As the world anxiously awaits a coronavirus vaccine, a Maryland biotechnology company already has signed deals to do initial production of three candidates. If one of them works, the firm has a factory in place to manufacture hundreds of millions of doses a year.

Emergent BioSolutions of Gaithersburg has long been preparing for a global disease outbreak. The firm got started making a vaccine against anthrax, and since then has produced candidates for the Ebola and Zika viruses.

Image: Luis M. Branco, PhD Managing Director and Co-Founder

Emergent BioSolutions Inc.’s $135 million deal struck late last month to manufacture Johnson & Johnson’s Covid-19 vaccine candidate isn’t just a big financial win for the company — it’s also a key geopolitical move in the race to defeat the virus.

According to The New York Times, the Department of Health and Human Services made sure Johnson & Johnson (NYSE: JNJ) — which is headquartered in New Jersey but has its research based in the Netherlands — joined a manufacturing partnership with the Maryland-based biotech to ensure the earliest available large batches of the vaccine, if approved, are produced stateside.

Grants for Technology Product Development

Market-driven new technology and innovation leads to new products and new jobs. Creating jobs in innovative Maryland companies is what the Maryland Industrial Partnerships (MIPS) program has been doing for 32 years: bringing the inventive minds and extensive laboratory resources of the University System of Maryland (USM) to bear on creating the new products that feed the growth of Maryland businesses. Since the program’s inception in 1987, MIPS–enabled products have generated sales of $40 B.  MIPS is nationally recognized by the U.S. Small Business Administration as a model program for best practices in transferring technology and is a proven program that contributes significantly to job creation and high tech product development in Maryland.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is urgently soliciting proposals and can provide up to $500M across multiple projects to rapidly produce innovative SARS-CoV-2 diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics (RADx), is a fast-track technology development program that leverages the National Institutes of Health (NIH) Point-of-Care Technology Research Network (POCTRN). RADx will support novel solutions that build the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches. RADx is structured to deliver innovative testing strategies to the public as soon as late summer 2020 and is an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available to every American.

Johns Hopkins University has been given $200,000 in federal funds to support its global COVID-19 tracker that has become the preeminent resource worldwide for tracking the spread of the coronavirus.

Democratic Senators Ben Cardin and Chris Van Hollen and Democratic Representatives Dutch Ruppersberger and John P. Sarbanes said the federal funds will be disbursed through the National Science Foundation Rapid Response Research grant program. The federal coronavirus stimulus package, under the CARES Act, allocated $75 million to the foundation to fund efforts that prevent, prepare for and respond to the coronavirus, domestically or internationally.

BASEL: Roche Holding received emergency use approval from the US Food and Drug Administration (FDA) for an antibody test to help determine if people have ever been infected with the coronavirus, the Swiss drugmaker said on Sunday (May 3).

Governments, businesses and individuals are seeking such blood tests, to help them learn more about who may have had the disease, who may have some immunity and to potentially craft strategies to end lockdowns that have battered global economies.

Beth Blauer and Dr. Jennifer Nuzzo, two key members of the Johns Hopkins team that is tracking every confirmed coronavirus case, tell Brian Stelter how they do it, what the numbers do and don't reveal, and why people can have confidence in the data, even though it is incomplete. With regards to the death toll, "we may see that the true number is actually larger than what's been reported," Nuzzo says, "not the other way around."

Scientists at George Mason University are working to develop an easy-to-administer COVID-19 antibody test, which could mean using a simple swab in the mouth for saliva.

Dr. Lance Liotta works for the Applied Proteomics and Molecular Medicine Center at GMU. He said they’ve been working on saliva testing for many years and already had a collection device that would work.

“We thought let's apply our expertise on that topic to that new challenge,” Liotta said.

Image: https://www.nbcwashington.com

The Association of University Research Parks (AURP), a global nonprofit membership organization serving the university and institutional research parks community, today announced its BIO Health Caucus will take place June 3-4, 2020 in a digital environment. AURP’s BIO Health Caucus represents anchor life science institutions building communities of health innovations in the U.S and around the world.

AURP’s 2020 BIO Health Caucus explores trends in life science research, opportunity zone funding, the marriage of life science and philanthropy, and finding funding for projects and facilities during a global pandemic. At this digital event, attendees will discover the role that biomedical clusters play in innovation ecosystems and translating discoveries from lab to market.

Image: Joel Marcus

The Association of University Research Parks (AURP), a global nonprofit membership organization serving the university and institutional research parks community, today announced its BIO Health Caucus will take place June 3-4, 2020 in a digital environment. AURP’s BIO Health Caucus represents anchor life science institutions building communities of health innovations in the U.S and around the world.

