AstraZeneca Sees $4B In COVID-19 Vaccine Sales

AstraZeneca recorded a big jump in revenue on Thursday as it begins to take a profit from its coronavirus vaccine for the first time.

The company recorded full-year revenues of $37.4 billion, an increase of 38% from the year before at constant exchange rates. Part of the boost came from $4 billion in sales of its COVID-19 vaccine, developed with the University of Oxford.

Despite rising revenue, AstraZeneca reported a pre-tax loss of $265 million due to costs from its purchase of U.S. drug company Alexion Pharmaceuticals and new drug research.

The Anglo-Swedish drugmaker said in November it would begin to take a “modest” profit from the COVID-19 shot, which it had been providing “at cost” — around $2 to $3 —following an agreement with Oxford. Other COVID-19 vaccine producers, such as Pfizer and Moderna, have been booking hefty profits on their shots all along.

Dr Tamara Joffe administer a dose of the AstraZeneca COVID-19 vaccine to Mustafa Field of the Faiths Forum, during a pilot project of pop up vaccination drive called Vaxi Taxi in Kilburn, London, Sunday, Feb. 28, 2021.  (AP Photo/Alastair Grant)

In the three months to September, the company said revenue jumped by about 50%, to a record $9.9 billion. The increase was due to sales of more than $1 billion in COVID-19 vaccines and the inclusion for the first time of some $1.3 billion worth of revenue from its rare disease business unit following the recent acquisition of Alexion.

Ticker Security Last Change Change %
AZN ASTRAZENECA PLC 59.24 +2.04 +3.58%

AstraZeneca forecast total group sales to rise by a “high teens percentage” in 2022, but said COVID-19 revenues would decline by a “a low-to-mid twenties percentage.”

Chief executive Pascal Soriot said AstraZeneca had “delivered on our promise of broad and equitable access to our COVID-19 vaccine with 2.5 billion doses released for supply around the world.”

“AstraZeneca continued on its strong growth trajectory in 2021, with industry-leading R&D (research and development) productivity, five of our medicines crossing new blockbuster thresholds, and the acquisition and integration of Alexion,” he said.

Soriot said the company would raise the dividend to shareholders by 10 cents to $2.90, the first increase in a decade.

AstraZeneca shares were trading about 3% higher at 8.62 pounds ($11.68) on the London Stock Exchange on Thursday morning.

Source: AstraZeneca sees $4B in COVID-19 vaccine sales | Fox Business

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Critics:

AstraZeneca (AZN.L) said it would begin to earn a modest profit from its coronavirus vaccine as the world learns to live with the virus and the drugmaker is in talks with several countries about new orders for delivery next year.

AstraZeneca made a commitment to sell the shot developed with Oxford University at cost during the pandemic and in a press conference on Friday said low-income nations would continue to receive the vaccine on a no-profit basis, while a post-pandemic commercial approach would apply to other new orders even as infections in Europe rise again. read more

The Anglo-Swedish company’s third-quarter results showed the vaccine contributed one cent to core earnings per share of $1.08, a rise of 14%. Total product sales jumped 49% to $9.74 billion, as its vaccine sales topped $1 billion.

“We started this project to help … but we also said that at some stage in the future, we will transition to commercial orders,” Chief Executive Pascal Soriot told journalists.”It will never be high priced. Because we want the vaccine to remain affordable to everybody around the world,” he added.

Soriot, a French national, said the virus was becoming endemic, a term for a background level of infections that is part of everyday life.Talks about new orders with undisclosed countries were underway, mainly for delivery next year, with some prospective customers focusing on booster shots, Soriot said.

AstraZeneca unveiled plans this week to set up a separate unit to focus on its coronavirus efforts and other respiratory infections. It said on Friday the unit would independently manage production and distribution. read more

Shares of the FTSE 100 (.FTSE) drugmaker were down 3.4% at about 91.22 pounds at 1209 GMT as overall third-quarter profit fell short of analysts’ expectations.

There were strong performances of core products like kidney disease treatment Farxiga and established asthma drug Symbicort, and from the addition of rare-disease specialist Alexion from July 21, thanks to last year’s $39 billion takeover deal.

However, integration costs related to that deal ate into profits, as did a $1.2 billion writedown for an experimental kidney disease drug AstraZeneca acquired in 2012, with overall expenses also rising on investments into the drug pipeline.

Top selling drug Tagrisso for lung cancer also posted lower-than-expected growth in sales due to price cuts in China. AstraZeneca said a profit boost from the vaccine in the fourth quarter would make up for costs related to its antibody cocktail for preventing and treating COVID-19, as it stuck with its earnings forecast for the year.

