BHI Weekly News Archives

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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.

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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.

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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.

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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

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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.

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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

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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. 

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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)

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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.

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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.

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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.

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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)

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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.

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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.

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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

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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.

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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.

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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

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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.

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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

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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.

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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.

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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/

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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.

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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.

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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.

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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.”

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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. 

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(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.”

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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.

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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.”

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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.

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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

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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) 

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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“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

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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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Over the past nine months, more than $7 billion in federal money has poured into the BioHealth Capital Region in support of therapies, diagnostics, and vaccines against COVID-19. In that short time, the region has shown its importance in halting the spread of the ongoing pandemic.

At the 6th Annual BioHealth Capital Region Forum, COVID-19 was a central focus of attendees and panelists. One panel, Strength of Our Region: Combating Infectious Diseases, included representatives from four companies in the region that provided an overview of the region’s role in combating the novel coronavirus as well as other infectious threats. Company representatives from Novavax, Emergent BioSolutions, BioFactura, and Aperiomics pointed to the work conducted by their organizations in COVID, as well as other infectious diseases, including Ebola, influenza, RSV, and SARS. The panel was moderated by Karen Smith, chief medical officer of Emergent BioSolutions, who said she was struck early on in the pandemic that companies in the BioHealth Capital region battling the pandemic are “all in the same storm, just in slightly different boats.” She said they are all trying to figure out a solution to this pandemic but in different manners due to their areas of expertise.

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The Glocal Innovation Life Sciences Meet-Up is run by the UK/Europe based #coffeebuddies online Thought-Leadership community. This is headed by Prof Tony Sedgwick and Graham Combe, and has an Agile Leaders Advisory Board of 18 life science innovation leaders and investors.

This Meet-Up has been inspired by huge advances in technology that allow us to connect, engage, inspire and entertain life science professionals from around the world. There are no boundaries for our abilities to connect and network with other global Thought-Leaders. We started with connecting our #coffeebuddies community with networks in Australia and NZ which is a phenomenal success. This event is the first in the series where we connect with the East Coast of the Americas.

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MADISON, Wis. and CAMBRIDGE, Mass., Oct. 27, 2020 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) and Thrive Earlier Detection Corp. (“Thrive”), a healthcare company dedicated to incorporating earlier cancer detection into routine medical care, today announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion. The transaction was unanimously approved by both companies’ Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions.

Combining Thrive’s pioneering early-stage screening test, CancerSEEK, with Exact Sciences’ best-in-class scientific platform, clinical organization, and commercial infrastructure will establish Exact Sciences as a leading competitor in blood-based, multi-cancer screening. Thrive, with an early version of CancerSEEK, has conducted a first-of-its-kind 10,000-patient, prospective, interventional study in a real-world clinical setting. In this landmark study, using its mutation and protein biomarker approach, CancerSEEK achieved promising results detecting 10 different types of cancer, including seven with no recommended screening guidelines, with very few false positives. Bringing together highly complementary scientific approaches and the strengths of both organizations, Exact Sciences expects to develop a more accurate test and accelerate the widespread adoption of this potentially life-saving advancement.https://d-1827656436805240469.ampproject.net/2010132225002/frame.htmlAd

Image: https://biobuzz.io

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GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company’s rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company’s immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

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ROCKVILLE, Md., Oct. 27, 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 will receive a milestone payment of $80.0 million from Novartis AG based upon the achievement of $1.0 billion in cumulative net sales of Zolgensma. REGENXBIO expects to recognize this revenue in the third quarter of 2020.

“Zolgensma is a transformative, one-time gene therapy for the treatment of pediatric patients with SMA, a debilitating and potentially deadly disease, and the first approved gene therapy based on REGENXBIO’s NAV Technology. We believe that this achievement provides further validation of the broad potential of NAV Technology to improve the lives of patients in need,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are pleased to have contributed to a therapy that has impacted the lives of over 700 patients with SMA and their families around the world.”

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Neuraly, Inc., a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease. NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020.

“Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “Alzheimer’s has proven to be a particularly challenging disease to address therapeutically. We believe that targeting neuroinflammation via this novel mechanism of action represents a compelling pathway with the potential to be a disease-modifying agent for both Alzheimer’s and Parkinson’s disease.”

