- 2024 -
October 7, 2024
Council on Undergraduate Research
CUR Releases 2024 STR Program Participants
Congratulations to Paula Chaves da Silva (Research Associate) and Franchesca Vilmenay (Undergraduate Research Assistant) on being one of 63 teams accepted to be a part of CUR's 2024-2025 Scholars Transforming Through Research (STR) Program. "The STR Program is a competitive application-based professional development opportunity for teams consisting of a campus representative and one to three undergraduate students. These teams will participate in a multi-month program aimed at developing their communication and advocacy skills which will empower them to convey the power of the high-impact practices of undergraduate research, scholarship, and creative inquiry experience to diverse stakeholder groups." [...]
October 4, 2024
Chemical & Engineering News (C&EN)
The US presidential election’s implications for chemistry
"'We very much ascribe to the idea that the government is the lead investor in innovation,' says Ledley of Bentley University. 'Whether it’s computers or life sciences or anything else, that’s the lifeblood that fuels the industry.'" [...]
September 2024
Institute for New Economic Thinking (Video)
The Inflation Reduction Act might be working better than expected
"Last week, lowered prices were announced for the ten drugs subject to price negotiations under the Inflation Reduction Act. The average savings across the ten drugs was 66%. We can now begin to assess the impact of the IRA and what the impact on Big Pharma will be with these lowered prices. As Professor Fred Ledley explains, both the industry and the market don't seem worried and have already factored these lowered prices into their revenue projections" [...]
August 26, 2024
Chemical & Engineering News (C&EN)
IRA negotiations will save Medicare $6 billion
"Pharmaceutical companies decried the law, saying that it would put price controls on drugs for the first time in US history and that innovation would ultimately suffer, as less money would be available to fund the discovery of new drugs. But a recent study led by Fred D. Ledley of the Center for Integration of Science and Industry at Bentley University found that the IRA 'could have little or no impact on the number of drug approvals' (Soc. Clin. Trials 2024, DOI: 10.1177/17407745241259112)." [...]
August 22, 2024
PharmaVoice
Will the IRA squash new drugs? Those worries are likely exaggerated, studies say.
"Before the IRA established price negotiations on behalf of Medicare, industry insiders were concerned the cost cuts would bring about an exodus in pharma investment. But according to a new analysis, those estimates were likely exaggerated. Even with global pharma revenue reductions of up to 10%, the industry could maintain the current level of drug approvals, and large companies can strategically allocate their R&D spending in a way that would sustain both current levels of product approvals and profits, the analysis found. The paper, from researchers at Bentley University’s Center for Integration of Science and Industry, showed that for smaller biotech companies, which sponsor the majority of clinical trials, there was no relationship between R&D spending and revenue. Rather, these companies usually acquire most of their R&D capital through new investment in equity offerings." [...]
August 17, 2024
STAT News
First Opinion readers on Noah Lyles and Covid-19, the dearth of geriatricians, PBMs, and more
"'Give pharmaceutical execs the benefit of doubt — but they need to work for it,' by Fred D. Ledley
In this First Opinion essay, I described research suggesting that the distinct financial structures of large pharma manufacturers and smaller, science-based biotech companies coupled with historical patterns of investment and valuations in biotech could enable the industry to maintain profits and productivity at current levels despite the reductions in drug prices anticipated under the Inflation Reduction Act (IRA). Pharmaceutical executives seem to agree!" [...]
August 16, 2024
Bloomberg Law
Medicare Drug Price Savings Obscured by Health-Care Complexities
"Similarly, Fred Ledley, director for the Center for Integration of Science and Industry at Bentley University, said the program sets positive precedent.
'People forget that the prohibition on negotiating price was kind of a poison pill in the original Medicare Act,' Ledley said. 'We see this as a return to normal business-government interactions, where you negotiate a fair price. That’s what the government does in general, on behalf of the public.'" [...]
August 14, 2024
BioSpace
Experts Analyze IRA’s Effect as the Industry Awaits Negotiated CMS Drug Prices
"Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University and the senior author of two recent studies analyzing the IRA’s impact, noted that there would be minimal effects on biotech pipelines and drug approvals. In an interview with BioSpace, Ledley added that the law is intended to help negotiate products and essentially act as a basic economic principle of negotiating for what is seen as the fairest price for a drug." [...]
August 10, 2024
STAT News
First Opinion readers respond to essays on right to try lies, pharma execs, and more
"'Give pharmaceutical execs the benefit of doubt — but they need to work for it,' by Fred D. Ledley. The author believes 'the pharmaceutical industry can develop products that are affordable, universally available…without compromising their profits' and yet also contends that industry executives are not the monocled barons the media makes them out to be. How can both be true? If the utopian vision Fred Ledley describes is so easily attainable, surely it is the malaise and greed of industry that prevents it. But, as he is quick to point out, that simply is not his experience — or a reality experienced by thousands of scientists, entrepreneurs, investors and yes, corporate executives, dedicated to bringing medicines to patients." [...]
August 8, 2024
Bio.News
Understanding the IRA’s real-world impacts starts with understanding the innovation ecosystem
Research from the Center for Integration of Science and Industry concerns Biotechnology Industry Organization.
August 3, 2024
Patients For Affordable Drugs Now
This Week in Drug Pricing: Court Watch: US V. Pharma, End Of Medicare Negotiation For First 10 Drugs, and ICYMI
"A recent analysis from Bentley University found that, despite pharma’s fear mongering around the drug price law, it will have little to no impact on the number of new drug approvals and research and development (R&D) funding. Patients played a critical role in the passage of the landmark drug pricing law that authorized Medicare’s ability to negotiate lower drug prices and eagerly await potential savings of up to thousands of dollars per medication when negotiated prices take effect in 2026. — (The Hill, Medical Xpress, Fierce Biotech, The Nevadan)"
July 31, 2024
Fierce Biotech
IRA drug price reductions won't hurt biotech innovation, analyses find
"In a 2022 quarterly conference call, Merck CEO Robert Davis said the bill’s reduction of drug prices would be “highly chilling on future innovation.” But two new studies suggest these fears may be overblown. Analyses of R&D spending and equity investment in biotech predict that the industry is capable of weathering a drop in revenue due to lower drug prices, with no corresponding loss in new approved drugs. Big Pharma “can protect both their earnings and their pipeline with pretty straightforward reallocation of R&D to late-stage development [and] continued or increased licensing or acquisition of early-stage products,” Fred Ledley, M.D., told Fierce Biotech in an interview. Ledley, a physician-scientist and former biotech executive, is senior author of the studies and director of the Center for Integration of Science and Industry at Bentley University in Massachusetts." [...]
July 2024
Institute for New Economic Thinking (Video)
Is it true, as Big Pharma claims, that negotiating lower drug prices with the government will kill innovation in drugs?
"Professor Fred Ledley explains that most new drug innovation comes from smaller biotech companies that do not rely on revenues for their R&D. The larger pharmaceutical companies, which only make up 5% of the industry, typically acquire the smaller biotech firms once they have developed a new drug and removed most of the risk. Therefore, the government negotiating lower drug prices shouldn't impact innovation." [...]
July 25, 2024
Bentley University
Biotechnology companies can sustain the pipeline of new drugs under the Inflation Reduction Act
Differences in the financial structure of large pharmaceutical producers and smaller biotechnology companies create resiliency
July 14, 2024
Accountable US
Top Drugmakers Use Patent Tactics to Block Medicare Price Negotiations, Keeping Costs High
"Even though the companies hold the patents, one study found that the federal government spent a combined $11.7 billion on basic and applied research that led to the development of these drugs: Stelara: $6.5 billion, Xarelto: $764 million, Imbruvica: $566 million, Eliquis: $791 million, Entresto: $901 million, Farxiga: $437 million, Enbrel: $2.6 billion, Jardiance: $433 million, Januvia: $228 million" [...]
