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.
Fred Ledley
By this expert
Forget the Posturing – The Inflation Reduction Act May Work Better Than Many Expected
The IRA has the potential to rectify the imbalance between public benefit and private incentives
Crying Wolf: Why Negotiating Lower Drug Prices Will Not Harm Pharmaceutical Innovation
Increasing evidence that the IRA is probably not harming pharmaceutical innovation.
Implications of the Inflation Reduction Act for the Biotechnology Industry
Sensitivity of investment and valuation to drug price indices and market conditions
The Global Pharmaceutical Industry Isn’t Investing in Products for the Greatest Burden of Human Disease - Are Non-Profits a Solution?
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.
Featuring this expert
Who Pays for New Drugs?
Drug development can better serve public needs—especially in neglected diseases—by reimagining the balance between government, private industry, and nonprofit models.
Bentley University Study Shows NIH Investment in New Drug Approvals Is Comparable to Investment by Pharmaceutical Industry
INET-funded study: Government provides early investment in pharmaceutical innovation
Ledley, Cleary & Jackson’s INET working paper is cited in Missoulian
“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
“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