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ROCKVILLE, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) (“Rexahn”) announced today that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. (“Ocuphire”) and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from “Rexahn Pharmaceuticals, Inc.” to “Ocuphire Pharma, Inc.”; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing.

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ROCKVILLE, Md., Oct. 29, 2020 /PRNewswire/ — Emmes today announced that the Montgomery County Chamber of Commerce has selected Emmes as the recipient of its 2020 Corporate Achievement Award. Dr. Anne Lindblad, who recently retired as the company’s president and chief executive officer, accepted the award at a virtual event hosted by the chamber on October 29.

According to Lowell Yoder, chairman of the Montgomery County Chamber of Commerce and M&T Bank’s group vice president for the Greater Washington Market, “Over the years, Emmes has set high standards for financial performance, sound management, and sustained growth – while contributing significantly to our community along the way.”

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Through a partnership with NIH, D.C. virtual reality startup Floreo is expanding from autism spectrum disorder to attention deficit hyperactivity disorder.

Image: Floreo’s platform allows kids to practice skills such as pointing or eye contact, with a linked tablet for parents to follow along. COURTESY FLOREO

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Greater Baltimore is one of few regions ideally suited to pioneer the future of digital health, an industry that will revolutionize healthcare as we know it. Companies in Greater Baltimore benefit from a rich ecosystem of healthcare assets that collectively provide every component necessary for digital health innovation: transformative research, specialized business incubation, access to funding, a talented workforce, and easily-accessible local and federal clients. The growing list of successes among Greater Baltimore’s digital health companies and groundbreaking partnerships showcase tremendous potential for this industry to play a defining role in the Region and influence healthcare throughout the nation for decades to come. The pandemic has accelerated the development of digital health technologies.

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The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZeneca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555).

The U.S. Department of Defense (DoD) disclosed yesterday that the Army this week awarded firm-fixed-price contracts of $312.5 million with Lilly (W911QY-21-C-0016) on Tuesday, and more than $286.9 million with AstraZeneca (W15QKN-21-C-0003) on Wednesday. The contracts, awarded by U.S. Army Contracting Command, cover an unspecified quantity of bamlanivimab to be made at a Lilly production site in Indianapolis; and 200 million doses of AZD1222 to be produced at AstraZeneca sites in West Chester Township, OH, and Albuquerque, NM.

Image: Spc. Selena M. Castillo prepares to administer a flu vaccination on Fort Sill, Okla., Nov. 15, 2019. Spc. Castillo is a medic for 3rd Battalion, 2nd Air Defense Artillery Regiment, 31st Air Defense Artillery Brigade. The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZenca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555). (Photo By: Army Sgt. Amanda Hunt, U.S. Department of Defense)

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Fina Biosolutions has been issued European patent No. 3099800, Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains. The patent covers expression of the conjugate vaccine carrier protein CRM197 in our E. coli strain engineered to have an oxidative cytoplasm. FinaBio markets the E. coli expressed CRM197 under the name EcoCRM®.

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WAKEFIELD, Mass. and FAIRFAX, Va., Oct. 30, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID), today jointly announce completion of extensive laboratory testing supporting anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment.

Research findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.

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Sep 05, 2020 (IssueWire via COMTEX) — San Diego, Sep 5, 2020 (Issuewire.com) – Jaan Biotherapeutics (“JBT”), announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health under Award Number R43HL154884. Under the Phase I grant, JBT intends to advance its lead cardiac muscle regeneration viral delivered drug, JBT-miR2 through preclinical testing in large animals. The first indication of JBT-miR2 is for the treatment of Ischemic Heart Disease (IHD), the single largest cause of death of both men and women in the Western World.

JBT-miR2 is a first in class viral delivered microRNA inhibitor that reprograms cardiac muscle cells to divide within the damaged heart, and repair the heart muscle after permanent heart muscle injury, for example following a heart attack.

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When all the votes are cast and counted in this year’s momentous November 3 election, the results will have deep and potentially long-lasting impacts on numerous areas of society, including science. President Donald Trump and his challenger, former vice president Joe Biden, have presented vastly different visions for handling crucial issues—ranging from the deadly coronavirus pandemic to the damaging impacts of climate change and immigration policies.

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Have you heard of a little thing called Covid-19? So has Big Pharma, and the race to develop a vaccine is on. It’s high-stakes geopolitical chess and every country and company involved badly wants to win, including Anglo-Swedish drugmaker AstraZeneca.

