BHI Weekly News Archives

On April 3rd, 2020, DLA Piper and BioHealth Innovation, Inc. (BHI) presented an overview of the key provisions for BioHealth Capital Region Life Sciences companies in the $2 trillion Coronavirus Aid, Relief, and Economic Security Act stimulus package via webinar.

The hour-long review and discussion was recorded and is NOW AVAILABLE to access online.

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New Members Continue GSK and NEA’s commitment to the BHI mission and the BioHealth Capital Region

ROCKVILLE, MARYLAND, April 6, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of two new board members, Rebecca Farkas, PhD, Director, External R&D, Scientific Collaborations at GSK, and Sara Nayeem, M.D., Partner at New Enterprise Associates (NEA). BHI’s leadership also thanked outgoing Board of Directors members Rip Ballou of GSK and David Mott of NEA for their contributions to the organization and friendship of many years.

 “I am honored to welcome both Rebecca and Sara to our Board of Directors,” said Richard Bendis, BHI President and CEO. “They both bring a combination of experience and fresh vision to our already robust collection of industry leaders. We are excited to to work with them to help grow the BioHealth Capital Region industry cluster.”

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Sean M. Kirk, Executive Vice President, Manufacturing and Technical Operations at Emergent BioSolutions joins Rich Bendis to discuss the COVID-19 Health Crisis, Emergent’s Capabilities in Manufacturing in the BioHealth Capital Region and Beyond

Mr. Kirk joined Emergent BioSolutions in 2003 and has served as executive vice president, manufacturing and technical operations since April 2019. Prior to this position, Mr. Kirk has held various senior leadership roles including senior vice president, manufacturing operations and contract development and manufacturing operations (CDMO) business unit lead from April 2017 to March 2019, senior vice president, biodefense operations from November 2015 to March 2017, senior vice president, biosciences operations from February 2014 to November 2015 and senior vice president, biodefense vaccines and therapeutics development from March 2012 to February 2014. Mr. Kirk also served in multiple roles of increasing responsibility at Emergent’s manufacturing operations site in Lansing, Michigan.

Before joining Emergent, Mr. Kirk worked at Merial, a multinational animal health company, serving in various positions from 1996 to 2001. Mr. Kirk received both an M.B.A. and B.S. in Microbiology from the University of Georgia.

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Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs through video conference on one of the following dates: 4/22, 5/20. (45 minute blocks of time beginning at 9:00 in the morning.)

Pre-registration is required; sign up here:

For questions/more information, contact BHI.

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Immunomic Therapeutics Inc. is pivoting, as many are, in this new era to work on a vaccine for the novel coronavirus. But it’s also pursuing goals that would be considered ambitious even before the world changed: It’s closing in on a $50 million raise, advancing its brain cancer program — and positioning itself for an initial public offering.

The Rockville vaccine maker secured the first $10 million of this latest fundraising round at the end of January from Korean investment group HLB, and it expects to close on another $40 million-plus in the next couple of weeks, said Bill Hearl, founder and CEO of ITI. That capital would support the immuno-oncology company’s therapy for glioblastoma, an aggressive brain cancer, now heading into a phase 2 clinical trial after a successful phase 1 study that extended the typical 14- to 16-month median survival rate to 41 months.

Image: Bill Hearl is CEO and founder of Immunomic Therapeutics in Rockville. COURTESY IMMUNOMIC THERAPEUTICS

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BioHealth Capital Region COVID19 Resources:

In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19.  Please use these links to stay abreast of the last news and resources available for your business.

District of Columbia 

Maryland

• Governor’s Update – https://governor.maryland.gov/coronavirus/
• General Update – https://coronavirus.maryland.gov/
• Business Resources – https://govstatus.egov.com/md-coronavirus-business\

Montgomery County, MD

Virginia

US Small Business Administration 

Volunteers

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Like many states across the nation, Maryland is preparing for a possible surge of COVID-19 patients.  Johns Hopkins is working with the state and the University of Maryland to erect an Alternate Care Site at the Baltimore Convention Center (ACS BCC). The ACS BCC is planned to open by mid-April and is intended to be used as a post-acute treatment facility.

