BHI Weekly News Archives

BioHealth Innovation, Inc., (BHI) is a regional non-profit innovation intermediary, which facilitates the development of growth-stage biohealth companies by connecting commercially relevant research assets to appropriate funding, management and markets.

JOB TITLE – Senior Life Sciences Business Strategist

Reporting to the Vice President of Economic Development, the Senior Life Sciences Business Strategist evaluates the commercial potential of emerging technologies and provides 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.

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists and manages consultants and interns, as needed.

Click here to download a PDF with the details.

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What a roller coaster. After stomach-clenching drops in 2020, the Washington, D.C., area market clambered up to new heights in 2021. Multifamily rents rebounded in and outside the District, development flourished in suburban downtowns and along the D.C. waterfront, and a stream of new life sciences tenants populated the I-270 corridor.

Still, while renters and tourists have largely returned, the office population has not, as wave after wave of COVID infections delayed a fuller return to office, leading to what now appears to be a permanent shift. In addition, 2022 brought with it new concerns about inflation, rising costs of capital, and an economic pullback in some areas.

Image: https://commercialobserver.com

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Treatment of Precursor Lesions Was Found to Significantly Reduce the Risk of Progression to Anal Cancer, with Study Result Highlighted in the New England Journal of Medicine

ROCKVILLE, Md., June 16, 2022 /PRNewswire/ — Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that a team of its researchers contributed to a successful AIDS Malignancy Consortium (AMC) study. Results of the study, which demonstrated that treating and removing anal cancer precursor lesions reduced the cancer risk for HIV-infected men and women, were published in the New England Journal of Medicine. The Phase 3 trial results included 4,446 participants at 21 clinical sites across the U.S. and Puerto Rico.

The study enrolled people living with HIV aged 35 years and older who had at least one precursor lesion for anal cancer, called high-grade squamous intraepithelial lesions (HSIL). Participants were randomized into two groups: those who received treatment for the lesion(s) and those who were actively monitored but did not receive treatment. Participants were re-evaluated every three to six months. Rates of progression to anal cancer were compared between the two groups. The findings showed that treating HSIL resulted in a nearly 60 percent reduction in anal cancer progression among people living with HIV.

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Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient's age.

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Children’s National Hospital in Washington, D.C., was ranked #5 nationally in the U.S. News & World Report (USNWR) Best Children’s Hospitals annual rankings. It’s the sixth straight year has been in the top 10. Also for the 6th straight year, Children’s National’s neonatology program was ranked No. 1 among all children’s hospitals in the nation. Children’s National’s neurology and neurosurgery program is ranked the best in the Mid-Atlantic for a second year in a row.

Image: https://www.washingtonian.com

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Antimicrobial resistance (AMR) is named one of the top 10 global health threats facing humanity by the World Health Organization and was associated with nearly 5 million deaths in 2019. With a challenge of this magnitude, it’s critical to have visibility in the supply chain for antimicrobials—medicines used to prevent and treat infections that include antibiotics (also known as antibacterials), antifungals, antivirals and antiparasitics.

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Avidea Technologies, a Baltimore-born developer of immunotherapies, had been acquired in December in a splashy $40 million deal by high-profile UK biopharma firm Vaccitech. The 14-employee startup, since folded in as Vaccitech’s North American subsidiary, would be doubling in size and needed a true home base after the five years it spent growing in Johns Hopkins Tech Ventures’s (JHTV) FastForward 1812 incubator in East Baltimore.

Image: A rendering of a planned building with wet lab space and other facliities for the University of Maryland BioPark in West Baltimore. (Image via Wexford Science + Technology, ZGF and the City of Baltimore's Urban Design & Architecture Advisory Panel)

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The biopharma bear market has ended the financing boom of recent years and led the valuations of companies to plunge after years of soaring—conditions that may compel smaller biotechs to pursue merger-and-acquisition (M&A) deals with pharma giants, according to a recently released report.

The challenges to valuations and access to capital come as the industry and the rest of the world move beyond the COVID-19 pandemic, EY, the professional services firm formerly known as Ernst & Young, observed in the 32nd annual edition of its “Beyond Borders” report.

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SAN DIEGO — (June 14, 2022) — The licensing of university and nonprofit research has made a significant contribution to US gross domestic product (GDP), industrial gross output, and jobs over the last 25 years and underscores the importance of basic and applied research to the US economy, as well as the demand for public-private partnerships. The findings are based on an independent study released today and commissioned by the Biotechnology Innovation Organization (BIO) and AUTM, a global nonprofit that works to advance ideas from research institutions into the marketplace.