When Oxford’s Jenner Institute partnered with AstraZeneca on its vaccine candidate, ChAdOx1 nCoV-19, analysts scratched their heads. AstraZeneca is not a leader in vaccines, unlike its major UK competitor GlaxoSmithKline. It’s relatively small and has a tumultuous history. But if you look, the signs are there that AstraZeneca is building a blueprint to thrive as a 21st century pharma company.

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Three Emmes employees were among the co-authors of the recent report, “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.” The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.

In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis.

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ANNAPOLIS (WJZ) — A NIH initiative will fund a new Johns Hopkins center to research COVID-19 immunity as the pandemic continues to affect people of all ages.

The five-year grant will fund more than $2 million a year to the new Johns Hopkins Excellence in Pathogen to support the studies, to start immediately, the immune elements that determine whether people get mild or severe coronavirus after being exposed.

Image: https://baltimore.cbslocal.com – From Video

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Leverage the only verified source of angel investment data to anticipate future trends with the Angel Funders Report 2020!

The Angel Funders Report 2020 is the only source of verified data provided directly by active angel investing groups. The report is based on information collected from a variety of ACA member groups, including some of the most active investing communities. It analyzes angel capital investments made during 2019, and features profiles and insights from leading angel investors and startup company executives. The Angel Funders Report 2020 also includes initial perspectives regarding the impact of the COVID-19 pandemic on the investing ecosystem.

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Scott Carmer, CEO of NexImmune, joins BioTalk to discuss his career in the BioHealth Capital Region, recent Milestones, and his Long-Term Vision for the company

Listen now via Apple https://apple.co/3kxdC3J, Google https://bit.ly/31FlUPB, Spotify https://spoti.fi/3kuVszD, or TuneIN https://bit.ly/2TqqD3f

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– Winning company has FDA cleared device to rapidly and objectively assess brain injury at point of care.

ROCKVILLE, MARYLAND, October 26, 2020 – BrainScope, a medical neurotechnology company that is a pioneer in the use of A.I. and machine learning in the creation of biomarkers of brain injuries and disease was selected from five finalists as the company with the most commercial potential at the 5th Annual BioHealth Capital Region Crab Trap Competition. The Bethesda, Maryland based company is helping hospital Emergency Departments (EDs) objectively triage the almost five million patients that present each year with suspected mild traumatic brain injuries. BrainScope’s FDA-cleared decision support tool provides a rapid and accurate assessment of the likelihood of a brain bleed and a concussion, at the point of care.

BrainScope’s outstanding 99% sensitivity to a head CT scan is performed without the use of radiation, in a fraction of the time, and can improve ED efficiency and increase patient satisfaction. Clinical studies have demonstrated that when BrainScope is used in triage, hospitals can reduce the number of patients being sent for head CT by about a third. According to BrainScope CEO Susan Hertzberg, “We are honored to have been chosen from this exceptional group of companies and are very excited by the early reception we are receiving from the emergency medical community.  Now more than ever in this COVID-19 world, emergency departments need to have fast, accurate, objective tools to rapidly assess patient status and needed care.”

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After posting positive results from a midstage test for its RNAi candidate back in the spring, Sirnaomics has grabbed a $105 million series D round.

The cash boost, co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co. Ltd. and Sunshine Riverhead Capital, will go toward the biotech seeking to push deeper into the clinic and one day follow rival and RNA pioneer Alnylam to regulatory approval.

The $105 million will be put toward that R&D process for its RNAi therapeutics, which are on tap to treat a diverse range of diseases including cancers, fibrosis diseases, metabolic diseases and viral infections.

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What happens when you fund Black Founders? With $100K funding & support from Google for Startups Black Founders Fund, TruGenomix plans to further advance its efforts to bring earlier diagnosis & treatment for behavioral health disorders like PTSD to military, veterans, first responders, healthcare workers & trauma-exposed communities at large. This is why the initiative matters: https://goo.gle/2SqjS10

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Rockville, Md.—Autonomous Therapeutics, Inc. (ATI), a rapidly growing antivirals company, has chosen Montgomery County’s Rockville, Maryland, for its new headquarters. ATI chose to relocate from New York City to take advantage of Rockville’s proximity to leading U.S. researchers, regulators, and funders. Their new 17,700 SF home at 1530 E. Jefferson Street is also in an Opportunity Zone, which offers an advantage for the company in attracting future investment.

