and preparedness for research emergencies. Dr. Cobb was an undergraduate at Vanderbilt University and received his medical degree from the University of Louisville School of Medicine. He trained in general surgery at the University of California, San Francisco, and completed fellowships in critical care at NIH and the University of Pittsburgh. His early research focus was the treatment of sepsis; he worked nationally with trauma collaborators to develop a novel sepsis diagnostic, the riboleukogram, which uses contemporary genomics and microfluidics technology to track the host response to injury and infection. More recently, he has worked with federal partners to establish new capabilities to conduct clinical research during public health emergencies, in the process standardizing data collection, analysis, and reporting tools. Dr. Cobb’s work has been supported by NIH, CDC, ASPR, FDA, BARDA, the American Association for the Surgery of Trauma, the Society of Critical Care Medicine, and the Barnes Jewish Hospital Foundation. His awards include the Research Scholarship Award of the American Association for the Surgery of Trauma, the Founders Grant for Critical Care Research of the Society of Critical Care Medicine, the George H.A. Clowes, Jr. Memorial Research Career Development Award of the American College of Surgeons, and the 2nd Annual Critical Care Medicine Distinguished Alumnus of the University of Pittsburgh. Dr. Cobb is a former president of the Association for Academic Surgery.

Rhona H. Cooper, M.S.N., M.A., RN, is the clinical coordinator on the Bioterrorism–Public Health Preparedness team at the Philadelphia Department of Public Health (PDPH), Division of Disease Control. She is responsible for the development and implementation of all plans relevant to the procurement, distribution, and dispensing of MCMs during a PHE in Philadelphia. She has a lead role in collaboration with state and federal partners, including the SNS, and coordinates with public and private agencies to expand mass medication capacity and readiness. Most recently, Ms. Cooper participated in the City of Philadelphia’s public health readiness planning and operations for the Papal visit in 2015 and the Democratic

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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National Convention in 2016. Ms. Cooper received her master’s degree in nursing from La Salle University and her master of arts in education from Arcadia University. Prior to joining PDPH, Ms. Cooper worked for the School District of Philadelphia, first as a school nurse and later as school nurse coordinator, where she had responsibility to oversee the health services provided by 200 certified school nurses in more than 350 public and nonpublic schools serving more than 150,000 school children in the City of Philadelphia.

Jeffrey R. Coughlin, M.P.P., is the senior director of Federal and State Affairs at the Healthcare Information and Management Systems Society (HIMSS). In this position, he leads HIMSS’s efforts to build stronger relationships with federal agencies and facilitates the building of a nationwide network of advocates for state-based initiatives that affect all aspects of health IT. Before joining HIMSS, Mr. Coughlin was the team leader for corporate accounts at the Marwood Group, where he worked with nonprofit health systems, health IT vendors, professional societies, and trade associations, analyzing how they could most effectively influence legislative and regulatory processes and focus their advocacy efforts. His career also included several years in the health care nonprofit advocacy world, where he led efforts in policy development, directed outreach to Congress and Executive Branch agencies, built advocacy coalitions with like-minded organizations, and created robust grassroots networks. Mr. Coughlin also worked for HHS, where he was part of the team responsible for the development, implementation, and management of the Government Performance and Results Act within HHS. Mr. Coughlin’s educational background includes a master’s degree in public policy from the College of William and Mary and a bachelor’s degree in political science from Providence College.

Theresa Cullen, M.D., M.S., is a family physician who retired from the U.S. Public Health Service (USPHS) in 2012 after more than 25 years of active duty. During her tenure with USPHS, she was a practicing family physician on multiple rural American Indian and Alaska Native reservations. She also led multiple software development and deployment initiatives within the Indian Health Service. When she was chief information officer for the Indian Health Service, RPMS (the Service’s health IT system) became the only ONC-certified health IT software suite within the federal government. Between 2012 and 2015, Dr. Cullen worked as the chief medical information officer for the Veterans Health Administration, where she developed a new model for field and community involvement in health IT, as well as supporting and expanding work in multiple areas of health IT, including interoperability and data sharing, standards and terminology, and informatics patient safety. She has worked to develop population health IT software

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

suites since 2002, including electronic clinical quality measures and expanded population health capabilities at the point of care. Her interests are in using health IT to help achieve health equity throughout the globe as well as ensure the use of appropriate technology to meet identified clinical needs. Dr. Cullen currently serves as the associate director for the Global Health Informatics Program at Regenstrief Institute, Inc., as well as visiting associate professor of family medicine at Indiana University School of Medicine.

