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Ellington West, CEO & Co-founder of Sonavi Labs, joins BioTalk to discuss their building the startup, their medical device, and raising funds in the BioHealth Capital Region.

Listen via Apple https://apple.co/3H25FPN, Google https://bit.ly/3kfXaXH, Spotify https://spoti.fi/3kgBLxI, and TuneIn https://bit.ly/3H43oU6.

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BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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GAITHERSBURG, MD, November 2, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has entered into an agreement with the Antibacterial Resistance Leadership Group (ARLG) to support a multi-center Phase 1b/2, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa. 

ARLG consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. Created in 2013, ARLG is funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. It is facilitated by the Duke Clinical Research Institute and works under the leadership of an executive committee, four component centers, and two Principal Investigators: Vance Fowler, MD, of Duke University, and Henry "Chip" Chambers, MD, of University of California, San Francisco. The NIAID is the Sponsor of this study.

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Rockville, Md. — Thus far in 2021, a record pace for initial public offerings (IPO), private investment and venture capital deals has been set in Montgomery County. Over $18 billion of investment across 76 companies and 87 separate transactions have been made in the first three quarters of the year from January 1 through September 30. The companies receiving funding span major industries from life sciences and health tech to quantum and media.

Image: https://thinkmoco.com

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Germantown, MD (November 4, 2021) – Deka Biosciences is pleased to announce the appointment of six new members to its Scientific Advisory Board: Aurélien Marabelle, MD, PhD (Gustave Roussy), Aung Naing, MD, FACP (MD Anderson Cancer Center), Abhishek Tripathi, MD (OU Health Stephenson Cancer Center), Khusru Asadullah, MD (The Charité – Universitätsmedizin Berlin, Dermatological Practice in Potsdam), Hans-Dieter Volk, MD (The Charité – Universitätsmedizin Berlin), and Florin Selaru, MD (John’s Hopkins University). 

“It is my honor to welcome such a highly esteemed group of world leaders and experts in regulation of the immune system to the company’s Scientific Advisory Board” said Dr. John Mumm, CEO, Deka Biosciences. “Each member will be invaluable to Deka as we continue to develop our Diakines into the next generation targeted cytokine platform that drive cures in both cancer and in patients suffering from autoinflammatory disease.”

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The efforts to find a functional cure for HIV are speeding up for one Maryland company after the Data Safety and Monitoring Board found no serious, adverse events with the third patient, as was the case for the previous two, American Gene Technologies announced.

"One patient can be lucky. Two can be very lucky. Three is a trend, and so actually the Data Safety and Monitoring Board has decided that they will meet quarterly from now on. We don't need to check in with them between each patient, so that means we can greatly accelerate the clinical trial," said CEO and Founder of American Gene Technologies Jeff Galvin.

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November 2, 2021, Baltimore, MD – In a move to accommodate its continued fast growth, Early Charm – a company that creates, owns and operates ventures that convert science to revenue – announced today it is more than doubling its production and lab space at Baltimore's 1100 Wicomico building.

This significant expansion will occur adjacent to Early Charm's 3,200 square feet of current production and development space, bringing total production and development space to just under 7,000 square feet.

Image: https://www.earlycharm.com/

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By Giacomo Bologna

November 03, 2021, Maryland is on track to top $2 billion worth of venture capital deals in 2021, its highest ever total.

The state had 34 deals totaling almost $400 million in the third quarter of the year, according to the most recent PitchBook-NVCA Venture Monitor report, which is released quarterly with support from Silicon Valley Bank and Affinity.

Through three quarters of 2021, Maryland has had 134 deals worth about $1.6 billion, the report said. This surpasses the entire amount of venture capital raised in 2020, when companies in Maryland raised about $1.26 billion.

PitchBook-NVCA Venture Monitor revised some figures it released earlier this year, but Greater Baltimore still appears headed for a record-breaking year. The area had 13 deals totaling $72 million in Q3, pushing its year-to-date total past $500 million. That's just shy of 2020's $524 million VC total for the entire year.

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Since the start of the COVID-19 pandemic, the response from public health agencies, regulators, researchers, and industry has been dominated by the development of vaccines. As of October 14, McGill University’s McGill COVID19 Vaccine Tracker listed 153 vaccines in clinical development, of which 23 had been approved or authorized for emergency use in at least one country.

In the United States, the FDA has approved one COVID-19 vaccine (Pfizer/BioNTech’s Comirnaty) and authorized for emergency use two others (Moderna’s Moderna COVID-19 Vaccine and Johnson & Johnson’s Janssen COVID-19 Vaccine). Beyond the United States, most approvals and authorizations have been granted to those vaccines and others developed by AstraZeneca/University of Oxford (122 countries), Sinopharm (65), Sinovac Biotech (40), Russia’s Gamaleya Research Institute (16), and CanSino Biologics (9).

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Amritha Jaishankar, PhD, Executive Director, Maryland Stem Cell Research Fund (MSCRF), joins BioTalk to discuss her career, investing in Maryland, and accelerating cures.

