“I Have Never Seen a Moment So Rich in Collaboration, Ingenuity and Acts of Bravery”: Johnson & Johnson Announces It Has Identified a Lead Covid-19 Vaccine Candidate
By Alex Gorsky, Chairman & CEO
A scientist in the Janssen labs in Leiden, The Netherlands
Chairman & CEO Alex Gorsky shares that the company could have the first batches of a Covid-19 vaccine available for emergency-use authorization in early 2021-a substantially accelerated time frame in comparison to the typical vaccine development process.
The Covid-19 pandemic is one of the greatest challenges to our society in living memory. Yet even as we are heartbroken by the lives lost and the strain on our institutions and communities, countless people have been working tirelessly to offer the world a reason to feel pride, inspiration and hope.
In my 31 years working in healthcare, I have never seen a moment so rich in collaboration, ingenuity and acts of bravery. Public health authorities, private sector companies, research universities, governments and, most of all, the heroes on the front lines of care are mobilizing in ways that current generations have never before witnessed.
In 1918, Johnson & Johnson supported the doctors and nurses treating Spanish influenza through scientific innovation, just as we are now deploying the full strength of our company against this new pandemic.
And as a result of focused efforts and extensive collaboration underway since January, today we are able to announce that Johnson & Johnson has selected a lead Covid-19 vaccine candidate. We expect to initiate human clinical studies by September 2020, and anticipate that the first batches of a Covid-19 vaccine could be available for emergency-use authorization in early 2021-a substantially accelerated time frame in comparison to the typical vaccine development process.
Through a landmark new partnership, the Biomedical Advanced Research and Development Association (BARDA) and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development and clinical testing-and to expand our company’s global manufacturing capacity to enable the supply of more than 1 billion doses of a safe and effective vaccine to the public for emergency pandemic use on a not-for-profit basis.
FYR Diagnostics, a Missoula, Montana-based molecular diagnostics company focused on developing next generation tests for the early detection of human and agricultural diseases, announced that it is developing a test for COVID-19 viral infection that is more cost effective than existing rapid tests, while also being scalable and suitable for use outside of a medical facility in low-resource environments.
“We are proud to be doing our part to address the COVID-19 crisis,” said Chris Booth PhD, CEO of FYR Diagnostics. “Our team is working around the clock to develop Adaptive Low Resource Testing (ALRT), a rapid diagnostic test for SARS-CoV-2, the virus that causes COVID-19, that can be used in hospitals as well as at testing sites in the community.”
Currently, the FDA has approved two different types of COVID-19 tests: antibody tests that detect an individual’s immune response to the virus, and viral tests that detect the presence of the SARS-CoV-2 virus itself. Both types of tests are crucial tools in fighting the spread of COVID-19. Antibody tests can determine who has been previously exposed to the virus and may be immune, but they are not effective in identifying those who are newly infected because antibodies take many days to develop after exposure. Tests that directly detect the virus, on the other hand, are effective at finding who has a potentially active and contagious infection even in asymptomatic individuals but are not effective at identifying those who have recovered from the virus.
Although several viral detection diagnostic tests have been approved by the FDA and are being used across the country, supply chain and equipment shortages are keeping this testing capability from being used on a mass scale. FYR Diagnostics’ ALRT test opens this bottleneck through alternative reaction components and technologies that do not require scarce equipment or costly specialized devices. The ALRT test is designed to be low cost, simple to administer without specialized training, and suitable for use at low-resource testing sites beyond hospitals and clinics. It can produce a yes/no test result in 30-40 minutes.
“Insufficient testing capacity here in Montana and throughout the US is amplifying and prolonging the COVID-19 crisis while putting more lives at risk,” says Mike Goguen, Executive Chairman of FYR Diagnostics. “FYR’s highest priority is to quickly enable mass COVID-19 testing in our home state, and then expand elsewhere.”
“We still have some work ahead of us,” says Sarj Patel PhD, President of FYR Diagnostics “Our goal is to obtain Emergency Use Authorization approval from the Food and Drug Administration for our test. This would permit us to deploy our test on a broader scale in Montana.”
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Sanofi and GlaxoSmithKline collaborate to speed up
The French drug giant Sanofi said Tuesday that it plans to use technology from GlaxoSmithKline to accelerate the development of its experimental vaccine against the novel coronavirus, SARS-CoV-2.
Sanofi and GSK said in a statement that the vaccine would be ready to begin testing in humans in the second half of 2020 and that they aim to complete all of the work required to file for regulatory approval by the second half of 2021.
