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Tag: NIH

  • Appeals court upholds ruling preventing NIH from cutting millions from NC

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    A federal appeals court upheld an injunction Monday that prevents the National Institutes of Health (NIH) from making cuts that would’ve translated to hundreds of millions of dollars in lost grant money for North Carolina.

    21 other states joined the State Department of Justice in suing the Trump Administration to block the cuts from taking effect. 

    The Triangle would’ve been North Carolina’s hardest hit region. The grant money impacts medical and public health research conducted at schools like NC State University, the University of North Carolina and Duke University. An analysis found the cuts would’ve cost the region $1.2 billion in direct funding and indirect economic impact. 

    “This was a big win for the state,” Attorney General Jeff Jackson (D-North Carolina) said in an interview with WRAL. “This would have really impacted treatment of patients, but also clinical tests and a lot of medical research. Now, fortunately, that’s not going to happen.” 

    Jackson argued that if the cuts went through, medical research projects wouldn’t have been able to continue. That could’ve led to thousands of job cuts across the region. 

    The Trump Administration announced a plan for a 15% cut to NIH grant funding in February 2025, shortly after President Donald Trump returned to office as he kick-started efforts to try shrinking the size of the federal government. 

    In August, a Department of Health and Human Services spokesperson sent WRAL a statement justifying the cuts: 

    “NIH is committed to restoring the agency to its tradition of gold-standard, evidence-based science. For too long, resources have drifted toward projects with limited relevance to the health challenges facing Americans. NIH remains committed to research that is free from ideology and bias — science that is exploratory, rigorous, and focused on improving health outcomes. It is a deliberate course correction to strengthen accountability and ensure NIH funds research that delivers measurable impact for all Americans.” 

    This is the latest legal battle putting the NC Dept. of Justice at odds with the White House. Jackson has filed many lawsuits over the past year. >>Triangle at the epicenter of proposed cuts to federal funding for medical research

    >>Triangle at the epicenter of proposed cuts to federal funding for medical research

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  • Man living with cancer goes door-to-door in effort to keep research going

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    SIGNATURES TO PUSH LAWMAKERS TO DO SOMETHING TO GET THAT MONEY BACK. DOCTOR PETER BRIDGMAN IS SPENDING HIS HOLIDAYS GOING DOOR-TO- DOOR CHATTING WITH HIS NEIGHBORS. HE’S THANKFUL FOR THE CANCER TREATMENTS THAT ARE KEEPING HIM ALIVE. THE 72-YEAR-OLD FORMER NEUROLOGIST WAS DIAGNOSED IN 2013 WITH MULTIPLE MYELOMA – A BONE MARROW CANCER – TREATABLE WITH INFUSION THERAPIES. HE’S DOING WELL…BUT WORRIES ABOUT THE DAY HE MIGHT NEED MORE ADVANCED TREATMENT OPTIONS CURRENTLY UNDER DEVELOPMENT AT THE “NATIONAL INSTITUTES OF HEALTH” – AND THE “NATIONAL CANCER INSTITUTE.” THE AGENCIES ARE FORCED TO CUT BILLIONS OF DOLLARS NOW THAT PRESIDENT TRUMP’S BUDGET HAS PASSED. “NIH AND THE NCI EXPECTED SMALL CUTS LIKE FIVE OR TEN PERCENT, BUT THEY WERE COMPLETELY FLOORED BY THE 37-PERCENT CUT TO THE NCI.” “ACTIVE RESEARCH IS GOING ON AND THAT MIGHT BE CURTAILED. SO, BY THE TIME I NEED IT, IT MAY NOT BE THERE FOR ME.” SO, HE’S ASKING HIS NEIGHBORS TO SIGN AN ON-LINE PETITION CALLING FOR FUNDS TO BE RESTORED TO PREVIOUS LEVELS. “IN ORDER TO SAVE LIVES, WE HAVE TO RESTORE FUNDING TO CLOSE TO WHAT IT WAS BEFORE. IF WE LET THE FUNDING BOUNCE UP AND DOWN, RESEARCHERS WILL GO TO OTHER COUNTRIES. THEY’LL GO TO THE EUROPEAN UNION. THEY’LL GO TO CHINA. AND WE’LL LOSE ALL OF THAT. IT WOULD TAKE DECADES TO BUILD IT BACK. SO, THAT’S THE RISK. THAT’S THE SERIOUS RISK.” HIS NEIGHBOR, JOHN AUBLE WAS HAPPY TO SIGN. WAS HAPPY TO SIGN. “OVERALL, I THINK CANCER IN UNDER FUNDED SO EVERY TIME WE HAVE SOMEBODY WHO IS WILLING TO PUT IN THE TIME THAT HE DOES – IT’S REALLY TOUCHING. WE NEED MORE PETERS.” IF YOU ARE INTERESTED IN LEARNING MORE ABOUT THE PETITION – YOU CAN VISIT WWW.FIGHTCANCER.ORG “NEXT TUESDAY AFTERNOON DR. BRIDGMAN AND OTHERS FROM THE AMERICAN CANCER SOCIETY WILL HAND DELIVER THOSE PETITION SIGNATURES TO SENATOR SUSAN COLLINS HERE AT HER PORTLAND OFFICE. AND THEY WAIT FOR CONGRESS TO RECONVENE AND HOPE THAT RESEARCH FUNDI

    Man living with cancer goes door-to-door in effort to keep federal research going

