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.

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……” 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.

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.

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.

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.

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.

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

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.

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.

Information about immunity to SARS-CoV-2, both in the context of COVID-19 disease pathogenesis and in the context of how to develop a good vaccine, remains limited. But developing a vaccine and predicting how the coronavirus pandemic will unfold until such a vaccine is available are both contingent upon the understanding of whether the immune system can mount a substantial and lasting response to SARS-CoV-2 and whether exposure to other, common, circulating coronaviruses provides any kind of protective immunity.

Hundreds of thousands of small businesses that took Paycheck Protection loans finally have a path to getting their loans forgiven, but much delayed guidance released by the federal government is nowhere near final.

On Friday, the U.S. Treasury and Small Business Administration released an 11-page loan forgiveness application with instructions on how to complete it. While the document clarifies a number of administrative queries, such as when, exactly, does the eight-week covered period begin, it fails to address several key issues. Those include whether bonuses can count as cash compensation, and how quickly forgiveness will work. The agencies also noted that the SBA would "soon" issue regulations and guidance to further assist borrowers and lenders. There's no timeline for this next release.

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

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.”

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.

Of all the venture funding flowing into the medtech industry, a lower proportion than ever is being invested in companies at the start-up stage, a new analysis by Evaluate Vantage shows. Less than 5% of venture cash has been put into seed funding and series A rounds so far this year.

This shifting of cash from early into later rounds is a continuation of a trend that has been clear for some time. What is somewhat unexpected, however, is the relative prominence of series D financings in 2020 so far. Granted, this year is hardly typical; perhaps the pressures of the pandemic have pushed investors to mid- as well as late-stage rounds.

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.”

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

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.

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.

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.

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.  

AstraZeneca Plc will make as many as 30 million doses of coronavirus vaccine available to the U.K. by September and has committed to delivering 100 million doses this year. The U.K. will be the first country to get access to the vaccine should it be successful.

The vaccine being developed at the University of Oxford will get 65.5 million pounds ($79 million) of funding, U.K. Business Secretary Alok Sharma said today in a statement. The inoculation is already being studied in humans and could reach late-stage trials by the middle of the year. Another 18.5 million pounds will go to Imperial College London as trials accelerate.

ROCKVILLE, MD – May 19, 2020

Creatv MicroTech (Creatv), a cancer screening and diagnostic company with headquarters in Rockville, Maryland, is announcing a collaboration with the University of Miami School of Medicine on a study supported by the National Institutes of Health / National Cancer Institute entitled “MRI Imaging and Biomarkers for Early Detection of Aggressive Prostate Cancer”. Allan Pollack, Sanoj Punnen and Radka Stoyanova are the study’s Principal Investigators.

The study objective is to evaluate and validate the integration of quantitative imaging features with pathologic, molecular and blood markers to better manage prostate cancer diagnosis and treatment selection. Creatv’s biomarker, cancer associated macrophage-like cells (CAMLs) originated within the cancer stroma and can be found along with circulating tumor cells (CTCs).  

Since 2016, CARB-X has been funding and supporting the early development of innovative vaccines, rapid diagnostics, antibiotics and other life-saving therapeutics to address drug-resistant bacteria. Even as we struggle with coronavirus, we must continue the fight against superbugs. www.carb-x.org/60thproject #antibioticresistance #amr #diagnostics #vaccines #antibiotics #microbiome

ROCKVILLE, Md., May 18, 2020 - Emmes today announced that it was ranked as the seventh largest biosciences employer in the greater Washington area. The ranking is compiled annually by the Washington Business Journal.

Emmes reported revenues of $125 million in 2019 and has more than 750 employees globally. More than 675 employees work in Maryland, Virginia and Washington, D.C.

The company is expecting to hire nearly 70 new employees to support new and expanded clinical research projects. This represents an increase of approximately 10 percent of its area-wide workforce. The positions include clinical operations staff, biostatisticians, bioinformatics experts, project control analysts, project managers, data management staff, technical writers, clinical research auditors, and proposal manager. The company has offices in Rockville, MD, Frederick, MD and Tysons Corner, VA. Emmes continues to maintain a robust teleworking environment.

When infectious disease expert Crystal Icenhour began offering COVID-19 testing last month at her Aperiomics commercial laboratory in Sterling, Va., she expected a flood of orders. She could deliver results within 24 hours, compared to backlogged larger labs, and she could process up to 2,500 tests a week.

“We thought we’d be turning work away,” she said. Instead, she runs a few hundred tests a week, “a fraction of our capacity so far.”

Image: Crystal Icenhour, CEO of Aperiomics in Sterling, Va., say they can process about 2500 COVID-19 tests a week. Like many labs in the D.C. region, they are running at a fraction of capacity, despite an urgent need for more widespread testing. Daniella Cheslow / WAMU

University System of Maryland Chancellor Jay Perman said the system's colleges are "planning to resume at least some in-person teaching and learning" in the fall, after the coronavirus forced most campuses nationwide to close down during the spring semester.

Image: Jay Perman is the chancellor of the University System of Maryland. BBJ FILE

Researchers at Cedars-Sinai Medical Center are planning a randomized, controlled trial to evaluate a form of allogeneic cell therapy for COVID-19, after four out of six patients critically ill with the disease recovered well enough following infusions of the cells to be discharged from the hospital. The remaining two patients who received the treatment are also alive, in the hospital.

In 2009, a remarkable partnership started with an unsolicited email and a “cold call.”

Ten years later, Rockville, Maryland’s Sanaria and the Bioko Island Malaria Elimination Project (BIMEP) consortium won the P3 Impact Award from a pool of nearly 2,000 applicants, marking a milestone for a unique and remarkable global health consortium that’s turning the tide in the global fight against malaria.

Image: http://www.biohealthcapital.com

The COVID-19 pandemic has caused— and will continue to cause—much uncertainty in the worldwide financial markets. We expect to see substantial declines in the coming months in the number and aggregate dollar value of venture financings, similar to the declines during the dot-com crash in the early 2000s and during the 2008 financial crisis.

We are living and working through a period in human history when scientific leadership and knowledge are crucial for our nation, our organization and ourselves. It is a time for us to bring to the fore the focus on this most critical of human capabilities. 

As you know, against the backdrop of the profound challenges we face as an industry – and now overlaid by the additional impact of COVID-19 – BIO has conducted a search for a new President and CEO. On behalf of the Executive Committee of the BIO Board of Directors, I am delighted to announce that we have appointed Dr. Michelle McMurry-Heath to lead BIO at this pivotal moment in our organization’s history, effective June 1, 2020. 

Immunomic Therapeutics Incorporated (ITI), located in Rockville, Maryland recently announced it had closed on $61.3M in financing, exceeding its initial fundraising projections by over $11M. The Korean investment group HLB Co., LTD led the financing round, which is just the latest accomplishment for the clinical-stage biotechnology company that launched in 2006.

PITTSBURGH, May 14, 2020 /PRNewswire/ -- Net Health, a premier provider of cloud-based Electronic Health Record (EHR) software for specialized care settings, today announced that it has acquired Tissue Analytics, a pioneering developer of automated mobile wound and skin imaging and predictive analytics solutions. The acquisition of Tissue Analytics expands Net Health's leadership position within the wound care market, and for all customers, will accelerate the delivery of next generation wound care technology solutions, including predictive analytics. Net Health is a portfolio company of The Carlyle Group, Level Equity, and Silversmith Capital Partners. Silversmith invested additional equity to support the acquisition of Tissue Analytics.