The new vaccine will combine a vaccine technology that Sanofi currently uses to make a flu vaccine, FluBlok, with GlaxoSmithKline’s adjuvant, an additive that increases the potency of vaccines, making them more likely to be effective and easier to manufacture in large quantities.
Unlike most flu vaccines, which are manufactured in chicken eggs, the FluBlok vaccine is made using a genetically modified virus in cultures of cells from the fall armyworm, a type of moth. The cells are used to produce a protein identical to one on the surface of the virus, which the immune system learns to recognize and attack. The Food and Drug Administration approved the FluBlok vaccine in 2013. Sanofi bought Protein Sciences, which developed the vaccine, for $750 million in 2017.
MSU researcher wins prestigious fellowship for immunology research
By Reagan Colyer, MSU News Service
April 8, 2020
Montana State University research scientist Kelly Shepardson was awarded a Parker B Francis fellowship. The fellowships focus on pulmonary and respiratory research and include funding of $225,000 over three years. MSU photo by Kelly Gorham.
A Montana State University research scientist looking into why people recovering from the flu can be more susceptible to secondary infections received the prestigious Parker B. Francis Fellowship last month to advance her work studying fungal infections.
Kelly Shepardson is a postdoctoral researcher in the Department of Microbiology and Immunology in MSU’s College of Agriculture. Originally from upstate New York, Shepardson received her doctorate from Dartmouth University before joining Agnieszka Rynda-Apple’s Lab at MSU in 2014. The work in Rynda-Apple’s laboratory focuses influenza A – seeking to develop a flu vaccine that could target multiple strains of the flu at once and exploring novel platforms for vaccine delivery. Rynda-Apple’s research also aims to understand how the immune system recognizes viruses prior to infection and how that determines a patient’s susceptibility to secondary infections which, for influenza, is a major cause of death.
“Most people who get influenza don’t die from the flu,” Shepardson said. “They die from a secondary infection they get while their immune system is on its way to recovering from the virus infection, creating a transiently suppressed immune environment.”
She said much of the focus in her field is on understanding what it is about these immunocompromised states that makes people more susceptible to secondary infections. Shepardson’s research specifically focuses on infections by a fungus called Aspergillus fumigatus, which is primarily seen in patients with suppressed immune systems.
Shepardson’s early work with the Rynda-Apple Lab helped identify genetic markers involved in determining susceptibility to both influenza and common secondary infections. She determined that two genetic receptors – known as IFNAR 1 and IFNAR 2 – play a role in both immunity and that secondary susceptibility. The work found that early in a person’s recovery from the flu, there is increased resistance to secondary infections, and that that resistance fluctuates over time.
This susceptibility applies to both bacterial infections and Apsergillus, the fungus on which her newer project is focused.
Curtis Noonan will direct UM’s new Center for Population Health Research, which will focus on disease prevention strategies.
As emergent pathogens like coronavirus and climate-related health challenges like wildfire smoke plague human populations, the University of Montana has received funding for a center dedicated to understanding and addressing public health challenges to Montana and the region.
The National Institutes of Health awarded the University a five-year $10.75 million grant to establish the Center for Population Health Research (CPHR, pronounced “see-far”). The center will support epidemiological and mathematical modeling approaches to better understand risk and resilience factors for children’s health outcomes. It also will create disease prevention strategies developed for, adapted to and tested in rural communities.
“We are excited about this opportunity to improve the health of children in Montana and the region,” said Curtis Noonan, center director and a professor of epidemiology in UM’s School of Public and Community Health Sciences. “This comes at a challenging time for the public health community.
“We could not have predicted the current coronavirus threat when we started building this center over two and a half years ago,” he said, “but we did recognize the importance of developing the capacity to work with medical and public health data to better understand health risk in our communities and identify disease prevention strategies that are relevant to rural states.”
CPHR research projects establish scientific capacity and a collaborative infrastructure highly relevant to the COVID-19 pandemic. Erin Landguth leads a project to better understand the factors that influence respiratory infection among children.
“In the face of today’s infectious disease complexities, mathematical models offer essential tools for synthesizing information to understand epidemiological patterns and for developing the quantitative evidence base for decision-making in public health,” Landguth said. “Partnering with pediatric health care providers, my project will integrate novel data streams, computational capacity and new modeling tools, allowing for the description of how respiratory infections vary across space and time – particularly in rural communities where such work is limited.”
