Policy Matters: A monthly newsletter for Duke Faculty, Students, and Staff from the
Duke-Margolis Center for Health Policy
Health Policy Update: August 2020
COVID-19 RESPONSE:
HEALTH POLICY IN ACTION
NATIONAL

COVID-19 Symptom Data Challenge Launched

Duke-Margolis, in partnership with Catalyst @ Health 2.0, Facebook Data for Good, the Delphi Group at Carnegie Mellon University (CMU), the Joint Program on Survey Methodology at the University of Maryland (UMD), and Resolve to Save Lives, an initiative of Vital Strategies, is sponsoring the COVID-19 Symptom Data Challenge. In this competition, participants will try to improve early detection and situational awareness of the outbreak using real-time symptom data that Carnegie Mellon University and the University of Maryland have been collecting with Facebook’s help. Duke-Margolis will convene researchers and stakeholders as part of the Challenge, which is accepting submissions until due Tuesday, September 29, 2020 11:59:59 PM ET. Learn more about the COVID-19 Symptom Data Challenge here: https://bit.ly/symptomdata.

Register for the Challenge’s September 8 informational webinar (more details in Events below).
Duke-Margolis authors Mark McClellan and Christina Silcox, together with Caitlin Rivers, PhD, an epidemiologist and assistant professor at the Johns Hopkins Center for Health Security, released “Legislative and Regulatory Steps for a National COVID-19 Testing Strategy,” a legislative brief that outlines actions and federal appropriation targets that Duke-Margolis believe are needed to get a robust, diversified testing strategy in place for the nation by fall 2020. Read the brief.

The report was covered by the New York Times news article and featured in a Times editorial
Duke-Margolis issued a primer on COVID-19 testing to provide guidance to employers, local, state, and federal officials in addressing the testing crisis. The report, funded by the Gordon and Betty Moore Foundation, addresses the pipeline challenges of COVID-19 testing from development to market and details critical issues to that need to be addressed to improve the nation’s testing response. Read the report.


It is urgent that policymakers come to grips with the COVID-19 testing issues and shape new approaches at the local, state, and national level,” said the authors. “The time for action is now.”
Duke-Margolis, represented by Managing Associate Nirosha Mahendraratnam Lederer, is leading the development of a protocol to study remdesivir use and outcomes in the real world, including alignment on data This work is part of the COVID-19 Evidence Accelerator (EA) an initiative launched by the Reagan-Udall Foundation, in collaboration with Friends of Cancer Research, and with support from FDA. The EA aims to provide a unique venue for major data organizations, government and academic researchers, and health systems to gather and design quick-turn-around queries and share their results. The Duke-Margolis has crafted a protocol that will be implemented by several data partners in parallel to generate rapid and robust results to fill key evidence gaps.
Core Faculty Member Janet Prvu Bettger published “Telerehabilitation in the Age of COVID-19: An Opportunity for Learning Health System Research,” in Physical Therapy. Read the article.
Core Faculty Members Nathan Boucher and Courtney Van Houtven also co-authored “A day in the life during COVID-19: long-term care providers in Durham, North Carolina,” in the Permanente Journal. Read the article

Center Deputy Director for Policy Marta Wosińska has been appointed to the National Academies of Sciences, Engineering, and Medicine’s Committee on Security of America’s Medical Product Supply Chain. Marta has addressed the a range of COVID-19 issues this month, including community spread in Politico and preparing young children for remote learning in Parade.  
Center Director Mark McClellan and fellow former FDA Commissioner Scott Gottlieb published an op/ed in the Wall Street Journal that addresses the FDA’s extraordinary role in the COVID-19 response, issues regarding convalescent plasma therapy, and the approaches necessary to reduce similar issues with future therapeutics. Read the op/ed.

Mark also commented on the revised FDA guidance regarding asymptomatic testing. Read the Wall Street Journal article.  
Four former FDA Commissioners McClellan, Gottlieb, Califf, and Hamburg published a Washington Post op/ed calling for new pathways for quickly advancing promising, safe, effective therapies, including plasma therapy, to treat patients fighting COVID-19. Read the op/ed.

We can’t waste precious time and put people at risk by treating them with therapies that don’t work or miss opportunities to collect data and determine when a treatment is beneficial.”
Core Faculty Members Corinna Sorenson and Mark McClellan with Center researchers Mark Japinga and Hannah Crook published a commentary in NEJM Catalyst that discusses the current, unprecedented opportunity to shape the health system, in general, and how to on build a better health system post-COVID through reducing low-value care, in particular. Read the commentary.
Core Faculty Members Brystana Kaufman and Marta Wosińska co-authored a commentary in NC Policy Watch, “Duke researchers: We must protect meat packing workers to combat community spread of COVID-19.” Read the commentary.
Director Mark McClellan discussed the COVID-pandemic, its unprecedented public health and economic impact, and the ongoing national challenges to control its spread in a Duke Alumni Magazine
Q & A and on the WillTalk podcast.
GLOBAL

Core Faculty Member Gavin Yamey published a Time commentary, “We Need to Take Care of the Growing Number of Long-Term COVID-19 Patients.” He also discussed vaccines as a global public good with the New Scientist (read the article) and gave a live interview with France 24 on the different manifestations of COVID-19. Watch here.
EVENTS
COVID-19 Symptom Challenge Webinar
Tuesday, September 8
1:00-2:00 pm (ET)

Join a COVID-19 Symptom Data Challenge webinar to learn more about this initiative, how to apply, hear more about experts’ responses to COVID-19, and the importance of data during the pandemic.
 