    Updated: 12:13 PM PST Nov 29, 2025

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    Dr. Peter Bridgman, a retired neurologist who has cancer, is a man on a mission to get funding restored for federal agencies that are conducting cancer research.Bridgman, 72, was diagnosed with multiple myeloma in 2013. Multiple myeloma is a bone marrow cancer that is treatable with infusion therapies.The Yarmouth resident said he is doing well and is thankful for the treatments that are keeping him alive, but he is concerned about the future of cancer research.Advanced cancer treatment options are under development at the National Institutes of Health (NIH) and National Cancer Institute (NCI), but the federal agencies face funding cuts in the billions.”NIH and the NCI expected small cuts like five or 10 percent, but they were completely floored by the 37 percent cut to the NCI,” Bridgman said. “Active research is going on and that might be curtailed. So by the time I need it, it may not be there for me.”Bridgman is now going door-to-door and asking his neighbors to sign an online petition calling for NIH and NCI funds to be restored to previous levels.”In order to save lives, we have to restore funding to close to what it was before. If we let the funding bounce up and down, researchers will go to other countries. They’ll go to the European Union. They’ll go to China, and we’ll lose all of that,” Bridgman said. “It would take decades to build it back, so that’s the risk. That’s the serious risk.”John Auble, one of Bridgman’s neighbors, said he was happy to sign the petition.”Overall, I think cancer is underfunded. So every time we have somebody who is willing to put in the time that he does, it’s really touching,” Auble said. “We need more Peters.”People who are interested in learning more about the petition can visit fightcancer.org.On Tuesday, Dec. 2, Bridgman and others from the American Cancer Society will hand deliver the petition signatures they have collected to U.S. Sen. Susan Collins’ office in Portland. They will then wait for Congress to reconvene and hope that research funding will be restored.

    Dr. Peter Bridgman, a retired neurologist who has cancer, is a man on a mission to get funding restored for federal agencies that are conducting cancer research.

    Bridgman, 72, was diagnosed with multiple myeloma in 2013. Multiple myeloma is a bone marrow cancer that is treatable with infusion therapies.

    The Yarmouth resident said he is doing well and is thankful for the treatments that are keeping him alive, but he is concerned about the future of cancer research.

    Advanced cancer treatment options are under development at the National Institutes of Health (NIH) and National Cancer Institute (NCI), but the federal agencies face funding cuts in the billions.

    “NIH and the NCI expected small cuts like five or 10 percent, but they were completely floored by the 37 percent cut to the NCI,” Bridgman said. “Active research is going on and that might be curtailed. So by the time I need it, it may not be there for me.”

    Bridgman is now going door-to-door and asking his neighbors to sign an online petition calling for NIH and NCI funds to be restored to previous levels.

    “In order to save lives, we have to restore funding to close to what it was before. If we let the funding bounce up and down, researchers will go to other countries. They’ll go to the European Union. They’ll go to China, and we’ll lose all of that,” Bridgman said. “It would take decades to build it back, so that’s the risk. That’s the serious risk.”

    John Auble, one of Bridgman’s neighbors, said he was happy to sign the petition.

    “Overall, I think cancer is underfunded. So every time we have somebody who is willing to put in the time that he does, it’s really touching,” Auble said. “We need more Peters.”

    People who are interested in learning more about the petition can visit fightcancer.org.

    On Tuesday, Dec. 2, Bridgman and others from the American Cancer Society will hand deliver the petition signatures they have collected to U.S. Sen. Susan Collins’ office in Portland. They will then wait for Congress to reconvene and hope that research funding will be restored.

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  • TCU professors get $7.2 million to study this alternative to arrest

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    FortWorth

    The Institute of Behavioral Research at TCU has been awarded a $7.2 million grant from the NIH National Institute on Drug Abuse to study alternatives to arrest or prosecution that connect people with treatment instead.

    The project will work with 20 communities across Colorado, Illinois, New Mexico, Pennsylvania and Wisconsin.

    “We know that substance use and crime are deeply connected, and arrests alone aren’t fixing the problem,” said senior research scientist Jenny Becan, PhD. “Often arrests actually make things worse for people and their families.”

    Instead of arresting an individual, the program would link that person to medical or emotional support, Becan said, and offer to enroll them into deflection. If someone opts into deflection, they would be connected with a peer navigator who could help them set up appointments or do anything else they need assistance with, Becan said.

    “It’s all about reducing arrest and getting people to treatment, and it’s always about team effort between law enforcement, first responders, and community-based health providers,” Becan said.

    The research is led by Becan and Kevin Knight, Ph.D., professor and IBR director.

    The goal is that law enforcement can play a role in both public safety and public health, Becan said.

    “Hopefully we’ll see reduced reoffending or recidivism, and breaking down that costly cycle of repeated, you know, going through the arrest and jail and back in the community,” she said.

    Becan said she expects the research to further understanding of how deflection improves outcomes for people who use drugs and to inform best practices for communities using deflection.

    Related Stories from Fort Worth Star-Telegram

    Ciara McCarthy

    Fort Worth Star-Telegram

    Ciara McCarthy covers health and wellness as part of the Star-Telegram’s Crossroads Lab. She came to Fort Worth after three years in Victoria, Texas, where she worked at the Victoria Advocate. Ciara is focused on equipping people and communities with information they need to make decisions about their lives and well-being. Please reach out with your questions about public health or the health care system. Email cmccarthy@star-telegram.com or call or text 817-203-4391.

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    Ciara McCarthy

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  • Steep Trump cuts haven’t effectively ended medical research

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    President Donald Trump has made historically large cuts to medical research, some of them aimed at ending what he refers to as diversity, equity and inclusion in federally funded studies. His administration is proposing more: Overall funding for the National Institutes of Health would return to its 2007 level if Trump’s budget proposal were to be enacted. A recent New York Times story highlighted Trump’s billions in proposed National Cancer Institute cuts and carried the headline, “Trump Is Shutting Down the War on Cancer.”

    In the midst of a fight with Republicans over spending and a possible government shutdown, House Minority Leader Hakeem Jeffries, D-N.Y., criticized the Trump administration’s efforts to cut back medical research funding during a Q&A with reporters.

    “Republicans have effectively ended medical research in the United States of America,” Jeffries said Sept. 24.

    Has the Trump administration really ended medical research? While a substantial amount has disappeared, and more could be on the way out if Trump gets his way, Jeffries exaggerated the outlook, even allowing for his “effectively” caveat. Billions of dollars would remain even in the most austere scenario, and there’s uncertainty about whether his most severe proposed cuts will receive congressional approval. 

    Even after proposing substantial cuts to the budget of the National Institutes of Health — the main engine funding U.S. medical research — Trump’s proposal would give the institutes $27 billion for fiscal year 2026. 

