BHI Weekly Newsletter Archives Archives - Page 24 of 65

Jan 12 2021

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438th Edition, January 12, 2021

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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January 13, 2021

FOUNDING MEMBER OF

Chris Mathia, Chief Executive Officer, Innara Health, and Keith Molzer, Managing Partner, Flyover Capital, join Rich Bendis from Kansas City on BioTalk

While home in Kansas City for the season, BioTalk host Rich Bendis virtually sits down two local business leaders. Innar Health CEO, Chris Mathia, and Flyover Capital Managing Partner, Keith Molzer chat about the opportunities and challenges of BioHealth and Fund-Raising in Middle American.

Listen now via Google http://bit.ly/39ikNss, Apple http://apple.co/3shRRtk, Spotify http://spoti.fi/39ocgUz, and TuneIn http://bit.ly/2XvT0za.

SBIR Virtual Office Hours (BHI and MCEDC)

Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate.

Click here to schedule a time.

REGENXBIO Announces Proposed Public Offering Of Common Stock

ROCKVILLE, Md., Jan. 6, 2021 /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 that it intends to offer and sell, subject to market conditions, $175,000,000 of its common stock in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. In addition, REGENXBIO intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares sold in connection with the offering.

BofA Securities, Morgan Stanley and Barclays are acting as joint book-running managers of the offering.

NexImmune Strengthens Scientific Leadership by Appointing Jerome Zeldis as EVP R&D and Jeffrey Weber as Chief Scientific Advisor

GAITHERSBURG, MD — January 04, 2021 – NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response that mimics natural biology, today announced the hiring of veteran biopharmaceutical industry leader Jerome (Jerry) Zeldis, MD, PhD, as Executive Vice President of Research & Development and the appointment of leading immunotherapy expert Jeffrey Weber, MD, PhD, as Chief Scientific Advisor and Scientific Advisory Board Chair.

Behrman Capital’s Emmes acquires Neox

Headquartered in Prague, Czech Republic, Neox is a CRO with over 150 employees who support biotechnology, pharmaceutical, and medical device customers. Neox has provided clinical research support for more than 1,000 studies and has built deep experience across multiple therapeutic areas. The company has operations primarily in central and eastern Europe, with a direct presence in the Czech Republic, Bulgaria, Germany, Hungary, Poland, Romania, Slovakia and Slovenia. Neox operates in another 11 European countries, including a recently established entity in the United Kingdom.

Emergent BioSolutions Secures DOD Aid for Covid Treatment Test – TheStreet

Emergent BioSolutions (EBS) – Get Report shares rose Wednesday after the life sciences company and Mount Sinai Health System announced a trial for Emergent’s coronavirus preventative with $34.6 million of support from the Pentagon.

Emergent recently traded at $92.70, up 2.84%, and has surged 71% year to date amid investor enthusiasm for companies involved with Covid treatments.

Children’s National Hospital, NIH launch COVID-19 diagnostics AI challenge

Washington, D.C.-based Children’s National Hospital is partnering with the National Institutes of Health and tech firm NVIDIA to launch a challenge in which participants will develop artificial intelligence tools to improve the detection of COVID-19 in the lungs, the hospital announced Jan. 7.

Participants in the COVID-19 Lung CT Lesion Segmentation Grand Challenge will use a multi-institutional, multinational NIH dataset that houses data on patients with a diverse range of age, gender and disease severity to create AI-powered imaging models to help clinicians better identify and treat COVID-19 infection in patients’ lungs.

Maxcyte | Myeloid Therapeutics and MaxCyte Enter Clinical and Commercial Licensing Agreement to Advance Myeloid’s Cell Therapy Programs

CAMBRIDGE, MA and GAITHERSBURG, MD, January 11, 2021 — Myeloid Therapeutics, Inc., a company harnessing and reprogramming yeloid cells to treat cancers, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announce the signing of a clinical and commercial licensing agreement.

Myeloid Therapeutics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. This agreement enables Myeloid to advance its pipeline programs, including for engineered cell therapies targeting solid tumors, T cell lymphoma, and glioblastoma. In return, MaxCyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.

Veralox Therapeutics Announces IND Submission for VLX-1005 to Treat Heparin-Inducted Thrombocytopenia

FREDERICK, Md – January [XX], 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

Maryland Gov. Larry Hogan proposes $1B stimulus bill, including checks for low-income households and tax relief – Baltimore Business Journal

Gov. Larry Hogan on Monday unveiled a state economic relief package designed to put money into the pockets of low-income Marylanders, help businesses stay afloat and forgive hundreds of millions of taxes on unemployment benefits and other aid.

The $1 billion legislative package, which Hogan is introducing as emergency legislation when the General Assembly session begins Wednesday, is called the Recovery for the Economy, Livelihoods, Industries and Families (RELIEF) Act. Its purpose is to provide “immediate financial relief and tax cuts for Maryland working families, small businesses and those who have lost their jobs” during what Hogan summarized as “one of the worst economic crises in our country’s history.”

Image: Gov. Larry Hogan gives an update on the state’s coronavirus response during a Dec. 1 press conference. JOE ANDRUCYK/MARYLAND GOVPICS/CC 2.0/FLIC.KR/P/2KCWGCT

Montgomery County biotechs received nearly $8B in research funding in 2020 | WTOP

COVID-19 vaccine research drove a lot of funding to biotechnology companies in Maryland’s Montgomery County last year, but it didn’t all come from coronavirus research.

Life sciences companies based in, or with a presence in, Maryland’s largest county received nearly $7.7 billion in research and development funding from the federal government, private investors and nonprofit organizations in 2020, according to the Montgomery County Economic Development Corp., a public/private partnership aimed at helping private companies connect with funding, permits and other resources.

Noble Life Sciences announces its collaboration with George Mason University to access the National Center for Biodefense and Infectious Diseases BSL-3 facility – BioHealth Capital Region

Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

Paul VanVeldhuisen, Ph.D., Named President of Emmes’ New Public Sector Group

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that long-time employee, Dr. Paul VanVeldhuisen, has been named President of Emmes Public Sector.

Emmes is now organized into two business groups: Emmes Public Sector and Emmes Biopharma. The public sector group includes all the company’s existing federal government clients and contracts, as well as work for foundations, public/private sector partnerships, and not-for-profit organizations.

Image: Paul VanVeldhuisen – PRNewsfoto/Emmes

TEDCO will provide $5M in COVID-19 aid for Maryland tech businesses – Technical.ly Baltimore

The state is providing aid for startups that are struggling to survive this economic downturn.

As part of an economic relief package announced by the State of Maryland in December, TEDCO will be making $5 million available for technology businesses that were hit hardest by the COVID-19 pandemic.

The funding will be available for technology-based businesses that are socially or economically disadvantaged, or based in rural areas, according to TEDCO, which is the quasi-public state agency that supports early-stage tech companies. The funding is expected to be made available in early February.

Image: Les Williams, CRO of Risk Cooperative, speaks at a TEDCO Builder Fund event. (Photo courtesy of TEDCO)

Johnson & Johnson Nurses Innovate QuickFire Challenge on Mental Health

The Johnson & Johnson Nurses Innovate QuickFire Challenge in Mental Health, together with the American Psychiatric Nurses Association (APNA), invites nurses and nursing students worldwide to submit their nurse-led novel concepts, education programs, protocols, prevention or treatment approaches, screening tools, and consumer product ideas with the power to potentially transform mental health care and well-being for their fellow healthcare professionals or the patients they serve amid the current pandemic environment and beyond.

Areas of interest

Treatment protocols
Health technologies
Medical device
Preventive approach
Consumer product
Community health approach
Screening tools

Johns Hopkins Coronavirus Resource Center passes 1 billion views | Hub

The Johns Hopkins Coronavirus Resource Center, a site launched in the spring of 2020 to offer critical data and perspective during the pandemic, logged its billionth page view today.

Launched March 3, the Coronavirus Resource Center has become a trusted destination for data on the spread and reach of COVID-19. Its continuously updated data trackers and tools help the public, policymakers, and health care professionals worldwide respond to the pandemic. The site includes the latest numbers on cases, testing efforts, and the vaccine rollout as well as expert analysis.

CIT Announces Inaugural Solicitation for the New Commonwealth Commercialization Fund

Richmond, VA, Jan. 07, 2021 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) announced today its Request for Proposals (RFP) for the first solicitation under the newly formed Commonwealth Commercialization Fund (CCF).

The CCF was launched on July 1, 2020 to foster innovative and collaborative commercialization efforts in Virginia, consolidating two legacy programs: the Commonwealth Research Commercialization Fund (CRCF) and the Virginia Research Investment Fund (VRIF). In FY2021, CIT is conducting a single CCF solicitation for young Virginia companies that have strong potential to drive economic growth in Virginia, including through revenue and job creation. Up to $7 million is available to award; a one-to-one match is required.

This competitive round will provide grants up to $100,000 to support companies’ commercialization and market entry goals through product or service development, market research, intellectual property protection, marketing, pilots, and more. High-potential projects are sought in seven strategically important sectors: agricultural and environmental technologies, autonomous systems, clean energy, cybersecurity, data science and analytics, life and health sciences, and space and satellites. All Virginia companies that meet the eligibility criteria are invited to seek funding.

Baltimore’s Port Covington Ramps Up After Financing Boost

With more than $650 million in financing in place, vertical construction in excess of 1.1 million square feet of mixed-use space at Port Covington in Baltimore is set to begin at the 235-acre redevelopment site along the city’s waterfront.

