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).

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.

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.

BALTIMORE, MD, OCT. 29, 2021 – The University of Maryland BioPark (UM BioPark) today announced that JuneBrain Inc., a telehealth device company that empowers ophthalmology and neurology communities, joined the UM BioPark as its newest tenant. JuneBrain, a Maryland-based company, is located in the BioPark’s innovation space in the Lion Brothers Building on Hollins Street.

“We are delighted to welcome JuneBrain to our tenant community,” said Jane Shaab, executive director of the UM BioPark. “The BioPark is an ideal fit for emerging technology companies seeking pre-built space to grow. By fostering unique opportunities and connections, we provide a supportive environment that helps companies thrive at any stage in their development.”

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

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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.

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. 

BALTIMORE, MD (October 26, 2021) — The Maryland Department of Commerce has launched the Maryland Innovation Investment Tax Credit, which will help foster the growth of the state’s technology sectors by incentivizing investment in early-stage companies. The program, which has $2 million in funding for FY 2022, will also help increase overall investments in current and emerging tech sectors, and boost the number of individual investors in Maryland tech companies.

Applications from potential qualified Maryland technology companies are now being accepted. To submit an application, click here. To be eligible, a company must have 50 employees or less; an aggregate capitalization of at least $100,000; and be in a qualifying tech sector, which includes advanced manufacturing, aerospace, agriculture, artificial intelligence, blue technology, cybersecurity, education, energy and sustainability, financial, life sciences, quantum, and sensors and robotics. 

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.

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.

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.

Ten Johns Hopkins University faculty members have been elected to the National Academy of Medicine, an independent organization of leading professionals from diverse fields, including health, medicine, and the natural, social, and behavioral sciences. It serves alongside the National Academy of Sciences and the National Academy of Engineering as adviser for the nation and the international community.

Through its domestic and global initiatives, the academy works to address critical issues in health, medicine and related policy. Membership is considered one of the highest honors in health and medicine.

Image: https://hub.jhu.edu

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.

In today's world, successful entrepreneurs know that effective leadership requires development through diligent, intentional practice; and the best leaders among us invest in building their skill sets to improve their performance over time. 

Many of us still focus on strengthening the traditional skills associated with leadership, such as effective decision-making, strategic thinking and managing others. But one of the most vital skill sets a leader can have is often the least understood: emotional intelligence.

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.

We thought 2021 would bring a stronger path forward for Greater Washington — and the world — after a debilitating, unpredictable, unprecedented 2020.

And yet, we remain steeped in uncertainty and adversity after a Delta variant of the Covid-19 virus deepened the death toll and put thousands more at risk on a daily basis, physically and mentally, while businesses and employers continue to navigate through reopening delays and staff departures. 

OCT 06, 2025 08:30 EST

PediaMetrix received 510(k) clearance from the US Food and Drug Administration (FDA) for SoftSpot^TM, a cross platform software solution for infant cranial evaluation at the point of care. The FDA clearance demonstrates SoftSpot’s safety and efficacy for infant cranial measurements using a smartphone.

“This is an important milestone for PediaMetrix and we see great potential in now bringing this innovative technology to pediatricians in the US and around the world”, said Fereshteh Aalamifar, PhD, President & CEO of PediaMetrix. Currently, pediatricians are not equipped with any tool for quantitative measurement of cranial shape and only perform visual assessment. They refer parents of children at risk to specialists for quantitative measurements, which can cause delays in the early detection and intervention. SoftSpot brings the power of a specialist to a pediatric office using a smartphone.

Andrea Alms, Co-Fund Manager & Partner, BioHealth Capital Fund, recently joined a panel on “Impact Firms Take the Lead: Private Equity & Private Credit” with Emerge Capital Management on October 11th. Emerge’s EMPWR Program has a talented roster of sub-advisors that features a special focus on women private fund leaders. During this special webinar panel, we will be focusing on EMPWR’s private equity and private debt sleeve. We will have three private fund managers join us and present how their private, impact funds can improve the quality of life around the world.

Click here to watch the recording.

