In June of 2021, the Therapeutics Parallel Analysis (TxPA) work group of the COVID-19 Evidence Accelerator paused to conduct a retrospective or “retro”. For those of you who are unfamiliar with the expression, a retro is an opportunity to review the work of a previous cycle or “sprint” in Agile…

Following our August break for the Diagnostics group, we’re ready to start working, step-by-step, through the COVID-19 testing data journey, with an eye towards better understanding—and improving—data interoperability. At Thursday’s meeting, we will focus on a core data element: the unique device…

Our focus for this Therapeutics and Vaccine discussion includes an update on the treatment, and characterization, of Post-Acute Sequelae of SARS-CoV-2 infection (PASC) or long-COVID. As this condition develops in real time, we’re getting a clearer picture each day—and real-world data is providing…

As the battle against SARS-CoV-2 continues, it’s time for the COVID-19 Evidence Accelerator to return to an earlier focus for this Thursday’s meeting (3pmET) -- exploring therapeutic interventions for active infection.

 COVID-19 exposed significant racial and ethnic health inequities in our U.S. health system. The current pandemic demonstrates the structural challenges we must overcome as health professionals to ensure equitable access to health-promoting services and the role data collection can play.

More than 32 million individuals have survived a confirmed COVID-19 viral infection in the USA [1, 2], and a substantial proportion of post-COVID survivors are suffering from prolonged, recurrent, and/or newly emerging symptoms that span across bodily systems and organs [3]. The spectrum of…

The Reagan-Udall Foundation’s Evidence Accelerator program is navigating novel data flow challenges when it comes to assessing the safety and effectiveness of COVID-19 vaccines.

When talking about data interoperability, researchers should understand that most data issues can be traced back to a lack of alignment.

As mentioned in last Friday’s newsletter, this Wednesday, June 9, 12pmET, we will be hosting our broad monthly Therapeutics Parallel Analysis meeting. On the agenda this month is a “retro” of our Parallel Analysis process and we invite your comments and suggestions.

Among the poster presentations was Accelerating Evidence Generation by Convening Diverse Stakeholders Across the Real World Data Ecosystem.  It details how the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research and active participation by FDA and key stakeholders…

CDER's Office of Surveillance and Epidemiology (OSE) recently issued their first Annual Report. The 2020 Annual Report highlights OSE’s key initiatives to improve public health by reviewing and assessing the safety of medicines, with a special focus on its efforts to respond to the COVID-19…

The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health…

Our national and global shared experience with COVID-19 crystallized the criticality of near real-time, real-world data (RWD) to generate insights and actionable information; and the imperative to drive towards a learning health system.

As part of our March 18 COVID-19 Diagnostics Evidence Accelerator Collaborative meeting, Dr. Timothy Stenzel, Director of FDA’s Office of In Vitro Diagnostics and Radiological Health detailed the impact of viral mutations on COVID-19 testing and answered key questions posed by meeting participants.

The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and…

We’re excited to connect with you this week to touch on two topics you raised in our early 2021 ‘Retro’: virus variants and interoperability.

We’re excited to welcome March (and the prospect of spring) with discussion of SARS-CoV-2 viral variants…what does this mean for testing? We’ll hear directly from FDA’s CDRH and from the team at LabCorp for updates on the emerging data and its implications. We’ll also report out from our early…

Join us for an introduction from Dr. Bala Hota (Rush University) to Chicago’s COVID-specific health information exchange (a potential model for post-COVID interoperability) and a reflection on prior interoperability efforts with Dr. Kenneth Mandl (Boston Children’s & Harvard University). We’ll…

Happy February! It’s the first week of the month, so we’ll gather at noonET this Thursday for the next step in our journey to share insight on COVID-19 diagnostic testing. This week’s discussion continues our exploration of various testing strategies and underlying priorities.

Happy New Year! We are looking forward to seeing you at our January 21st Diagnostics Lab meeting (12pmET)—and invite you to come with your ideas.

It’s early 2021 in the Northeast and a major snowstorm has just been announced. Schools will be closed for the next two days. Kids will be home and likely, quite happy to be off from school. Under normal circumstances, parents would be home too, trying to work and probably attempting to create some…

Pune, India, March 01, 2021 (GLOBE NEWSWIRE) -- The global COVID-19 diagnostics market size is projected to reach USD 8.04 billion by 2027, exhibiting a CAGR of 2.7% during the forecast period.

Across every facet of life, 2020 tested our resolve and resilience. COVID-19 stretched our systems to the breaking point, exposing inexcusable gaps and limitations in our systems.