Johns Hopkins is working on the recruitment, contracting, and credentialing of temporary Physicians and Advanced Practitioners. Compensation will be provided. We are reaching out to you, as a leader within your organization, in hopes that you might forward this to interested parties who may be willing to temporarily assist in treating patients recovering from COVID-19. Please see the attached job posting for details.

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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. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

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One of America’s biggest companies has teamed up with one of the country’s least-known federal agencies to make doses of a coronavirus vaccine. Lots of them.

The deal underscores the important role that the U.S. Biomedical Advanced Research and Development Authority, or BARDA, plays behind the scenes in protecting Americans—and everyone, really—from pandemics.

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Last week, we spoke to the head of Emergent BioSolutions’ Therapeutics Business Unit Dr. Laura Saward about her company’s work developing plasma-based potential treatments for COVID-19. Now, the company announced that it has received $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS), to speed the development of one of its treatment candidates.

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The U.S. Food and Drug Administration approved a clinical trial Friday that will allow Johns Hopkins University researchers to test a therapy for COVID-19 that uses plasma from recovering patients.

Arturo Casadevall, a Johns Hopkins infectious disease expert, proposed the use of convalescent plasma to treat critically ill COVID-19 patients and to boost the immune systems of health care providers and first responders. He assembled a team of physicians and scientists from around the United States to establish a network of hospitals and blood banks that can collect, isolate, and process blood plasma from COVID-19 survivors

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QIAGEN (Hilden, Germany) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The EUA approval status comes after QIAGEN recently began shipping QIAstat-Dx SARS-CoV-2 test kits to the US under a new FDA Policy allowing the kits to be made commercially available.

Image: QIAstat-Dx Respiratory SARS-CoV-2 Panel test (Photo courtesy of QIAGEN)

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The number-one pressure on small-business owners right now is payroll. Whether you’re a sole proprietor one-person-show or a company with 500 employees, you’ve certainly felt the pressure. Maybe you’ve already stopped paying yourself, have laid off workers or cut hours. Well, you can thank your federal government for the best aid program recently offered for small business, the Paycheck Protection Program loan (aka Coronavirus Stimulus Loan, or PPP Loan).

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GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

Image: Global supplies of testing reagents and other materials, including swabs, have been faced with overwhelming demand in recent weeks. (NIAID – Rocky Mountain Laboratories)

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Not long ago, working from home was an option for some of us.

Today, it’s the norm for nearly all of us.

Unless your job absolutely requires you to be on the front lines, the coronavirus pandemic has caused us all to set up home offices and social distance ourselves from coworkers and clients alike.

That shift has likely carried some stumbling blocks, something even the most seasoned remote worker can attest to.

Image: https://www.bizjournals.com

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We’re currently tracking 95 potential treatments and 52 potential vaccines in the pipeline to combat hashtag#COVID19.

There are thousands of researchers all over the world racing to get a treatment or vaccine to market.

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ROCKVILLE, Md., April 6, 2020 /PRNewswire/ — Emmes today announced that Heather Hill, Dr. Adam Mendizabal and Dr. Nilay Shah have been promoted to vice president. According to Dr. Anne Lindblad, president and chief executive officer, “These promotions reflect their talent and value to the organization. Heather, Adam and Nilay demonstrate our commitment to developing staff and promoting from within. They will strengthen and add great value to our leadership team and will support our plans to grow both internally and externally.”

Heather Hill

Dr. Adam Mendizabal

Dr. Nilay Shah

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A few weeks ago, I was in New Orleans for a jam-packed wedding weekend, complete with a crawfish boil, second line parade, Hawaii-themed 30th birthday luau for the bride-to-be, and more gumbo and jambalaya than we could eat (and guys, we’re talking authentic Louisiana Creole, which was just delicious.)

Image: Image via the Business Journals

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COVID-19 Notice for Maryland SBDC Clients, Stakeholders, and Partners

We are committed to serving our clients during the COVID-19 (Coronavirus) health emergency.

