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RICHMOND, VA. (December 16, 2020) ‐ BRAINBox Solutions today announced it is beginning enrollment in its pivotal clinical trial, HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma), of the company’s concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site trial, which will enroll up to 2,000 patients, aims to generate data to support an application for regulatory clearance by the U.S. FDA.

The BRAINBox TBI (Traumatic Brain Injury) test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test Breakthrough Device designation.

“We do not have a validated objective method to determine an early TBI diagnosis. While a head CT identifies anatomic abnormality, it does not predict post-concussive symptoms or disability at the time when interventions change outcomes. We need an early objective test,” said W. Franklin Peacock MD FACEP, the Principal Investigator of the study. Dr. Peacock is Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine.

In the Spring of 2020, members from seven university tech transfer offices met with partners from six venture capital firms to discuss challenges both parties routinely face when working on life science deals together. Below is the resulting set of best practices, meant to benefit universities and VCs more broadly. Individuals interested in sharing feedback on the below guidelines should contact techventures@columbia.edu and include their name, organization, and work email. Please note that not all of these recommendations may be appropriate for startups outside of the life sciences. Comments and feedback will be posted at the bottom of this page. 

The hemafuse set contains a big syringe, which acts as the collection barrel, a nozzle connected to a filter on the syringe pulls the blood in while sieving the clots.

With a push, the blood is redirected through another tube, connected to the same syringe and operated by a stopcock, to the blood bag for transfusion back to the patient.

Image: Dr Gerald Osei-Owusu with the hemafuse medical device - https://dailyguidenetwork.com

As health agencies across the US rush to distribute the first round of COVID-19 vaccines, a new online tool aims to track their progress.

A dashboard hosted by Johns Hopkins University shows how many doses of COVID-19 vaccines have been administered across the US, according to publicly available data published by state health agencies and aggregated by the Centers for Civic Impact.

The US Food and Drug Administration said Monday it has approved a genetically modified pig whose body doesn’t make a component that can trigger allergies in people.

The pigs should produce meat that is safe to eat, and organs and tissues safe for transplants and for the other biomedical uses for people allergic to the compound — a sugar found on the surface of animal cells known as alpha-gal, the FDA said.

BALTIMORE — The Maryland Department of Commerce is partnering with the Maryland Business Innovation Association to launch the Maryland Business Innovation Challenge, a program aimed at bringing together the state’s corporate community with local innovators to solve real-time business challenges.

Image: https://www.myeasternshoremd.com

The 20-year-old company's first product tackles certain breast cancers.

Image: Dr. Scott Koenig is president and CEO of Rockville biotech MacroGenics. JOANNE S. LAWTON

Celebrating 20 years of supporting women-led companies and industry transformation, Springboard Enterprises announces Natalie Buford-Young as its first CEO. Buford-Young will work alongside Springboard President and co-founder Amy Millman, broadening the breadth and depth of the organization. 

To date, Springboard’s portfolio numbers 819 women-led companies, which have created $27.2 Billion in value.  

In her role, Buford-Young will be responsible for leading Springboard’s mission to accelerate the growth of entrepreneurial companies led by women through access to essential resources and a global community of experts. An accomplished and innovative corporate executive, entrepreneur, and community builder, Buford-Young joins from Deloitte, where she served as Managing Director of Market Development for Deloitte’s venture capital, private equity and emerging private company practices.

Qiagen North American Holdings has announced plans to renovate and expand its U.S. headquarters and R&D and manufacturing facility in Montgomery County, Md.

More specifically, Qiagen plans to renovate its 146,000-square-foot facility at 19300 Germantown Road in Germantown, Md., to accommodate expanded production of testing products for COVID-19 and other diseases, as well as lease additional space in the area.

Image: Image by DarkoStojanovic via Pixabay.com

National Institute of Standards and Technology (NIST) researchers are working to reduce the uncertainty associated with climate-change measurements using a mobile temperature-sensing technology made for tracking delicate or perishable, high-value packages in transit. Developed by international shipper FedEx and tested with help from NIST, the device connects to cell phone networks to provide users with near real-time information on the package's precise location, temperature, humidity, pressure, acceleration, elevation and exposure to light.

Image: Credit: Strouse/NIST Developed by international shipper FedEx and tested with help from NIST, the Senseaware device connects to cell phone networks to provide users with near real-time information on a packages precise location, temperature, humidity, pressure, acceleration, elevation and exposure to light. NIST researchers plan to deploy the technology as part of a pilot project to monitor and improve climate measurements.

GlaxoSmithKline is stumping up $85 million upfront and up to an extra $730 million in biobucks for Surface Oncology’s early-stage antibody asset.

The drug the U.K. pharma is betting on, known as SRF813, is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells and T cells.

In preclinical tests, Surface Oncology says, SRF813 has shown the “potential to elicit a strong anti-tumor response and promote immunological memory.” It’s still only in IND-enabling studies, but the company has an IND planned for next year.

Image: (GlaxoSmithKline)

Work on the $5.5 billion project has been at a standstill since April due to the Covid-19 pandemic.

Image: Work on the $5.5 billion redevelopment at Port Covington was shut down in April amid the Covid-19 pandemic. Developer Marc Weller previously said it would not resume until the TIF bonds were sold. MELODY SIMMONS

“5 Questions With…” is a weekly 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. This edition features 5 Questions with Brian Darmody, CEO, Association of University Research Parks (AURP).