John Fleming, M.D., serves as ONC’s deputy assistant secretary for Health Technology Reform. Prior to serving at ONC, Dr. Fleming served as a Representative from Louisiana’s 4th Congressional District from 2009 to 2017. He is an early adopter and supporter of health IT, having implemented an EHR in his Minden, Louisiana, practice in 1997. His public career also includes medical service in the U.S. Navy. Dr. Fleming was the 2007 Louisiana Family Practice Physician of the Year. Dr. Fleming earned his B.S. and M.D. at the University of Mississippi.

Henry “Skip” Francis, M.D., has been the director of the Data Mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, since March 11, 2013. In that capacity he directs a transdisciplinary group of senior sciences to test, create, and operate data analysis programs facilitating the efficient use of scientific methods to evaluate complex data information in order to make regulatory decisions for drug approval and drug safety. From October 2007 until March 10, 2013, Dr. Francis was the deputy director of the Office of Surveillance and Epidemiology (OSE) in CDER. Dr. Francis worked with the OSE director to lead five divisions of pharmacy and clinical scientists in the detection and study of adverse medical events occurring after the release of new drugs into the American health market (the post-market period). Dr. Francis’s specific interest is in the development of data mining techniques to enhance pharmaco vigilance capabilities in national medication use and health care databases. Prior to working in FDA, Dr. Francis was a basic and clinical researcher in NIAID, NIH. He worked in several clinical and epidemiologic research projects conducting AIDS and tropical research projects in the Democratic Republic of the Congo (DRC) and other projects in the Caribbean and the South Pacific. Dr. Francis was the director of the USPHS and Belgian Project SIDA (AIDS research) Research Laboratories in Kinshasa, DRC.

John D. Grabenstein, Ph.D., is the executive director for Medical Affairs for Merck Vaccines. He leads medical affairs and scientific policy activities for Merck’s and MSD’s global vaccine enterprise of more than 150 million doses annually for 12 vaccines to help reduce the burden of vaccine-preventable

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

diseases worldwide. A pharmacist with 37 years’ experience, he has served on multiple committees advising the U.S. government and published more than 400 articles and 9 books, primarily on topics of immunization, public health, and leadership. Dr. Grabenstein received his pharmacy degree from Duquesne University in 1980, a master’s degree in education from Boston University in 1988, and his doctorate in epidemiology from the University of North Carolina in 1999. Previously, as a colonel in the U.S. Army, Dr. Grabenstein directed the Military Vaccine Agency, where he organized “Immunization University” to train clinicians from many health disciplines. He oversaw U.S. Department of Defense immunization programs for 9 million troops, retirees, and family members spread across four continents and dozens of ships at sea. In 1996, he wrote the curriculum for “Pharmacy-Based Immunization Delivery,” a CDC-recognized 20-hour course coordinated by the American Pharmacists Association.