AURP’s 2020 BIO Health Caucus explores trends in life science research, opportunity zone funding, the marriage of life science and philanthropy, and finding funding for projects and facilities during a global pandemic. At this digital event, attendees will discover the role that biomedical clusters play in innovation ecosystems and translating discoveries from lab to market.

Image: Joel Marcus

Larry Hogan has got another of his ideas, and this one cracks him up. “I’m gonna call Pence!” says Hogan, startling his chief of staff, Matthew Clark, who sits across a large, round faux-wood table. Hogan, the Republican governor of Maryland, is meeting with his coronavirus command team, a skeleton crew of state officials still reporting to the capitol in Annapolis. The conference rooms are all too narrow, so they are gathered in a cavernous event room, seated in alternate chairs to maintain social distancing. Hogan, a ruddy 63-year-old with jug-handle ears, has in front of him a dispenser of hand sanitizer, a can of Diet Coke and a starfish-shaped conference-call speaker.

Image: https://governor.maryland.gov/governor-larry-hogan/

Sponsored by the Division of Strategic Partnerships and Applied Research, the StarTUp Accelerator supports student and local business ventures in an intensive eight-week, cohort-based fellowship where start-up businesses take residency and work in a collaborative space to accelerate their ventures. The inaugural cohort is a diverse group that includes two student-based ventures, a 100% halal-certified consumer cosmetics brand, a sports betting game from recent TU grads, and ventures from current TU faculty.

Sykesville, MD; March 13, 2020- Noble Life Sciences is excited to announce renewal of full accreditation from Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council. Noble Life Sciences has held full AAALAC accreditation since October 10, 1989. Accredited contract research organizations (CROs) are re-evaluated every three years through an extensive internal review and on-site inspection conducted by members of AAALAC accreditation council and reviewed by the full council to determine accreditation status.

AstraZeneca will oversee global development, manufacturing, and distribution of the COVID-19 vaccine candidate that was created by researchers at University of Oxford, and is now being studied in a human clinical trial launched last week, the partners said today.

AstraZeneca, the University, and its spinout company Vaccitech—which has joint rights to the platform technology behind the vaccine candidate, ChAdOx1 nCoV-19—said they will start work immediately while hammering out final terms of their collaboration agreement. The partnership is designed to enable rapid production and distribution of the vaccine should it prove effective in clinical studies.

Image: AstraZeneca will oversee global development, manufacturing, and distribution of the COVID-19 vaccine candidate that was created by researchers at University of Oxford, and is now being studied in a human clinical trial launched last week. (University of Oxford)

Vaccitech Ltd and the University of Oxford today announce an agreement with the UK-based global biopharmaceutical company AstraZeneca for the further development, large-scale manufacture and potential distribution of the COVID-19 vaccine candidate currently being trialled by the University.

The partnership is to begin immediately with the final terms being agreed in the coming weeks. This will allow for rapid vaccination around the world if the COVID-19 vaccine candidate proves to be effective. The vaccine candidate was developed by the University’s Jenner Institute who began trials in humans last week jointly with the University’s Oxford Vaccine Group.

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the first patient was dosed in a randomized, doubleblind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 patients with severe pneumonia.

The primary objective of this investigator-sponsored trial, named FORCEa , is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).

Since the enactment of the CARES Act, the Small Business Administration and U.S. Department of the Treasury have continually updated the rules governing the Paycheck Protection Program (PPP) through formal rulemaking and less formal guidance. In some cases, these rules and guidance have contradicted the plain language of the Act itself.

The PPP, of course, is designed to provide businesses and nonprofits with 500 or fewer employees (subject to certain notable exceptions) access to 2 months of payroll for their employees in light of the economic uncertainty brought on by the COVID-19 Pandemic.

The National Institutes of Health today announced a new initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies, a pivotal component needed to return to normal during this unprecedented global pandemic. With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. At the same time, NIH will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability. NIH will work closely with the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority (BARDA) to advance these goals.

Image: https://www.nibib.nih.gov

Gilead Sciences’ closely-watched COVID-19 drug candidate remdesivir outperformed placebo in a clinical trial sponsored by the NIH’s National Institute of Allergy and Infectious Disease (NIAID), the agency announced today—the first clinical study launched in the U.S. of a therapeutic for the virus.

NIAID released preliminary data showing that the study met its primary outcome of statistically significant improvement in time to recovery by Day 29. Patients who were treated with remdesivir showed a median time to recovery of 11 days compared with 15 days for those who received placebo—a 31% faster time to recovery.

Gilson and QIAGEN have entered into a strategic partnership that will provide researchers the ability to limit operator-dependent variation in their manual nucleic acid extraction results and improve the traceability of their workflows.

This agreement brings together two influential leaders in the life science industries: Gilson, a global manufacturer of sample preparation technology, and QIAGEN, a leading global provider of molecular diagnostics and sample preparation technologies.

