TrialSite introduced the Quantum Leap Healthcare Collaborative of San Francisco back in July. Our title read “The I-Spy Trial: An Interesting Model that Perhaps the NIH & FDA Should Consider for Classes of COVID-19 Studies.” Well, as it turns out, recently the U.S. The Department of Health of Human Services and the Department of Defense have been engaging this innovative, non-profit organization for COVID-19 research: perhaps they read TrialSite’s idea and it resonated? As it turns out, HHS and DOD will engage Quantum Leap Healthcare Collaborative in a search for effective treatments for the most ill COVID-19 patients. Backing this new partnership: $66.5 million.
Silicon Valley Meets DC: A Race for COVID-19 Treatments
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense on a $66.5 million agreement with Quantum Leap Healthcare Collaborative to add three investigational treatments to the research organization’s platform clinical trial. The agreement also doubles the number of sites where the organization is conducting its platform clinical trial, growing from 20 to 40 locations in the United States.
What is a Platform Trial
A platform clinical trial uses the same protocol as a traditional clinical trial with a group of volunteers receiving either a placebo or an experimental product, but with a platform clinical trial, volunteers could receive one of several products being studied. Quantum Leap Healthcare Collaborative uses the approach for screening, with data reviewed frequently to eliminate ineffective treatments quickly and move promising treatments quickly into later-stage clinical trials.
Candidate therapeutics will be assessed by a panel of federal and academic experts to determine eligibility for inclusion in the trial. Promising results could position those potential treatments for late-stage clinical trials with the private sector or inclusion in the ACTIV clinical trials led by the National Institutes of Health.
Candidates will be selected that target the body’s response to the virus, known as host-targeted treatments, for the sickest patients. Other criteria include: the candidate’s development stage; the safety and efficacy data available to-date; available supply of the drug; realistic expectation that emergency use authorization could be granted during the current pandemic; and manufacturing capability that could get promising treatments to patients quickly.
The single platform clinical trial approach is less costly and more efficient than traditional multiple clinical trials of a single drug candidate. The approach also allows researchers to compare the drug candidates head-to-head to identify which ones would be best for specific conditions or could be useful in combination. Such information would aid healthcare providers in making decisions about patient treatment.
HHS Point of View
Dr. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, commented on this important alliance, noting, “Through our Operation Warp Speed partnership, we have worked feverishly with private industry to develop and make treatments available to reduce hospitalization, either shortening the length of stay or treating people with mild or moderate COVID-19 infections before they have to be hospitalized.” The HHS official continued, “While we’re making significant progress, treatments to save lives of the sickest patients, such as patients in intensive care or ventilators, remain an urgent need.”
The Fed Players
A few groups out of the federal government align to partner with the innovative Silicon Valley area-based organization. They include U.S. Health and Human Services (HHS) along with ASPR and BARDA. While HHS works to enhance and protect the health and well-being of all Americans—the umbrella organization—ASPR serves to save the lives and protect Americans from 21st-century health security threats. BARDA, part of ASPR, invests in the innovation, advanced research and development, acquisition and manufacturing of medical countermeasures (MCMs), including vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceutical products necessary to combat health security threats. To date, BARDA-supported MCMs have achieved 56 FDA approvals, licensures or clearances.
Meanwhile, within the Department of Defense (DoD) the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing MCMs and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, from vaccines to therapeutics and diagnostics, to combat CBRN and emerging threats such as COVID-19. Follow the link for more details.
Operation Warp Speed, set up by POTUS in the Spring, opened the door to game changing impact suggested TrialSite. The public-private partnership led by POTUS brought together key federal government players in a bid to accelerate vaccine and therapy development. The effort has definitely had positive impact. Critics have suggested the group needs more transparency into how decisions are made for funding, for example.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 510c3 charitable organization set up in 2005 as a collaborative between researchers at University of California, San Francisco and Silicon Valley entrepreneurs with a mission to integrate care and research, including the support and promotion of high-impact clinical studies with embedded clinical processes and systems technology as well as improved data management, greater access to trial matching, and improved benefit to patients, providers and researchers.