May 21, 2024
Senate Committee on the Judiciary
TESTIMONY OF JOCELYN B. ULRICH, VICE PRESIDENT, POLICY AND RESEARCH PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
"An analysis of the contribution of NIH funding to new drug approvals 2010 – 2016 found that although NIH funding contributed to published research associated with every one of the 210 new drugs approved by the FDA in those years, 90% of the NIH funding supported basic research related to the biological targets for drug action rather than the drugs themselves." [...]
April 2024
Institute for New Economic Thinking (Video)
Nonprofits are leading the charge in developing drugs for diseases, which the pharmaceutical industry often overlooks
"Did you know that since 1975, there has been little progress in drug development for diseases like Tuberculosis that are not common in the US and Europe but quite prevalent in Africa and Asia? Due to the lack of ROI for drugs that don't have a large market in the US or Europe, big Pharma often ignores the development and distribution of drugs that address these so-called "rare diseases" that affect millions of people. Non-profits and public-private partnerships are stepping up to fill this gap. Payal Arya, PhD from Center for Integration of Science and Industry at Bentley University talks about INET's new article exploring the role that non-profits play in addressing this critical market failure." [...]
March 2024
Institute for New Economic Thinking (Video)
You are paying more for medicine than you think
"US taxpayers provide billions of dollars of early investment in the research and development of new drugs. Bentley University's Fred Ledley outlines exactly what taxpayers provide to develop and research new medicines." [...]
March 2024
Institute for New Economic Thinking (Video)
The Inflation Reduction Act allows the government to negotiate drug prices
"US Taxpayers spent $187 billion dollars on the development of new drugs in the last 10 years. Now is the time to get a return on our investment. The Inflation Reduction Act allows the government to negotiate the price of 10 select drugs for Medicare patients. Bentley University's Professor Fred Ledley argues that the early investment taxpayers made in the development of these drugs must be included in these negotiations." [...]
March 2024
Institute for New Economic Thinking (Video)
US Taxpayers provide half the development of new drugs
"$187 billion dollars of Taxpayer money went into the development of new drugs between 2010-2019. Professor Fred Ledley from Bentley University talks about how the National Institute of Health contributes to the development of new drugs in this country. Check out his blog to learn more about how the US should negotiate with drug companies in order to ensure that US taxpayers are getting a good return on our investment." [...]
March 30, 2024
Naked Capitalism
The Global Pharmaceutical Industry Isn't Investing in Products for the Greatest Burden of Human Disease - Are Non-Profits a Solution?
"Yves here. This post provides compelling evidence as to why running health care, and particularly pharmaceutical development, on a market basis is a bad idea. One has to wonder how much prejudice leads to the neglect of deadly diseases that afflict many millions....but in tropical areas, stereotyped as poor. The post does not mention as a possible driver that stock investors view life-saving drugs that would be sold in huge numbers, but significantly in poorer countries, as much less sexy than drugs to treat the ailments of the affluent."
March 14, 2024
Institute for New Economic Thinking
Experts: Negotiating Big Pharma's Prices Won't Stifle Innovation—They Don't Use the Money to Innovate!
"Ledley and his colleagues are unimpressed by the argument that the IRA will have a negative impact on innovation. Why? Because the biggest drug companies haven’t been doing much innovation in a long time. 'This is a very centralized industry with the top 25 companies accounting for well over 70% of all the sales,' notes Ledley. 'That’s not where the innovation is happening.' He points out that since major companies prioritize marketing and selling drugs rather than developing them, a revenue dip will hardly make a dent in innovation."
March 12, 2024
Bentley University
US drug approvals 2010-2019 align with US, but not global, burden of disease; expedited approval programs may make the gap worse
Expedited approval programs may disincentivize development of drugs for conditions associated with greatest burden of disease.
March 12, 2024
Bentley University
Research Considers Returns on "Maximum Fair Price" of Medicare Drugs
NIH spent $11.7 billion on research leading to approval of drugs selected for price negotiations in year one of the Inflation Reduction Act. Negotiated drug prices must provide equitable returns on both public and private sector investments.
February 22, 2024
The Lever
Americans paid $11 Billion To Make Drugs You Can't Afford
"According to the new study out of the Center for Integration of Science and Industry at Bentley University, which has not yet been published, the 10 selected prescription drugs received anywhere from $227 million to $6.5 billion in funding from the government’s National Institutes of Health (NIH) for crucial, foundational research.
'When the average taxpayer is paying for the drug, it’s not just what’s being paid at the pharmacy,' said Fred Ledley, professor of natural and applied sciences at Bentley and senior author on the study."
February 21, 2024
The Good Science Project
NIH and March-In Rights under Bayh-Dole
"One of the most famous articles here (Cleary et al., PNAS, 2018) found that “NIH funding contributed to published research associated with every one of the 210 new drugs approved by the Food and Drug Administration from 2010-2016.” This study was prominently highlighted in the Sanders memo that urges the use of march-in rights: ..."
February 6, 2024
UNITED STATES DEPARTMENT OF COMMERCE National Institute of Standards and Technology
Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights: COMMENT OF THE UNITED STATES FEDERAL TRADE COMMISSION
"Development of pharmaceutical products in the United States has long benefited from
taxpayer support, with a substantial number of breakthroughs in drug development stemming
from government-funded research. NIH funding directly or indirectly contributed to every one of
the 210 new molecular entities (“NMEs”) approved from 2010-2016.48 ... NIH funding contributed to published research related to 354 of 356 new drugs approved by the FDA from 2010 to 2019.50 In terms of dollars spent, NIH contributed $187 billion for basic or applied research related to the 356 drugs approved from 2010-2019.51"
January 30, 2024
Endpoints News
The academic-entrepreneur model built companies and minted millionaires. What happens when one of its earliest advocates quits?
"The analogy flounders with translation, however, because the research center notoriously failed to commercialize many of its most prescient ideas. 'What everyone remembers about Bell Labs is that they won Nobels and invented the transistor,' said Fred Ledley, who leads the Center for Integration of Science and Industry at Bentley University. 'But they didn’t develop the stuff they invented. That’s the irony.'"
January 25, 2024
Rolling Stone
How Big Pharma Is Fueling a Radical MAGA Agenda
"Maybe the most galling part of the situation is that the U.S. government subsidizes research and development on virtually all new drugs that are approved for sale."
January 12, 2024
The New York Times
The Billionaires Spending a Fortune to Lure Scientists Away From Universities
"A sizeable percentage of drugs originate from government or university grants, or a mix of the two. From 2010 to 2016, each of the 210 new drugs approved by the Food and Drug Administration was connected to research funded by the National Institutes of Health, according to the scientific journal PNAS."
- 2023 -
December 20, 2023
American Action Forum
March-In Rights: A Hostile Regulatory Environment
"...as almost all basic science is funded by the federal government, it is unlikely that a pharmaceutical company would create a second patent without any information learned from similar sources. In fact, a 2023 study found that the NIH funding contributed to 99.4 percent of drugs approved from 2010 to 2019."
December 14, 2023
Assistant Secretary for Planning and Evaluation (ASPE)
—Inflation Reduction Act Research Series— Medicare Drug Price Negotiation Program: Understanding Development and Trends in Utilization and Spending for the Selected Drugs
Research Report from the ASPE Inflation Reduction Act Research Series references our work: "Federal investments provide critical foundation and support for drug development across the continuum, from knowledge generated through basic science to clinical trials investigating the safety and efficacy of a product in patients. While it has been well-established that nearly every medical product can be linked to basic research funded by the federal government, it can be challenging to connect federal support for R&D to specific drug products. Merely by way of example, published findings from basic biomedical research can also be used to support a variety of subsequent studies, including multiple drug development efforts, and both successes and failures. For example, one recent study found NIH funding contributed to publications associated with 99.4 percent (354 out of 356) of new drugs approved by the FDA from 2010-2019." (Galkina Cleary et al. 2023)
December 7, 2023
The White House
FACT SHEET: Biden-Harris Administration Announces New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition
"Promoting equitable access to lower-priced taxpayer-funded drugs. Taxpayers have spent hundreds of billions of dollars on research catalyzing the discovery and development of new prescription drugs. The Biden-Harris Administration believes taxpayer-funded drugs and other taxpayer-funded inventions should be available and affordable to the public. When an invention is made using taxpayer funds, under certain circumstances march-in authority under the Bayh-Dole Act enables the federal government to license the invention to another party. The prior Administration proposed a rule preventing the government from exercising this authority on the basis of high price alone. The Biden-Harris Administration decided not to finalize that proposal earlier this year, consistent with President Biden’s Executive Order on Promoting Competition in the American Economy. Today, the Department of Commerce (DOC) and HHS released a proposed framework for agencies on the exercise of march-in rights that specifies for the first time that price can be a factor in determining that a drug or other taxpayer-funded invention is not accessible to the public. DOC and HHS invite public input on how this framework can promote access to taxpayer-funded inventions, including treatments for patients, while promoting innovation."
