Biohealth Innovation - 398th Edition

BioHealth Innovation

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March 24, 2020

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BioHealth Capital Region Resources for Businesses Impacted by COVID-19

Here are some resources you might find useful if you’re impacted by COVID-19

Volunteers

Urgent Need for Healthcare Workers

As our community responds to COVID-19, Adventist HealthCare hospitals are caring for those most impacted by the virus in our community. Their need for health care professionals will grow more urgent as the number of local cases increase. As part of its preparedness planning, Adventist HealthCare is asking the research community to help. They are looking for physicians, nurses or technicians who could assist with testing, registration and patient care. If you would be willing to serve Adventist HealthCare during this unprecedented time, please contact Yasmin Nasser at (This email address is being protected from spambots. You need JavaScript enabled to view it./301-315-3220) to be added to a list of reserve employees. Whether you are social distancing and practicing good hygiene, or choose to serve in a more direct way, we applaud everyone’s efforts to stop the spread of COVID-19 in our community.

BHI portfolio company MockV Solutions led by David Cetlin acquired by Maravai LifeSciences

SAN DIEGO (March 17, 2020) – Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech partners, announced today that it has acquired MockV Solutions. MockV plays an important role in helping biopharma customers develop manufacturing processes that are free of viral contamination, leading to the production of safe biotherapeutics. The MockV acquisition, coupled with Maravai’s previous acquisition of Cygnus Technologies, expands Maravai’s leadership position in bioprocess impurity testing. Impurity testing is a critical step in the development and manufacture of biotherapeutic products.

QIAGEN dramatically ramping up global production capacity for RNA extraction kits for use in detection of SARS-CoV-2 coronavirus

Hilden, Germany, and Germantown, Maryland, March 17, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to dramatically ramp up global production capacity of RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the novel coronavirus that causes COVID-19.

QIAGEN has historically allocated global production capacity to manufacture RNA nucleic extraction reagents to supply about 1.5 million patient tests on a monthly basis. Now QIAGEN is ramping up production capacity for these reagents to support a level of more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June 2020. A significant capacity expansion project is underway at sites in Europe and the United States to reach more than 20 million patient tests on a monthly basis by the end of 2020 to support the response to this global public health crisis.

For Maryland, medical worker shortage may be top concern as coronavirus spreads | WTOP

There have been concerns about possible shortages of hospital beds and protective gear during the COVID-19 pandemic, but the biggest concern in Maryland may be not having enough medical workers.

“Staffing might be more of a constraint than beds and supportive equipment,” said Bob Atlas, president and CEO of the Maryland Hospital Association. The group represents all of the state’s hospitals.

Emergent Biosolutions will manufacture Vaxart's experimental coronavirus vaccine in Baltimore - Technical.ly Baltimore

Gaithersburg-based Emergent Biosolutions on Wednesday said it signed a second agreement in a week that will bring manufacturing of a coronavirus vaccine candidate to Baltimore.

The new agreement is with Vaxart, a San Francisco-based biotechnology company that is developing an experimental oral vaccine candidate that would be administered by tablet.

Image: https://technical.ly - Courtesy photo

COVID-19 Resources for Applicants and Recipients of NIH Funding | NIH Extramural Nexus

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. This is a rapidly evolving situation, and we are aware that many institutions are taking a variety of “social distancing” measures, including switching to telework and cancelling or postponing classes and non-essential meetings.

In Conversation: Sean Kirk, Emergent BioSolutions · BioBuzz

Following up on the recent article Two Maryland Biotechs Partner to Bring Coronavirus/COVID-19 Vaccine Candidate into Clinical Trials, BioBuzz had the opportunity to speak with Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.

Let’s start by having you provide a brief background on your role at Emergent.

I have been with the company for nearly 17 years, and have had the good fortune of working in and being responsible for many key parts of the business including manufacturing operations, quality assurance, regulatory affairs, product development, U.S. government program management, global operational excellence, global supply chain, medical and clinical affairs. In these roles I have spent a lot of time across Emergent’s sites and have been based in Lansing, Mich. – where I started – Gaithersburg, Md, and Winnipeg, Manitoba.

