MRIGlobal

Infectious Disease Diagnostics for Influenza, RSV and SARS-CoV-2, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, February 14, 2024
MPH, RSV, Disease, Safety, Infection, Machine learning, SARS-CoV-2, Doctor of Philosophy, MRIGlobal, Research, Marker beacon, Vaccine

TORONTO, Feb. 14, 2024 /PRNewswire-PRWeb/ -- The need for rapid, accessible and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives. Join an informative webinar focused on in vitro diagnostic development to meet this need, ranging from assay design, the use of bioinformatics in identifying emerging pathogens and optimizing assays, and securing the necessary regulatory approvals that support market access.

Key Points: 
  • In this free webinar, learn about the importance of expertise at all stages of infectious disease diagnostics development.
  • The featured speakers will discuss the value of bioinformatics in the development of infectious disease diagnostics.
  • TORONTO, Feb. 14, 2024 /PRNewswire-PRWeb/ -- The need for rapid, accessible and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives.
  • Register for this webinar to learn how to effectively take an infectious disease diagnostic assay from initial design stages through regulatory approvals that support market access.

ReAlta Life Sciences Strengthens Board of Directors with Appointment of Two Accomplished Biotechnology Innovators

Retrieved on: 
Wednesday, January 24, 2024
Research, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Artificial intelligence, NSRI, University, Patient, Principal, Executive Committee, UARC, Government, JHUAPL, Partnership, Containerization, Epigenome, GSK, Diagnosis, DTRA, Drug discovery, Chemical engineering, COVID-19, Applied Physics Laboratory, Biomedical engineering, CBCS, Department of Defence, DARPA, Therapy, Doctor of Philosophy, Traumatic brain injury, Nursing care plan, Machine learning, Pennsylvania State University, STRATCOM, MRIGlobal, SVP, ARA, Medical device

“We are delighted to welcome Dr. Baldoni and Dr. Van Gieson to our Board of Directors and look forward to their expertise as we continue to advance our EPICC platform beyond our current portfolio,” said Buzz Heidt, Chairman of ReAlta’s Board of Directors.

Key Points: 
  • “We are delighted to welcome Dr. Baldoni and Dr. Van Gieson to our Board of Directors and look forward to their expertise as we continue to advance our EPICC platform beyond our current portfolio,” said Buzz Heidt, Chairman of ReAlta’s Board of Directors.
  • Dr. Baldoni’s Platform Technology and Science team supported the development of small molecules, biopharmaceuticals and cell and gene therapy modalities from discovery through commercialization.
  • Dr. Baldoni stepped away from that leadership role in 2017 to start the first AI-driven drug discovery unit at GSK.
  • After retiring from GSK in 2019, he spent a year as the Chief Technology Officer of a stealth AI-enabled drug discovery startup.

Reference Standard Management for Pharmaceutical Development, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, December 13, 2023
ICH, MRIGlobal, Acquisition, Safety, Food, FDA, CGMP, Drug reference standard, Doctor of Philosophy, API, Food and Drug Administration, International Council, Audit

TORONTO, Dec. 13, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar focused on maintaining regulatory compliance with a high-quality reference standard program for pharmaceutical development. Reference standards are a cornerstone of the pharmaceutical industry, critical to assessing product quality, safety and potency during development. Throughout the drug development process, properly characterized reference standards are required to ensure quality control in critical areas such as the release of new product batches and stability evaluation. This webinar is designed for industry professionals looking to gain a practical understanding of reference standards, from their acquisition and qualification to their application in maintaining product quality and regulatory compliance.

Key Points: 
  • Attendees will learn about the challenges in reference standard management and strategies to mitigate them.
  • Attendees will also gain insights into the importance of a comprehensive reference standard management program in supporting key aspects of pharmaceutical development.
  • TORONTO, Dec. 13, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar focused on maintaining regulatory compliance with a high-quality reference standard program for pharmaceutical development.
  • This webinar will provide attendees with essential insights into the qualification and distribution of reference standards, and the importance of developing a formal program for reference standard management.

T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel

Retrieved on: 
Tuesday, September 19, 2023
Ochsner Medical Center, ASPR, Burkholderia pseudomallei, Plague, Emergency, Biomedical Advanced Research and Development Authority, CBRN, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Administration for Strategic Preparedness and Response, Public, Infection, Tularemia, Public Health Service Act, Unitary state, Typhus, Biosafety, Glanders, Yersinia pestis, Government, Melioidosis, Bacillus anthracis, Burkholderia mallei, Development, Administration, Disaster, MRIGlobal, Francisella tularensis, Biological warfare, Public health, Patient, Rickettsia prowazekii, Bacillus, Mortality, FDA, Anthrax, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Food, Pharmaceutical industry, Vaccine, Medical device

LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.
  • The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
  • The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center.
  • The T2Biothreat Panel is able to detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.

