BHI Weekly Newsletter Archives Archives - Page 16 of 65

Jul 25 2022

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518th Edition, July 26, 2022

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July 26, 2022

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BHI Seeks Senior Life Sciences Business Strategist – Apply Now!

Currently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessCurrently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessStrategist evaluates the commercial potential of emerging technologies and provides recommendations ongo-to-market strategies.

Deka Biosciences Breaks Ground on New Facility

GERMANTOWN, Md., July 19, 2022 /PRNewswire/ — Deka Biosciences announced today that it is breaking ground on a 14,000 square foot office and lab which will house a state of the art Research and Development, Process Development, and Manufacturing facility to further develop their novel cytokine therapies. This will be the first facility to house a dual targeted cytokine development lab in the DC/Maryland/Virginia region and the only company in the US developing a therapeutic of its kind. The new headquarters will be located at 20380 Seneca Meadows Parkway in Germantown, Maryland and Deka anticipates the move to be completed in the first quarter of 2023.

Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company’s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

Polaris Genomics Announces Continued Research & $100K Grant Awarded from Maryland Industrial Partnership Program (MIPS) – EIN Presswire

ROCKVILLE, MD, UNITED STATES, July 19, 2022 /EINPresswire.com/ — The biotech startup that brought to light the first and only PTSD genomic test announces continued research and innovation with continued funding from a second $100,000 matching grant awarded by the Maryland Industrial Partnership Program (MIPS).

In the Fall of 2020, Polaris Genomics was awarded a $100,000 matching grant by MIPS and began partnering with researchers at the University of Maryland Baltimore to test the performance of PTS-ID, a genomic blood test to identify persons with PTSD, measure disease severity and detect treatment response.

Children’s National Hospital gets federal funding for pandemic preparedness – Washington Business Journal

The grant focuses on a few areas across four years, including addressing health disparities.

Novavax Announces Expanded Agreement with SK bioscience to Manufacture COVID-19 Vaccine Containing Omicron Variant and Manufacture the Novavax COVID-19 Vaccine in Prefilled Syringes

GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has signed agreements with its partner, SK bioscience, for the manufacturing and supply of a version of the Novavax COVID-19 vaccine (NVX-CoV2373) containing Omicron variant and for the manufacture of the vaccine in prefilled syringes.

The companies signed an agreement for the technology transfer of Novavax' proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants including the Omicron BA.5 subvariant.

Maryland Inno – Baltimore startup Delfi Diagnostics raises $225M with plans to change how lung cancer is diagnosed

Baltimore biotechnology startup Delfi Diagnostics has raised $225 million as it embarks on a 15,000-person trial for its early cancer detection technology.

The oversubscribed Series B round was the second mega-deal of the year in Greater Baltimore. DFJ Growth led the round, with participation from local Baltimore institutions such as T. Rowe Price Associates, Brown Advisory, PTX Capital and Rock Springs CapitalNational institutions such as Eli Lilly and Co., Point 72, Menlo Ventures and others also participated. The company previously raised $100 million in a Series A round in January 2021, and all of Delfi's previous investors also joined in the Series B round. Delfi began the fundraise in early 2022 and closed in July.

Image: Delfi Diagnostics, led by founder and CEO Victor Velculescu closed a $225 million series B round. Julien Capmeil

Maryland Inno – Maryland sees an increase in VC dollars in Q2 despite a national decline

Maryland bucked a national trend in venture capital funding in the second quarter of 2022, recording an increase in the number of companies able to raise money even as the rest of the nation continued to struggle with the declining markets.

Nationally, VC deals decreased massively from $341.5 billion in the first quarter of 2022 to $144.2 billion in the second quarter. Maryland trended in the opposite direction seeing a massive increase in VC funding this quarter compared to the beginning of the year. In the first quarter, Maryland companies saw $325 million in funding, and in the second quarter that number more than doubled to $747.95 million.

Construction Continues at Progress Labs in Gaithersburg – The MoCo Show

Progress Labs at Progress Way in Gaithersburg, MD is a two-building approximately 495,000 SF development situated on 44 acres with I-270 visibility and access off of exit 11 Montgomery Village Avenue. Construction commenced at Progress Labs at 700 N. Frederick Avenue in Gaithersburg, MD back in October, and according to the video below (posted by Progress Labs on Monday, July 18th), is scheduled to be delivered in Q4 of 2022, which is ahead of schedule based on the schedule provided on its website, also seen below:

Building 1 Early TI Start: 11/2022

Building 2 Early TI Start: 2/2023

Building 1 Base Building Substantial Completion: 1/2023

Building 2 Base Building Substantial Completion: 4/2023

Novavax, advancing COVID-19 shot, recruits AstraZeneca exec as its chief medical officer | Fierce Pharma

On the heels of some big fundraising moves and in the hunt for a COVID-19 vaccine, Novavax is adding some Big Pharma experience to its executive team.

