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A new health IT partnership aims to improve clinical data quality and thereby increase the volume of data available for care quality measurement.

The partnership will combine Chicago-based Apervita and Farmington, Connecticut-based Diameter Health’s expertise to provide payers, providers and other healthcare stakeholders with access to clean clinical data for value-based care delivery, said Rick Howard, Apervita’s chief product officer, in an email.

“The healthcare industry has no shortage of data, but the way it’s leveraged continues to be a challenge for both quality measurement and for supporting value-based contracts,” he said.

Apervita provides stakeholders with the infrastructure necessary to develop value-based care models.

Per the new partnership, the company’s quality measurement and value optimization solutions will leverage Diameter Health’s Fusion engine to clean healthcare data in multiple formats, including clinical, claims, behavioral health and laboratory data, Howard explained.

The clean data can be used to glean performance insights that are needed to develop value-based contracts between providers and payers.

Diameter Health’s technology ingests raw — that is, poorly formed, unstructured or incorrectly coded — health information from EHRs, labs and aggregators, and automatically normalizes, re-organizes, deduplicates and summarizes the data, said a Diameter Health spokesperson in an email. The technology identifies data quality errors early in the ingestion process, which makes data sharing more efficient.

“We are thrilled to be a critical and foundational component to Apervita’s platform by delivering clean, normalized, and enriched multi-source clinical data to their customers, empowering providers, payers and other healthcare stakeholders to improve quality and deliver value,” said Eric Rosow, CEO of Diameter Health, in a news release.

Healthcare data is proliferating as the industry becomes more digitized. Telehealth and remote patient monitoring services, in particular, grew exponentially amid the Covid-19 pandemic. And the data generated by these services also grew.

In addition, wearable health technology, like glucose monitors and the Apple Watch, are becoming more widely used to track patient diagnostics and encourage patient engagement, Howard said. This provides even more data for the healthcare industry to contend with.

“As the volume of healthcare data continues to grow, so will the need to have technology that normalizes the data so that it can be used to support quality measurement, value-based contracts and analytics,” he said.

Photo: Dmitrii_Guzhanin, Getty Images

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Breast cancer cells

Athenex’s lead drug candidate, an oral formulation of the chemotherapy paclitaxel, is intended to bring patients comparable, if not better, efficacy and fewer side effects than the intravenous version. But the company now faces questions about the drug’s safety in the wake of an FDA rejection.

Buffalo, New York-based Athenex announced the rejection of the cancer drug Monday. According to the company, the regulator recommended the biotech conduct a new clinical trial in metastatic breast cancer patients. The agency also suggested the company take steps to mitigate the drug’s toxicity.

Shares of Athenex fell sharply after the FDA rejection was announced, and closed Monday at $5.46 apiece, down nearly 55% from Friday’s closing stock price.

Paclitaxel, also known as Taxol, is a widely used chemotherapy for treating breast, ovarian, and lung cancers. Intravenous dosing of the drug can cause adverse reactions. To mitigate those effects, cancer patients are given steroids and antihistamines prior to dosing of the chemotherapy. Other side effects of intravenous paclitaxel include nerve damage, hair loss, and neutropenia, which is an abnormally low level of a type of white blood cell called neutrophils. Those side effects may reduce how much of a dose of the chemotherapy a patient can receive.

Athenex’s version of paclitaxel is given in combination with another drug, encequidar. According to the company, this compound blocks a protein in the intestinal wall that limits the absorption of chemotherapies. In results of a Phase 3 study testing Athenex’s oral paclitaxel in patients with metastatic breast cancer, the company reported its drug met the main goal of showing statistically significant improvement in the overall response rate compared against treatment with the IV version of the chemotherapy.

The company also reported that its drug can reach levels in the blood comparable to IV paclitaxel, and for a longer period of time. The company said in securities filings that this capability may translate to a better clinical response to the therapy. In the 402-patient Phase 3 study, Athenex observed a higher tumor response rate along with lower incidence and severity of nerve problems compared to IV paclitaxel.

Athenex said that the agency’s complete response letter cited the risk of an increase in problems related to neutropenia in the oral paclitaxel arm compared with the group treated with the IV formulation. The FDA also expressed concern about how the results of the study primary endpoint were evaluated under blinded independent central review, a group of independent physicians. According to Athenex, the FDA said there may have been “unmeasured bias and influence” on the review.

