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ROCKVILLE, Md.--(BUSINESS WIRE)--Creatv MicroTech, a privately-held biotechnology company has pioneered a blood test for the universal screening of early stage cancer. They will present their initial clinical data showing the ability to identify invasive cancer with 87% accuracy. “We are delighted to present results from a training set of 10 different types of cancers,” said Dr. Cha-Mei Tang, Chief Executive Officer of Creatv. “The data shows that we obtained 85% sensitivity for all cancers (from 79% of patients in Stage I and increasing to 95% of patients in Stage IV), and also shows 100% specificity when tested against healthy normal controls. This represents a significant step towards pan cancer screening by a routine blood draw with high sensitivity and specificity.”

 

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ROCKVILLE, Md., Feb. 11, 2020 /PRNewswire/ -- The Institute for Bioscience and Biotechnology Research (IBBR) is accepting proposals to lease a bio-manufacturing facility configured to produce biologicals under cGMP conditions in compliance with FDA requirements for phase I/II clinical trials. The facility is also equipped to perform process development research, pre-clinical manufacturing for material necessary to conduct IND-enabling toxicology studies, proof of concept (POC) studies, and process demonstration in advance of Good Manufacturing Practices (GMP) manufacturing. IBBR is a joint research enterprise between the University of Maryland and the National Institute of Standards and Technology (NIST).

Image: IBBR is strategically located in Rockville, MD within easy reach of major academic, industry, and federal research laboratories, including the University of Maryland campuses, NIST, NIH, FDA, NCI, and USDA. By Institute for Bioscience and Biotechnology Research

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The University System of Maryland (USM) Maryland Momentum Fund has invested $150,000 in College Park, Md.-based pathOtrak, a company that has developed a rapid food test for salmonella and E. coli in food.

The investment closes out pathOtrak’s $1.2 million seed round, along with a $200,000 investment from a global life sciences company with a food safety division and $310,000 from the Dingman Center Angels.

The Momentum Fund continues to invest in companies affiliated with the USM despite the COVID-19 pandemic and encourages applications through the Fund website at https://momentum.usmd.edu.

 

Queer 50 Martine Rothblatt

In 2013, Martine Rothblatt made $38 million, making her the highest-paid female CEO in the country at the time. Though Rothblatt told New York magazine that topping the list was like “winning the lottery,” it didn’t quite sit right with her. “I can’t claim that what I have achieved is equivalent to what a woman has achieved,” she said at the time. “For the first half of my life, I was male.”

Image: https://www.fastcompany.com

Morgan Eichensehr

Johns Hopkins spinout Personal Genome Diagnostics Inc. is looking to raise up to $3.5 million in new funding in support of its push to commercialize its cancer diagnostic technology.

Canton-based PGDx has already raised $2.7 million in the new round of debt and security financing, according to documents filed with the U.S. Securities and Exchange Commission. CEO Megan Bailey said the new funding comes from existing investors. The company is previously backed by about $147 million and its recent backers include Innovatus Capital Partners, Bristol-Myers Squibb, Cowin Capital, Helsinn Investment Fund, Inova Health System, Windham Venture Partners, as well as Maryland Venture Partners, New Enterprise Associates and Camden Partners.

 

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GAITHERSBURG, Md., May 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the acquisition of Praha Vaccines a.s., part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

 

Montgomery County Maryland

Montgomery County Executive Marc Elrich and County Health Officer Dr. Travis Gayles today announced critical benchmarks to reduce the spread of COVID-19 have been achieved, allowing the County to begin a gradual reopening. Phase I will start this Monday, June 1 at 6 a.m. The County plans for an incremental reopening, based on public health data. 

Image: https://www2.montgomerycountymd.gov

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It may not be quite business as usual as the state reopens and a new sense of normal takes shape amidst the COVID-19 pandemic, but a business accelerator program is pivoting to the health industry and University of Virginia students are testing out an app that could bolster contact tracing. 

Lighthouse Labs RVA, a Richmond-based accelerator program, is seeking applications for its Fall 2020 cohort. The program, which occurs twice a year, is a three-month intensive where seed-stage startups receive investment and mentoring. This cohort will place a focus on health through a partnership with the Health Innovation Consortium.