University of Montana Regents Professor Richard Bridges spends his days making hand sanitizer to fulfill a critical need. UM photo
Under normal circumstances, University of Montana Regents Professor Richard Bridges spends his days researching potentially life-saving projects in neuroscience, in specific how and why brain cells die in diseases like Alzheimer’s and ALS.
With the arrival of Covid-19, he’s working in another endeavor that, while not as heady as spinal cord neurotransmissions, can be just as lifesaving. For the past week, the Cornell-trained biochemist has been elbow deep in isopropyl alcohol and vegetable glycerin, mixing gallons of hand sanitizer for fire, police and medical personnel around Missoula.
“These days, hand sanitizer is worth its weight in toilet paper,” said Bridges, summarizing the feelings of consumers across the country.
Bridges works in UM’s Division of Biological Sciences and teaches in the neuroscience and pharmacy programs. He recently became a hand sanitizer brew master after his wife, Dr. Carol Bridges, said one of her firefighter patients was concerned about the shrinking supply of hand sanitizer for first responders. After a field trip to a Missoula fire house and conversations with firefighter Chris Kovatch, a member of the Western Montana Incident Management Team, Bridges realized he might be able to help and said he just started “winging it.”
There was plenty of information on the CDC website for making properly potent hand sanitizer, he said, but finding the raw materials was a challenge. Alcohol, glycerin and plastic bottles are now as scarce as hand wipes. It is also important to use the CDC-recommended strengths the different alcohols (70% for isopropyl or 60% for ethanol). For help, Bridges turned to several UM colleagues including Scott Wittenburg, vice president for Research and Creative Scholarship, and Chief of Staff Kelly Webster to secure enough ingredients to make the first 25 gallons.
MSU alumni help supply coronavirus field hospitals in New York
By Marshall Swearingen, MSU News Service
April 13, 2020
HVAC equipment made by Tulsa, Oklahoma-based AAON, founded by MSU alumnus Norm Asbjornson, is pictured in MSU’s Norm Asbjornson Hall. MSU photo by Kelly Gorham
Montana State University alumni are playing an important role in the emergency response to the novel coronavirus pandemic, aiding in the construction of field hospitals in New York, where the number of COVID-19 patients is straining the medical system.
AAON, the company founded by the MSU engineering alumnus Norm Asbjornson, expedited design and manufacturing of 80 large, custom cooling and ventilation units for new, temporary hospitals being built by the U.S. Army Corps of Engineers at Stony Brook University and SUNY Old Westbury.
After being contacted early last week by consulting engineers who knew of AAON from previous New York projects, the company designed a custom air conditioning unit configured for the tent-like hospitals, then dedicated a production line at the company’s Tulsa, Oklahoma, plant to make roughly 14 of the units per 24 hours – more than double the normal production rate.
“A lot of people would say you couldn’t possibly do that, but we did it, and we were able to do it because we have a lot of talented people here,” said Asbjornson, who earned his bachelor’s in mechanical engineering from MSU and gave $50 million in 2014 to fund design and construction of MSU’s Norm Asbjornson Hall.
Whereas a typical AC unit would sit on the flat roof of a hospital, circulating air through inlets and outlets on top and bottom, the temporary tent hospitals required AC units that would sit on the ground and circulate air sideways. The AAON units were also optimized to handle humidity and filter air.
MSU research equipment and expertise repurposed to help diagnose, research coronavirus
By Marshall Swearingen, MSU News Service
April 17, 2020
MSU researcher Michelle Flenniken conducts preparations for doing COVID-19 testing at Bozeman Health Deaconess Hospital. Photo courtesy Michelle Flenniken.
In the effort to slow the spread of the novel coronavirus and treat infected patients, special equipment that performs cutting-edge research at Montana State University has been repurposed to help Gallatin County health care providers.
Before the outbreak of the novel coronavirus, formally named SARS-CoV-2, a machine in MSU researcher Michelle Flenniken‘s lab called a qPCR analyzer was used to detect viruses that attack bees and other pollinators around the state. Now it has been temporarily moved to Bozeman Health Deaconess Hospital, where the tool can perform up to 60 much-needed COVID-19 tests per day.
“As part of our effort to understand the impact of viruses on honey bee colony losses, we routinely quantify viruses in honey bee samples using qPCR, and the testing process for detecting SARS-CoV-2 in human patient samples isn’t all that different,” said Flenniken, assistant professor the Department of Plant Sciences and Plant Pathology in MSU’s College of Agriculture. “As a virologist, it is nice to meld my lab’s expertise with the expertise at Bozeman Health to work together to provide an important service to the community. Together, we are addressing this pandemic.”