Related contents:

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AstraZeneca’s COVID-19 vaccine gets the green light in the UK”. biopharma-reporter.com. Retrieved 30 December 2020.

“Registered office and corporate headquarters”. AstraZeneca. Retrieved 27 February 2020.

“A history of AstraZeneca”. pharmaphorum.com. 18 September 2020. Retrieved 31 March 2021.

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 AstraZeneca to ax 1,600, relocate thousands in global R&D reshuffle”. fiercebiotech.com. FierceBiotech.

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“Our History – AstraZeneca Careers”. AstraZeneca Careers.

“AstraZeneca Selects Wilmington, Del. for New US Headquarters”.

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AstraZeneca buys biotech company for £120m The Telegraph, 23 December 2005

AstraZeneca and Astex ally for anticancer agents Business Intelligence, 1 July 2005

“Pennsylvania Bio – Member Listings”. Pennsylvania Bio web site. Archived from the original on 14 December 2005. Retrieved 8 October 2005.

AstraZeneca agrees to buy Arrow Therapeutics for US$150M Marketwatch, 1 February 2007

AstraZeneca seeks a remedy for its patent pain The Telegraph, 21 April 2012

“AstraZeneca to pay $15.2B to purchase rival MedImmune; Deal sees London-based drugmaker take on debt for the first time in order to fill product line”. Bloomberg.

AstraZeneca Buys MedImmune for US$ 15.6 Billion The New York Times, 24 April 2007

“AstraZeneca To Acquire Infection Research Company Novexel And Expand Collaboration With Forest Laboratories”. 23 December 2009. Retrieved 20 February 2015.

“Novexel to be Acquired by AstraZeneca”. Retrieved 20 February 2015.

AstraZeneca to buy Chinese generics firm Healthcare News, 8 December 2011

AstraZeneca and Amgen collaborate on treatments for inflammatory diseases Medcity News, 4 February 2012

AstraZeneca Reaches $1.26 Billion Deal for Ardea Biosciences The New York Times, 23 April 2012

Peacock, Louisa (30 June 2012). “AstraZeneca to pay £2.2bn towards ‘joint venture’ diabetes deal”. The Daily Telegraph. London. Archived from the original on 4 August 2012. Retrieved 1 July 2012.

How Connected Life Sciences Devices Lead To Continuous Care

With connected medical devices, apps and data, life sciences organizations can bridge long-standing gaps in healthcare and deliver a more continuous care experience, says Brian Williams, Cognizant’s Chief Digital Officer for Life Sciences.

Global health systems have traditionally delivered services episodically, by focusing on acute, critical care rather than individual health and well-being. It should come as no surprise, then, that life sciences companies often deliver their solutions following that same model of care.

Sadly, this leads to gaps in data and service alignment, not to mention significant disconnects with the broader healthcare ecosystem. Consumer devices and wellness apps, for example, often exist within their own individual siloes — causing organizations to miss out on valuable data that could inform patient diagnosis, management and treatment.

This lack of orchestration produces sub-optimal outcomes at significant expense to providers, payers and patients alike. It is also at direct odds with patients’ increasing digital expectations when using medical devices and when taking drugs and therapies. Whether they are participating in a clinical trial, living with a chronic condition or recovering from a procedure, patients expect to be informed and cared for with seamless digital experiences on par with what they receive when shopping or banking online.

However, the emergence of integrated, connected devices, apps and data has opened new possibilities for treatments and clinical trials. This new level of connectivity helps bridge a longstanding gap in wellness: the disconnect between an individual’s everyday health behavior and their episodic healthcare. These experiences generate valuable data insights, creating new commercial opportunities and the promise of better patient outcomes.

The impact of life sciences connectivity

Drawing from our recent series on healthcare IoT, here are three stakeholder groups within the healthcare and life sciences ecosystem that stand to benefit greatly from this new level of connectivity and the more continuous, predictive and preventive care it enables.