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    And Trump’s proposal is not final; Congress could increase that amount. Some experts call that scenario likely.

    “The appropriations language making its way through Congress is much less draconian, so it may be too early to know where all this is going to land,” said Richard Frank, a senior fellow at the Brookings Institution, a Washington, D.C., think tank.

    Jeffries’ office did not provide additional evidence for his statement.

    What cuts has Trump made so far?

    Trump’s cuts so far take several forms, said Joshua Weitz, a University of Maryland biology professor who co-founded the Science and Community Impacts Mapping Project, which is tracking the impacts of federal funding cuts nationally. Some of these cutbacks are being challenged in court.

    • Weeks after Trump’s inauguration, the National Institutes of Health announced major cuts to “indirect costs” —  funds that pay for facilities, safety and grant administration. It capped indirect costs for labs working on NIH grants at 15%. Previously, the average rate was about 28%, and sometimes above 60%.

    • The White House has terminated thousands of research grants worth approximately $5 billion. Some of these were canceled for being related to diversity, equity and inclusion, a top target of the administration, such as a $3.8 million Asian Bipolar Genetics Network study to a $1.05 million Alzheimer’s and dementia study focusing on Black Americans. Others were related to administration efforts to punish elite universities for allegedly allowing antisemitism on campus, leading to hiring freezes and holds on clinical trials, Harvard University economist David Cutler and Harvard economist Edward Glaeser co-wrote a recent paper in JAMA Health Forum. “A fraction of these grants have been reinstated, but science does not turn on and off like a spigot,” Weitz said. “Interrupting research leads to wasted studies, risks projects, and is already causing job loss.”

    • Through early April, the NIH ousted 1,200 employees, and granted an unknown number of retirements and resignations. At the Food and Drug Administration, which approves drugs, thousands of jobs have been eliminated.

    • The president’s budget proposal would cut NIH funding from about $45 billion to about $27 billion. That’s a roughly 39% cut for a budget item that in recent decades has almost always increased from year to year. The proposed budget would eliminate the National Institutes for Nursing Research, the National Center for Complementary and Integrative Health, the Fogarty International Center, and the National Institute on Minority Health and Health Disparities.

    The consequences of these cuts could be significant. 

    “Our research shows that while cutting NIH funding may appear to save money in the short term, it can trigger a chain of effects that increase long-term health care costs and slow the development of new treatments and public health solutions over time,” Harvard University health policy and data specialists Mohammad S. Jalali and Zeynep Hasgül wrote for The Conversation. 

    Between 2010 and 2019, all but two of the 356 drugs approved by the Food and Drug Administration received some NIH funding, one study found. So any cuts could reduce the number of drugs in the pipeline, experts say.

    Once all the follow-on impacts reverberate throughout the U.S. economy and health care system, the cuts could prompt an “$8 trillion health care catastrophe,” Cutler and Glaeser wrote. They estimated that the losses from reduced health would be 16 times greater than the proposed budgetary savings.

    Despite the cuts, medical research is here to stay

    The cuts are extensive but do not end U.S. medical research.

    Trump’s slashed NIH budget would still spend more than $27 billion in fiscal year 2026. 

    “Novel biomedical discoveries that enhance health and lengthen life are more vital than ever to our country’s future,” the agency said in its budget proposal. “NIH research is critical to protect national security and sustain the United States’ scientific competitiveness, globally.”

    The president’s proposal highlighted initiatives on nutrition, obesity, heart disease, diabetes, asthma, autism, and cancer, all priorities of Health and Human Services Secretary Robert F. Kennedy Jr.

    The FDA would receive a modest budgetary bump under Trump’s budget proposal, to almost $6.8 billion. 

    Despite the Republican majority’s generally close alignment with Trump’s policy agenda, Congress is on record rejecting his proposed medical research cuts, at least in the preliminary stage. 

    The Senate and House appropriations committees have voted for modest increases in NIH’s budget rather than Trump’s large cuts. They also voted to fund CDC and FDA at higher levels than Trump set out in his budget proposal.

    These increases are not guaranteed; they will have to go through negotiations between lawmakers and the president before final passage. 

    “Congress is likely to approve much smaller cuts than the Administration had proposed,” said Sherry Glied, a professor at New York University’s Robert F. Wagner Graduate School of Public Service.

    Our ruling

    Jeffries said, “Republicans have effectively ended medical research in the United States of America.”

    Trump has proposed severe cuts to medical research at the National Institutes of Health and other agencies, including caps on indirect costs for grantees’ labs, terminated grant funding and staff reductions. But this is not tantamount to effectively ending U.S. medical research.

    Even if Trump gets his way on a 39% cut to NIH’s budget in 2026, the institutes would still have more than $27 billion to spend in fiscal year 2026.

    Trump’s fellow Republicans in Congress may not go along with cuts on the scale the president proposed. Appropriations committees in both the Senate and the House have already rejected Trump’s steep cuts on medical research.

    Trump’s medical research cuts are real and sweeping, but they have not “effectively ended medical research.” We rate the statement Mostly False.

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  • RFK Jr. promised to ‘Make Our Children Healthy Again.’ Here’s how he plans to do it

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    (CNN) — President Donald Trump’s strategy to ‘Make America Healthy Again’ includes investigating vaccine injuries and pharmaceutical practices but stops short of new regulatory action, for now.

    US Health and Human Services Secretary Robert F. Kennedy Jr. unveiled the MAHA strategy on Tuesday, joined by Agriculture Department Secretary Brooke Rollins, Environmental Protection Agency Administrator Lee Zeldin, and other top Trump officials.

    The report hews closely to a draft document circulated in August that cites earlier Trump administration announcements — developing a definition for ultraprocessed foods, educating the public about synthetic kratom — but largely bypassed industry crackdowns.

    Language around pesticides strategy also remained unchanged. Environmental and food activists had rallied for the administration to include steps to reduce pesticide usage and probe potential health risks of commonly used chemicals such as RoundUp.

