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 COVID-19 shot 95% effective, seeking clearance soon

Pfizer says that more interim results from its ongoing coronavirus vaccine study suggest the shots are 95% effective and that the vaccine protects older people most at risk of dying from COVID-19.

The announcement, just a week after Pfizer first revealed promising preliminary results, comes as the company is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

Pfizer initially had estimated its vaccine, developed with German partner BioNTech, was more than 90% effective after 94 infections had been counted. With Wednesday’s announcement, the company now has accumulated 170 infections in the study — and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.

The company has not yet released detailed data on its study, and results have not been analyzed by independent experts.

Pfizer said its vaccine was more than 94% effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those people’s ages.

Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5% effective after an interim analysis of its late-stage study.

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Pfizer says it now has the data on the vaccine’s safety needed to seek emergency authorization from the Food and Drug Administration.

The company didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% of participants.

The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and efficacy data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

U.S. officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December. The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

LINDA A. JOHNSON

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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CBC News

Pfizer says that more interim results from its ongoing coronavirus vaccine study suggest the shots are 95 per cent effective. The company is preparing within days to formally ask U.S. regulators to allow emergency use.   »»» Subscribe to CBC News to watch more videos: http://bit.ly/1RreYWS Connect with CBC News Online: For breaking news, video, audio and in-depth coverage: http://bit.ly/1Z0m6iX Find CBC News on Facebook: http://bit.ly/1WjG36m Follow CBC News on Twitter: http://bit.ly/1sA5P9H For breaking news on Twitter: http://bit.ly/1WjDyks Follow CBC News on Instagram: http://bit.ly/1Z0iE7O Subscribe to CBC News on Snapchat: https://bit.ly/3leaWsr Download the CBC News app for iOS: http://apple.co/25mpsUz Download the CBC News app for Android: http://bit.ly/1XxuozZ »»»»»»»»»»»»»»»»»» For more than 75 years, CBC News has been the source Canadians turn to, to keep them informed about their communities, their country and their world. Through regional and national programming on multiple platforms, including CBC Television, CBC News Network, CBC Radio, CBCNews.ca, mobile and on-demand, CBC News and its internationally recognized team of award-winning journalists deliver the breaking stories, the issues, the analyses and the personalities that matter to Canadians.

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…

Why Pfizer May Be The Best Bet to Deliver A Vaccine By The Fall

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In the middle of March, Pfizer chief Albert Bourla beamed into a WebEx video call with the leaders of the American pharmaceutical giant’s vaccine research and manufacturing groups. The two teams had worked late into the night on a robust development plan for Pfizer’s experimental Covid-19 vaccine and told Bourla that they aimed to make it available lightning-fast. It could be ready sometime in 2021.

“Not good enough,” Bourla said. The faces of the researchers tensed up, and conscious of the Herculean effort that had taken place, Bourla made sure to thank them. But he also kept pushing. He asked if people on the call thought the virus might come back in the fall, and what they expected would happen if a vaccine were not available when a new flu season hit at the same time, an issue the federal Centers for Disease Control raised weeks later.

“Think in different terms,” Bourla told them. “Think you have an open checkbook, you don’t need to worry about such things. Think that we will do things in parallel, not sequential. Think you need to build manufacturing of a vaccine before you know what’s working. If it doesn’t, let me worry about it and we will write it off and throw it out.”

Says Mikael Dolsten, Pfizer’s chief scientific officer: “He challenged the team to aim for a moon shot–like goal—to have millions of doses of vaccine in the hands of vulnerable populations before the end of the year.”

On the first Monday of May, Pfizer dosed the initial batch of healthy American volunteers in Baltimore with an experimental Covid-19 vaccine it developed with Germany’s Bio-NTech. Bourla was informed immediately. The following day, in an interview from his home in suburban Scarsdale, New York, he pointed out that it normally takes years to accomplish what Pfizer had just done in weeks. “How fast we moved is not something you could expect from the big, powerful pharma,” he said. “This is speed that you would envy in an entrepreneurial founder-based biotech.”

A Greek veterinarian who worked his way up the Pfizer corporate ladder for 25 years before becoming CEO in 2019, Bourla says nothing in his career could have prepared him for this moment. But he does believe the massive corporate transformation he has led—steering a behemoth conglomerate (2019 sales: $51.8 billion) deeper into the high-risk, high-reward game of developing new patented medicines and away from generic drugs and consumer products like Advil and Chapstick—has prepared Pfizer.

For Bourla, 58, the last four months have been a rollercoaster, an unending series of setbacks and victories. Pfizer is not alone in the race. Most of the world’s biggest pharmaceutical companies, including Johnson & Johnson, Sanofi, AstraZeneca and Roche, are throwing everything they can at Covid-19.

