Washington University School of Medicine

An NIH cap on indirect cost payments for grant recipients is casting a shroud of uncertainty for research universities despite a judge’s order to block it. A federal judge this week temporarily halted the 15% cap for reimbursements that would cover facilities, IT, support, maintenance and other similar activities. Universities have stressed that the situation is fluid, with the University of Massachusetts Chan Medical School saying it remains in an “unavoidable period of uncertainty.” The University of Iowa briefly paused its submission of new NIH grant applications, but reversed course after the temporary restraining order was granted. Despite the initial court order, legal experts say the Trump administration’s action sends a signal of how the NIH will prioritize research going forward. Some lawyers say grant recipients should assume the cap could take effect until ongoing court cases are resolved. “Generally, I’ve been telling clients that they should act as if the cap was here to stay, get their accounting under review, see where they might tighten their accounting,” Wiley partner George Petel told Endpoints News on Wednesday. He added that some universities may lose students or have to cut programs if the limit takes effect. A group of Wiley lawyers advised grant recipients in an alert to “be mindful of the cap and consider it effective.” The NIH action, which was announced Feb. 7, is being challenged in at least three separate lawsuits by 22 states, several universities and organizations representing schools and hospitals. Universities and research organizations argue that indirect costs are necessary for innovation and that the cuts could devastate their work. “The total cost of funding needed to support scientific research is an iceberg; a grant’s direct costs reflect only the part visible above the water,” the American Society of Gene and Cell Therapy said in a statement. The University of Pennsylvania, which has been behind some of the pharma industry’s biggest discoveries in gene editing, CAR-T therapies and more, said in a statement the NIH’s indirect cost cuts would reduce the school’s annual funding by $240 million. UPenn has negotiated a 62.5% rate for indirect costs, and said that only covers half of its infrastructure costs. The university is part of one of the lawsuits filed against the NIH. Petel said some institutions might attempt to reclassify what constitutes direct funding, or change how they use certain facilities or equipment if limits are imposed. “If the only way to get reimbursed for this multi-million dollar equipment is to only let one grant use it at a time, so that they can charge it as direct, that may be something that we start to see,” he said. Regardless of the outcome in court, Petel said “people are going to be more hesitant to spend the time and effort in putting together grant applications.” “It’s a lot of work, a lot of time, a lot of money to even apply for these grants, and they go through months and months of scrutiny and back and forth,” he said. Temporary restraining orders are typically in place for about two weeks while a judge considers the details of a case, though that could be extended, Washington University law professor Pauline Kim told Endpoints. Plaintiffs have asked for a preliminary injunction, which would extend the court’s restraint on the cap as the case proceeds. If a preliminary injunction were granted, the government could appeal. It’s unclear how long the cases will proceed, but any extensions could add to the current uncertainty. “The fact that the judge granted the TRO suggests that it’s more likely than not that the preliminary injunction would be granted,” Kim said. While Kim’s unit does not rely on NIH funds, the Washington University School of Medicine received the second-highest NIH funding among US medical schools in 2023. A hearing on the cases is scheduled for Feb. 21. “We’re at least in a holding pattern until the 21st and possibly beyond that,” said Dianne Bourque, an attorney with the Boston law firm Holland & Knight who advises researchers and other healthcare clients. “It really is up to the judge,” she said.