Speaking on a conference call, CEO Johnson Lau said the company was “surprised and extremely disappointed” by the FDA’s rejection. The neutropenia concerns cited are a known risk of paclitaxel, he said. Lau added that the review remained blinded, was conducted by independent radiologists, and the regulator had not issued any formal warnings flagging problems at the imaging lab.

The FDA’s recommendation that Athenex conduct another clinical trial specified that the study should include patients more representative of the U.S. population. Rudolf Kwan, the company’s chief medical officer, said on the call that none of the clinical trial sites were in the U.S. But he added that the company had discussed the clinical trial design with the regulator, and the single study, as proposed by the company, was understood to be sufficient to support approval if the results were positive.

Lau said that the company plans to request a meeting with the FDA to discuss the letter and clarify the scope of the new clinical trial needed to address the agency’s concerns.

“Whether it requires the whole study be done in U.S., we’ll have to clarify in the meeting,” Lau said.

Though Athenex has a pipeline of clinical-stage cancer therapies, company currently generates most of its revenue from the sales of generic injectable products. In 2020, it reported more than $105 million in product sales, a 73% increase over 2019 sales. In its financial report of fourth quarter 2020 and full-year results, Athenex attributed the revenue increase to growing sales of specialty pharmaceutical products used to treat hospitalized Covid-19 patients. As of Dec. 31, 2020, Athenex had $86.1 million in cash and $138.6 million in short-term investments.

Photo by American Cancer Society/Getty Images

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The FDA has authorized Johnson & Johnson’s Covid-19 vaccine for emergency use, adding a third vaccination option—one that comes with storage and distribution advantages.

The regulatory decision followed the review of an FDA advisory panel, which voted unanimously on Friday to recommend authorization of the vaccine. J&J said it has begun shipping its vaccines to the federal government, which will manage distribution. The company expects to deliver enough vials for the vaccination of more than 20 million people in the U.S. by the end of March, ramping up to 100 million vaccinations by mid-year.

The J&J shot joins the messenger RNA vaccines developed by Moderna and partners Pfizer and BioNTech as the only authorized Covid vaccines in the U.S. The mRNA vaccines must be transported and stored at ultra-cold temperatures well below temperatures of typical medical freezer equipment. However, vaccination sites now have a little more flexibility in how they can store mRNA vaccines. Last week, the FDA approved a request from Pfizer and BioNTech to permit storage of their vaccine at pharmaceutical-grade freezers for up to two weeks.

The J&J vaccine can be transported and stored at refrigerator temperatures, making it a better option for rural areas or vaccination sites that don’t have the specialized freezer equipment required to store the mRNA vaccines. It has the additional advantage of being a single shot, unlike the mRNA vaccines that are given as two doses weeks apart. A single shot avoids the challenges of getting people to return for a second injection.

“The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance.

The J&J vaccine uses a virus to fight a virus. The company’s Janssen subsidiary takes adenovirus, which causes the common cold, and engineers it so that it cannot replicate and does not cause illness. This engineered virus becomes the vehicle that transports into cells a piece of DNA from SARS-CoV-2, the novel coronavirus. Cells use that genetic material to make the spike protein found on the surface of SARS-CoV-2. Those proteins spark the immune response that leads to immunity. This vaccine technology, which J&J calls AdVac, is the basis of the company’s Ebola vaccine, which was approved by the FDA in 2019.

The FDA authorization for J&J’s Covid vaccine was based on results from a global, placebo-controlled Phase 3 study that enrolled nearly 44,000 volunteers. Those participants were followed for a median of eight weeks. The main goal of the study was to evaluate the first occurrence of moderate-to-severe Covid infection with the onset of symptoms after 14 days, and then after the 28-day mark.

Overall, the J&J vaccine was about 67% effective in preventing moderate-to-severe or critical Covid infection after two weeks. After 28 days, the vaccine was about 66% effective at preventing infection. The FDA added that the J&J vaccine was about 77% effective in preventing severe or critical illness two weeks after vaccination. After 28 days, the vaccine was 85% effective in preventing severe or critical illness.