T2 Biosystems Announces Positive Results upon Completion of U.S. Clinical Evaluation for the T2Biothreat Panel

Retrieved on: 
Monday, February 13, 2023
Administration, Francisella tularensis, Anthrax, Office of Inspector General, U.S. Department of Health and Human Services, Tularemia, Burkholderia mallei, Food and Drug Administration, Development, Plague, Patient, Biosafety, BARDA, Clinical trial, Yersinia pestis, Glanders, Food, Health, Melioidosis, Bacillus anthracis, Burkholderia pseudomallei, Mortality, U.S. Department of Defense Strategy for Operating in Cyberspace, MRIGlobal, Typhus, Biological warfare, Biomedical Advanced Research and Development Authority, FDA, Public health, Bacillus, Public, Infection, Administration for Strategic Preparedness and Response, Vaccine, Pharmaceutical industry, Rickettsia

LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.
  • “We are extremely pleased with the results of the clinical evaluation.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.
  • The results of the clinical trial demonstrated very high sensitivity and specificity across all six targets.

Appili Therapeutics ATI-1701 Biodefense Vaccine Secures ~US$14 Million of Funding from the U.S. Department of Defense in Partnership with the U.S. Air Force Academy

Retrieved on: 
Thursday, November 24, 2022
Biotechnology, Pharmaceutical, Health, Other Health, Negotiation, Public health, Nature, PRV, Infection, Investigational New Drug, Chairperson, IND, Lead, Research, Animal, Failure, Partnership, Death, U.S. Department of Defense Strategy for Operating in Cyberspace, News, Principal investigator, Francisella tularensis, Degenerative disease, Therapy, Anthrax, Priority review, United States Department of Defense, Risk, OTCQX, TSX, Bioterrorism, Government, Documentation, Survival, NIH, Tularemia, DTRA, Drug development, Defense Threat Reduction Agency, FDA, MRIGlobal, Pharming, Pharmaceutical industry, Vaccine, Management, Risk management, USAFA

ATI-1701 is a potential first-in-class vaccine candidate for the prevention of infection with aerosolized Francisella tularensis, a top-priority biothreat.

Key Points: 
  • ATI-1701 is a potential first-in-class vaccine candidate for the prevention of infection with aerosolized Francisella tularensis, a top-priority biothreat.
  • This revised funding represents a 40% increase over the originally anticipated DTRA funding for this program, as announced in February 2022.
  • This funding is expected to strengthen Appilis foundation in infectious disease and biodefense, said Dr. Don Cilla, Pharm.D., M.B.A., Appilis President and CEO.
  • The expected total program funding amount is ~US$14 million, with a portion of the funding subject to future U.S. federal budget approval.

Ambri Selected by Xcel Energy as Part of Their Commitment to Deliver 100% Carbon-Free Electricity by 2050

Retrieved on: 
Thursday, August 25, 2022
Alternative Energy, Energy, Utilities, Aurora, Technology, Heat, XEL, NASDAQ, Carbon, MRIGlobal, Learning, Gas, Leadership studies, Power, Electricity, Xcel Energy, Economic development, Industry, Transport, Renewable energy, Management, Ambri

Ambri , a provider of long-duration energy storage, today announced that Xcel Energy , a leading energy provider focused on delivering a clean energy future, will use the world-class Solar Technology Acceleration Center (SolarTAC) to demonstrate Ambris energy storage technology.

Key Points: 
  • Ambri , a provider of long-duration energy storage, today announced that Xcel Energy , a leading energy provider focused on delivering a clean energy future, will use the world-class Solar Technology Acceleration Center (SolarTAC) to demonstrate Ambris energy storage technology.
  • We are honored to be selected by Xcel Energy as they continue to drive towards a carbon-free future, said Adam Briggs, Chief Commercial Officer at Ambri.
  • In 2018, Xcel Energy became the first utility in the industry to set a long-term goal of providing its customers with zero carbon electricity.
  • Xcel Energy (NASDAQ: XEL) provides the energy that powers millions of homes and businesses across eight Western and Midwestern states.

