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439th Edition, March 30, 2021




BioHealth Innovation


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March 30, 2021












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BioHealth Innovation Recruiting Managing Director, Economic Development Position

Montgomery County, Maryland County Executive Marc Elrich has notified the Montgomery County Council of his appointment of BHI’s Managing Director for Economic Development, Judy Costello, as Special Projects Manager.  Confirmation is expected to take place next month. 

“While we are excited for Judy and know she will bring her economic development expertise and passion for supporting innovation and entrepreneurship to the County, we will miss her positive attitude and support of many of our different programs,” said BHI CEO Rich Bendis. “We now are actively recruiting for her position. Anyone interested is welcome to contact me directly.” 

Click here to view the job description.

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Knowing Your Assets with Richard Bendis Talent Talks Ep. 14

Check out this weeks episode of Talent Talks on YouTube and Spotify! This week we sit with Richard Bendis President and CEO of BioHealth Innovation, Inc. He talks about the importance of knowing your assets and the region around you with our hosts Robb Hoyle CEO GTS Scientific and Gregory Hoyle. Click below to watch and make sure to like and subscribe: https://hubs.li/H0JRgfF0

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Leveraging Artificial Intelligence in Human Health | B.S. in Biocomputational Engineering

The University of Maryland hosted a free webinar, Leveraging Artificial Intelligence in Human Health, on Friday, March 19, 2020. This event featured a fireside chat with Dr. Robert Scharpf (Delfi Diagnostics) and Dr. Christie Bergerson (Exponent), moderated by Rich Bendis (BioHealth Innovation/BioTalk podcast).

Together, the group shared insights into how artificial intelligence is impacting biomedical engineering and the wider world of human health, and spoke candidly about future applications for these and other biotech platforms.

Image: https://biocomp.umd.edu

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8 digital health trends emerging from the pandemic – Technical.ly Baltimore

What did we learn during the pandemic, and what should we watch moving forward?

Those are two of the key questions that many professional conversations center on these days. On Thursday, they were approached by a group of digital health experts who came together for a virtual forum organized by the Economic Alliance of Greater Baltimore and Rockville-based BioHealth Innovation.

Image: Panelists at EAGB and BioHealth Innovation’s Digital Health Forum. (Courtesy image)

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Novavax trials highlight Maryland’s COVID-fighting complex

When Novavax Inc. received $1.6 billion last year from the federal government to speed up testing and production of a coronavirus vaccine, some observers were incredulous. The small biotechnology firm, based in Gaithersburg, Maryland, was largely unknown and had never successfully brought a product to market.

But now that the company nears completion of its Phase 3 trials for its COVID-19 vaccine, which was found to be nearly 90% effective during clinical testing in the United Kingdom, it is grabbing headlines around the world.

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CASI Pharmaceuticals Announces Pricing Of $32,500,000 Public Offering Of Common Stock

ROCKVILLE, Md. and BEIJING, March 24, 2021 /PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the pricing of an underwritten public offering of 15,853,658 shares of its common stock at a price to the public of $2.05 per share. CASI has granted the underwriters an option to purchase up to an additional 2,378,048 shares of common stock, which terminates on the earlier of 30 days and the day before CASI files to the U.S. Securities and Exchange Commission (“SEC”) its Annual Report on Form 10-K for the fiscal year ended December 31, 2020. The offering is expected to close on or about March 26, 2021, subject to satisfaction of customary closing conditions. The gross proceeds to CASI from the offering, excluding any exercise by the underwriters of their option to purchase additional shares, are expected to be approximately $32.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by CASI.

 

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Bethesda’s BrainScope launches Concussion Index, eyes big raise – Washington Business Journal

BrainScope received FDA clearance in September 2016 to sell its first product, which it developed with the Department of Defense to assess a range of traumatic brain injuries.