Elizabeth S. Higgs, M.D., MIA, DTMH, is a global health science advisor for the Division of Clinical Research (DCR), NIAID, NIH, HHS. During the 2014–2015 West African Ebola outbreak, Dr. Higgs was part of the NIAID DCR senior team designated to establish and advance the clinical research response for HHS under the Liberia–U.S. Joint Clinical Research Program, also known as PREVAIL in West Africa. During the outbreak, the PREVAIL program established research capacity and conducted clinical trials for Ebola vaccines and therapeutics, and it is currently conducting an Ebola natural history study for survivors. PREVAIL launched a study in summer 2016 to assess the ability of a novel compound to eradicate persistent Ebola viral RNA from semen. Dr. Higgs serves as the DCR liaison for the World Health Organization and collaborates with U.S. government agencies, including an interagency White House endeavor to mitigate the risk of Ebola transmission from survivors in West Africa. Dr. Higgs provided leadership for NIH collaborative international infectious disease research, including the Southeast Asia Infectious Disease Clinical Research Network and International Collaborations in Tropical Disease Research Network. She led the U.S. government interagency clinical design group on influenza therapeutics during the H1N1 2009 pandemic. She was formerly seconded by NIH to the U.S. Agency for International Development (USAID) as science advisor for research and innovation to the U.S. government Global Heath Initiative and the USAID Global Health Bureau, where she focused on science for development issues, including U.S. government Global Health Evidence Summits, evidence evaluation frameworks for global health decision making, and smart linkages between U.S. government development and science agencies, such as Partnerships for Enhanced Engagement in Research’s Implementation Science for Child Survival. Dr. Higgs initiated and is helping to steer a multilateral effort to

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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establish norms for social sciences in global health with a particular focus on integration with biomedical interventions for women and children. A career focus includes the development of independent research capacity in low- to middle-income countries. Research interests have focused broadly on influenza therapeutics, HIV, tropical diseases, nutrition, emerging infectious diseases, Ebola, and research responses to pandemics. She is trained in internal medicine and infectious diseases. She received a doctorate in medicine from the University of Virginia (UVA), a master’s degree in international affairs from Columbia University, an interdisciplinary bachelor’s degree in bioethics from UVA, and a diploma in tropical medicine and hygiene from the London School of Tropical Medicine & Hygiene.

Lou Ann Lance, RN, M.S.N., is a public health program nurse at the New York State Department of Health in the Bureau of Communicable Disease Control, Division of Epidemiology. She serves as a nurse epidemiologist and provides technical assistance and clinical guidance to local and state jurisdictions for MCM screening and dispensing operations, including PODs and community reception center sites. She is responsible for developing medical and epidemiological data collection and screening protocols, including clinical algorithms, and serves as a member of the program leadership team to guide all-hazard development priorities for the New York State Countermeasure Data Management System. She routinely provides onsite clinical leadership for large-scale immunization and mass dispensing events. Until 2011, Ms. Lance served as the clinical director for a local health department where she led a team of public health professionals responsible for all jurisdictional public health education and prevention activities as well as communicable disease, nutrition, and emergency preparedness and response programs. She also provided administrative and clinical oversight for the Article 28 dental clinic and a certified home health agency. Ms. Lance previously served as an adjunct professor at Elmira College and a clinical associate at the State University of New York at Binghamton, Decker School of Nursing. Ms. Lance received her bachelor’s degree from Cedar Crest College, Allentown, Pennsylvania, and completed her M.S.N. degree at Syracuse University.

Joseph Larsen, Ph.D., is the acting director of the Division of CBRN Medical Countermeasures within the BARDA. In that role, he oversees a $2.8 billion fund for the development and procurement of medical products for use during public health emergencies. He is also the BARDA lead for BARDA’s work on combating antibiotic-resistant bacteria and is an executive member of CARB-X, a novel $450 million public–private partnership focused on promoting innovation in antibacterial drug development. Dr. Larsen has been actively involved in discussing potential reforms to the

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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economic incentive structures for antibacterial drug development. Previously Dr. Larsen served as deputy director of BARDA’s CBRN Division. During 2010–2014, Dr. Larsen served as chief of the Broad Spectrum Antimicrobials program at BARDA. The goal of this program is to develop additional antimicrobial treatment options needed to counter the growing threat of antimicrobial resistance. In that role, he oversaw a portfolio of approximately $1.2 billion in programs that support the development of novel antibacterial and antiviral drugs. Dr. Larsen also serves as the BARDA representative on the U.S. Transatlantic Task Force on Antimicrobial Resistance. Dr. Larsen received his Ph.D. in microbiology from the Uniformed Services University of the Health Sciences and his B.A. with honors from the University of Kansas.