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WASHINGTON, D.C. – The Senate Health, Education, Labor and Pensions Committee today passed S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The legislation is the Senate's version of user fees reauthorization, including the Medical Device User Fee Amendments agreement (MDUFA V) between the medical technology industry and the FDA. The Senate committee action follows full House of Representatives passage of its version of the legislation last week. Scott Whitaker, president and CEO of AdvaMed, the world's largest trade association representing medical technology companies, made the following comment on the Senate committee work.

"A well-functioning user fee system is essential to help ensure FDA's timely review of innovative medical technology for patients. AdvaMed appreciates the timely work of each chamber of Congress to reauthorize this critical system with improvements to make the process better. MDUFA V has historic firsts, including provisions for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations.

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The Seoul National University Bundang Hospital (SNUBH) set up a "K-Bio Health Regional Center" in a ceremony Tuesday in line with a government project supporting the commercialization of biohealth technology.

SNUBH President and CEO Paik Nam-jong, Seongnam Mayor Eun Soo-mi, Ryu Hae-pil, director of Seongnam Industry Promotion Agency, Lee Cheon-haeng, head of the Health Industry Promotion Corps at Korea Health Industry Development Institute (KHIDI), and CEOs of companies in the center attended the opening ceremony.

Image: SNUBH President Paik Nam-jong (third from right) and Seongnam Mayor Eun Soo-mi (fourth from right) were among the dignitaries who cut the tape to open the K-Biohealth Reginal Center on Tuesday. 출처 : KBR(http://www.koreabiomed.com)

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ROCKVILLE, MARYLAND, June xx, 2022 – BioHealth Innovation Inc. (BHI) announces the additions of Anna Zornosa, MA, as an Entrepreneur-in-Residence (EIR) with the NIH Office of Extramural Research, and Aliye Hashemi, B.Sc., a BHI Analyst. The Entrepreneur-in-Residence Program at BHI ensures that disruptive technologies receive all the resources required to transform the technology from a discovery into a commercially relevant product and eventually have a measurable impact on human health. The program was created to support scientists, early-stage startups, and licensed technologies to provide them with access to these resources.

“BHI is proud to welcome Anna and Aliye to the team,” said Richard Bendis, BHI President and CEO. “Anna brings a wealth of experience, and Aliye is ready to continue her impressive development with us.”

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These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

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The Gaithersburg biotech has had no product to market in its 35-year history.

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QIAGEN CEO Thierry Bernard joins Yahoo Finance Live to explain how his company is utilizing technology to track the spread of COVID through wastewater and also discusses how to track the monkeypox outbreak.

Accurately testing wastewater for COVID could help cities and towns prepare for outbreaks, stock up supplies, or put measures in place to prevent further community transmission of COVID-19. And one company recently receiving a nod from the CDC for wastewater testing is German company QIAGEN.

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Biotechnology firm United Therapeutics has showcased what it claims to be the “world’s most complex 3D printed object” in partnership with 3D printer manufacturer 3D Systems at the recent LIFE ITSELF conference in San Diego.

The partners have produced a 3D printed human lung scaffold capable of demonstrating gas exchange in animal models, and are now planning to cellularize the scaffold with a patient’s own stem cells to create tolerable, transplantable human lungs.

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The Deka Biosciences team is now 17 strong –  and growing!

Image: https://www.linkedin.com

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ABU DHABI, UAE , June 9, 2022 /PRNewswire/ — The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate of Abu Dhabi, signed a Declaration of Collaboration with the Children's National Hospital, home to the Sheikh Zayed Institute for Pediatric Surgical Innovation, as part of the Abu Dhabi Life Science Mission to the USA.

The signing cements the long-standing partnership between Abu Dhabi and Children's National Hospital in Washington DC and facilitates both entities collaborating on three key areas including genomics and oncology research and other innovations to address pediatrics, diseases and patients' management. The agreement also explores establishing Abu Dhabi as a regional pediatric hub.

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The fourth annual HERstory Gala took place on Thursday, April 21, 2022 at the VisArt Studio in Rockville Town Square. This gala is the chapter’s premier event honoring outstanding women in biotech in the Washington DC metro region. Attendees included 85 members and supporters from diverse professional backgrounds, including science, marketing, legal, and entrepreneurship.

Image: https://www.womeninbio.org

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The life sciences revolution remains robust.

A variety of megatrends (demographic, economic, technological, etc.) coupled with rapid advances in technology have boosted life sciences growth over the last decade. More recently, the COVID-19 pandemic catapulted the life sciences industry to a new level of prominence with cutting-edge innovations.

Fierce competition for talent—exacerbated by demographic changes, pandemic-induced burnout and shifting family responsibilities—presents challenges as the industry seeks to meet growing demand for its products and services.