November 23, 2023
European Parliament
Improving public access to medicines and promoting pharmaceutical innovation
"The few comparative estimates of profitability available tend to indicate that returns are higher in the pharmaceutical industry than in other sectors (Ledley et al., 2020; Thakor et al., 2017) even after adjusting for risk. ... The current system is characterised by huge public investments. Pharmaceutical R&D costs are directly and indirectly supported by a combination of public sector grants to research either upstream or directly to firms (Florio et al., 2021; Cleary et al., 2018; Rottingen et al., 2013). For example, the NIH contributed on average $1,344.6 million per target for basic research on drug targets and $51.8 million per drug for applied research on products for drugs approved by the FDA from 2010 to 2019 (Cleary et al. 2023)."
November 15, 2023
Harvard Medical School
Annual Awards Propel Basic Discoveries Into Clinic
"However, with some notable exceptions, the process is fraught, protracted, and can lead to numerous - and often costly - dead ends. It could take several decades for a basic discovery to become a new medicine."
November 3, 2023
University of California
Senate HELP Committee letter, dated September 29, 2023, seeking input on modernizing NIH
"A recent study in JAMA Health Forum showed that NIH funding contributed to 99.4% (354 of 356) of all drugs approved by the Food and Drug
Administration (FDA) between 2010 and 2019.2"
October 16, 2023
WVCAEF
Letter to HHS and Commerce Urging Interagency Review of March-In-Rights To Lower Drug Prices
"NIH funding has contributed to basic and applied research underlying virtually every new FDA-approved drug in recent years.iii"
Fall 2023
Issues in Science and Technology
Fairer Returns on Public Investments
"To what extent would ARPA-H have to expand its current funding—$1.5 billion in 2023 and $2.5 billion requested for 2024, in contrast to $187 billion spent by the NIH to enable new drug approvals between 2010 and 2019—to make a substantial impact on the development of new, high-value pharmaceuticals? What degree of price and profit restriction would companies be willing to accept? Could the benefit of higher prices to taxpayers as shareholders be used to justify the excessive prices that benefit company executives and other shareholders even more? Should not the burden on those who pay for the pharmaceuticals by financing public and private insurances be taken into account? Finally, would politicians be willing, in the face of fierce lobbying by pharma, to provide ARPA-H with the required funds and authority?"
September 29, 2023
Congressional Research Service
The Cancer Moonshot: Overview and Issues
"A time lag often exists between initial investments in research and new medical innovations for patients. As an example, major investments in cancer research followed the National Cancer Act of 1971 (P.L. 92-216). One analysis links the early 1970s funding to new drugs approved by the U.S. Food and Drug Administration decades later after the science became established." This comment is based, in part, on our analysis of the 1970s "War on Cancer", which showed that products emerged only when the basic science stimulated by the National Cancer Act was sufficiently established to support successful drug development.
September 18, 2023
Financial Times
The Biden administration takes on the US drugs industry
"Given the partisan nature of US politics, and the power of the pharmaceutical lobby, it is a moment some thought would never come. 'These historic reforms follow a public debate that persisted for half a century in the US,' says Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University. 'There has been a growing political consensus that something had to be done about drug prices, particularly given the huge profits generated by pharmaceutical companies,' he adds. 'But it has been a polarising debate, given the potential impact of reforms on R&D budgets and what that means for global innovation.'"
September 11, 2023
Research Professional
Counting the cost of drug price negotiations
"Fred Ledley, professor of natural and applied sciences at Bentley University, thinks pharma companies will probably cut R&D spending in future as a result of the price negotiations. 'It’s normal for companies to prioritise profits,' he says. 'It’s all about the shareholders.' But 'negotiating prices is also normal', he adds. 'We think these companies are really overreacting when they think negotiating a price is unfair to them.' He points out that big pharma companies only do about 35 per cent of the clinical trials that discover the drugs. 'Most of the clinical trials are being done by smaller companies,' he says. The drugs may then be bought by the bigger companies, which do 'some of the finishing work to get them over the line'. Ledley also highlights that those working in the pharmaceutical industry tend to be 'impressive business leaders'. 'They are not going to lose business; they are going to find ways to get the job done. That’s the essence of capitalism. You find a way.'"
September 6, 2023
The New York Times
The 4 Arguments You Will Hear Against Drug Price Negotiation
"It’s also important to remember that scientific breakthroughs resulting in new drugs are not only the result of private industry research and development. Basic science funded by the National Institutes of Health using taxpayer dollars plays a significant role in drug development and will continue to irrespective of curbs on prices."
September 3, 2023
Chicago Tribune
Colleen Grogan: Big Pharma is wrong. Allowing Medicare to negotiate drug prices won't hinder new cures.
August 8, 2023
Times Higher Education
US universities ‘short-changed’ by industry on research
"Companies consistently don’t pay full value for medical discoveries in what Bentley study calls a ‘systematic problem’"
July 26, 2023
Bentley University
NIH spent $950M for basic or applied research leading to patents providing market exclusivity for drugs approved 2010-19
This represents <1% of all NIH-funded research related to these products that are subject to public interest protections of Bayh-Dole Act.
July 14, 2023
Fierce Biotech
Industry, not NIH, fronts most of the cash for clinical trials: report
"In a study published July 14 in JAMA Health Forum, researchers from Bentley University’s Center for Integration of Science and Industry calculated that the NIH spent $8.1 billion on phased clinical trials of drugs approved between 2010 and 2019—about 10% of what the pharma and biotech industry committed over roughly the same period."
July 14, 2023
JAMA Health Forum
Drug Development—Social and Private Returns
JAMA Health Forum published an Invited Commentary regarding our recent publications, Cleary et al. and Zhou et al. "Two articles published in JAMA Health Forum bring some new data and analysis to a debate about the apportionment of credit for new prescription drugs that has been raging since the 1950s."
July 14, 2023
Bentley University
NIH spent $8.1B for phased clinical trials of drugs approved 2010-19, ~10% of reported industry spending
Bentley University study further describes public and private sector investments in pharmaceutical innovation.
June 12, 2023
United States Senate HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE
Majority Staff Report: Public Investment, Private Greed
"First, at the earliest stage, the federal government plays a role in pushing forward research for virtually all new medicines. Government scientists and federally funded researchers set the foundation for new medicines by making critical discoveries about how a disease works. This includes finding the right “biological target” to shoot for with new drug candidates. According to one study, NIH funding “contributed to published research associated with every one of the 210 new drugs approved by the Food and Drug Administration from 2010–2016” at a cost of more than $100 billion to taxpayers.13 This underlying work is the riskiest and the most uncertain phase of research. ...
Over the past twenty years, the median price of new treatments that NIH scientists helped invent is $111,000. U.S. taxpayers virtually always pay more than people in other countries for treatments that NIH scientists helped invent. With the exception of one treatment, U.S. prices exceeded prices in other G7 countries. The major limitation of this analysis is its scope. The treatments invented with the help of NIH scientists represent a small fraction of the medicines developed with NIH funding and support, which itself is only a portion of the entire federal government’s support.23 But neither NIH nor other federal agencies publish detailed information about how the researchers they fund across the country support drug development. The analysis may also undercount the total number of treatments invented with the help of NIH scientists because it may exclude treatments where the corporation has not been required to secure a license (i.e., patent co-inventorship), or where a corporation has failed to secure a license (i.e., patent infringement). NIH does not publish this information. More transparency is needed."