Eva K. Lee, Ph.D., is the Virginia C. and Joseph C. Mello chair (for health care delivery and operations) and professor in the H. Milton Stewart School of Industrial and Systems Engineering at Georgia Institute of Technology, and director of the Center for Operations Research in Medicine and HealthCare, a center established through sponsorships from the National Science Foundation (NSF) and the Whitaker Foundation. The center focuses on biomedicine, public health, and defense, advancing domains from basic science to translational medical research; intelligent, quality, and cost-effective delivery; and medical preparedness and protection of critical infrastructures. She is a distinguished scholar in Health Systems, Health System Institute at Georgia Tech and Emory University. She is also the co-director of the Center for Health Organization Transformation, an NSF Industry/University Cooperative Research Center. Dr. Lee partners with hospital leaders to develop novel transformational strategies in delivery, quality, safety, operations efficiency, information management, change management, and organizational learning. Her research focuses on mathematical programming, information technology, and computational algorithms for risk assessment, decision making, predictive analytics and knowledge discovery, and systems optimization. She has made major contributions in advances to medical care and procedures, emergency response and medical preparedness, health care operations, and business operations transformation. Dr. Lee serves on the National Preparedness and Response Science Board, a federal advisory committee that provides advice and guidance to ASPR within the HHS, and to the HHS secretary on preventing, preparing for, and responding to adverse health effects of emergencies. She is the principal investigator of an online interoperable information exchange and decision support system for mass dispensing, emergency response, and casualty mitigation. The system integrates disease-spread modeling with response processes and human behavior and offers efficiency and quality assurance in operations and logistics performance. It currently has more than 10,000

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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public health site users. Dr. Lee has also performed field work within the United States on mass dispensing design and evaluation, and she worked with local emergency responders and affected populations after Hurricane Katrina, the Haiti earthquake, the Fukushima Japan radiological disaster, and Hurricane Sandy. Dr. Lee has received prestigious analytics and practice excellence awards including, the INFORMS Franz Edelman award and the Daniel H. Wagner prizes for novel cancer therapeutics, bioterrorism emergency response dispensing for mass casualty mitigation, optimizing and transforming clinical workflow and patient care, vaccine immunity prediction, and reducing hospital-acquired conditions. She is an INFORMS fellow and has received seven patents on innovative medical systems and devices.

Alison Levy, M.P.P., CEM, is the emergency operations manager for Public Health–Seattle and King County, a metropolitan health department serving a diverse jurisdiction of more than 2 million people. As the second in command for the public health preparedness program, she oversees a suite of capabilities, including emergency operations, medical materiel management, MCM dispensing, responder health, volunteer management, and training and exercise. She is a past chair of the National Association of County and City Health Officials’ MCM work group and serves as a mentor to new public health preparedness coordinators across the country. She is a frequent national speaker on alternative dispensing modalities, including pharmacy- and health care–based mass dispensing and closed points of dispensing. Ms. Levy has worked in the field of PHE preparedness since 2002, and in that time has coordinated the health and medical response to more than 50 emergencies. Prior to working in public health preparedness, she was a health policy analyst with AARP in Washington, DC. She completed her master’s degree in public policy at American University.

Boris D. Lushniak, M.D., M.P.H., Rear Admiral (retired), has been the dean of the School of Public Health at the University of Maryland since January 2017. Prior to that, he served as a professor and chair of the Department of Preventive Medicine and Biostatistics and Professor of Dermatology, F. Edward Hébert School of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. Dr. Lushniak was the U.S. Deputy Surgeon General from November 2010 to September 2015, assisting the Surgeon General to articulate the best available scientific information to the public to improve personal health and the health of the nation. He also oversaw the operations of the USPHS Commissioned Corps, comprising approximately 6,700 uniformed health officers who serve in locations around the world to promote, protect, and advance the health and safety of our nation. Dr. Lushniak served as acting surgeon general from July 2013 to December 2014 and was responsible for the release of the

