465th Edition, July 20, 2021

If you are interested in pediatric medical device innovation or alternative solutions to surgery such as focused ultrasound, these two topics will merge at the Pediatric Device Innovators Forum, July 22, from 2 – 3:30 p.m. This free livestream event, hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), features clinical, regulatory and reimbursement experts discussing the topic “Focused Ultrasound for Pediatric Indications.”

Image: https://medcitynews.com

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DNA-modified cells can behave unpredictably in the body and there is a risk that they could proliferate uncontrolled, cause severe toxicities, and even survive unchecked for months or years. Cartesian uses its platform technology to engineer RNA into cells, making time-controlled changes. The company is developing treatments for cancer, respiratory conditions, and autoimmune diseases such as myasthenia gravis. We spoke to Murat Kalayoglu, president and CEO of Cartesian, about its RNA-engineered cell therapies, how they work and how the company is pushing the use of cell therapies beyond cancer.

Image: https://globalgenes.org

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President Biden will nominate Laurie E. Locascio to lead the federal agency in charge of promoting innovation and technology, the National Institute of Standards and Technology.

Driving the news: Biden will name Locascio, currently vice president for research at the University of Maryland, as Undersecretary for Standards and Technology at the Department of Commerce.

Image: https://news.yahoo.com

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Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the U.S. Pharmacopeia (USP) since February 2014. USP is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements, and food ingredients worldwide. USP’s quality standards are legally recognized in the United States and elsewhere and are used in more than 150 countries.

Image: Ronald Piervincenzi, CEO of U.S. Pharmacopeia

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Improving university/corporate research partnerships is key to advancing US competitiveness. Reform of the IRS rules surrounding corporate sponsored research taking place in university facilities funded by tax-exempt bonds has long been sought by the higher education community and will stimulate more public-private partnerships. With Congress considering new ways to fund research through a new NSF Technology Directorate and the possibility of a large infrastructure package, an opportunity is now open for Congress to address these long-standing reforms in IRS rules.

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SUZHOU, China, and ROCKVILLE, Md., July 19, 2021 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of National Institutes of Health, under which they will collaborate on the non-clinical and clinical development of Ascentage Pharma’s drug compound pelcitoclax.

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The Data Safety and Monitoring Board has met and evaluated the safety data from the first participant treated with AGT103-T, our HIV-cure drug candidate. The participant experienced no significant adverse events, and the DSMB voted unanimously to “continue the study with no modification”.

AGT is now a clinical-stage biotech company with initial safety data on a potential cure for a disease affecting over 1.2 million people in the U.S. and nearly 40 million people globally!

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BUFFALO, N.Y.–(BUSINESS WIRE)–Emerge Capital Management (“Emerge”) has officially launched EMPWR, an emerging managers program. Emerge’s EMPWR program includes a roster of elite, emerging portfolio managers with a special focus on women portfolio managers. It provides full back-office support, platform support, and ESG monitoring dedicated to high performance.

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On a sweltering June morning, Novavax CEO and COVID vaccine maker Stanley Erck stood on a stage unmasked and did something that would have been unthinkable six months ago: He shook hands with Maryland’s governor.

Erck was with Gov. Larry Hogan to announce Novavax’s global vaccine headquarters ― a Gaithersburg campus expected to house laboratories and more than 800 employees. Hogan called Novavax’s future “bright” and crowed that more than 71% of the state’s adults had received at least one shot.

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

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With the opening of its state-of-the-art facility in Rockville in 2017, GSK has been strengthening its manufacturing presence in the US. As a result, the site’s portfolio of programs and bulk production has been growing steadily, with many immediate full-time job openings at the site. BioBuzz recently hosted a Virtual Recruitment Event for job-seekers to learn more about the various roles at GSK Rockville BioPharm, its work culture, and what the company is looking for in prospective employees.

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The news: Johns Hopkins spinoff Bayesian Health has $15 million in VC backing to offer an AI-based clinical decision support platform designed to make health systems’ electronic health records (EHRs) more predictive.

Here’s how it works: The system analyzes EHR-collected patient data and sends providers real-time clinical signals when a critical moment is detected. It targets high-priority areas such as clinical deterioration, sepsis, pressure injury, and transitions of care.

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Montgomery County, Maryland, home of the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and more than 480 life sciences companies, continues its momentum as a magnet for new life sciences development with a major surge in leasing and investment. With rising demand and just 5.2% availability for the county’s existing lab space, an additional 1.6 million square feet (SF) of lab space is in development—joining the current 10.6 million SF of total lab inventory already in Montgomery County.