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The University System of Maryland may soon have a new pilot program to fund early stage startups.

The measure, which was approved by both the USM Board of Regents Committee on Economic Development and Technology Commercialization and the Committee on Finance on Thursday, would allocate $200,000 per year to the Early Capital Pilot fund over three years.

Image: The University System of Maryland may establish a new fund to help early stage entrepreneurs. Jessica Iannetta/BBJ

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Tackling health inequities. Pinpointing the sources of pain. Helping the immune system target cancer. These are just some of the ambitious goals of the companies residing at Johnson & Johnson's newest incubator, JLABS @ Washington, DC. Meet three healthcare innovators leading the way.

Image: https://www.jnj.com/

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Ear infections, or the inflammation of the middle ear typically caused by bacteria, are a notorious nuisance in early childhood. The high incidence, recurrent nature, and non-specific presentation of ear infections in children have made it a feared diagnosis among parents. According to the National Institute on Deafness and Other Communication Disorders, ear infections are the most common reason for a trip to the pediatrician, with five out of six children experiencing at least one ear infection by age three, and 25% of children having repeated ear infections. Researchers at the University of Maryland (UMD), in collaboration with Johns Hopkins University (JHU), have developed an innovative technology that could save a trip to the doctor’s office by enabling virtually anyone to record and triage a child’s symptoms and status confidently and competently.

Image: Inventor John Rzasa Photo by Sage Levy

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Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S. GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

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Rockville, MD – On June 8th, Korea SMEs and Startups Agency (KOSME), its Korean Business Development Center (KBDC) and BioHealth Innovation, Inc. (BHI) will kick-off their second virtual US Market Entry program for Korean companies expanding to the United States.

Last summer, BHI and KOSME conducted a similar pilot program, which included five medical device and diagnostics companies.

This year’s competitively selected 5-member cohort includes medical diagnostics, medical devices, health AI and software companies. Over 25 Korea-based health-tech companies applied to the program.

The program will guide the cohort to adopt cultural business differences and communication methods, outline a go-to-market strategy, connect with strategic partners & key opinion leaders, and suggest product or prototype modifications. BHI’s Entrepreneurs in Residents (EIRs) mentor the cohort to achieve a successful US biohealth market entry.

image: KOSME President Hakdo Kim and BHI President Rich Bendis

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May 31, 2022

Trial will assess safety and antibody responses of NVX-CoV2515 to the Omicron variant of COVID-19 Two-dose primary regimen of NVX-CoV2373 already demonstrated cross-reactive immune responses against Omicron and other variants

Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine. The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine.

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Lung scaffolds developed in partnership with 3D Systems Corporation represent the most complex objects ever printed; reveal took place at the LIFE ITSELF Conference in San Diego

3D-printed lung scaffolds are demonstrating gas exchange in animal models

United Therapeutics expects human clinical trials of 3D-printed, cellularized lungs in the next five years

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & ROCK HILL, S.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that in partnership with 3D Systems Corporation (NYSE: DDD) it has produced the world’s most complex 3D-printed object – a human lung scaffold – and demonstrated it at the LIFE ITSELF Conference that occurred May 31 to June 3, 2022 in San Diego. The event was organized and hosted by Dr. Sanjay Gupta and Marc Hodosh and was sponsored by CNN, United Therapeutics, and other prominent corporate leaders in healthcare.

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Health and Human Services Secretary Xavier Becerra appointed Adam Russell, Chief Scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS), to serve as acting deputy director of the new Advanced Research Project Agency for Health (ARPA-H).

Proposed by President Joseph R. Biden to improve the U.S. government’s ability to speed biomedical and health research, ARPA-H was established by law on March 15 and will operate as an independent entity within the National Institutes of Health.

image: National Institutes of Health in Bethesda, Md.

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GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, the companies said today, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology.

GSK is counting on Affinivax to help it compete better with Pfizer’s blockbuster pneumococcal vaccine franchise, marketed as Prevnar®, and shore up its vaccine offerings as it prepares to spin off its consumer products joint venture with Pfizer.

Image: GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology. (GlaxoSmithKline)

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Richmond medical technology company Tympanogen is a finalist in a national pitch competition from the National Capital Consortium for Pediatric Device Innovation.

The company, which develops nonsurgical treatments for ear, nose and throat issues, earned its place in the “Make Your Medical Device Pitch for Kids!” competition for its gel-patch system for eardrum repair, called Perf-Fix.

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The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation's potential. Learn about the aspects of product development beyond the science of the awards.