This $500 million development phase, known as Chapter 1B, includes 440,000 square feet of office, 586,000 square feet of residential with 537 units, 116,000 square feet of retail, more than 1,000 parking spaces and 10 acres of parks and public space.

Image: Port Covington. Image courtesy of Weller Development Co.

Power Moves: These Baltimore tech firms are growing sales and biz dev teams to start 2021 – Technical.ly Baltimore

Ernesto Chanona joined Glen Burnie-based CSSi LifeSciences as its director of business development.

The organization works with companies to advance drugs and medical device technologies from discovery to commercialization.

“The onset of the COVID-19 pandemic has catalyzed business growth throughout the industry, and as such, CSSi LifeSciences is poised to expand in 2021,” Chanona said. “Initially, I’ll be focusing on managing the company’s early-stage clients, housed at incubators all over the world. Growing the pipeline through strategic partnerships with economic development agencies, incubators, universities and startups is also part of the plan.”

Seven Biopharma Trends to Watch in 2021

Last year, when GEN prepared an editorial titled Eight Biopharma Trends to Watch in 2020, who could have foreseen COVID-19 and the deaths, illnesses, and economic disruption that the disease would wreak? And who could have foreseen how armies of industry and academic researchers would race to develop hundreds of new and repositioned vaccines and drugs? (GEN tracks more than 300 on its COVID-19 Drug and Vaccine Tracker webpage).

While biopharma was dominated by COVID-19, which prompted a surge of research and business activity, the industry also saw developments that will position it for further growth even after the virus is brought under control.

How the coronavirus vaccine relies on Maryland’s strangest fishery: horseshoe crabs – Baltimore Sun

Far from the medical labs and test tubes, a fisherman in old rubber boots walks across the docks of West Ocean City to inspect his catch.

He peers in a crate of spiny tails and grasping claws, hundreds of a common yet precious creature, among the oldest species on Earth: horseshoe crabs.

The scene on the docks is a glimpse into a strange and guarded Maryland fishery, one supporting a multimillion-dollar industry as surprising as the catch itself — a seemingly alien creature with 10 eyes, 12 legs and magical, milky blue blood.

Agreements reached between the United Kingdom of Great Britain and Northern Ireland and the European Union – GOV.UK

The Trade and Cooperation Agreement and other agreements below are provided for information only. No rights may be derived from them until the date of application. The numbering of the articles is provisional.

Healthcare Investments & Exits 2021 Annual Report | Silicon Valley Bank

US healthcare venture fundraising soared in 2020, totaling $17B, a 57% increase over 2019’s record.

Image: https://www.svb.com

Jan 04 2021

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437th Edition, January 5, 2021

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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January 5, 2021

FOUNDING MEMBER OF

Task force report outlines steps to build stronger post-pandemic economy in Maryland, Virginia, D.C. – The Washington Post

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

SBIR Virtual Office Hours (BHI and MCEDC)

Wednesday, January 13, 2021

Click here to schedule a time.

Novavax Candidate COVID-19 Vaccine Moves into Phase III Trial

The National Institute of Allergy and Infectious Diseases (NIAID) announced the commencement of the Phase III trial (NCT04611802) of the Novavax investigational COVID-19 vaccine, in a press release issued on Monday, December 28, 2020. The trial will evaluate the effectiveness, immune response, and safety of a COVID-19 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland, called NVX-CoV2373, and is estimated to complete data collection by March 31, 2021.

Emmes Acquires Neox s.r.o., a Clinical Research Organization Headquartered in the Czech Republic

ROCKVILLE, Md., Dec. 30, 2020 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Neox s.r.o., a European-based CRO. Neox will add over 150 employees who support biotechnology, pharmaceutical, and medical device companies.

“This is an important and exciting step for Emmes, demonstrating significant progress on our strategic plans to grow our biopharmaceutical business,” said Dr. Christine Dingivan, Chief Executive Officer of Emmes. “Neox adds a sizable, well-established biopharmaceutical research services business to Emmes and significantly expands our international presence.”

U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca – The New York Times

LONDON — Britain on Wednesday became the first country to give emergency authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, clearing the path for a cheap and easy-to-store shot that much of the world will rely on to help end the pandemic.

Image: https://www.nytimes.com – From Video

7 Cell Therapy Companies in Maryland Helping to Revolutionize Drug Discovery: The Latest News | American Gene Technologies

Maryland is home to one of the largest life science clusters in the United States with more than 500 biotech companies. In addition to several state-of-the-art labs, Maryland is home to the NIH in Bethesda. Research opportunities, as well as BS and MS degree programs, are offered at Johns Hopkins in Baltimore and the University of Maryland in College Park. Montgomery College in Germantown offers the AAS degree and certificate programs in biotech. World-class training by companies like BioTrac and Biotech Primer attracts an international audience of professionals.

Image: https://www.americangene.com

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million | BioSpace

ROCKVILLE, Md., Dec. 22, 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 that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

BHI’s Judy Costello Recognized with BioBuzz Community Builder Award

BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region. This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.

BioTalk with Rich Bendis Wins BioBuzz Media Award

The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

United Therapeutics Announces Agreement To Acquire Priority Review Voucher

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

Genetically Modified Pigs May Save Your Life: FDA Allows GMO Pigs

The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET’S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

Biotech Showcase™ | Investor conference | Co-produced by Demy-Colton and EBD Group

We are now only a few weeks out from Biotech Showcase and excited to launch the Spotlight Sessions on our on-demand hub on partneringONE.

We have also posted several Digital Medicine and Medtech Showcase sessions this week. Sponsor Insight content, on-demand public and private company presentations as well as Investor strategy videos are available for you to watch on demand.

Be sure to look at the sessions we have planned for the weeks of January 5 and 11.

Dr. James Crowe, Director, Vanderbilt Vaccine Center, Guests on BioTalk

BioTalk Media Award-Winning Podcast BioTalk Welcomes Dr. James Crowe, Director, Vanderbilt Vaccine Center, Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair and Founder of ID Biologics.

Listen now on Apple http://apple.co/34u0kz6, Google http://bit.ly/38jfE2I, Spotify http://spoti.fi/3pddVme, and TuneIn http://bit.ly/37D2M8z.

His laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

How I Lost 65 Pounds In 18 Months Without Any Fad Diets or Gimmicks | by Mark Suster | Jan, 2021 | Both Sides of the Table

I’ve been reluctant to write this blog post because historically I don’t like talking about weight. But I’ve been promising to publish how I lost 65 pounds in the past 18 months without any fad diets or gimmicks to try and be helpful to others. I have a plan,

I know it works and for the friends and family who have followed what I’ve done they’ve equally lost a lot of weight.

Dec 29 2020

Love0

436th Edition, December 29, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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December 29, 2020

FOUNDING MEMBER OF

Task force report outlines steps to build stronger post-pandemic economy in Maryland, Virginia, D.C. – The Washington Post

Virginia Bio Will Direct New “Virginia Bio-Connect” Statewide Consortium to Strengthen Competitiveness of Virginia’s Life Science Ecosystem | Business Wire

RICHMOND, Va.–(BUSINESS WIRE)–Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD – Supernus Pharmaceuticals

ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).

At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.

SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million | BioSpace

Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico | Novavax Inc. – IR Site

GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

Genetically Modified Pigs May Save Your Life: FDA Allows GMO Pigs

Image: TIM MACPHERSON

Quantum technology is moving from the lab to startups. Here’s why it’s a strength for UMD – Technical.ly Baltimore

Advances in technology that shape the future come in different forms. Some help us realize possibilities of systems that already exist. Others allow us to reframe what’s possible.

Take computing, for instance. Advances in transistors over time have produced more powerful processors that can fit into ever smaller and more affordable packages. This has made it possible to do computing tasks more efficiently and conveniently, but in the end these improvements apply the same principles of classical computing that were used when there were room-sized mainframes.

Image: Sarah Kreikemeier tunes an optical assembly at IonQ’s offices. (Photo courtesy IonQ/Erin Scott)

End of Year Update: 2020 Life Science Venture Capital Funding Roundup in the BioHealth Capital Region · BioBuzz

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best-laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C., and Maryland.

Image: https://biobuzz.io

United Therapeutics Announces Agreement To Acquire Priority Review Voucher

Venture capitalist injects £10m into Oxford vaccine firm Vaccitech | This is Money

A biotechnology company whose research and intellectual property has helped to create the Oxford-AstraZeneca Covid vaccine has raised new investment from venture capitalists.

Oxford-based Vaccitech has agreed the funds – understood to be as much as £10million – from Future Planet Capital which also invests in health, climate change and education projects.

Johns Hopkins Team Wins Global COVID-19 Mask Design Challenge – CBS Baltimore

BALTIMORE (WJZ) — A team from Johns Hopkins University won a global mask design challenge.

Two dozen undergraduates from the university make up Team Polair. Together, they created a clear mask they said people would want to wear.

Image: https://baltimore.cbslocal.com

Exclusive: D.C. med-tech startup Nanochon raising new funding for 3D-printed implant for joint injuries – Washington Business Journal

Nanochon is aiming to close the round in January to fund the first human study of its product.

Image: Ben Holmes is co-founder and CEO of Nanochon. COURTESY BEN HOLMES

These breakthroughs will make 2021 better than 2020 | LinkedIn

The latest on the innovations that will let us go back to normal. This has been a devastating year. More than 1.6 million people have died in the COVID-19 pandemic, with more than 75 million cases and tens of trillions of dollars in economic damages. Millions of people are out of work and struggling to pay their bills, and more than a billion children are missing out on crucial time in school. In the U.S., this year also saw the horrifying killings of George Floyd and Breonna Taylor, ruinous wildfires, and a presidential election unlike any other in modern times.