Some experts feel Bourla’s timeline—a viable vaccine in a matter of a few months—is simply unrealistic. Undeterred, Bourla has tasked hundreds of researchers to scour Pfizer’s trove of experimental and existing medicines to look for potential therapies. Early on, he openly authorized having discussions and sharing proprietary information with rival firms, moves unheard of in the secretive world of big pharma. Bourla has made Pfizer’s manufacturing capabilities available to small biotech concerns and is in talks as well to make large quantities of other companies’ Covid-19 drug candidates.

Pfizer’s most prominent effort is its work with Mainz, Germany–based BioNTech, an innovative $120 million (2019 sales) outfit that is mostly known for making cancer medications. The resulting experimental Covid-19 vaccine works with messenger RNA, a bleeding-edge technology that has never resulted in a successful treatment. Pfizer is hoping to get emergency-use authorization from the U.S. government for the vaccine by October. Its unique strategy is to rapidly pit four different mRNA vaccine candidates against one another and double down on the most likely winner.

In preparation, the company is shifting production at four manufacturing plants to make 20 million vaccine doses by the end of the year and hundreds of millions more in 2021. Bourla says Pfizer is willing to spend $1 billion in 2020 to develop and manufacture the vaccine before they know if it will work: “Speed is of paramount importance.”

While the vaccine effort is getting most of the public’s attention, Pfizer is also rushing to start a clinical trial this summer for a new antiviral drug to treat Covid-19. Additionally, it’s involved in a human study that seeks to repurpose Pfizer’s big arthritis drug, Xeljanz, for later-stage Covid-19 patients.

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“Being the CEO of a pharma company that can make a difference or not in a crisis like this is a very heavy weight,” Bourla says. “Even the way my daughter or son ask me, ‘Do you have something or not?’ Every person who knows me does the same. You feel if you get it right, you can save the world. And if you don’t get it right, you will not.”

In January, Uğur Şahin, the brilliant immunologist who founded BioNTech, read an article about Covid-19 in The Lancet. Şahin built BioNTech to hack human cells to go after diseases, particularly cancer, and he thought similar tech might work against the coronavirus. Soon after, Şahin spoke to Thomas Strüngmann, the German pharma billionaire who for years has backed Şahin and his wife, immunologist Özlem Türeci, in their ventures. “He said, ‘This is a big disaster.’ He said the schools will be closed, that this will be a pandemic,” Strüngmann says, referring to Şahin. “He switched most of his team to the vaccine.”

In February, Şahin (who is also now a billionaire, as BioNTech’s stock has soared) called up Kathrin Jansen, who heads vaccine research and development for Pfizer. Şahin told Jansen BioNTech had come up with vaccine candidates for Covid-19 and asked if Pfizer would be interested in working with him. “Uğur, you are asking?” Jansen replied. “Of course we are interested.”

Over the last few years, scientists have become intrigued by the idea of using messenger RNA, the genetic molecule that gives cells protein-making instructions, to develop medicines for cancer, heart disease and even infectious viruses by transforming human cells into drug factories. Because SARS-CoV-2, as the coronavirus is formally known, is an RNA virus, researchers like Şahin focused on the idea of giving mRNA the cellular machinery to make proteins that would create virus-protecting antibodies.

An mRNA vaccine has huge advantages over a traditional one. Because it can be made directly from the genetic code of the virus, it can be invented and entered into clinical trials in a matter of weeks, rather than months or years. But there’s a big downside: No one has ever successfully made one.

BioNTech is not alone in pursuing an mRNA vaccine. Moderna Therapeutics, a biotech in Cambridge, Massachusetts, also got going in January and has launched a big human trial for its mRNA vaccine, backed by $483 million from the federal government. Moderna is likewise aiming to produce millions of doses per month by the end of the year.

Pfizer was already comfortable with BioNTech. Two years ago, the two companies inked a $425 million deal to develop an mRNA flu vaccine. Pfizer was intrigued by the potential of an mRNA approach to short-circuit the process of developing a vaccine for a new strain of the flu every year. That same flexibility and speed appealed to Bourla when it came to working with a partner on a potential vaccine for Covid-19.

On March 16, Bourla convened Pfizer’s top executives and informed them that return on investment would not play a role in the company’s Covid-19 work. “This is not business as usual,” Bourla told them. “Financial returns should not drive any decisions.”

Pfizer signed a letter of intent with BioNTech the next day. The contract they finalized in April makes no mention of commercialization. Pfizer is bringing its enormous manufacturing, regulatory and research capabilities to the effort. BioNTech is bringing the basic science.

At the same time, Bourla made the decision to spend $1 billion on the project, so if the vaccine works, it can be made available this autumn. Pfizer will also be on the hook to pay BioNTech an additional $563 million if everything goes according to plan. “A billion dollars is not going to break us. And, by the way, I don’t plan to lose it. I plan to make sure we use this product,” Bourla says. “You never know until you see the data. So yes, we are going to lose a billion if” the vaccine doesn’t work.