  • Patients with chronic conditions. Chronic diseases are often accompanied by additional conditions, such as depression, that can impede effective treatment. Consequently, information about an individual’s behavioral health status has become increasingly important in treatment decisions, as has information about the individual’s relationships with the people around them.
  • Wearable IoT devices that monitor fitness and health conditions can pair with an ever-growing set of apps for health, wellness and nutrition monitoring. Over time, a baseline of physiological indicators such as an individual’s heart rate and blood pressure, as well as activity, diet and sleep patterns, will develop. When additional data from clinical encounters, including diagnostic imaging, lab tests, genomics, stress tests and physician notes, is integrated with that baseline, it increases the ability to predict how an individual may respond to any particular treatment.
  • Elderly patients. Quite often, the most effective tools for early detection of a developing condition in elderly patients are not implants or biometric monitors, but devices that monitor changes in activities of daily living (ADL).
  • For example, the onset of congestive heart failure can be detected through reduced use of the bed, as patients with trouble breathing when lying down switch to sleeping semi-upright in a recliner. Changes in toilet flushes, meanwhile, can detect a urinary tract infection or incipient dehydration. Moreover, while one in four Americans over 65 falls each year, only half tell their doctor.
  • Passive infrared motion detectors, pressure sensors in beds and chairs, sensors for CO2 concentration, sound (vibration) and video — anonymized as necessary for privacy — can all be used to first establish a baseline of normal variability, and then be applied to detect significant deviations from that baseline. This continuous and nearly invisible sensing can be surprisingly effective in assisting in care.
  • Hospital clinicians and support staff. Healthcare is increasingly a team enterprise — including not only physicians, nurses, allied health staff and technicians but also AI-enabled equipment. The point of care is also expanding, with shortened hospital stays and more care delivered in outpatient facilities and in-home settings.
  • Connected sensors enable every member of the team to access to real-time data relevant to their task. Smart hospitals with a real-time health system (RTHS) can leverage sensors to collect data widely, distill and analyze it — and then quickly distribute curated findings to users. When captured remotely, this eases the transition in care from the hospital to other settings, allowing a more continuous and participatory level of care that extends long past a patient’s physical stay in a healthcare facility.
  • An RTHS can improve operations, clinical tasks and patient experience. For example, providers that boost operational effectiveness typically rely on a wide range of IoT-enabled asset management solutions that locate mobile assets, monitor equipment operating conditions and track inventories of consumables, pharmaceuticals and medical devices. This optimizes equipment utilization, reduces waste, increases equipment uptime and ensures optimal inventories.
  • Once clinicians and support staff can view how long various steps take in their workflows, where delays occur and what patients experience as a result, they can then evolve solutions based on a combination of their intimate day-to-day knowledge and data on how that workflow interacts with or is used by other functions.

From episodic to continuous care

Too often, the life sciences industry has delivered a one-size-fits-all approach to clinical trials and patient care that may not represent real-life, individual situations — situations that require tailored engagement that wrap therapies and interventions in end-to-end, digital solutions.

This can and should change. Device connectivity and access to data are impacting every aspect of healthcare and life sciences, moving the industry away from acute, episodic care, to a system that is more participatory and predictive.

For example, a patient may be walking a mere 24 hours after a typical hip surgery and could be discharged from the hospital a day or two after the procedure. However, that episodic care experience belies a much longer recovery and rehabilitation period spanning weeks or months.While that care experience today takes place largely outside the purview of the orthopedic surgeon, better device connectivity can enable patient monitoring — and even patient services — to be extended well beyond the length of the initial hospital visit.

Rather than relying on spotty reporting from physical therapists or the patients themselves, an orthopedist can continuously and seamlessly track a patient’s progress, and then decide when and how to intervene if things aren’t going as expected. Zimmer’s mymobility application, which supports patient engagement and monitoring outside the hospital following surgery, is a good example of what this looks like in practice.

A fully orchestrated ecosystem

Sensors and instrumentation — and the hundreds of APIs that connect them — can provide accurate and timely data about many parameters of the human condition. When this is all properly orchestrated, we can better understand how diseases progress and how bodies respond to various interventions.

That’s the intent behind our alliance with Philips and its HealthSuite Digital Platform, which is built on AWS and designed to simplify and standardize device connectivity, data access, identity management, and structured and unstructured data management within a high-trust, HIPAA and GDPR-compliant environment.

We believe that life sciences companies can derive true value from this influx of new data. Not only can the resulting insights inform new services, drugs and therapies and inspire new models of continuous engagement; they can also improve adherence to treatment and patient health.

To learn more, visit the Life Sciences section of our website.

Brian is Cognizant’s Chief Digital Officer for Life Sciences and is responsible for designing digitally enabled solutions to facilitate care access and delivery. He is also the Global Life Sciences Consulting

Source: How Connected Life Sciences Devices Lead To Continuous Care

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Related Contents:

M. Birkholz; A. Mai; C. Wenger; C. Meliani; R. Scholz (2016). “Technology modules from micro- and nano-electronics for the life sciences”. WIREs Nanomed. Nanobiotech. 8 (3): 355–377. doi:10.1002/wnan.1367. PMID 26391194

“What is Biomonitoring?” (PDF). American Chemistry Council. Archived from the origin(2005-04-08). Natural Fibers, Biopolymers, and Biocomposites. CRC Press. ISBN 978-0-203-50820-6.

