Biomedical Innovation
Duke-Margolis, in partnership with FDA and a wide array of other stakeholder groups, is focused on improving the process of medical product development and regulatory review to increase the treatment options available to patients and the value that these products can introduce into the health care system. Our works centers on the following areas:
Regulatory Science
Medical Product Pricing and Payment
Real-World Evidence
Artificial Intelligence and Clinical-Decision Making Software
Projects Relating to Biomedical Innovation
Project
Advancing Hepatitis C Elimination
Through this research project, Duke-Margolis, in partnership with a range of stakeholders and experts, will develop an evidence-based implementation plan for a national hepatitis C elimination strategy. This work will build on evidence from past and current implementation activities, particularly previous initiatives undertaken by Louisiana and other states, as well as by CDC, HRSA, and other...
Through this research project, Duke-Margolis, in partnership with a range of stakeholders and...
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Duke-Margolis ReVAMP Drug Supply Chain Consortium
Reliable drug supply, Valuing availability, Advanced Manufacturing Technologies, and Patient-Center Focus (ReVAMP) The Consortium’s mission is to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and, ultimately, reduce the frequency and severity of drug shortages. Based on input from a wide range of experts involved in...
Reliable drug supply, Valuing availability, Advanced Manufacturing Technologies, and Patient-Center...
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Project
Project
Alzheimer's
FDA’s accelerated approval of aducanumab for the treatment of Alzheimer’s disease (AD) has added urgency to the discourse around evidence generation for this and other AD monoclonal antibodies (mAbs), treatment costs, and patient access to treatment. As more information is expected to flow from aducanumab’s phase 4 trial and pivotal trials of other anti-amyloid mAbs, important evidentiary gaps and...
FDA’s accelerated approval of aducanumab for the treatment of Alzheimer’s disease (AD) has added...
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Antimicrobial Incentives and Payment Reform
Combating the growing threat of antimicrobial resistance (AMR) requires generation of innovative antibiotics, but a low expected return on investment limits commercial development. Existing incentives have not adequately addressed the financial challenges developers encounter. Reviving investment and development in this space will require new approaches that create a sustainable market for...
Combating the growing threat of antimicrobial resistance (AMR) requires generation of innovative...
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Value for Medical Products Consortium
Duke-Margolis formed the Value for Medical Products Consortium (formerly the Value-Based Payment for Medical Products Consortium) in 2017 to address challenges to VBP arrangement implementation, including legal and regulatory barriers, and operational challenges to carrying out arrangements. Since its inception the Consortium has expanded its focus to include the advancement of VBPs and other...
Duke-Margolis formed the Value for Medical Products Consortium (formerly the Value-Based Payment for...
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Early-Stage Alzheimer's Disease Treatment
Alzheimer’s disease (AD) is a significant health burden for the elderly population, and is associated with more than 1.9 million annual deaths worldwide and more than $226 billion in direct healthcare costs in the U.S. With only five drugs currently on the market, there is an unmet medical need for patients. A number of innovative “early stage” AD therapies are currently under development that...
Alzheimer’s disease (AD) is a significant health burden for the elderly population, and is...
Read MoreDuke-Margolis Faculty & Research Team
Vignesh Alagappan
2020 Margolis Intern
Nancy Allen LaPointe
Faculty Fellow, Duke-Margolis Institute for Health Policy
Adjunct Associate Professor in the Department of Medicine Faculty
Margolis Core Faculty
Nitzan Arad, LLM
Assistant Research Director
Laura Benzing
2020 Margolis Intern
Beena Bhuiyan Khan, MSc
Research Director for Payment and Coverage Policy
Hayden Bosworth, PhD
Professor in Population Health Sciences
Margolis Affiliated Faculty
Beth Boyer, MPH
Policy Research Associate
Christina Bush, MPH
Policy Analyst
Brian Canter, Ph.D.