PASADENA, Calif., Oct. 18, 2021 /PRNewswire/ -- Alexandria Venture Investments, the strategic venture capital platform of 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, agtech and technology campuses in AAA innovation cluster locations, was recognized by Silicon Valley Bank in its Healthcare Investments and Exits: Mid-Year 2021 Report as the #1 most active biopharma corporate investor by new deal volume from 2020 to 1H21 for the fourth consecutive year and the #1 most active new Series A investor in biopharma by new deal volume from 2020 to 1H21. These most recent leadership rankings are a testament to Alexandria's position at the vanguard and heart of the life science ecosystem. In addition to its leadership in early-stage life science venture capital investing, Alexandria Venture Investments was listed as one of the five most active U.S. investors in agrifoodtech in the 2021 AgFunder AgriFoodTech Investment Report earlier this year. Alexandria Venture Investments has for more than 25 years strategically invested in some of the most disruptive life science, agrifoodtech and technology companies advancing transformative new modalities and platforms to meaningfully improve human health. Fully integrated into Alexandria's differentiated and multifaceted business, the highly successful mission-critical Alexandria Venture Investments platform provides the company with strategic insight into these industries, strengthens relationships with key entrepreneurs and investors and enables the curation of the highest-quality tenant base.

October 19, 2021 07:00 AM Eastern Daylight Time

GYEONGGI-DO, Korea & GAITHERSBURG, Md.--(BUSINESS WIRE)--D&D Pharmatech Inc., a clinical-stage biotechnology company focused on development and commercialization of revolutionary medicines, and parent company of U.S.-based Neuraly Inc., Precision Molecular, Inc., Theraly Fibrosis Inc., P4Microbiome and Valted Seq, today announced that it has completed a $51 million Series C round of financing led by Praxis Capital Partners, a private equity firm that focuses on growth acquisitions and investments in Asia; other investors included DS Asset Management, Kudos Ventures and Korea Investment & Securities. The new round of financing builds upon the $137.1 million the company secured in Series B financing in August 2019. The company is planning an initial public offering in Korea in 2022.

BETHESDA, Md., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced the appointment of Matthias Alder as Chief Operating Officer to advance the Company’s strategic and operational objectives, including the establishment of additional industry partnerships and the transition of the Company’s lead program in Gaucher and Parkinson’s Disease into clinical trials, which is expected to occur in 2022.

“I am delighted to welcome Matthias to Gain’s growing team as we methodically scale our platform and build our internal clinical trial capabilities and operations,” said Eric Richman, Chief Executive Officer of Gain. “He brings extensive experience in the pharma and biotech industries and is a seasoned executive who will complement our current executive team at a pivotal time for Gain as we grow the organization and prepare to advance our lead program into clinical trials.”

Home to an array of renowned universities, federal labs, and government resources, it’s no surprise that the globally renowned Milken Institute found that Maryland “has one of the nation’s strongest life sciences industries,” according to its recent report.

It’s clear that Maryland’s efforts to grow its recognition as a life sciences/biotech hub have paid off. However, there is still more work to be done in order for Maryland’s R&D growth trajectory to keep up with other leading hubs such as Massachusetts and North Carolina.

Image: https://biobuzz.io

Scientists temporarily attached a pig’s kidney to a human body and watched it begin to work, a small step in the decades-long quest to one day use animal organs for life-saving transplants.

Pigs have been the most recent research focus to address the organ shortage, but among the hurdles: A sugar in pig cells, foreign to the human body, causes immediate organ rejection. The kidney for this experiment came from a gene-edited animal, engineered to eliminate that sugar and avoid an immune system attack.

Image: Photo: Joe Carrotta/NYU Langone Health via AP. In this September 2021 photo provided by NYU Langone Health, a surgical team at the hospital in New York examines a pig kidney attached to the body of a deceased recipient for any signs of rejection. From left are Drs. Zoe A. Stewart-Lewis, Robert A. Montgomery, Bonnie E. Lonze and Jeffrey Stern. The test was a step in the decades-long quest to one day use animal organs for life-saving transplants.

Phlow is strategically working with the U.S. government to ensure preparedness for future national health crises  

October 20, 2021 09:00 AM Eastern Daylight Time

RICHMOND, Va.--(BUSINESS WIRE)--Phlow Corp., a U.S.-based essential medicines impact company, today announced that it has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) contract development and manufacturing organization (CDMO) network. The network is part of a comprehensive effort by the U.S. government to provide a domestically integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools to address public health emergencies.  

935 Prose is a 10-story trophy-class, state-of-the-art research/lab building that marries iconic design, and superior lab functionality. It is positioned to recruit and retain the best-and-brightest scientific talent and will set a new standard for life science facilities.

