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Financing Innovation: Proposal for Novel Adaptive Platform Trial Fund Offers New Model for ALS Drug Development
Financing Innovation: Proposal for Novel Adaptive Platform Trial Fund Offers New Model for ALS Drug Development

Yahoo

time3 hours ago

  • Business
  • Yahoo

Financing Innovation: Proposal for Novel Adaptive Platform Trial Fund Offers New Model for ALS Drug Development

Researchers propose new royalty-based investment model to bridge the 'valley of death' and accelerate drug development New royalty-based investment model for ALS drug development Cambridge, Mass., July 02, 2025 (GLOBE NEWSWIRE) -- A team of researchers from the MIT Sloan School of Management, the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (MGH), Questrom School of Business at Boston University, and QLS Advisors have introduced a new approach to funding clinical trials for amyotrophic lateral sclerosis (ALS) therapies. The study 'Financing Drug Development via Adaptive Platform Trials,' published today in PLOS One, outlines a financing model that merges the efficiencies of adaptive platform trials — lower costs and shorter durations — with an innovative royalty-based investment structure designed to accelerate therapeutic development for ALS and other serious — also often called Lou Gehrig's disease — is a progressive, neurodegenerative disease with no cure. Despite its devastating impact, the pace of new therapy development has remained sluggish — largely due to the high cost, duration, and risks associated with traditional clinical trials. This bottleneck has often discouraged conventional investors, leaving promising research to tackle this challenge, the authors propose an investment fund that finances half the cost of an adaptive platform trial in exchange for future royalties from successful drugs that emerge from the trial. Adaptive platform trials allow multiple drug candidates to be tested simultaneously under a single master protocol and results are interpreted on a real-time basis to determine efficacy or futility. Drawing on data from the HEALEY ALS Platform Trial administered by the Healey & AMG Center for ALS and realistic assumptions, their simulated fund generated an expected return of 28%, with a 22% probability of total loss, which may be attractive to more risk-tolerant and impact-driven investors such as hedge funds, sovereign wealth funds, family offices, and philanthropists. Their findings suggest that generating returns more palatable for mainstream investors could be achieved by funding multiple platform trials simultaneously and by employing financial tools such as securitization — a method that bundles future income from assets like loans or royalties into investment study represents a multidisciplinary collaboration among physicians, clinical trial experts, and financial engineers including Annette De Mattos, Kristin Drake, Merit E. Cudkowicz, Ricardo Ortiz, Meredith Hasenoehrl, Marianne Chase, Brittney Harkey, and Sabrina Paganoni of the Sean M. Healey & AMG Center for ALS at MGH; Eugene Sorets of Questrom School of Business at Boston University; Shomesh Chaudhuri and John Frishkopf of QLS Advisors; and Joonhyuk Cho and Andrew W. Lo of MIT. Their work bridges the gap between biomedicine and capital markets, laying a new path forward for how lifesaving therapies are financed and delivered.'ALS clinical trials face significant hurdles — from high costs and long timelines to limited funding pools,' said Dr. Cudkowicz, Executive Director Mass General Brigham Neuroscience Institute and Director of the Healey & AMG Center for ALS. 'Our platform trial model has already shown that we can test more therapies more efficiently. What's still missing is sustainable financing. This novel approach could be a game-changer, enabling us to launch trials faster, include more promising therapies, and bring us closer to our shared goal: delivering effective treatments to people with ALS as quickly as possible.'Dubbed a 'Fund of Adaptive Royalties' (FAR), this model is uniquely positioned to transform how diseases like ALS are addressed, providing developers with access to shared infrastructure, centralized data analytics, and significantly reduced upfront capital requirements while offering investors a diversified, portfolio-based exposure to multiple drug candidates and the potential for high returns. While their study focused on ALS, the authors believe such a funding model could be applied to other disease areas as well, especially those with well-defined endpoints, where treatment success can be measured clearly and reliably, and few existing therapies.'This financing framework addresses one of the core issues in biomedical innovation — bridging the valley of death between discovery and delivery,' said co-author Lo, MIT Charles E. and Susan T. Harris Professor and director of MIT Sloan's Laboratory for Financial Engineering. 'By aligning incentives between investors and developers and distributing risk across a portfolio of candidates, we can unlock new sources of capital for diseases that urgently need them.' About MIT Sloan School of Management The MIT Sloan School of Management is where smart, independent leaders come together to solve problems, create new organizations, and improve the world. Learn more at About the Sean M. Healey & AMG Center for ALS at Mass General At the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD, and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent many clinical trials and lab-based research studies in progress right now, we are ushering in a new phase of ALS treatment and care. Together, we will find the cures. About the Boston University Questrom School of Business Founded in 1913, the Boston University Questrom School of Business is a global top-tier academic research business school. Led by Allen Questrom Professor and Dean Susan Fournier, Questrom develops business leaders who create value for the world. Questrom redefines transformational business programs, strengthens partnerships with the business community, advances the impact of research on business, and manages the school as a high-performing enterprise committed to excellence with a service mindset. Comprising a renowned full-time faculty of 165 researchers, teaching faculty, and accomplished practitioners, Questrom generates insights to address today's business challenges and prepares students with the tools they need to succeed from Day 1 in their professional lives. Questrom's portfolio of academic programs is robust and includes a Top 20 undergraduate program of over 2,200 students; distinctive MBA offerings including 900 students in a full- and part-time MBA, the affordable Online MBA and specialty MBAs in social impact, health, and digital technology; several thriving specialized masters programs in areas including business analytics, mathematical finance, and management studies; and a rigorous PhD program. More than 50,000 Questrom alumni form a powerful global network of leaders driving value creation that changes the world. QUESTROM MEANS BUSINESS. For more information, visit About QLS Advisors QLS is an investment manager that is dedicated to improving outcomes for both patients and investors. We aim to achieve these goals by applying the tools of financial engineering, including modern portfolio theory, machine learning, and healthcare finance to our discretionary investment process. At QLS, we believe that quantitative and fundamental techniques are not mutually exclusive but can be combined to build enhanced portfolios in the healthcare space. Attachment New royalty-based investment model for ALS drug development CONTACT: Casey Bayer MIT Sloan School of Management 914.584.9095 bayerc@ Brandon Chase Sean M. Healey & AMG Center for ALS 413.575.9795 bchase7@ Paul Alexander Boston University Questrom School of Business 617.470.9772 pasystem@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Siemens Healthineers forms theranostics research collaboration with MGH
Siemens Healthineers forms theranostics research collaboration with MGH