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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50th Anniversary Surgeon General’s Report on Smoking and Health and the first-ever Surgeon General’s Call to Action to Prevent Skin Cancer. From January to March 2015 he served as commander of the USPHS Monrovia Medical Unit in Liberia, the only U.S. government hospital providing care to Ebola patients. Dr. Lushniak began his USPHS career in 1988 in the Epidemic Intelligence Service and initially served with CDC’s National Institute for Occupational Safety and Health (NIOSH) in Cincinnati, Ohio, where he conducted epidemiological investigations of workplace hazards. In 1993 he completed a dermatology residency at the University of Cincinnati and established an occupational skin disease program at NIOSH. He also served on assignments in Bangladesh, St. Croix, Russia, and Kosovo, was part of the CDC/NIOSH team at Ground Zero and part of the CDC anthrax team in Washington, DC. In 2004 he transitioned from CDC to FDA in the Office of Counterterrorism and was appointed FDA assistant commissioner in 2005. He was deployed to Hurricane Katrina and also served as the FDA deputy incident commander for the 2009 pandemic response. He was promoted to Rear Admiral, Lower Half in 2006 and attained the rank of Rear Admiral, Upper Half in 2010. He retired from USPHS On October 1, 2015, after 27 years of service. He was admitted to the 6-year Honors Program in Medical Education at Northwestern University and completed his B.S. degree in 1981 and M.D. in 1983. In 1984 he completed an M.P.H. degree at Harvard University. He completed a residency in family medicine in 1987 (St. Joseph Hospital, Chicago) and maintains certifications in dermatology and preventive medicine (occupational). A firm believer in leadership by example, Dr. Lushniak promotes the core messages of the National Prevention Strategy via his active lifestyle.

Carmen Maher, M.A., RN, RAC, is a nurse officer in the USPHS Commissioned Corps. She is an assistant surgeon general and is currently serving as acting assistant commissioner for counterterrorism policy and acting director of the Office of Counterterrorism and Emerging Threats in the Office of the Chief Scientist, FDA. In this capacity, Rear Admiral (RADM) Maher is responsible for providing leadership, coordination, and oversight for FDA’s national and global health security, counterterrorism, and emerging threat portfolios. She serves as FDA’s point of entry on policy and planning matters concerning counterterrorism and emerging threats and collaborates across the U.S. government and internationally on actions to advance global health security and U.S. national security. RADM Maher works in collaboration with other U.S. government agencies to define and prioritize requirements for MCMs to respond to public health emergencies, coordinate research for evaluating MCMs, set strategies for deployment and use of MCMs, and facilitate access to MCMs during public health emergencies. RADM Maher also leads FDA’s Medical Countermeasures Initiative, a key component of

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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a broad U.S. government program to improve the United States’ capacity to respond quickly and effectively to public health emergencies. RADM Maher has supported MCM and counterterrorism programs at FDA since 2006. From 2002 to 2006, she served as nurse officer and lead regulatory officer for preclinical and early clinical development of infectious disease vaccines and therapeutics at the Division of Microbiology and Infectious Diseases, NIAID, NIH. RADM Maher began her nursing career in 1993 as an ensign in the U.S. Navy, assigned to the National Naval Medical Center in Bethesda, Maryland. She has more than 20 years’ experience in nursing, regulatory affairs, clinical trials and medical product development, public health, and emergency response. RADM Maher earned an associate’s degree and B.S.N. from the University of Puerto Rico. She earned an M.A. in national security and strategic studies with highest distinction from the U.S. Naval War College in Rhode Island, and holds a regulatory affairs certification in U.S. health care product regulations.

