Resilience raises over $800 million to transform pharmaceutical manufacturing in response to COVID-19

Resilience, a new biopharmaceutical company backed by $800 million in financing from investors including ARCH Venture Partners and 8VC, has emerged from stealth to transform the way that drugs and therapies are manufactured in the U.S.

Founded by ARCH Venture Partners investor Robert Nelsen, National Resilience Inc., which does business as Resilience was born out of Nelsen’s frustrations with the inept American response to the COVID-19 pandemic.

According to a statement the company will invest heavily in developing new manufacturing technologies across cell and gene therapies, viral vectors, vaccines and proteins.

Resilience’s founders identified problems in the therapeutic manufacturing process as one of the key problems that the industry faces in bringing new treatments to market — and that hurdle is exactly what the company was founded to overcome.

“COVID-19 has exposed critical vulnerabilities in medical supply chains, and today’s manufacturing can’t keep up with scientific innovation, medical discovery, and the need to rapidly produce and distribute critically important drugs at scale. We are committed to tackling these huge problems with a whole new business model,” said Nelsen in a statement.

The company brings together some of the leading investment firms in healthcare and biosciences including operating partners from Flagship Pioneering like Rahul Singhvi, who will serve as the company’s chief executive’ former Food and Drug Administration commissioner Scott Gottlieb, a partner at New Enterprise Associates and director on the Resilience board; and Patrick Yang, the former executive vice president and global head of technical operations at Roche/Genentech .

“It is critical that we adopt solutions that will protect the manufacturing supply chain, and provide more certainty around drug development and the ability to scale up the manufacturing of safe, effective but also more complex products that science is making possible,” said Dr. Gottlieb, in a statement. “RESILIENCE will enable these solutions by combining cutting edge technology, an unrivaled pool of talent, and the industry’s first shared service business model. Similar to Amazon Web Services, RESILIENCE will empower drug developers with the tools to more fully align discovery, development, and manufacturing; while offering new opportunities to invest in downstream innovations in formulation and manufacturing earlier, while products are still being conceived and developed.”

Other heavy hitters in the world of medicine and biotechnology who are working with the company include Frances Arnold, the Nobel Prize-winning professor from the California Institute of Technology; George Barrett, the former chief executive of Cardinal Health; Susan Desmond-Hellmann, the former president of product development at Genentech; Kaye Foster, the former vice president of human resources at Johnson and Johnson; and Denice Torres, the former President of Johnson & Johnson Pharmaceutical and Consumer Companies.

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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

#astrazeneca, #covid-19, #jake-tapper, #jennifer-doudna, #johnson-johnson, #moderna-therapeutics, #pfizer, #pharmaceutical, #tc, #vaccine, #world-health-organization

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Thirty Madison raises $47 million for its direct to consumer treatments of hair loss, migraines, and indigestion

Thirty Madison, the New York-based startup developing a range of direct to consumer treatments for hair loss, migraines, and chronic indigestion, has raised $47 million in new financing.

After last week’s nearly $19 billion merger between Teladoc and Livongo, remote therapies and virtual care companies are all the rage among the healthcare industry and Thirty Madison’s business is no exception. 

An indicator of just how important these companies are to the future of the healthcare business can be seen in the presence of Johnson & Johnson Innovation – JJDC, Inc. (JJDC) in the latest round for Thirty Madison. 

Existing investors Maveron and Northzone also returned to back the company in a deal led by Polaris Partners. Thirty Madison has raised a total of $70 million so far. 

Founded just three years ago by Steven Gutentag and Demetir Karagas, Thirty Madison expanded from treating hair loss with its Keeps brand in 2018 to migraine treatments in early 2019 with Cove, and launched Evens (the company’s acid reflux treatment service) later that year. 

Thirty Madison has just begun offering urgent care consultations for users on a pay what you will model.

And the company’s founders differentiate Thirty Madison’s business from their better-funded competitors like Hims and Ro by emphasizing that their company provides continuing care after a diagnosis and offers a range of treatment options for the conditions that the company treats. That, coupled with the more narrow focus on a few specific conditions, distinguish Thirty Madison from its peers in the industry.

“Over 59% of Americans suffer from at least one chronic condition, but few resources exist to help them connect the dots of their care,” said Amy Schulman, a partner with Polaris Partners and new director on the Thirty Madison board. 

 

#articles, #healthcare, #healthcare-industry, #hims, #johnson-johnson, #keeps, #livongo, #maveron, #new-york, #partner, #polaris-partners, #ro, #tc, #teladoc-health, #telemedicine

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Moderna set to start final-stage trial of its coronavirus vaccine by July

Pharmaceutical company Moderna told Bloomberg on Thursday that it’s on pace to begin the final-stage clinical trial of its vaccine for the novel coronavirus that causes COVID-19 by July. Moderna was the first company to begin human clinical trials of its vaccine candidate in the U.S., and the last stage of its study will include 30,000 people and be conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the study will be to show definitive clinical proof that Moderna’s vaccine actually does prevent people from developing COVID-19, and, secondarily, that it prevents at least severe symptoms and cases that require hospitalization from materializing. Moderna’s second-stage clinical trial kicked off last month, and the company has previously said that it could potentially begin offering experimental doses available to healthcare workers in limited capacities as early as this fall.