    The report says that USDA, EPA and the National Institutes of Health will develop a framework to study cumulative exposures to chemicals including pesticides and microplastics. USDA and EPA will also invest in new farming approaches to reduce chemical use, and EPA will launch a public awareness campaign about the limited risk of approved products.

    The commission’s first report this May suggested a broad range of factors driving chronic disease in the US, including ultraprocessed foods, environmental exposures, and overprescription of pharmaceuticals like antidepressants.

    The report noted previous announcements that HHS, the NIH and the Centers for Medicare and Medicaid Services are studying the causes of autism. Kennedy had previously promised some answers on the root causes in September; NIH is expected to announce autism research grants this month.

    Recent reports suggest that HHS will issue a report that links the development of autism to taking Tylenol during pregnancy.

    Medicines and vaccines

    Kennedy has drawn criticism for suggesting antidepressants, particularly those that are part of a family known as SSRIs are as addictive as heroin and can be dangerous. Following the August 27 shooting in Minneapolis, he told Fox News that HHS is launching studies “on the potential contribution of some of the SSRI drugs and some of the other psychiatric drugs that might be contributing to violence.”

    SSRIs, or selective serotonin reuptake inhibitors, are the most prescribed class of antidepressants for depression, anxiety disorders and many other mental health conditions. Several SSRIs have been on the market in the United States since the 1990s, including Prozac, Zoloft and Celexa. Experts agree that there is no scientific evidence or correlation between these drugs and violence towards others.

    Tuesday’s report states that HHS will assemble a working group of federal officials to evaluate SSRI prescribing patterns, specifically among children. HHS will also “evaluate the therapeutic harms and benefits of current diagnostic thresholds,” or the current common practices doctors use to diagnose patients with mental health disorders.

    Dr. Theresa Miskimen Rivera, president of the American Psychiatric Association said access to care, not over-medication is the bigger problem when it comes to helping kids’ mental health in the country, and there is no mention of the issue in the report. The report said addressing a child’s nutrition, screen time, and exercise can improve their mental health, but can’t address everything. “Psychiatric conditions are complex in nature,” she said. Extreme poverty, post traumatic stress disorder, trauma-related factors should also be addressed, but there is no mention in the report of any of those issues either.

    “In terms of over medication, that’s not what we do. We have a comprehensive evaluation and we are evidence based. We diagnose than create a comprehensive treatment plan, “ Miskimen Rivera told CNN. “Medication can save lives, not only in children, but in adults and elderly.”

    When asked about whether or not the commission chose to consider gun violence – the leading cause of death for children – as one of the issues to be investigated, Kennedy doubled down on the issue of prescription drugs, saying “We are doing studies now, or initiating studies to look at the correlation and the connection, potential connection between over medicating our kids and this violence.”

    HHS will also work with the White House Domestic Policy Council on a new vaccine framework that, the report said, will ensure “America has the best childhood vaccine schedule” and ensure “scientific and medical freedom.”

    The report comes as Kennedy continues to defend his shakeup of the US Centers for Disease Control and Prevention over vaccine policy, including the ouster of CDC Director Dr. Susan Monarez.

    The administration will also increase oversight of “deceptive” direct-to-consumer advertising of pharmaceutical products, including from social media influencers and telehealth companies, it said.

    Food policy stays the course

    FDA will continue work on developing a definition for ultraprocessed foods, but the report bypasses recommendations, like those of former FDA Director Dr. David Kessler, to essentially order certain additives off the market until they are reviewed.

    Dr. Dariush Mozaffarian, director of Tufts Food is Medicine Institute said a definition of ultraprocessed foods would be “really important.” With more than half of calories in the food supply coming from ultraprocessed foods, addressing this and other issues involving the nation’s diet would mean a “massive fight with the industry and is going to be incredibly controversial, but is much needed.”

    “Overall, this is really quite thorough, quite specific, and even if parts of this are accomplished, this could have tremendous positive impact for Americans,” Mozaffarian told CNN.

    Other experts, like Marion Nestle, agreed the report was ambitious in scope, but noted it fell short on regulatory action. “What’s still missing is regulation. So much of this is voluntary, work with, promote, partner,” said Nestle, who is the Paulette Goddard professor emerita of nutrition, food studies and public health at New York University.

    The report also nods to new, user-friendly dietary guidelines expected later this year. Kennedy has promised a vastly shortened set of recommendations that will emphasize whole foods.

    The commission also cited ongoing work to reduce ultraprocessed foods in the Supplemental Nutrition Assistance Program (SNAP) and Head Start.

    While the report also touches on agriculture deregulation with the aim of making it easier for small farms to get greater access to markets and schools, Ken Cook, co-founder of the Environmental Working Group, a health advocacy organization said the report abandons earlier MAHA promises to ban toxic pesticides and instead “echoes the pesticide industry’s talking points.”

    “Secretary Kennedy and President Trump cynically convinced millions they’d protect children from harmful farm chemicals – promises now exposed as hollow,” Cook said in a statement.

    There were minor changes from the draft document leaked in August. For instance, the August 6 draft stated that the FDA and other agencies will crack down on “Illegal Chinese Vapes,” while the final version promises enforcement on vapes more broadly.

    “We support the goal of making children healthier and addressing and preventing chronic disease, but unfortunately, the recommendations fall short in some really critical ways,” Laura Kate Bender, vice president nationwide advocacy and public policy for the American Lung Association told CNN.

    “They continue to cast doubt on vaccines, one of the most, important, proven public health interventions that we can have for kids health. They don’t address some major contributors to diseases in kids like pollution, tobacco use, beyond the mention of vaping, and this report is coming out at the same time that we’re continuing to see dramatic cuts in staff and funding of a lot of the programs that could make the good parts of the report a reality.”

    The report’s emphasis on kids’ health can help overall, Dr. Michelle Macy, director of the Mary Ann & J. Milburn Smith Child Health Outcomes, Research and Evaluation Center in Chicago told CNN. “I’m really trying to look for bright spots in this report, and I think that the focus on data and infrastructure for us to be able to answer big questions about what environmental and food exposures and medication exposures do to shape the trajectory of someone’s health and chronic disease across the lifespan is something that has promise and potential.”