Image: Susan Hertzberg is CEO and chairwoman of Bethesda-based BrainScope. COURTESY BRAINSCOPE

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NeoImmuneTech Announces Closing of Initial Public Offering – BioHealth Capital Region

ROCKVILLE, Md.–(BUSINESS WIRE)–NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced the closing of its initial public offering of 3,133,334 shares of common stock, equivalent with 15,666,670 Korea Depository Receipts (KDRs) priced at KRW 37,500 per share, equivalent with KRW 7,500 per KDRs. The aggregate gross proceeds to NeoImmuneTech, before deducting underwriting discounts and commissions and other offering expenses, were KRW 117.5 billion ($103.4 million). NeoImmuneTech’s common stock began trading on the Korea Exchange on March 16, 2021, under the KOSDAQ code number “950220.”

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Bio Lab Pilot Program — MCEDC

Rockville, Md. — The Montgomery County Economic Development Corporation (MCEDC) awarded a total of $96,430 to six small life science companies as part of its recently completed Bio Lab Pilot Project. The project was launched in 2019 to assist local growth-stage life science companies with their wet lab and infrastructure needs. Applicants seeking financial help to build out small wet lab space less than 5,000 SF were encouraged to apply for $10 per SF of lab fit out costs, up to $30,000 per company. Project funding was provided by MCEDC and the Maryland Department of Commerce.

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Precigen Announces First Patient Dosed for PRGN-2012 AdenoVerse™ Immunotherapy in Patients with Recurrent Respiratory Papillomatosis (RRP)

GERMANTOWN, Md., March 23, 2021 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the first patient has been dosed in the Phase I study of PRGN-2012, a first-in-class, investigational off-the-shelf (OTS) AdenoVerse™ immunotherapy in adult patients with recurrent respiratory papillomatosis (RRP) (clinical trial identifier: NCT04724980). The US Food and Drug Administration recently granted Orphan Drug Designation for PRGN-2012 in RRP in March 2021.

PRGN-2012 is an innovative therapeutic vaccine with optimized antigen design that uses Precigen’s gorilla adenovector technology, part of Precigen’s proprietary AdenoVerse platform, to elicit immune responses directed against cells infected with HPV 6 or HPV 11. Gorilla adenovectors have numerous advantages, including the ability for repeat administration, the inability to replicate in vivo, which may improve safety, and the ability to deliver large payload capacity. In preclinical models, PRGN-2012 has demonstrated strong and specific immune response against HPV 6 and HPV 11.

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TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility — TCR2 Therapeutics

CAMBRIDGE, Mass., March 29, 2021 (GLOBE NEWSWIRE) — TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. (NYSE: ARE) for an existing 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland which is ready for Current Good Manufacturing Practice (cGMP) build-out. The site will support clinical and commercial production of gavo-cel with a capacity to treat several thousand cancer patients annually. The facility is expected to accelerate the Company’s commercial-scale manufacturing timelines with production anticipated in 2023.

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BioFactura Funded $13M Contract Option for Smallpox Biodefense Therapeutic | Global Biodefense

BioFactura, Inc. today announced a contract option activation of over $13 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, as part of BioFactura’s prime contract valued at up to $67.4 million for the advanced development of a smallpox biodefense therapeutic.

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Construction on New Buildings Underway at Port Covington Development

New buildings are now rising out of the ground on the first major phase of construction at the 235-acre, $5.5-billion, multi-decade Port Covington development. Construction on five new buildings totaling 1.1 million sq. ft. is underway with a tower crane currently on the site. The Port Covington Development Team held a groundbreaking today to celebrate the start of vertical construction.

Image: https://www.southbmore.com

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What It Takes to Manufacture a Vaccine | NAM

You may not know it, but one company has the capacity to manufacture bulk drug substance for more than a billion doses of COVID-19 vaccines annually: Emergent BioSolutions, a global supplier for the Johnson & Johnson vaccine and U.S. supplier for the AstraZeneca vaccine. Emergent Executive Vice President of Manufacturing and Technical Operations Sean Kirk spoke with us recently to explain what goes into the heroic production of all these doses—in other words, what it takes to help defeat COVID-19.

Image: https://www.nam.org/

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Northern Virginia’s bioscience industry grows stronger | WTOP

Exciting things are happening at Innovation Park in Manassas. Researchers are working on global solutions, industry jobs are on the rise, and new facilities are being developed – and wait, there’s more!

“Companies are seeing really big wins across the state and the region and the life science industry is only going uphill from here,” said Amy Adams, Executive Director for the Institute for Biohealth Innovation at George Mason University (GMU).