Existing therapeutics, new applications in COVID-19. That’s the theme we’ll be discussing on Thursday, as we look at the desire to continue success of treating COVID-19 by repurposing drugs which are already on the market. As you might expect, there is a lot to discuss, and our agenda includes:

We’re looking forward to seeing you at 3pmET on Thursday for our twice-monthly gathering, with our sights set on learning more about the long-term effects of a COVID-19 infection. We’ll hear from one of the first clinics established to explore these effects—the Mt. Sinai Center for Post-COVID Care—…

After nine months of suffering, isolation and economic downturn on an unprecedented international scale, the expedited development and approval of COVID-19 vaccines has shown us the light at the tunnel’s end. Having an end in sight is not the same as getting there, however: Inoculating the majority…

During a recent COVID-19 Evidence Accelerator (EvAcc) Therapeutics Parallel Analysis meeting1 we saw the synergy and creativity that arises when multiple partners work on the same data challenges. As all of us listened (and have been listening) to data partners express frustration over wrangling…

Happy New Year! We are looking forward to seeing you at our January 21st Therapeutics Lab meeting (3pmET).

As we see more COVID-19 vaccines move from vials into arms, this community knows that we’re seeing more data flow from vaccination sites into public health systems, EHRs, and claims. To kick off the expansion of our discussions to include data related to vaccinations, we have three important…

In recent months, scientists and policymakers around the globe have rallied together with one common goal: to eliminate Covid-19. Budgets have been revised to funnel money toward research, competitive barriers between scientists and companies have been lowered, and regulatory processes have been…

Tom Skelton, CEO of Surescripts, recently spoke with Dr. Amy Abernethy of the FDA, about the impact of COVID-19 and the evolving data needs of public health.  

Reagan-Udall receives $250,000 from Rockefeller Foundation for COVID-19 Diagnostics Evidence Accelerator

The Reagan-Udall Foundation for the FDA has received funding from The Rockefeller Foundation to support the COVID-19 Diagnostics Evidence Accelerator launched earlier this year in collaboration with Friends of Cancer Research. As a science-driven philanthropy focused on building collaborative…

COVID-19 has swept across the world, overwhelming healthcare systems and raising countless questions about how best to diagnose patients, treat infections, save lives, and contain the pandemic. In short order, researchers have launched randomized trials to uncover pharmacologic interventions that…

“Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernathy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on Tuesday (October 13).

I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research.  I only wish that we could be together in person. I want to thank Bill Slikker and his co-chair of the Scientific Program Committee, Marta Hugas, for their hard work in putting…

Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and Friends of Cancer Research, the COVID-19 Evidence…

On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for a device if it reasonably…

Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and Friends of Cancer Research, the COVID-19 Evidence…

Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far. Aetion, the New York health tech startup, has for the second time raised an extension to their Series B, adding $19…

On August 11, 10:30-11:30AM ET, DIA is hosting a live panel discussion to dive deeper into methodological and clinical learnings of the Evidence Accelerator and the next steps in the therapeutic and diagnostic/serological testing spaces. The Panel will include the following speakers: Ellen Sigal,…

The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, FDA’s Oncology Center of Excellence; and Director, Division of Oncology 2, FDA’s Center for Drug Evaluation and Research:

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.

The COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research (Friends), convenes leaders in the health care data and analytics space to answer key questions about COVID-19 with real-world data (RWD). 

Traditionally, the healthcare industry has moved slowly when embracing new technology innovations. However, over the past few months, it has been forced to rapidly advance to confront the challenges posed by COVID-19. One area that has received increased attention is real-world data (RWD),…

The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. Read more

At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic. The FDA will be working to provide industry what data it believes is…

FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing quality, better inform population testing strategies and help under

FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.

Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used PCR-based diagnostics and serological antibody…

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID-19.   

Today, the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, announced the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder, collaborative project to leverage real-world data in the diagnostic test (e.g., nucleic acid or antigenic) and antibody…

The Reagan-Udall Foundation for the FDA (Foundation) in collaboration with Friends of Cancer Research (Friends) today announced the COVID-19 Evidence Accelerator, an expansive public-private partnership combining the efforts of academic, government, and private sector organizations applying data…

FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion's ability to perform consistent analyses across a variety of data sets was key for FDA in selecting the the…

The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19, including how diagnostics and medications…

Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, described in podcast interviews with BioCentury’s Washington Editor Steve Usdin how the pandemic has accelerated progress on integrating…

Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has demonstrated its ability to kill people of all ages. Even…

"Identifying key questions and core data elements is at the heart of a new initiative launched by the Reagan-Udall Foundation and Friends of Cancer Research. The COVID-19 Evidence Accelerator provides a venue for major data organizations, government and academic researchers, and health systems to…

"A new initiative called the COVID-19 Evidence Accelerator aims to pool ongoing data sources from government and academic researchers, health systems, and private companies to solutions for Covid-19. With so much information becoming available rapidly, the accelerator will aid data sharing and…