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

Optimizing formulation or manufacturing operations Establishing an advisory board  Layering intellectual property protection Preparing for regulatory interactions Gathering evidence to support reimbursement value Engaging with investors or strategic partners Learn more in this video about innovator consultations

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In recent days, prominent venture capital funds have come out with survival tips for their portfolio companies. While asking startup founders to tighten their belt is sound advice, it’s worth wondering when venture capital titans might be urged by their investors to scale back their own pay, too.

Their compensation has been rising fast. Last year, median cash pay for a partner at a venture capital firm, including base salaries and bonuses, rose 10% to $928,000, reported The Information, citing a survey conducted by Holt Private Equity Consultants.

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First approval of a dry powder inhaler for treatment of PAH and PH-ILD

DPI device represents a convenient option for administration of treprostinil therapy

Commercial launch activities underway; patient availability expected in June 2022

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the U.S. Food and Drug Administration (FDA) has approved Tyvaso DPI™ (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.

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These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

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COLUMBIA, Md. (May 25, 2022)—TEDCO, Maryland’s economic engine for technology companies, announced today it will receive up to $50 million from Governor Hogan’s small business relief plan that was approved for funding from the United States Treasury Department’s State Small Business Credit Initiative (SSBCI). TEDCO will allocate the funds into four existing programs targeting technology-based Maryland businesses and entrepreneurs.

“We want to express our thanks to our colleagues at DHCD for their leadership on getting us to this point,” said TEDCO CEO Troy LeMaile-Stovall. “And this point is about investing in individuals and communities that are underrepresented in our innovation ecosystem, while also creating additional funds for TEDCO to invest in firms that will start and scale in Maryland – generating a more equitable future.”

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Health and Human Services Secretary Xavier Becerra today announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health and the appointment of Adam H. Russell, D.Phil., as acting deputy director. Currently, Dr. Russell is the Chief Scientist at University of Maryland's Applied Research Laboratory for Intelligence and Security (ARLIS). He spent more than a decade as a Program Manager, first at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA). Dr. Russell will begin his new role in June.

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Hemafuse is the Solution

There is an urgent need for blood in Ukraine. With donor blood in short supply, Hemafuse can meet this need. It is a simple, handheld device that enables surgeons to capture and reuse a trauma patient's own blood. Hemafuse is completely mechanical and can be used regardless of infrastructure. For more information visit Sisu Global's website.

Image: https://fundrazr.com

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The U.S. Department of the Treasury awarded the first batch of funding awards for the State Small Business Credit Initiative (SSBCI), a program designed to increase access to capital for traditionally underserved small businesses and entrepreneurs.

The new, expanded SSBCI provides nearly $10 billion to states, the District of Columbia, territories, and Tribal governments to promote entrepreneurship, especially in traditionally underserved communities. SSBCI funding is expected to catalyze up to $10 of private investment for every $1 of SSBCI capital funding. State governments filed plans with the Treasury on using their SSBCI allocation to provide funding to small businesses.

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First, there was Delta. Then Omicron. Now, it’s the Omicron subvariant BA.2.12.1. And, public health officials are keeping a close watch on the BA.4 and BA.5 subvariants. These waves of cases, caused by infections with new variants, have characterized the COVID-19 pandemic. But how can public health officials know which variants are likely to cause large numbers of cases and which will not take hold in the population?

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Legal & General Capital and U.S.-based real estate developer Ancora establish landmark 50:50 partnership as LGC internationalizes its platform to drive shareholder value

London, England, UK and Durham, NC | May 25, 2022 08:00 AM Eastern Daylight Time

Legal & General Capital (LGC) today announced that it has formed a 50:50 partnership with U.S.-based real estate developer Ancora to create a real estate platform dedicated to driving life science, research and technology growth across the U.S. The deal will see Legal & General Capital investing an initial $500 million of seed capital to form a new company, Ancora L&G, LLC. Operating under the name Ancora, the business’ geographic focus will sit predominantly within emerging regional markets in the U.S. where early mover advantages are available.

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Female-founded companies account for less than one-fourth of venture funding recipients in every U.S. state with a startup scene. But they’re a lot closer to the top of the spectrum in some states, and much nearer to the bottom in others.

That was the finding from a state-by-state analysis of funding over the past three years to companies with at least one female founder. We focused on 25 states that collectively account for  over 95 percent of total U.S. funding rounds.

Image: https://news.crunchbase.com

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TEDCO’s strategic plan, The Time, Talent, and Treasure Imperative for Maryland’s Ecosystem (T3IME), seizes this moment to build upon past successes and move forward differently than we have in the past. Specifically, we must scale significantly, and expand the type of resources over the next ten years (FY23-FY33). We must ensure that in this growth, we expand and include those that have been historically excluded.  We will achieve this not only with market-based fiscal returns but also by curating, investing, and growing to scale enterprises that drive societal change for our citizens and the world.