Image: Credit: Mike Kropf / Charlottesville Tomorrow

Matthias Evers

Imagine a world in which we can produce meat without animals, cure previously incurable diseases by editing the genetic fabric of an individual, and make industrial chemicals in yeast factories. The foundational technologies that could make all this possible largely exist. This is a Bio Revolution that could transform economies, societies, and our lives—and is already helping to respond to the COVID-19 pandemic.

 

Digital RESI June Welcomes BioHealth Capital Region as a Gold Sponsor Next Phase Newsletter

The action item today is keeping up your business momentum in these challenging days. LSN has seen a distinct uptick in global regional-based tech hubs taking advantage of Digital RESI to expand into the new digital paradigm of global partnering conferences. The main strategy is to get the early stage companies back in the mix and secondly, to showcase the technology assets that are teeming in these dynamic regional hubs. The BioHealth Capital Region is a perfect example of deciding to take advantage of RESI and to expand their global reach.

 

Adaptive Phage Therapeutics A New World of Treatment A New World of Treatment

Bacteriophages have long been used to treat infections. These naturally occurring virus are capable of killing bacteria, but each strain of phage is highly specific. Because of their unique mechanism of action, they provide a potential to address the growing threat posed by multidrug-resistant bacteria, but to treat someone, the right phage must be matched to each patient’s infection. Adaptive Phage Therapeutics believes it’s found a way to create phage therapies suited to treat patients with drug-resistant infections by building a bank of targeted and genomically-screened bacteriophage and testing individual patient’s bacterial colony against that to determine the appropriate phage to treat them. We spoke to Greg Merril, co-founder and CEO of Adaptive Phage Therapeutics, about the origins of the company, how its technology works, and the regulatory hurdles for producing customized therapies to treat individual patients.

Image: https://www.linkedin.com

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COLUMBIA, Md., May 4, 2020 (Newswire.com) – 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. The project will address a significant public health issue, as it is expected to help reduce the burden of disease caused by Shigella. It will also help enhance our program on developing bacteriophage-based therapeutic preparations as complementing modalities to other anti-infectives, such as vaccines and antibiotics, for managing bacterial diseases, including those caused by multi-drug resistant bacterial pathogens.” Dr. Sulakvelidze concluded, “This award paves the way for an important clinical study, and also shows that Intralytix continues to demonstrate innovative leadership in successfully developing bacteriophage products for various applications.”

 

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GAITHERSBURG, Md., May 25, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax’ proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

 

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BARDA is dispatching another billion dollars-plus for the war on Covid-19, lining up 300 million doses for the US that could start arriving as soon as October.

Allied with researchers at Oxford University on one of the leading vaccines now in development for Covid-19, AstraZeneca reported that it has secured more than $1 billion from BARDA for the development, production and delivery of the vaccine, starting in the fall. The injection dwarfs the additional £84 million ($102 million) in funding for 30 million doses (up to 100 million doses) from the United Kingdom, which envisions inoculating at least half its population by September.

 

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ROCKVILLE, Md.--(BUSINESS WIRE)--20/20 GeneSystems, Inc. announced today that it will offer in its CLIA laboratory a COVID-19 antibody test that received an Emergency Use Authorization (EUA) from the FDA on May 3. According to test manufacturer Roche Diagnostics, the blood test has a specificity greater than 99.8% and sensitivity of 100% (14‑days post-PCR confirmation) and is used to determine if a person has developed antibodies to SARS-CoV-2, the virus that causes COVID-19.

 

Task Force Holds Kick Off Meeting Affirms Support for Regional Collaboration to Tackle the Pandemic

WASHINGTON, D.C., May 22, 2020 – Connected DMV’s COVID-19 Strategic Renewal Task Force held its kickoff meeting on Thursday and affirmed their support for regional collaboration to tackle the pandemic with the following statement:

“The COVID-19 health pandemic has reinforced the importance of regional collaboration and cooperation between the District, Maryland and Virginia. It is also a necessity, if we are to secure the long-term stability and vitality of the DMV, solidify our position as a hub of innovation and leadership, and instill confidence in all our residents – on the safest path forward. Together and inclusive of our diverse communities, we need to define how our region can best recover, emerge, and thrive after the most acute conditions of the pandemic have subsided. The Connected DMV Strategic Renewal Task Force is committed to that shared future. Every step we make together as a region will ensure a stronger future for the DMV.”