The most common side effects reported from the studies were pain at the injection site, headaches, fatigue, muscle aches, and nausea. The FDA said these side effects were mostly mild to moderate and lasted for a day or two. J&J does not yet have enough data to determine how long protection from the vaccine lasts. The studies conducted to date also do not show whether the vaccine stops people from transmitting the virus. As part of the emergency authorization, J&J must continue to collect data about its vaccine and report and serious adverse events.

The J&J vaccine is given as a 0.5 mL intramuscular injection. The vaccine is shipped in vials, each containing five doses. The company estimates the vaccine will remain stable for two years stored at minus 4 degrees Fahrenheit (minus 20 degrees Celsius). At refrigerator temperatures in the range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius), the company says the vaccine can be stored for up to three months. The company will deliver the vaccine with the same cold chain currently used to ship its other medicines.

The federal government will manage the allocation and distribution of the J&J vaccine according to guidelines set by the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Johnson & Johnson said that it plans file an application seeking a formal FDA approval later this year. The company is also seeking authorizations for its vaccine in other markets.

Photo: Esben_H, Getty Images

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The U.S. is one step closer to making available another Covid-19 vaccine after a panel of experts voted unanimously Friday to recommend emergency use authorization for a shot developed by Johnson & Johnson.

The independent panel, comprised of mostly physicians, voted 22-0 to support the vaccine with no one abstaining. These votes aren’t binding on the FDA, but the agency often follows the recommendations of its panels. A decision could come as early as this weekend. The two Covid vaccines currently cleared for emergency use received their authorizations the day after their respective advisory panel meetings.

The Johnson & Johnson vaccine would offer an alternative to the ones currently available from the Pfizer and BioNtech alliance, and Moderna. Those messenger RNA vaccines must be distributed and stored at ultra-cold temperatures, then thawed before use. Those shots are given as two doses, weeks apart. The J&J vaccine can be kept at refrigerator temperatures. Another key difference is that the J&J jab requires a single shot. Together, those features will make the J&J vaccine easier to distribute to more people in more places through distribution channels that are already in place.

Panel members expressed support for the J&J vaccine, saying that the safety and efficacy data supported its authorization. But panelists also cautioned the public against picking vaccine favorites.

“It’s important that people do not think one vaccine is better than another,” said Cody Meissner, an infectious disease expert and professor of pediatrics at the Tufts University School of Medicine. “There is no preference for one vaccine over another and all vaccines work with what appears to be equal safety and equal efficacy as of this time.”

Emergency authorization is not the same as an approval. Federal law permits the FDA to allow marketing of unapproved medical products for emergency situations, such as a pandemic. Authorizations only last for the duration of the emergency. These authorizations can also be revoked if new data show that the product is not safe or effective. Stanley Perlman, a professor in the departments of microbiology and immunology at the University of Iowa, said that while the clinical studies to date have produced data about the vaccine’s safety and efficacy, it would be “nice to have more.”

The J&J vaccine may be new, but compared to the mRNA vaccines, the technology behind it has bit of a longer track record. J&J vaccine makes it using its AdVac technology, the same platform that produced the company’s Ebola vaccine, which the FDA approved in 2019. The technology takes the virus that causes the common cold and modifies it so it doesn’t cause illness. That engineered virus is the delivery vehicle that ferries into cells a snippet of genetic code for the novel coronavirus’s spike protein. The genetic material serves as the blueprint from which the body’s cells produce spike proteins. The immune system responds by producing antibodies to those proteins, conferring immunity.

The clinical data to date for J&J Covid vaccine covers 44,000 adults from all over the world. In Phase 3 data reported in late January, the vaccine was 66% effective overall in preventing moderate-to-severe infection, 28 days after vaccination. Furthermore, the vaccine showed 85% efficacy in preventing severe disease, and showed complete protection against Covid-related hospitalization and death, also measured at day 28.

Those marks look inferior to the greater than 90% efficacy demonstrated in mRNA vaccine trials. But cross-trial comparisons are difficult and can be misleading because trials have different designs and different goals. Also, the mRNA studies were conducted earlier in the year when there were fewer variants circulating. Public health experts have said that if those vaccines were tested under current conditions, their efficacy rates might be lower, too.