Consulting Services – New clients already in business can request COVID consulting assistance by clicking on the “I’M IN BUSINESS- GET CONSULTING” on our home page. The link is right below this notice towards the right side of the page. Continuing clients may continue to contact their consultant by phone, web conference, or email.

Training – All in-person training scheduled during the month of April has been canceled, postponed or offered online. If a paid training class is canceled or postponed, participants may request a refund or apply the funds to another class. If the class will be offered online, registered participants will receive an email with instructions for participating in the online class.

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Information regarding the hashtag#montgomerycountymd Public Health Emergency Grant Program passed by County Council yesterday. The County Executive’s staff is preparing regulations and plans to implement the program as quickly as possible. Businesses may submit questions about the program to: BizinfoCovid19@montgomerycountymd.gov. More info to come! hashtag#covid19response hashtag#moco

Image: https://www.linkedin.com

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Steve Bulger has heard all the complaints.

The acting director for the U.S. Small Business Administration’s Mid-Atlantic region knows about the technical issues that applicants for the agency’s Economic Injury Disaster Loans (EIDL) faced last week.

He’s received questions about why those loans come with interest rates well above the Federal Reserve’s current standard rate.

Image: Steve Bulger, acting director for the U.S. Small Business Administration’s Mid-Atlantic region, has been dealing with an overflow of loan applications from small businesses struggling amid the COVID-19 crisis. U.S. SMALL BUSINESS ADMINISTRATION

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The agency said it had redeployed some staff and streamlined processes to enable it to review clinical trial protocols faster and respond faster to companies and scientists developing new drugs for the disease.

The Food and Drug Administration hopes to expedite development of treatments for Covid-19 under a new program that the agency announced Tuesday.

The FDA said that under the Coronavirus Treatment Acceleration Program, or CTAP, it is redeploying staff and streamlining processes with the goal of speeding up reviews of clinical trial protocols and single-patient expanded-access requests.

Image: https://medcitynews.com

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In the middle of a hand-sanitizer shortage caused by the coronavirus pandemic, Johns Hopkins and Baltimore distillery Sagamore Spirit are working together to manufacture the disinfectant for use by the Johns Hopkins Health System.

The collaboration came together in less than 10 days, with Sagamore Spirit converting 100% of its distillation processes from rye whiskey mash bills to corn ethanol in support of the effort.

Image: IMAGE CREDIT: WILL KIRK / JOHNS HOPKINS UNIVERSITY

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Prominent research universities and government agencies are keeping the public abreast of the scope of the coronavirus pandemic as well as the reported outcomes of identified cases.

Major media outlets are doing their best to share information in real-time, but often portray spiking case numbers in hotspots like New York City as the accelerating spread of COVID-19. The reality, in many states across the U.S., is that COVID-19 has already infected large swaths of the population, so the coronavirus is not necessarily “spiking” but rather being revealed through better diagnostics and wider access to COVID-19 testing.

Image: https://biobuzz.io

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Newswise — When T.C. Wu, M.D., Ph.D., M.P.H., and Chien-Fu Hung, Ph.D., heard earlier this year about a new coronavirus that was spreading in China, their pathology labs immediately started developing a vaccine. That’s because nearly 20 years ago, Wu and Hung worked on a vaccine for another coronavirus that originated in China — severe acute respiratory syndrome, or SARS. So far, Wu and Hung have observed that the new coronavirus is “smarter” and “sneakier” than SARS, and they are concerned it will not go away like SARS did. Wu and Hung can discuss how their lab administered the new coronavirus vaccine to mice, and that preliminary results should be back by the end of the month. Watch this video and read this story about their efforts.

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Anthony Fauci has been an extraordinary presence during the COVID-19 crisis: calm yet urgent, informative yet plain-spoken. Along the way, he’s doing something even more difficult than explaining COVID-19. He’s providing insight about the role of the scientific expert in a liberal democracy.