Policy Research Associate
Matt D'Ambrosio
Policy Analyst
Nora Emmott, MPH
Senior Policy Analyst
Nikhil Gadiraju
2020 Margolis Intern
Victoria "Tori" Gemme, MS, MBA
Research Associate
Hannah Graunke, MPP
Senior Policy Analyst
Marianne Hamilton Lopez, PhD, MPA
Senior Research Director, Biomedical Innovation
Faculty Director of the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty
Nicholas R. Harrison, MPH, MA
Policy Research Associate
Rachele Hendricks-Sturrup, DHSc, MSc, MA
Research Director
Senior Team Member
Grace Hoover
Policy Research Assistant
Cameron Joyce, MPA
Senior Policy Analyst
Dure Kim, PharmD
Assistant Research Director
Regina LaBelle, JD
Principal, LaBelle Strategies
Visiting Fellow
Trevan Locke, PhD
Assistant Research Director
Herbert Kim Lyerly, MD
George Barth Geller Distinguished Professor of Surgery
Margolis Core Faculty
Mark McClellan, MD, PhD
Director of the Duke-Margolis Institute for Health Policy
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty
Maryam Nafie
Policy Research Assistant
Valerie Parker, MS
Policy Research Associate
Kristin Podsiad, MPH
Senior Policy Analyst
Arti K. Rai, JD
Elvin R. Latty Professor of Law
Margolis Core Faculty
Eric S. Richardson, PhD
Faculty Executive Committee
Professor of Practice in Biomedical Engineering
Founding Director, Duke Design Health
Margolis Core Faculty
David Ridley, PhD
Professor of the Practice of Business and Economics
Margolis Executive Core Faculty
Thomas Roades, MPP
Senior Policy Analyst
Morgan Romine, MPA
Chief of Staff
Senior Team Member
Gillian Sanders Schmidler, PhD
Deputy Director, Duke-Margolis Institute for Health Policy
Professor of Population Health Sciences, School of Medicine
Margolis Executive Core Faculty
Anti-Racism and Equity Committee Member
Christina Silcox, PhD
Research Director, Digital Health
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty
Frank Sloan, PhD
J. Alexander McMahon Distinguished Professor Emeritus of Health Policy and Management
Corinna Sorenson, PhD, MHSA, MPH
Faculty Director of Undergraduate and Graduate Studies
Senior Advisor and Founding Director, Margolis Scholars Program
Assistant Professor in Population Health Sciences and Public Policy
Margolis Core Faculty
Anti-Racism and Equity Committee Member
Erin Soule, PhD
Assistant Research Director
Sabine Sussman, MPH
Policy Analyst
Kate Tsiandoulas, MBE
Policy Analyst
Sreekanth Vemulapalli, MD
Assistant Professor of Medicine
Margolis Core Faculty
Sandra E. Yankah, Ph.D.
Postdoctoral Researcher
Events About Biomedical Innovation
More EventsEvent 4/11/2024
2024 Health Policy Conference: Updating Health Reform for the Next Decade: Key Challenges and New Opportunities
WASHINGTON, DC
As the near-term national dialogue turns to the 2024 election, how do we take this moment to…
Read MoreEvent 3/19-3/20/2024
Enhancing Adoption of Innovative Clinical Trial Approaches
WASHINGTON, DC
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is…
Read MoreEvent 12/12/2023
Improving Regulatory Practices to Sustain Antibiotic Innovation
The third webinar in the series will focus on antibiotic development and consider how the…
Read MoreEvent 12/5/2023
Advancing Hepatitis C Elimination: A Coordinated National Approach
The Duke-Margolis Center for Health Policy is hosting a public conference to introduce and present…
Read MorePublications About Biomedical Innovation
More PublicationsCommentary
A key rapid-response tool for the next pandemic? Drug repurposing
Tanisha Carino and Beth Boyer
Tanisha Carino and Beth Boyer
2023
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Considerations for FDA’s New Advanced Pharmaceutical Manufacturing Programs
Stephen Colvill, Cameron Joyce, Thomas Roades, Gerrit Hamre
Stephen Colvill, Cameron Joyce, Thomas Roades, Gerrit Hamre
2024
Read MoreProject Report
Advancing Hepatitis C Elimination: A Coordinated Public Health and Health Care Strategy
Beena Bhuiyan Khan, Christina Bush, Victoria Gemme, Hannah Graunke, Mark McClellan
Beena Bhuiyan Khan, Christina Bush, Victoria Gemme, Hannah Graunke, Mark McClellan
2023
Read MoreWhite Paper
Bolstering Public Health Preparedness by Investing in Post-Market Incentives for Novel Antibiotics
Nicholas R. Harrison, Marianne Hamilton Lopez
Nicholas R. Harrison, Marianne Hamilton Lopez
2023
Read MoreNews About Biomedical Innovation
More NewsPress Release March 29, 2023
Duke-Margolis Launches Drug Supply Chain Resilience and Advanced Manufacturing Consortium
The Duke-Margolis Center for Health Policy has launched a new consortium to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and, ultimately, reduce the frequency and severity of drug shortages. The consortium’s growing...
The Duke-Margolis Center for Health Policy has launched a new consortium to identify effective...
Read MoreDecember 14, 2021
Duke-Margolis Postdoctoral Program in Health Policy
Educating the next-generation of health policy professionals comes at critical juncture with the US managing a global pandemic, improving clinical trial and real-world evidence development, and growing demands for a flexible regulatory apparatus that works to continue advancing innovative medical...
Educating the next-generation of health policy professionals comes at critical juncture with the US...
Read MoreTopics Related to Biomedical Innovation
More TopicsTrending Topic
Drug-Resistant Infections & Antimicrobial Resistance (AMR)
Drug-resistant infections and antimicrobial resistance (AMR) are increasingly concerning. According…
Trending Topic
Digital Health
Digital Health leverages the digitalization of health data and novel tools to empower more…
Trending Topic
Real-World Evidence
As thought leaders in RWE, Duke-Margolis engages public and private stakeholders in this burgeoning…