Plans are already underway to gather more data about J&J’s shot, including a study of the vaccine in children and teens. Johan Van Hoof, the global head of the infectious diseases and vaccines for J&J’s Janssen subsidiary, told the advisory panel that a clinical trial testing the vaccine in those 17 and younger is expected to begin this spring. He also said that the company is assessing how the vaccine responds to variants of the novel coronavirus.

Shortly after Friday’s meeting, the FDA issued a statement saying that it would “rapidly work” with J&J toward finalization and issuance of an emergency use authorization. The agency added that it has notified federal partners involved in the allocation and distribution of vaccines, so that they are ready.

Photo: Getty Images, Sezeryadigar

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On the heels of a coordinated care agreement with Anthem, St. Louis-based Mercy is partnering with another health insurer.

On Thursday, the health system announced it was entering into an agreement with Louisville, Kentucky-based Humana to expand patient access to virtual health resources.

Per the new agreement, Humana’s Medicare Advantage members who are patients at Mercy facilities and physician practices will gain in-network access to Mercy Virtual. Staffed with more than 300 clinicians, Mercy Virtual offers 24/7 telehealth services, including virtual primary care at home.

In addition, the agreement links provider reimbursement to quality of care, shifting the payment model for Mercy physicians from fee-for-service to value-based compensation.

“Mercy is committed to working with our communities to improve healthcare while also reducing the total cost of care,” said Shannon Sock, Mercy’s executive vice president, chief strategist and CFO, in a news release. “Strong payer relationships, like this one with Humana, will help in our long-term journey to provide more seamless care for our patients. Together we can make a real difference for patients, which is especially critical during this pandemic.”

The new agreement brings together an insurer with a sizeable membership and a vast healthcare organization.

Mercy includes more than 40 acute care, managed and specialty hospitals, urgent care locations, imaging centers and pharmacies, as well as 4,000 primary and specialty care clinicians in Arkansas, Kansas, Missouri and Oklahoma. And, as of January, Humana’s Medicare Advantage membership totaled more than 4.8 million.

“This agreement unites two organizations striving to offer care that is more accessible, personalized and coordinated — a commitment that is more important than ever right now,” said Jeremy Gaskill, Humana regional Medicare president, in a news release.

The news of the partnership between Humana and Mercy comes just a few weeks after the health system entered into a cooperative care agreement with Anthem. That partnership includes a closer alignment between clinical care and reimbursement as well as increased data flow between Mercy and Anthem.

As the healthcare industry moves toward value-based care, provider-payer partnerships that aim to improve care quality have become more popular.

For example, at the end of last year, Salt Lake City-based Intermountain Healthcare and UnitedHealthcare established an accountable care organization with the goal of improving care coordination and health outcomes for the payer’s Medicare Advantage members. In another instance, Butler Hospital, a mental health facility, partnered with Blue Cross & Blue Shield of Rhode Island to reduce hospital readmissions.

“If either a payer or provider is looking to fill a gap and expand optionality of services for partners or members, these types of innovative partnerships are beneficial because they provide both parties an opportunity to quickly refine and build versus recreating the wheel,” said Nick Donkar, PricewaterhouseCoopers’ health services deals leader. “This strategy enables a win-win solution in short order.”

Provider-payer partnerships will likely continue into the future to help both entities fill gaps as they think about improving care in a virtual environment, he said.

Photo: Gerasimov174, Getty Images

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Gaining insights into social factors affecting patients’ lives can be used to augment healthcare delivery in a big way.

That’s according to Dr. Courtney Lyles, an associate professor at the University of California San Francisco, who helped create an expansive social determinants of health-focused data visualization platform. She discussed the platform and its development at the Workgroup for Electronic Data Interchange’s The Quest for Health Equity virtual conference on Feb. 23.

The platform, UCSF Health Atlas, was released last April. Focused on California-based data, it is designed to enable researchers to explore neighborhood-level characteristics and see how they relate to health outcomes. It also includes data on Covid-19.

“It’s pretty clear, and Covid has made it even more clear, that health is really impacted by place,” said Lyles, who is also co-principal investigator of the UCSF Population Health Data Initiative. “Where we live, including our physical and social environment, directly influences health outcomes.”

The interactive platform includes more than 150 social determinates of health variables at different levels of granularity down to the census tract level, which includes between 1,200 and 8,000 people. The platform draws from several sources including the American Community Survey from the Census Bureau, CalEnviroScreen developed by the California Environmental Protection Agency and the California Department of Public Health.