Image: https://en.wikipedia.org/wiki/Anthony_Fauci

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WASHINGTON — Nearly 300 children have now been tested in the District’s first drive-thru COVID-19 coronavirus test site, with no kids in the nation’s capital needing life-saving ventilators as the virus wreaks havoc on older populations.

But after the first American infant died of coronavirus in Chicago on Saturday, a new focus on testing children has entered the national conversation – with treatment for the youngest coronavirus patients potentially playing a key role in fighting the outbreak.

Image: https://www.wusa9.com

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Emergent BioSolutions (EBS) – Get Report may be a small company up against the heavy hitters, but it has a plan for a coronavirus treatment, one indication that many players are taking their shot at a vaccine, as the world eagerly waits a solution.

Monday, Johnson & Johnson (JNJ) – Get Report said it will start human testing of a vaccine for the Coronavirus as early as September. The company joins Gilead Sciences (GILD) – Get Report, which the World Health Organization says is a front-runner in making a viable drug, in finding a solution to Covid-19.

Image: https://www.thestreet.com

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The massive bailout package that the U.S. government passed last week to stave off an economic collapse from measures put in place to mitigate the spread of the COVID-19 epidemic is giving out billions to American small businesses. But startups that received venture capital money could be left out.

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GAITHERSBURG, Md., April 02, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

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GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (EBS) today announced an agreement with Novavax, Inc. (NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

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A small study reported by researchers in Beijing and the United States found that 50% of patients treated for COVID-19 infection still carried the virus for up to eight days after their symptoms had disappeared. The authors, reporting their results in American Journal of Respiratory and Critical Care Medicine, say they don’t yet know whether the virus might still be capable of transmission at the late stages of disease. However, the results indicate that quarantine periods might need to be lengthened in some recovered patients.

Image: NIAID

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SAN FRANCISCO–(BUSINESS WIRE)– venBio Partners LLC today announced the closing of venBio Global Strategic Fund III (“venBio Fund III”), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

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We’re proud to announce a partnership with the U.S. Government on a comprehensive response to expedite development of our plasma-derived therapy to address hashtag#COVID19. https://lnkd.in/eHGC5F6

hashtag#toprotectandenhance hashtag#emergentbiosolutions hashtag#COVID19 hashtag#coronavirus

Image: https://www.linkedin.com

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Solicitations play an important role in making the general public aware of funding opportunities available to the small businesses of the nation. Participating Federal Agencies post these funding opportunities on a regular periodic basis throughout the year associated to SBIR/STTR.

To become involved with the Small Business Innovation Research (SBIR) or the Small Business Technology Transfer (STTR) program, small businesses can compete by submitting solicited proposals to these agencies. A winner in the competitive solicitation process is awarded a grant or contract. The SBIR/STTR program does not fund unsolicited proposals (proposals that do not refer to and address a specific topic in a current agency SBIR/STTR solicitation).

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

• District of Columbia
• Maryland Commerce
• Maryland Business Express
• Virginia
• US SBA

Volunteers

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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 (ynasser@adventisthealthcare.com/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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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

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

http://vivacreative.vzaar.me/21376036

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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

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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.”

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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

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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

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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.

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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

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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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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

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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).

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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.

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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

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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.

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BioBuzz and Workforce Genetics Founder, Chris Frew, Joins BioTalk to discuss building two organizations, talent acquisition, and his role in the BioHealth Capital Region ←Sub title

Chris is the Founder and CEO of Workforce Genetics, LLC (WGx), and BioBuzz Media to foster highly engaging experiences that connect people and companies across biohealth ecosystems. His insights into talent attraction, employer branding, and marketing have helped top companies to tackle their most pressing challenges in the new talent economy. Previously as Vice President at Breezio, a leading innovator in cloud-based online communities, he lead the development of the new Internship Network of Maryland (inMD) platform that was approved by Gov. Hogan in 2017. As Vice President of Tech USA’s Scientific Division Chris founded and ran a national staffing division operating at $23M annually when he left in 2015. Chris is passionate about impacting others, especially his family and his team, and helping to foster a strong community within the BioHealth Capital Region. He is a Maryland native and a graduate of Towson University. Learn more at https://www.workforcegenetics.com/ and http://biobuzz.io/

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Register Now for the 6th Annual BioHealth Capital Region (BHCR) Forum held on April 14-15 at AstraZeneca in Gaithersburg, MD. Join your peers biotech and life science executives and expert speakers from industry, academia, healthcare, government, finance and real estate development, among others, converged to discuss the BHCR’s path forward to becoming a top three U.S. biotech cluster by 2023.