Emergent BioSolutions Signs Development and Manufacturing Agreement with Vaxart for their Experimental Oral Vaccine Candidate for Coronavirus Disease - BioHealth Capital Region

GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

Critical Conversations with Rich Bendis

Rich speaks with VIVA Creative • Business Development & Strategic Partnerships. Image:

http://vivacreative.vzaar.me - From Video

http://vivacreative.vzaar.me/21376036

Maryland company swamped with applicants to help assemble coronavirus test kits | wusa9.com

GERMANTOWN, Md. — German company Qiagen is racing to assemble new COVID-19 test kits. Already approved for use in Europe, Qiagen’s new kits are now getting assembled in their North American headquarters in Germantown, Maryland.

Image: Qiagen's North American headquarters in Germantown, Maryland Nathan Baca

Catching Up to Coronavirus: Top 60 Treatments in Development

Anthony Fauci, MD, Director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), offered hope to the thousands of people with confirmed cases of COVID-19, and the millions around the world whose lives have been disrupted by the pandemic caused by SARS-CoV-2, when he expressed to a congressional panel last week his hope that the first patients would be dosed with vaccines in development for the novel coronavirus “in a few weeks.”

Md. biotech companies are working on new COVID-19 vaccines, tests - Baltimore Business Journal

Novavax and Emergent Biosolutions are not the only Maryland companies developing COVID-19 countermeasures. More than 15 local companies will meet virtually Friday to share their efforts.

Image: Maryland biotechs are coming together to build vaccines and diagnostic tests for COVID-19. CENTERS FOR DISEASE CONTROL AND PREVENTION

Pathogen-testing company Aperiomics has launched a COVID-19 test - Technical.ly DC

Sterling, Virginia-based biotech company Aperiomics has launched a new test that can detect COVID-19.

Founded in 2014, the company uses genomic analysis and machine learning to detect known pathogens from a sample of any nature in just one test. Aperiomics reports that its Xplore-PATHO tech can accurately identify nearly 40,000 microorganisms including over 12,000 clinically relevant pathogens.

Image: An Xplore-COVID-19 testing kit from Aperiomics - Courtesy Photo

FDA Just Approved a Rapid Coronavirus Test That Can Diagnose COVID-19 in 45 Minutes

The US Food and Drug Administration has approved a coronavirus test that can deliver a COVID-19 diagnosis in 45 minutes.

The test, made by California-based Cepheid, got emergency clearance on Saturday, eight days after the agency gave fast-track approval for a test by Roche, which can diagnose the novel coronavirus within three hours.

These 17 Maryland biotech companies are collaborating in the fight against COVID-19 - Technical.ly Baltimore

As more cases of COVID-19 are being reported and leaders seek tests and treatments, biotech companies are stepping up efforts to develop new tests and treatments.

That includes Maryland, where life sciences companies are working on vaccines, therapeutics and diagnostics. They’re also seeking to share what they’re working on and offer up resources: On Friday, Maryland Life Sciences is putting together a call with more than 15 companies where they’ll look to connect and share needs.

COVID-19 Reinfection Not a Concern, Monkey Study Suggests

Concerns about SARS-CoV-2 infection have reached an all-time high in the United States and around the globe. With increasing numbers of COVID-19 cases, hospitalizations, and deaths—and “social distancing” now a household word—the possibility of being infected is on everyone’s mind.

As if that weren’t enough to worry about, the surfacing of multiple personal accounts—primarily out of China and Japan—of patients who recovered after infection only to fall ill a second time, have some worried about the possibility of reinfection.

Lung Bioengineering in Silver Spring evaluates donated lungs to determine if they are suitable for transplant

Heather Phillips was supposed to be getting ready to join her extended family at its annual pumpkin carving celebration in Clarksburg, but instead she was still at work at Lung Bioengineering in downtown Silver Spring. It was late on a Saturday morning in October, and she’d been working all night. Now she stood inside the loading dock of the two-story building awaiting, for the third time in 12 hours, the delivery of an insulated cardboard box filled with ice and a pair of human lungs.

