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Advancing 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 Advancing Biomedical Innovation
Project
Health System AI Governance
Duke-Margolis researchers are conducting a multi-part research project to better understand how health systems can effectively implement AI governance at their organizations.
Duke-Margolis researchers are conducting a multi-part research project to better understand how...
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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...
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Related Work
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Emerging Initiative: Cell and Gene Therapy Policy
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Leveraging cutting-edge medical science, cell and gene therapies now offer new options for patients with previously untreatable conditions, and are poised to revolutionize the treatment of genetic disorders, cancers, and potentially many chronic diseases. The pipeline of cell and gene therapies is expanding—with thousands of active trials globally, targeting oncology, central nervous system disorders, infectious diseases, sickle cell anemia, and other conditions. Despite this potential, significant challenges exist to advance these novel treatments from labs to the bedsides of the patients with serious and life-threatening conditions that they are designed to help.
This Emerging Initiative is built on foundational work, including these Issue Spotlights:
Clinical Trial Innovation
Clarifying the Pathway for Novel Alzheimer's Disease Drugs
Strengthening Drug Supply Chain Reliability and Leveraging Advanced Manufacturing Technologies
The State of Real-World Evidence
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Drug-Resistant Infections & Antimicrobial Resistance
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Click here for more Duke-Margolis work on Drug-Resistant Infections & Antimicrobial Resistance
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Reducing Viral Disease
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Click here for more Duke-Margolis work on 21st Century Public Health
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Early-State Alzheimer’s Disease Treatment
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Click here for more information regarding our work on Early-State Alzheimer’s Disease Treatment
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Issue Spotlight: Clarifying the Pathway for Novel Alzheimer’s Disease Drugs
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Duke-Margolis developed a framework that incorporates two potentially complementary options for a path forward to pursue needed post-market evidence development for Alzheimer's disease monoclonal antibodies treatments. This framework aims to address crucial evidence questions related to Medicare populations by refining and enhancing the adequacy of current and upcoming evidence systems. This forward-looking strategy will not only streamline evidence generation for AD therapies but also contribute to a more robust foundation for informed decision-making in AD health care.
More information:
Emerging Initiatives - Duke-Margolis Cell and Gene Policy Initiative and Enabling the Digital Health Revolution
Project Page - Alzheimer's
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Biosimilars
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Click here for more Duke-Margolis work on Biosimilars
Duke-Margolis Faculty & Research Team
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Vignesh Alagappan
2020 Margolis Intern
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Nancy Allen LaPointe
Faculty Fellow, Duke-Margolis Institute for Health Policy
Margolis Core Faculty
Adjunct Associate Professor in the Department of Medicine Faculty
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Nitzan Arad, LLM
Area Lead for Drug Pricing and Competition Policy
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Laura Benzing
2020 Margolis Intern
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Beena Bhuiyan Khan, MSc
Research Director for Payment and Coverage Policy
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Hayden Bosworth, PhD
Professor in Population Health Sciences
Margolis Affiliated Faculty
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Beth Boyer, MPH
Policy Research Associate
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Brian Canter, PhD
Policy Research Associate
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Madi Cordle
Policy Research Assistant
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Matt D'Ambrosio
Policy Analyst
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Nora Emmott, MPH
Policy Research Associate
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Nikhil Gadiraju
2020 Margolis Intern
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Hannah Graunke, MPP
Senior Policy Analyst
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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
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Nicholas R. Harrison, MPH, MA
Policy Research Associate