Register Now

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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.

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U.S. laboratory equipment maker Thermo Fisher Scientific Inc. agreed to buy Qiagen NV, a Dutch maker of tests for diseases including cancer and the new coronavirus, for about 9 billion euros ($10 billion) in the biggest health-care acquisition so far this year.

Investors will get 39 euros in cash for every Qiagen share, Thermo Fisher said Tuesday. That’s 23% higher than Monday’s closing price. Qiagen also sells products for food and forensic testing. Bloomberg earlier reported the companies were nearing a deal after reviving discussions that broke off late last year.

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Novavax Inc. is already cashing in on its stock spike after announcing plans to develop a vaccine for the COVID-19 coronavirus.

The Gaithersburg biotech has raked in $98.7 million in net proceeds this quarter from selling 10.5 million shares of common stock at $9.55 per share, the company reported Monday in Securities and Exchange Commission filings. And it could sell up to $150 million more in common stock shares, the company said.

Novavax’s (NASDAQ: NVAX) stock was trading at $12.09 per share Monday early afternoon — which, though down about 24% from Friday’s close (as stocks see general volatility amid the coronavirus outbreak), is still notably high for the Maryland biotech.

Image: Novavax is developing a vaccine candidate for the COVID-19 coronavirus. This Centers for Disease Control and Prevention illustration shows the structure of coronaviruses. CENTERS FOR DISEASE CONTROL AND PREVENTION

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CEL-SCI Corporation (NYSE:CVM) announces that it is developing an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The LEAPS peptides will utilize conserved regions of coronavirus proteins to stimulate protective cell mediated T cell responses and reduce viral load. The LEAPS peptide technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties. Consequently, these products not only target the virus infection against which they are directed, but also elicit the appropriate protective response(s) against it.

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Montgomery College and George Mason University (Mason), in collaboration with AWS Educate, will partner to create a Bachelor of Applied Science (BAS) pathway in cloud computing. This degree offers students a seamless transfer pathway from a two-year associate’s degree to a four-year bachelor’s degree in cloud technology, providing a clear path to high-demand careers in cloud computing with AWS (Amazon Web Services) partners and customers.

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Are you an experienced biohealth industry executive seeking full time or part time employment as a consultant or start-up C suite executive? BioHealth Innovation is updating its database of experienced industry executives who may be able to share their expertise with early stage/growing companies. To be considered by companies or technology transfer organizations seeking leaders for their spin-out companies and/or advisors to support their business growth, please this form and upload a copy of your resume. (For questions/more information, please email: BHI@BioHealthInnovation.org.)

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Tomorrow and every day, we recognize the hashtag#RareDisease community on behalf of the Innate Pharma team. We do what we do because of you. hashtag#RareDiseaseDay hashtag#WRDD hashtag#HairyCellLeukemia hashtag#cutaneouslymphoma hashtag#SézarySyndrome hashtag#MycosisFungoides

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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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NEURALY ANNOUNCES FIRST PATIENT DOSED IN PHASE 2 CLINICAL TRIAL OF NLY01 FOR PATIENTS WITH PARKINSON’S DISEASE

Novel Mechanism of Action Inhibits Pathological Activation of Microglial Cells and Prevents Neuronal Cell Death

Neuraly, a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced the dosing of the first patient in its Phase 2 clinical trial of NLY01 for Parkinson’s disease.

