
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
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...
Read MoreProject
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...
Read MoreProject
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...
Read MoreProject
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

Adam Aten, MPH, MSc
Assistant Research Director

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
Senior Policy Analyst

Nikhil Gadiraju
2020 Margolis Intern

Victoria "Tori" Gemme, MBA
Research Associate

Mira Gill, MS
Policy Analyst

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

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
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
Events About Biomedical Innovation
More EventsEvent 3/2/2023
Data Capture to Measure, Track, and Improve Antibiotic Use
Report on stakeholder interest in real-world evidence that might contribute to more frequently…
Read MoreEvent 9/15/2022
Advancing Bacterial Diagnostic Development
Policymakers, researchers, and others combating AMR Duke-Margolis are invited to join Duke-Margolis…
Read MoreEvent 5/24-5/25/2022
Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More
As the biological mechanisms of diseases and pharmacological activities of therapeutics are better…
Read MoreEvent 4/12/2022
Duke-Margolis 2022 Inaugural Health Policy Conference
WASHINGTON, DC
The Duke-Margolis Inaugural Health Policy Conference will engage national health policy experts,…
Read MorePublications About Biomedical Innovation
More PublicationsWhite 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 MoreLetter
Health Innovation Caucus Comment Letter on Request for Information, January 2021
Mark McClellan, Marta Wosinska, Nitzan Arad, Rachel Roiland, Alec Lintz, Marianne Hamilton Lopez, Robert S. Saunders
Mark McClellan, Marta Wosinska, Nitzan Arad, Rachel Roiland, Alec Lintz, Marianne Hamilton Lopez, Robert S. Saunders
2021
Read MoreLetter
HHS Comment Letter on Self-Referral Regulations and Anti-Kickback Statute, December 2019
Mark McClellan, Nitzan Arad, Rachel Roiland, Karley Whelan, Marianne Hamilton Lopez, Robert S. Saunders
Mark McClellan, Nitzan Arad, Rachel Roiland, Karley Whelan, Marianne Hamilton Lopez, Robert S. Saunders
2019
Read MoreNews About Biomedical Innovation
More News
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 Biomedical Innovation
More Topics
Trending 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
Value-Based Payment for Medical Products
Amidst the broader shift from a fee-for-service (FFS) payment structure to a value-based U.S…

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