    Dr. Richard Besser, pediatrician and president and CEO of the Robert Wood Johnson Foundation said that having a focus on preventing chronic disease in children is a good thing, but he said, with Kennedy’s track record that includes firing thousands of federal health employees, slashing millions in health research funding, dismantling entire offices that managed important issues like smoking and chronic disease specifically, in addition to his “assault on vaccinations” will undermine any potential good of this kind of report.

    “Neither RFK Jr.’s record, nor his policies outlined in the report give me confidence that he is going to make any difference whatsoever on chronic diseases in children,” Besser told CNN.

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    Sarah Owermohle, Jen Christensen and CNN

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  • Maryland researcher’s insight into regenerating tissue leads to TIME innovator list – WTOP News

    Maryland researcher’s insight into regenerating tissue leads to TIME innovator list – WTOP News

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    Research into the immune system’s ability to encourage severely injured tissue to regenerate has landed a Maryland researcher on a TIME list of 2024 innovators.

    NIH researcher Kaitlyn Sadtler in her Bethesda, Md. lab.(WTOP/Neal Augenstein)

    Research into harnessing the ability of the body’s immune system to encourage severely injured tissue to regenerate has landed a Maryland researcher on a TIME magazine list of 2024 innovators.

    The TIME100 Next list recognizes today’s most influential and innovative leaders.

    During a WTOP visit to the laboratory she leads at the National Institute of Biomedical Imaging and Bioengineering, researcher Kaitlyn Sadtler, explained its goal is to understand the immune system’s role in wound healing and how it could be leveraged by medical technology to regenerate tissue.

    “Our laboratory works on traumatic injury and the intersection of trying to build those broken tissues back,” said Sadtler, who grew up in Frederick — 40 miles from the National Institutes of Health campus where she works in Bethesda.

    Researchers are still trying to fully understand and predict how the immune system will react. Currently, introducing medical devices, including pacemakers, knee replacements as well as chin and breast implants can elicit hostile immune responses.

    However, in other cases immune responses can stimulate healing.

    Sadtler said her lab’s research is “not just preventing the infection that might occur, but actually building those tissues.”

    As an example, she said after a car crash, understanding the immune system could help regenerate skeletal muscles. Her research includes “learning the different materials that surgeons use to help reconstruct and regrow those tissues and organ, and how we can make better materials, to help us regenerate.”

    Sadtler said the current standard of care for people with soft tissue injuries, including skin and muscle injuries, is to use grafts and transfers. That treatment requires surgeons to cause another injury, while trying to treat the larger one.

    “The general goal with biomaterials and bioengineering is to be able to avoid stuff like that, and put in materials that will help use our immune cells to grow the tissue back, without having to take it from somewhere else on your body,” she said.

    The lab’s research includes finding ways to complete a repair, while steering the immune system toward stimulating reparative processes.

    As an example, Sadtler displayed a small container of polyethylene, a plastic used to make orthopedic implants that can trigger long-term inflammation and scarring as small pieces of it are shed into surrounding tissues. Often those implants need to be removed and replaced.

    Another small bottle contained decellularized small intestinal submucosa — pig tissue that has been stripped of its cells, leaving behind mostly collagen. While natural biomaterials might not be suitable for all medical applications, she said researchers are learning about the possibilities.

    “If we can design materials that our immune system likes, won’t reject and will accept into body, we can avoid those issues” of inflammation and scarring.

    Sadtler said the study of the immune system’s role in regenerating tissue is ongoing from the lab setting, ranging from a Petri dish to preclinical trials, including Sadtler’s group study on stimulating the regeneration of leg muscles in mice, published last year in the journal Nature Materials.

    “We want to make therapies for humans,” said Sadtler. “There have been clinical products that have been put into people, and these are used in hospital around the globe that are growing those tissues back.”

    With her lab’s current research on the body’s immune system, “we’re trying to improve on those materials, and learn from the ones that work and get them to work better.”

    Get breaking news and daily headlines delivered to your email inbox by signing up here.

    © 2024 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

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    Neal Augenstein

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  • USC neuroscientist faces scrutiny following allegations of data manipulation

    USC neuroscientist faces scrutiny following allegations of data manipulation

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    A star neuroscientist at USC is facing allegations of misconduct after whistleblowers submitted a report to the National Institutes of Health that accused the professor of manipulating data in dozens of research papers and sounded alarms about an experimental stroke medication his company is developing.

    The accusations against Berislav V. Zlokovic, professor and chair of the department of physiology and neuroscience at the Keck School of Medicine of USC, were made by a small group of independent researchers and reported in the journal Science.

    The report identifies allegedly doctored images and data in 35 research papers in which Zlokovic is the sole common author. It also raised questions about findings in Phase II clinical trials of a drug called 3K3A-APC, an experimental stroke treatment sponsored by ZZ Biotech, the Houston-based company Zlokovic co-founded.

    Preclinical data appeared to have been manipulated, the report authors allege. In addition, the Phase II results appear to contain errors that would skew interpretation of the data in favor of the drug.

    An attorney for Zlokovic said the neuroscientist takes the accusations “extremely seriously” and was “committed to fully cooperating” with a USC inquiry into the matter. However, he said his client could not comment on the allegations while the review was pending.

    “Professor Zlokovic would normally welcome addressing every question raised, insofar as allegations are based on information and premises Professor Zlokovic knows to be completely incorrect,” attorney Alfredo X. Jarrin wrote in an email. “And other questions address work not performed at his lab or papers where he was not the senior author or contact author and his role was limited.”

    The university also issued a statement saying it takes allegations of research integrity seriously. “Consistent with federal regulations and USC policies, the university forwards any such allegations to its Office of Research Integrity for careful review,” the university said in a statement. “Under USC policy, this review is required to be confidential. As a result, we are unable to provide any further information.”

    Last year, USC’s Keck School of Medicine received from NIH the first $4 million of a planned $30-million grant to conduct Phase III trials of the experimental stroke treatment on 1,400 people.

    Given the serious issues outlined in their report, the whistleblowers say those trials should be stopped immediately.