Topics addressed include:
o  Shortcomings of the existing tools for COVID-19 surveillance in the US
o  The case for better situational awareness of COVID activity
o  Overview of Symptom Data survey methodology
o  Preliminary analyses relating symptom trends to COVID intensity
o  Goals and operation of the Symptom Data Challenge
 
Learn more and register here
Safe and Effective Coronavirus Vaccination: The Path from Here
Thursday, September 10, 12 noon-2:15 pm (ET) via Zoom
 
Join former FDA commissioners and Dr. Peter Marks – the FDA official responsible for oversight of vaccines – along with trusted public health experts for a webinar on how FDA’s scientists will determine whether vaccines for COVID-19 are safe and effective, and how those vaccines can be equitably distributed and administered. View the event details and register here.
Annual Real World Evidence Conference: Applying Lessons Learned from RWE in the Time of COVID-19 to the Future
Thursday, October 1, 1:00-4:00 pm

COVID-19 has disrupted the evidence-generation paradigm, resulting in the expanded use of novel technologies, data, and evidence that will inform the future of drug-development. This meeting will explore how COVID-19 has accelerated decision-maker understanding and use of real-world data (RWD) and real-world evidence (RWE) and its application in a post-COVID-19 environment. View the event details and register here.
EDUCATION
Bass Connections, in partnership with Duke-Margolis, launched a COVID-19 Bass Pop Up Theme encompassing 13 interdisciplinary projects. In one week, nearly 500 student applications were received. that is engaging students, faculty, and external partners in addressing the myriad of complex health, health policy, economic, and social issues that have arisen as a result of COVID-19. Core Faculty member Buz Waitzkin with Assistant Director for Education Sarah Dunn Phillips are leading this effort in collaboration with faculty and researchers across the Center. Read more about the Duke-Margolis/Bass Connections COVID-19 projects here.
 
Core Faculty Member Barak Richman with Research Associate Hilary Campbell are part of interdisciplinary team teaching a new class this fall entitled, “Readings: Health Inequalities in the U.S.: Before, During, and After COVID.” Learn more here
RESEARCH
Core Faculty Member Brystana Kaufman is co-author of “National Trends in Hospice Facility Deaths in the United States, 2003-2017,” published in the Journal of Pain and Symptom Management. This analysis of national mortality data finds that the proportion of decedents in the United States dying in hospice facilities has markedly increased since 2003; however, significant disparities were noted. Read the article.
Duke-Margolis Senior Research Assistant Nicholas Harrison and Research Associate Sarah Sheehan published “Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases.” The brief summarizes challenges impeding the development of therapies for NASH and cholestatic liver disease and recommends goals for basic research and clinical study. Read the issue brief.

Duke-Margolis released “A Roadmap for Developing Study Endpoints in Real-World Settings.” This paper standardizes key definitions, details considerations for developing and validating endpoints in the real-world setting, and explores the opportunities to advance real-world endpoint development and validation through multi-stakeholder collaboration. It will serve as an important RWE resource for researchers and decision-makers throughout the drug life cycle. Read the paper.
Core Faculty Member Matthew Maciejewski with Duke colleagues is part of a deprescibing bariatric grant. Deprescribing refers to the thoughtful and systematic process of identifying problematic medications and either reducing the dose or stopping these medications in a manner that is safe, effective, and helps people maximize their wellness and goals of care. Read more about the effort.
Core Faculty Members Nathan Boucher, Courtney Van Houtven, Nina Sperber and Megan Shepherd-Bannigan co-authored “Inclusion of caregivers in veterans’ care: a critical literature review,” in Medical Care Research and Review. Read the article. Nathan also co-authored “Cultivating Cultural Competence: How Are Hospice Staff Being Educated to Engage Racially and Ethnically Diverse Patients?” in the American Journal of Hospice and Palliative Medicine. Read the article.
PEOPLE
Core Faculty Member Yousuf Zafar was named Chief Quality & Innovation Officer for the Duke Cancer Institute (DCI). "Dr. Zafar will collaborate with DCI, DUHS, and Duke Forge leaders on strategies to reduce emergency department visits, hospitalizations, over-utilization of care and cost to our patients," said Michael Kastan, MD, PhD, executive director of DCI. "These efforts will be key to realizing DCI’s value-based-care vision." Read more here
 



Core Faculty Member Rachel Greenup has been appointed Deputy Director of the Duke Surgical Center for Outcomes Resources (SCORES), is an interdisciplinary effort that promotes excellence in health services research for various surgical patient populations.