DC Inno – The top D.C.-area innovation stories of 2020

It’s tempting to look forward to the new year — especially after such an abysmal 2020 for so many.

But before we do, let’s not forget all that happened in the region’s innovation ecosystem this year. It wasn’t all bad.

Here, we recap some of the top trends, events and topics over the last 12 months.

Image: Husband-wife co-founders Matthew and Marnel Goins run Puzzle Huddle, which saw increased demand amid stay-at-home orders, school closures and the refocus on supporting Black-owned businesses. Puzzle Huddle

Dec 29 2020

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435th Edition, December 22, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

December 22, 2020

FOUNDING MEMBER OF

Dr. James Crowe, Director, Vanderbilt Vaccine Center, Guests on BioTalk

Listen now on Apple http://apple.co/34u0kz6, Google http://bit.ly/38jfE2I, Spotify http://spoti.fi/3pddVme, and TuneIn http://bit.ly/37D2M8z.

BHI’s Judy Costello Recognized with BioBuzz Community Builder Award

BioTalk with Rich Bendis Wins BioBuzz Media Award

Biotech Firm to Expand in Washington’s Maryland Suburbs

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

5 Questions with Brian Darmody, CEO, Association of University Research Parks · BioBuzz

“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.

MacroGenics wins FDA approval to sell its first product, Margenza – Washington Business Journal

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

MacroGenics Enters Research Collaboration with Janssen to Develop Novel DART® Molecule

ROCKVILLE, MD, Dec. 18, 2020 (GLOBE NEWSWIRE) —

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced today a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics’ proprietary DART® platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology.

Noble Life Sciences announces its collaboration with George Mason University to access the National Center for Biodefense and Infectious Diseases BSL-3 facility

Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

The Hemafuse Solution To Donor Blood Challenge In Ghana – DailyGuide Network

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

BRAINBox Solutions Announces Enrollment Begins in Pivotal, HeadSMART II Clinical Study of BRAINBox TBI Concussion Diagnostic and Prognostic Test

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.

COVID-19 vaccine deployment tracked in Johns Hopkins dashboard – Business Insider

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.

GSK puts up to $815M on the table for Surface Oncology’s antibody | FierceBiotech

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)

Weller Development’s Port Covington project gets boost as $137.5 million in bonds hit market – Baltimore Business Journal

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

State officials launch Maryland Business Innovation Challenge | News | myeasternshoremd.com

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

AstraZeneca to acquire Alexion for $39 billion in blockbuster deal

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

NIST/Industry Developed Temperature Tracking Device for Packages May Have Climate Metrology Applications | NIST

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.

FDA approves new genetically modified pig for allergy-free medical and food products – KTVZ

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.

Springboard Enterprises Appoints Natalie Buford-Young as its First CEO | LinkedIn

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.

MacKenzie Scott Donates Tens of Millions to Maryland HBCUs – NBC4 Washington

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

Term Sheet Recommendations for Launching University Life Science Startups (VC / TTO Roundtable, Spring 2020) | Technology Ventures

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.

Dec 29 2020

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434th Edition, December 15, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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December 15, 2020

FOUNDING MEMBER OF

AstraZeneca to acquire Alexion for $39 billion in blockbuster deal

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, producer of COVID tests, to expand in Germantown, add 300 jobs – Maryland Daily Record

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 …

EIR Feedback (BHI) – Wednesday, December 16, 2020 – Biohealth Innovation

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 on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

COVID-19 Strategic Renewal Task Force Report | ConnnectedDMV

COVID-19 STRATEGIC RENEWAL TASK FORCE REPORT

2020: The Human Immunome: Small Moves Become a Movement — The Golden Goose Award

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.

United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

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.

USM COVID Research & Innovation Task Force Launches Student PSA Public Health Challenge – USM

Baltimore, Md. (Dec. 11, 2020) – The University System of Maryland (USM) COVID Research and Innovation Task Force is bringing together people, expertise, and resources from its 12 universities to rapidly advance solutions to challenges presented by the COVID-19 pandemic. With the generous support of several local organizations, the Task Force is inviting members of the USM community to take part in a multimedia, Public Health Challenge seeking creative submissions that highlight ways for USM students, members of the broader university community, and all Marylanders to stay safe and healthy while waiting for a vaccine to become available.

Funding Opportunities | MSCRF – 1/14 Deadling to Apply

We offer six programs to accelerate discovery and commercialization of human stem cell-based technologies. Please verify eligibility, read the appropriate RFA below and apply here.

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

Novavax Appoints Vaccine Industry Expert Margaret G. McGlynn to Board of Directors | Novavax Inc. – IR Site

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.

REGENXBIO Announces Positive Interim Data and Update for Phase I/II Trial of RGX-121 for the Treatment of MPS II | BioSpace

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 2.0×1011 GC/g brain mass. REGENXBIO expects to begin enrolling patients in Cohort 3 in the first quarter of 2021.

Liquid Biopsy Predicts Esophageal Cancer Patient Response to Treatment | Business Wire

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.

Avoid these 5 real-world data pitfalls when planning your patient registry, cohort study, or observational clinical study

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.

Vaccitech, Future Planet backed Oxford Spinout, Offers Global Path to End of COVID-19 — Future Planet Capital

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.

Emmes Announces its Contribution to Second Remdesivir Clinical Trial for COVID-19 | BioSpace

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.

COVID-19 — The Disease That Is Reshaping Manufacturing | NIST

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.”

Reflecting on 2020 and Wishing You Happy Holidays

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.

George Washington University, US Patent Innovations targeting cancer and Covid in $3.2M corporate research agreement – Washington Business Journal

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

The Enactment of Bayh-Dole, An Inside Perspective – IPWatchdog.com | Patents & Patent Law

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.)

Where In The World Should I Conduct My Pivotal Clinical Trial? · BioBuzz

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:

Novo Holdings: the world’s largest biotech investor | Sifted

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.

AUTM 2021 Conference

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.

Dec 08 2020

Love0

435th Edition, December 8, 2020

By admin BHI Weekly Newsletter Archives

<!doctype html> BioHealth Innovation

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December 8, 2020

FOUNDING MEMBER OF

Connected DMV President & CEO Stu Solomon joins Rich Bendis on BioTalk

Stu Solomon, President & CEO, Connected DMV joins BioTalk to discuss formation of the Strategic Renewal Task Force, their Covid-19 Pandemic Pivot, the Global Pandemic Prevention and Bioterrorism Center, and much more.

Listen now on Apple https://apple.co/3gqmJlB, Google https://bit.ly/3mVtled, Spotify https://spoti.fi/3mO0j05, and TuneIn https://bit.ly/37FMf2t.

BRAINBox Solutions Announces First Close in $23 Million in Series A Financing to Support Development and Pivotal Clinical Trial of ‘Breakthrough’ Concussion Diagnostic/Prognostic Test

Scott Gazelle, MD, PhD, MPH, FACR Appointed to Board of Directors and Damon Kuehl, MD, FACEP Joins Scientific Advisory Board

RICHMOND, Va. (December 4, 2020) ‐ BRAINBox Solutions today announced the initial closing on a $23 million Series A financing to support the clinical development of the company’s BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate.

“The BRAINBox TBI test has enormous potential to significantly improve patient care as an aid to objectively diagnosing and managing the treatment of concussion patients,” said Marc Goldberg, BioVentures Investors Co-Founder and Managing Partner. “The company has made great progress, particularly in this challenging COVID-19 environment, in advancing the development of the BRAINBox TBI testing system, including laying the groundwork for the pivotal, HeadSMART II clinical trial and securing ‘Breakthrough Designation’ from the FDA.” He noted there are more than five million patients evaluated in emergency rooms annually for mild TBI as well as additional patients in urgent care settings.

EIR Feedback (BHI) – Wednesday, December 16, 2020 – Biohealth Innovation

For questions/more information, contact BHI.

SBIR Virtual Office Hours – Wednesday 12/09/20 (BHI and MCEDC) – Biohealth Innovation

Are you and early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Learn more about whether or not federal or state non-dilutive funding makes sense for you. Discuss potential strategies for success. Sign up for a free 1:1 advice and feedback regarding non-dilutive funding strategy and applications with BHI staff who have helped companies secured SBIR, STTR and other awards—at twice the national average win rate.

Click here to schedule a time.

MacroGenics strikes commercialization deal with Eversana ahead of potential Food and Drug Administration approval for breast cancer treatment – Washington Business Journal

The agency’s decision is expected to drop Dec. 18.

Image: MacroGenics is led by CEO and co-founder Scott Koenig. JOANNE S. LAWTON

QIAGEN to launch QuantiFERON SARS-CoV-2 for research into causes, spread and control of COVID-19 through T-cell response

Hilden, Germany and Germantown, Maryland, December 7, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today the launch of its QuantiFERON SARS-CoV-2 RUO solution that can detect T-cell responses of the human immune system to the pathogen that causes COVID-19, which could help researchers find out more about immunity levels and disease progression.

Studies suggest that T-cell response to SARS-CoV-2 declines much more slowly than antibody response, which presents several benefits to researchers who want to push beyond the existing detection of active infections to screen for potential courses of the illness and long-term immune responses to it. QIAGEN’s QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution could be a valuable tool in this research.