 

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19). (CDC/Alissa Eckert, MS)

The phase I trial in healthy adult volunteers began in April. More than 1,000 immunisations have been completed and follow-up is currently ongoing.

The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions across the country.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children:

• Aged 56-69 • Aged over 70 • Aged between 5-12 years

 

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REUTERS: Oxford University and AstraZeneca are recruiting around 10,000 adults and children in Britain for trials of an experimental coronavirus vaccine, a day after receiving US backing worth up to US$1.2 billion.

Institutions across Britain had begun enrolling up to 10,260 adults and children to see how well the human immune system responds to the vaccine and how safe it is, the university said.

 

WASHINGTON - (May 21,2020) -- Children's National Hospital is establishing a regional pediatric telehealth consortium in response to coronavirus with $928,000 in funding awarded by the Federal Communications Commission's Wireline Competition Bureau. The funding, which is part of the FCC's COVID-19 Telehealth Program, enables the nationally-ranked pediatric hospital to expand its telehealth platform to support 15 healthcare sites in the D.C.-Maryland-Virginia region serving children and young adults, providing care to children with COVID-19 as well as those who are medically vulnerable and helping to protect healthcare workers as the pandemic threat continues.

 

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ROCKVILLE, Md., May 26, 2020 /PRNewswire/ -- Emmes today announced that its data and statistical analysis work for the Adaptive COVID-19 Treatment Trial (ACTT) played an important role in the accelerated timetable to evaluate remdesivir's effectiveness in treating hospitalized COVID-19 patients. 

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored the clinical trial, which included 1,063 participants at 60 sites in 10 countries. Emmes has a long history in supporting NIAID's Division of Microbiology and Infectious Diseases and has served as a Statistical and Data Coordinating Center for more than 350 of its clinical trials since 1998.  

 

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WASHINGTON — Michelle McMurry-Heath doesn’t talk about biotech the way her peers do.

Where other executives and experts might bring up “access,” and “reimbursement,” McMurry-Heath talks about fairness and ethics.

Image: Michelle McMurry-Heath has been named the new CEO of BIO.

Digital RESI June 2020 Innovation Challenge Finalists Announced Next Phase Newsletter

Our 3-day Digital RESI June Conference is coming up in less than 3 weeks, and we are very excited to announce our Innovation Challenge finalists. With a diverse representation across therapeutics, medical devices, diagnostics, and digital health, these companies were selected on the basis of innovative technology, strong management team, clear pathway to commercialization, and other positive factors that demonstrated high growth potential.

 

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GAITHERSBURG, Md. — The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) is pleased to announce the appointment of Mojdeh Bahar as associate director for innovation and industry services (ADIIS). In this capacity, she will report to Under Secretary of Commerce for Standards and Technology and NIST Director Walter G. Copan and serve as a member of the NIST senior leadership team. 

Image: Mojdeh Bahar will serve as NIST's second associate director for innovation and industry services. - The Daily Record

Johns Hopkins Launches Hub for Immunology and Engineering Research

It seems like there will never be enough “thank you’s” for the incredible doctors, nurses technicians and support staff members who are working around the clock to help patients with this dangerous disease. It is their dedication, determination and spirit that allow Johns Hopkins to deliver the promise of medicine.

 

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The Children’s National Research Institute recently released its 2019-2020 academic annual report, titled 150 Years Stronger Through Discovery and Care to mark the hospital’s 150th birthday. Not only does the annual report give an overview of the institute’s research and education efforts, but it also gives a peek in to how the institute has mobilized to address the coronavirus pandemic.

“Our inaugural research program in 1947 began with a budget of less than $10,000 for the study of polio — a pressing health problem for Washington’s children at the time and a pandemic that many of us remember from our own childhoods,” says Vittorio Gallo, Ph.D., chief research officer at Children’s National Hospital and scientific director at Children’s National Research Institute. “Today, our research portfolio has grown to more than $75 million, and our 314 research faculty and their staff are dedicated to finding answers to many of the health challenges in childhood.”

Image: Children’s National Research Institute directors Vittorio Gallo, Ph.D., and Mark Batshaw, M.D.