Deven McGraw, J.D., M.P.H., L.L.M., is the deputy director for Health Information Privacy at the HHS OCR and is the acting chief privacy officer for the ONC. She is a well-respected expert on HIPAA rules and brings to her positions a wealth of experience in both the private sector and the nonprofit advocacy world. Prior to joining HHS, she was a partner in the health care practice of Manatt, Phelps & Phillips, LLP. She previously served as the director of the Health Privacy Project at the Center for Democracy and Technology, which is a leading consumer voice on health privacy and security policy issues, and as the chief operating officer at the National Partnership for Women and Families, where she provided strategic leadership and substantive policy expertise for the partnership’s health policy agenda. Ms. McGraw graduated magna cum laude from the University of Maryland. She earned her J.D., magna cum laude, and her L.L.M. from Georgetown University Law Center and was executive editor of the Georgetown Law Journal. She has an M.P.H. from the Johns Hopkins University School of Hygiene and Public Health.

Amanda Fuller Moore, Pharm.D., served as the North Carolina SNS, CHEMPACK, and Cities Readiness Initiative coordinator for 11 years. Currently, she is the interim bioterrorism coordinator for the North Carolina (NC) Department of Health and Human Services Division of Public Health and will transition to serve as the NC Division of Public Health Pharmacist. After graduating from the University of North Carolina School of Pharmacy in 2003, she completed two pharmacy residencies at Wake Forest University Baptist Medical Center in Winston Salem, NC, where she specialized in critical care. After gaining hands on experience with

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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SNS after Hurricane Katrina, Dr. Moore joined the NC Division of Public Health’s Office of Public Health Preparedness and Response. As part of her responsibilities, she worked with all local health departments and hospitals in North Carolina to ensure they met CDC requirements for SNS. She also oversaw other pharmacy projects related to bioterrorism and natural disasters, including MCMs for radiation emergencies and pandemic planning. In addition, Dr. Moore works with the Epidemiology Section on 340b issues, serves as the Board of Pharmacy Liaison, and participates in the HHS Pharmacy Task Force.

J. Marc Overhage, M.D., Ph.D., is the chief medical informatics officer and vice president for Strategic Intelligence for Cerner. Prior to this role he was the founding chief executive officer of the Indiana Health Information Exchange and was director of Medical Informatics at the Regenstrief Institute, Inc., and the Sam Regenstrief Professor of Medical Informatics at the Indiana University School of Medicine. He has spent more than 25 years developing and implementing clinical and scientific systems and evaluating their value. Working at the Regenstrief Institute, he created a community-wide electronic medical record (the Indiana Network for Patient Care) containing data from many sources including laboratories, pharmacies, and hospitals in central Indiana. More than 104 acute care hospitals and more than 22,000 physicians participate in the system, which includes inpatient and outpatient encounter data, laboratory results, immunization data, and other selected data. To create a sustainable financial model, he helped create the Indiana Health Information Exchange, a not-for-profit corporation. In addition, Dr. Overhage has developed and evaluated clinical decision support including inpatient and outpatient computerized physician order entry and the underlying knowledge bases to support them. He practiced general internal medicine for more than 20 years in ambulatory, inpatient, and emergency care settings. Over the past decade, Dr. Overhage has played a significant regional and national leadership role in advancing the policy, standards, financing, and implementation of health information exchange. He serves on the HIMSS Board of Directors and has served on the HIT Standards Committee, the National Committee for Vital and Health Statistics, and the Board of Directors of the National Quality Forum, eHealth Initiative, and the American Medical Informatics Association. Dr. Overhage earned his M.D. and a doctorate in biophysics from the Indiana University School of Medicine, where he also completed a residency in internal medicine and served as chief resident in medicine, and he completed a fellowship in medical informatics at the Regenstrief Institute. He is a fellow of the National Academy of Medicine, a master of the American College of Physicians, and a fellow of the American College of Medical Informatics.