NEA Welcomes Scott Gottlieb, M.D., as Special Partner | NEA | New Enterprise Associates

Chevy Chase, MD – May 22, 2019 – New Enterprise Associates, Inc. (NEA), a leading global venture capital firm, today announced the appointment of Scott Gottlieb, M.D., as a Special Partner on the firm’s healthcare investment team. Dr. Gottlieb was a Venture Partner at NEA from 2007 to 2017 before being appointed the 23rd Commissioner of the U.S. Food and Drug Administration (FDA), where he served from 2017 to 2019.

Under Dr. Gottlieb’s leadership, the FDA advanced new policies for the safe and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs, and digital health devices; implemented new reforms to standardize drug and medical device reviews; and promoted policies to reduce death and disease from tobacco, improve food innovation and safety, promote better nutrition, and aggressively confront addiction crises.

AstraZeneca Gears Up to Vaccinate the World Against Covid-19 – WSJ

Among the front-runners racing to deliver a Covid-19 shot, AstraZeneca PLC has the least vaccine experience. But it has promised the world the most doses—more than three billion.

The company has assembled an unprecedented network of manufacturing and distribution partners spanning the globe, complementing a series of deals with governments that have sought to lock in vaccine supplies for their countries.

Novavax Expands Gaithersburg Real Estate Footprint As It Works On COVID-19 Vaccine

The effort to develop a COVID-19 vaccine is continuing to create new demand for life sciences space in Montgomery County, with one of the leading vaccine developers taking over a former industrial building and land previously planned for mixed-use development.

Novavax, a biotech company that has received $2B in funding for its COVID-19 work, announced Monday it signed a 122K SF lease at 700 Quince Orchard Road in Gaithersburg.

REGENXBIO Announces Dosing of First Patient in Phase I/II Trial of RGX-111 for the Treatment of Mucopolysaccharidosis Type I | BioSpace

ROCKVILLE, Md., Dec. 1, 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 that the first patient has been dosed in the Phase I/II trial of RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I). RGX-111 is an investigational one-time gene therapy designed to deliver the α-l-iduronidase (IDUA) gene directly to the central nervous system (CNS) using the NAV AAV9 vector.

MPS I is a rare, autosomal recessive genetic disease caused by deficiency of IDUA, an enzyme required for the breakdown of the polysaccharides in lysosomes. These polysaccharides, called glycosaminoglycans (GAGs), accumulate in tissues of MPS I patients, resulting in characteristic storage lesions and diverse clinical signs and symptoms including in the central nervous system (CNS), which can include excessive accumulation of fluid in the brain, spinal cord compression, and cognitive impairment.

CEL-SCI’s LEAPS Peptides Demonstrate Clear Survival Benefit as a Treatment for COVID-19 in Preclinical Studies | Business Wire

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) announced today its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in transgenic mouse models as compared to 0% survival in the two control groups in studies conducted at the University of Georgia Center for Vaccines and Immunology.

Scientists at the University of Georgia working in conjunction with CEL-SCI’s scientific team conducted a challenge study in human(h) ACE2 receptor transgenic mice infected with a dose of SARS-CoV-2 (the causative agent of COVID-19 disease) virus sufficient to cause death in all animals within 8 days. This transgenic animal model is useful to study COVID-19 disease because the mice express the molecule that provides entry for the SARS-CoV-2 virus into human cells. Virus infection is optimized in this animal model providing an ideal system to determine vaccine induced immune protection or therapy against a SARS-CoV-2 infection of humans.

First use of nView medical’s novel 3D imaging technology in pediatric spine surgery

Children’s National Hospital today performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely. The 3D images provide surgeons with better visualization, allowing them to continue improving patient care and outcomes.

Matthew Oetgen, M.D., division chief of Orthopaedic Surgery at Children’s National, is overseeing the first use of this 3D imaging technology in orthopaedic procedures.

Alexandria Real Estate Equities, Inc. Receives Two #1 Global GRESB Rankings, and Earns 5 Star Rating for Highly Sustainable Development Initiatives and “A” Disclosure Score in the 2020 GRESB Assessment, Reinforcing Its ESG Leadership

PASADENA, Calif., Dec. 1, 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, today announced that it has been recognized as the #1 real estate company in the world in the Global Real Estate Sustainability Benchmark (GRESB) 2020 Science & Technology sector for its leadership in championing sustainability initiatives that promote the health and well-being of its tenants and employees and enhance local communities. Alexandria also earned the #1 global ranking and a 5 Star Rating—the highest GRESB Rating—in its Diversified Listed Peer Group for its highly sustainable development work and green building initiatives, as well as an “A” disclosure score for the third consecutive year. GRESB is one of the leading global environmental, social and governance (ESG) benchmarks for real estate and infrastructure investments across the globe.

UMD computer scientist’s VisiSonics raises $3.5M to amplify 3D sound technology – Technical.ly Baltimore

When it comes to virtual reality, truly immersing someone in another space requires a lot of things to be just right. For one, there’s a question of visuals. The objects have to be three-dimensional enough to look like they’re in front of a player, and a character has to be able to move around to see those objects to the right or left.

Image: VR on the RMI Manufacturing Day demo floor in 2017. (Courtesy photo)

Entrepreneurial Spirit: UMB Startups Receive Support from Maryland Momentum Fund – Catalyst Magazine

The University of Maryland, Baltimore (UMB) strives to support the entrepreneurial talents of its students, faculty, staff, and alumni as it works to improve the human condition and serve the public good.

To this end, the University System of Maryland (USM) continues to aid entrepreneurs at UMB and throughout the state with the $10 million Maryland Momentum Fund (MMF).

Pitch Perfect: The Art and Science of Communicating with Investors

Pitch Perfect: The Art and Science of Communicating with Investors Before AND After Funding Communicating with investors before AND after funding is both an art and science. Learn best strategies at this truly informative webinar.

This free webinar is brought to you by the Society of Physician Entrepreneurs and the George Washington University Technology Commercialization Office.

The Pinkney Innovation Complex for Science and Technology (PIC MC) Brings Together Innovation and Education · BioBuzz

The Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC) Combines Innovation and Education – a smart choice for co-location.

The BioHealth Capital Region has come to be known for its unique blend of Industry, Government, and Academia from Baltimore to Charlottesville. Unlike many of the other Biotech Hubs across the United States, the geographic spacing, which at times has been seen as a challenge in the region, has created new opportunities.

Image: https://biobuzz.io/

BioInnovation Institute takes in new cohort of promising early-stage innovations – PharmiWeb.com

Seven start-up companies and university research projects across a range of therapeutic areas and geographical locations form latest intake for life science incubator BioInnovation Institute

COPENHAGEN, Denmark, 2nd December – BioInnovation Institute (BII), a Novo Nordisk Foundation initiative incubating and accelerating world-class life science research, today identifies its latest cohort of program participants. Comprising a pan-European spread of start-up companies and university research projects in countries including Denmark, Sweden and the UK, the seven ventures are developing revolutionary science across BII’s three sector specialised areas – therapeutics, bioindustrial and health tech.

TEDCO’s Entrepreneur Expo 2019 – Recap | TEDCO

TEDCO’s 2019 Entrepreneur Expo took place on October 29, 2019, at The Hotel At The University of Maryland! See what Maryland has to offer entrepreneurs.

Image: https://www.tedcomd.com

Doudna Talks Nobel Success and Women in Science

Jennifer Doudna PhD, the UC Berkeley biochemist who shared the 2020 Nobel Prize in Chemistry with Emmanuelle Charpentier PhD, was the recent guest of honor for the final episode in the “Women in Science” web series, co-organized by GEN and the Rosalind Franklin Society.

In 2012, the Doudna and Charpentier labs teamed up to publish a landmark paper in which they adapted the CRISPR microbial anti-viral defense system to create a programmable method for genome targeting. The work laid the foundation for CRISPR genome editing, which has become not only a ubiquitous research tool but also applied in clinical gene therapy, diagnostics, agriculture, and many other applications.

Image: https://www.genengnews.com

Nov 30 2020

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434th Edition, December 1, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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December 1, 2020

FOUNDING MEMBER OF

Novavax Announces COVID-19 Vaccine Clinical Development Progress | Novavax Inc. – IR Site

GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 Minutes · BioBuzz

Rockville, Maryland’s Maxim Biomedical (MaximBio) is on the cusp of bringing 3 million of its new and effective point-of-care COVID-19 tests to the fight against the coronavirus pandemic in early 2021, with a scale up to 15 million tests per month expected by Q2 2021.

The company’s brand new point-of-care (POC), ready out-of-the-box antigen test is based on a Lateral Flow Assay technology (LFA) that produces visually interpreted results within 15 minutes.

Sisu’s Life Saving Hemafuse Device Introduced in Five Frontier Hospitals of Kenya – APO Group – Africa Newsroom / Press release

BALTIMORE, United States of America, October 29, 2020/APO Group/ — Sisu Global’s (SisuGlobal.health) flagship medical device is Hemafuse, a surgical autotransfusion device that is revolutionizing blood access across Africa. There is a global shortage of 100 millions units of donor blood worldwide, and only 40% of the demand for blood transfusions is met across Africa. The COVID-19 pandemic has dramatically worsened the global blood shortage as blood drives and large gatherings have been cancelled. Autotransfusion is the process of salvaging and retransfusing the patient’s own blood in cases of internal bleeding. Studies show that autotransfusion reduces a patient’s recovery time and risk of infection and removes the potential for rejection when compared to donor blood. Notably, autotransfusion is viable for cases of ruptured ectopic pregnancy. Other viable cases include blunt trauma, traffic accidents, and cardiac and orthopedic surgeries.