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Critical need for electrophysiology devices to treat pediatric heart patients is focus of medical device pitch competition with $150K in awards | BioSpace

WASHINGTON, March 23, 2021 /PRNewswire/ — Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated by arrhythmias, a condition where the heart beats too rapidly, too slowly or irregularly due to a misfiring of the body’s electrical impulses. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period. As a result, pediatric specialists are often using off-label or improvised devices to treat pediatric arrhythmias, including in the smallest newborns.

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Fireside Chat – Development of Countermeasures for Viral Diseases – Webinar Registration – Zoom

Development of Countermeasures for Viral Diseases

The best defense against viral infectious diseases are safe and effective medical countermeasures that function at level of prevention of infection (prophylaxis) and treatment of disease (therapeutic). These include microbicides and vaccines, direct acting antivirals, and immunotherapies. This fireside chat will focus on features and characteristics of effective countermeasures, how they defend against viral infection and disease, and the preclinical development pathways to advance them from bench to bedside.

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5 Questions with Natalie McKinney, Industry Programs Director, Biologics, US Pharmacopeia · BioBuzz

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. March is WOMEN’S HISTORY MONTH and BioBuzz will celebrate by featuring Women in the BioHealth industry all month, especially in “5 Questions With…”. This week we continue the series with Natalie McKinney, Industry Programs Director, Biologics, US Pharmacopeia.

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209 PERRY PARKWAY – GAITHERSBURG, MARYLAND, 20877

SPACE FEATURES

  • Existing laboratory suite with closed and open o ices
  • Grade-level loading doors
  • 17′ ceiling heights • breakroom with kitchenette
  • 180 free surface spaces (Parking Ratio 3.50/1,000 SF)
  • Surrounded by numerous amenities
  • Located 1.2 miles from the Gaithersburg MARC
  • Easy access to I-270 and the new Watkins Mill Interchange

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Novavax Trials Highlight Dozens of Maryland Companies Fighting COVID – NBC4 Washington

When Novavax Inc. received $1.6 billion last year from the federal government to speed up testing and production of a coronavirus vaccine, some observers were incredulous. The small biotechnology firm, based in Gaithersburg, Maryland, was largely unknown and had never successfully brought a product to market.

But now that the company nears completion of its Phase 3 trials for its COVID-19 vaccine, which was found to be nearly 90% effective during clinical testing in the United Kingdom, it is grabbing headlines around the world.

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TEDCO Announces Request for Applications for the Agriculture and Rural Rebuild Challenge | TEDCO

COLUMBIA, Md. (March 25, 2021) –TEDCO, Maryland’s economic engine for technology companies, announced today its request for applications for the Agriculture and Rural Rebuild (ARR) Challenge, created to assist Maryland’s rural and agricultural businesses that have been detrimentally impacted by the COVID-19 pandemic and associated economic downturn. TEDCO will award grants up to $200,000 per project.

“The ARR Challenge encourages purposeful collaboration between rural businesses, research institutions and industry partners,” stated Dr. Arti Santhanam, MII executive director. “Examples of a successful project may include, but is not limited to, the development of an innovative product or a novel application of an existing technology applicable to agriculture or other rural industry sectors.”

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Tribute in Light: AstraZeneca Gaithersburg Campus Honors José Baselga

Our AstraZeneca Gaithersburg Campus will be illuminated this week to pay tribute to José Baselga, our beloved Oncology R&D leader and Site Head who passed away last weekend. Our entire community is devasted by this unexpected news following a period of temporary medical leave that he began in January 2021. An outstanding scientific leader, José leaves a lasting legacy in the scientific community and especially here at AstraZeneca Gaithersburg. He set our Oncology R&D function on a remarkable trajectory, and his visionary leadership, deep scientific expertise and strategic insight have delivered so many achievements that will benefit patient lives in the years to come. The blue and garnet lights were chosen to celebrate his favorite hometown soccer club, FC Barcelona. He will be deeply missed across our campus, and we will continue to be inspired by his work and vison.

For any inquiries please reach out to Joe Sanchez at joseph.sanchez @astrazeneca.com.

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