ATI is developing a suite of first-in-class “Therapeutic Interfering Particles” (TIPs) to prevent respiratory pandemics, including influenza and COVID-19. The company’s lead candidates include therapeutics that are designed to prevent infections by any coronavirus strain—from COVID-19 to the next pandemic. ATI has raised millions of dollars in capital from public and private partners to transition its antiviral candidates into first-in-human clinical trials.

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She said the Rockville research company is set to grow and details Covid’s larger impact on research.

Image: Dr. Christine Dingivan took over as president and CEO of Rockville contract research organization Emmes at the end of September. COURTESY EMMES

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It will support pediatric research at the health system.

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MARSEILLE, France, Oct. 23, 2020 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

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What is BARDA Industry Day?

BARDA Industry Day is the annual meeting held to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space. This year, BARDA Industry Day 2020 will be virtual and will feature one day of exciting speakers, breakout sessions, and valuable networking opportunities!

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The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps on board full time. This comes two months after it nabbed U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation prospects, including the AstraZeneca vaccine it helped develop.

Image: Vaccitech’s headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

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The startup is now looking for a lead investor for its Series A round to fund the company’s go-to market roadmap.

Image: Sam Owen is founder and CEO of D.C.-based Otolith Labs ALEXANDRA WHITNEY PHOTOGRAPHY

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America’s long-term economic growth demands a stepped-up commitment to promoting the innovation impact of the nation’s top-tier universities and other research institutions.

For research institutions themselves, this commitment means prioritizing research, empowering great researchers, building efficient and outcomes-focused technology transfer operations, instilling cultures of innovation and entrepreneurship, and engaging with surrounding business and innovation communities. For America as a whole, it means funding more research resources and paying more attention to the worldwide competition for human talent, including high-skilled immigrants.

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By Brian Darmody 

Seventy-five years ago, Vannevar Bush, an electrical engineer who directed government research during the Second World War, authored Science—The Endless Frontier. His report called for a centralized approach to government research, which led to the creation of the National Science Foundation in 1950 and is credited as a path breaking roadmap for US science policy.  

Over the next 75 years, the federal government invested billions of dollars of research, creating the world’s leading research universities, while places like Stanford University and state of North Carolina launched research parks; tech transfer programs stimulated by the Bayh-Dole Act flourished; and reforms in SEC regulations created the venture capital sector. 

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A few months ago, we all woke up to a new reality as COVID-19 changed everything. Personally, I shut down one of my startups while one of my portfolio’s startups boomed and a close friend — who had closed a large Series B in January — fired a third of her employees.

Then I saw community members rise to the occasion, taking action to help others, and governments acting faster than ever to enact bold and effective policy. Clearly, we are the ones we’ve been waiting for. It’s in our hands as a global community to shape how this will play out.

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In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look at COVID-19’s impact on Medicare telehealth. Other articles include: the next installment in the series of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for entrepreneurs; the Bayh-Dole Act turns 40; and the lack of public guidance available regarding COVID-19 related apps.

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Real estate investment trusts (REITs) have done an excellent job creating outsized wealth for their investors over the years. From 1972 through the end of last year, REITs generated an average annual total return of 13.3%, which outperformed the S&P 500’s 12.1% total return. Those higher long-term returns mean REITs have turned small initial investments into big-time paydays at a faster pace than the S&P 500.

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Johns Hopkins moved up a spot to No. 10 in the annual U.S. News & World Report Best Global University Rankings released today, a year after moving up to No. 11 from No. 12 in the 2020 rankings.

Johns Hopkins also ranks among the top 10 universities in the world in 15 subject areas and among the top 20 in 19 subject areas. Ten new subject area rankings were added to the list this year, bringing the total to 38.

Image: https://hub.jhu.edu

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New Enterprise Associates Inc., one of the world’s largest venture capital firms, is in talks to sell a minority stake in itself, according to people with knowledge of the matter.

The Silicon Valley firm has held discussions with several potential investors, said the people, who requested anonymity because the talks are private. No deal has been reached, and it’s possible one won’t materialize. Representatives for NEA didn’t immediately respond to requests for comment.