National Human Genome Research Institute (2010-11-08). “FAQ About Genetic and Genomic Science”

Scientists Must Speak Out Against Misinformation About Immune Boosting Supplements

The COVID-19 pandemic saw huge increases in searches for immunity boosters, including for things like supplements claiming to improve immune function. But even before COVID-19 scared people into their nearest supermarket aisle, “wellness” through supplements was a multi-billion dollar industry.

Celebrities and influencers across social media platforms regularly advertise and promote a myriad of supplements to improve health and the immune system. However, there are some major problems with these claims — namely, vitamin companies are not regulated by the Food and Drug Administration (FDA) as drugs, and many supplements don’t work as claimed.

Unlike pharmaceuticals, which must undergo clinical trials that are reviewed by the FDA for the product’s safety and efficacy, dietary supplements have a less stringent path to market shelves. Even though they are most often found in or next to the store pharmacy, dietary supplements are regulated as food, not as drugs. This means that they have not been evaluated or proven effective.

Furthermore, while the manufacturer must prove the ingredients are “reasonably safe”, none of these products are formally “approved” by the FDA. But these supplements are not always inherently harmless options for people trying to live a healthy lifestyle. A 2015 study concluded adverse effects from dietary supplements caused an “estimated 23,000 emergency department visits in the United States every year.”misperception

Despite these risks, there has been an unfortunate absence of expert voices contesting supplement company claims with real data. “There needs to be a more robust response from the science community in the face of pseudoscience and misinformation,” says Tim Caulfield, a professor of health law at the University of Alberta, who has worked on studies and books examining ads and posts claiming to support the immune system on social media.

He explains that supplement marketing often builds on the common misperception that if the right amount of a vitamin is good for you, more is better. “That’s not the case at all,” he says. On the topic of supplement misinformation, Pieter Cohen, an associate professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance, says, “The main problem is that the law permits companies to promote supplements as if they have important benefits for health even if there has never been a single study in humans to study the product’s efficacy or safety.”

Indeed, dietary supplements are not required to be reviewed by the FDA before they are distributed because they are not considered medications. Vitamins say right on the bottle that their claims “have not been reviewed by the FDA.” Instead, they are predominantly regulated by the Federal Trade Commission, or FTC, which monitors the claims the labels make; however, this is limited to ensuring that the supplement makers are not explicitly claiming the product can be used as a treatment.

The FTC does allow companies to suggest a range of benefits their products provide, which may be why up to 70 percent of adults in the United States take at least one dietary supplement daily, with the most common reason being to try to maintain or improve their health. While some individuals with specific vitamin deficiencies may benefit from these products (under a doctor’s supervision), most of us do not. However, those marketed as “immune boosters” or “immune boosting” are more problematic.

Despite suggestive labels, there is no way to “boost” the immune system. The immune system is a complicated and dynamic network of cells, proteins, hormones, and other biological components. Even if it were possible to ratchet up such a complex system, you wouldn’t necessarily want to, because the immune system operates primarily by inducing inflammation. This alerts various immune cells to mobilize and fend off danger.

In moderation, this is perfectly healthy, and the system has a braking mechanism all its own. But if a product were to truly “boost” the immune system, this mechanism would be amplified. We know what too much inflammation looks like: autoimmune disorders, inflammatory disease, and allergies.

Ironically, in some cases, products heralded to improve immune function can actually suppress it. Take vitamin D, touted for its ability to enhance “immunity.” While it may increase the inflammatory response, it has been shown to actually reduce the activity of other cell types—namely T cells, which are critical in forming long-term memory. The same is true of many other popular supplements, such as zinc, when a person takes substantially more than the recommended daily amount.

Supplements can be actively harmful in other ways too. Since supplements aren’t regulated by the FDA, they aren’t evaluated for safety in the same way as pharmaceuticals. Of course, the manufacturers cannot knowingly use or include compounds that are known health hazards — legislation from 1994 dictates that ingredients used in supplement products must not have been shown to cause harm.

But that doesn’t mean these products aren’t without yet unrecognized risks. “I think one of the biggest things that gets overlooked is the potential for a drug-drug interaction,” says Dr. Kathryn Nelson, a medicinal chemist at University of Minnesota. Physicians need patients to disclose what supplements they are using, including multivitamins, because they might interact with prescribed medications.

From inactivating a pharmaceutical prescription, to dangerously exacerbating its effects, these products can have significant consequences. Yet many patients do not disclose or discuss their supplement use with their healthcare providers, due to their misguided perception that vitamins are safe or not worth mentioning.