AstraZeneca’s COVID-19 vaccine, up to 90% effective in late-stage trials, is being manufactured in Baltimore – Baltimore Sun

Late-stage trials showed that AstraZeneca’s coronavirus vaccine, which is being manufactured for the United States in Baltimore, was up to 90% effective, the English pharmaceutical company said Monday.

AstraZeneca’s vaccine candidate gives public health officials hope they may soon have access to a vaccine that is cheaper and easier to distribute than those of some of its rivals.

Even though the vaccine still needs regulatory approval, it’s already being made at Emergent BioSolutions’ plant in East Baltimore. The Gaithersburg-based contract drug manufacturer was named AstraZeneca’s U.S. manufacturing partner in June. The partnership was expanded in July and is now valued at $261 million.

Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December Nasdaq:ALT

GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. AdCOVID is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract.

Dr. Carol Nacy, CEO of Sequella Incorporated, joins BioTalk to discuss her career, the evolution of their science, and vision for the future.

Listen now via Apple https://apple.co/374aOFI, Google https://bit.ly/3pTGqqj, Spotify https://bit.ly/3nIl7WO, and TuneIn https://bit.ly/3nIl7WO

Dr. Nacy co-founded our Sequella in 1997 and has served as our CEO and Chairman of the Board since 1999. Prior to Sequella, Dr. Nacy served during 1997 and 1998 as Chief Scientific Officer (CSO) for Anergen, Inc., a California company acquired by Corixa Corporation in December 1998. From 1993 through 1997, Dr. Nacy was Executive Vice President and CSO at EntreMed, Inc. and participated in its successful initial public offering in June 1996. Previously, Dr. Nacy was Career Scientist (GS-15) at the Walter Reed Army Institute of Research, Washington, DC. Dr. Nacy currently serves on the board of directors of companies and non-profit agencies.

Click here for the Transcript

Johns Hopkins study shows ‘magic mushrooms’ may be effective in treating major depression – Baltimore Business Journal

Four weeks after receiving monitored doses of psilocybin, researchers reported more than half of the study’s 24 participants had achieved remission from their depression.

Nov 25 2020

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433rd Edition, November 24, 2020

By admin BHI Weekly Newsletter Archives

November 24, 2020

FOUNDING MEMBER OF

Dr. Carol Nacy, CEO of Sequella Incorporated, joins BioTalk to discuss her career, the evolution of their science, and vision for the future.

Listen now via Apple https://apple.co/374aOFI, Google https://bit.ly/3pTGqqj, Spotify https://bit.ly/3nIl7WO, and TuneIn https://bit.ly/3nIl7WO

Click here for the Transcript

OS Therapies Acquires All Indications for OST-HER2 (Listeria monocytogenes) in Solid Tumors, Including Canines

CAMBRIDGE, Md., Nov. 17, 2020 /PRNewswire/ — OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in children and adults, today announced the acquisition of all indications for OST-HER2 (Listeria monocytogenes), including Canine. The technology that was developed and extensively tested at University of Pennsylvania, has been provisionally approved by the USDA for Osteosarcoma in canines. Phase I and Phase III trials conducted in canines have had very positive results.

Immunomic Therapeutics and CoImmune Therapeutics Enter into Partnership to Manufacture ITI-1020, a Novel Experimental Cell Therapy for Glioblastoma | Business Wire

ROCKVILLE, Md. & DURHAM, N.C.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, and CoImmune, Inc. (“CoImmune”), a privately held clinical-stage immuno-oncology company developing cell-based therapeutics to treat unmet medical needs in blood-borne and solid tumor indications, announced today that the companies have entered into a license agreement for ITI to use CoImmune’s proprietary dendritic cell process for certain ITI cell therapy vaccine programs. The partnership highlights the oncology pipeline of ITI and CoImmune’s expertise and technology in the development and manufacture of cell-based therapeutics.

TIME Names Johns Hopkins’ COVID Dashboard A Top Invention Of 2020 – CBS Baltimore

BALTIMORE (WJZ) — TIME Magazine has named the Johns Hopkins University’s COVID-19 dashboard a top invention of 2020.

The Johns Hopkins Coronavirus Resource Center was called “2020’s Go-To Data Source” by the magazine. The dashboard, which reported Wednesday the U.S. recorded 250,000 coronavirus deaths, has tracked the spread of coronavirus around the world.

The annual list, which was announced Thursday, recognized 100 groundbreaking inventions that “are making the world better, smarter and even a bit more fun.”

Image: TIME

Merck to Acquire Maryland-based OncoImmune’s Promising COVID-19 Drug in $425 Million Deal · BioBuzz

KENILWORTH, N.J., & ROCKVILLE, Md.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and OncoImmune, a privately-held, clinical-stage biopharmaceutical company, today announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of OncoImmune for an upfront payment of $425 million in cash. In addition, OncoImmune shareholders will be eligible to receive sales-based payments and payments contingent on the successful achievement of certain regulatory milestones. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate CD24Fc for the treatment of patients with severe and critical COVID-19.

The risks and rewards of Operation Warp Speed’s approach to vaccines | PBS NewsHour

The race to develop vaccine candidates to prevent COVID-19 represents an unprecedented national and global effort. President Trump and some public health experts say encouraging early results from Pfizer and Moderna suggest the approach is working. But there are also questions about the risks of ramping up vaccine research and development at this scale and on this timeline. Miles O’Brien reports.

Image: https://www.pbs.org

Alexandria Real Estate Equities, Inc. Achieves the World’s First WELL Health-Safety Rating for Laboratory Space at Alexandria LaunchLabs in New York City

PASADENA, Calif., Nov. 16, 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, today announced that Alexandria LaunchLabs® at the Alexandria Center® for Life Science in New York City is the first laboratory space in the world to achieve the WELL Health-Safety Rating for Facility Operations and Management. Building on its prior recognition as the world’s first laboratory space to receive a WELL Certification for excellence in improving human health and well-being through building design, this latest evidence-based, third-party verified rating for the flagship location of Alexandria LaunchLabs—the premier startup platform accelerating the growth of early-stage life science companies—further affirms Alexandria’s longstanding, robust and meticulous initiatives to help keep its tenants, employees, visitors, service providers and key industry stakeholders healthy and safe.

Image: Alexandria LaunchLabs® – New York City. Courtesy of Alexandria Real Estate Equities, Inc.

Maryland Today | UMD Ranked in Top 10 for Innovation and Entrepreneurship Education for Sixth Straight Year

For the sixth consecutive year, the University of Maryland (UMD) earned a top 10 ranking in The Princeton Review’s annual survey of top schools for entrepreneurship. In the 2021 rankings released today and featured in the December issue of Entrepreneur magazine, UMD placed No. 6 for undergraduate entrepreneurship education—climbing one spot from last year—and No. 3 among public universities. UMD additionally was listed at No. 23 for graduate entrepreneurship education, marking the ninth consecutive year that the university has been named a top 25 program.

Image: Since cracking the Top 10 in 2016, UMD has climbed steadily in The Princeton Review’s undergraduate entrepreneurship rankings, now ranking No. 6 overall in the 2021 rankings. (Photo by Stephanie S. Cordle)

Funding Opportunities | MSCRF

We offer six programs to accelerate discovery and commercialization of human stem cell-based technologies. Please verify eligibility, read the appropriate RFA below and apply here.

Join the Force: An Info Session on JLABS @ Washington, DC and the BLUE KNIGHT™ Collaboration

BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority (BARDA), offers emerging life science companies an opportunity to join the JLABS incubator ecosystem with additional support from BARDA. BLUE KNIGHT™ companies, selected for their mutual alignment to Johnson & Johnson and BARDA areas of interest, may have an opportunity to receive additional support including fee assistance and mentorship. At JLABS @ Washington, DC and other select JLABS sites, BLUE KNIGHT™ companies will join the full breadth of Johnson & Johnson Innovation, including opportunities for funding, third-party services, educational events and access to R&D experts from medical technology, consumer healthcare product and Janssen pharmaceutical teams.

About Blue Knight

Johnson & Johnson Innovation – JLABS is collaborating with the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, to form Blue Knight.

This collaboration aims to stimulate innovation and incubation of technologies that improve health security and response through companies focused on public health threats and emerging infectious diseases. Find out more about BARDA and its mission at www.PHE.gov/BARDA.

If you are looking to learn more about the Johnson & Johnson Innovation – JLABS model, JLABS @ Washington, DC, BLUE KNIGHT™, mutual areas of interest between Johnson & Johnson and BARDA, and what the application process entails, join us for our Informational Session! We are currently accepting applications.

NORTHPOND VENTURES: Harvard’s Wyss Institute Creates Research And Innovation Alliance With Northpond Labs | Business Wire

BOSTON–(BUSINESS WIRE)–Harvard University’s Wyss Institute for Biologically Inspired Engineering has established its first research and innovation alliance by joining forces with Northpond Labs, the research and development-focused affiliate of a leading science and technology-driven venture capital firm, Northpond Ventures. Through the alliance, Northpond Labs will provide $12 million to create a Laboratory for Bioengineering Research and Innovation at the Wyss Institute and to support impactful research with strong translation potential.