But one of the main challenges of developing a platform like this is deciding what publicly available data to include from the massive trove that is available, said Lyles.

To create Health Atlas, UCSF relied heavily on the Health People 2020 framework created by the Office of Disease Prevention and Health Promotion. This framework helped the UCSF team think through five domains of social factors, said Lyles. These domains were:

  • Demographic characteristics
  • Socioeconomic factors
  • Community characteristics
  • Neighborhood characteristics
  • Health and healthcare indicators

The UCSF team then went in and selected useful variables within each of the five domains. For example, within the community domain, the team selected individual variables like language and foreign-born status as well as wider variables like population density and household composition — that is, people living in households with children versus single-adult households versus seniors living alone.

“Thinking about those variables has really been interesting,” said Lyles. “[It allowed us to] think through what matters for population health and health equity risk.”

Combining all this data on an interactive map enables researchers and clinicians to drill down into granular data on any one variable, and also compare different variables, she said.

UCSF has gone a step further and made it possible to link that social determinants of health data with its EHR data. For example, UCSF combined the two to gain insights into racial disparities in hypertension outcomes. Eliminating this disparity was a pre-Covid goal for the health system, Lyles said.

First, the team extracted every single address that existed within UCSF’s EHR, and then they geo-coded those addresses onto latitude and longitude. They assigned census tract identifiers to those geo-coded addresses so that they could be linked out to the publicly available datasets. Finally, they gathered clinical and demographic data for patients with hypertension receiving care within the system.

By combining all this the system was able to track hypertension patients by race, neighborhood and socioeconomic status in San Francisco on the map and compare these variables with health outcomes, Lyles said. They found that Black patients are concentrated in certain neighborhoods, and they’re struggling with hypertension control.

“This is not showing us something that perhaps we didn’t know already about structural disparities in care or structural disparities in our society,” Lyles said.

But it does show the urgent need for including place-based strategies in health systems’ disparity reduction and quality improvement programs.

“When you put it out there in a visual display, it actually gives you even more impetus to think about neighborhoods you want to target, or [places where] you might think differently about your interventions moving forward,” she said.

Photo: GarryKillian, Getty Images

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AppliedVR’s program includes a feature for users to go through guided breathing exercises, which are visualized in a 3-D nature scene. Photo credit: AppliedVR

For the past six years, AppliedVR has been distributing VR headsets to hospitals to see if it could help reduce pain and anxiety during what for many patients can be a stressful experience. Now, the digital health startup is testing its platform to see if it can have a similar effect in a home setting.

The Los Angeles-based company shared the results of a pivotal trial showing its VR program was effective in helping people manage chronic lower back pain at home. The results of the randomized controlled trial, published Wednesday in the Journal of Medical Internet Research, showed that users reported a 42% reduction in pain intensity, though the study had certain limitations.

“We were ecstatic with the results we got,” CEO Matthew Stoudt said in a phone interview, adding that he plans to make a submission to the Food and Drug Administration this year.

“Our long-term vision has always been, how do we bring this into the home?” he added. “Ultimately, we are a doctor-prescribed payer-reimbursed model. We’re focused on building a body of evidence.”

Last year, AppliedVR got Breakthrough Device designation from the FDA after publishing results showing early successes in using its program to help people manage fibromyalgia and lower back pain at home. The designation could help accelerate the company’s pathway through the FDA and, thanks to a recent regulatory change, could even lead to a short path to Medicare coverage.

The most recent study tested whether the digital program was effective in reducing lower-back pain for people that went through an eight-week program. Unlike some other virtual programs, it’s focused less on physical therapy exercises and more on cognitive-behavioral therapy for pain management.

Called EaseVRx, the self-guided course walks users through pain education and guided breathing exercises with a nature scene that responds to their breathing. For example, wind blowing in the background might calm as a user slows their breath.

“We’re trying to help people acquire key pain management skills, and the way we can enhance learning and encoding of information is to provide rapid biofeedback in an immersive environment,” said Beth Darnall, AppliedVR’s chief science advisor, who co-authored the study.