Additionally, the active ingredient in vitamins must be either be purified from a natural source or synthesized in a lab, and both methods have the potential for carry-over from compounds used in these methods. Such contamination is called “residual complexity,” Nelson says.

This is particularly concerning when heavy metals are used and possibly present in the final product. In pharmaceutical drugs, these compounds would usually go to clinical trials, and any potential introductions of heavy metals removed in what’s called “process chemistry” to gain FDA approval. But the purification process of supplements are not reviewed by the FDA. This has opened the door for potential contaminants-heavy metals as well as other drugs and even pathogens-into these products.

Given all of this negative and even contradictory information about these products, why is the supplement market a multi-billion dollar industry? Much of the answer lies in its advertising. Companies often collaborate with social media influencers, who talk up how great the product is. And despite thousands of scientists across the country with expertise in nutrition and immunology, experts rarely publicly contradict these statements.

Science communication is an important part in the scientific process. However, more often than not, important conversations happen only with other scientists at scientific conferences, or in journals behind paywalls. As a result, the larger non-expert community is left in the dark. Daniel Pham, the associate director of the Milken Institute’s Center for Strategic Philanthropy, wrote an essay in 2016 which detailed the lack of support for science outreach by scientists, and an absence of communication training.

Almost five years later, he says, “The same issues have resonated with me even more in the times of COVID. I feel like there’s a bigger sense of the need for improved communication of science to the public. But the tools we’re using are just woefully inadequate.” The evidence of his statement can be seen in a recent study by Arizona State University, which showed the majority of scientists believe that it is important to inform and engage the general public about science topics.

However, when asked about their personal interest or intentions of doing this, the answers are less enthusiastic. Often scientists are not encouraged or even rewarded for public outreach, which doesn’t aid securing funding, publishing, or gaining tenure. One possible solution might be to reform the funding and promotion institutions so they reward researchers for this kind of public service.

However, scientists should also not anticipate their feedback will be immediately accepted based on their resumes. As Nelson points out, the first step in improving the public’s access to verified information is building trust with experts. That includes breaking down the stigmas surrounding what it means to be a scientist, and making expertise more accessible.

A recent example is the initiative Science on Tap, where a scientist describes their research in general terms to patrons at a local bar or venue. Pham has also started a similar effort at Johns Hopkins University, called Project Bridge, bringing small, introductory science demonstrations to public spaces such as farmer’s markets. Specific tactics to counter supplement marketers could also include partnering with influencers who are willing to share verified research, as well as lobbying for legislative reform.

The supplement industry is a prime example of the dangers of misinformation, which is damaging to both science and the public at large. Cohen notes that the next steps are to urge the FDA and FTC to enforce existing laws prohibiting the promotion of products with disease claims, in an attempt to get them off the shelves. In the long-term, he notes the existing law on these products needs to be reformed so that “all products [are] registered with the FDA.”

Scientists and researchers have the expertise to get information to the public and enact policy change. But it will require getting creative. “A lot of the misinformation really has become a social media story,” Tim Caulfield says, “so we need to go to where the misinformation resides.” Scientists, he adds, “need to find their own voice.

By Shelby Bradford

Source: Scientists must speak out against misinformation about “immune-boosting” supplements | Salon.com

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Related Contents:

Dietary Supplement Label Database

Regimens of vitamin D supplementation for women during pregnancy

Dietary Supplements Market Size & Trends Report

The genetics of vitamin C loss in vertebrates

Dietary Reference Intakes (DRIs): Recommended Intakes for Individuals

Selenium and a Reduced Risk of Site-specific Cancers

Effects of whey protein supplement in the elderly submitted to resistance training

Dairy Intake Enhances Body Weight and Composition Changes during Energy

Calcium supplementation commencing before or early in pregnancy

Immunomodulatory Functions of Nutritional Ingredients in Health and Disease

Molecular nutritional immunology and cancer

Role of “Western Diet” in Inflammatory Autoimmune Diseases

Nutrition and fasting mimicking diets in the prevention and treatment of autoimmune diseases and immunosenescence

Supplement Industry Contributes $122 Billion To U.S. Economy

Some protein powders fail fitness test

Meal Replacements  Convenience or Compromise

Impact of Medicaid Expansion on Cardiac Surgery Volume and Outcomes

Liver injury from herbal and dietary supplements

Herbal Supplements Post Strongest Sales Growth in Two Decades

Probiotics for the prevention of pediatric antibiotic-associated

Billionaire Eric Lefkofsky’s Tempus Raises $200 Million To Bring Personalized Medicine To New Diseases

On the surface, Eric Lefkofsky’s Tempus sounds much like every other AI-powered personalized medicine company. “We try to infuse as much data and technology as we can into the diagnosis itself,” Lefkofsky says, which could be said by the founder of any number of new healthcare companies.. But what makes Tempus different is that it is quickly branching out, moving from a focus on cancer to additional programs including mental health, infectious diseases, cardiology and soon diabetes. “We’re focused on those disease areas that are the most deadly,” Lefkofsky says. 