TEDCO, EcoMap are creating the Maryland Entrepreneur Hub for business-building resources – Technical.ly Baltimore

Maryland organizations are building an AI-powered web platform where entrepreneurs can find all of the resources available to them in the state.

It’ll be called the Maryland Entrepreneur Hub, EcoMap Technologies CEO Pava LaPere said this week.

TEDCO, the quasi-public agency that supports early-stage tech companies, recently selected the Baltimore-based EcoMap to build the platform after a formal RFP. Maryland Department of Commerce and University System of Maryland are also partnering on the effort.

Image: Carl Grant, Angie Collier and Juan Pablo Segura discuss networking strategies at TEDCO’s 2019 Entrepreneur Expo. (Photo by Karuga Koinange)

Assistant Secretary Robert Kadlec announces new BARDA Director=

I am pleased to announce today the selection of Gary Disbrow, PhD, as Deputy Assistant Secretary for Preparedness and Response and Director of the Biomedical Advanced Research and Development Authority (BARDA). BARDA, a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat 21st century health security threats.

Protecting Our Future: Spurring Innovation to Support Pediatric Preparedness

With COVID-19, we’ve seen our preparedness response tested, and the question remains, how can we be better prepared to protect some of the most vulnerable members of our communities, our babies and children, from future threats? Unfortunately, less innovation takes place in the pediatric space due barriers in the discovery and development environment, including, ethical dilemmas, and regulatory requirements.

How can innovators work to develop pediatric therapeutics, diagnostics, vaccines, and other technologies that may protect the smallest members of society during a pandemic? Join us as we sit with key thought leaders, innovators and game-changers in the pediatrics space to discuss what is being done to develop groundbreaking medical countermeasures that aim to prepare and protect pediatric populations from the health threats of today – and those imagined and unimagined of tomorrow.

Army teams with Johns Hopkins to advance materials research | Article | The United States Army

ABERDEEN PROVING GROUND, Md. — The U.S. Army signed a new cooperative agreement with Johns Hopkins University Sept. 30, 2020, to advance materials research using artificial intelligence and machine learning.

Researchers from the U.S. Army Combat Capabilities Development Command (DEVCOM) Army Research Laboratory will collaborate with Johns Hopkins faculty and students on four focused projects:

Using artificial intelligence to accelerate the iterative materials design cycle by high-throughput microstructural characterization and rapid processing
Acoustic signature and reconstruction of defect avalanches in metals
Real-time monitoring of laser-material interactions
Toward self-repairing devices: Data-directed design of active, hierarchical colloidal assembly and reconfiguration

Image: https://www.army.mil/article/240874/army_teams_with_johns_hopkins_to_advance_materials_research

UK Biotech Companies Thriving in Maryland and Philadelphia Hubs · BioBuzz

For decades, the United States and the United Kingdom have enjoyed a special relationship that crosses political, economic, and military lines. But, the two nations also share a similar comradery in the Life Sciences arena, and prominent biotech hubs like the BioHealth Capital Region and Philadelphia showcase that connection.

There are several similarities between the BioHealth Capital Region, Philadelphia, and the U.K. They all have vital programs in gene and cell therapy. And they are home to key government institutions. The Midlands in the U.K. is home to the National Health Service and multiple academic and commercial institutions. Maryland is home to the U.S. Food and Drug Administration, the National Institutes of Health, and other government agencies. The U.S. region is also home to multiple significant academic and commercial institutions as well. Most recently, decades-old messenger RNA work originating out of Philadelphia’s University of Pennsylvania is a major contributor to Moderna’s COVID vaccine.

Announcing the Maryland Future 20 | Maryland Business News

Following a statewide search to identify Maryland’s most innovative start-up companies with the potential to be the state’s next major business success story, Governor Larry Hogan today announced Maryland’s Future 20.

The Maryland Future 20 is part of Innovation Uncovered, an ongoing initiative by the Maryland Department of Commerce to highlight the state’s talented innovators, entrepreneurs, and growing small businesses. The search for the Future 20 garnered 125 nominations from the business community and general public. The list was selected based on a variety of factors, including innovation, future growth potential, the company’s Maryland story, and “wow” factor.

What monoclonal antibodies are – and why we need them as well as a vaccine

When President Trump was diagnosed with COVID-19, one of the cutting-edge experimental therapies he received was a mixture of monoclonal antibodies. But now a vaccine may soon be available. So are other therapies necessary or valuable? And what exactly is a monoclonal antibody?

Over the past few months, the public has learned about many treatments being used to combat COVID-19. An antiviral like remdesivir inhibits the virus from replicating in human cells. Convalescent plasma from the blood of donors who have recovered from COVID-19 may contain antibodies that suppress the virus and inflammation. Steroids like dexamethasone may modify and reduce the dangerous inflammatory damage to the lungs, thereby slowing respiratory failure.

Image: Y-shaped proteins called antibodies are vital for attacking and destroying the virus. Dr_Microbe/Getty Images – ROYALTY FREE

SR One Completes Spin-out from GSK and Closes First Fund at $500 Million | Business | thedailytimes.com

SR One, a trans-Atlantic biotech venture capital firm, announced today the close of its first independent fund, having recently completed its spinout from GlaxoSmithKline (GSK). GSK is the largest investor in the oversubscribed $500 million fund, joined by a global pool of institutional asset managers, endowments, foundations, pension funds and family offices. SR One will seek to continue to build elite biotechnology companies developing innovative medicines that address significant unmet needs.

Private S. Korean investments in biohealth to reach 10 trillion won by 2023 – EconoTimes

South Korea’s leading biologics companies will invest hundreds of billions of won to building additional plants that would push the total amount of private investments for the biohealth industry to 10 trillion won by 2023.

Samsung Biologics will pour 1.7 trillion won into its new Plant 4 while Celltrion will invest 500 billion won to its Global Life Science Research Lab and Plant 3, all in Songdo, Incheon.

As its action plan for a more robust bio-industry ecosystem, the Government also pledged a 1.7 trillion won budget in 2021, up 30 percent from last year’s. The budget will prioritize pharmaceuticals, medical devices, and digital health care.

Image: Samsung Biologics will pour 1.7 trillion won into its new Plant 4 – https://www.econotimes.com

Registration for Pantheon 2020 | Recognizing Progress in an Unprecedented Year

Pantheon 2020 on Thursday, December 3, will feature breakout sessions, including “Diversity & Disruption: How 2020 Will Make Life Sciences Stronger”.

Join us as we discuss how everyone in life sciences can approach diversity and inclusion from end-to-end to create a sustainable path forward for all of us and a new blueprint for life sciences success.

The state of AI in 2020 | McKinsey

The results of this year’s McKinsey Global Survey on artificial intelligence (AI) suggest that organizations are using AI as a tool for generating value. Increasingly, that value is coming in the form of revenues. A small contingent of respondents coming from a variety of industries attribute 20 percent or more of their organizations’ earnings before interest and taxes (EBIT) to AI. These companies plan to invest even more in AI in response to the COVID-19 pandemic and its acceleration of all things digital. This could create a wider divide between AI leaders and the majority of companies still struggling to capitalize on the technology; however, these leaders engage in a number of practices that could offer helpful hints for success. And while companies overall are making some progress in mitigating the risks of AI, most still have a long way to go.

BLUE KNIGHT™ Symposium

In seeking to combat emerging infectious diseases and other 21st century health threats, the path to better prepared, protected, and healthy individuals, families, and communities could rely on unlocking the collective power of the global community. BLUE KNIGHT™ seeks to answer this call.

On December 8-10, Johnson & Johnson Innovation – JLABS and BARDA will virtually convene the emerging Blue Knight community of thought leaders, innovators and entrepreneurs for a three-day symposium, including interactive sessions focused on key areas of interest in infectious disease, public health, and company acceleration. Sessions will explore high priority areas of interest for scientific and technological innovation aimed for improving our preparedness and response to emerging health security threats.

Image: https://blueknightsymposium2020.splashthat.com/

Nov 17 2020

Love0

432nd Edition, November 17, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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November 17, 2020

FOUNDING MEMBER OF

Billions Pour into BioHealth Capital Region to Battle COVID-19 · BioBuzz

Over the past nine months, more than $7 billion in federal funding has poured into the BioHealth Capital Region aimed at the battle against COVID-19 and has shown a spotlight on the broad impact biopharma life science companies and academic institutions are making in the fight against the pandemic.

“The moons are aligned over the BioHealth Capital Region right now and people are beginning to see how important the region is in helping to address the research development and manufacturing needs to address this dreaded disease,” said Richard Bendis, president and chief executive officer of BioHealth Innovation.

Novavax prepares $500M raise as Covid, flu programs move forward – Washington Business Journal

Novavax Inc. has the option to raise up to $500 million in a possible stock offering as it shepherds its Covid-19 vaccine candidate through clinical trials, juggles its seasonal flu vaccine program and sees its stock sustain dramatic highs.

The Gaithersburg biotech said it could offer up to 5.37 million shares of common stock based on its Nov. 5 closing price of $93.11, according to documents filed Tuesday with the Securities and Exchange Commission. That follows Novavax’s sale earlier this year of 3.4 million shares of common stock, which brought in $238.3 million in net proceeds.

Genetron Health moving HQ from North Carolina to Montgomery County – Washington Business Journal

Oncology company Genetron Health Inc. said Monday it is relocating its U.S. headquarters from North Carolina to Montgomery County.