Image: Specialists Sam Popa (left) and Erin Larrabee prepare a set of lungs in a Lung Bioengineering operating room. Photo by Lisa Helfert

Aurinia Pharmaceuticals, helmed by Peter Greenleaf, expands into Rockville - Washington Business Journal

A Canadian pharmaceutical company is expanding into Rockville about a year after an executive with a long history in Maryland’s bioscience industry took the helm.

Aurinia Pharmaceuticals Inc. of Victoria, British Columbia, announced plans to open a new office in the city of Rockville on Tuesday, bringing about 100 employees to 30,000 square feet. The company could someday expand to employ as many as 500 people and occupy up to 120,000 square feet in Rockville during the next seven years, depending on its success in securing federal approvals for one of its drugs.

Image: Peter Greenleaf, a biotech executive with lots of history locally, is bringing his latest company to Rockville. JOANNE S. LAWTON

Biobuzz Directory - Immunomic Therapeutics Announces Completion of Pre-IND Meeting With US FDA for ITI-1001, a Vaccine for the Treatment of GBM

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

Biobuzz Directory - Aurinia Pharmaceuticals to Bring 500 New Jobs to Maryland at New Commercial Operations Center in Rockville

VICTORIA, British Columbia--(BUSINESS WIRE)--

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that the Company has established its U.S. commercial center of operations in Rockville, Maryland. The new site will support Aurinia’s plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021.

Why Investment And IP Clustering Is Key To An Innovative Future Across The Globe, With Joel Marcus

Joel S. Marcus is the Executive Chairman and Founder of Alexandria Real Estate Equities, Inc. (NYSE:ARE), an urban office REIT and the first and longest-tenured owner, operator and developer uniquely focused on collaborative life science, technology and ag-tech campuses in AAA innovation cluster locations. Mr. Marcus co-founded Alexandria in 1994 as a garage startup with $19 million in Series A capital. As CEO from March 1997 to April 2018, he led its growth into an investment-grade-rated S&P 500 company.

Image: https://www.forbes.com

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

INDIANAPOLIS, March 16, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping the first allotment of its cobas® SARS-CoV-2 Test for COVID-19 (coronavirus) to a network of hospital and reference laboratories across the U.S. to enable automated, high-volume patient testing. Shipping of the initial 400,000 test kits began Friday, March 13, and will be completed this week. Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

Startups developing tech to combat COVID-19 urged to apply for fast-track EU funding | TechCrunch

The European Commission put out a call Friday for startups and small businesses which are developing technologies that could help combat the COVID-19 outbreak to apply for fast-track EU funding.

The push is related to a €164M pot of money that’s being made available for R&D via the European Innovation Council (EIC) — a European Union funding vehicle which supports the commercialization of high risk, high impact technologies.

GeneDx Celebrates 20 Year History as Pioneer In Genetic Sequencing and Testing · BioBuzz

GeneDx, a global leader in genomics and patient testing, is celebrating its remarkable 20th anniversary throughout the month of March.

The Gaithersburg, Maryland company has played an important role in the history of genetic sequencing and the rise of the BioHealth Capital Region as a global biohealth cluster. GeneDx was the very first company to commercially offer NGS (Next Generation Sequencing) testing in a CLIA (Clinical Laboratory Improvement Amendments) lab and has been at the leading edge of genetic sequencing and testing for two decades. The company’s whole exome sequencing program and comprehensive testing capabilities are world-renowned.

Image: https://biobuzz.io

Study Shows How Mild Coronavirus Infection is Beaten by Immune Response

Researchers at the Peter Doherty Institute for Infection and Immunity in Australia have mapped immune responses in a patient in response to COVID-19 infection, demonstrating the body’s ability to fight the virus and recover from the infection. The team tested blood samples taken from one of Australia’s first cases of COVID-19, at four different time points during the infection. “We looked at the whole breadth of the immune response in this patient using the knowledge we have built over many years of looking at immune responses in patients hospitalized with influenza,” said Oanh Nguyen, PhD, co-author of the researchers report, which is published in Nature Medicine.

