Breethe

Last week, Abiomed acquired Baltimore-based startup Breethe for its innovative respiratory device. Breethe is a startup out of the University of Maryland, Baltimore (UMB) that was founded by Bartley P. Griffith, MD, the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery and director of the cardiac and lung transplant programs at the University of Maryland School of Medicine (UMSOM).

Image: https://www.umaryland.edu

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As a result of the ongoing COVID-19 pandemic and the impact on both government and business operations, under the authority of executive order, the Maryland Department of Commerce (Commerce) has delayed the application process for the FY21 BIITC until mid-August 2020. BIITC provides an income tax credit equal to 50% (more in certain locations) of an eligible investment in a QMBC up to $250,000 for each QMBC per fiscal year. Total credits issued during the fiscal year cannot exceed the budget amount and are, therefore, issued on a first come basis. The credit is refundable if the investor has no Maryland income tax liability. Please stay tuned to the Commerce website for updates regarding the new application system and dates. 

 
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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan?  Sign up by noon 5/22 to schedule your feedback session with BHI Entrepreneurs-in-Residence and analysts on May 27th.  Pre-registration is required; sign up here.  For questions/more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it. .

 
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Intralytix Receives Multimillion-Dollar Clinical Trial Award From NIAID to Manage Shigella Infections in Humans

COLUMBIA, Md., May 4, 2020 Intralytix, Inc. announced today that it has received a multimillion-dollar grant (AI 148054) from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), for the clinical development of its bacteriophage therapy preparation for managing infections caused by the bacterial pathogen Shigella. Dr. Alexander Sulakvelidze, Executive Vice President of Intralytix and the Program Director of the multi-PI grant, commented, "We are very pleased to have this collaborative opportunity with NIAID.

Image: https://biobuzz.inloop.com

Venable LLP

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. Join a team of Venable Financial Services and Corporate partners for a discussion around guidance for preparing for an audit (and potential investigation). Our discussion will include best practices for documenting decision making, what we can expect from the SBA going forward, and how best to manage an audit and address any potential investigation.

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Early reports of the COVID-19 pandemic, created an initial widespread impression that children were not severely affected by the virus. This understanding was framed by data from China which showed that less than 1 percent of cases occurred in children younger than 10. However, this consensus is now being challenged by new reports, including one in the New England Journal of Medicine from Wuhan Children's Hospital, which found a pediatric infection rate of more than 12 percent.

 

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I know what you’re thinking…it’s hard enough to raise venture capital for life science/healthcare startups in normal times, but throw a global pandemic and economic meltdown into the mix and even the best-laid plans will certainly go astray! So here are the questions that entrepreneurs would like answers to: Is there an inevitable slowdown in venture financing? How can VC firms conduct due diligence efficiently and thoroughly during a lockdown? Is a videoconference enough to establish a trusting relationship with a CEO and a Board? Does every startup have to take a hit on valuation if they want to get funding? Has the Coronavirus fundamentally changed expectations, time horizons, governance, and risk tolerance? What’s it gonna take to get someone to write a check?

 

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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

UM Ventures Backed Startup Breethe Acquired by Abiomed to Bring Better Solutions to Patients Suffering from Lung Failure UM Ventures

BALTIMORE, May 7, 2020 /PRNewswire/ -- Pumas-AI, a University of Maryland, Baltimore (UMB) startup company, has been granted worldwide, exclusive rights to Lyv, a cutting-edge clinical decision support system designed to help health care professionals personalize treatment trajectories for patients in real-time.

The Lyv platform leverages clinical research and Electronic Health Record (EHR) data from millions of patients to derive algorithms that can personalize health care delivery. Lyv will have modules for anti-infectives, anti-epileptics, anti-coagulants, and anti-cancer that can be used in a hospital setting, and can also incorporate algorithms during new drug development. By personalizing treatment, Lyv can help improve therapeutic success rates and minimize dosing errors.

 

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ROCKVILLE, Md.--(BUSINESS WIRE)--May 5, 2020--

Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the appointment of five new members to its Board of Directors from HLB, Co. Ltd (“HLB”) and its HLB Bio subsidiaries.

“I am delighted to welcome the new members from HLB to our board as they bring exceptional scientific, operational and commercial expertise to the group,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “As we advance our UNITE platform and our efforts in immune-oncology, their expertise and successful track record in bringing novel oncology drugs to market will be invaluable to our team.”

 

Emergent Kramer

Emergent Biosolutions CEO Robert Kramer told CNBC Monday it is uncertain that a coronavirus vaccine can be available by the end of the year to fulfill President Donald Trump’s wishes.

The specialty biopharmaceutical company is collaborating with drug giant Johnson & Johnson on a Covid-19 vaccine candidate, which Johnson & Johnson hopes will receive emergency use authorization in 2021.

 

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About 48 hours after a Seattle woman received the first dose of an experimental vaccine against SARS-CoV-2, scientists in China—not to be outdone—announced that they had regulatory approval to launch an ambitious vaccine trial as well. The Seattle volunteer received a messenger RNA vaccine that Moderna Therapeutics developed to prevent infection with the pandemic virus. The Chinese scientists, representing CanSino Biologics, described their plans to evaluate a recombinant vaccine.

 

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When VAST Data hit the hallmark of this era’s Silicon Valley start-up boom last month, a $1 billion so-called unicorn valuation, it didn’t come through a perfect pitch delivered in a venture capital firm’s conference room. Face-to-face interactions typically considered crucial to VC transactions have moved online as Covid-19 spreads, but for VAST the virtual meetings weren’t deal breakers.