May 2, 2023
Boston Business Journal
NIH investment as effective as private sector for biopharma innovation, Bentley report shows
"NIH funding played a role in all but two drugs approved over the course of a decade, with an average of $1.4 billion spent on each drug. The public funding yielded savings of $2.9 billion per drug, compared with $1.5 billion in private-industry investment on each new drug and savings of $2.8 billion, the research showed."
April 28, 2023
Bentley Newsroom
New study shows NIH investment in new drug approvals is comparable to investment by pharmaceutical industry
"The National Institutes of Health (NIH) spent $187 billion for basic or applied research related to 354 of the 356 drugs approved by the FDA from 2010-2019, according to a new study from Bentley's Center for Integration of Science and Industry. The study, published in JAMA Health Forum, shows that the amount invested per approved drug by the NIH is comparable to that of reported investment by the biopharmaceutical industry. It's the first study to compare the total value of NIH and industry investments taking into account actual spending on research related to approved products and failed product candidates as well as the time-value of these investments."
April 28, 2023
Bentley University
Bentley University study shows NIH investment in new drug approvals is comparable to investment by pharmaceutical industry
Government provides early investment in pharmaceutical innovation.
April 19, 2023
House Appropriations Committee
Dr. Lawrence A. Tabak references our work in his testimony during the Budget & Oversight Hearing for Fiscal Year 24
Dr. Lawrence Tabak, Director of the National Institutes of Health states, "An independent analysis by researchers at Bentley University found that NIH funding contributed to development of every new drug, all 356, approved by the FDA from 2010-2019." (43:46)
March 31, 2023
Bentley University
Academic institutions receive lower financial returns from biotechnology licenses than commercial firms
Bentley University study shows disparity between returns from public and private sector investment in biomedical science.
February 9, 2023
Jacobin
The Biden Administration Is Letting Big Pharma Profiteer Off a Cancer Drug
"Studies have shown that most, if not all, major new drugs are originally developed with funding from the US government."
February 9, 2023
The Wall Street Journal
Pfizer, Novartis, Merck Executives Say They Are Hunting for Deals Again
An article in the Wall Street Journal confirms the predictions made in our Center's white paper "Will Reducing Drug Prices Slow Innovation?" that the Inflation Reduction Act could increase large pharmaceutical companies' dependence on acquisition or licensing of clinical-stage product candidates from smaller biopharmaceutical companies. Our model of pharmaceutical innovation suggests that, while large companies are likely to reduce R&D in response to any decrease in revenues, R&D and investment in small companies that do the majority of clinical trials is unlikely to be affected and there will continue to be a robust flow of products in the innovation pipeline.
January 20, 2023
Fierce Pharma
'The Top Line': Panelists at Fierce's JPM Week event talk drug pricing policy, and Bayer's oncology head discusses cancer strategy
Sarah Edmond (19:33) comments on "what 2023 is going to look like from a drug pricing perspective," stating that she sees "an opportunity to be adaptable" while referencing Dr. Fred Ledley and our Center's work.
January 10, 2023
Medical Xpress
How the pharmaceutical industry uses disinformation to undermine drug price reform
“Drug companies make threats to maintain their ability to make extraordinarily high profits. The rest of us need to stand up for the right of patients to get drugs at affordable prices.”
August 19, 2022
Health
How the Inflation Reduction Act Will Affect Healthcare Costs - Especially for Medicare Beneficiaries
“The legislation has faced fierce opposition from pharmaceutical companies, which have historically been much more profitable than other large public companies.”
July 21, 2022
Common Dreams
Pharma Mobilizes Army of Lobbyists to Tank Democrats' Medicare Drug Pricing Plan
“To patient advocates, the industry's alarmist protests against Democrats' compromise proposal are nothing more than a desperate attempt to preserve its outsized profit margins at the expense of people's health.”
June 6, 2022
Bentley Magazine
Solving Society's Ills
“'Our research shows that the biopharma industry can successfully deliver new drugs to the market while ensuring that essential medicines are affordable for all Americans.' - Dr. Fred Ledley...Ledley and Vaughan’s findings corroborate earlier research that shows how pharma companies have stacked the deck against us, so policymakers can avoid what he calls the “false choice” of affordability or innovation. At Bentley, their work joins that of colleagues like Danielle Blanch Hartigan, who are similarly determined to improve the state of American health care — and prepare students to do the same.”
January 24, 2022
ProQuest
Bentley Researchers Say Govt. Price Controls Wouldn't Hurt Innovation
“Contrary to Congressional Budget Office projections, Bentley University researchers say government drug price controls would not hurt innovation. Fred Ledley, the director of the Center for Integration of Science and Industry at Bentley University, said there is no evidence that prices are related to research and development spending. Companies can either increase revenue by raising prices or by introducing new products, so when prices are constrained, it pressures companies to spend more on developing new products.” Learn more here.
December 21, 2021
European Parliament
European pharmaceutical research and development: Could public infrastructure overcome market failures?
"A recent cross-sectional study (Ledley et al., 2020), which compared the annual profits of 35 large pharmaceutical companies with 357 companies in the Standard and Poor's 500 Index from 2000 to 2018, found out statistically significant differential profit margin favouring pharmaceutical companies. In bivariable regression models controlling for company size and year, the difference in gross profit margin is 30.5%, the difference in EBITDA margin is 9.2%, and the net income margin difference is 3.6%. Other studies find similar conclusions."
October 7, 2021
The Wall Street Journal - A Custom Event
Technology Innovation, Misinformation and Public Health
Science, technology and innovation have a long history of reducing risks and improving public health outcomes. And yet, the road from health innovation with proven, evidence-based benefits, to adoption is not always straightforward. Dr. Fred Ledley was joined by Ramin Beheshti (The News Movement), Dr. Moira Gilchrist (Philip Morris International), Elizabeth Marsh (Florida International University), and host Phillipa Leighton-Jones to discuss how health innovation can rise above the cacophony of misinformation in today’s digital age. A recording of this Philip Morris International sponsored Wall Street Journal event can be viewed here.
August 12, 2021
PR Newswire
Can Big Pharma Afford to Reduce Drug Prices?
For years, biopharmaceutical companies have justified the hefty price tags for new medications by arguing that reducing consumer costs would compromise their ability to discover and develop additional products. During a recent Congressional briefing on drug pricing, however, Fred Ledley, MD, dispelled this “innovation myth,” citing the Center's latest research that the industry is “sufficiently robust to accommodate a decrease in drug prices without decreasing the number of new drugs coming to market.” This research was led by Assistant Professor of Mathematical Science, Gregory Vaughan, PhD, and was funded by West Health Policy Center.
August 12, 2021
Bentley Newsroom
Can Big Pharma Afford to Reduce Drug Prices?
In Congressional briefing, professor shares new research indicating consumer affordability isn’t a barrier to innovation.
August 9, 2021
Families USA
Our Broken Drug Pricing and Patent System Diverts Resources Away from Innovation and into Mergers, Patent Gaming and Price Gouging
"Notably, U.S. taxpayer dollars funded the research that underlaid every drug developed from 2010 to 2019, totaling more than $230 billion.13"
July 28, 2021
NCHC & West Health Hill Briefing
Drug Pricing Reform: The Costs of Inaction
The West Health Policy Center and the National Coalition on Health Care hosted a second Congressional briefing on the need for drug pricing reform where Fred Ledley addressed the false choice between affordability and innovation. Fred was also joined by Congressman Peter Welch (D-VT), Sean Gremminger, Director of Health Policy at the Purchaser Business Group on Health (PBGH), and Amy Herr, Director of Health Policy at West Health Policy Center. A recording of the event can be viewed here.
July 13, 2021
The Senate Judiciary Subcommittee
Prescription Drug Prices and Anticompetitive Practices
Research from the Center for Integration of Science and Industry was referenced by Senator Richard Durbin at a meeting of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights focused on Prescription Drug Prices and Anticompetitive Practices. His comments refer to research supported by the Institute for New Economic Thinking, which examined NIH funding for basic and applied research associated with drugs approved 2010-2019. This is one of a series of studies on the public sector contribution to new drug discovery and development.