Separating immersion from intervention
The double-blind study was also designed to answer questions from the FDA on how much of the therapeutic effect was from merely wearing a headset versus interacting with AppliedVR’s program. To test this, the company created a “sham” VR program that consisted of 2-D nature scenes, designed to hold users’ attention but without a specific therapeutic effect.

While the intervention group reported their average pain intensity decreased from 5.1 to 2.9 after eight weeks, the control group saw a more modest decrease, from 5.2 to 4.

“It’s exciting that we substantially exceeded the effect of the sham,” she said.

Participants that used EaseVRx also reported reductions in pain interfering with their activity, sleep, mood and stress levels.

Study limitations
That said, the study still had some significant limitations. An important one: The vast majority of the 179 adults who participated were white, female and college-educated, representing a narrow demographic.

Since the study was not linked to medical care, all data were self-reported, other than participants’ use of the VR headset. Because of this, “…there was no ability to confirm pain diagnoses or analgesic prescription information,” according to the paper.

About 90% of users stuck with the program, which Stoudt attributed to years of work to make the headset easier to use.

In addition to seeking FDA clearance, AppliedVR plans to build a system into the headset that would capture users’ breathing rate, so that no other devices need to be connected for them to receive feedback while going through the program.

“We have a ton of scars on our back from a lot of things we’ve done wrong in terms of sending devices into the home,” he said. “Ease of use is going to be the biggest barrier to ultimate adoption.”

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Vial and syringe with a vaccine

Clover Biopharmaceuticals, a clinical-stage firm developing a Covid-19 vaccine with potential manufacturing and distribution advantages over other vaccine technologies, has raised $230 million as it prepares to advance its lead candidate into pivotal testing.

Chengdu, China-based Clover said Tuesday that it expects to start a global Phase 2/3 clinical trial for its vaccine candidate, SCB-2019, in the first half of this year. The company added that it has already started planning for the production of potentially hundreds of millions of vaccine doses.

The Clover Covid-19 vaccine is protein-based. SARS-CoV-2, the virus that causes Covid-19 infection, is an enveloped RNA virus—the outer coating is dotted with spike proteins that bind to a receptor on the host cell. These spikes are trimeric, meaning they’re formed by three proteins.

Using its Trimer-Tag technology, Clover developed a trimeric spike protein that resembles the one found on the outer envelope of the novel coronavirus. The vaccine uses an adjuvant, an ingredient that boosts immune response, supplied by Dynavax Technologies.

As a protein-based vaccine similar to many of the vaccines developed for influenza, shingles, and hepatitis B, Clover said production can use manufacturing processes that are already well established. The company added that this production can be rapidly scaled up to large quantities.

Another advantage of the Clover vaccines are the temperature requirements. The company said its vaccines and adjuvant should be stable for long periods at refrigerator temperatures of 2 to 8 degrees Celsius. At room temperature, Clover has said its vaccines are stable for at least two months. Those temperature and storage requirements stand in contrast to messenger RNA vaccines, which must be distributed frozen and stored at temperatures well below what medical-grade freezers can achieve. Last week, Pfizer and BioNTech asked the FDA to approve a change in the storage temperatures permitted once vaccines reach a vaccination site.

The new financing follows publication in The Lancet earlier this month of peer-reviewed results from an early-stage test of two Clover Covid-19 vaccine candidates. The 150-patient study showed that the vaccines were well tolerated and safe. Both vaccines also induced neutralizing antibodies at levels comparable to or higher than those found in the blood of those who have recovered from Covid-19.

Clover said that its research includes vaccines that could address multiple variants of the novel coronavirus. In addition to supporting its Covid-19 vaccines, Clover said the new capital will support plans to advance multiple programs into human testing later this year. Other vaccines in the Clover pipeline include programs for rabies and influenza. The company also said it plans to expand its manufacturing and capabilities.

GL Ventures and Temasek both led the Series C financing. Oceeanpine Capital, OrbiMed, and Delos Capital also invested. Clover said it has raised more than $400 million in the past year.

Clover also has financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed to finance development of the company’s Covid-19 vaccine candidate up through licensure with a total investment of $328 million. Some of that cash will fund the global Phase 2/3 study. If the Clover vaccine is shown to be safe and effective, it would be distributed through Covid-19 Vaccines Global Access, or COVAX, the World Health Organization’s initiative to ensure equitable vaccine access throughout the world.