    “It should certainly be paused in my opinion,” said Matthew Schrag, an assistant professor of neurology at Vanderbilt and co-author of the whistleblower report. “There are red flags about the safety of that treatment.”

    He said that evidence from the USC-led phase II trial of the drug, which was published in 2018 and called RHAPSODY, raised questions of patient safety. Patients in that trial were more likely to die in the week after treatment, and more likely to be disabled 90 days later than those who were given a placebo.

    In addition, Schrag said, some patients given the placebo had to wait longer for the standard stroke treatment of the drug tPA or surgery to dissolve the blood clot.

    “The faster you’re able to intervene to either restore blood flow with the drug or restore blood flow by removing the clot, the more brain cells survive,” he said.

    He added that he did not believe the delay was intentional but that it had the effect of “skewing the results in favor of the drug.”

    Schrag previously raised questions about the integrity of other neurological research, work he said was separate from his employment at Vanderbilt.

    Scientists have questioned Zlokovic’s research anonymously for years, Schrag said. Many of these concerns were published on PubPeer, a website on which anonymous contributors can examine scientific papers and highlight potential flaws.

    Yet scientists working with Zlokovic did not complain publicly, he said, allowing the studies to continue for years and succeed at attracting tens of millions of dollars in taxpayer funding.

    “I think people are concerned about the potential for backlash for harm to their own careers,” Schrag said. “And so I think that motivates people to just go along.”

    In its report, the journal Science interviewed four former employees of Zlokovic’s lab who said that Zlokovic routinely pressured them to manipulate data. Two said they were told to discard notebooks with results that didn’t fit preferred conclusions he hoped to reach.

    “There were clear examples of him instructing people to manipulate data to fit the hypothesis,” one former employee told the journal.

    The severity of the data manipulation charges merits a thorough investigation of Zlokovic’s data, said Elisabeth Bik, a microbiologist and scientific integrity consultant who co-wrote the whistleblower report.

    “Appropriate steps would be for USC to ask Zlokovic to give them the lab’s notebooks and data,” Bik said. “For example, for images where it appears that certain parts might have been duplicated or erased, the original images as they came off a scanner or microscope need to be compared to the published figure panels.”

    Bik is among a subset of the report’s authors who are considering filing a federal whistleblower lawsuit. Should the NIH deem that any federal grant money was used improperly, a successful suit would entitle the plaintiffs to a portion of the money the government can claw back.

    Zlokovic has received roughly $93 million in NIH funding, according to Science. A spokesperson for NIH’s Office of Extramural Research would not comment on the specifics of the case.

    “We take concerns related to research integrity very seriously, and this may include allegations of research misconduct,” the office said in a statement.

    Over the years, Zlokovic has created several biotech companies aimed at commercializing his scientific work. In 2007, he co-founded ZZ Biotech, which has been working to gain federal approval of 3K3A-APC.

    Last year, Kent Pryor, ZZ Biotech’s chief executive, called the drug “a potential game-changer.”

    “I believe, based on the positive clinical results to date, our 3K3A-APC will potentially create the first new drug class to treat ischemic stroke since 2003,” Pryor said.

    On Tuesday, Pryor declined to comment on the details in the whistleblowers’ report. “I don’t want to get into particular explanations right now because of the ongoing investigations,” he said.

    He said the Phase III clinical trial had not yet begun.

    Zlokovic is a leading researcher on the blood-brain barrier, with particular interest in its role in stroke and dementia. He received his medical degree and doctorate in physiology at the University of Belgrade and joined the faculty at USC’s Keck School of Medicine after several fellowships in London.

    A polyglot and amateur opera singer, Zlokovic left USC and spent 11 years at the University of Rochester before returning in 2011. He was appointed director of USC’s Zilkha Neurogenetic Institute the following year.

    “My role will be to enhance an already very strong neuroscience base and try to make USC the No. 1 place in the neurosciences in the country and the world,” Zlokovic said upon rejoining the USC faculty. “It’s a big goal, but I think, with what’s going on right now, it’s actually moving in that direction. I think that could be my greatest contribution.”

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    Corinne Purtill, Melody Petersen

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  • Bernie Sanders Demands Probe of Proposal To Patent Taxpayer-Funded Cancer Drug | High Times

    Bernie Sanders Demands Probe of Proposal To Patent Taxpayer-Funded Cancer Drug | High Times

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    Sen. Bernie Sanders is once again keeping drug makers in check, suggesting that people living with cancer are being preyed on by greedy interests.

    On Monday, Sanders demanded a Department of Health-led investigation into a proposal to grant a company with an exclusive patent license for cancer treatment and methods, produced with public resources and a potential conflict of interest.

    The sexually transmitted infection Human papillomavirus (HPV) can lead to six types of cancer and most cervical cancer, the National Cancer Institute (NCI) reports. It can be dormant for years or cause genital warts or worse. Last month, National Institutes of Health (NIH) proposed granting Kingston, New Jersey-based Scarlet TCR a patent for a T-cell therapy for HPV, which has undergone a Phase I trial and has a Phase II trial scheduled to conclude in 2025.

    There’s no cure for HPV, but drug developers are examining T-cell therapies to combat HPV and the cancers it leads to, including Scarlet TCR. Sometimes they’re gene-engineered. (CBD is also being explored for its potential to inhibit cervical cancer cells.) 

    There’s a problem though. The patent proposal and the company’s ties to an ex-government employee and other inconsistencies were revealed in an Oct. 18 report by The American Prospect. The NIH quietly applied to be granted “an exclusive patent for a cancer drug, potentially worth hundreds of millions or even billions of dollars, to an obscure company staffed by one of its former employees,” The American Prospect reports.

    Sanders, chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, demanded a probe of the patent proposal in an Oct. 23 letter to Christi Grimm, who is inspector general of the U.S. Department of Health and Human Services. The HELP committee also announced Sander’s open letter on Oct. 23.

    Sanders suggested the NIH is allowing a company to take advantage of a life-saving cancer drug.

    “I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders wrote. “One particularly egregious example has recently been brought to my attention that I believe demands your immediate attention.”