June 2, 2021
MassBioEd
Life Sciences Workforce Conference
Research from the Center for Integration of Science and Industry was featured in the keynote presentation of the 2021 MassBioEd Life Sciences Workforce Conference and a workshop titled “Inspiring college students to pursue STEM careers” co-led by Dr. Fred Ledley. The featured research results addressed the importance of integrating business with science education to engage students in preparation of careers in the life science industry and was a collaboration with Dr. Naomi Wernick, University of Massachusetts, Lowell. The workshop was co-led with Dr. Liz Nulnick, Northeastern University.
May 28, 2021
Bentley Newsroom
Rewarding Research; Annual awards honor faculty's academic contributions
Gregory Vaughan, PhD, assistant professor of Mathematical Science, has collaborated with our Center on various projects since 2018. As a result of his co-author contributions for the published work titled “Profitability of Large Pharmaceutical Companies Compared with Other Large Public Companies,” he has been honored with an Outstanding Scholarly Contribution Award for the year of 2020.
May 27, 2021
Common Dreams
It's Time to Break Big Pharma's Grip on Healthcare and Empower Medicare to Negotiate Cheaper Drug Prices
“It’s an industry intent on protecting the status quo that has made pharmaceuticals the most profitable industry in the U.S., even as a growing number of Americans struggle to afford the medications they need.”
April 23, 2021
The Chronicle of Higher Education
A Tipping Point? Dozens of Public Colleges Announce Covid-19 Vaccine Mandates
The majority of colleges to require students or employees to be vaccinated for the fall have been private institutions, and public schools are beginning to follow suit. Hesitancy remains until the vaccine receives formal FDA approval, which Fred Ledley believes is "very likely" to occur by midsummer.
April 22, 2021
Tradeoffs
Preventing HIV Just Got A Lot Cheaper. What Took So Long?
After nearly a decade of sky-high prices, new generics have sent the price of the HIV prevention drug PrEP plummeting. What kept it so expensive for so long, and will the price drop help us finally eradicate HIV? Fred Ledley receives thanks for his contributions to this episode.
April 22, 2021
Bentley University
COVID-19 vaccine development built on >$17 billion in NIH funding for vaccine technologies
Broad foundation of NIH-funded research for enabling technologies prior to pandemic provided a tool kit for rapid development of COVID vaccines.
April 5, 2021
Scholars @ Bentley
Response to proposed rulemaking on Bayh Dole
Fred Ledley comments on the "Rights to Federally Funded Inventions and Licensing of Government Owned Inventions," National Institute of Standards and Technology (NIST), United States Department of Commerce. The comment made Knowledge Ecology International's (KEI) list of notable comments filed.
March 19, 2021
Bentley University
Pricing Healthcare Innovation in the US
Fred Ledley receives a shoutout and contributes to a conversation on price strategy.
February 24, 2021
Bentley University
Economics and Politics of COVID-19 Vaccine Financing. Fireside Chat with Hannah Kuchler, Financial Times
Center for Integration of Science and Industry co-sponsors event. Fred Ledley joins Hannah Kuchler for a discussion.
January 12, 2021
Academic Minute
Fred Ledley, Bentley University – Pharmaceutical Companies Profitability
On Bentley University Week: Drug companies seem to be making a lot of profit, but are they? Fred Ledley, professor of natural and applied sciences, finds out.
January 6, 2021
Bentley University
Investment risk & return from emerging public biotech companies comparable to non-biotech
Biotech companies with Initial Public Offerings between 1997-2016 generated more than $100 billion in shareholder value despite high failure rate.
January 6, 2021
Bentley University
Majority of biotech companies completing an IPO from 1997-2016 achieved product approvals
Biotech companies completing IPOs continue to initiate new product development, but 78% were conventional small molecule drugs, not biologicals.
January 4, 2021
LA Times
Pfizer, Moderna expect billions in profits from COVID vaccine. That's a scandal
“…federally funded basic and applied research at the National Institutes of Health, the Defense Department and academic labs created the foundation for the mRNA technology. In fact, almost no drugs reach market in the U.S. without such funding.”
November 16, 2020
LA Times
Private firms keep stranglehold on COVID vaccines, though you paid for the research
The biotech company Moderna injected a new dose of optimism into the fight against COVID-19 on Monday by announcing that its vaccine candidate had shown a success rate of 94.5% in clinical trials. The announcement, however, raises new questions about how a successful vaccine will be distributed to the public — how fast, how broadly and at what price? That’s especially relevant for the Moderna vaccine because federal funding of the company’s effort approaches $1 billion, and because the government owns at least one patent crucial for the product’s manufacture.
October 22, 2020
STAT
Remdesivir’s hefty price tag ignores NIH investment in its creation October 2020
Prior to 2020, the National Institutes of Health invested $6.5 billion to research enabling Emergency Use Authorization of remdesivir, yet the cost of new drugs does not reflect the life-saving role of governmental agencies. Once a Covid-19 vaccine and more treatments emerge, the government must be able to shield its citizens from being priced out of access.
September 2020
Institute for New Economic Thinking
Economics & BEYOND with Rob Johnson. How US Taxpayers Subsidize Pharma Research and Companies Reap the Profits
Fred Ledley, professor at Bentley University spoke with Rob Johnson, President, Institute for New Economic Thinking. Dr. Ledley, co-author of an INET-funded research paper on pharma research funding, discusses the research and how US taxpayers might get more social benefit out of the initial investment they put into all new pharmaceuticals released over the past decade.
July 2020
The New Republic
How to Break a Big Pharma Monopoly on a COVID-19 Vaccine | Opinion
"It is a fundamental flaw in our system that the critical role played by government funding in establishing the scientific and technological foundation for the products developed by industry goes ignored." Fred Ledley
May 2020
Newsweek
Yes, the Government Can Control the Cost of a Coronavirus Vaccine | Opinion
The claim that the U.S. government has no control over drug prices is, simply put, a lie. But it isn't a new lie. It's one that millions of Americans have already been living with for decades.
March 4, 2020
Newsweek
Big Pharma Companies Earn More Profits than Most Other Industries, Study Suggests
Big pharmaceutical companies appear to be more profitable than large companies in most other industries, according to a new study. Researchers writing in the Journal of the American Medical Association (JAMA) investigated the financial balances of pharma companies dealing in the business of developing, manufacturing, marketing and selling drugs.
March 3, 2020
Bentley University
New Research Finds Pharma Companies More Profitable than Most S&P 500 Companies
Big pharmaceutical companies appear to be more profitable than large companies in most other industries, according to a new study. Researchers writing in the Journal of the American Medical Association (JAMA) investigated the financial balances of pharma companies dealing in the business of developing, manufacturing, marketing and selling drugs.
March 3, 2020
BioPharma Dive
High prices fuel pharma profits. New research provides more context
Merck & Co., long a standard bearer for the U.S. pharmaceutical industry, earned $10 billion in profits last year. Pfizer, its larger peer, booked even more: $16 billion. Across the top ranks of drugmakers, profits regularly add up to billions of dollars, if not tens of billions, making the sector one of the most lucrative in business.
February 7, 2020
BioSpace
Life Sciences Will Continue to Boom in Massachusetts - Will the Workforce Needs Be Met?
"In an opinion piece published in the Boston Business Journal, Fred Ledley, the director of the Center for Integration of Science and Industry and a member of MassBioEd’s Academic Advisory Group, noted that STEM students are often provided with a negative view of working in the industry as some instructors emphasize corporate practices that “compromise human health or the environment.” This practice, Ledley said, ignores the “role business plays in translating scientific discoveries into products that benefit public life.” He said STEM educators need to emphasize the cross-over appeal of business and science and reveal the countless career opportunities out there."