Image: Outbreak response in action: Centers for Disease Control and Prevention (CDC) staff support the COVID-19 response in the CDC’s Emergency Operations Center (EOC). (CDC; photo credit James Gathany)

GSK, AstraZeneca, Genentech, and Novartis Identified as the Top Companies Driving Therapeutic Innovation in Asthma

MORRISTOWN, N.J., March 18, 2020 /PRNewswire/ -- In an ongoing series of research conducted by KMK Consulting, Inc. covering Innovation & Customer Value, GSK was ranked as the top company delivering superior customer value and sales force engagement, as well as delivering therapeutic innovation in the asthma market according to pulmonary disease specialists. The research was conducted in February 2020, using KMK's Rapid Pulse Survey platform. AstraZeneca, Genentech, and Novartis rounded out the top organizations driving innovation and customer value in this space.

Trials to begin on Covid-19 vaccine in UK next month | Health | The Guardian

A massive effort is under way to develop a UK vaccine for coronavirus within months and make it available to save lives before the end of the year, the Guardian has learned.

Researchers at Oxford University, led by Prof Sarah Gilbert, are planning a safety trial on humans of what is expected to be the UK’s first coronavirus vaccine next month. Provided that it goes smoothly, they will move directly into a larger trial to assess how effective the vaccine is at protecting against the infection.

Council Post: How Digitizing Healthcare Can Transform Patient Care

The biopharma industry spent $90 billion on R&D in 2016, a figure that represents about 20% of total sales. Despite this significant financial investment by the industry and splashy media headlines, how much, or little, is healthcare really digitizing?

During the 2020 JP Morgan Healthcare Conference, a panel of senior executives, including Brent Saunders, chairman, president and CEO of Allergan, Tariq Shaukat, president of industry product and solutions for Google Cloud, and Sara Nayeem, MD, partner at New Enterprise Associates, joined me to share their perspectives and insights on how biopharma and medtech companies are driving digital health.

Maryland Industrial Partnerships (MIPS) - SPRING 2020 UPDATE

Despite the serious impacts of the coronavirus, MIPS is continuing its normal business activities, although we have moved many of our operations online. Our upcoming round of proposals are due May 1 at 5 p.m. We continue to work with the Maryland business and academic communities to support your efforts to develop technology products and services. Now is an excellent time to develop new products in order to have them ready for market when the U.S. economy begins to recover in the not-too-distant future.

Thermo Fisher Scientific Continues Investments to Accelerate Biopharma Commercialization

NEEDHAM, Mass., March 23, 2020 /PRNewswire/ -- For biopharma companies faced with increasing demand for new biologics, cell and gene therapies, and drug products, Thermo Fisher Scientific is investing more than $475 million in new capabilities and capacity in 2020. This investment, in addition to those made in 2019, brings the total investment over two years to approximately $800 million across the company's pharma services business.

"We've invested strategically to ensure that lack of capabilities, capacity or supply is never a reason medicines are delayed in reaching patients," said Mike Shafer, president, Thermo Fisher's pharma services business. "Our offering can provide solutions at all points along the pathway to commercialization, whether it's an emerging biotech working on vaccine for a novel virus or a high-volume pharmaceutical manufacturer delivering necessary drugs at scale."

The Zidd and Fizz Show

Keeping angels and startups company while working from home! Great guests and great topics! The ZIDDANDFIZZ Show: Angels Talk Ziad Henry Moukheiber Faz Bashi hashtag#podcasting hashtag#podcasts

Cellphire Begins Phase 2 Trial of Thrombosomes® in Bleeding Thrombocytopenic Patients

ROCKVILLE, Md., March 18, 2020 /PRNewswire/ -- Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start a Phase 2 clinical trial of Thrombosomes in bleeding patients with thrombocytopenia.

In July 2019, Cellphire successfully completed a Phase I clinical trial of its lead product, Thrombosomes, a platelet-based freeze-dried hemostatic. Utilizing its patented technology to stabilize and freeze-dry platelets, Cellphire is developing next-generation therapeutics to treat bleeding patients. Standard liquid platelets only have a 5- to 7-day shelf life, making inventory management difficult and can lead to widespread platelet shortages during public health emergencies. By contrast, Thrombosomes have a 3-year shelf life.