Joining the company's leadership team as chief medical officer is Filip Dubovsky, an AstraZeneca veteran. Dubovsky joins Novavax directly from the British drugmaker, where he served as head of clinical engagement and policy, plus as chief medical officer for clinical affairs. Before that role, he oversaw a portfolio of more than two dozen malaria vaccines at the PATH Malaria Vaccine Initiative.

Image: ovavax recruited two pharma and biotech veterans to senior posts. (Novavax)

Omicron subvariants and the changing landscape of COVID-19 | Hub

Omicron is mutating in giant leaps, with scientists racing to keep up. Its diversity is challenging vaccine efficacy and complicating treatment. But this fall, broad spectrum bivalent vaccines may help mitigate the seemingly never-ending spread of COVID-19.

Johns Hopkins virologist Andy Pekosz has been tracking coronavirus variants since the early days of the pandemic. He recently spoke to the Public Health On Call podcast about the range of omicron subvariants, omicron-specific vaccines, and what we can expect to see in the future from this "game-changer" variant.

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Jul 18 2022

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517th Edition, July 19, 2022

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July 19, 2022

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D.C. region (ranked #2) gets boost in CBRE's new life sciences talent ranking – Washington Business Journal

A new CBRE report ranked the top 25 life sciences research talent clusters for the first quarter.

Canon Medical Systems USA Inc. Announces Expansion of Distributorship with the Acquisition of NXC Imaging – Cardiac Vascular News

Tustin, California, July 11, 2022 (GLOBE NEWSWIRE) — Canon Medical Systems USA Inc., a commercial subsidiary of Canon Medical Systems Corporation and a global leader in innovative diagnostic imaging technology, today announces it has signed a definitive agreement to acquire NXC Imaging, a medical imaging equipment distributor and service provider headquartered in Minneapolis, Minnesota. Founded in 1964, NXC Imaging’s distributorship area spans the U.S. Upper Midwest. The acquisition is expected to close in the third quarter of the 2022 calendar year.

Crab Trap 2022 applications are being accepted through August 31st! Entrepreneurs with innovative diagnostics, medical devices, therapeutics, or other transformative health solutions are invited to apply to the 7th annual BioHealth Capital Region Crab Trap pitch competition. Finalists for the 2022 Crab Trap competition will pitch IN PERSON on September 21st as part of the BioHealth Capital Region Investor Conference. The winning teams will receive cash prizes from our sponsors.

Applications are due by 5pm on Wednesday, August 31st. Crab Trap finalists will be notified the week of 9/5/22. Mandatory virtual pitch coaching for all finalists will take place the week of 9/12/22.

BioFactura Announces Activation of a $15.9M Contract Option for its Smallpox Biodefense Therapeutic

The contract from BARDA will advance development of an antibody cocktail therapeutic for the treatment of smallpox.

FREDERICK, MD. (PRWEB) JULY 15, 2022

BioFactura today announced its second contract option activation of $15.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of an antibody cocktail therapeutic for the treatment of smallpox.

This funding is part of BioFactura’s prime contract valued at up to $68.2 million for the advanced development of its smallpox biodefense therapeutic. This contract option will provide an accelerated path for product development leading to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for first-in-human studies.

Materic and LaunchPort Announce Partnership to Drive Advanced Materials Manufacturing for Medical Device Technology – The LaunchPort

July 18, 2022, Baltimore, MD – Materic, a custom manufacturer of advanced materials, and LaunchPort, LLC, a medical device venture center and GMP contract manufacturing operation today announced a partnership to drive the use of advanced materials in the development of emerging medical device technologies.

Emergent BioSolutions Announces Appointment of Sujata Dayal to Board of Directors | Emergent BioSolutions Inc.

GAITHERSBURG, Md., July 06, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Sujata Dayal as a Class II director to serve on the board effective July 15, 2022, with an initial term expiring at the 2023 annual meeting of stockholders. Ms. Dayal was also appointed as a member of both the Nominating and Corporate Governance Committee and the Special Committee on Manufacturing and Quality Oversight.

