
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
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 MoreDuke-Margolis Faculty & Research Team

Vignesh Alagappan
2020 Margolis Intern

Adam Aten, MPH, MSc
Research Associate

Laura Benzing
2020 Margolis Intern
Beth Boyer, MPH
Research Associate

Joy Eckert, MPH
Research Associate

Nick Fiore
Policy Analyst

Nikhil Gadiraju
2020 Margolis Intern

Marianne Hamilton Lopez, PhD, MPA
Research Director, Value-Based Payment Reform
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty

Nicholas Harrison, MPH, MA
Senior Policy Analyst

Adam Kroetsch, MPP
Research Director, Biomedical Innovation and Regulatory Policy
Senior Team Member

Regina LaBelle, JD
Principal, LaBelle Strategies
Visiting Fellow

Trevan Locke, PhD
Research Associate
Nirosha Mahendraratnam Lederer, PhD, MSPH
Managing Associate, Real World Evidence
Senior Team Member
2020 Intern Mentor

Mark McClellan, MD, PhD
Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty

Valerie Parker
Policy Analyst
Caleigh Propes
Research Assistant

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

Rebecca (Becky) Ray
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
Policy Analyst

Morgan Romine, MPA
Chief of Staff
Senior Team Member

Gillian Sanders Schmidler, PhD
Deputy Director of Academics, Margolis Center
Professor of Population Health Sciences, School of Medicine
Margolis Executive Core Faculty
2020 Intern Mentor

Monika Schneider, PhD
Managing Associate
Senior Team Member

Sarah Sheehan, MPA
Managing Associate
Senior Team Member

Christina Silcox, PhD
Digital Health Policy Fellow
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty

Corinna Sorenson, PhD
Director of Graduate Education Initiatives and the Margolis Scholars Program
Assistant Professor in Population Health Sciences
Margolis Core Faculty

Sreekanth Vemulapalli, MD
Assistant Professor of Medicine
Margolis Core Faculty

Marta Wosińska, PhD
Deputy Director, Policy, Duke-Margolis Center for Health Policy
Margolis Core Faculty
Consulting Professor, Duke-Margolis Center for Health Policy

Anna Zavodszky
Research Assistant
Events About Biomedical Innovation
More EventsEvent 12/9/2019
Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases
SILVER SPRING, MD
There is significant unmet medical need in the prevention and treatment of nonalcoholic…
Read MoreEvent 2/25/2019
Aligning Access with Outcomes for Early-Stage Alzheimer’s Disease Drugs
A number of innovative “early stage” Alzheimer’s disease (AD) therapies are currently under…
Read MoreEvent 10/3/2017
Advancing Structured Benefit-Risk Assessment in FDA Review
WASHINGTON, DC
Advances in cancer care have resulted in significant improvement in patient outcomes, but spending…
Read MoreEvent 9/15/2017
Public Event: Mobilizing mHealth Innovation for Real-World Evidence Generation
WASHINGTON, DC
As consumers embrace new technologies as part of their everyday lives, patient-facing mHealth apps…
Read MorePublications About Biomedical Innovation
More PublicationsProject Report
Characterizing the FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle
Nicholas R. Harrison and Sarah Sheehan
Nicholas R. Harrison and Sarah Sheehan
2020
Read MoreWhite Paper
Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software
Christina Silcox, Isha Sharma, & Arti Rai.
Christina Silcox, Isha Sharma, & Arti Rai.
2020
Read MorePolicy Brief
Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases
Nicholas R. Harrison & Sarah Sheehan
Nicholas R. Harrison & Sarah Sheehan
2020
Read MoreJournal Article
Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs
Nicholas R. Harrison, Philip T. Sager, Mitchell W. Krucoff, Michael A. Weber, & William B. White
Nicholas R. Harrison, Philip T. Sager, Mitchell W. Krucoff, Michael A. Weber, & William B. White
2020
Read MoreNews About Biomedical Innovation
More NewsNews 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 MoreNews Update May 25, 2018
A Preferable Path For Thwarting Pharmaceutical Product Hopping
The recently announced White House blueprint to curb the high cost of pharmaceuticals addresses a policy problem that both ranks near the top of consumers’ health care concerns, and is a leading reason why US healthcare spending is the highest among OECD nations. Many critics attribute significant...
The recently announced White House blueprint to curb the high cost of pharmaceuticals addresses a...
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