Fred D. Ledley is a physician-scientist, entrepreneur, and educator, who has authored >200 articles on topics ranging from molecular human biology and biotechnology, to STEM education, business, and bioethics. His work has contributed to emerging knowledge and policy related to human gene therapy, personalized medicine, and the translation of science for public value. He is currently Professor of Natural & Applied Sciences and Management, and Director of the Center for Integration of Science and Industry, at Bentley University. He served previously on the faculties of the Howard Hughes Medical Institute, Baylor College of Medicine, and Texas Children’s Hospital. He was a founder of several biotechnology companies, including GeneMedicine, where he served as Vice President Research & Development, and Varigenics, where he served as President & CEO. Dr. Ledley has a B.S. in physical science from the University of Maryland and a M.D. from Georgetown University School of Medicine, trained in Pediatrics and Genetics at Boston Children’s Hospital, and was an American Cancer Society post-doctoral fellow with Dr. David Baltimore at the Massachusetts Institute of Technology. He is the author of a novel, Sputnik’s Child.

By this expert

The Global Pharmaceutical Industry Isn’t Investing in Products for the Greatest Burden of Human Disease - Are Non-Profits a Solution?

Article | Mar 29, 2024

Programs for expedited review may be preferentially reducing the development costs for conditions with lesser disease burden, potentially making investments in addressing the most significant disease burdens even less appealing and exacerbating the market failure further.

How Should the Government Negotiate Medicare Drug Prices? A Guide for the Perplexed

Article | Mar 4, 2024

The “maximum fair price” for a drug must not only be equitable to those with unmet medical needs who may benefit from the use of the drug but also provide equitable returns on both public and private sector investments.

Considering Returns on Federal Investment in the Negotiated “Maximum Fair Price” of Drugs Under the Inflation Reduction Act: an Analysis

Paper Working Paper | | Mar 2024

The empirical analysis of public sector investments and the health value created by the drugs selected for Medicare price negotiations provides a cost basis for the assessment of the maximum fair price.

US Tax Dollars Funded Every New Pharmaceutical in the Last Decade

Article | Sep 2, 2020

Amid debates over costs—and profits—from a coronavirus vaccine, a new study shows that taxpayers have been footing the bill for every new drug approved between 2010 and 2019

Featuring this expert

Bentley University Study Shows NIH Investment in New Drug Approvals Is Comparable to Investment by Pharmaceutical Industry

News Apr 28, 2023

INET-funded study: Government provides early investment in pharmaceutical innovation

Ledley, Cleary & Jackson’s INET working paper is cited in Missoulian

News May 19, 2021

“But COVID vaccines are by no means unique — most medicines developed and approved in the United States involve taxpayer investment. Between 2010 and 2019, every single new medicine approved by the Food and Drug Administration included taxpayer-funded research through NIH. Drug companies patent the drugs we pay to develop and then charge us exorbitant prices for them that increase every year — sometimes twice a year.” — Terry Minow, Missoulian

Senator Baldwin cites INET's working paper on pharmaceutical funding in the HELP Committee meeting

News Mar 24, 2021

“From 2010 to 2019 the FDA approved 356 drugs. Recent research from Bentley University finds that NIH funding contributed to every single new drug approved. At a cost to the tax payer of roughly $230 billion dollars. In spite of this contribution the NIH is listed on only 27 of those patents. This suggests that while tax payers provide funding for the bulk of the early stage research they do not get patent protections supposedly secured by the by dole act. In essence American tax payers are paying the highest prices in the world for drugs they already paid to help develop.” — Senator Tammy Baldwin

INET working paper is cited in a corrective letter to the editor of the Washington Post

News Nov 17, 2020

“Her omission understates drug spending by almost one-third, or about $145 billion. She claimed most drugs are developed in pharmaceutical firms, but funding from the National Institutes of Health contributed to all 356 new drugs approved by the Food and Drug Administration from 2010 to 2019. Drug corporations take a handoff after the most risky research is done and a drug shows promise.” — David Mitchell