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

Anita Patel, Pharm.D., M.S., is a senior advisor and the lead for pandemic medical care and countermeasures with the Influenza Coordination Unit in the National Center for Immunization and Respiratory Disease (NCIRD), CDC. She is a clinical pharmacist with more than 13 years of experience in managing and improving programs related to public health response, including implementing new strategies and improving systems for drug and vaccine dispensing and administration, creating new tools for communication and surveillance, and science-based operational solutions. Prior to her role in NCIRD, Dr. Patel spent more than 10 years providing scientific oversight, management, strategic development, and budget planning for the CDC’s SNS. Her past experience also includes having a key role in CDC’s MCM response efforts for various responses, including Hurricane Katrina, the 2009 H1N1 influenza pandemic, and the 2014 Ebola response. Dr. Patel graduated with a doctorate in pharmacy from the University of the Sciences, Philadelphia College of Pharmacy, and completed a 2-year Rutgers post-doctoral pharmaceutical industry fellowship. She also holds a master’s degree in biosecurity and disaster preparedness from Saint Louis University School of Public Health.

Amanda F. Peppercorn, M.D., is a late-stage clinical development leader at GSK. She attained her medical degree at Harvard Medical School in 1998 and completed her internal medicine residency and adult infectious diseases fellowship at Massachusetts General Hospital. She was on faculty at the University of North Carolina (UNC) at Chapel Hill, from 2005 to 2009, focusing on immune-compromised hosts (transplant infectious diseases and HIV), and she continued as an adjunct professor of medicine at UNC until 2014. Since joining GSK in 2009, she has played a leadership role in the development of biomedical countermeasures, leading the programs for raxibacumab, a monoclonal antibody treatment for anthrax, and intravenous zanamivir, an intravenous treatment for severe and/or pandemic influenza. She has experience leading a large cross-functional matrix team in the development and execution of Phase 2 and 3 clinical trials, engaging with U.S. and global regulatory agencies, and partnering with key public health agencies such as BARDA and CDC.

Paul E. Petersen, Pharm.D., is the director of the Tennessee Department of Health’s Emergency Preparedness Program. He serves as principal for Tennessee’s federally funded ASPR Hospital Preparedness Program (HPP) and the CDC Public Health Emergency Preparedness (PHEP) cooperative agreements. He oversees the operations and strategic direction of approximately 120 staff members statewide. Dr. Petersen serves as lead in Tennessee’s response to all public health and medical emergencies. Tennessee has experienced a wide range of threats and public health emergencies requiring

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

decisive action by the HPP-PHEP–funded Emergency Preparedness program staff, health care coalitions, and partners. Events of the past 5 years include the 2012 fungal infections outbreak, 2013 Jefferson County Interstate bus crash, 2014–2015 Ebola infections, 2015 Blount County train derailment, 2016 Zika infections, and the 2016 Gatlinburg wildfire response. Each event has presented opportunities to demonstrate the life-saving impact of the infrastructure built by preparedness funding over time. Dr. Petersen earned his doctorate of pharmacy at the University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences. He completed his postgraduate pharmacy practice residency at Saint Thomas Hospital in Nashville, where he also served as the clinical operating room pharmacist prior to his move to state government. He is an active member of several professional public health and pharmacy associations. He also serves on various national preparedness policy committees, including work with the National Academy of Sciences.

Richard Platt, M.D., M.Sc., is an internist and infectious disease clinician and epidemiologist. He is professor and chair of the Harvard Medical School Department of Population Medicine and executive director of the Harvard Pilgrim Healthcare Institute. He is principal investigator of the FDA Sentinel system, which has created a distributed data network based on information available to national insurers, health plans, and CMS. He led the development, with the Massachusetts Department of Public Health, of ESPnet, a system for doing real-time EHR-based surveillance for both syndromes of interest and individually notifiable conditions. This work was funded by a CDC National Center of Excellence in Public Health Informatics and ONC. He is also co-principal investigator of the National Patient-Centered Clinical Research Network Coordinating Center, which is developing standard methods for extracting and using EHR data for multiple uses. Dr. Platt co-leads the coordinating center of the NIH Healthcare System Research Collaboratory and leads a CDC Prevention Epicenter. He co-chairs the CER Innovation Collaborative of the National Academy of Medicine’s Leadership Consortium for a Value and Science-Driven Health System, and he is a member of the American Medical Colleges Advisory Panel on Research.