Hospitals and health systems around the nation have struggled to procure ready-made COVID-19 test kits due to high demand. Although more labor intensive than the ready-made kits, the tests using the MSU machine have been rigorously tested and give accurate results comparable to those at the state lab in Helena, according to Bozeman Health system manager for laboratory services Doug Smoot.
“We’re hugely appreciative,” Smoot said. Doing the testing in-house also saves time and frees up testing capacity at the state lab for other Montana communities that send patient samples there, he explained. “It means we have the same capabilities as many of the larger medical facilities in the country.”
Invisible enemy unveiled by Rocky Mountain Laboratories researchers
Perry Backus, Billings Gazette
April 7, 2020
This scanning electron microscope image shows SARS-CoV-2 (yellow) – also known as 2019-nCoV, the virus that causes COVID-19 – isolated from a patient in the U.S., emerging from the surface of cells (blue/pink) cultured in the lab.
Researchers at Rocky Mountain Laboratories have been working hard to put a face on an invisible enemy that has turned the world upside down.
Using electron microscopes capable of producing images of a virus 10,000 times smaller than a human hair, the scientists have provided researchers around the world with invaluable information on the inner workings of the novel coronavirus.
One of the first images widely disseminated by RLM displays a series of yellow dots against a background of blues and purples. The yellow dots are the coronavirus shedding off a cell cultured at the laboratories from one of the first patients inflicted with COVID-19 in the United States.
“The virus is a very small part of a cell,” said RML’s Research Technologies Branch interim chief Beth Fischer, who leads the laboratories’ microscopy unit. “Most people don’t have an idea of scale. It’s something that we look at all the time.”
“In this case, we are sharing an image of what to many is an invisible enemy,” she said. “Hopefully, it can take a bit of mystery out of the adversary and give people something they can actually visualize
A vial of the remdesivir, an investigational drug from Gilead. Gilead Sciences via AP
A Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.
The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.
The outcomes offer only a snapshot of remdesivir’s effectiveness. The same trials are being run concurrently at other institutions, and it’s impossible to determine the full study results with any certainty. Still, no other clinical data from the Gilead studies have been released to date, and excitement is high. Last month, President Trump touted the potential for remdesivir – as he has for many still-unproven treatments – and said it “seems to have a very good result.”
In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
The past few weeks have been a whirlwind for our industry, as companies wage a fierce battle against COVID-19-from the biopharmas researching and developing treatments, vaccines and diagnostics in record time, to biofuel producers shifting to manufacture hand sanitizer for frontline medical workers, to the food industry ensuring the public has plenty of healthy, comforting produce to eat, to even BIO’s staff, working round-the-clock from home to continue facilitating critical industry collaboration.
To quote former CDC Director Dr. Julie Gerberding, EVP and Chief Patient Officer at BIO member Merck, “This is the industry’s finest moment.” It’s clear we all have an important role to play-and it’s clear the biotech industry will lead the world out of the crisis.
To achieve the rapid progress we need right now, we formed the BIO Coronavirus Collaboration Initiative (BCCI),led by Dr. George Scangos, CEO of Vir Biopharmaceuticals, alongside Phyllis Arthur, BIO’s VP of Infectious Disease and Diagnostics Policy. In 48 hours, we organized an online resource hub for companies to get information and tools they need, and in March we held a virtual summit, which brought together more than 500 stakeholders to collaborate and work towards solutions, as quickly as possible. (Keep reading below for more on both efforts.)
We’ve also had to make some tough decisions-like changing the 2020 BIO International Convention, scheduled for June 8-11, to a digital format this year. While BIO Digital 2020 is not a substitute for in-person meetings, we know the industry relies on BIO to continue facilitating collaboration. So, we quickly put together a virtual conference with expanded partnering opportunities and expert-level educational content, mixing live and on-demand sessions…because nothing stops innovation. Watch our video announcement to learn more about it:
While there’s still much we don’t know about the weeks and months ahead, we do know the American biotech industry will lead us through this challenge-and I’m confident we’ll soon be able to look back on this time as one of the industry’s finest moments.
Bozeman area businesses making medical gowns, masks for hospital
Simms Fishing Products in Four Corners has begun producing gowns for hospital workers in response to the COVID-19 pandemic. Courtesy of John Frazier/ Simms Fishing
Simms Fishing Products has stopped making outdoor equipment in its Bozeman plant and is now producing medical gowns for Bozeman Health.
Simms, which delivered its first batch of reusable gowns on Friday, is one of several local businesses designing and manufacturing personal protective equipment in the face of a nationwide shortage stemming from the coronavirus pandemic.