    Sanders argued that the NIH should be doing more to lower the cost of drug therapy.

    “There does not appear to be anything reasonable and necessary about granting a monopoly for a treatment that was invented, manufactured and tested by the NIH, is already in late stage trials and could potentially enrich a former NIH employee who was one of the major government researchers of this treatment,” Sanders wrote. “Based on current law and the best interest of U.S. taxpayers who paid for this cancer therapy, it would seem to make more sense for the NIH to offer non-exclusive licenses so that multiple manufacturers can produce this important cancer therapy at reasonable and affordable prices. The apparent abuse of the system by the NIH with respect to the exclusive patent license for this cancer therapy is so egregious that it has been characterized as a ‘how-to-become-a-billionaire program run by the NIH.’”

    “If accurate,” Sanders wrote, “that would be absolutely unacceptable. The NIH should be doing everything within its authority to lower the outrageously high price of prescription drugs. It should not be granting a monopoly on a promising taxpayer-funded therapy that could cost hundreds of thousands of dollars for cancer patients in a way that appears to exceed its statutory authority.”

    The American Prospect story pointed out that the NIH offering an exclusive license for a cancer treatment to a company with no website or SEC filings staffed by a former NIH employee

    More Ethical Drug Research

    There is historical precedence on life-saving drugs or therapies that didn’t need a patent: On Jan. 23, 1923, Sir Frederick G. Banting, James B. Collip, and Charles Best, discoverers of insulin, were awarded U.S. patents on insulin and the methods used. They all sold these patents to the University of Toronto for $1 each. Banting said, “Insulin does not belong to me, it belongs to the world.” 

    While things have changed and the price of insulin skyrocketed, new efforts are being made by the drug’s top three makers to make insulin affordable once again.

    When the polio vaccine was found to be 90% effective, its discoverer wasn’t in it for the money. On April 12, 1955, Edward R. Murrow asked Jonas Salk who owned the patent to the polio vaccine. “Well, the people, I would say,” Salk responded. “There is no patent. Could you patent the sun?”

    In today’s pharmaceutical world, some of those values are lost.

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    Benjamin M. Adams

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  • COVID pandemic is officially over in the U.S., excess-deaths data show

    COVID pandemic is officially over in the U.S., excess-deaths data show

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    The COVID-19 pandemic is definitively over, according to two recent reports focused on the same metric.

    That metric is excess deaths, a measure of the difference between the number of deaths that occurred through the pandemic years, beginning in March 2020, and the number that would be expected in a nonpandemic year, based on data from earlier years.

    At…

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  • 3D map reveals DNA organization within human retina cells

    3D map reveals DNA organization within human retina cells

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    Newswise — National Eye Institute researchers mapped the organization of human retinal cell chromatin, the fibers that package 3 billion nucleotide-long DNA molecules into compact structures that fit into chromosomes within each cell’s nucleus. The resulting comprehensive gene regulatory network provides insights into regulation of gene expression in general, and in retinal function, in both rare and common eye diseases. The study published in Nature Communications.

     “This is the first detailed integration of retinal regulatory genome topology with genetic variants associated with age-related macular degeneration (AMD) and glaucoma, two leading causes of vision loss and blindness,” said the study’s lead investigator, Anand Swaroop, Ph.D., senior investigator and chief of the Neurobiology Neurodegeneration and Repair Laboratory at the NEI, part of the National Institutes of Health.

    Adult human retinal cells are highly specialized sensory neurons that do not divide, and are therefore relatively stable for exploring how the chromatin’s three-dimensional structure contributes to the expression of genetic information.

    Chromatin fibers package long strands of DNA, which are spooled around histone proteins and then repeatedly looped to form highly compact structures. All those loops create multiple contact points where genetic sequences that code for proteins interact with gene regulatory sequences, such as super enhancers, promoters, and transcription factors. 

    Such non-coding sequences were long considered “junk DNA.” But more advanced studies demonstrate ways these sequences control which genes get transcribed and when, shedding light on the specific mechanisms by which non-coding regulatory elements exert control even when their location on a DNA strand is remote from the genes they regulate.

    Using deep Hi-C sequencing, a tool used for studying 3D genome organization, the researchers created a high-resolution map that included 704 million contact points within retinal cell chromatin. Maps were constructed using post-mortem retinal samples from four human donors.

    The researchers then integrated that chromatin topology map with datasets on retinal genes and regulatory elements. What emerged was a dynamic picture of interactions within chromatin over time, including gene activity hot spots and areas with varying degrees of insulation from other regions of DNA.

    They found distinct patterns of interaction at retinal genes suggesting how chromatin’s 3D organization plays an important role in tissue-specific gene regulation.

    “Having such a high-resolution picture of genomic architecture will continue to provide insights into the genetic control of tissue-specific functions,” Swaroop said. 

    Furthermore, similarities between mice and human chromatin organization suggest conservation across species, underscoring the relevance of chromatin organizational patterns for retinal gene regulation. More than a third (35.7%) of gene pairs interacting through a chromatin loop in mice also did so in human retina.

    The researchers integrated the chromatin topology map with data on genetic variants identified from genome-wide association studies for their involvement in AMD and glaucoma, two leading causes of vision loss and blindness. The findings point to specific candidate causal genes involved in those diseases.

    The integrated genome regulatory map will also assist in evaluating genes associated with other common retina-associated diseases such as diabetic retinopathy, determining missing heritability and understanding genotype-phenotype correlations in inherited retinal and macular diseases. 

    The study was supported by the NEI Intramural Research Program, grants ZIAEY000450 and ZIAEY000546. 

    Reference: Marchal C, Singh N, Batz Z, Advani J, Jaeger C, Corso-Diaz X, and Swaroop A. “High-resolution genome topology of human retina uncovers super enhancer-promoter interactions at tissue-specific and multifactorial disease loci.” Published October 7, 2022, Nature Communications. DOI:10.1038/s41467-022-33427-1

     

    ##

    This press release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process— each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research. To learn more about basic research, visit https://www.nih.gov/news-events/basic-research-digital-media-kit.