Yahoo

time23-06-2025

  • Health
  • Yahoo

Siemens Healthineers forms theranostics research collaboration with MGH

Siemens Healthineers has struck a research partnership with Massachusetts General Hospital (MGH) in the US to establish a Therapy Command Center. This centre is designed to implement theranostics across the hospital and its facilities in Massachusetts, Maine, and New Hampshire. It will facilitate data collection, provide real-time monitoring, and support healthcare professionals in making informed patient care decisions. Theranostics combines molecular imaging techniques to assess disease progression and evaluate treatment efficacy. MGH nuclear medicine and molecular imaging chief Umar Mahmood said: 'The Therapy Command Centre helps provide a framework that will enable the integration of a wide variety of patient imaging and laboratory data, combined with population-based data for enhanced individual patient outcomes. 'This collaboration will help expand theranostics across the region, advancing personalised medicine through precision diagnoses and tailored therapies.' Researchers from Siemens Healthineers and MGH will use advanced imaging technology, including the Biograph Vision Quadra and Biograph Trinion positron emission tomography/computed tomography (PET/CT) scanners. Their research aims to understand the effects of radiation on molecular and biological processes, as well as assess toxicity levels in both cancerous and healthy tissues of patients undergoing radiopharmaceutical therapy. This knowledge is crucial for advancing personalised medicine, according to the company. Siemens Healthineers Molecular Imaging James Williams said: 'This research collaboration, which is based on a relationship between Siemens Healthineers and Massachusetts General Hospital that spans more than 20 years, will enable innovations along the patient's clinical pathway, provide precision diagnoses, and deliver highly effective forms of customised therapy.' In July 2024, Redhill Cancer Hospital, part of RVL Healthcare, signed a memorandum of understanding (MoU) with Siemens Healthineers to create a Cancer Centre and Research Park in Nairobi, Kenya. "Siemens Healthineers forms theranostics research collaboration with MGH" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

MGH and Siemens Healthineers to establish Therapy Command Center
MGH and Siemens Healthineers to establish Therapy Command Center

Yahoo

time23-06-2025

  • Health
  • Yahoo

MGH and Siemens Healthineers to establish Therapy Command Center

Massachusetts General Hospital (MGH) in the US has formed a research partnership with Siemens Healthineers to establish a Therapy Command Center. This centre is designed to implement theranostics across the hospital and its facilities in Massachusetts, Maine, and New Hampshire. It will facilitate data collection, provide real-time monitoring, and support healthcare professionals in making informed patient care decisions. Theranostics combines molecular imaging techniques to assess disease progression and evaluate treatment efficacy. MGH nuclear medicine and molecular imaging chief Umar Mahmood said: 'The Therapy Command Centre helps provide a framework that will enable the integration of a wide variety of patient imaging and laboratory data, combined with population-based data for enhanced individual patient outcomes. 'This collaboration will help expand theranostics across the region, advancing personalised medicine through precision diagnoses and tailored therapies.' Researchers from Siemens Healthineers and MGH will use advanced imaging technology, including the Biograph Vision Quadra and Biograph Trinion positron emission tomography/computed tomography (PET/CT) scanners. Their research aims to understand the effects of radiation on molecular and biological processes, as well as assess toxicity levels in both cancerous and healthy tissues of patients undergoing radiopharmaceutical therapy. This knowledge is crucial for advancing personalised medicine, according to the company. Siemens Healthineers Molecular Imaging James Williams said: 'This research collaboration, which is based on a relationship between Siemens Healthineers and Massachusetts General Hospital that spans more than 20 years, will enable innovations along the patient's clinical pathway, provide precision diagnoses, and deliver highly effective forms of customised therapy.' In July 2024, Redhill Cancer Hospital, part of RVL Healthcare, signed a memorandum of understanding (MoU) with Siemens Healthineers to create a Cancer Centre and Research Park in Nairobi, Kenya. "MGH and Siemens Healthineers to establish Therapy Command Center" was originally created and published by Hospital Management, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.

Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease

Business Wire

time13-05-2025

  • Health
  • Business Wire

Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease

KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD) —a condition responsible for significant morbidity and mortality. The designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs. HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs delivers actionable insight through a simple, non-invasive blood draw, bridging critical diagnostic gaps in current cardiovascular care. 'The FDA's Breakthrough Device Designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive coronary artery disease,' said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. 'We are committed to expanding the use of HART CADhs from outpatient settings into emergency care environments to ensure that patients receive earlier, more accurate, and potentially life-saving diagnoses.' HART CADhs is currently available as a Lab Developed Test (LDT) with a 2 to 10-day turnaround, making it ideal for evaluating stable, non-urgent patients. The Breakthrough Device Designation enables close collaboration with the FDA and an expedited review process, supporting Prevencio's goal to advance the test into a rapid, FDA-cleared in vitro diagnostic (IVD) with a one-hour result time —ideal for evaluating chest pain patients in emergency rooms. HART CADhs was developed using Prevencio's proprietary HART platform in collaboration with researchers at Massachusetts General Hospital (MGH). In clinical research, the test demonstrated high accuracy (0.86 AUC) in detecting obstructive CAD, significantly outperforming standard-of-care tests such as stress echocardiography and nuclear imaging, which yielded only 0.52 AUC. 'With nearly half of U.S. counties lacking access to a cardiologist and long wait times in urban centers, a simple, accurate blood test to diagnose obstructive CAD offers tremendous potential to improve access to early diagnosis and intervention,' said James L. Januzzi, MD, a practicing cardiologist at MGH, Professor of Medicine at Harvard Medical School, Chief Scientific Officer at the Baim Institute for Clinical Research and Principal Investigator for the HART test development and validation. 'Our studies show HART CADhs is informative in a broad range of patient types including those with acute symptoms as well as those not diagnosed with a heart attack yet may have dangerous arterial obstruction. This suggests usefulness in both acute and outpatient settings.' Cardiovascular disease remains the leading cause of death in the United States and worldwide. According to the American Heart Association, cardiovascular disease and stroke account for over $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed to improve patient outcomes and reduce costs through earlier, more accurate, and more accessible diagnostics. In addition to HART CADhs, Prevencio also offers HART CVE®, a second AI-driven, multi-protein blood test that assesses a patient's one-year risk of heart attack, stroke, or cardiovascular death. Both tests are currently available to healthcare providers. About Prevencio HART Tests: Powered by AI, Prevencio is revolutionizing cardiac diagnostics with AI-driven blood tests for cardiovascular disease and custom diagnostics for diagnostic, medical device and pharmaceutical companies. Using this novel approach, the company has developed seven blood tests that significantly improve diagnosis and risk assessment for a variety of heart and blood vessel-related complications. HART test results have been peer-reviewed published 35 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress; American College of Cardiology Scientific Sessions; American Heart Association Scientific Sessions; American Diabetes Association Scientific Sessions; and Transcatheter Cardiovascular Therapeutics Sessions) and in top-tier journals—(Journal of American College of Cardiology; American Journal of Cardiology; Clinical Cardiology; Biomarkers in Medicine; Journal of American Heart Association; and European Journal of Preventive Cardiology). About Prevencio, Inc. Prevencio's vision is to revolutionize cardiac diagnostics with AI-driven blood tests—thereby improving care with highly accessible, accurate and cost-effective diagnosis and earlier treatment. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic risk scores and coronary artery calcium. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc. Forward-Looking (Safe Harbor) Statement: Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The company does not undertake to update disclosures contained in this press release.

MAAS Group Holdings Ltd. (MGH) Gets a Buy from Wilsons
MAAS Group Holdings Ltd. (MGH) Gets a Buy from Wilsons

Business Insider

time12-05-2025

  • Business
  • Business Insider

MAAS Group Holdings Ltd. (MGH) Gets a Buy from Wilsons

In a report released on May 8, James Ferrier from Wilsons maintained a Buy rating on MAAS Group Holdings Ltd. (MGH – Research Report), with a price target of A$4.75. The company's shares closed last Friday at A$4.40. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. According to TipRanks, Ferrier is an analyst with an average return of -0.9% and a 40.38% success rate. Ferrier covers the Consumer Cyclical sector, focusing on stocks such as G.U.D. Holdings, ARB Corporation , and Collins Foods . The word on The Street in general, suggests a Strong Buy analyst consensus rating for MAAS Group Holdings Ltd. with a A$4.90 average price target. The company has a one-year high of A$5.05 and a one-year low of A$3.30. Currently, MAAS Group Holdings Ltd. has an average volume of 718.7K. Based on the recent corporate insider activity of 6 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of MGH in relation to earlier this year.

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