“Current therapies for Parkinson’s disease provide only temporary symptomatic improvement and fail to slow or halt the relentless progression of the disease,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “The initiation of this Phase 2 study is an important milestone in the ongoing advancement of NLY01 which we believe has the potential to be a ground-breaking therapy for Parkinson’s patients based on results we have seen to date in preclinical trials.”

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A Cyber Living Innovation Lab with robotic platforms to evaluate 5G performance and a fleet of driverless cars will provide experiential learning opportunities to students from universities across the region as the anchor of George Mason University’s cybersecurity research expansion, thanks to $2.5 million in funding as part of a statewide initiative.

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As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals.

“Amid the expanding global outbreak of COVID-19, Americans need diagnostics, vaccines, and medicines to mitigate the potential impact of this virus”, said BARDA Director Rick Bright, Ph.D. “To accelerate the availability of these lifesaving tools, BARDA took an important step today to request proposals for development of COVID-19 diagnostics, vaccines, or therapeutics, many of which will be developed using existing platform technologies to permit rapid development.”

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PASADENA, Calif. and NEW YORK, March 6, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, and its executive chairman and founder, Joel S. Marcus, were honored to receive the 2020 Navy SEAL Foundation Patriot Award. This recognition highlights Alexandria’s contributions to our nation and unwavering support for the Naval Special Warfare community, as well as its embodiment of the values that epitomize the SEAL community. Congressional Medal of Honor recipient and retired U.S. Navy Master Chief Special Warfare Operator Britt Slabinski presented the prestigious award to Mr. Marcus yesterday evening during the Navy SEAL Foundation’s 12th annual New York City Benefit Dinner celebrating the Foundation’s 20th anniversary.

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If you’ve been on the web to learn more about the latest pandemic, chances are you’ve stumbled upon at least one or two coronavirus dashboards. These are the landing pages for interactive maps and visuals that show where the virus has spread, as well as numbers on the latest in infection rates and deaths, breakdowns of what countries are suffering from new cases and what regions are likely seeing new outbreaks, and much more.

Image: UPCODE ACADEMY

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The Maryland Economic Development Association (MEDA) is proud to announce the winners of the 2020 MEDA Awards. The 2020 awards, sponsored by Miles & Stockbridge P.C., recognize the exceptional people, programs and projects that bring economic prosperity to Maryland.

“We’d like to thank all who submitted a nomination for recognizing such deserving programs, projects and individuals, and our awards judges for their hard work determining the winners,” says Pamela Ruff, MEDA executive director. “The 2020 winners exemplify the Maryland communities that are going above and beyond when it comes to economic expansion and prosperity.”

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Northern UK Trade Mission to the BioHealth Capital Region with British Department of Trade and Industry of the UK Embassy at AstraZeneca

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The region’s politicians and business leaders are mourning the fact Baltimore stands to lose another headquarters of a prestigious, publicly traded company with the news that Legg Mason Inc. was acquired by Franklin Resources Inc. But investors should remain bullish about the city’s business future. The acquisition of Legg Mason was part of a natural cycle of industry consolidation and not a measure of Baltimore’s business climate. In fact, Baltimore and the surrounding region are poised to lead a business revolution in health.

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As the world scrambles to monitor and contain the COVID-19 outbreak, drug companies are racing to develop or repurpose treatments to combat the potential pandemic. The death toll continues to climb. The first U.S. death associated with the SARS-CoV-2 virus was reported in Washington state February 29. As of March 2, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, 3,048 people in 11 countries had died worldwide, nearly all of them (96% or 2,914) in China.

Image: Credit: NASA/Johns Hopkins University Applied Physics Laboratory/Southwest Research Institute/Roman Tkachenko

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What is Crab Pot?

The Crab Pot Pitch Competition is Southern Maryland’s premier pitch competition for entrepreneurs with cutting edge, disruptive and innovative technologies. Made popular by television shows like ABC’s “Shark Tank,” pitch contests provide an opportunity for entrepreneurs to present their ideas to a panel of judges or investors in front of an audience.