December 19, 2019
Bentley University
Center’s Lead Data Analyst Dr. Ekaterina Cleary digs into library data
Dr. Ekaterina Cleary, lead data analyst at the Center for Integration of Science and Industry and an adjunct professor in Mathematical Science, worked with graduate students in her Data Visualization course to team up with library staff to analyze the library's data and provide recommendations on specific areas of operation.
December 17, 2019
Bentley University
Professor Fred Ledley Awarded the 2019 Mee Family Prize
As director and founder of the Center for Integration of Science and Industry, Fred Ledley’s mission is to build a bridge between the worlds of science and business, accelerating scientific discoveries for the public’s benefit. … In recognition of his efforts, he recently received the Mee Family Prize.
October 22, 2019
Bentley University
Response to OSTP Request for Information on the Bioeconomy
In September 2019, the Office of Science and Technology Policy (OSTP) issued a Request for Information (Office of Science and Technology Policy (OSTP). ACTION: Notice of request for information (RFI) for Bioeconomy Federal Register /Vol. 84, No. 175 /Tuesday, September 10, 2019). The question posed was: "What specific actions could the U.S. Government take to reinforce a values-based ecosystem that will guide the transformation and expansion of the U.S. Bioeconomy, in both the short and long-term?" The Center for Integration of Science and Industry submitted a response addressing the importance of sustained funding for the basic science that provides the essential foundation for biomedical innovation and the bioeconomy. The response proposes four actions to ensure sustained funding from both the public and private sectors."
October 2019
Institute for Quantitative Biomedicine, Rutgers University
Accelerating the Translation of Scientific Discoveries for Public Value
Dr. Fred Ledley spoke at the Institute for Quantitative Biomedicine and the Protein Data Bank at Rutgers University on "Accelerating the Translation of Scientific Discoveries for Public Value." The talk described the critical role of a mature body of foundational science, including data on protein structures and function, on the success of biopharmaceutical development.
September 25, 2019
C-SPAN
Testimony of Dr. Francis Collins to House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies
"Dr. Francis Collins and other National Institutes of Health leaders testified before a House Appropriations subcommittee on funding and research efforts. The witnesses addressed the institutes' ongoing research, impact, and investment needed to sustain such efforts." Congressman Mark Pocan requests update of study from Center for Integration of Science and Industry demonstrating the foundational role of NIH funding in pharmaceutical innovation.
July 31, 2019
U.S. Senator Chris Van Hollen
We Paid Act
"Research from the Center for Integration of Science and Industry has figured prominently in two pieces of legislation aimed at controlling drug prices. The "We PAID Act," introduced by Senators Chris Van Hollen (D-MD) and Rick Scott (R-FL), calls for the government to have authority to regulate prices based on the level of NIH support for the underlying science. A similar bill was introduced in the House by Representative by Congressman Peter DeFazio (D-OR)."
May 28, 2019
Science
Where Drugs Come From: A Comprehensive Look
"Here's another such study that appeared last year from a group at the Center for the Integration of Science and Industry at Bentley University, which found (from one direction) that NIH-funded basic research contributed in some way to every single one of the 210 FDA-approved drugs from 2010-2016, but (from the other direction) that ">90% of this funding represents basic research related to the biological targets for drug action rather than the drugs themselves". Both of those conclusions sound correct from my experience as well. The basic research funded by the NIH and others is absolutely crucial to finding drugs. But the applied research in industry is absolutely crucial, too. Both of these things can be true at the same time, and both of them are."
April 2, 2019
House Committee on Appropriations
Chairwoman DeLauro Statement at Hearing on FY 2020 NIH Budget Request
"Congresswoman Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee, delivered the following remarks at the Subcommittee's hearing on the National Institutes of Health's fiscal year 2020 budget request." Congresswoman DeLauro's remarks include reference to Dr. Ekaterina Cleary's research publication, "Contribution of NIH funding to new drug approvals 2010–2016."
April 2019
Graduate Institute of Geneva
Webinar: Public Funding of Drug Development
Dr. Ekaterina Cleary presented a webinar at the Graduate Institute of Geneva's webinar series describing the contributions of the US National Institutes of Health to drug development. This presentation was based on the March 2018 "Contribution of NIH funding to new drug approvals 2010--2016, which demonstrated that every one of the 210 drugs approved in this time period traces its origin back to basic research supported by the National Institutes of Health (NIH).
February 4, 2019
NowThis News
Alexandria Ocasio-Cortez Stands Up to Big Pharma
Representative Alexandria Ocasio-Cortez uses information from the Center for Integration of Science and Industry's PNAS paper to build a case around "...your tax dollars are helping big pharmaceutical companies get rich..."
November 29, 2018
Bentley University
New Study: U.S. Biology Textbooks Present Business in a Negative Light
Biology textbooks used in introductory college courses across the country present an overwhelmingly negative picture of businesses, according to a new study from Bentley University’s Center for Integration of Science and Industry. This may alienate students pursuing business careers from fully engaging in science education at a time when scientific literacy is increasingly important for U.S. businesses to compete in the technology-driven global economy. [...]
November 28, 2018
STAT
Science takes a dim view of business — perhaps to the disadvantage of science
Some academics recently chewed through the text of 29 undergraduate biology books and came up with a curious conclusion: Science takes a dim view of business. The analysis, from the Center for Integration of Science and Industry at Bentley University, found that references to the business world were significantly more likely to be negative than positive, including anecdotes about dangerous drugs, unethical executives, and environmental degradation. [...]
October 9, 2018
Common Dreams
A Nobel Prize-Winning Cancer Therapy Will Be Unaffordable for Most Americans. Public Pharmaceuticals Can Help Change That.
Last week, researchers James Allison and Tasuku Honjo were awarded this year's Nobel Prize in medicine for their work on cancer immunotherapies, heralded by the Nobel committee as "seminal discoveries" that "constitute a landmark in our fight against cancer." Immunotherapies like those developed on the basis of Allison and Honjo's work are indeed an important step towards a whole new way to treat cancer, as well as a host of other chronic diseases. [...]
October 2, 2018
Vox
The Nobel Prize is a reminder of the outrageous cost of curing cancer
For the first time ever, we’re living in a moment when many of our most promising medical advances are far out of reach for the vast majority of people who could benefit from them. And nowhere is that truer than for cancer immunotherapy, the fast-moving field of cancer treatment research that was honored on Monday with the Nobel Prize in physiology or medicine. [...]
August 24, 2018
Bentley University
New Findings on Breakthrough Science
How many new medicines rely on government funding? The short answer: all of them. Research on the topic at Bentley, by the Center for Integration of Science and Industry, brought government and biotechnology industry leaders to campus in April. Participants such as U.S. Rep. Katherine Clark (pictured above) explored the essential role of public funding for basic biomedical science and how the science helps create medicines, jobs and successful companies. The Bentley center’s study shows that, in the past decade, the National Institutes of Health (NIH) invested more than $100 billion in research that led to new medicines. NIH support contributed to the basic science underlying every one of the 210 new drugs approved by the Food and Drug Administration (FDA) between 2010 and 2016. [...]
August 23, 2018
U.S. Government Publishing Office: Senate Hearing 115-844
PRIORITIZING CURES: SCIENCE AND STEWARDSHIP AT THE NATIONAL INSTITUTES OF HEALTH
"We, at N.I.H., as you quoted this recent study, just published in the 'Proceedings of the National Academy of Sciences of the United States of America,' where Fred Ledley and colleagues looked across a five-year or a six-year period and said every single one of the FDA-approved drugs in that timetable were based upon basic science discoveries that N.I.H. has supported." [...]
May 28, 2018
The New York Times
‘Paying Twice’: A Push for Affordable Prices for Taxpayer-Funded Drugs
On Aug. 30, the Food and Drug Administration approved a radical new cancer treatment that harnesses a patient’s immune system to attack tumor cells. The drug, known as Kymriah, grew out of research conducted and supported by the National Institutes of Health. Seven weeks later the F.D.A. approved a second cancer therapy that uses similar technology. This treatment, Yescarta, “got its start right here at N.I.H.,” said Dr. Francis S. Collins, the director of the health institutes. It was developed by Kite Pharma using technology licensed from the N.I.H. Kymriah costs $475,000 for a one-time treatment, and Yescarta goes for $373,000. As President Trump vows to lower prescription drug prices, consumer advocates and health policy experts are increasingly saying that the government should insist on reasonable prices for drugs developed with taxpayer funds. [...]