Image: NEA’s Scott Sandell Photographer: David Paul Morris/Bloomberg

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In a long-awaited meeting on America’s crash program to deliver vaccines against the Covid-19 coronavirus, leaders of the program reviewed the measures they have taken to assure the effectiveness and safety of the vaccines. The U.S. Food and Drug Administration convened a panel of independent vaccine experts to ask questions during the Thursday online session. The meeting was designed to reassure the public on the integrity and transparency of the FDA’s vaccine oversight, as the agency has wrestled with political pressure and pockets of public vaccine hesitancy.

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Introduction

The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law.

From 1st January 2021 the UK will be able to adopt an independent regulatory framework with the Medicines and Healthcare products Regulatory Agency (MHRA) positioned as the stand-alone regulator for medicines and medical devices.

Negotiations between the EU and UK are still ongoing to define the future relationship and with only a matter of months left before the end of the transition period there has been no formal agreement. For the pharmaceutical industry this presents numerous challenges as companies prepare to continue supply of medicines that comply with new legislation. The preferred outcome for many within the industry will be to implement a mutual recognition agreement for areas such as GMP certification, batch testing, etc. between the UK and EU. It is unclear at this stage if an encompassing mutual recognition agreement is achievable so all involved parties should be preparing for a ‘no deal’ scenario and review existing guidance to understand risk exposure and mitigating actions.

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Last week, the Department of Defense (DOD) announced a seven-year award of $87 million for a new Manufacturing USA institute: BioMADE. The BioIndustrial Manufacturing and Design Ecosystem (BioMADE) institute joins a network of 8 other DOD institutes, making for a total of 16 institutes supported across the federal government in the Manufacturing USA program. ASME has been a long-time supporter and advocate of the Manufacturing USA program.

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Different geographies and jurisdictions play different roles in the global economy. Some specialize in what economists call “seedbed” functions—generating new products and firms, often through cutting-edge innovation. Others specialize in corporate functions by offering attractive environments for company headquarters or other management activities. Still others specialize in more routine production functions for goods or services, handling aspects of the work that involve less innovation and have lower skill requirements. Finally, some regions specialize in resource production tied to geographical endowments, such as minerals, arable land, or lumber.

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BLUEPRINT FOR ECONOMIC RECOVERY BEYOND THE TRIANGLE: Most experts agree Raleigh and Durham are well positioned for a strong recovery from the pandemic, but what about the areas well beyond the Triangle’s core?

A new report released Wednesday from RTI International is meant to address that very question. The Innovation Corridor Blueprintincludes 12 areas of focus for leaders and stakeholders to tackle in a 100-mile radius around the Triangle. Topics range from digital infrastructure and affordable housing to biohealth technology and addressing systemic racism.

Image: An illustration of the Raleigh-Durham skylines. SEANPAVONEPHOTO

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Recordings of Keynotes, Panels and the Fireside Chat Available Online

The 6th Annual BioHealth Capital Region (BHCR) Forum like many events in 2020, went virtual this year with over 1,200 online registrants and 59 speakers coming together. The Forum, which has been held at AstraZeneca (Formerly MedImmune) since 2014 in Gaithersburg, MD, brought together the BioHealth Industry with a full slate featuring leaders of industry, academia, and government. The common message throughout the entire agenda was how this region has continued to operate and innovate while working to help the world solve the COVID-19 Pandemic.

The 2020 Crab Trap Competition, typically held during the Forum, will take place at Noon on October 21st. The Crab Trap focuses on companies in therapeutics, diagnostics, medical devices, healthcare services, e-health, mobile health, electronic medical records, health informatics, and BioHealth cyber security. This years’ finalists include BrainScope, CARRTECH, Creative Bio-Peptides, innara HEALTH, and KaloCyte.

The entire 6th Annual BioHealth Capital Region is currently available by visiting https://eventmobi.com/biohealth2020.

NOTE: If you haven’t already registered, please enter your information for immediate access. Click on the “Agenda” line to browser all the videos now available.

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The Sixth Annual BioHealth Capital Region Forum brought together industry leaders from across the region who discussed the accomplishments and strengths of the region as its member companies continue to innovate new therapies and medicines in one of the strongest bio-hub regions in the United States.

The forum, which drew more than 1,100 registrants and included 59 world-class speakers and panelists, had a different look this year due to the ongoing COVID-19 pandemic. Instead of gathering together in the heart of the BioHealth Capital Region at AstraZeneca’s Gaithersburg facility, the forum was held virtually. The event offered multiple panels and keynotes that highlighted advancements made in the region across several areas, including cell and gene therapies, the use of artificial intelligence and the ongoing battle against COVID-19.