Crab Pot provides an opportunity for the community to celebrate the efforts of local entrepreneurs and innovators. Audience members get to see what entrepreneurs in Southern Maryland are up to. Crab Pot provides an opportunity for the community to celebrate the efforts of local entrepreneurs and innovators. Audience members get to see what entrepreneurs in Southern Maryland are up to. Entrepreneurs get to practice their pitches and win cash prizes. This year will be the 6th annual competition!

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Facing record-high volatility and market uncertainty, one biotech is scheduled for the week ahead.

Formed by New Enterprise Associate’s orphan drug accelerator Cydan, genetic disorder biotech Imara (IMRA) plans to raise $76 million at a $301 million market cap. The Boston-based company’s sole candidate IMR-687 is a once-a-day therapy targeting sickle cell disease and beta-thalassemia by inhibiting PDE9. It is expected to begin a Phase 2b trial in the 1H20. While there is significant unmet medical need for both disorders, it is a crowded space, with three products approved in 2019.

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With more than 378 confirmed coronavirus cases in the U.S. and more than 15 associated deaths, the Centers for Disease Control and Prevention (CDC) is actively monitoring, and trying to contain, the transmission of the disease, called COVID-19.

In some cases, depending on risk level, the CDC may ask individuals or families to self-quarantine or remain in isolation. Here’s a look at what that means and tips for implementing such measures.

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In this age of near-exclusive reliance on electronic communication, practically nobody asks for your number any longer — we just text, email or AirDrop critical identifiers.

However, some of us still must record our activities numerically, and innovators are certainly not immune from exchanging numbers — usually with interested leaders or colleagues, for the purpose of benchmarking.

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This is our fourth annual STAT Madness, a bracket-style tournament to find the best innovations in science and medicine.

The second round of voting begins Monday, March 9 at 12 a.m. EDT and is open until Sunday, March 15 at 11:59 p.m. EDT.

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The BioHealth Capital Region (BHCR) has a long history of leading the fight against new, frightening diseases, like Ebola and the novel Coronavirus (COVID-19) which is quickly spreading across the globe. Leading public health agencies such as the World Health Organization (WHO) and others believe the COVID-19 virus has the potential to reach pandemic levels as infection numbers rise beyond China’s borders.

Image: https://www.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

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As one of the largest healthcare tech deals in 2020, Thermo Fisher is buying coronavirus diagnostics company Qiagen NV for €9 billion. QIAGEN is considered a leading global provider of molecular diagnostics and sample preparation technologies. The deal has been approved by the boards of directors at both companies as well as the managing board of QIAGEN.

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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.

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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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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/EIR feedback and send your ppt presentation including the top 3 topics on which you would like feedback to BHI@BioHealthInnovation.org by 2 p.m. 3/17/20.  The next sessions are scheduled to take place by videoconference on 4/22 and 5/27.

(by videoconference)

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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.

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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.

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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.

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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.

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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.

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MENLO PARK, Calif. and NEW YORK, March 11, 2020 /PRNewswire/ — New Enterprise Associates, Inc. (NEA) today announced that it has closed on $3.6 billion for its latest fund, bringing the firm’s committed capital to nearly $24 billion over its 42-year history. In conjunction with the new fund, Liza Landsman has been named General Partner. Landsman, who joined the firm’s New York office as a Venture Partner in 2018 after serving as president of NEA portfolio company Jet.com, focuses on software and services investments across the consumer landscape.

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U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons. Contrastingly, biologic drugs are larger and more complex molecules, for example proteins, viruses, and living cells such as CAR-T cells.

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OSLO, NORWAY, March 10, 2020 – CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its COVID-19 vaccine portfolio. CEPI will be investing a further $4.4 million in partnering agreements with Novavax, Inc. and The University of Oxford to rapidly develop vaccine candidates against COVID-19. This brings CEPI’s total investment in COVID-19 vaccine R&D to $23.7 million.