What makes Pfizer’s approach unique is that it’s testing four distinctive vaccines—different mRNA platforms that are supposed to induce a safe immune response. The complex trial will start by testing different dosing levels of the four vaccines in 360 U.S. volunteers and 200 in Germany, eventually expanding to around 8,000 participants.

The U.S. trial was designed to evolve so the company could quickly stop testing any one of the vaccines if immunogenicity data show it is not producing enough antibodies to confer virus protection. The companies are making adjustments on the fly. BioNTech recently realized one of the vaccine candidates should be dosed at a lower level to be safe—an early fling of a monkey wrench into the plans.

There is considerable skepticism among experts that Pfizer’s goal of providing millions of doses to vulnerable populations by the fall is possible. Drew Weissmann, whose University of Pennsylvania laboratory has worked with BioNTech on mRNA vaccines for infectious diseases, recently told Forbes it is simply not known if an mRNA vaccine can prevent infectious disease.

Jansen, Pfizer’s vaccine research chief, expects that Pfizer and BioNTech will have a better idea around the beginning of July as to which of the four vaccine candidates is the most promising and whether their hyper-accelerated timeframe is feasible. The company will likely move just one or two of the most promising vaccines to more advanced trials.

“It’s not easy. As a matter of fact, it has never been done before—I can’t give you a probability,” Jansen says. “An unprecedented crisis, such as the ongoing pandemic, requires unprecedented action. Albert was the first to see that and act on it, and to provide the support and the environment for us to think and act boldly.”

When Albert Bourla started his run at the top of Pfizer in January 2019, he removed the bulky brown table from the CEO’s conference room and did not replace it, re-arranged the chairs in a circle and put up photographs of patients on the wall. The idea was to promote open discussion and remind people about the real purpose of a pharmaceutical company. Soon after, other Pfizer employees began to put pictures on their desks of patients they know or love.

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The unorthodox way Bourla took to the pinnacle of corporate power started in Greece’s second-biggest city, Thessaloniki, a northern port city on the Aegean Sea. He grew up middle-class—his father and uncle owned a liquor store—as part of a tiny Jewish minority that survived the German occupation and the Holocaust.

A love of animals and science drove Bourla to become a veterinarian. At Thessaloniki’s Aristotle University, he was known for playing the guitar and singing, and during the summers worked as a European tour guide. He joined Pfizer’s Greece office in 1993, working in its animal-health division, beginning an ascent that saw him move his family to eight cities in five countries, including Poland and Belgium.

By 2014, Bourla was a high-level executive at Pfizer’s Manhattan headquarters on 42nd Street, where, among other things, he ran Pfizer’s vaccine and cancer divisions. He brought a Mediterranean flair to the buttoned-up conglomerate. His group meetings were boisterous, echoing through the otherwise largely silent corridors. He forced company units to express their metrics in terms of how many patients they were helping, not merely in terms of dollars and cents.

Ian Read, Pfizer’s Scottish-born CEO at the time, had reversed the company’s fortunes on Wall Street, where its stock had been badly underperforming, by repurchasing lots of shares and divesting businesses that sold baby formula and animal medicines. Less visibly, Read reinvigorated Pfizer’s drug pipeline in its core vaccine business and empowered Pfizer’s researchers to develop targeted therapies, particularly for cancer, as some of its mass-marketed drugs, like the cholesterol-lowering blockbuster Lipitor, went off-patent.

Bourla’s last job before ascending to the C-suite was as head of Pfizer’s innovation group. He approached the position as though he was running a life-sciences venture capital firm. He forced each of his six business units, which included oncology, vaccines and rare diseases, to compete for financing. “I was telling all of them, ‘I’m your boss, I am private equity, the one who has the better ideas will get the money,’ ” he says. “A company that has the scale of Pfizer and the mindset of a small biotech was always my dream.”

“Albert has a sense of urgency, and that is coming out in the way he is marshaling the company’s resources behind trying to develop a vaccine or treatment for Covid-19,” says Read, his former boss. “He is a charismatic people person, energizing groups of people to get the job done.”

Bourla’s urgency was evident after a difficult weekend in February when he realized that Covid-19 was not going to be just a problem for China. On a call the following Monday morning, Bourla fired off instructions to Pfizer’s top brass. He told the science executives to make sure the company’s labs remained open, and that Pfizer needed to contribute to a medical solution to the pandemic. “If not us, then who?” Bourla said. He instructed the manufacturing group to make a list of Pfizer’s drugs—including those that treat heart failure and opportunistic bacterial infections—that would be in high demand in a pandemic and make sure they wouldn’t be hampered by production bottlenecks. He then officially informed the board that he was pivoting the company toward Covid-19.