Image: https://www.tedcomd.com

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Quantum World Congress is the first-ever gathering of its kind – connecting the world’s quantum ecosystem, including the brightest researchers, innovators, technology developers, legislators, and industry experts – to accelerate the value of the growing quantum industry.

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1:45 PM – 2:45 PM (PDT), Wednesday, June 15, 2022 ・ Upper Level, Session Room 6D

Longevity tech is one of the fastest-growing yet relatively underserved markets worldwide. Forty percent of today’s older adults self-identify as early adopters of new technology, making the field ripe for innovation. To meet the needs of older consumers, we must understand their needs and behaviors, develop strategies designed to target them, and provide capital to seed technological innovations. Non-profit foundations and accelerators, such as AARP and its Innovation Labs, play a critical role helping entrepreneurs understand, optimize, and test longevity innovations

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Linshom is First to Deliver an Operating-Room-Quality Respiratory Profile to Patient Bedside for Continuous, Predictive Respiratory Monitoring (CPRM)

Baltimore, Md. (April 27, 2022) – Linshom (“to breathe”), a Maryland-based startup developing a respiratory monitoring system, closed a $1.5 million Series A funding round with investment from the Maryland Momentum Fund and current investors.

The Linshom Respiratory Sensor and Monitor is the first predictive, continuous respiratory monitoring system able to practically reach the patients’ bedside. Severe respiratory events can begin to cause brain damage only three minutes after breathing ceases. While critical care patients are continuously monitored for respiratory function, patients on general care floors are not monitored as closely, but are still at risk for serious respiratory complications. The Linshom Respiratory System bridges that gap, helping clinicians respond more quickly to severe respiratory-related events.

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These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

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May 16, 2022 (Columbia, Md.)—The Maryland Stem Cell Research Commission announced it will grant $7,067,409 in award funding to innovative research that will strengthen and advance stem cell treatments and technologies in Maryland. Awardees submitted proposals to the Commission in response to its Request for Applications (RFAs) for its second round of funding cycle in 2022.

Recipients include 24 scientists accelerating research at Johns Hopkins University, Britecyte, Inc., RenOVAte Biosciences, Inc., RoosterBio, Inc., and the University of Maryland, Baltimore.

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Working with rats, neuroscientists at Johns Hopkins University have pinpointed a mechanism in the brain responsible for a common type of age-related memory loss. The work, published in Current Biology, sheds light on the workings of aging brains and may deepen our understanding of Alzheimer's disease and similar disorders in humans.

Image: https://hub.jhu.edu

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The GW TCO SBIR Matching Fund will help startups collaborate with GW researchers to develop innovations licensed from GW.

The first awards will be available in summer 2022. Applications from startups will be considered on a rolling basis and may now be submitted.

The GW TCO SBIR Matching Fund will provide up to $100K per award for internal GW research. It will match 2:1 the amount of research the applicant company has sponsored at GW in the last 2 years. Also included in the match are amounts the company is providing to GW as a subaward on a Phase I SBIR or STTR, which started in the last 2 years. The maximum award is $100,000. The scope of work is to further develop a technology licensed from GW TCO. Up to 2 GW TCO SBIR Matching Funds will be provided per fiscal year.

Image: https://commercialization.gwu.edu

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If I asked you, “Where in the United States is biotechnology innovation occurring at a record pace, what states or cities come to mind? You probably thought of Boston, San Francisco, or even New York immediately.

These are not bad guesses, but what if I told you that the Washington, D.C./Maryland/Virginia (DMV) region is one of the country’s best places to engage in the biotechnology sector?

Image:  Courtesy of the National Cancer Institute (via Unsplash)

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The National Institutes of Health (NIH) is a critical pillar of the U.S. public health system and a beacon of guidance for healthcare best practices across the globe. This has never been more evident than during the COVID-19 crisis.

A lesser-known NIH facet is its long and productive history of technology transfer success.

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What is a pre-IND? Why have a pre-IND? What goes into preparing for a pre-IND? And, what documents are required? All of these questions and more will be answered in this webinar presented by Dr. Carmella Moody, a regulatory affairs specialist at RTI International. Dr. Carmella Moody brings her expertise in regulatory affairs and the development of small molecules to the Catalyze program, where she serves as a technical project lead. In this 1-hour webinar, Dr. Moody will explain the process of preparing and approaching an effective pre-IND meeting, but also what to expect from FDA feedback and how to incorporate it into your project to ultimately save time and money.