The pace of development of a number of leading vaccine candidates is actually moving just as quickly, if not more quickly. Johnson & Johnson said early this week that it would start trials of its vaccine later in July, while AstraZeneca and its research and development partner the University of Oxford will be entering its own final-stage clinical trials as of this month.

Moderna’s vaccine candidate is an mRNA vaccine, which is a technology that essentially provides instructions to healthy cells to produce antibodies to the coronavirus, without having to actually introduce any of the active or inactive virus itself. mRNA vaccines, while used in veterinary medicines, are relatively new technology and have not yet been approved for use in human patients, but they represent a number of the early vaccine attempts, because of their advantages in terms of speed of development and the lessened theoretical health risk they pose to people, including early trial participants.

#astrazeneca, #coronavirus, #covid-19, #drugs, #health, #johnson-johnson, #medicine, #moderna, #tc, #united-states, #vaccines

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Cue Health raises $100 million to speed development of rapid, portable COVID-19 diagnostics

San Diego-based startup Cue Health has closed a $100 million Series C funding round, including participation from Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation, ACME Capital and others. The funding will be used to help Cue finish up development, validate and scale production of its Cue Health Monitoring System and test cartridges, including test kits designed to diagnose COVID-19, which are currently being reviewed by the U.S. Food and Drug Administration (FDA) for emergency use authorization.

Cue has been developing its connected, portable lab to provide on-site care including molecular diagnostic tests since its founding a decade ago. The company also secured a $13 million contract in March specifically targeted towards development of a portable point-of-care COVID-19 test. Cue co-founder and CEO Ayub Khattak says that this pandemic has only re-emphasized the need for its product, which is primarily aimed at providing rapid, simple-to-use diagnostics that can be implemented quickly by a wide range of frontline workers in a variety of settings.

Concurrently with its EUA process for the Cue COVID-19 test, the company is also finishing up validation of the results for its influenza A and B tests, which will be used to submit to the agency for final approval of those tests as well. Its tests would provide at-home molecular based testing, with a connected results platform that can immediately provide diagnostics to certified healthcare providers within 20 minutes, unlocking a new level of remote care.

In total, Cue has $30 million in contract from the U.S. HHS’ Biomedical Advanced Research and Development Authority (BARDA) across its efforts both for flu testing and for COVID-19 diagnostics.

#biomedical-advanced-research-and-development-authority, #coronavirus, #covid-19, #cue-health, #flu, #foresite-capital, #funding, #health, #johnson-johnson, #madrone-capital-partners, #san-diego, #science, #tc

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Locatee raises $4M Series A for its workplace analytics platform

Locatee, a Swiss startup that uses existing sensors and IT infrastructures to provide employers and commercial real estate owners with detailed data about how their spaces are utilized, today announced that it has raised a $4 million Series A funding round led by San Francisco-based FYRFLY Venture Partners and Zurich-based Tomahawk VC.

“We started the company based on the experience we had with the big banks,” Locatee CEO and co-founder Thomas Kessler told me. “As users, we were introduced to this new world of working. You can work from any place. You can work from Starbucks. You can work from any area. And in the office, I did not have my own desk anymore. I could choose between meeting rooms, focus areas and so on. But that also has some challenges for managing the space.”

Corporate real estate managers often don’t understand how their buildings are utilized these days because they simply don’t have the tools to gather this data. As a result, they overprovision their office spaces and large chunks of it remain empty — which organizations then unnecessarily pay for.

What makes Locatee stand out from similar players in this space is that it integrates with existing motion sensors inside a building and other data sources, like Wi-Fi networks. For Swiss Re’s Munich office, for example, Locatee was able to work with NetCloud and integrate with the existing Cisco network infrastructure. Thanks to the data it gathered, Swiss Re was able to reduce its local office space by 10%, which Locatee says allowed the company to save about €290,000 per year.

On top of the core data analytics, Locatee also offers a number of other tools, ranging from smart signage for meeting rooms and workstations, for example, to desk finders for workers who now (or at least once they return to their offices) are often not working from a single, pre-assigned cubicle every day but who roam around a building and work from a different spot every day.

As Keller stressed, Locatee approached its first customers by trying to understand their use cases, not by trying to sell them technology. One of Locatee’s first customers was Biogen, but today, it also calls Swiss Re, Johnson & Johnson and Zurich (the financial services company, not the city) among its users.