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Rachele Hendricks-Sturrup, DHSc, MSc, MA
Research Director, Real-World Evidence
Senior Team Member
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Cameron Joyce, MPA
Senior Policy Analyst
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Regina LaBelle, JD
Principal, LaBelle Strategies
Visiting Fellow
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Trevan Locke, PhD
Assistant Research Director
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Herbert Kim Lyerly, MD
George Barth Geller Distinguished Professor of Surgery
Margolis Core Faculty
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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
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Maryam Nafie
Policy Analyst
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Valerie Parker, MS
Assistant Research Director
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Kristin Podsiad, MPH
Senior Policy Analyst
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Arti K. Rai, JD
Elvin R. Latty Professor of Law
Margolis Core Faculty
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Eric S. Richardson, PhD
Faculty Executive Committee
Professor of Practice in Biomedical Engineering
Founding Director, Duke Design Health
Margolis Core Faculty
Margolis Executive Core Faculty
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David Ridley, PhD
Professor of the Practice of Business and Economics
Margolis Executive Core Faculty
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Thomas Roades, MPP
Policy Research Associate
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Patrick Rodriguez, MA
Policy Analyst
2024 Margolis Intern
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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
Molly Shields
Policy Research Assistant
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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
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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
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Sabine Sussman, MPH
Senior Policy Analyst
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Sreekanth Vemulapalli, MD
Assistant Professor of Medicine
Margolis Core Faculty
Events About Advancing Biomedical Innovation
More EventsEvent 5/13/2025
Health Policy Conference 2025: Evolving Better Health Care for Every American
WASHINGTON, DC
Join us for the 2025 Duke-Margolis Health Policy Conference. We will bring together leading policy…
Read MoreEvent 12/10/2024
Mortality and Antipsychotic Use in Dementia-Related Behavioral Disorders
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is…
Read MoreEvent 11/18/2024
From Principles to Practice: Exploring AI Governance in Health Systems
During this public webinar, Duke-Margolis and Duke Health will dive deeper into the topic of their…
Read MoreEvent 9/24/2024
The Second Annual Future of Prescription Drug Promotion and Digital Marketing Meeting
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is…
Read MorePublications About Advancing Biomedical Innovation
More Publications
Operational Tools and Best Practices to Support Electronic Health Record-Sourced Data Quality, Relevance, and Reliability at the Data Accrual Phase
Matt D'Ambrosio, Patrick Rodriguez, Nora Emmott, Rachele Hendricks-Sturrup
Matt D'Ambrosio, Patrick Rodriguez, Nora Emmott, Rachele Hendricks-Sturrup
2025
Read MoreIssue Brief
Building Value into Reimbursement for Prescription Digital Therapeutics
Christina Silcox, Sabine Sussman, Beena Bhuiyan Khan
Christina Silcox, Sabine Sussman, Beena Bhuiyan Khan
2024
Read MoreWhite Paper
Building a Resilient and Secure Pharmaceutical Supply Chain: The Role of Geographic Diversification
Thomas Roades, Cameron Joyce, Madi Cordle, Katherine Hamilton, Gerrit Hamre, Mark McClellan
Thomas Roades, Cameron Joyce, Madi Cordle, Katherine Hamilton, Gerrit Hamre, Mark McClellan
2024
Read MoreIssue Brief
Early Recommendations for Promoting Future Cell and Gene Therapy Competition Through Biosimilars
Brian Canter, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai
Brian Canter, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai
2024
Read MoreNews About Advancing Biomedical Innovation
More News
Press 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...
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December 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 MoreNews Update January 14, 2019
Susan Dentzer Appointed Visiting Fellow
The Duke-Margolis Center for Health Policy has appointed Susan Dentzer as a Visiting Fellow. Dentzer has been involved with the Center since its beginning as a member of the Duke-Margolis Advisory Board. As a Visiting Fellow, she will take on a larger role in supporting and contributing to the...
The Duke-Margolis Center for Health Policy has appointed Susan Dentzer as a Visiting Fellow. Dentzer...
Read MoreTopics Related to Advancing Biomedical Innovation
More TopicsTrending Topic
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Trending Topic
Drug-Resistant Infections & Antimicrobial Resistance (AMR)
Drug-resistant infections and antimicrobial resistance (AMR) are increasingly concerning. According…