
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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Drug Supply Chain Resilience and Advanced Manufacturing Consortium
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 manufacturing, distributing, purchasing, prescribing, and regulating prescription drugs, the Consortium will put forward...
The Consortium’s mission is to identify effective policy solutions that promote a resilient drug...
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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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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 Center for Health Policy
Adjunct Associate Professor in the Department of Medicine Faculty
Margolis Core Faculty

Laura Benzing
2020 Margolis Intern

Hayden Bosworth, PhD
Professor in Population Health Sciences
Margolis Affiliated Faculty

Beth Boyer, MPH
Policy Research Associate

Christina Bush, M.P.H.
Policy Analyst

Brian Canter, Ph.D.
Policy Research Associate

Ethan Chupp
Policy Analyst

Matt D'Ambrosio
Policy Research Assistant

Nora Emmott, MPH
Senior Policy Analyst

Nikhil Gadiraju
2020 Margolis Intern

Victoria "Tori" Gemme, MBA
Research Associate

Hannah Graunke, MPP
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

Cameron Joyce
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 Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty

Maryam Nafie
Policy Research Assistant

Valerie Parker
Policy Research Associate
Caleigh Propes
Policy Analyst

Arti K. Rai, JD
Elvin R. Latty Professor of Law
Margolis Core Faculty

Derick Rapista
Research Assistant

Rebecca (Becky) Ray
Senior Policy Analyst

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, Margolis Center
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

Sreekanth Vemulapalli, MD
Assistant Professor of Medicine
Margolis Core Faculty

Sandra Yankah, Ph.D.
Postdoctoral Researcher
Events About Biomedical Innovation
More EventsEvent 6/8/2023
Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches
Innovative manufacturing technologies have the potential to improve the manufacture of…
Read MoreEvent 6/7-6/8/2023
Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development
The Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, is…
Read MoreEvent 5/17/2023
Duke-Margolis 2023 Health Policy Conference: Reversing the Slide in America's Health
WASHINGTON, DC
Join the Duke-Margolis Center for its 2023 Health Policy Conference, May 17, offered in-person at…
Read MoreEvent 5/9/2023
Drug-Resistant Infections & the Immediate and Future Demand for Novel Antimicrobials
Congressional policymakers, congressional staff, federal policy professionals, and stakeholders…
Read MorePublications About Biomedical Innovation
More PublicationsPolicy Brief
Alzheimer’s Disease Monoclonal Antibodies with Traditional Approval: Clarifying the Pathway for Medicare Postmarket Evidence Development and Use
Nitzan Arad, Elizabeth Staton, Marianne Hamilton Lopez, Mark McClellan
Nitzan Arad, Elizabeth Staton, Marianne Hamilton Lopez, Mark McClellan
2023
Read MoreComment Letter
Comment Letter on Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization
Beth Boyer, Brian Canter, Nicholas Harrison, Frank McStay, Thomas Roades, Christina Silcox, Morgan Romine, Mark McClellan
Beth Boyer, Brian Canter, Nicholas Harrison, Frank McStay, Thomas Roades, Christina Silcox, Morgan Romine, Mark McClellan
2023
Read MoreWhite Paper
Preventing Bias and Inequities in AI-Enabled Health Tools
Trevan Locke, Valerie J. Parker, Andrea Thoumi, Benjamin A. Goldstein, Christina Silcox
Trevan Locke, Valerie J. Parker, Andrea Thoumi, Benjamin A. Goldstein, Christina Silcox
2022
Read MoreIssue Brief
How To Motivate Drug Development For Infectious Diseases
Beth Boyer, Adam Kroetsch, Andrea Thoumi, David B. Ridley
Beth Boyer, Adam Kroetsch, Andrea Thoumi, David B. Ridley
Health Affairs, 2022
Read MoreNews About 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 MoreTopics Related to Biomedical Innovation
More Topics
Trending Topic
Drug-Resistant Infections & Antimicrobial Resistance (AMR)
Drug-resistant infections and antimicrobial resistance (AMR) are increasingly concerning. According…

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Digital Health
Digital Health leverages the digitalization of health data and novel tools to empower more…

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Value-Based Payment for Medical Products
Amidst the broader shift from a fee-for-service (FFS) payment structure to a value-based U.S…

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Real-World Evidence
As thought leaders in RWE, Duke-Margolis engages public and private stakeholders in this burgeoning…