Image: https://biobuzz.io

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New Members Continue BHI’s Commitment and Mission in the BioHealth Capital Region

ROCKVILLE, MARYLAND, October 20, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of three new board members, Sally Allain, Head of JLABS @ Washington, DC, Joseph F. Sanchez, PhD, Director, Science Engagement, R&D North America, AstraZeneca, and Robert Silverman, Chief Business Officer, Alloy Therapeutics, Inc. BHI’s leadership also thanked outgoing Board of Director member Tracey Vetterick, formally of AstraZeneca for her contributions to the organization and support of many years.

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Montgomery County Executive Marc Elrich joins BioTalk to discuss his Career Path, the BioHealth Industry and plans to support the Industry in MoCo.

Listen now on Apple https://apple.co/37dYS5Z, Google https://bit.ly/2IC4eOp, Spotify https://spoti.fi/2IDpN11, TuneIn https://bit.ly/31cjHuZ, and YouTube (Audio) https://bit.ly/31bsiho.

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BARDA Director of the DRIVe Catalyst Office, Justin Yang, Joins BioTalk to share how BARDA collaborates with the BioHealth Industry, partners with Incubators, and helps fund innovation.

Listen now via Apple https://apple.co/3dqDyLH, Google https://bit.ly/3jZyeRU, Spotify https://spoti.fi/34YL9xg, and TuneIn https://bit.ly/3k1uM9x.

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Maryland is on pace to see its second-largest funding year ever.

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The U.S. government is providing roughly $486 million to AstraZeneca to accelerate the Big Pharma company’s experimental Covid-19 therapy.

The funds will be used to advance AstraZeneca’s antibody combination, AZD7442, into two phase-III clinical trials. The last-stage studies, expected to begin later this month or early next month, will involve more than 6,000 study participants at sites in and outside the United States. (Phase-III clinical trials are typically the last hurdle a pharmaceutical company must successfully clear before seeking approval for a new drug candidate.)

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Adaptive Phage Therapeutics can take its therapy for superbugs to human trials.

Image: Dr. Carl Merril, third from right, with his son Greg, CEO and co-founder of Adaptive Phage Therapeutics, and other members of the team. ADAPTIVE PHAGE THERAPEUTICS INC.

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She aims to have a big presence in the local business community.

Image: Paula Sorrell is the new associate vice president of innovation and economic development at George Mason University. GEORGE MASON UNIVERSITY

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What is MedTech Color?

MedTech Color is a non-profit organization focused on ensuring people of color enter, remain, and flourish in the medtech industry. There is immense untapped potential from people of color, and we’re committed to providing and promoting opportunities for them to make a meaningful contribution to the industry.

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JOHN WHYTE: You’re watching “Coronavirus in Context.” I’m Dr. John Whyte, chief medical officer at WebMD. Today I’m joined by Dr. Stephen Hahn. He’s the commissioner of the US Food and Drug Administration. Dr. Hahn, thanks for joining me.

STEPHEN M HAHN: John, thank you. Really appreciate the opportunity, and it’s great to be part of this webcast.

Image: Stephen M. Hahn M.D.

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VC investment dollars hit a seven-quarter high in the U.S. in the third quarter of 2020: A total of $36.5 billion was invested in U.S. tech and healthcare companies, according to data from the MoneyTree Report by PwC/CB Insights. That’s up 30% from the second quarter. The total number of deals rose to 1,461 investments in companies, up 1% over the prior quarter.

It’s the second straight quarter of growth, indicating that a slowdown toward the end of March as the pandemic set in didn’t become the norm.

“Things are still going gangbusters,” said Brad Phillips, a director in PwC’s Emerging Company Services practice. “It’s been a relief for a lot of people that were in the market and just didn’t know what was going to happen.”

Image: Whitebox’s Baltimore team inside its Curtis Bay HQ. (Courtesy photo)

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“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 Martha Schoonmaker, Executive Director, Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC).

Martha Schoonmaker is the first Executive Director for the PIC MC Foundation, the entity that develops, manages, and markets the Germantown campus on behalf of Montgomery College for company locations. PIC MC is an integrated academic, business, and research campus and is the only community college with a hospital, Holy Cross Germantown Hospital, located as the anchor resident partner.

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