Now, the billionaire founder has an additional $200 million to reach that goal. The Chicago-based company announced the series G-2 round on Thursday, which includes a massive valuation of $8.1 billion. Lefkofsky, the founder of multiple companies including Groupon, also saw his net worth rise from the financing, from an estimated $3.2 billion to an estimated $4.2 billion.

Tempus is “trying to disrupt a very large industry that is very complex,” Lefkofsky says, “we’ve known it was going to cost a lot of money to see our business model to fruition.” 

In addition to investors Baillie Gifford, Franklin Templeton, Novo Holdings, and funds managed by T. Rowe Price, Lefkofsky, who has invested about $100 million of his own money into the company since inception, also contributed an undisclosed amount to the round. Google also participated as an investor, and Tempus says it will now store its deidentified patient data on Google Cloud. 

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“We are particularly attracted to companies that aim to solve fundamental and complex challenges within life sciences,” says Robert Ghenchev, a senior partner at Novo Holdings. “Tempus is, in many respects, the poster child for the kind of companies we like to support.” 

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Tempus, founded by Lefkofsky in 2015, is one of a new breed of personalized cancer diagnostic companies like Foundation Medicine and Guardant Health. The company’s main source of revenue comes from sequencing the genome of cancer patients’ tumors in order to help doctors decide which treatments would be most effective. “We generate a lot of molecular data about you as a patient,” Lefkofsky says. He estimates that Tempus has the data of about 1 in 3 cancer patients in the United States. 

But billing insurance companies for sequencing isn’t the only way the company makes money. Tempus also offers a service that matches eligible patients to clinical trials, and it licenses  de-identified patient data to other players in the oncology industry. That patient data, which includes images and clinical information, is “super important and valuable,” says Lefkofsky, who adds that such data sharing only occurs if patients consent. 

At first glance, precision oncology seems like a crowded market, but analysts say there is still plenty of room for companies to grow. “We’re just getting started in this market,” says Puneet Souda, a senior research analyst at SVB Leerink, “[and] what comes next is even larger.” Souda estimates that as the personalized oncology market expands from diagnostics to screening, another $30 billion or more will be available for companies to snatch up. And Tempus is already thinking ahead by moving into new therapeutic areas. 

While it’s not leaving cancer behind, Tempus has branched into other areas of precision medicine over the last year, including cardiology and mental health. The company now offers a service for psychiatrists to use a patient’s genetic information to determine the best treatments for major depressive disorder. 

In May, Lefkofsky also pushed the company to use its expertise to fight the coronavirus pandemic. The company now offers PCR tests for Covid-19, and has run over 1 million so far. The company also sequences other respiratory pathogens, such as the flu and soon pneumonia. As with cancer, Tempus will continue to make patient data accessible for others in the field— for a price. “Because we have one of the largest repositories of data in the world,” says Lefkofsky, “[it is imperative] that we make it available to anyone.” 

Lefkofsky plans to use capital from the latest funding round to continue Tempus’ expansion and grow its team. The company has hired about 700 since the start of the pandemic, he says, and currently has about 1,800 employees. He wouldn’t comment on exact figures, but while the company is not yet profitable he says Tempus has reached “significant scale in terms of revenue.” 

And why is he so sure that his company’s massive valuation isn’t over-inflated? “We benefit from two really exciting financial sector trends,” he says: complex genomic profiling and AI-driven health data. Right now, Lefkofsky estimates, about one-third of cancer patients have their tumors sequenced in three years. Soon, he says, that number will increase to two-thirds of patients getting their tumors sequenced multiple times a year. “The space itself is very exciting,” he says, “we think it will grow dramatically.” Follow me on Twitter. Send me a secure tip

Leah Rosenbaum

Leah Rosenbaum

I am the assistant editor of healthcare and science at Forbes. I graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

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Eric Lefkofsky

To impact the nearly 1.7 million Americans who will be newly diagnosed with cancer this year, Eric Lefkofsky, co-founder and CEO of Tempus, discusses with Matter CEO Steven Collens how he is applying his disruptive-technology expertise to create an operating system to battle cancer. (November 29, 2016)

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Pfizer Has A Head Start, But The Covid-19 Vaccine Market Is Still Up For Grabs

Pfizer and BioNTech pulled ahead in the race to develop a Covid-19 vaccine this week, announcing preliminary data showing 90% effectiveness. Financial markets rallied on the tantalizing prospect that a return to normalcy is getting closer. But the lead may be short-lived as competitors, whose vaccines may be easier to transport or administer, are gearing up to report data in the coming weeks and months. “Pfizer will probably have a first-mover advantage, but won’t last that long,” says Damien Conover, director of healthcare equity research at Morningstar. “It’ll probably only be two or three months at the most.” 