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Columbia, MD – March 11, 2020 – Welldoc, a leading digital health company, announced today a collaboration with Dexcom, the global leader in continuous glucose monitoring (CGM) systems for people with diabetes. Welldoc and Dexcom signed an initial data partnership in 2019. This new collaboration will allow Welldoc’s award-winning BlueStar®, a digital health product for individuals living with type 1 and type 2 diabetes, to deliver insights to Dexcom G6® CGM system users. These insights go beyond glucose trends to inform individuals how their glucose is being affected by other key parameters, including medication adherence, activity, nutrition, sleep and more. The parties will also explore additional opportunities with Welldoc customers to leverage a more integrated offering.

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BALTIMORE — Two Johns Hopkins microbiologists have developed an in-house coronavirus screening test that may soon allow the health system to test as many as 1,000 people per day.

Karen Carroll, M.D., and Heba Mostafa, M.B.B.Ch., Ph.D are the microbiologists leading this.

“We will be able to diagnose more cases. This will allow the control of exposure,” said Mostafa, assistant professor of pathology and director of the molecular virology laboratory at The Johns Hopkins Hospital.

Image: Photo by: Johns Hopkins Medicine

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The Bill & Melinda Gates Foundation is teaming up with Wellcome and Mastercard to form the COVID-19 Therapeutics Accelerator, a $125 million effort to help find potential treatments for the coronavirus epidemic and future threats.

The accelerator will bring together the World Health Organization, pharmaceutical companies, biotech firms, government, and other philanthropic groups to develop therapies for COVID-19.

Image: Mark Suzman. (Gates Foundation Photo)

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The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number and severity of symptoms post-infection can vary by age and other risk factors (CDC Report). High level officials and politicians have been reported to be infected by, or in contact with, the virus. And there is no U.S. Food and Drug Administration (FDA) approved or licensed cure for COVID-19 (other than time, supportive measures as necessary, and a healthy immune system). “Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness.”

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GEN publishes its updated annual A-List highlighting the top 15 best-selling drugs of 2019. Eleven of last year’s 15 top-selling drugs registered year-over-year sales gains, with seven of the 11 racking up double-digit increases . . .

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All TBS Osteo features and main arguments. Included, in greater detail.

• What is TBS Osteo powered by TBS iNsight and what is TBS (Trabecular Bone Score): the main arguments.
• TBS Osteo compatibilities with different DXA systems.
• Main evidence of TBS clinical validation.
• How TBS can be a significant aid to better characterize your patient’s risk profile.
• Short grid to understand the risk of fracture based on a combined model of TBS and BMD.

Updated for TBS Osteo 3.1

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Last Wednesday, the House Science Committee, Subcommittee on Research and Technology, invited Under Secretary of Commerce and Director of the National Institute of Standards and Technology (NIST) Dr. Walter Copan to testify before the Subcommittee on reauthorizing the agency. NIST was last authorized in 2016 as part of the American Innovation and Competitiveness Act. Director Copan’s testimony covered each of the technologies the Trump Administration is collectively referring to as “industries of the future,” including Quantum Information Science, Artificial Intelligence, 5G, Advanced Manufacturing, and Biotechnology. He specifically commented on how NIST catalyzes partnerships between industry, academia, government, and other organizations to promote U.S. innovation and economic competitiveness.

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Precise loading of diverse peptides for vaccination is enabled by a strategy for peptide–TLR7/8 conjugate self-assembly of uniform nanoparticles. The approach is compatible with the development of personalized strategies, such as cancer vaccines targeting patient-specific neoepitopes.

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University of Maryland athletics on Wednesday announced a series of safety measures for its home events amid concern over the coronavirus outbreak, now labeled a pandemic by the World Health Organization.

Among several changes announced in a release, “Effective immediately, only student-athletes, coaches, essential personnel, officials, credentialed media and a limited number of family members of the competing teams will be permitted to attend games, until at least April 10.”

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New Enterprise Associates has raised $3.6 billion for its 17th venture fund, the largest in the more than 42-year history of the firm.

NEA set out in the second quarter of 2019 to raise New Enterprise Associates 17 LP and held a final closing in February at its target, said General Partner Mohamad Makhzoumi.

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