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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.

 

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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.

 

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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

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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).

 

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The BioHealth Capital Region Forum Planning Committee has made the difficult decision to postpone our 6th annual BioHealth Capital Region Forum that was scheduled for April 14th and 15th at AstraZeneca. We believe the health and safety of all participants is of paramount importance. Following the most recent reports from the CDC, the WHO, and the state of Maryland’s ban on gatherings of 250 people or more, we have made this decision.

 

Bendis- and Edelstein

Executive Director of the Universities at Shady Grove, Stewart L. Edelstein, Ph.D., joins BioTalk to discuss his career, USG, and its role in the BioHealth Capital Region

Dr. Stewart Edelstein joined the Universities at Shady Grove (USG) as Executive Director in 2002 and in 2007 was named to the dual title of Associate Vice Chancellor for Academic Affairs for the University System of Maryland (USM).

USG is a regional campus of USM that offers both undergraduate and graduate degree programs from nine partner universities. During Dr. Edelstein’s tenure, USG expanded its number of participating universities, as well as the breadth and depth of its academic programs, and enrollment has grown significantly, to more than 3,000 students. The campus’s capacity for future enrollment growth has doubled with the recent opening of a new Biomedical Sciences and Engineering Education Facility, which is expanding degree and certification offerings in healthcare, engineering, biosciences, computer science and other areas.

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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.

 

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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

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).

 

Coronavirus vaccine news boosting Gaithersburg s Novavax Washington Business Journal

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.

 

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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

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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)

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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.

 

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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.

 

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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

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.

 

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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."

 

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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

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.

 

Giving It Their All Maryland Company Ready To Manufacture Potential Coronavirus Vaccines CBS Baltimore

BALTIMORE (WJZ) — A Maryland company said it’s ready to manufacture multiple potential coronavirus vaccines.

Emergent BioSolutions manufactures drugs like Narcan and was involved in the Ebola response. Now, the Baltimore manufacturing facility will be involved with two companies hoping to develop a coronavirus vaccine.

“Our people certainly feel that level of responsibility and they’re giving it their all,” Emergent’s senior vice president Syed Husain said.

Image: https://baltimore.cbslocal.com - From Video

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Thirty innovators will compete on March 23, 2020 in a virtual showcase

WASHINGTON, March 19, 2020 /PRNewswire/ --  Thirty semi-finalists have been named in the annual "Make Your Medical Device Pitch for Kids!" competition presented by the National Capital Consortium for Pediatric Medical Devices (NCC-PDI).  The competition is adopting a virtual format for the March 23rd event to eliminate the need for travel or an in-person gathering due to the COVID-19 pandemic. Organized by nonprofit accelerator MedTech Innovator, contestants and judges will connect in online meeting rooms for the pitch presentations, which feature innovations in cardiovascular, orthopedic and spine, and NICU devices.

 

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Hosting Online Event Leadership Summit, Thursday, March 19 @ 1 pm EST

WASHINGTON, March 19, 2020 /PRNewswire/ -- VIVA Creative, a leading Metro DC live events producer and creative agency, is helping companies quickly move canceled events online. VIVA became a leading producer of online and virtual events post 9/11, and again during the global financial crisis. Today, the company brings expertise in audience engagement and communication in times of restricted travel.  As several brands and event organizers are canceling or postponing major meetings due to COVID-19, VIVA is offering immediate solutions. 

 

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Not long ago, American entrepreneur and President of Lung Biotechnology PBC, Martine Rothblatt, was told her aspiration of converting conventional helicopters to electric power was impossible.

Fast forward to 2018 and not only is it a possibility but it’s also a reality – a reality that has granted Rothblatt along with her "dream team" – Tier 1 Engineering (USA) and test pilot, Captain Ric Webb of OC Helicopters (USA) – an official Guinness World Records title for Farthest flight by an electric helicopter (prototype).

Image: https://www.guinnessworldrecords.com

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TERLING, Va., March 20, 2020 /PRNewswire/ -- Aperiomics, a biotechnology company deploying advanced technologies to identify the root causes of infectious disease, announced today it is now offering a test for the novel coronavirus.