MRIGlobal Announces New CEO

Retrieved on: 
Thursday, June 9, 2022
Global health, Sustainable energy, Research, LLC, SRI International, Infection, Pittsburgh, Contract, CEO, MRIGlobal, National Renewable Energy Laboratory, U.S. Department of Defense Strategy for Operating in Cyberspace, University, Bachelor of Science in Human Biology, Growth, GLOBE, U.S. Department of Energy, Office of Inspector General, Health, NREL, Sleep, Psychology, Strategic planning, Safety, Management

MRIGlobal employs about 480 people, including chemists, biologists, engineers, and staff professionals working in multiple US locations and overseas.

Key Points: 
  • MRIGlobal employs about 480 people, including chemists, biologists, engineers, and staff professionals working in multiple US locations and overseas.
  • He brings incredible passion, strong business acumen, and a depth of experience to this position, saidDavid Oliver, Chairman of the MRIGlobal Board of Directors.
  • MRIGlobal is well-positioned financially, technically, and contractually, with the right customers and a tremendous reputation, to expand its market share, Colrain said.
  • I look forward to leading MRIGlobal as we solve the worlds most challenging problems in defense and health.

Appili Therapeutics Announces Over US$10 Million in New Funding from US Department of Defense for Biodefense Vaccine Candidate ATI-1701

Retrieved on: 
Monday, February 28, 2022
Other Defense, Medical Supplies, Contracts, Infectious Diseases, FDA, Other Health, Biotechnology, Pharmaceutical, Health, Defense, Risk, TSX, DTRA, Government, Anthrax, Animal, Bioterrorism, Public health, NIH, U.S. Department of Defense Strategy for Operating in Cyberspace, MRIGlobal, Francisella tularensis, Therapy, Company, Infection, Drug development, Documentation, Survival rate, IND, News, Intention, FDA, Tularemia, Defense Threat Reduction Agency, Death, OTCQX, Degenerative disease, Technology, Survival, CEO, Pharmaceutical industry, Vaccine, ATI-1701, Appili Therapeutics, ATI-1701, APPILI THERAPEUTICS

The new funding is designed to replace and expand upon a prior contract awarded to one of Appilis development partners.

Key Points: 
  • The new funding is designed to replace and expand upon a prior contract awarded to one of Appilis development partners.
  • The expected total funding amount of over US$10 million will fund this expanded scope of work.
  • The award is subject to successful negotiations between the DTRA contracting division and Appili.
  • Last month, the Company announced positive one year results from its preclinical study evaluating the efficacy of biodefense vaccine candidate ATI-1701 in a lethal model of tularemia.

MRIGLOBAL CHIEF SCIENCE ADVISOR PART OF AMBITIOUS PANDEMIC RESPONSE TEAM TO SPEED DRUG COCKTAILS FOR COVID-19 AND FUTURE DEADLY VIRUS WAITING IN THE WINGS

Retrieved on: 
Wednesday, January 5, 2022
Vaccine, COVID-19, Microbiology, University, University of Washington Department of Bioengineering, Fred Hutchinson Cancer Research Center, MRIGlobal, University of Virginia School of Medicine, Emergency, UVA, Doctor of Philosophy, Virginia School for Girls, Inhalation, Patient, Vaccination, White, National, Plasma protein binding, History of the University of Maryland, College Park, Pandemic, HIV, Mouth, MD, Infection, Gene, Virus, Cell biology, MBio, Human, Biology, Solution, Globe, Animal, Coronavirus, Pharmaceutical industry

"We need to pro-actively develop drug cocktails against virus families as a whole, for example all coronaviruses, to be ready on 'day 1' if a new virus or variant emerges. The cocktail should be low cost, easy to transport and distribute, and easy to self-administer---therefore available to people across the globe," said researcher Judith M. White, PhD, a professor emeritus at the University of Virginia School of Medicine. "We hope that this concept of 'smart drug cocktails'---smart because of the choice of drugs for testing and computer modeling of their effectiveness in humans---will be the basis for a robust coordinated effort against coronaviruses and other pathogenic viruses (e.g., Zika and Lassa fever viruses, just to name a few)."

Key Points: 
  • The pipeline could speed new and better treatments that the newly diagnosed and recently exposed could take at home to prevent serious illness.
  • The proactive drug development strategy could also offer a first line of defense against future pandemics, the researchers say.
  • "We need to pro-actively develop drug cocktails against virus families as a whole, for example all coronaviruses, to be ready on 'day 1' if a new virus or variant emerges.
  • But they say their strategy could lead to better outcomes for patients who contract COVID-19 or the next dangerous virus waiting in the wings.