Image: A man cleans up on the trading floor, following traders testing positive for Coronavirus disease (COVID-19), at the New York Stock Exchange (NYSE) in New York, U.S., March 19, 2020. Lucas Jackson | Reuters

Social Media

Social media is no longer just a numbers game for pharma companies. Counting followers, tallying likes or tracking shares was a good start, but numbers alone can’t tell if business goals are met.

That’s especially true in the current era of paid promotions, where numbers can be artificially inflated. Pharma companies today need to figure out how social media helps them reach the right influencers and key opinion leaders, drive traffic to websites or change perceptions of the products or company.

 

Rich Bendis

Today we hear phrases such as “In these difficult times” to highlight the challenges of the world with COVID-19 which is on all of our minds. Many industries have been adjusting via telecommuting employees if possible, while others cut back hours, furlough staff, or letting employees go. In the biotech industry and, more specifically, the BioHealth Capital Region (BHCR), we have seen a call to action and new collaborations by local key players in our shared mission to find a test, vaccine, and treatment for COVID-19. Before the current healthcare crisis, the BHCR had become the 4th largest biopharma hub in the United States as ranked by Genetic Engineering News in their annual study. We have over 1,000 biohealth companies in the such as AstraZeneca, Emergent, GSK, Qiagen, Novavax, and others, many of which are making valuable contributions during this COVID-19 pandemic as well as what they do in their everyday operations. The region is also the home of National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and their Director, Dr. Anthony S. Fauci, who has become a Trusted National Treasure. NIH also has 6,000 scientist and 16,000 overall workers in Bethesda, Md. Which makes it the largest basic research institution in the world. We are also home to the U.S. Food and Drug Administration (FDA) which has accelerated approvals in this time of crisis. We also have leading educational and healthcare institutions like the University System of Maryland, John’s Hopkins, George Mason, and Children’s National Health System and many more.

The May 4th edition of the Washington Post features an article titled “Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine” by senior regional correspondent covering government and politics, Robert McCartney. This article highlights the efforts over half-a-dozen companies in the region focused on different aspects of the COVID-19 crisis and how some have begun working together to find solutions faster.

The BioHealth Innovation Team, along with the BioHealth Capital Region Community, are proud of the hard work and research taking place and find that in the face of adversity, the BHCR is coming together and is forgetting about how artificial boundaries like State and County lines, Bridges and Rivers have prevented collaboration in the past.

 We will all get through this together. 

  • Rich Bendis, President and CEO
BillAndRich

He joins BioTalk host Rich Bendis to discuss their recent successes in funding, research, and their growth in the BioHealth Capital Region

Dr. William Hearl is the founder of Immunomic Therapeutics, Inc. and is an experienced and successful life science businessman and entrepreneur. Dr. Hearl is adept at brokering mutually beneficial partnerships and identifying non-traditional collaborations and investment opportunities.

The advent of the commercial development of LAMP technology came from discussions between Dr. Hearl and Dr. Tom August at Johns Hopkins University. Based on their mutual vision of the value of LAMP, ITI emerged and began operations in 2006. Dr. Hearl’s extensive experience in intellectual property management and business development led to the reward of a sub-license of the LAMP technology to Geron Corporation within 30 days of initiating operations and subsequent license agreements, valued at over $300 million, in 2015 with Japan-based Astellas for next generation allergy vaccines based on the LAMP platform.

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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

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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.

 

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Are you working with a technology that may be valuable to the fight against COVID-19?  BHI has expanded its federal funding assistance program to provide resources to assist early stage companies seeking funding through the NIH and BARDA.   To learn how the BioHealth Innovation team can help you advance your technologies, please contact BHI:  This email address is being protected from spambots. You need JavaScript enabled to view it..

 
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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

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I know what you’re thinking…it’s hard enough to raise venture capital for life science/healthcare startups in normal times, but throw a global pandemic and economic meltdown into the mix and even the best-laid plans will certainly go astray! So here are the questions that entrepreneurs would like answers to: Is there an inevitable slowdown in venture financing? How can VC firms conduct due diligence efficiently and thoroughly during a lockdown? Is a videoconference enough to establish a trusting relationship with a CEO and a Board? Does every startup have to take a hit on valuation if they want to get funding? Has the Coronavirus fundamentally changed expectations, time horizons, governance, and risk tolerance? What’s it gonna take to get someone to write a check?

 

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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)

Larry Hogan

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/

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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).

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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.

 

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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.

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Breethe, the medical device company founded by renowned University of Maryland School of Medicine surgeon and professor Dr. Bartley Griffith, has been acquired by Danvers, Massachusetts-based Abiomed, the companies announced this week.

Breethe’s system, which is designed to behave like a human lung, will become part of the Abiomed’s product portfolio. The device is designed to be portable, which can eliminate the need to use bulky oxygen tanks during ECMO therapy, which circulates blood from a patient’s body through an artificial lung. The device will help “to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation,” a news release states.

Image: Breethe's machine is desgined to behave like a human lung. (Courtesy photo)

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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.

 

Meet the minds behind the Johns Hopkins coronavirus map

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."

 

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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.

 

Vaccitech and Oxford University announce landmark partnership with AstraZeneca for the development and large scale distribution of the COVID 19 vaccine candidate Vaccitech

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.

 

Risks and Implications of Post Hoc Changes to the Borrower Certification Requirements What PPP Borrowers Need to Know Insights Venable LLP

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.

 

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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

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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