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

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Health System AI Governance

Duke-Margolis researchers are conducting a multi-part research project to better understand how...

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Clinical Trial Modernization

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Advancing Hepatitis C Elimination

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...

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21st Century Cures Act 2.0

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Real-World Evidence Collaborative

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Artificial Intelligence in Health Care

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Opioids and Substance Use

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Alzheimer's

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...

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Value for Medical Products Consortium

Duke-Margolis formed the Value for Medical Products Consortium (formerly the Value-Based Payment for...

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Timely Guidance on Payment and Coverage Reform

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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...

Emerging Initiative: Cell and Gene Therapy Policy: 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.

Read more here.

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

Drug-Resistant Infections & Antimicrobial Resistance: Click here for more Duke-Margolis work on Drug-Resistant Infections & Antimicrobial Resistance

Reducing Viral Disease: Click here for more Duke-Margolis work on 21st Century Public Health

Early-State Alzheimer’s Disease Treatment: Click here for more information regarding our work on Early-State Alzheimer’s Disease Treatment

Issue Spotlight: Clarifying the Pathway for Novel Alzheimer’s Disease Drugs: 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.

Read the full text here.

More information:

Emerging Initiatives - Duke-Margolis Cell and Gene Policy Initiative and Enabling the Digital Health Revolution

Project Page - Alzheimer's

Biosimilars: Click here for more Duke-Margolis work on Biosimilars

Vignesh Alagappan

2020 Margolis Intern

Nancy Allen LaPointe

Faculty Fellow, Duke-Margolis Institute for Health Policy
Margolis Core Faculty
Adjunct Associate Professor in the Department of Medicine Faculty

Nitzan Arad, LLM

Area Lead for Drug Pricing and Competition Policy

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

Brian Canter, PhD

Policy Research Associate

Madi Cordle

Policy Research Assistant

Matt D'Ambrosio

Policy Analyst

Nora Emmott, MPH

Policy Research Associate

Nikhil Gadiraju

2020 Margolis Intern

Victoria "Tori" Gemme, MS, MBA

Assistant Research Director

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

Dr. Rachele Hendricks-Sturrup, Research Director, Real World Evidence

Rachele Hendricks-Sturrup, DHSc, MSc, MA

Research Director, Real-World Evidence
Senior Team Member

Cameron Joyce, MPA

Senior Policy Analyst

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 Analyst

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
Margolis Executive Core Faculty

David Ridley, PhD

Professor of the Practice of Business and Economics
Margolis Executive Core Faculty

Thomas Roades, MPP

Policy Research Associate

Patrick Rodriguez, MA

Policy Analyst
2024 Margolis Intern

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