NexImmune Announces IND Clearance by the US FDA for NEXI-003 for the Treatment of HPV-Related Cancers

First IND for NexImmune’s AIM nanoparticle platform in solid tumors
IND clearance enables commencement of a clinical trial to evaluate NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), in patients with relapsed or refractory human papillomavirus (HPV)-related cancers

GAITHERSBURG, Md., July 14, 2022 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, has received IND clearance for the Company’s first cellular therapy product candidate addressing solid tumors. NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.

Kristi Jones, NexImmune’s CEO, commented, “The FDA clearance of our third IND marks another significant milestone for NexImmune and demonstrates our team’s continued focus and commitment to bringing novel therapies to patients with significant unmet need. NEXI-003 is our third T cell therapy and first candidate to address solid tumors. NEXI-003 consists of T cell populations simultaneously directed against multiple HPV tumor-relevant antigen targets. The T cells in our product candidate will consist of T cell subtypes critical to both potential anti-tumor activity and a phenotype intended to produce long-term immunologic memory required for durable responses.”

BHI/NIH Seeks Life Science Business Analyst

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life science business analyst to support the NIH SEED Office (https://seed.nih.gov/). The analyst will provide business landscape analysis and other project support on product development, corporate strategy, and private investment for NIH-funded companies. This will entail market landscape, technology, and other business intelligence research to support Entrepreneur-in-Residence and other SEED life science commercialization activities.

Novavax receives FDA authorization for its Covid vaccine – Washington Business Journal

The announcement comes days after the Biden administration reached a deal to buy 3.2 million doses.

Image: Novavax has received emergency use authorization from the Food and Drug Administration for its two-dose Covid vaccine. MATTHEW FELDMAN

FDA Grants Orphan Drug Designation (ODD) Status to Rockville’s NeoImmuneTech's NT-I7 for the treatment of Glioblastoma Multiforme

· Glioblastoma multiforme is one of the most complex, deadly and treatment-resistant cancer with a 5-year survival rate of 6.8% and an average length of survival of only 8 months *

· FDA ODD designation bolsters NeoImmuneTech's determination to accelerate the clinical development of NT-I7 as a potential new therapy for this difficult-to-treat cancer

ROCKVILLE, Md, July 13, 2022 /PRNewswire/ — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation for the treatment of Glioblastoma Multiforme.

Despite decades of research, GBM remains one of the deadliest and hardest-to-treat cancers. More than 13,000 Americans are expected to be diagnosed with GBM in 2022.1 Standard treatments using surgery, radiation, TMZ and TTFs have failed to date to greatly improve survival, and there is no standard treatment for recurrence, which is inevitable. Also, among the multiple factors impacting the survival of GBM patients, the current treatment options expose patients to a severe and prolonged systemic lymphopenic state known as "treatment-related lymphopenia" (TRL). TRL is associated with shorter survival both in GBM and other solid tumors. With its potential to restore lymphocyte levels and subsequently reverse systemic lymphopenia, NT-I7 may offer promising ways to effectively treat GBM, if confirmed by its development program.

Altus Realty Acquires Pair of Rockville Office Buildings for $26M – Commercial Observer

Altus Realty has acquired Research Square, two office buildings comprising 90,000 square feet in Rockville, Md., for $25.5 million.

Westat, an employee-owned research company headquartered in Rockville, was the seller of the two properties, located at 1500 and 1550 Research Boulevard.

SEE ALSO: Alan Mruvka On His E! Past and StorageBlue Future The Arlington, Va.-based Altus plans to turn the property into life sciences space, given that the buildings’ attributes make them amenable to such a conversion, according to CBRE, which represented the seller in the deal.

Westat decided to let go of the building as its workspace needs changed.

Image: RESEARCH SQUARE. PHOTO: CBRE

Jul 12 2022

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516th Edition, July 12, 2022

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July 12, 2022

FOUNDING MEMBER OF

Accepting 2022 Crab Trap Applications

Applications are due by 5pm on Wednesday, August 31st. Crab Trap finalists will be notified the week of 9/5/22. Mandatory virtual pitch coaching for all finalists will take place the week of 9/12/22.

NRL Announces the Washington Metropolitan Quantum Network Research Consortium

WASHINGTON – To advance quantum network capabilities and leadership, the U.S. Naval Research Laboratory (NRL) announced work with five other U.S. Government agencies on May 18 to establish the Washington Metropolitan Quantum Network Research Consortium (DC-QNet) to create, demonstrate and operate a quantum network as a regional testbed.