This Forbes special section showcases how the state continues to step up its game to keep businesses thriving. Maryland's dynamic and ever-growing aerospace, cybersecurity, energy, financial services, life sciences, manufacturing, and real estate industries are all showcased throughout the publication.

Each year BioProcess International publishes over 150 articles focusing on the latest science, technologies, and techniques supporting biopharmaceutical research, development, and manufacturing. As publishers, we work closely with industry authors and our editorial advisory board members to select, edit, and review every article before publication to ensure that it meets the high standard you have come to expect from BPI.

The United States is on edge in ways the nation has rarely experienced throughout its young history. The country’s global leadership is being challenged in a rapidly changing and increasingly competitive world. Meanwhile, the nation’s sustained complacency in dealing with long-festering domestic needs has weakened our institutions from within and placed in grave danger our leadership in the critical fields of science and technology—on which so much of our economy and security is based. America is at a tipping point, in short, and Americans are justifiably unsettled.

Mr. Hakdo Kim, President, Korea SMEs & Startups Agency KOSME), joins Rich Bendis from the BHI Offices to discuss their biotech mission, their relationship with Maryland, and opportunities to expand in the United States

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University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, announced today that UMSOM has been awarded $1.25 million in matching funds from the Maryland E-Nnovation Initiative Fund (MEIF), administered by the Maryland Department of Commerce. The funds, totaling $2.5 million when combined with private philanthropy, will enable the establishment of a new Center for Pathogen Research. They will also enable UMSOM to support research professorships in the Department of Microbiology and Immunology and the Department of Neurology.

The Alicia and Yaya Foundation made a $750,000 philanthropic commitment to establish the Alicia and Yaya Foundation Professorship in Pathogen Research in the Department of Microbiology and Immunology. Matching state funds bring the total to $1.5 million, which will establish an endowed professorship for Matthew Frieman, PhD, associate professor of Microbiology and Immunology at UMSOM. He will also serve as the director of a new Center for Pathogen Research.

Danae expands its 3-D Print manufacturing capacity, adds access to unique 3D printing technologies from Materic

October 21, 2021, Baltimore, MD – Danae, Inc., a Baltimore-based 3-D Printing design and manufacturing company, today announced it has partnered with Materic, LLC and received investment from Conscious Venture Partners through their Conscious Venture Fund II.

Located at Baltimore’s 1100 Wicomico, Danae has used this investment to install eight new printers to meet its rapidly growing customer demand. The new machines extend Danae’s capabilities allowing them to manufacture parts using Selective Laser Sintering (SLS) or Stereolithography (SLA) technologies. SLS uses a laser to transform powder into a 3D model whereas SLA uses a laser to cure liquid resin into hardened plastic.

GYEONGGI-DO, Korea & GAITHERSBURG, Md., October 19, 2021--(BUSINESS WIRE)--D&D Pharmatech Inc., a clinical-stage biotechnology company focused on development and commercialization of revolutionary medicines, and parent company of U.S.-based Neuraly Inc., Precision Molecular, Inc., Theraly Fibrosis Inc., P4Microbiome and Valted Seq, today announced that it has completed a $51 million Series C round of financing led by Praxis Capital Partners, a private equity firm that focuses on growth acquisitions and investments in Asia; other investors included DS Asset Management, Kudos Ventures and Korea Investment & Securities. The new round of financing builds upon the $137.1 million the company secured in Series B financing in August 2019. The company is planning an initial public offering in Korea in 2022.

ROCKVILLE, MARYLAND, Oct 18, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Aubrey Watkins III, Ph.D., M.S. as a new board member. Aubrey Watkins III is a Senior Director, Corporate Development, Scientific Affairs, with Emergent BioSolutions Inc. in Gaithersburg, Maryland; where he leads due diligence and technical evaluations to facilitate mergers and acquisitions that supports the company’s growth strategy. BHI would also like to congratulate Board of Directors members Jarrod Borkat as he takes a new role at CareDx as Vice President Corporate Development, and Bob Silverman in his new role as Chief Business Officer with Rejuveron Life Sciences.

 “I am delighted to welcome Aubrey to our Board of Directors,” said Richard Bendis, BHI President, and CEO. “BioHealth Innovation and Emergent BioSolutions have had a long and productive relationship. We look forward to having Aubrey as a part of this Board to share his experience and perspective.”

Leaders from the BioHealth Capital Region welcome the over 1,000 registrants to the 7^th Annual BioHealth Capital Region Forum.

Please visit this link.

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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.