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The Advanced Regenerative Manufacturing Institute ("ARMI") is focused on empowering the U.S. regenerative medicine industry to bring new life-saving products to market by lowering the barriers to manufacturing. Our goal is to improve lives by restoring or replacing the function of damaged cells, tissues, and organs for patients. BioFabUSA's mission is to develop a highly diverse, competitive, capable and innovative cell, tissue, and organ ecosystem that ensures a low-cost and high-quality domestic healthcare system, and domestic leadership in the biofabrication industrial base.

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Life sciences in New York City is poised for growth, but industry leaders said that will only be assured if developers build enough spaces for startups of all sizes. Unless the city can accommodate life sciences companies in their earlier years, when they need less space, experts warn NYC could lose talent to rival life sciences hubs.

Image: Bisnow/Ellie Meyer
Outshine Properties' Bill Hunter, New York Economic Development Corp.'s Susan Rosenthal, Hunter Roberts Construction Group's Brian Aronne, Nan Fung Life Sciences' Matt Powers and SGA's Brooks Slocum.

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Vita Therapeutics CEO & Co-founder Douglas Falk chats with Rich Bendis to discuss his career, their platforms, and moving into the University of Maryland BioPark.

Listen now on Apple https://apple.co/3wwzX8N, Google https://bit.ly/3wxbQag, Spotify https://spoti.fi/3sCZH2t, Amazon https://amzn.to/3G3DLDb, and TuneIn https://bit.ly/3FStLfF.

Douglas Falk, MS is the Co-founder and CEO of Vita Therapeutics, a biotechnology company generating state-of-the-art cellular therapeutics for the treatment of muscular dystrophies and solid tumors. He has experience in healthcare equity research investing as a former Principal at Brown Advisory. He has led direct investment into more than 30 biotechnology companies and is a Board Member of Johns Hopkins University’s Biotech Investment Group.

Click here for the transcript.

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HILDEN, Germany & GERMANTOWN, Md.–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has signed agreements to acquire a 96% majority ownership stake in BLIRT SA (Polish Stock Exchange: BLR), a manufacturer of recombinant enzymes for the life science industry based in Gdansk, Poland.

BLIRT develops, manufactures and commercializes standardized and customized solutions for proteins and enzymes as well as molecular biology reagents. Its offering includes proteins and enzymes that are critical to the life sciences industry and diagnostic kit manufacturers, especially for non-COVID-19 applications. BLIRT, founded in 1994 in Gdansk, Poland, has approximately 90 employees and generated 2021 sales of less than $10 million.

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The cloud platform will empower biotech companies and CROs with an integrated solution for clinical data management and is supported by Emmes specialist data management teams

ROCKVILLE, Md., May 11, 2022 /PRNewswire/ — Emmes – a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces that it will introduce to market its third generation version of Advantage eClinical at Society for Clinical Trials (SCT) in San Diego, May 15th – 18th. The cloud platform of Advantage eClinical will be available as a standalone software product after undergoing more than two years of development. The system has been specifically designed to provide fast study builds, greater flexibility, and insights to clinical trial sponsors of all sizes.

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GAITHERSBURG, Md., May 16, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into a definitive agreement with Chimerix, Inc. (NASDAQ: CMRX), to acquire Chimerix’s exclusive worldwide rights to TEMBEXA® (brincidofovir), the first antiviral approved by the U.S. Food and Drug Administration (FDA) for all age groups for the treatment of smallpox. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

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MIMETAS, a global leader in Organ-on-a-Chip models and technology and headquartered in the Netherlands (Europe), announces  that it has expanded its license to the HUB Organoid Technology to include all organs. The license covers organoid technology developed by Professor Hans Clevers, a pioneer in adult stem cells.

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ROCKVILLE, Md., May 16, 2022 /PRNewswire/ — Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it is providing data, statistical analysis, and project management support for new research that will test the Moderna mRNA vaccine at more than 50 sites in South and East Africa.

The clinical trial, which will include about 15,600 participants, seeks to better understand infection and disease in immunocompromised populations in order to prevent severe COVID-19 and chronic SARS-CoV-2 infections and minimize the risk of transmission.  The study will also address the COVID-19 mRNA vaccine's resistance to the variants that have been detected in South Africa and surrounding countries.

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We are very excited for this year’s conference theme!  Our theme will be a “green thread” that is woven throughout our many sessions to bring a fresh and holistic view into the future of HEOR in patient-driven digital healthcare systems.

The last two years have seen a rapid rise of real-time solutions, digital healthcare interactions and an accelerated expansion of mobile healthcare. As digital systems mature and incorporate a broader array of patient-reported outcomes and preference measures, the trajectory of adoption of new services will be influenced by better information on how they are affecting patients’ lives….