Locatee’s data is anonymized and Kessler argues that employees don’t tend to worry about being tracked. “[Employees] have a benefit,” he said. “They have an app, for instance, where they can see available meeting rooms and desks. And they can see where colleagues are — on an opt-in basis. So it’s more like a ‘share your location’ feature like in iOS Messenger or in WhatsApp .”

With that kind of momentum, Kessler told me, finding investors was relatively easy — though it surely helped that the company closed this raise before the coronavirus pandemic hit Europe.

“Locatee’s vision to transform how space is used will ultimately elevate the quality of life for employees and can also contribute significantly to sustainable development goals,” said Philipp Stauffer, co-founder and managing director at FYRFLY Venture Partners. “Office space is only one component and increasingly all ‘work points’ matter for productivity optimization. A quantitative approach to space optimization and productivity holds both significant top- and bottom-line potential for large global organizations. Furthermore, aggregated data can help predict larger market trends, which is exciting to us.”

The company says it wants to use the new funding to become the “Google Analytics of office buildings.” And while its technology could also be used in other environments, Kessler says he wants to focus on office space for now. “There is still a lot of wasted real estate that needs to be optimized,” he said.

#analytics, #economy, #europe, #fyrfly-venture-partners, #google, #johnson, #johnson-johnson, #locatee, #real-estate, #recent-funding, #san-francisco, #social-media, #startups, #swiss-re, #tc, #telecommuting, #tomahawk-vc, #whatsapp, #working-conditions, #zurich

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Desperate to exit, a $10B price tag for Magic Leap is crazy

Augmented reality headset maker Magic Leap has struggled with the laws of physics and failed to get to market. Now it’s seeking an acquirer, but talks with Facebook and medical goods giant Johnson & Johnson led nowhere according to a new report from Bloomberg’s Ed Hammond.

After raising over $2 billion and being valued between $6 billion and $8 billion back when it still had momentum, Hammond writes that “Magic Leap could fetch more than $10 billion if it pursues a sale” according to his sources. That price seems ridiculous. It’s the kind of number a prideful company might strategically leak in hopes of drumming up acquisition interest, even at a lower price.

Startups have been getting their valuations chopped when they go public. The whole economy is hurting due to coronavirus. Augmented Reality seems less interesting than virtual reality with people avoiding public places. Getting people to strap used AR hardware to their face for demos seems like a tough sell for the forseeable future.

No one has proven a killer consumer use case for augmented reality eyewear that warrants an expensive and awkward-to-wear gadget. Our phones can already deliver plenty of AR’s value while letting you take selfies and do video chat that headsets can’t. My experiences with Magic Leap at Sundance Film Festival last year were laughably disappointing, with its clunky hardware, ghostly projections, and narrow field of view.

Apple and Facebook are throwing the enduring profits of iPhones and the News Feed into building a better consumer headset. Snapchat has built intermediary glasses since CEO Evan Spiegel thinks it will be a decade before AR headsets see mainstream adoption. AR rivals like Microsoft have better enterprise experience, connections, and distribution. Enterprise AR startup Daqri crashed and burned.

Magic Leap’s CEO said he wanted to sell 1 million of its $2300 headset in its first year, then projected it would sell 100,000 headsets, but only moved 6,000 in the first six months, according to a daming report from The Information’s Alex Heath. Alphabet CEO Sundar Pichai left Magic Leap’s board despite Google leading a $514 million funding round for the startup in 2014. Business Insider’s Steven Tweedie and Kevin Webb revealed CFO Scott Henry and SVP of creative strategy John Gaeta bailed in November. The company suffered dozens of layoffs. It lost a $500 million contract to Microsoft last year. The CEOs of Apple, Google, and Facebook visited Magic Leap headquarters in 2016 to explore an acquisition deal, but no offers emerged.

Is AR eyewear part of the future? Almost surely. And is this startup valuable? Certainly somewhat. But Magic Leap may prove to be too little too early for a company burning cash by the hundreds of millions in a market newly fixated on efficiency. A $10 billion price tag would require one of the world’s biggest corporations to believe Magic Leap has irreplicable talent and technology that will earn them a fortune in the somewhat distant future.

The fact that Facebook, which does not shy from tall acquisition prices, didn’t want to buy Magic Leap is telling. This isn’t a product with hundreds of millions of users or fast-ramping revenue. It’s a gamble on vision and timing that looks to be coming up snake eyes. It’s unclear when the startup would ever be able to deliver on its renderings of flying whales and living room dinosaurs in a form factor people actually want to wear.

 

One of Magic Leap’s early renderings of what it could supposedly do

With all their money and plenty of time before widespread demand for AR headsets materializes, potential acquirers could likely hire away the talent and make up the development time in cheaper ways than buying Magic Leap. If someone acquires them for too much, it feels like a write-off waiting to happen.

#apple, #augmented-reality, #daqri, #facebook, #fundings-exits, #gadgets, #google, #hardware, #johnson-johnson, #magic-leap, #microsoft, #microsoft-hololens, #startups, #sundar-pichai, #tc, #wearables

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