Leading breast oncology experts to provide insight and guidance for clinical studies, market readiness, and pipeline development for cancer detection and treatment platform CALGARY, AB, Feb. 11, 2025 /PRNewswire/ - Syantra, Inc., a precision biotechnology company revolutionizing cancer detection and treatment, proudly announces Dr. Edith A. Perez as chair and Dr. Maria Theodoulou and Dr. Adetunji Toriola as members of the Scientific Advisory Board (SAB). The board will work with Syantra leadership and advise on clinical testing and early commercialization of Onco-ID™ Breast, a blood test for early detection of breast cancer, as well as R&D and corporate strategy. "We are very excited to have this incredible group of cancer luminaries join the SAB. Their expertise and experience link in well to our strategic initiatives and complement our team. We look forward to working together to advance our technologies and introduce the world to the test and the platform it was built on, Onco-ID™," said CEO Rob Lozuk. Onco-ID™ is Syantra's patent-pending platform that helps the company take a new approach to early cancer detection. "Unlike most liquid biopsies on the market, which look for cancer in the bloodstream, Onco-ID™ leans into the body's own immune system, identifying biomarkers that indicate the presence of early stage cancer. We believe this is an entirely new approach with extraordinary potential," said Lozuk. Syantra's Scientific Advisory Board includes: Edith A. Perez, M.D., Chair, SAB. An internationally recognized clinical translational oncologist, Dr. Perez holds the distinction of Professor Emeritus at Mayo Clinic with a career that has spanned academic and industry leadership in medical affairs, drug development, clinical operations, regulatory and medical affairs, pharmacovigilance, and biometrics. Dr. Perez served as Chief Medical Officer at Bolt Biotherapeutics (2020-2024), where she directed the development of a novel immuno-oncology pipeline. As a core member of the company's C-suite, Dr. Perez played a pivotal role in securing the company's successful IPO in 2021. Prior to joining Bolt Biotherapeutics, Dr. Perez was Vice President of the BioOncology Medical Unit at Genentech from 2015 to 2018. At Genentech, she led a team of 150 healthcare professionals, spearheaded numerous clinical trials and scientific collaborations, and directly contributed to the successful launches of life-changing oncology therapeutics. During Dr. Perez's 20-year academic and clinical tenure at the Mayo Clinic, she made deep contributions to the treatment of breast cancer and the advancement of translational biomarkers in collaboration and with funding from the National Cancer Institute (NCI), the NIH, as well as leading Foundations such as the Breast Cancer Research Foundation. She has authored or co-authored over 700 peer-reviewed manuscripts and abstracts, was granted an endowed professorship, and served as Deputy Director at Large for the Mayo Clinic Cancer Center. Maria Theodoulou, M.D. Recognized internationally for her impact on breast cancer care and the community, Dr. Theodoulou is a clinical oncologist and Program Director Breast Medicine with New York Oncology Hematology (NYOH). Prior to joining NYOH, Dr. Theodoulou was an attending physician at Memorial Sloan Kettering Cancer Center, and a Professor of Medicine at the Joan and Sanford Weill Medical College of Cornell University. Her awards and honors include the Hally Yaccino Steiner Award- Susan G. Komen for the Cure, Greater New York City, Outstanding Physician Award- Sass Foundation for Medical Research, Clinical Excellence & Community Advocacy in Breast Cancer- Brook Air Force Base, San Antonio, TX, and the AXIOS Award from American Hellenic Educational Progressive Association's Cancer Foundation. Adetunji Toriola, M.D., PhD. Dr. Toriola is internationally recognized for his research on the molecular basis of breast cancer. He is Professor of Surgery at Washington University School of Medicine and has a multidisciplinary background in medicine (MD), public health (MPH), anesthesia (DA), and epidemiology (PhD). He is a William H. Danforth Washington University Physician-Scientist Scholar and co-leads the Cancer Prevention and Control Program at Siteman Cancer Centre. Dr.Toriola was recognized with the 2022 American Association for Cancer Research (AACR) Outstanding Investigator Award for Breast Cancer Research. He also serves on several national scientific committees and leading cancer journal editorial boards. "We are thrilled by the caliber of talent and experience currently on our Scientific Advisory Board and we look forward to adding more members who understand this unique sector of healthcare, and who are as passionate as the rest of us at Syantra about changing the present and future of cancer detection and treatment," said Lozuk. About Syantra Founded by a Calgary-based team of innovators in biomedical engineering and medicine and supported by world-leading clinicians, Syantra Inc. is a privately held, precision biotechnology company pioneering a platform to change the way cancer is detected and treated. For more information, visit , or contact [email protected]. SOURCE Syantra Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

German drugmaker Boehringer Ingelheim didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.\n Boehringer Ingelheim has cemented the potential of its idiopathic pulmonary fibrosis (IPF) drug with a second phase 3 win in a related lung disease leading the drugmaker to expand the indications it will seek FDA approval for.The FIBRONEER-ILD trial saw 1,178 patients with progressive pulmonary fibrosis (PPF) receive either a 9 mg or 18 mg dose of the PDE4B inhibitor nerandomilast or placebo twice a day for 52 weeks. The study hit its primary endpoint of demonstrating an absolute change from baseline in forced vital capacity—a measure of the volume of air that a patient can breathe out—Boehringer said in a Feb. 10 release.The German drugmaker didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.“Initial data readouts of the FIBRONEER trials support a generally consistent safety and tolerability profile when compared to the phase 2 IPF study, with overall adverse events comparable to those seen in the placebo group,” the company said.Armed with the latest results, Boehringer said it will request that FDA and global regulators approve nerandomilast as a treatment for PPF, a type of interstitial lung disease. The company has already said it will seek approval for nerandomilast in IPF after proclaiming a win in a phase 3 trial for that lung disease in September 2024. Again, the company opted to hold back any concrete data from that trial for later in this year.When it comes to managing IPF, physicians already have Boehringer’s Ofev and Roche’s Esbriet. However, those drugs only slow the progression of fibrosis, while attempts to produce molecules that further slow, or ideally stop, progression have failed to prove their worth.By targeting phosphodiesterase 4B (PDE4B), nerandomilast is meant to have a mechanistic advantage over the incumbent products. Targeting PDE4 drives anti-inflammatory and antifibrotic effects, but attempts to develop oral inhibitors of the enzyme in respiratory diseases have been hindered by class-related systemic adverse events such as diarrhea and headaches.“The positive FIBRONEER-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis,” Shashank Deshpande, Head of Human Pharma at Boehringer, said in the release. “The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.”