Brian Darmody is CEO of AURP, a global nonprofit representing research parks and innovation districts sponsored by universities, federal labs, communities, hospitals, and other institutions in the US and 12 other countries.

Philanthropist and author MacKenzie Scott is donating tens of millions of dollars to historically black universities in Maryland.

The Baltimore Sun reported Tuesday that the schools are Morgan State, Bowie State and the University of Maryland Eastern Shore.

Image: As shipments of Moderna’s vaccine begin, health officials warn the public not to get complacent. News4’s Darcy Spencer has the warning from a local doctor about Christmas travel and gatherings. - https://www.nbcwashington.com

Companies or Universities/Research Institutes that wish to conduct human stem cell-based clinical trials in the State of Maryland. 1:1 match of non-state money is required. IND required

ROCKVILLE, Md.--(BUSINESS WIRE)--Creatv MicroTech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. “We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood,” said Dr. Cha-Mei Tang, CEO of Creatv. “Now, patients who are not responding to CRT can be identified quickly for alternative therapy.” Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

COVID-19 STRATEGIC RENEWAL TASK FORCE REPORT

ROCKVILLE, Md., Dec. 8, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced interim data from Cohorts 1 and 2 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with Mucopolysaccharidosis Type II (MPS II). In addition, REGENXBIO announced plans to evaluate a higher dose of RGX-121 in a third cohort of patients at an increased dose of 2.0x1011 GC/g brain mass. REGENXBIO expects to begin enrolling patients in Cohort 3 in the first quarter of 2021.

GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

“Margie’s deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval,” said Stanley C. Erck, Novavax President and Chief Executive Officer.

This week, interim Phase III data was released for the Oxford / AstraZeneca Vaccine, co-invented by our portfolio company Vaccitech. From late December, assuming the full dataset has been analysed and confirmed to meet formal regulatory requirements, AstraZeneca has announced that they believe they will be in a position to provide a vaccine for a quarter of the world's population. The vaccine will not just benefit the UK, EU and US who have ordered millions of doses, but the developing world, too. The Serum Institute of India has already begun producing 1 billion doses for the global south.

What’s the world’s largest charitable foundation? Nope, its not the Bill and Melinda Gates Foundation. Not even the Wellcome Trust.

It’s Novo Nordisk Foundation, a $65bn endowment headquartered in Copenhagen.

Top Reasons to  Attend:

• The world may have stopped, but your professional development doesn't have to. 
• Education and networking from the comfort of your own couch. 
• Loads of partnering opportunities. 
• The programming is tops in the industry. 
• It's a great value — in fact it's a great year for the whole office to attend. 
• It's an important investment in your future.

The Human Immunome: Small Moves Become a Movement

“We’re basic scientists. We did not set out initially just to make drugs. That’s not what it was about when we started. I’ve just always been interested in how the human immune system even recognizes a virus,” says James E. Crowe, Jr., a well-known infectious disease expert who directs the Vanderbilt Vaccine Center in Nashville, Tennessee. “Now we can study how the body works and have curiosity about that, but also have drugs in the pipeline. It’s the unexpected benefit we get by delving deeply into the human immune system.” Crowe is one of the recipients of the 2020 Golden Goose COVID-19 Recognition for his decades-long pursuit of a better understanding of the human immune system, which is now paying dividends in the fight against COVID-19.

Unless you’ve been living on private island (send invite immediately!), it’s no secret that the pandemic has changed the way manufacturers operate and run their businesses in order to survive these challenging times.

At least that’s what we at the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP) have heard from manufacturers over 11 virtual listening sessions we call the “National Conversation with Manufacturers.”

When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.

Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent. 

Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins. 

Though it began like any other year, 2020 has proven to be one of the most difficult and frustrating periods of our lifetime. This was especially true for our business community, which faced numerous new obstacles including shifting consumer needs, new safety requirements and a general uncertainty about what lay ahead. 

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics' investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics' next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.

The university licenses its original patent to the company to develop the product and conduct early-stage clinical trials.

Image: Michael Keidar, a mechanical engineer by training, is a professor of engineering at George Washington University. WILLIAM ATKINS

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

Image: U.S. Senator Birch Bayh (ret.)

The COVID pandemic has certainly forced us to re-think the whole paradigm of conducting clinical trials. From design, site and CRO selection, patient recruitment, data management, to execution, the world of clinical trials has been altered significantly in 2020… and most likely beyond.

Here are some relevant questions you should be asking yourself and that we will be asking our panelists in today’s webinar:

ROCKVILLE, Md., Dec. 14, 2020 /PRNewswire/ -- Emmes today announced that it has conducted the data and statistical analysis for the second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2).  The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.

Baricitinib, produced by Eli Lilly and Company, has been used to treat adults with moderate to severe rheumatoid arthritis.  Baricitinib, in combination with remdesivir for COVID-19 patients, received Emergency Use Authorization on November 19.

AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.

The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.

Image: KRISTOFFER TRIPPLAAR/SIPA/AP

AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.

The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.

Image: KRISTOFFER TRIPPLAAR/SIPA/AP

Qiagen, an international life sciences company that provides molecular sample and assay technologies, is expanding its United States headquarters in Germantown to accommodate increased production of testing products for COVID-19 and other diseases.  The company, which is based in the Netherlands, has already spent over $7 million on new equipment and improvements to its 146,000-square foot ...