Public domain photo by Flickr user Alachua County

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As 2021 dawned and vaccine distribution has picked up, many people had one overarching question on their minds: how and when will they get vaccinated.

At the same time, providers have had to grapple with another question:  how to best approach for this historic, monumental task.

For Stamford Health in Connecticut, the way forward was clear: Leverage existing partnerships with the city of Stamford, community organizations and the state to distribute the much-anticipated vaccines.

The health system has been sharing data and information with the city of Stamford throughout the pandemic, including positivity rates, hospitalizations and other key metrics, said Kathleen Silard, CEO of Stamford Health, in a phone interview. Stamford Health and the city worked collaboratively to set up testing sites, and in the last few months, they also worked together to set up vaccination sites — including one at an old hospital on Stamford Health’s campus.

“The collaboration [with the city] really is to pool our resources, because we know, together we are better,” Silard said.

The health system began vaccinating healthcare workers, first responders and other eligible essential workers on Dec. 17, when the state was in Phase 1a of its vaccine rollout. Back on Jan. 18, it began vaccinating people older than 75 and recently added those older than 65 to the list, as part of Phase 1b of the rollout.

So far, the health system has administered around 27,000 vaccines, and is averaging between 750 and 930 doses a day, Silard said. But Stamford Health has ambitious plans to increase this number three-fold.

The health system is planning to open a new, much larger, site around March 1, which will enable the provider to administer up to 3,000 doses a day, she said.

But getting shots in people’s arms is not without its challenges.

Vaccine availability has been one of the biggest hurdles the health system has faced, but working closely with Connecticut Gov. Ned Lamont and his team has helped the system get the doses and resources it needs, Silard said.

Aside from uncertainty with vaccine availability that has since receded into the background, Stamford Health is tackling a more intractable problem: vaccine hesitancy and health inequity. Both present a formidable barrier to its 3,000-a-day vaccination goal.

To help combat vaccine hesitancy, Stamford Health is conducting outreach programs, including setting up panels with people who have already received the vaccine to talk about their experience, Silard said. The system is also participating in Stamford Mayor David Martin’s weekly Zoom calls to further educate the public on the vaccine.

The Covid-19 pandemic shone a harsh light on existing health disparities in the country, with people in minority racial groups and low-income populations most likely to get the disease and die from it.

Stamford Health has put together a task force, which includes health system members, city officials and members of community health organization Vita, to ensure that vaccines are being administered in an equitable manner, said Silard.

In addition, the health system is partnering closely with the National Association for the Advancement of Colored People and Building One Community, an organization that works with the undocumented community, to focus vaccine administration efforts on underserved populations.

Building One Community has developed a great deal of trust with a population that is typically hesitant to use healthcare services, said Dr. Anka Badurina, executive director of the organization, in a phone interview.

Through the pandemic, the organization has been working to ensure immigrant and underserved communities are included in response efforts — from testing to, now, vaccination.

One of its main areas of focus has been helping the elderly in these communities get registered for vaccine appointments, Badurina said. Those currently eligible often don’t have access to the internet or an email address, which is typically required for registration. Building One Community, which has interpreters on hand, helps them with the process.

Further, the organization helps organize transport to vaccination sites.

“Stamford Health partners with organizations like Building One Community [because] you have to go to those that have a trusted voice in the community,” Badurina said. “They are the ones that know where the community is and know exactly what the community is lacking.”

With the help of its community partners Stamford Health has established a “No Barriers” day, where members from minority groups and under-resourced communities can come to a vaccination site without an appointment, get registered and get vaccinated, Silard said. No individuals are asked about their immigration status or other questions that might keep people from coming to get vaccinated.

Stamford Health wants to eliminate any traditional barriers to vaccination to ensure that the largest swath of eligible individuals can get vaccinated, Silard said.

“We see [vaccine administration] as our moral, ethical responsibility to help fight this deadly disease,” she said.

Photo: LarisaBozhikova, Getty Images

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The Covid-19 pandemic has affected every sector of our society and requires coordinating a broad coalition of assets to contain it. The response includes multiple federal and state government agencies, thousands of hospitals, and a broad swath of commercial manufacturing capabilities and supply chains. We saw this coordination and collaboration early on with personal protective equipment and ventilators, and we see it again as we ramp up vaccine distribution.