    NEI leads the federal government’s efforts to eliminate vision loss and improve quality of life through vision research…driving innovation, fostering collaboration, expanding the vision workforce, and educating the public and key stakeholders. NEI supports basic and clinical science programs to develop sight-saving treatments and to broaden opportunities for people with vision impairment. For more information, visit https://www.nei.nih.gov.

    About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov/.

    NIH…Turning Discovery Into Health®

     

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    NIH, National Eye Institute (NEI)

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  • AirAnswers Detects Viruses in the Air

    AirAnswers Detects Viruses in the Air

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    Inspirotec, Inc. announced today that their currently available commercial air sampling device, AirAnswers, has the capability to detect viruses in the air and potentially Covid 19.

    Press Release



    updated: Mar 5, 2020

    Inspirotec Inc., a Chicago based company, has developed a highly sensitive patented technology for testing and measuring biological agents in the air including fine particle molds and allergens to address allergies and asthma healthcare concerns. The company announced today that their currently available commercial air sampling device (AirAnswersTM) has the capability to detect viruses in the air and potentially Covid 19.

    “Considering the uncertainties about how the Covid 19 is transmitted, it would be essential for national security to be able to directly track the virus itself and how it is spreading prior to people actually getting sick. We will then be able to anticipate and prevent public exposure to the virus,” said Co-Founder and Chief Scientific Officer, Dr. Julian Gordon.

    Inspirotec has previously shown feasibility for the detection of airborne viruses in collaboration with US Army Edgewood Chemical Biological Center (ECBC), the United States’ principal research and developmental resource for non-medical chemical and biological defense. Inspirotec has reached-out to Dr. Anthony Fauci of the NIH, Dr. Rick Bright of BARDA (Biomedical Advanced Research & Development Authority), Dr. Andre Kalil of the University of Nebraska Medical Center, and Dr. Robert Redfield of the CDC. 

    “We are prepared to enter into an initial study to test and validate our technology today against Covid-19. We believe our proprietary device can contribute to public health against this global crisis,” said President & CEO, Tom Brya.

    About Inspirotec., Inc.

    Inspirotec., Inc. is the only company providing airborne allergen detection either through physicians, industrial hygienists, indoor air quality professionals, home resale, or direct to consumer. https://airanswers.com

    Inspirotec’s vision is to improve health and happiness by finding allergy and mold solutions in transforming the home environment critical to our wellbeing. Our mission is to deliver the most personalized prevention and management solutions for allergies, asthma, and respiratory conditions.

    Inspirotec has an extensive portfolio of patents* as well as publications in the peer-reviewed literature.

    *US patents 8,038,944, 9,216,421, 9,360,402, 9,481,904, 9,618,431 as well as patents and application world-wide.

    Contact

    Tom Brya
    President & CEO Inspirotec, Inc.
    866-539-4253, ext. 805
    support@inspirotec.com

    Source: Inspirotec, Inc.

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  • With Massive Cuts in Federal Research Grants on the Horizon, Industry-Sponsored Research Management Offers Guidance in Building Funding From Corporate Partnerships

    With Massive Cuts in Federal Research Grants on the Horizon, Industry-Sponsored Research Management Offers Guidance in Building Funding From Corporate Partnerships

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    Press Release



    updated: Apr 6, 2017

    ​​It has become frighteningly clear that the Trump Administration will be wielding a large axe when it comes to federal research funding, with more than $1 billion in cuts targeted at the NIH budget alone in 2017, and more than $30 billion – 18% of the NIH budget – in 2018. The White House is particularly targeting “indirect” or overhead costs, which comprise just under 30% of federal grant payments to university research labs.

    University research leaders are protesting the proposed cuts as shortsighted and damaging to the future of U.S. competitiveness on the world’s innovation stage. So far those protests are falling on deaf ears, however, and many schools are bracing for the worst and preparing their campuses for an increasingly bleak future when it comes to federal funding.  A growing number of universities have already been working hard to increase their research funding from industry partnerships, and that effort is taking on new urgency given the news out of Washington.

    “Working with industry in sponsored research partnerships is imperative to supplement the reduced level of federal grant funding, but it’s unfamiliar ground for many research managers.”

    David Schwartz, CEO and Publisher

     That’s where Industry-Sponsored Research Management comes in.  Launched last month by Atlanta-based 2Market Information Inc., it’s the first and only publication devoted to helping universities build and manage their portfolios of corporate-sponsored research agreements.

    Each monthly issue of Industry-Sponsored Research Management contains high-level strategies and best practices designed to help research managers bring in more industry research contracts, negotiate deals effectively, build lasting relationships with corporate sponsors, protect valuable intellectual property, and ensure airtight compliance practices.

    “When we launched the publication we had no idea the Trump budget would include these draconian cuts to federal research funding,” says David Schwartz, 2Market Information’s CEO and publisher. “We had already identified a strong need for information on attracting and managing industry sponsorships, but now that need has become more urgent as more universities realize that funding alternatives will be required to keep their labs open and their promising innovations moving forward.”

    Industry-Sponsored Research Management fills a critical information void, providing how-to guidance and expert strategies focused on the many challenges associated with corporate-sponsored research.  “Working with industry in sponsored research partnerships is imperative to supplement the reduced level of federal grant funding, but it’s unfamiliar ground for many research managers. These partnerships involve new intellectual property issues, contracting and negotiation issues, conflict of interest challenges and regulatory concerns. We’re helping our readers navigate these issues while bringing in critical new sources of funding,” Schwartz comments. 

    For a free copy of the premiere issue, CLICK HERE or call 239-263-0605. For further information on the publication or to become a charter subscriber for just $297 (a $100 discount), plus receive the three-program distance learning collection Best Practices in Forming and Managing Industry-University PartnershipsCLICK HERE.

    Atlanta-based 2Market Information Inc., publisher of Technology Transfer Tactics, is the world’s leader in providing practical guidance and professional development for technology transfer and research commercialization professionals. To learn more about its products and services, go to www.techtransfercentral.com.   

    Source: 2Market Information Inc.

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