One day in the midst of this retooling, Pfizer director Scott Gottlieb, who used run the FDA, left the company’s Manhattan headquarters, and within hours his fears were coming to pass: Reports were emerging from California indicating community spread in America. That evening Gottlieb posted a Twitter thread: A long fight could be ahead, one requiring shared sacrifice, he said—but partly because of Bourla’s efforts at Pfizer, he could also say that development of vaccines and therapeutics was already underway.

“Albert laid out early why it was so important to put up the enormous resources of Pfizer without an eye toward the business bottom line,” Gottlieb says. “Coming up with a vaccine could change the course of human history. That is literally what’s at stake, and big companies have the ability to scale up manufacturing and run big trials in a way not available to small product developers.”

In the middle of March, Bourla decided to publicly release Pfizer’s plan to share data from its Covid-19 research with rival pharmaceutical companies. He promised to use any excess manufacturing capacity and even shift production at Pfizer’s facilities away from its own products to make Covid-19 treatments from other companies. “You know the saying,” Bourla says. “Beware [of] what you wish for.”

Since then, Pfizer has heard from 340 companies. It has already given technical support to some of them and is on the brink of signing large manufacturing agreements with others. It is also in discussions with additional firms that need financing for their own Covid-19 therapies.

“Will my kids go to school next fall?” Bourla wonders. “I’m also part of society. You cannot stay silent.”

At a video meeting of Pfizer’s board of directors in late April, Bourla was asked what would happen if multiple vaccine makers were successful. That would be the best possible outcome, he replied, because enormous amounts of vaccine could be quickly produced.

Beyond the holy grail of a vaccine, Pfizer is also trying to come up with therapeutic solutions. The researchers tasked with combing through Pfizer’s molecular database became intrigued by several of its antiviral compounds that might attack the virus by stopping it from reproducing. After Pfi-zer got the DNA sequence of the coronavirus in January, researchers figured out which could work best.

Conducting preclinical work on the selected compounds, however, was difficult. Pfizer had trouble finding a lab that could perform the proper assays. The company had scaled down its antiviral research a decade ago and no longer owned a suitable biosafety lab to work with the live virus. At one point, Bourla feared the lack of a lab would delay the clinical-trial process. But a separate government medical agency helped Pfizer find a good one in the Netherlands.

There have been “multiple moments of bad news coming to spoil the good news you had three hours earlier,” Bourla says. Pfizer’s laboratory work has since shown one of its protease inhibitors, initially developed to battle SARS, to exhibit antiviral activity against SARS-CoV-2. Pfizer is now aiming to start a human trial for that antiviral, which is administered intravenously, by the end of the summer.

Another Pfizer drug getting attention is Xeljanz, a rheumatoid arthritis pill generating $2.2 billion annually. It is seen as a potential way to tamp down the massive immune response to Covid-19 that overwhelms some infected patients. Pfizer is supporting a Xeljanz trial in Italian Covid-19 patients, as well as another U.S. trial that will test a different arthritis medicine, an experimental drug that targets the Irak-4 protein, against the virus.

While all this is going on, of course, Bourla still needs to run the rest of Pfizer. He recently planned a symbolic visit to a Pfizer plant—none has closed—but after making the arrangements, he was informed that he would not be allowed to enter because he was not deemed essential.

“I don’t know if I was ever prepared for something like this,” Bourla says. “But you feel that you need to suck it up and rise to the occasion because that’s what you have to do.”

I am a senior editor at Forbes who likes digging into Wall Street, hedge funds and private equity firms, looking for both the good and the bad.

Source: https://www.forbes.com

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Dr. Mikael Dolsten, Pfizer chief scientific officer, joins ‘Closing Bell’ to discuss Pfizer’s new partnership. The company plans to start COVID-19 trials by April. The race is on to develop an immunization against COVID-19. Dozens of companies and public labs around the world are working to develop a vaccine to prevent the spread of the flu-like virus. Over the last 48 hours, three biotech companies, in particular, have been thrust into the spotlight for their promise: BioNTech, CureVac and Moderna. All three of these firms specialize in messenger RNA (mRNA) therapeutics. These mRNA molecules are used to instruct the body to produce its own immune response to fight a range of different diseases. This type of vaccine can potentially be developed and produced more quickly than traditional vaccines. Moderna is a Massachusetts-based biotech company working with the U.S. National Institutes of Health (NIH). It kicked off its first trial Monday in Seattle, Washington. This is called a “phase one” study and is being conducted by the NIH. Moderna is also preparing for a potential “phase two” study that it would conduct itself. Moderna shares rose 27% in Monday’s trading session. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://www.cnbc.com/pro/?__source=yo… » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic
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