Scott Proestel, M.D., is the director of the Division of Epidemiology at the FDA Center for Biologics Evaluation and Research. His division uses active and passive surveillance strategies to identify new safety issues with medical therapies approved for use in the United States. He is the primary investigator for a project exploring the use of IBM Watson to perform causality assessments of spontaneous adverse event reports submitted to the FDA Adverse Event Reporting System and the Vaccine Adverse Event

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

Reporting System. Dr. Proestel received his bachelor’s degree in biology from Johns Hopkins University and his medical degree from Columbia University College of Physicians & Surgeons. He completed his internal medicine residency at Johns Hopkins Hospital.

Joe Vasey, Ph.D., is a health care epidemiologist with more than 25 years of experience in health outcomes and health care quality research. At Practice Fusion, Dr. Vasey is responsible for the design, planning, oversight, and interpretation of studies related to quality of care and outcomes of care based on data collected through the Practice Fusion platform. Before working at Practice Fusion, Dr. Vasey was with Quintiles and General Electric Healthcare. At Quintiles, he served as director of Epidemiology, Late Phase, and Real-World Evidence, where he was responsible for the development, planning, scientific oversight, and execution of programs and studies in clinical data services for the biopharmaceutical industry. He occupied a similar position at GE Healthcare IT. Prior to that, Dr. Vasey held a research scientist appointment at Penn State’s Center for Healthcare and Policy Research, where, in addition to his research activities, he taught graduate-level courses in statistics and research methods.

Adam Wilcox, Ph.D., is the chief analytics officer at the University of Washington (UW) School of Medicine and a professor of biomedical informatics at UW. He has broad experience in applied and research informatics, with experience both in academia and health care delivery organizations. He leads efforts to develop and implement a data and analytics strategy to help UW Medicine effectively use data to improve care delivery and transformation. Nationally, he is noted for his work with designing, developing, and sustaining research data systems for populations with research and EHR data; for design and implementation of health information systems; and for advancing methods in sustainability of data systems. Previously, he was a director of medical informatics at Intermountain Healthcare, where he led Intermountain’s clinical decision support efforts and directed its analytic health repository. At Columbia University and New York Presbyterian Hospital, he designed research systems that advanced patient-reported data for population health, and he was the director of clinical databases, managing both the clinical data repository and data warehouse. Prior to this role, he worked at Intermountain Healthcare where he led efforts in development of primary care and care management systems. He is an elected fellow of the American College of Medical Informatics, a senior editor for eGEMs, and a Clinical Informatics Subcommittee member for the American Board of Preventive Medicine, which administers the board examination for the clinical informatics subspecialty. He has authored more than 100 book chapters, peer-reviewed articles, and abstracts in clinical informatics. In

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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2015, he was appointed a member of the PCORI Methodology Committee, where he is a leader on that committee in informatics and investigating issues with the use of secondary data for outcomes research.

Yon C. Yu, Pharm.D., is the associate director for regulatory affairs in the National Center for Emerging and Zoonotic Infectious Diseases, CDC. She provides scientific regulatory expertise and programmatic support for CDC’s oversight regarding stockpiled MCMs. Among other tasks, she coordinates to ensure that FDA-compliant regulatory mechanisms are in place for the stockpiled MCMs to facilitate their rapid deployment and optimal clinical use during potential public health emergencies involving high-consequence or emerging threats such as pandemic influenza, anthrax, and botulism. She also leads regulatory support for various experimental drugs that are only available through CDC for routine public health needs regarding rare diseases, such as Chagas disease, free-living amoebae infections, and malaria given the lack of approved treatment options. She coordinates CDC’s assessment of unmet medical needs and most effective drugs for a given threat agent to develop the protocols that inform and guide the health care providers about the appropriate safe and effective use of the MCMs.

Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Appendix C: Biographical Sketches of Workshop Speakers and Moderators." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication.

As part of the United States’ scientific and research preparedness enterprise, there is an imperative to go “beyond the last mile” of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6–7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.

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