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Lab Space industry analysis included the latest data on revenue numbers, product information and earnings of the major firms. The data includes a breakdown of earnings for the Lab Space international marketplace and a forecast for exactly that same period. This report also includes the most important business strategies that have been identified by the key players in the global Lab Space marketplace. The report also highlights the risks and strengths of key competitors in the global Lab Space market. The market’s vital information is provided by the study on Worldwide Lab Space Market 2021. This report covers all the current facts about Lab Space marketplace, which is crucial in helping to foster this market. A comprehensive assessment of the Lab Space marketplace’s dynamic background is provided at the end of the research.

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Emergent BioSolutions (EBS +1.1%) has gained in morning hours after the company announced that a government agency exercised an option to extend a contract term related to its supply of Smallpox vaccine into the U.S. Strategic National Stockpile (SNS). The Office of the Assistant Secretary for Preparedness and Response (“ASPR”), part of the U.S. Department of Health and Human Services (“HHS”), has modified the contract with the exercise of the second of nine annual contract term extension options, the company said.

Image: https://seekingalpha.com

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The deal is expected to close this calendar year.

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GlaxoSmithKline (GSK) has plans to open an approximately $549m (£400m) biotechnology campus in Stevenage, UK, which would possibly create up to 5,000 skilled jobs in the coming five to ten years.

The plan for the new hub was developed in collaboration with Stevenage Bioscience Catalyst (SBC), the UK Government, Stevenage Borough Council and the Local Enterprise Partnership.

Image: GSK’s R&D site in Stevenage, UK. Credit: GSK / Flickr.

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FREDERICK, Md., July 15, 2021 /PRNewswire-PRWeb/ — Beckham Gumbin Ventures (BGV), a commercial real estate investor and developer, is beginning construction on brand new R&D laboratory spec suites and amenities at Ballenger Bio (321 Ballenger Center Drive) in Frederick, Maryland. Ballenger Bio will offer several 3,000 to 7,000 SF R&D laboratory spec suites, with the ability to combine up to 37,000 SF of contiguous space on a single floor. Building such spec labs will allow for growing biotech companies to focus on their business as opposed to construction costs and timelines.

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In May 2021, American Gene Technologies (AGT), a clinical-stage biotechnology company, announced the treatment of the first participant in its Phase I clinical trial to evaluate the safety of the cell and gene therapy product AGT103-T. Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants are infused once with their own CD4 T cells that were enriched, for cells capable of reacting to HIV, and genetically modified to resist infection. This is a first-in-human study for AGT103-T. The primary endpoint is safety; testing related to secondary endpoints evaluates responses to treatment including changes in the immune response to HIV. This video explains AGT’s research and HIV cure program strategy.

https://www.youtube.com/watch?v=fiA2s7JCkJ8

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As the world waits for the results of the investigation into the Wuhan biosafety laboratory and the verification of the COVID-19 origin , experts are turning to other high-security biological research facilities with a renewed interest. The Wuhan lab is only one of many around the world, but where are these other facilities? What are they working on? And most importantly, what security procedures are in place to keep future pandemics from happening?

Image: https://schar.gmu.edu/

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NEWARK, Del., July 14, 2021 /PRNewswire/ — Today, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) confirms that it has received $153M in new funding from the National Institute of Standards and Technology (NIST) as announced by U.S. Commerce Secretary Gina Raimondo at NIIMBL’s National Meeting in Washington, DC. The two awards include $70M to continue federal funding for NIIMBL for an additional five years and an additional $83M for coronavirus response projects under the American Rescue Plan (ARP).

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Venture capital totals for D.C. area companies got off to a strong start in 2021, and they’re continuing to rise with a new record high through the halfway point of the year.

In the second quarter of 2021, companies in the metro area collectively raised $1.27 billion across 72 deals, according to data from the PitchBook-NVCA Venture Monitor, a quarterly report produced by PitchBook and the National Venture Capital Association with support from Silicon Valley Bank.

Image: Venture capital. ((Photo by Flickr user, used via a Creative Commons license))

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Until recently, biotech companies tended to be founded with a focus on a single technology or biological pathway. An early exemplar of this was Genentech, founded in 1976 on the promise of recombinant DNA to generate proteins relevant for human health.1 Proof of concept came with the production of the hormone somatostatin in 1977, and the company made its synthetic insulin breakthrough in 1978, alleviating the need to harvest the protein from animal pancreases.

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