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Students across the University System of Maryland are graduating. But there are no auditoriums and arenas packed with people, cheering and taking photos as their children, grandchildren, spouses, parents and friends cross the stage. There is no stage. But there are virtual ceremonies online, produced with as much fanfare as our universities can create.

This isn’t the way graduates wanted to celebrate their enormous accomplishment. It isn’t how our universities wanted to celebrate their graduates. But COVID-19 has subordinated what we want to do in service of what we need to do — for the safety of our students, faculty, staff and neighbors.

 

Remote medicine. Telehealth. Digital medicine. Virtual visits.

Whatever it might be called, Children’s National Hospital (Children’s National) has been developing and deploying innovative telemedicine protocols, technologies and approaches for nearly two decades. 

So when the pandemic hit the region full force in mid-March 2020, Children’s National was ready. 

As COVID-19 took hold, the way patients engaged with medical professionals shifted nearly overnight. What was once seen as the future of medical treatment had suddenly, and perhaps irrevocably, been transformed into the standard of care for children and adults unable or unwilling to physically visit their healthcare provider because of the pandemic.

 

I Corps

The National Science Foundation’s Innovation Corps (I-Corps™) program uses experiential education to help researchers gain valuable insight into entrepreneurship, starting a business or industry requirements and challenges.

I-Corps enables the transformation of invention to impact. The curriculum integrates scientific inquiry and industrial discovery in an inclusive, data-driven culture driven by rigor, relevance, and evidence. Through I-Corps training, researchers can reduce the time to translate a promising idea from the laboratory to the marketplace.

Image: https://www.nsf.gov

5 Questions with Byung Ha Lee Director R D at NeoImmuneTech Inc BioBuzz

“5 Questions With……” is a new BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. We’re happy to have NeoImmuneTech’s Byung Ha Lee as our 2nd guest.

Byung Ha Lee is the Director, R&D at NeoImmuneTech, Inc. With degrees from Korea University, and his Ph.D. in Medical Sciences-immunology and microbiology from the University of Florida College of Medicine. He has extensive industry experience over 15 years in translational research, business development, field KOL interaction, leading strategic and research planning of drug development. Byung Ha finished his postdoctoral training at the NIAID at NIH.

 

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Baltimore, Md. (May 20, 2020) – University System of Maryland (USM) Chancellor Jay A. Perman and USM Board of Regents Chair Linda Gooden today announced that Dr. Stewart Edelstein, executive director of the Universities at Shady Grove (USG) and USM associate vice chancellor for academic affairs, has agreed to serve in his current position at USG through September 30, 2020, while the search for a new executive director continues. Dr. Edelstein’s existing contract would otherwise have expired on June 30.

 

hospital

Becker's Healthcare is pleased to release the 2020 edition of its list of "100 great hospitals in America."

The hospitals included on this list have been recognized nationally for excellence in clinical care, patient outcomes, and staff and physician satisfaction. These institutions are industry leaders that have achieved advanced accreditation and certification in several specialties. The list also includes industry innovators that have sparked trends in healthcare technology, hospital management and patient satisfaction.

 

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The most promising Covid-19 treatments and vaccines being explored right now were made possible by a little-known law that encourages licensing agreements between private pharmaceutical companies and government-funded researchers.

Treatments such as Gilead’s remdesivir, Ridgeback Biotherapeutics’ EIDD-2801 drug, and Moderna’s vaccine candidate were all achieved through public-private partnerships that didn’t exist before the Bayh-Dole Act in 1980.

image:  A magnified coronavirus is displayed on a desktop computer monitor during coronavirus patient sample detection tests in the virology research labs at UZ Leuven university hospital in Leuven, Belgium, on Feb. 28, 2020.

Photographer: Geert Vanden Wijngaert/Bloomberg

 

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The new rules come out of the recent public health emergency declaration, building on others announced in late March and early April. This round of changes, which take effect immediately, focuses on expanding testing capacity to help reopen the U.S. economy, according to CMS, along with delivering expanded care to seniors.

Image: https://www.healthcaredive.com

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FREDERICK, Md. – Frederick County Executive Jan Gardner today announced the launch of a new grant program to support local small businesses and farmers. She earmarked $5 million to award through the new Jump Start Grants Program. Jump Start grants are designed to assist small for-profit businesses and nonprofit organizations that experienced financial loss caused by the coronavirus. The county’s Office of Economic Development will administer the program.