This collaboration will integrate Gilson’s TRACKMAN® Connected digital bench tools and QIAGEN’s manual nucleic acid extraction kits to create consistency between collaborators, increase confidence in their execution of extraction protocols, and improve traceability at the bench.

Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test.

The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the company.

Image: Image Credits: Ed Uthman / Flickr (opens in a new window)under a CC BY 2.0 license.

BALTIMORE--(BUSINESS WIRE)--Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

BALTIMORE, Md., April 27, 2020 /PRNewswire/ -- LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

"We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors," stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. "The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible."

Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

FDA Cleared Medical Device Improves Feeding Outcomes of Infants Born Prematurely

Olathe, KS and Rockville, MD, April 28, 2020—Innara Health, developer of the only FDA cleared medical device designed to improve the feeding outcomes of infants born prematurely, is partnering with BioHealth Innovation (BHI) to support the company’s plans for growth through greater market access and the development of NextGen technology.  Innara Health is dedicated to improving feeding outcomes for newborn and infants born prematurely.  “As we continue to expand our domestic footprint, we are very fortunate to call BHI our partner as their infrastructure and access will certainly support Innara in our journey to redesign the NTrainer, enter into adjacent markets, and expand globally” states Innara CEO Chris Mathia.  “We are excited to support Chris and his team as they expand, grow and develop new technology ultimately enabling many more NICU patients to return home to their families sooner and healthier” said BHI CEO Rich Bendis.

ANNAPOLIS, MD—After weeks of consulting with leading scientists, business leaders, and public health experts, Governor Larry Hogan today introduced the ‘Maryland Strong: Roadmap to Recovery,’ which provides a safe, effective, and gradual approach to reopening the state as it continues to combat the COVID-19 pandemic.

“As we begin to reopen, it will continue to be important for Marylanders, particularly older and more vulnerable Marylanders, to continue to stay home as much as they can,” said Governor Hogan. “All Marylanders should continue to avoid crowds and gatherings, and they should continue to practice physical distancing and to take precautions to protect themselves, their families, and their fellow Marylanders. Together, we are going to defeat this virus, and together, the State of Maryland will return stronger and better than ever.”

Image: https://governor.maryland.gov

Maryland Gov. Larry Hogan on Friday announced his three-phase plan to eventually reopen the state amid the coronavirus pandemic.

Hogan called the plan a “well-thought-out, gradual, safe and effective path forward,” supported by four pillars he has spoken about often in recent weeks: increases in testing, personal protective equipment, contact tracing and hospital surge capacity.

Working as an emergency and critical care physician at the University of Maryland School of Medicine, Dr. Steven Tropello is seeing the lack of protective equipment for medical workers up close.

One particular area is during a procedure in which a tube is inserted into a patient’s airway, called intubation. It’s necessary to place someone on a ventilator, but presents danger of spreading the new coronavirus through the air or touch to doctors if they lack protection.

Image: CareCove. (Courtesy photo)

Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

A Baltimore company will be at the forefront of producing a potential coronavirus vaccine.

Once a COVID-19 vaccine is ready for mass production, the company is going to be making hundreds of millions of them.

"We'll be providing the drug substance manufacturing which is essentially the vaccine itself," says Syed Husain, senior vice president of Emergent BioSolutions.

All of that work will happen at Emergent BioSolutions, which is located in front of Johns Hopkins Bayview.

The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.

Image: https://www.biospace.com

In a different year, incoming freshmen would already have in hand a tightly choreographed schedule for late summer and early fall: the move-in date, the orientation and, finally, the first day of classes.

But on the coronavirus pandemic calendar, there are no dates yet for the next academic year. Just scenarios. And that unprecedented uncertainty is fueling a second wave of crisis for schools already plunged into financial distress.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, says “we are not in a situation where we can say we are exactly where we want to be with regard to testing” capacity for COVID-19 in the U.S.

Fauci, in a discussion for TIME 100 Talks: Finding Hope on Thursday, says that the U.S. needs to not only increase the number of tests, which is happening as commercial testing companies increase production and the Food and Drug Administration continues to clear tests using different types of samples (including ones from the nose and saliva, as well as blood). But, he says, we also needs to make sure tests can actually be run the way they should.

Johnson & Johnson (NYSE:JNJ) says it will work with Emergent BioSolutions (NYSE:EBS) to produce more than a billion doses of a COVID-19 vaccine candidate, as it seeks to scale up global manufacturing of its potential treatment.

J&J says it is already preparing for clinical vaccine production at its Leiden facility in the Netherlands, with the aim of starting its Phase 1 clinical trial of its vaccine candidate on humans in September and potentially having it ready under an emergency use authorization next year.