Listen via Apple https://apple.co/3ED5uIy, Google https://bit.ly/3EudFqG, Spotify https://spoti.fi/3EudHii, and TuneIn https://bit.ly/3bs9a3u.

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Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 – UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

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Listen now via Apple https://apple.co/3BSIFjn, Google https://bit.ly/3j7YyLt, Spotify https://spoti.fi/2Z474Ec, and TuneIn https://bit.ly/3DUweUz.

Divya Chadha Manek was appointed as the NIHR CRN’s Head of Commercial Business Development in 2015 then in 2020, Divya was seconded to the UK Vaccines Taskforce (VTF) which was set up in response to the COVID-19 pandemic to lead the UK’s search for a safe and effective vaccine. Divya was responsible for supporting global pharmaceutical companies to rapidly generate the evidence required for marketing authorisation of COVID-19 vaccines. Divya also played a pivotal role in conceptualising and developing the NHS Vaccine Research Registry.

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Congrats to Dr Sean Parsons and the Ellume team for taking out the Accenture Australia Award for Product Innovation at the Lord Mayor’s Business Awards.

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SOMERSET, N.J. – October 26, 2021 — Catalent, the global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced a $230 million expansion project to add three further commercial-scale viral vector manufacturing suites and associated support facilities and services at its gene therapy campus in Harmans, Maryland, to meet growing customer demand.

The Harmans campus, located close to Baltimore Washington International Airport (BWI), includes a now fully operational, state-of-the-art U.S. FDA- and EMA-approved facility comprising 10 commercial-scale manufacturing suites. A second facility is under construction following an initial $130 million investment by Catalent in 2020, which will add five new manufacturing suites that are expected to be operational mid-2022. This latest investment will include the construction of three additional multi-room commercial suites, as well as expanding the site’s storage capabilities for just-in-time inventory space, ultra-low temperature freezers, and its water-for-injection infrastructure. When complete at the end of 2022, the campus will house a total of 18 CGMP viral vector manufacturing suites, each designed to accommodate multiple bioreactors up to 2,000-liter scale and enable the execution of commercial manufacturing from cell bank to purified drug substance.

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Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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Noble Life Sciences is delighted to welcome Rigoberto Sanchez, Associate Director, Quality Assurance (QA).

Dr. Sanchez will be responsible for Quality Assurance and regulatory compliance with Title 21 of the US Code of Federal Regulations (CFR), Part 58, for studies conducted in accordance with Good Laboratory Practices; animal welfare regulations provided by the Guide for the Care and Use of Laboratory Animals and the Office of Laboratory Animal Welfare (OLAW); the Institutional Animal Care and Use Committee (IACUC); standards provided by the Association for Assessment and Accreditation for Laboratory Animal Care (AAALAC) and additional local, state, federal and international regulations.

Image: https://content.noblelifesci.com

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Nkarta to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its oncology cell-therapy candidates

SOUTH SAN FRANCISCO and GAITHERSBURG, Md., Oct. 28, 2021 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Nkarta, Inc., a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer.

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Novavax Inc. (NASDAQ: NVAX) has filed for regulatory approval of its Covid-19 vaccine candidate in the U.K. — a major step toward seeking approval in more countries, including the U.S.

The Gaithersburg biotech said Wednesday it has completed all of the requirements for its submission to the U.K.’s regulatory agency, after kicking off a rolling review process earlier this year. It’s a big step for the company, which has faced numerous manufacturing challenges that have prolonged its ability to get its protein-based vaccine across the finish line in multiple markets.

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October 2021, A 2020 survey conducted by BIO found that in the 100 biotech companies surveyed, women made up nearly half of total employees, but accounted for only 31% of executives and 23% of CEOs. Women’s representation suffers a steep decline in leadership positions across the life sciences, and the gap only widens for women of color.

When Lynn Johnson Langer and Debra Bowes, started their careers in the life sciences they both knew that gender diversity was rare, and even scarcer as women entrepreneurs. “Networking events I attended were mainly comprised of men. There were no opportunities to talk with women about their experiences and career opportunities,” said Johnson Langer.

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Organizations and governments around the world are pouring billions of dollars into quantum research and development, with the likes of Google, Microsoft and Intel racing to reach quantum supremacy. 

The stakes are high, and with so many major players, the arrival of full-scale quantum computers could be around the corner. 

In order to prepare, it’s vital that we as technology leaders educate ourselves on the reality of these machines, and the impacts they could have around the world. Unfortunately, it’s not all positive. 

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As creators, we are frequently told to find our passion and begin building our portfolio and network as early as possible. After all, the more time we can dedicate to something, the better the outcome will be. Inherently, entrepreneurs are creative which can lead to being multi-passionate, meaning a lot of different ideas excite us at once. Radmila Lolly, a musician and fashion designer, says being an artist isn’t a one-size-fits-all endeavor. In fact, finding success as an artist is all about not having limits.

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