The Beijing company, which specializes in the molecular profiling of cancer cells, has settled on a 6,000-square-foot hybrid lab space at 401 Professional Drive in Gaithersburg. Montgomery County has approved a $47,000 grant to assist Genetron’s move from the Raleigh-Durham area. The Montgomery County Economic Development Corp. facilitated the move for Genetron.

Qiagen stock rises on announced COVID-19 test – MarketWatch

Qiagen NV QGEN, -2.76% shares rose in the extended session Wednesday after the Netherlands-based medical diagnostics company said it will begin selling a portable COVID-19 test in the United States. Qiagen shares rose 4% after hours, following a 0.9% rise in the regular session to close at $46.51. Called the “QIAreach SARS-CoV-2 Antigen Test,” the company said the test can process up to 30 swab samples to detect antigens of SARS-CoV-2, the virus that causes COVID-19, in people who are actively infected with the virus in up to 15 minutes. The test was developed by Qiagen in partnership with Australian digital diagnostics company Ellume. Qiagen said the QIAreach “will be particularly valuable when vaccines are introduced.”

How anticipated COVID-19 vaccines are bulk manufactured under Operation Warp Speed – 60 Minutes – CBS News

Operation Warp Speed, the U.S. government’s crash program to inoculate 300 million Americans against the coronavirus, includes a number of pharmaceutical partners like Emergent BioSolutions in Baltimore. CBS News correspondent David Martin toured one of Emergent’s manufacturing suites where the company is producing two COVID-19 vaccines awaiting FDA approval.

Fina Biosolutions Announces European Patent for Conjugate Vaccine Development – Proprietary method of producing CRM197 will be used to develop low cost, affordable vaccines for children and adults in developing nations

(Rockville, MD, November 10, 2020) – Fina Biosolutions LLC (“FinaBio”) is pleased to announce that it has received a Certificate of Patent entitled “Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains” from the European Patent Office(EPO). EP Patent No. 3099800 is directed to the expression and purification of the conjugate vaccine protein CRM197 in E.coli.

“Our goal is to lower the vaccine cost barrier and grant people in need access to life-saving vaccines,” said Dr. Andrew Lees, Founder, and CEO of FinaBio. “We are pleased to announce that we succeeded in creating a needed vaccine protein, CRM197, efficiently, and cost-effectively. FinaBio’s proprietary production method will facilitate the availability of vaccines to protect adults and children in developing countries from pneumonia, meningitis, and more.”

BARDA seeks nonprofit partner for BARDA Ventures: Catalyzing the 21st Century Cures Act and launching a new way to do business with HHS

BARDA today announced a new type of public-private partnership, BARDA Ventures , that will realize authorities granted in the 21st Century Cures Act to utilize venture capital (VC) methods and practices. This will be the first time HHS has utilized VC practices to make investments. As part of the new program, BARDA is soliciting proposals for an existing nonprofit partner to manage an investment fund that will support breakthrough technologies and create entirely new approaches to enhance U.S. preparedness and response to 21st century health security threats, including COVID-19 and future pandemics.

Korro Bio Appoints Ram Aiyar, Ph.D., MBA (former BHI Entrepreneur in Residence), as Chief Executive Officer | Business Wire

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Korro Bio, Inc., a biotechnology company developing single-base RNA editing therapies, today announced the appointment of Ram Aiyar, Ph.D., MBA, as its chief executive officer. Dr. Aiyar brings nearly 20 years of diverse experience across company-building, biotech and pharma to advance Korro’s innovative RNA editing platform to treat previously intractable diseases. He will also serve on the company’s board of directors.

“Ram is a proven leader with a track record of driving growth and advancing programs,” said Nessan Bermingham, Ph.D., co-founder and executive chair of Korro. “His broad business experience across the life sciences complements our existing leadership team. We look forward to working closely with him to pioneer the future of RNA editing for medicines.”

Talis Expands Executive Team (ads Doug Liu former BHI Chairman of the Board) and Closes Additional Financing in Preparation for Commercial Launch of Talis One(TM) System | State | montereycountyweekly.com

MENLO PARK, Calif., Nov. 12, 2020 /PRNewswire/ — Talis Biomedical Corporation, a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point of care, today announced it has strengthened its executive management team with the appointment of Rob Kelley as its first Chief Commercial Officer and Douglas Liu as Senior Vice President, Operations. Additionally, it has closed a new $126 million financing to support expansion of its operations and the commercial scale-up of the Talis One™ System and further expand the test menu. The Talis One System is a sample-to-answer, cloud-enabled, molecular diagnostic platform designed to provide rapid and highly accurate point-of-care tests for the detection of infectious diseases, including COVID-19.

Step into the Unknown | Think Medium

In this conversation, Rachel King and Dr. Michelle McMurry-Heath share stories underlying their careers in scientific innovation, from the lab bench to government, consulting, and venture capital; and their experiences as one of the few women CEOs in biotechnology.

https://www.thinkmedium.com

Welcoming a New Leader for USG! | The Universities at Shady Grove

The Universities at Shady Grove (USG) marks its 20th anniversary this year and the campus has launched a new chapter in its history with the appointment of Dr. Anne Khademian as USG’s third executive director. Khademian, who joins USG after 17 years with Virginia Tech University, begins her tenure at a challenging time as USG and its partner universities grapple with the challenges of the COVID-19 crisis. But she is making rapid inroads in building strong relationships with colleagues and community leaders, and in laying out some of her initial priorities for advancing USG into the future. They include a continued focus on ensuring student success, and on strengthening the future of USG, which she sees as a unique asset for bolstering economic and workforce development in Montgomery County, the state of Maryland and throughout the D.C. metropolitan region.

AWE Project – Baltimore Accepting Applications thru 11/23

The Achieving Women Enterprise Foundation is offering a local program cosponsored by TEDCO, the Sage Policy Group, and others which includes a 4 day bootcamp and 6 months mentoring for minority women entrepreneurs. The deadline to apply is November 23rd. For more information, check online: https://www.awefoundation.org/the-awe-project

Image: https://www.awefoundation.org/the-awe-project

Coronavirus vaccine

Well just to lighten the mood I have just seen on my BBC news app that the Oxford University? Astra Zenaca group have just announced that they have tested 43,500 people from here and abroad and they are claiming that it prevents 90% of people getting Covid. They also announced there was no safety issues with this vaccine. Could this help life to start to get back to normal, they say they are approaching the government to start rolling it out next month, lets just hope this is the light at the end of a very dark tunnel.

Research Parks: Building the Region’s Innovation Ecosystem Tickets, Wed, Nov 18, 2020 at 12:00 PM | Eventbrite

Research parks and innovation districts historically have played important roles in development of innovation ecosystems in places like Silicon Valley, Boston, and North Carolina’s Research Triangle.

The DC/Md/Va region has strong universities and Federal labs, with a growing set of innovation parks and incubation facilities. Learn how communities of innovation are growing in the DC region through new research parks and contributing to a fuller range of technology commercialization activities.

Virginia’s Center for Innovative Technology (CIT) Announces Vice President for Entrepreneurial Ecosystems

Richmond, VA, Nov. 11, 2020 (GLOBE NEWSWIRE) — The Center for Innovative Technology announced the appointment of Sean Mallon as Vice President for its Entrepreneurial Ecosystems Division. The division is one of four recently created at CIT in its role as the operating arm for the Virginia Innovation Partnership Authority (VIPA). The other three divisions are Investment, Commercialization, and Strategic Initiatives.

The Entrepreneurial Ecosystems Division was established to connect and leverage the expertise and infrastructure of Virginia-based partner organizations and will work with stakeholders to develop and strengthen programs that support entrepreneurs in all regions of the Commonwealth. As Division VP, Mallon’s responsibilities will include developing a backbone of statewide resources to assist regional ecosystems and ensure that all programs are inclusive to communities that have been historically under-represented in entrepreneurship and capital formation. Mallon will be based in CIT’s Richmond headquarters office.

BioNTech: the German biotech behind the coronavirus vaccine | Sifted

BioNTech, the German biotech which announced an apparent vaccine to coronavirus on Monday, is a classic European startup story: created by Turkish immigrants, funded by US and Asian investors and listed on the Nasdaq.

Along with pharma giant Pfizer, BioNTech is the first drug maker to show successful results from clinical trials of a coronavirus vaccine. Trials on thousands of volunteers found no serious safety concerns, meaning the companies will seek emergency use authorisation for the vaccine in the US later this month.

State Technology and Science Index 2020 – Milken Institute (Marylands Ranked #4)

The State Technology and Science Index (STSI) provides a benchmark for evaluating the knowledge economies of all 50 US states. The index compares each state’s capacity for achieving prosperity through scientific discovery and technological innovation, by performing a cross-sectional analysis of their rankings on key indicators using the latest available data from US federal government and private-sector sources.

The index is a composite of five sub-indexes, which cover a diverse range of topics: research and development (R&D) inputs, risk capital and entrepreneurial infrastructure, human capital investment, technology and science workforce, and technology concentration and dynamism. By comparing how states rank in these areas, the index assesses their capacities for generating new scientific ideas, as well as for commercializing technologies that contribute to firm expansion, high-skills job creation, and broad-based economic growth.

BARDA launches public-private partnership to tap venture capital methods managed by nonprofit – Homeland Preparedness News

The Biomedical Advanced Research and Development Authority (BARDA) is innovating in terms of how it will invest in projects, creating a new public-private partnership known as BARDA Ventures, based on the 21st Century Cures Act and venture capital methods.

