Latest news with #Giroir
Malaysian Reserve
09-07-2025
- Health
- Malaysian Reserve
Giroir Commends Formation of Congressional BIOTech Caucus
Former Senior Trump Health Official Urges Focus on Innovative 'Upstream' Approaches that Disrupt Current Paradigm of Costly Chronic Care ATLANTA, July 9, 2025 /PRNewswire/ — Brett P. Giroir, M.D., former Assistant Secretary of Health and Acting FDA Commissioner in the first Trump Administration, praised the recently announced formation of the bipartisan BIOTech Caucus and noted the critical importance of its mission to engage with sector leaders and to build awareness and bioliteracy among Members of Congress. 'I applaud Reps. Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) for seizing the initiative to form the BIOTech Caucus. With new FDA reform initiatives and focused efforts in Congress, innovative biotech companies will be better able to shatter treatment paradigms that have become too comfortable and too profitable for Big Pharma to change,' said Giroir, CEO of Altesa BioSciences. 'This is precisely why I chose to lead a small innovative biotech company after completing my US government service,' he continued. 'The federal government can play a key role to help incentivize bio-entrepreneurship and leverage capital markets for the benefit of U.S. biotech companies poised to provide seismic, beneficial impacts to patients, taxpayers and the public-at-large.' Chronic Obstructive Pulmonary Disease (COPD) treatment as paradigm shift example: Giroir pointed to the transformation needed in the treatment of COPD, a condition that negatively impacts the health and well-being of 17 million Americans and nearly 500 million globally. COPD, the Altesa CEO noted, costs the U.S. approximately $50 billion annually in health care spending and is predicted to become the world's leading cause of death in 15 years. 'Until we can eliminate the underlying causes of COPD, namely smoking and air pollution, patients deserve better than costly downstream immune-modifying injections that only help a minority of COPD patients avoid a minority of flare-ups,' he continued. Instead, he said, patients must be empowered to better care for their disease by using and integrating wearable technologies, at-home diagnostics, artificial intelligence, and specific treatments for the number one cause of exacerbations – respiratory virus infections. 'Diagnostics coupled with effective oral medicines have transformed our treatment of flu, COVID, Hepatitis C, and HIV. If we can identify respiratory viruses early- and treat them early on, there is a good chance that we can markedly and cost-effectively reduce exacerbations of COPD, asthma, and other lung conditions,' the Altesa BioSciences CEO said. Giroir pointed to Altesa BioSciences collaborator, Sensifai Health, as emblematic of the needed emphasis on AI and wearables technology to facilitate upstream treatments to help people experiencing COPD. 'The entire rationale of 'upstream' disease treatment is to intervene before health crises occur,' Giroir pointed out. 'Sensifai's objectives align perfectly with our mission to deliver transformative respiratory therapeutics at a time when they can be most effective.' He noted a peer-reviewed study published in The Lancet Digital Health last week details the fact Sensifai's AI platform is the world's first wearable-powered system to predict acute inflammation with 90% sensitivity. To encourage paradigm change, Giroir urged payers like Medicare and Medicaid to evaluate innovative care models that compare costly chronic downstream therapies versus common-sense upstream approaches like AI-assisted wearables, vaccination, preemptive treatment of viral infections, exercise, digital coaching, and Vitamin D supplementation. 'If such commonsense approaches proved effective – and I believe they will – the lives of COPD patients would be forever changed, and the U.S. health care system would save tens of billions of dollars annually,' Giroir concluded. 'These are the types of conversations Congress needs to hear, and I look forward to working in a positive, constructive manner with the BIOTech Caucus to help detail and explain the 'upstream' diagnostic and treatment changes we can no longer afford to ignore.' Download study: About Altesa BioSciences, Inc. Altesa BioSciences is a clinical-stage pharmaceutical company dedicated to developing new treatments for age-old threats to human health: high-consequence viral infections. These infections are particularly severe in vulnerable people, including those with chronic health conditions, like lung diseases, as well as the elderly and many people in underserved communities. About Sensifai Health Inc. Sensifai Health is a Canadian-Israeli Preemptive Health startup at the forefront of bioconvergence. Its AI-powered platform continuously analyzes data from wearable biometric sensors to deliver early alerts of systemic inflammation before symptoms appear. By identifying silent immune signals in vulnerable individuals, Sensifai enables timely intervention that helps prevent critical health events, reduce hospitalizations, and improve long-term outcomes. Contact: Media Inquiries: Mia HeckCellular (210) 284-0388[email protected]
Yahoo
24-06-2025
- Health
- Yahoo
FDA's Accelerated Drug Review Plan Praised by Former Senior Trump Health Official
Brett P. Giroir M.D., Former Acting FDA Commissioner and Assistant Secretary for Health, Says New Commissioner's National Priority Voucher Program (CNPV) Can Help Speed Innovative "Upstream" Therapies to Patients ATLANTA, June 23, 2025 /PRNewswire/ -- The former Acting Commissioner of the Food and Drug Administration (FDA) and Assistant Secretary for Health in the first Trump Administration, Brett P. Giroir M.D., today said the new expedited drug review proposal announced by FDA last week could help speed new, innovative therapies to patients and boost smaller drug innovators' ability to better address unmet public health needs. Giroir, CEO of Altesa BioSciences, said: "FDA Commissioner Makary's timely initiative can better enable smaller biotech innovators with breakthrough 'upstream' therapies to compete with Big Pharma's fixation on costly 'downstream' chronic care," said Giroir. "I plan to discuss this 'upstream' versus 'downstream' dynamic frequently moving forward." The Commissioner's National Priority Voucher (CNPV) program provides drug developers the opportunity to redeem a voucher to participate in a novel priority FDA program. This would shorten its review time from approximately 10-12 months to 1-2 months, following a sponsor's final drug application submission. Giroir, who also served as Admiral in the US