Simms and Bozeman Health worked on the new medical gowns with financial donations from the Yellowstone Club Community Foundation and the Arthur M. Blank Foundation.
Like Simms, Bridger Aerospace and Ascent Vision Technologies, sister companies in Belgrade, have joined local efforts. The two companies are now making masks at their hangar near Bozeman-Yellowstone International Airport.
Spark R&D Co-Owner Will Ritter holds up a mask made at the company’s factory. Courtesy of Spark R&D.
This weekend, the companies produced their first mask and plan to donate 1,000 to Bozeman Health and local fire departments. Some may be sent to other places in the state, said Tim Sheehy, CEO of Bridger Aerospace and Ascent Vision Technologies.
Spark R&D, another local manufacturer, has been trying to make it easier for companies to produce masks. The business took a design for a 3D-printed mask – called the Montana Mask – and modified it for injection molding.
Spark R&D has made the injection-molding design available for free on its website. The local business is also using the design to produce masks. Spark R&D delivered its first 2,400 masks to Billings Clinic on Saturday and is making more.
Seeking New Businesses and Better Lives, Investors on the Coasts Move Inland
A wave of venture capitalists is heading to quieter, less-expensive locales, where they are helping fund start-ups.
By Craig S. Smith, The New York Times
April 15, 2020
Will Price is among the venture capitalists leaving the coasts for the interior. “We moved just to get out of the Bay Area,” said Mr. Price, who now lives in Montana.Credit…Janie Osborne for The New York Times.
Will Price grew up traveling the world, the son of a globe-trotting banker, and became a venture capitalist in Silicon Valley. But when he wanted to raise a family, he moved to Montana and started a fund of his own.
“We moved just to get out of the Bay Area,” said Mr. Price, founder and general partner of Next Frontier Capital. “I wanted to bring capital to places where capital hadn’t previously invested.”
Mr. Price, 48, is part of a growing wave of V.C. professionals leaving the congested, costly coasts for quieter, less expensive locales where they are helping fund start-ups in places like Montana, Nebraska, New Mexico and North Carolina. No longer do ambitious young entrepreneurs have to relocate to California, New York or Boston to build a business. Start-up ecosystems coalescing across the United States have sparked a surge in small businesses, many with national or even global ambitions.
The trend, focused largely on software companies or online businesses, has been facilitated by cloud computing, which gives anyone with an internet connection and a credit card access to almost unlimited computing power. Beyond that, experts agree that a few key ingredients are necessary to get an innovation hub rolling: a nearby research university, local wealth and an airport with flights to the coasts.
In Montana, Mr. Price discovered several businesses that were profitable and growing. Submittable, a company based in Missoula, automates the processing of all kinds of online submissions, including job applications and peer review journal articles. When Mr. Price periodically visited its offices, he noticed another company that kept taking more space in the building. That was LumenAd, which sells software for digital advertisers so they can compare things like video views that are counted differently on different ad platforms.
“Covid-19 will accelerate the demographic shift away from coasts,” Mr. Price said, echoing a sentiment heard from other V.C.s that the demand for capital may dip in a recession, but the inland trend will continue.
When collaboration is more vital than ever, you can still rely on BIO to bring the industry together.
For 2020, the BIO International Convention will transition to a new, virtual event format, BIO Digital. This virtual gathering of the global biotech industry provides access to key partners via BIO One-on-One Partnering, educational resources to help drive your business, and the insights you need to continue critical research and development.
We may not be able to gather in person, but nothing stops innovation.
Save the date! The SBIR Road Tour will include reverse pitches from SBIR agencies about their technology needs and programs, panels with US Patent and Trademark Office and Federal Lab Consortium representatives, one-on-one meetings with agency representatives and Montana service providers, and panels with successful Montana tech companies, accelerators, and business assistance providers.
Your registration will include all pre-conference webinars including an introduction to SBIR/STTR seed funding and how to prepare your pitch or quad chart for your one-on-one meetings with SBIR program managers. Registration will open in April!
Through its partnership with BIO, the Montana Bioscience Alliance (MBA) offers its members the opportunity to take advantage of the BIO Business Solutions® programs listed below. Click on the company name to learn more.
The Montana Bioscience Alliance serves as a hub for Montana’s biotechnology companies, entrepreneurs, laboratories, hospitals, clinics and universities to commercialize, grow and sustain globally competitive bioscience companies — ultimately to create high-quality jobs and economic opportunity in Montana.
Montana BioScience Alliance