May 7, 2018
STAT
The Miracle of Medicines
We don’t know what induced an ancestral human in pain to eat the seed head of the opium poppy. We do know, from the Ebers papyrus, that by 1500 B.C. the Egyptians were using complex mixtures of plants as medicine, and that they realized there was a fine line between doses that improved health and doses that caused toxicity. Opium might bring relief from pain, but it also caused sleepiness, addiction, and even death. Until relatively recently, all drug discovery began with folklore and folk medicine, like the elderly woman in the 1770s telling William Withering that her recipe for dropsy (heart failure) included the purple foxglove plant, which contained digitalis. [...]
February 27, 2018
NIH Director's Blog
Basic Research: Building a Firm Foundation for Biomedicine
A major part of NIH’s mission is to support basic research that generates fundamental knowledge about the nature and behavior of living systems. Such knowledge serves as the foundation for the biomedical advances needed to protect and improve our health—and the health of generations to come. Of course, it’s often hard to predict how this kind of basic research might benefit human populations, and the lag time between discovery and medical application (if that happens at all) can be quite long. Some might argue, therefore, that basic research is not a good use of funds, and all of NIH’s support should go to specific disease targets. [...]
February 23, 2018
CBC News
How many new drugs rely on government-funded science? All of them
There's public science in every single new drug. That was the surprising answer to a U.S. senator's question about how government-funded research is benefitting citizens. But it took a year to come up with the numbers. It all started last June when Bentley University professor Fred Ledley and his colleagues in Massachusetts were watching a senate budget hearing that was considering cutting the budget of the National Institutes of Health, the major medical science funding agency in the U.S. [...]
February 13, 2018
The Center for Biosimilars
Is the White House Budget at Odds With NIH's Contributions to New Drugs?
Yesterday, President Trump released his budget proposal for the 2019 fiscal year. Under the proposed plan, the National Institutes of Health (NIH) budget for 2019 would remain about equal to its 2017 budget: $34.8 billion. However, this figure would be roughly $2 billion less than the 2018 budget that was just approved by Congress on February 8.... On the same day that Trump put forward his budget proposal, the Proceedings of the National Academy of Sciences of the United States of America (PNAS) released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016. [...]
February 13, 2018
Endpoints News
$100B in NIH-funded research played an important role in all 210 new drugs approved over 7 years — study
The next time someone challenges the importance of NIH-funded research in drug development, you might want to point them to a new study that highlights the foundational role the Institutes plays in biopharma research.[...]
February 13, 2018
Bentley Newsroom
Federally funded research contributed to the science underlying all new medicines approved by the FDA over the past six years, according to a new study by Bentley University.
"The new report from the Center for Integration of Science and Industry at Bentley University, published in the Proceedings of the National Academy of Sciences, shows that the United States government invested more than $100 billion in the basic research that led to new medicines approved by the Food and Drug Administration (FDA) between 2010 and 2016. Basic research explores fundamental biological processes without specific applications or products in mind. Every one of the 210 new medicines approved over this six year period was associated with research funded by the National Institutes of Health (NIH). As much as $64 billion of this funding was associated with 84 innovative, first-in-class drugs, which treat disease through novel biological mechanisms or targets." [...]
Additional coverage on Medical Xpress
February 12, 2018
STAT News
NIH funding contributed to 210 approved drugs in recent years, study says
A new study makes a strong case for the importance of government support for basic research: Federally funded studies contributed to the science that underlies every one of the 210 new drugs approved between 2010 and 2016. Researchers at Bentley University scoured millions of research papers for mentions of those 210 new molecular entities, or NMEs, as well as studies on their molecular targets. Then, they looked to see which of those studies had received any funding from the National Institutes of Health. [...]
February 2018
PNAS
Contribution of NIH funding to new drug approvals 2010–2016
View a continuously updated news feed of Contribution of NIH funding to new drug approvals 2010–2016
Overview of attention for article published in Proceedings of the National Academy of Sciences of the United States of America
February 12, 2018
Bentley University
NIH funding and drug development
Researchers report the contribution of NIH funding to recent new drug development. The impact of public sector funding on drug development is not well understood, partly because this funding is focused on basic research, the translational impact of which is difficult to quantify. [...]
January 25, 2018
Bentley University: PreparedU
Thirty Years of Innovation Pays Off as Gene-based Drugs Come to Market
The recent approval of SpinrazaTM (nusinersen), jointly developed by Ionis Pharmaceuticals and Biogen, marks the arrival of a new class of biological products - oligonucleotide therapeutics, or gene-based drugs. A recently published study from Bentley's Center for Integration of Science and Industry shows that the thirty year path from the initiation of research on oligonucleotides as therapeutics to the emergence of effective products followed predictable patterns of innovation, in which novel products are successfully developed only after the underlying basic research reaches a requisite level of maturity. [...]
July 12, 2017
Waltham Public Library
Frankenfood or Promethean Promise? Science and Food Production
The foods we eat, whether “organic, “natural, or “locally sourced,” are no longer of nature. The strains of vegetables that we grow and subspecies of animals we use for milk and meat would be unrecognizable to our ancestors and unsuccessful in the wild. Even before the modern era of molecular genetic engineering, all of our foods have been subject to millennia of cross breeding and human selection. Have we created Frankenfoods, or a Promethean promise of sustainable future? Bentley University Professor Fred D. Ledley talks genetically modified foods at the Waltham Public Library. [...]
May 8, 2017
Bentley University: PreparedU
21st Century Cures Emerge As 20th Century Science Matures
Most of the new drugs approved by the FDA since 2010 arose from basic scientific research that was initiated in the 1970s or 1980s, a new study from Bentley University has found. The analysis shows that development of new targeted and biological therapeutics rest on the maturation of basic science over decades. The research, published today in the journal PLOS ONE, appears as scientists are increasingly concerned about federal support for basic biomedical research. [...]
March 28, 2017
BioWorld
Translation takes time: Study shows how to measure it properly
The lag between the initiation of new research and the approval of targeted or biologic drugs for treating cancer can exceed 40 years, according to a newly published analysis that examines the relationship between the maturation of technologies and their potential to generate successful products. To casualties of the early era of antibody development, the conclusion might appear obvious. [...]
March 27, 2017
Boston Business Journal
NIH cuts might cause 40 years of pain, Bentley study says
Massachusetts researchers say the effects of slashing funding for the National Institutes of Health could have negative impacts on scientific discovery for decades. Researchers at Bentley University reported in a study published this week in the science journal PLOS One that it takes over a decade and upward of 40 years for the discoveries coming from basic research to fuel commercial drugs and technologies. [...]
March 27, 2017
Bentley University: PreparedU
New Study Demonstrates the Importance of Long-Term Funding for Cancer Research
New drugs to treat cancer that are now emerging are the end products of research begun in the 1970s and ‘80s, a new study by Bentley University has found, demonstrating the importance of long-term research in bringing new therapies to market. The research, published today in the journal PLOS One, appears as Congress considers deep cuts to the National Institutes of Health, whose budget funds research into cancer and other diseases. [...]
December 19, 2016
Bentley University: PreparedU
Center for Integration of Science and Industry Expands Data Analytics Capabilities with New Appointments
Expanding its capabilities in the application of machine learning, big data and analytics to accelerate the translation of scientific discoveries into new medicines and treatments for diseases, the Center for Integration of Science and Industry at Bentley University has appointed Ekaterina Galkina Cleary, PhD, as a postdoctoral fellow and R. Mark Adams, PhD, as a visiting faculty in the Department of Natural and Applied Sciences. [...]
December 8, 2016
Bentley University: PreparedU
Could Edible Algae Hold the Key to Slowing Climate Change? Bentley Fellow Forecasts Yes.