Public Health Service Commissioned Corps and the national Covid "testing czar" during the 2020 pandemic, noted that by building on the investments made by the federal government during COVID, home tests for the majority of viruses that can be debilitating to vulnerable populations will soon be available -- including people living with chronic lung diseases like COPD or asthma. "We seek to lay the foundation for a new paradigm of prevention and treatment that moves us 'upstream' to intervene before health crises occur," continued Giroir. "The general thrust and intent of FDA's expedited drug review plan aligns perfectly with our mission to deliver transformative respiratory therapeutics at a time when they can be most effective." About Altesa BioSciences, BioSciences is a clinical-stage pharmaceutical company dedicated to developing new treatments for age-old threats to human health: high-consequence viral infections. These infections are particularly severe in vulnerable people, including those with chronic health conditions, like lung diseases, as well as the elderly and many people in underserved communities. Media Inquiries: Mia Heck Cellular (210) 284-0388 MHeck@ View original content to download multimedia: SOURCE Altesa Biosciences Inc. Sign in to access your portfolio
Yahoo
23-04-2025
- Health
- Yahoo
Former Trump official says DOGE cuts undermine HIV legacy
A former top federal health official who served during President Trump's first term warned that the drastic cuts to the Department of Health and Human Services (HHS) could have 'devastating and illogical' impacts on combatting the HIV epidemic. Brett Giroir, who served as assistant secretary for health, wrote in a post on LinkedIn that making progress on the HIV epidemic in the U.S. was one of his first goals when he assumed his new role in Trump's first administration. 'During my first week in office, I set an HHS goal to reduce new HIV infections in America by 50 [percent]. We had once-daily medicines that make the HIV virus undetectable, and when the HIV virus is undetectable, it is untransmittable by sex,' wrote Giroir. 'But the real key was identifying HIV infected people early and getting them into care – and we could surely do that.' As Giroir recounted, he told Trump in an Oval Office meeting the U.S. had the capability to essentially 'end HIV in America,' to which Trump replied, 'Can we really do that?' Giroir was a designated survivor during the 2019 State of the Union address and said he was 'glued to the broadcast' when Trump announced the Ending HIV Epidemic (EHE) initiative. Lauding the achievements of the initiative — such as a 21 percent reduction in new HIV cases — Giroir called it the 'legacy of Trump '45.' 'But that legacy is now threatened by changes currently proposed or already implemented, including eliminating the Office of Infectious Disease and HIV Policy (which I proudly created) that leads the EHE effort; eliminating 150 staff in the Office of HIV prevention at CDC; reassigning key leaders in HIV to other programs; and the elimination of about $750 million in HIV targeted NIH grants,' Giroir wrote. Advocates and stakeholders raised the alarm when several branches of key federal HIV offices were effectively eliminated by HHS layoffs. Some have characterized the move to be in stark contrast to what Trump set out to do in his first term. Giroir in his post on Wednesday expressed further concerns as leaked budget proposals from the HHS suggest zero funding for the EHE initiative and cuts to the Ryan White HIV/AIDS Program. 'The impact of these cuts would be devastating and illogical — reversing all the gains we have made and destroying what is a legacy of courage and expert implementation by Trump '45,' wrote Giroir. 'Trump '47 should not allow Trump '45's massive public health achievement to be cancelled — especially when that legacy will be remembered in history books as the beginning of the end of HIV/AIDS in America. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
23-04-2025
- Health
- The Hill
Former Trump official says DOGE cuts undermine HIV legacy
A former top federal health official who served during President Trump's first term warned that the drastic cuts to the Department of Health and Human Services (HHS) could have 'devastating and illogical' impacts on combatting the HIV epidemic. Brett Giroir, who served as Assistant Secretary for Health, wrote in a post on LinkedIn that making progress on the HIV epidemic in the U.S. was one of his first goals when he assumed his new role in Trump's first administration. 'During my first week in office, I set an HHS goal to reduce new HIV infections in America by 50 [percent]. We had once-daily medicines that make the HIV virus undetectable, and when the HIV virus is undetectable, it is untransmittable by sex,' wrote Giroir. 'But the real key was identifying HIV infected people early and getting them into care – and we could surely do that.' As Giroir recounted, he told Trump in an Oval Office meeting that the U.S. had the capability to essentially 'end HIV in America,' to which Trump replied, 'Can we really do that?' Giroir was a designated survivor during the 2019 State of the Union address and said he was 'glued to the broadcast' when Trump announced the 'Ending HIV Epidemic' (EHE) initiative. Lauding the achievements of the initiative — such as a 21 percent reduction in new HIV cases — Giroir called it the 'legacy of Trump '45.' 'But that legacy is now threatened by changes currently proposed or already implemented, including eliminating the Office of Infectious Disease and HIV Policy (which I proudly created) that leads the EHE effort; eliminating 150 staff in the Office of HIV prevention at CDC; reassigning key leaders in HIV to other programs; and the elimination of about $750 million in HIV targeted NIH grants,' wrote Giroir. Advocates and stakeholders raised the alarm when several branches of key federal HIV offices were effectively eliminated by HHS layoffs. Some have characterized the move to be in stark contrast to what Trump set out to do in his first term. Giroir in his post on Wednesday expressed further concerns as leaked budget proposals from HHS suggest zero funding for the EHE initiative and cuts to the Ryan White HIV/AIDS Program. 'The impact of these cuts would be devastating and illogical — reversing all the gains we have made and destroying what is a legacy of courage and expert implementation by Trump '45,' wrote Giroir. 'Trump '47 should not allow Trump '45's massive public health achievement to be cancelled — especially when that legacy will be remembered in history books as the beginning of the end of HIV/AIDS in America.