To coordinate an effective response, it is critical to integrate disparate data types from multiple domains and sources, something that has been a long-standing challenge in health care. Obstacles include government agency budget structures that don’t incentivize data sharing and legacy databases that create barriers to data integration. The commercial sector also brings the challenges of competition and proprietary systems. Even seemingly simple questions, such as how many ICU beds are available in a community, are maddeningly difficult to answer in near real time. While well-branded and user-friendly websites provide impressive updates on case counts, emergency operation centers have found it challenging to integrate that data with bed availability, hospitalization projections, work force data, supply chain data, mitigation interventions, social determinants of health, and other key data elements that allow for effective planning and response.

In addition to the public health challenges, new care delivery models have underscored the need to better integrate data to deliver care for chronic diseases. The pandemic has accelerated the adoption and use of telehealth. But again, tools, sensors, apps, and devices are often deployed on disparate data platforms that make it cumbersome for patients and providers to integrate data in a meaningful fashion.

The pandemic illustrates the need for better data integration to improve management of this crises as it continues to impede the everyday care of patients.

Lessons learned from defense and intelligence communities
The health industry lags behind other commercial sectors in its adoption of data management and open-source innovations. The health community can learn a great deal about data management from defense and intelligence agencies, which must integrate vast amounts of data from disparate systems to create a common operating picture to support life and death decisions for warfighters.

The 9/11 attacks demonstrated that data gaps can be deadly. The 9/11 Commission Report revealed that information that could have prevented this tragedy was scattered across several different intelligence agencies’ databases. Following the Commission’s critique, the intelligence agencies adopted low schema data “lakes” that could accommodate multiple “streams and rivers” of disparate data and allow for easier integration. Think of these data systems as giant spreadsheets, with each cell containing an entry item. With automated meta-tagging, each cell of information can be correlated with any other item of data to reveal patterns that would otherwise have gone undetected. These data platforms also enabled the accumulation of massive data stores that optimize advanced analytics and artificial intelligence. Intelligence agencies also benefited from security protections at the individual cell level that enhanced data security, an important feature to consider as health information increasingly comes under cyberattack.

The intelligence community also embraced open source tools and open architectures for these data systems. Open source allows the rapid development of new tools at lower cost. Open architectures avoid costly and stagnating vendor lock, and it enables the adoption of new best-in-class tools and capabilities as they are often developed by small niche firms and start-ups

While novel 15 years ago, many of these innovations have been avidly adopted in the commercial sector. However, the same cannot be said for the health domain. That said, there are notable exceptions that are bright spots on the health care landscape.

Advana: Uniting disparate systems and users on a common platform
Advana, a Department of Defense (DoD) data platform, pulls together more than 200 business systems across the DoD and makes data discoverable, understandable, accessible, and usable for advanced analytics for more than 17,000 users across the Army, Navy, and Air Force who need to make decisions about mission readiness, contracts, supply chain logistics and more. The platform has helped the DoD coordinate its Covid-19 response by enabling the easy integration of a wide range of data, including case, bed, supply chain, readiness, and financial data, to inform critical health care decisions. The open architecture platform supports multiple projection models and analytic tools, which allows the DoD to validate findings in a way that would not have been feasible with a single approach.

Advana faced many of the data integration obstacles familiar to health care IT leaders: non-standard interfaces, duplicate data and systems, legacy technologies, and a history of different units pulling their own data for decision making. To integrate disparate data from spreadsheets, application programming interface (APIs), database dumps, and data warehouses from across the enterprise, Advana streams data feeds, automatically categorizing, tagging, and transforming them into a common data model to improve enterprise level analytics.

Preparing for the next health crisis
The value of big data in health care is clear but unless we can integrate and correlate disparate types of data, we can’t realize the benefits. The data challenges of the Covid-19 response illustrate this issue. The seams between government agencies, health systems, and departments within the same organization create chronic barriers to data sharing. Few organizations manage more data than the defense and intelligence agencies, and as with health care, their decisions often have life and death consequences. For critical decisions, they have developed effective strategies to create a common operating picture through robust data integration. As we continue to respond to this pandemic and prepare for the next crisis, the health care community should learn from these mission critical organizations.

Editor’s Note – The author is a Department of Defense consultant.

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