While there are winners and losers in normal drug development, with the first company to enter a particular therapeutic area often gaining a significant advantage, that isn’t the case with Covid-19 vaccines, says Bunny Ellerin, director of the Healthcare and Pharmaceutical Management Program at Columbia Business School. “The pandemic affects everybody. The universe of people that you need to cover is huge,” she says. “There’s no one player that can provide vaccines for the entire world.” 

One of the main reasons why Pfizer’s preliminary data was so striking is that the mechanism the vaccine uses, messenger RNA or mRNA, has never been approved for use in humans before. To have 90% effectiveness, even among a small number of patients in ongoing trials, is very high compared to other common vaccines. For example, the yearly influenza vaccine can reduce the risk of flu from around 40% to 60%, depending on the year. “It’s tremendously powerful for the industry,” says Ellerin. “It shows that this platform can work and therefore will be used in the future.” It also bodes well for biotech company Moderna, which is developing a competing mRNA-based vaccine, and is planning to release interim data soon.

A supply of coarse dry ice pellets.
A supply of coarse dry ice pellets. Leon Neal/Getty Images

The Distribution Dilemma 

The downside of the current formulation of Pfizer’s mRNA vaccine is that it needs to be stored at ultra-low temperatures instead of the usual 2 to 8℃ (36 to 46℉) for many vaccines on the market. As Pfizer collects more stability data, it has determined the vaccine can stay at 2 to 8℃ for up to 5 days, but longer term storage needs to be around -70℃ (-94℉). “There’s never been a vaccine in the United States that required that kind of storage temperature prior to use,” says Dr. Kelly Moore, associate director for immunization education at the Immunization Action Coalition and an external advisor to Pfizer. 

This poses a unique challenge, given that there isn’t much ultra-low capacity freezer space in the United States or globally, says Prashant Yadav, an expert on healthcare supply chains and a professor at INSEAD. “The only places where we have ultra-cold chain equipment are either academic medical centers, so fairly big hospital systems, or a few of the sites that FedEx, UPS or [the big distributors] have created,” he says.

The usual route for routine vaccines is to go from the manufacturer to a big distribution center, run by a company like McKesson, Cardinal or AmeriSource Bergen, which then sends them to another stocking warehouse outside of major metropolitan areas, says Yadav. From there, the vaccines are sent to doctor’s offices, pharmacies, and hospitals as needed, which requires refrigerators in the warehouses and at the point of care. 

There are some freezers available for certain products, like oncology drugs and clinical trial materials, but these usually run from 0 to -20℃ (32 to -4℉), which isn’t cold enough for Pfizer’s vaccine. “The only way to distribute will then be to ship the product, either almost daily, or at least multiple times a week from the manufacturer to the point of vaccination” for ultra-cold chain products, says Yadav.

Other vaccines in development don’t need to be frozen and will only require refrigeration.

That’s Pfizer’s initial plan, to store its Covid-19 vaccines at ultra-cold storage sites in Kalamazoo, Michigan and Pleasant Prairie, Wisconsin, and then send them directly from there to point of use, according to a spokesperson. Pfizer, which is continuing to study storage conditions at warmer temperatures, has also designed special thermal shippers, “which can be used as temporary storage units by refilling with dry ice for up to 15 days of storage.” 

A Moderna spokesperson said the company expects its mRNA vaccine to be stored at -20℃ (-4℉), “which is an easier and more established protocol than deep freezing,” and close in temperature to a home freezer. “We expect to allow refrigerated conditions of 2 to 8℃ (36 to 46℉) for up to about a week,” the company said. 

But other vaccines in development that use different mechanisms, such as the protein subunit vaccine being developed by Novavax, don’t need to be frozen and will only require refrigeration, potentially making them easier to distribute through existing channels. The federal government’s Operation Warp Speed program is providing $1.6 billion to support large-scale manufacturing of 100 million doses of Novavax’s vaccine candidate. The program has also provided up to nearly $2 billion in funding to Moderna for the development and manufacturing of 100 million doses of its vaccine candidate, as well as agreed to purchase up to 100 million doses of Pfizer’s vaccine, once it gets regulatory approval, at a price of $1.95 billion.