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There is no doubt that Virginia is open for business to the life sciences industry. Over the past several years, the state has seen significant growth in pocket ecosystems across the land, particularly in areas like Charlottesville, Richmond, and Blacksburg.

Some of the growth has been fueled by an infusion of federal monies related to the government’s efforts to mitigate the COVID-19 pandemic, while other growth has been driven by old-fashioned scientific innovation. Across the Old Dominion state, companies are driving research and development of novel therapies and more as they all combine their forces to bolster the life sciences ecosystem.

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The Labs at Belward, located at the Belward Campus of The Johns Hopkins University, will Initially Provide 757,000 SF of Trophy Lab and R&D Facilities and Community Serving Amenities

Trammell Crow Company (TCC), a global commercial real estate developer, today unveiled plans to develop The Labs at Belward, a world-class life science campus, in the Shady Grove area of Montgomery County, Md. The Labs at Belward, located at the Belward Campus of The Johns Hopkins University, will initially include 757,000 square feet of trophy lab and research and discovery space across three buildings. The project has the potential to grow to approximately 1.6 million square feet across seven buildings. Construction of the initial 757,000 square feet will begin June 2023 and is slated to be completed in early 2025.

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IndyGeneUS plans to use the grant funding from Johnson & Johnson Innovation to Scale Blockchain-secured Genomic Data Marketplace and Proprietary GenēUS™ Discovery Platform

WASHINGTON, May 12, 2022 /PRNewswire/ — Today, IndyGeneUS AI was named an awardee of the Johnson & Johnson Innovation Veterans Lead QuickFire Challenge: Innovations by Vets.

Johnson & Johnson Innovation, together with Bunker Labs, a national nonprofit organization that aims to equip the military-connected community with the network, tools, and opportunities needed to launch and grow successful businesses, invited U.S. Veteran innovators and military spouses/legal partners to submit potentially ground-breaking ideas in all aspects of human healthcare.

The black-owned and Service-Disabled Veteran-owned Small Business (SDVOSB), IndyGeneUS AI, pitched their cutting-edge blockchain-encrypted and machine learning-powered bioinformatics "GenēUS™ Discovery Platform" to a panel of judges, which included both Johnson & Johnson Innovation and Bunker Labs executives.

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By: Brian Darmody, Chief Strategy Officer, AURP: Building Communities of Innovation

May 10, 2022

Sometime this September, the US Economic and Development Agency (EDA) will announce its Phase 2 awardees for the $1 billion Build Back Better Regional Challenge award winners.

Thirty or so lucky jurisdictions from across the U.S will receive between $25M -$100 M in EDA funding, although actual funding levels will be smaller to support projects on a regional basis for an industry cluster. These programs will develop or scale regional economies and devote funding to workforce training and support equitable development, including science parks and accelerators.

Thirty other finalists though will not be winners though as EDA only has funds to support thirty awards, much less the hundreds of jurisdictions from across the U.S. that applied for the program. (Five hundred and twenty-nine applicants were received by the EDA.)

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New blockchain talent marketplace seeks to solve hiring and diversity challenges in the rapidly growing biotech industry.

BALTIMORE, MD (May 10, 2022) – BioBuzz Media, the go-to community platform for biotech job seekers and industry professionals looking to access employers and plug into regional biotech communities, today announced its completion of the inaugural University of Maryland Blockchain Accelerator program. BioBuzz and other participating companies pitched to more than 70 attendees, including investors, mentors and industry leaders at Demo Day on May 4, 2022.

Selected from over 60 applicants to be one of eight startups in the inaugural cohort, BioBuzz is building a blockchain-based next-generation talent marketplace to de-risk hires and equitably expand the life sciences workforce. The new solution promises to provide employers with a more efficient recruiting process while providing job seekers with control of their data through a federated layer and enabling them to earn rewards for learning, training and contributing to the marketplace.

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COLLEGE PARK, Md., May 10, 2022 /PRNewswire/ — The University of Maryland today dedicated the new E.A. Fernandez IDEA (Innovate, Design and Engineer for America) Factory. Designed to foster technology innovations and advances through collaboration across engineering, the arts, business and science, the A. James Clark School of Engineering's new 60,000-square-foot building is the university's only facility funded entirely by private philanthropy.

Image: The University of Maryland Adds $67M IDEA Factory To Its Innovation Ecosystem – https://www.prnewswire.com

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No question about it—2021 was a banner year for initial public offerings.

Nasdaq data indicates 1,033 IPOs last year, more than double 2020’s 471.  As we move further into 2022, the market has slowed considerably. In the first quarter, only 95 companies filed initial public offerings as opposed to 419 in the first quarter of 2021.