Scientists affiliated with the Marine Algal Industrialization Consortium have published a research article demonstrating the potential of using microalgae (algae) to significantly mitigate greenhouse gas emissions if used as a source of food. Leading the study was Michael J. Walsh, a research fellow in Bentley University’s Center for Integration of Science and Industry [...]
November 29, 2016
Bloomberg L.P.
Fred Ledley on Bloomberg Radio: Finding the Proper Dose of Skills for Success in the Health Care Industry
Listen in as Dr. Fred Ledley, director of Bentley University's Center for Integration of Science and Industry (CISI), joins Bentley President Gloria Larson and Bloomberg Radio's Carol Massar and Cory Johnson to discuss the similar frameworks of business and healthcare.
October 18, 2016
Bentley University: PreparedU
Why Business Students Should Care About the Story of the Drug Humira
Developing new medicines is a hard business. While we live in an era of amazing discoveries in biomedical science, information technology, and medicine, there have not been comparable advances in the development of new drugs or the outcomes of major diseases. Why? Research at Bentley University suggests that it is often because innovative technologies are not in sync with business strategies and public policy. [...]
July 19, 2016
Bentley University: PreparedU
At the Forefront of Sustainable Food, Bentley Research Fellow Brings Algae to the Table
Think the bright green substance that might be overtaking your neglected fish tank is useless? Think again. Though it would be too difficult to harness the power of that naturally occurring fish tank algae, a Bentley scientist is working to create economic value from algae that can be intentionally and sustainably produced in mass quantities. [...]
March 1, 2016
Macquarie University
Vice-Chancellor welcomes Professor Ledley to campus
The Vice-Chancellor welcomed Professor Fred Ledley to campus last week, and provided an introduction to a guest lecture given to the University. Professor Ledley is the Director of the Centre for Integration of Science and Industry at Bentley University, and an expert in the commercialization of medical technology and developments. [...]
February 19, 2016
Bentley University: PreparedU
Center for Integration of Science and Industry Receives $2.3M in Funding
Bentley’s Center for Integration of Science and Industry, founded in 2013 with a $1.3M grant from the National Biomedical Research Foundation (NBRF), was awarded renewed funding from the NBRF: $2.3M over the next five years [...]
November 23, 2015
Wyatt Investment Research
Are Self-Driving Cars Headed For Your Portfolio?
Fred Ledley commented on the future of self-driving cars, emphasizing that “Experience teaches that computers are actually better at decision-making capability than humans. Humans tend to overestimate the value of 'experience' and 'feel,' and rarely compete successfully against computers and algorithms dedicated to particular purposes.”
November 20, 2015
The Boston Globe
FDA Approves Genetically Modified Salmon
The genetically engineered fish, named the AquAdvantage salmon, is produced by AquaBounty, a Maynard biotechnology company based in Massachusetts. With the FDA's OK, AquaBounty can now offer its modified salmon to American consumers.
October 27, 2015
Bentley University: PreparedU
Why a Business University and Its Students Should Be Invested in Healthcare Reform
The challenges facing our national healthcare system are undoubtedly among the most pressing concerns of our nation. With an aging population, healthcare costs escalating, and patient need increasing, we must look more than ever to innovative solutions. So what can a university do to prepare tomorrow’s future business leaders to help reform the healthcare system? [...]
August 18, 2015
Bentley University: PreparedU
Bentley University Study Suggests Alzheimer’s Research is Ready to Provide Cures
It has been more than a decade since a new drug was approved for the nearly 5 million Americans suffering from Alzheimer’s disease. Research from the Center for Integration of Science and Industry at Bentley University offers a hopeful view of the prospects for new Alzheimer’s drugs [...]
July 1, 2015
Bloomberg L.P.
Fred Ledley on Bloomberg Radio: Do stock buybacks compete with corporate R&D? (Audio)
Listen in on Dr. Fred Ledley, director of Bentley University's Center for Integration of Science and Industry (CISI), offer insight on how biotechnology companies are increasingly at odds with activist investors.
July 1, 2015
Science Direct
Algal Biofuel Production for Fuel and Feed in a 100-ha Facility
A comprehensive techno-economic analysis and life cycle assessment based on actual production by the Cornell Marine Algal Biofuels Consortium with biomass productivity > 23 g/m2-day.
March 16, 2015
Bentley University
Bentley University's Center for Integration of Science and Industry
"Professor Ledley discovered that there was a large disconnect between the business people and biotech companies, as well as the scientist, where the businessmen didn't understand the science and the scientists don't understand the business." - JR Brennan '15, former undergraduate research assistant.
February 16, 2015
American Association for the Advancement of Science
AAAS 2015 Annual Meeting Session - The Business of Innovation: Great Science Is Only the First Step
Fred Ledley discusses the business of innovation with Karen Bernstein, Co-Founder and Chairman of BioCentury, and Gail Naughton, CEO and Chairman of the Board of Histogen Inc.
February 11, 2015
Bentley University: PreparedU
Post-Doctoral Fellow Appointed to Research Treatment for Neurodegenerative Diseases
Expanding its research on how to accelerate the translation of scientific discoveries into new medicines, the Center for Integration of Science and Industry at Bentley University has appointed Jennifer Beierlein as a post-doctoral fellow. Beierlein will focus on strategies and policies that may lead to new treatments for neurodegenerative diseases including Alzheimer’s, Dementia and Parkinson’s disease [...]
June 11, 2014
Bentley University
Fred Ledley: Testifies to Congressional Committee on Energy and Commerce
Dr. Fred Ledley's testimony focuses on business incentives that encourage the development of the highly innovative medicines that are being enabled by the rapid advance of science, including some of the work being done at the Center for Integration of Science and Industry at Bentley University.
June 11, 2014
Bloomberg L.P.
Fred Ledley on Bloomberg's Taking Stock Radio Program: Comments on 21st Century Cures Act (Audio)
Listen in on Fred Ledley, director of Bentley University's Center for Integration of Science and Industry (CISI), and Sam Fazeli, director of research and senior pharmaceutical analyst for Bloomberg Industries, discuss advances in the health care industry geared towards getting drugs to patients more quickly.
June 11, 2014
Bentley University: PreparedU
Bentley Professor Advocates Incentives to Leverage 21st-Century Science for Innovative Medical Cures
As the U.S. Congress embarks on a first-of-its-kind initiative to help accelerate the pace of medical cures in America, Bentley professor Fred Ledley joined a panel of experts who testified at a congressional hearing in Washington, DC, on incentives for pharmaceutical and device development [...]
December 3, 2013
Bentley University: PreparedU
Fred D. Ledley Named Fellow, American Association for the Advancement of Science
Fred D. Ledley, Professor of Natural & Applied Sciences and Management, and Director of the Center for Integration of Science and Industry, was named a fellow of the American Association for the Advancement of Science (AAAS). He will be recognized at the AAAS Annual Meeting in Chicago in February 2014 [...]
March 5, 2013
Boston Business Journal
Researching Biotech Business Models
Bentley University is the recipient of a $1.3 million grant from the Boston-based National Biomedial Research Foundation, which is to be allocated to the newly created Center for Integration of Science and Industry (CISI) to fund research on biotech business models.
February 19, 2013
Bentley University: PreparedU
Bentley Receives $1.3M to Advance the Integration of Science and Business
The National Biomedical Research Foundation has awarded a $1.3M grant to Bentley University to establish a Center for Integration of Science and Industry, under the direction of Dr. Fred Ledley, Professor of Natural & Applied Sciences and Management [...]
November 30, 2012
Management INK
Taking Business Education Into the Future
Professor Fred Ledley of Bentley University talks with editor Jane Schmidt-Wilk about his paper, co-authored by Stephen Holt of Olin College, which argues that business programs should require science courses designed expressly to meet the needs of business students.
October 10, 2012
Nature
Patterns of technological innovation in biotech
Theories of innovation posit that effective product development and value creation require business models and strategies matched to the stage of technology evolution. Such theories are predicated on patterns of technology evolution observed in other fields, where periods of exponential advancement are followed by limits and obsolescence as new technologies emerge [...]