
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
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

Adam Aten, MPH, MSc
Assistant Research Director

Laura Benzing
2020 Margolis Intern

Milena Berhane, M.P.H.
Policy Analyst

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
Research Assistant

Nora Emmott
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
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty

Nicholas R. Harrison, MPH, MA
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

Valerie Parker
Senior Policy Analyst
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
Dr. and Mrs. Frank A. Riddick Professor of the Practice of Business Administration
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
Director of Graduate Education Initiatives and the Margolis Scholars Program
Assistant Professor in Population Health Sciences
Margolis Core Faculty
Anti-Racism and Equity Committee Member

Erin Soule, PhD
Assistant Research Director

Elizabeth (Liz) Staton
Policy Analyst

Sreekanth Vemulapalli, MD
Assistant Professor of Medicine
Margolis Core Faculty
Events About Biomedical Innovation
More EventsEvent 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 MoreEvent 3/28/2022
The Need for Transitional Coverage for Emerging Technologies
Recent policy and legislative proposals have highlighted a need for a Medicare coverage pathway…
Read MoreEvent 3/22/2022
AI/Machine Learning: Regulation, Development, and Real-World Performance Evaluation
On March 22, 2022 from 12:30 – 4:00 pm (EDT) the Duke-Margolis Center of Health Policy, with…
Read MorePublications About Biomedical Innovation
More PublicationsIssue 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
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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
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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
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HSS Comment Letter on Proposed Rebate Rule, April 2019
Mark McClellan, Gregory Daniel, Nitzan Arad, Nicholas Fiore, Thomas Barker, Susan Dentzer, Christian Springer, Marianne Hamilton Lopez
Mark McClellan, Gregory Daniel, Nitzan Arad, Nicholas Fiore, Thomas Barker, Susan Dentzer, Christian Springer, Marianne Hamilton Lopez
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 MoreNews Update July 17, 2018
Market Entry Rewards within the Broader Incentive Landscape
As part of a multifactorial approach to address weak incentives for innovative antimicrobial drug development, market entry rewards (MERs) are an emerging solution. Recently, the Duke-Margolis Center for Health Policy released the Priority Antimicrobial Value and Entry (PAVE) Award proposal, which...
As part of a multifactorial approach to address weak incentives for innovative antimicrobial drug...
Read MoreTopics Related to Biomedical Innovation
More Topics
Trending Topic
Antimicrobial Resistance (AMR)
Antimicrobial resistance (AMR) is a growing concern that threatens the foundation of modern…

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…