Image: https://www.crainsnewyork.com/

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Dave Saunders, CTO & Co-Founder of Galen Robotics, joins Rich Bendis before their 5/6/2022 Open House in Baltimore. (RSVP to OPENHOUSE@GALENROBOTICS.COM to attend) Also, view a demo of their technology at https://bit.ly/GalenRobotics. Rich and Dave and I discuss Digital Surgery, Choosing Baltimore, and their Design Philosophy.

Listen now via Google https://bit.ly/3w7lIr7, Apple https://apple.co/3MQRj6S, Spotify https://spoti.fi/3MNYfBH, Amazon https://amzn.to/3s7PTgj, and TuneIn https://bit.ly/3823iQo.

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CHARLOTTESVILLE, Va., May 3, 2022 — AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat inflammatory skin diseases, such as Lupus, Psoriasis, Atopic Dermatitis and Scleroderma. Revealed in the peer-reviewed journal Science Advances, the paper details AMPEL’s breakthrough machine learning approach to characterize disease activity from gene expression data obtained from patient skin biopsies. The lab test, only a concept for the last few years, is now ready for development for practical use. AMPEL's initial focus was Lupus, but the test can be used for many autoimmune or inflammatory skin diseases that affect more than 35 million Americans.

AMPEL's innovative machine learning approach, which is now ready to be developed as a decision support biomarker test, could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL’s approach is sufficiently sensitive to detect changes in clinically uninvolved skin so that early intervention may prevent systemic flares and skin damage apparent in lesions.  The application of AMPEL’s machine learning approach could also assist pharmaceutical companies in drug development and clinical trials.

Patients with chronic skin diseases often suffer from unpredictable disease activity that impacts daily activities like work and family life. Since unpredictable symptoms often result in trips to the Emergency Room, the ability to predict worsening disease and systemic involvement with routine skin biopsies has important health care and health economics implications. 

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It’s been a big few years in the Biohealth Capital Region, especially big for commercial real estate firm Scheer Partners. After the success of buildings like 704 Quince Orchard, a 77,000-square-foot office building converted to lab space, Scheer Partners has continued to bring new buildings to market with both spec suites and build-to-suit space available for tenants of all sizes.

“Speed to market has been the tagline for the last year or so,” said Aaron Gambini, Assistant Vice President at Scheer Partners. “So it’s sort of creating move-in ready options for the market. It seems to be the way to go to start getting activity. And it’s really the next building that delivers that is the next building to lease.”

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Mike Gill, Maryland Commerce Secretary, visits BioTalk to discuss Life Sciences in the State, growing the economy, and how we can continue building on our successes.

#Apple https://apple.co/3y8gVbA, #Google https://bit.ly/3vWZo3g, #Spotify https://spoti.fi/3w4uoP0, #Amazon https://amzn.to/3kz1uBc, #TuneIn https://bit.ly/3kxWZa0, or #YouTube https://bit.ly/39pFfLv.

Secretary Mike Gill is a business leader with four decades of experience as an entrepreneur, technology executive, investment banker, and public servant. He was tapped by Governor Larry Hogan in 2014 to lead the Maryland Department of Commerce as its first-ever Secretary and was asked by the Governor to again lead the Department in December 2021.

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Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Image: https://www.biopharma-reporter.com

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These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

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QIAGEN Associate Director of IP & Licensing, Raymond Blanchard, chats with Rich Bendis on BioTalk to discuss innovation, intellectual property and having a large footprint in the BioHealth Capital Region.=

Listen now via #applepodcast https://apple.co/38nyPw4, #googlepodcast https://bit.ly/37Bb83q, #spotifypodcasts https://spoti.fi/3Mx7Ahp, #amazonpodcast https://amzn.to/3OzKN6j, #TuneIn https://bit.ly/3Mspodh, or #YouTube https://bit.ly/38mJB5t. #podcast

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April 19, 2022 12:00 UTC   — Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies — Scalable and Adaptable Facility Provides Flexibility for Current and Future Cell Therapy Innovation   SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite Pharma, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.  

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The Life Sciences Advisory Board added three new members, Ellington West of Sonavi Labs, Michael Weingarten of the National Cancer Institute, and GlaxoSmithKline’s KaShauna G. Rohlehr.

Ellington West West was tapped to serve as chief executive officer of Sonavi Labs in 2018. Along with Ian McLane, she is the co-founder of the Johns Hopkins startup digital stethoscope technology company. West was the founder of West Labs Research Group at Johns Hopkins where the company’s core Feelix technology was developed.

Image: https://biobuzz.io

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