Aperiomics' Xplore-COVID-19™ test is available nationwide today and the company has already begun taking orders for the test. With the ability to process up to 1000 coronavirus tests per week, Aperiomics can provide test results within 48 to 72 hours of receiving a sample. The tests, which can be ordered for patients at a cost of $250 per sample, utilize a PCR technique designed to identify specific genetic markers within the coronavirus using samples obtained via throat swabs. This test utilizes existing sample collection, DNA extraction, and PCR identification technologies.

 

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In accordance with state and federal recommendations to combat COVID19, BioHealth Innovation has modified the EIR Feedback Sessions for the near future to take place by videoconference only.   There now are a couple openings tomorrow (3/18).  To participate in this session, please register using this link www.tinyurl.com/EIRfeedback feedback and send your ppt presentation including the top 3 topics on which you would like feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. by 2 p.m. 3/17/20.  The next sessions are scheduled to take place by videoconference on 4/22 and 5/27.

 
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OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI's team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

 
The HullSkater cleans boat bottoms to make them more efficient

Cargo ships are huge polluters—in 2015, as they traveled the ocean delivering everything from smartphones to bananas, they emitted more than 200 million metric tons of CO2, roughly as much as the entire country of Vietnam. Unlike cars, which can easily be replaced with electric versions, ships are harder to decarbonize. But a relatively simple intervention from a new type of underwater robot can help significantly shrink emissions.

Image: Semcon - https://www.fastcompany.com

Scientist Drugstore Microscope Free photo on Pixabay

It’s at the center of some of the most groundbreaking work to advance human ingenuity in the region — and save lives. And, economically, it’s been home to some of the biggest news about M&A activity, venture capital and job growth. When it comes to growing industries, the life sciences sector is among the most impactful in the area. Spanning hospital research labs and manufacturing centers where production takes place, harnessing living cells to create new treatments and other biotech, biomedical and pharma work is happening in a footprint that knits together Baltimore, the Maryland suburbs, D.C. and Northern Virginia.

 

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GAITHERSBURG, Md., March 10, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing (CDMO) services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19). Under the terms of the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.

 

Jayson Derrick

Global life sciences company Emergent Biosolutions Inc EBS 6.61% CEO Bob Kramer said Thursday that his company's partnership with Novavax, Inc. NVAX 6.3% could result in the creation of a therapy that poses a "fairly low risk."

Emergent Has Past Experience With Anthrax, Botulism Emergent is using its own platform to help Novavax with the creation of a coronavirus vaccine, Kramer said during a guest appearance on CNBC's "Squawk Box" segment Thursday morning. 

 

Adaptive Phage Therapeutics A New World of Treatment

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank™, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).

 

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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it will develop a new QIAstat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections and will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). Accelerated development of the QIAstat-Dx test kit further expands QIAGEN’s global mobilization for the emergency, which already includes a dramatic increase in production of components for a full range of U.S. and international testing protocols.

 

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The Food and Drug Administration has given an emergency approval to a test made by Swiss drug and diagnostics maker Roche for detecting the Covid-19 virus.

The company said Friday that the FDA had approved an emergency use authorization, or EUA, to its Cobas SARS-CoV-2 test. The test is designed to use nasopharyngeal and oropharyngeal swab samples to detect the coronavirus using Roche’s Cobas 6800 and 8800 lab-testing systems. The systems are designed to provide thousands of results over a 24-hour period, the company said.

 

Kristen Valdes

Baltimore health tech startup b. well Connected Health has raised a $16 million round as it looks to accelerate its growth.

The Series A round was led by UnityPoint Health Ventures, the venture capital arm of UnityPoint Health, an Iowa-based health system. Other investors include Wisconsin-based community health system ThedaCare and Well Ventures, a subsidiary of Walgreens Boots Alliance Inc., according to a release. The five-year-old company has previously raised $11.5 million in seed funding, bringing its total funding to over $27 million. In 2018, b. well also raised a total of $8.2 million in convertible debt funding from more than 60 investors.