As a result, BARDA seeks proposals from existing nonprofit partners to manage a long term health security fund no later than Dec. 8, 2020. That fund will be used to guarantee support for breakthrough technologies and new means of preparedness and response to health security threats. This, the organization hopes, will help its ability to stimulate innovation and promote disruptive technologies to close gaps in pandemic response and other healthcare preparedness.

Nov 09 2020

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431st Edition, November 10, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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November 10, 2020

FOUNDING MEMBER OF

Praduman (PJ) Jain, CEO and Founder of Vibrent Health, Joins BioTalk to Discuss Entrepreneurism, Funding, and Health Technology in the BioHealth Capital Region

Listen now on Apple https://apple.co/36iBbrp, Google https://bit.ly/32rZdiq, Spotify https://spoti.fi/2U7HEzs, and TuneIn https://bit.ly/3eOtb5i.

Praduman Jain, known to colleagues as “PJ,” is CEO and Founder of Vibrent Health and the Principal Investigator of the Participant Technology Systems Center of the National Institutes of Health Precision Medicine Initiative, the All of Us Research Program, for which the PTSC received a $75 million grant in 2017 and an additional award in 2020 with initial first-year funding of $39 million to build a national platform for health research and health management insights for 1 million people across the U.S. for at least 10 years. Jain is also the Chair of the Security Board of the Committee on Access, Privacy & Security for the NIH All of Us Research Program; a member of the Roundtable on Genomics and Precision Health at the National Academies of Sciences, Engineering, and Medicine; an invited external expert for eMERGE & Beyond, The Future of Electronic Medical Records and Genomics program of the Division of Genomic Medicine, National Human Genome Research Institute; and an external advisory board member for iTHRIVE – a Virginia Clinical and Translational Science Award.

BioBuzz Awards (VOTE NOW)· BioBuzz

This year, more than ever before, we’ve seen just how important it is for us all to stay connected and work together to build a stronger biotech ecosystem. In the face of great adversity, the biotech community has risen to the challenge and formed new collaborations and partnerships to innovate and rapidly develop new medicines and tools to help us beat this pandemic.

That’s why we decided that this year was the right time to launch the first annual BioBuzz Awards. This is an opportunity for us all to revisit the accomplishments of the past year and recognize the leaders and companies in the region who are doing great things to build a stronger BioHealth Capital Region across Maryland, DC and Virginia, and are making an impact on human health.

Exact Sciences Eyes Cancer Dx Leadership with Up to $2.5B in Deals for Thrive, Base Genomics

Exact Sciences said today it has agreed to a pair of acquisitions designed to create a diagnostics powerhouse across multiple cancers.

In the larger acquisition, Exact Sciences said it agreed to acquire blood-based diagnostics developer Thrive Earlier Detection for up to $2.15 billion in cash and stock. Exact Sciences also said it completed a $410 million cash acquisition of Base Genomics, adding Base’s DNA methylation analysis technology, designed to detect cancer at its earliest stages.

Image: Exact Sciences has announced a pair of acquisitions totaling up to $2.5+ billion intended to broaden its cancer diagnostics technology and test offerings. The company has agreed to acquire blood-based diagnostics developer Thrive Earlier Detection for up to $2.15 billion in cash and stock, and has completed its $410 million cash purchase of Base Genomics, adding Base’s DNA methylation analysis technology. (Exact Sciences)

China-Based Precision Oncology Company Genetron Health Inc. Relocates U.S. Headquarters to Montgomery County, Maryland

Received coveted FDA Breakthrough Device designation for its NGS test for early detection of hepatocellular carcinoma

Rockville, Md. — Citing proximity to leading U.S. regulators and researchers, fast-growing precision oncology company, Genetron Health Inc. (Genetron), is moving its U.S. headquarters to Montgomery County, Maryland from North Carolina’s Research Triangle. The China-based company is relocating to a 6,000 SF hybrid space for Research & Development and a state-of-the-art lab in Gaithersburg, Maryland for its planned rapid growth.

Genetron’s blood-based next generation sequencing (NGS) test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), designed for early detection of hepatocellular carcinoma due to chronic HBV infection and/or liver cirrhosis. Genetron believes they are one of the first China-based, cancer molecular diagnostic companies to receive this critical FDA designation.

SBIR Funding Proposals Due to NIH by January 5, 2021: 5 Tips for Your Submission | PilieroMazza PLLC – JDSupra

The Small Business Innovative Research (SBIR) program provides grant or contract funding to small businesses seeking to commercialize innovative technologies. With $3.2 billion allotted to SBIR each year, there are twelve different agencies that have set aside SBIR funding. One agency is Health and Human Services which provides funding through the National Institutes of Health (NIH). NIH has three grant funding proposal deadlines a year. The next deadline is January 5, 2021. On the NIH/SBIR website, NIH states that the electronic submission process for grants can take from six to eight weeks, so this is a reminder to start now. Below are five key tips to help small businesses in their NIH SBIR electronic submission process.

Novavax Covid-19 vaccine secures fast-track status from FDA – Washington Business Journal

Novavax Inc. (NASDAQ: NVAX) said Monday it received a crucial status for its Covid-19 vaccine candidate as the pandemic drags on and coronavirus cases once again soar across the country.

The Gaithersburg company has earned fast-track designation from the Food and Drug Administration for NVX-CoV2373, a coronavirus vaccine candidate in late-stage development. It means the biotech can submit parts of its application on a rolling basis for a speedier review by the agency, and gives Novavax more direct and frequent access to the FDA.

Novavax to Provide 40 Million Doses of Its COVID-19 Vaccine Candidate to Australia | The Motley Fool

Novavax (NASDAQ:NVAX) announced on Wednesday that it has reached an agreement to provide the Australian government with 40 million doses of its COVID-19 vaccine candidate, NVX-CoV2373, if it earns approval from health regulators. Two early clinical trials of the vaccine candidate were run in Australia, and so far, the results have been positive.

The small biotech has had notable success at finding governmental buyers for its coronavirus vaccine: Novavax has signed direct supply deals with the United States, the United Kingdom, and Canada, and through its distribution partnerships has arranged to supply NVX-CoV2373 to Japan, India, and South Korea as well.

DRIVE ReDIRECT: Program Seeks to Develop Countermeasures Against Chemical Threats | Global Biodefense

The rapid availability of effective medical countermeasures against chemical exposures, from either accidents or chemical weapons attack, is critical in the treatment of their acute health effects following exposures.

The ReDIRECT Program is a new initiative from the Biomedical Advanced Research and Development Authority (BARDA) which aims to identify existing, commonly available therapeutics that can be used to save lives during a chemical emergency.

Pill Protect QuickFire Challenge: Designing for Medication Safety – Challenge | JLABS

Keeping kids safe at home is more important than ever – including safely storing medicines. Especially, as many families are living a new normal with children spending more time at home due to the pandemic.

Every hour in the United States, 5 children under age 6 are rushed to emergency departments for medication poisonings, many due to unsafe storage practices. There has been a 142% increase in prescribed medications over the past two decades. At the same time, an aging population and drastic increase in three-generation households, kids living with their parents and grandparents, are likely contributing to approximately 200,000 children visiting emergency departments each year due to adverse drug events.

BioHealth Capital Region Showcases Strengths of Cutting Edge Therapies · BioBuzz

Biopharma and Life Science companies in the BioHealth Capital Region are known for their work with cutting edge technologies such as gene and cell therapies. Those strengths were on display at the 6th annual BioHealth Capital Region Forum.

The Strengths of our Region: Cutting Edge Therapies panel, which was moderated by Mark Cobbold, vice president of Discovery in Early Oncology at AstraZeneca, brought together leaders from three other companies to discuss their disruptive pipelines, the strength of the region and challenges brought by the COVID-19 pandemic. Cobbold touted the work performed by the three companies joining him on the panel, Cartesian Therapeutics, Adaptive Phage Therapeutics, and Ziel Bio. Pointing to the work being done by those three companies and AstraZeneca, Cobbold said they are representative of why the BioHealth Capital Region has become one of the most successful BioHubs in the United States.

Johns Hopkins COVID-19 dashboard provides ‘exhaustive information’ to clinicians

Johns Hopkins University launched its popular COVID-19 map on Jan. 22 — just 2 days after the first person in the United States was diagnosed with the novel coronavirus.

Exactly 8 months later, Healio and others cited the university’s COVID-19 dashboard on Sept. 22 when reporting that the U.S. had surpassed 200,000 deaths from COVID-19.

Image: https://www.healio.com

“Somewhere past the pandemic” celebrates the 30-year partnership between The National Institutes of Health and The Children’s Inn

“Somewhere past the pandemic” celebrates the 30-year partnership between The National Institutes of Health and The Children’s Inn in caring for the children and young adults who participate in clinical research to help make new treatments and cures possible. Thank you, NIH Director Dr. Francis Collins, for recognizing this milestone with an original song! #INNitfor30

Image: https://www.linkedin.com – From Video

5 Factors for Small Business Success: BioSensics | LinkedIn

If you’ve ever kept track of your steps or the quality of your sleep, you’re familiar with wearable sensor technology apps. It’s a big deal in the fitness and wellness space, but did you know it could help older adults remain independent as they age?

In 2007, Ashkan Vaziri, Ph.D.and a few friends started a company called BioSensics to execute their vision for technology to help older adults age in place. More than a decade later, the company’s success — spurred in part by small business funding from the National Institute on Aging (NIA) at the National Institutes of Health — has led to a partial acquisition by electronics retailer Best Buy and to a continuing pipeline of innovative research projects.

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