Core Faculty Member Aaron McKethan is featured in The Data Effect comic strip feature of the Duke Alumni Magazine. Read the feature. 

As part of ISPOR’s Professional Development Series on Replicate, Regulate, and Redefine: RWE use cases in the next decade, Managing Associate Nirosha Mahendraratnam Lederer presented on a Framework for Evaluating Real-World Data and Real World Evidence for Use in Regulatory Decisions.


New Margolis Scholar Ricky Anjorin (MD ‘21) published a prose piece entitled “Code Blue” in Annals of Internal Medicine, where she discusses the role of the medical field in combating racial injustice. Read the piece
Hemi Tewarson, JD MPH, joined Duke-Margolis as a Visiting Senior Policy Fellow. In this role, Hemi will have senior strategic responsibilities in the Center’s continued development and expansion of a substantial state health policy research and analysis program at Duke-Margolis. Specifically, Hemi will help strengthen the Center’s engagement in state-level COVID-19 response, including such areas as new models of care and effective strategies for COVID-19 testing and containment. Previously, Hemi served as the director for the Health Division of the National Governors Association’s (NGA) Center for Best Practices, overseeing a broad project portfolio including Medicaid transformation and coverage, Medicaid data systems, health care delivery and payment system reform, workforce, opioids, and behavioral health and social determinants. Prior to joining NGA, Hemi served as senior attorney for the Office of the General Counsel at the U.S. Government Accountability Office.
Gabriel Albors, MS, is the Portfolio Manager for Center research and operations. In this role, Gabriel coordinates and manages pre- and post-award activities for the Center’s diverse research portfolio of grants, contracts, and gift funding. Gabriel comes to Duke from Purdue University where he served most recently as the managing director for its Center for Implantable Devices. There, he contributed significantly to securing $4M in annual R&D grant funds and private company contracts. Simultaneously, he served as the Director of Operations and Clinical Trials for Bionde, LLC, a start-up company he helped build and for which he secured patents and IRB approval for its products.
Valerie Parker, MSc, has joined Duke-Margolis as Senior Research Assistant, working with Research Director Adam Kroetsch and the Biomedical Innovation team in DC. She comes to the Center from Epic Systems Corporation where she worked as a project manager where she coordinated and facilitated presentations of key software functionality to hospital executives and compiled and analyzed metrics and KPIs to monitor project success. Valerie is a Duke alum, earning both her Bachelor’s in cultural anthropology and her Masters of Science degree in Global Health. Core Faculty Member Krishna Udayakumar was her adviser for her Master’s thesis, “Barriers, Facilitators and Perspectives of Reverse Innovation in NHS England.” 
Richa Bhatt, MA, is the Center’s new Education and Workforce Development Program Coordinator, working with the Education team led by Sarah Dunn Phillips, Assistant Director of Education. In her role, Richa will coordinate and contribute to the planning, management, and execution of the Center’s student-facing Education programs and activities, including supporting Margolis Scholars, the Center’s internships, and para-curricular programs. Richa comes to Duke-Margolis from George Washington University, where she served as an Assistant Program Coordinator for the Office of Student Life. 
Nomair Alam, MS, has joined Duke-Margolis as a Senior Research Assistant working on the Value-Based Payment for Medical Products team lead by Marianne Hamilton Lopez. Nomair will focus in particular on antimicrobial product work with Managing Associate Monika Schneider. Nomair comes to Duke-Margolis from DAI, where he served as a Global Health Summer Intern working on antimicrobial resistance and stakeholder analysis for two related projects in Nigeria and Pakistan. He earned his Bachelor’s in Chemistry from Wake Forest University and his Master’s of Science in Public Health from UNC-Chapel Hill.
Caleigh Propes has joined Duke-Margolis as a Research Assistant with the Biomedical Innovation team, led by Research Director Adam Kroetsch. Caleigh is 2020 graduate of Yale University where she studied molecular, cellular, and developmental biology and completed her thesis on “Cancer Treatment and Associated Risk of Spontaneous Abortion.”
Anna Zavodszky has joined Duke-Margolis as a Research Assistant, working with Deputy Director, Policy, and Marta Wosinska on external engagements and internal projects related to operations of the Washington, DC office and working with our research teams on priority research projects. Her first set of projects involve the Rockefeller Foundation testing project headed by Managing Associate Christina Silcox, and the manufacturing capacity and drug shortages projects headed by Research Director Adam Kroetsch. Anna comes to Duke-Margolis from Research!America where she worked on biomedical and public health research funding issues.
Beverly Perkins has transferred from DCRI to fully join the Duke-Margolis team. Beverly is a long-standing member of the Duke community--she joined the Department of Medicine in 1996, joined Core Faculty Member Gillian Sanders Schmidler’s team at DCRI in 2009, and has been supporting Gillian as the Center’s Deputy Director of Academics, since 2017. 
Submissions Welcome!
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Policy Impact? Op Eds? 

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