In the first phase, the program “anticipates having a limited supply of COVID-19 vaccines to distribute, which should ease initial concern over potential long-term storage of vaccine doses,” according to a U.S. Department of Health and Human Services spokesperson. “The intent is to distribute vaccines to state-identified locations when vaccine administration can quickly follow, meaning that frequently the vaccines will be administered before needing to use storage other than the containers the vaccines are shipped in.” The effort includes the CDC, Department of Defense, private sector companies and state governments. 

Florida Volunteers Take Part In COVID-19 Vaccine Trials
A volunteer gets a vaccine as part of the Operation Warp Speed program. Joe Raedle/Getty Images

One Shot Too Many?

One of the other logistical hurdles is that the majority of vaccine candidates require a two-shot regimen, meaning patients get one shot and then must return for a second shot around 3 weeks later. While common vaccines, like the flu, may have pre-filled syringes or one-shot doses, most of the Covid-19 vaccines are going to be shipped in multi-dose vials. That means once providers open the vial, they must use the contents within 24-hours. “If we were to wait for things to be more convenient, thousands and thousands of people would die in the meantime, and that’s not a price we’re willing to pay,” says Moore, who is advising Pfizer.

During a pandemic, the first step is getting a safe and effective vaccine to market, with advancements like one-shot doses coming further down the line. The exception is Johnson & Johnson, which  is one of the only companies that is evaluating both single-dose and two-dose regimens as part of its Phase 3 trial. The company has received $456 million in federal funding for development and $1 billion for the first 100 million doses. 

Covid-19 vaccines will likely need to be given to large numbers of people in one go, so as not to waste any of the product given the temperature and multi-dosing constraints. “Mass vaccination clinics are not not something that we typically think of for routine immunization, but it’s certainly something that public health and healthcare facilities are very familiar with,” Moore says, harkening as far back as the 1950s when the polio vaccine was given to children in school. The first priority will be to inoculate frontline workers taking care of Covid-19 patients, and then moving to high-risk populations. The general public should set realistic expectations, given that the rollout won’t happen overnight. 

Human behavior will also be a factor when it comes to who decides to get immunized and who opts-out.

And even with all of the planning by companies and governments, there will still be some kinks along the way. On average, there is around 5 to 10% general wastage of vaccines, due to a range of issues, varying from incorrect storage temperature to open multidose vials and not having enough patients within the given period, says Yadav, the supply chain expert. “The production of vaccines is largely a technical feat,” he says. “But once it gets out of Pfizer’s factory gate, it’s not just about the logistics science, it starts to get into social science, because human behavior is at play.”

Human behavior will also be a factor when it comes to who decides to get immunized and who opts-out. The speed at which the companies and government are trying to get Covid-19 vaccines to market means there isn’t the type of long-term data associated with other vaccines. A big unanswered question is “how well does this vaccine work to keep you from getting infected compared to how well does it work to keep you from getting sick?” says Moore. 

One of the biggest issues with Covid-19 is asymptomatic spread, meaning people who don’t show outward signs of a viral infection but are spreading it to others. If the vaccine reduces symptoms but doesn’t stop infection, that means communities would have to continue other protocols, like mask-wearing and social distancing for longer than expected. It’s also not clear for how long immunity might last.

“The public needs to understand why vaccine manufacturers and experts in vaccines think that despite this uncertainty, we feel like it’s a good idea to move forward with vaccinating the public anyway and not waiting,” says Moore. “We will continue to gather information, so that we can address those areas of uncertainty in the months ahead and years ahead, and finally put this pandemic to rest.” Follow me on Twitter or LinkedIn. Send me a secure tip.

Katie Jennings

 Katie Jennings

I am a staff writer at Forbes covering healthcare, with a focus on digital health and new technologies. I was previously a healthcare reporter for POLITICO covering the European Union from Brussels and the New Jersey Statehouse from Trenton. I have also written for the Los Angeles Times and Business Insider. I was a 2019-2020 Knight-Bagehot Fellow in business and economics reporting at Columbia University. Email me at kjennings@forbes.com or find me on Twitter @katiedjennings.

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Associated Press

Pfizer says an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. This is “the first peek behind the curtain,” says Paul Duprex, director of University of Pittsburgh’s Center for Vaccine Research. (Nov. 9) Subscribe for more Breaking News: http://smarturl.it/AssociatedPress Website: https://apnews.com Twitter: https://twitter.com/AP Facebook: https://facebook.com/APNews Google+: https://plus.google.com/1158922418018… Instagram: https://www.instagram.com/APNews/ ​ You can license this story through AP Archive: http://www.aparchive.com/metadata/you…

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