Quantum networks, an emerging research frontier, will one day offer the ability to distribute and share quantum information securely among quantum computers, clusters of quantum sensors and related devices at regional and national distances. They can also be used to distribute ultra-precise time signals, and offer the potential to enable the creation of new applications not yet imagined.

Image: https://www.nrl.navy.mil/

Johns Hopkins made an inventor's guide to help its technologists commercialize. But it can help others, too – Technical.ly

With the support of its homegrown Johns Hopkins Technology Ventures (JHTV), Baltimore’s oldest private university has helped many of its own students and faculty bring their technological innovations to market — and with wildly successful results. Now, JHTV has a new guide to make the process even easier for those within and beyond its namesake school’s community to understand.

Image: Inside a Johns Hopkins Technology Ventures FastForward innovation hub. (Courtesy photo)

TEDCO’s Maryland Innovation Initiative helps propel ideas from the lab to the marketplace – Technical.ly

Kubanda Cryotherapy cofounder Bailey Surtees was building the foundation for her company as an undergraduate at Johns Hopkins University (JHU) before she knew it. In 2016, she was researching how to make breast cancer treatment more affordable and accessible for low- and middle-income countries. Surtees surmised that cryotherapy was the ideal solution because it doesn’t require a sterile operating room or anesthesia. Thus, she began developing a probe that could be used for this treatment.

Image: The team behind TEDCO's Maryland Innovation Initiative. (Courtesy photo)

EDA awards $1.6M to Maryland for small businesses | Maryland Business News

A $1.6 million grant has been awarded to the state of Maryland from the Economic Development Administration's American Rescue Plan.

The federal funding will go towards the Maryland Economic Adjustment Fund (MEAF), administered by the Maryland Department of Commerce, and will be used to assist underserved small businesses across the state.

The MEAF revolving loan fund will serve businesses that do not qualify for traditional financing or lending sources. According to the EDA, this investment could help create 250 new jobs and generate a private investment of $210,000 in Maryland.

BHI Seeks Senior Life Sciences Business Strategist

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

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists andmanages consultants, as needed.

Click here for more information.

BHI/NIH Seeks Life Science Business Analyst

Click here for more information.

Emergent BioSolutions and Ridgeback Biotherapeutics Enter Into Agreement for Ebanga™ Treatment for Ebola

GAITHERSBURG, Md. and MIAMI, July 07, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement with Ridgeback Biotherapeutics (“Ridgeback Bio”), a biotechnology company focused on emerging infectious diseases, intended to create a collaboration to expand the availability of Ebanga™ (Ansuvimab-zykl). Under the terms of the contemplated collaboration, Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga™ in the United States and Canada, and Ridgeback Bio will serve as the global access partner for Ebanga™, ensuring it remains available to patients in endemic countries free of charge through Ridgeback Bio’s compassionate use program. Ebanga™ was approved by the U.S. Food and Drug Administration (FDA) in December 2020 for the treatment of Ebola.

Where are the Leading Technology Clusters in Canada and the U.S.: A Webinar Discussion Previewing Issues AURP Will Feature at #AURPIC2022 in Toronto (September 19-22)

A state's competitiveness in the innovation economy stems from the extent of its involvement in the global economy, its capacity for innovation, and its cultivation of a knowledge-based workforce. Massachusetts, California, Ontario, Maryland, and Washington rank highest among North American states in ITIF's index scoring subnational innovation competitiveness. Canadian provinces overrepresent among North America's most competitive states in the innovation economy. Ontario ranks third, British Columbia fourth, and Quebec nineth. Mexico's industrially intensive states are among its most innovative: Nuevo Leon, Baja California, Chihuahua, and Tamaulipas are some of the highest-ranking Mexican states. Cross-border innovation clusters are taking shape in the Pacific Northwest's life-sciences industry and in the next-generation automobile and semiconductor industries near the U.S.-Mexico border. Canadian, U.S., and Mexican states should leverage each other's comparative advantages in different phases of innovation in order to build North American global value chains that are cost-competitive with Asia.

Click here to register.

Jul 05 2022

Love0

515th Edition, July 6, 2022

By admin BHI Weekly Newsletter Archives

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July 6, 2022

FOUNDING MEMBER OF

2022 Crab Trap Application

Applications are due by 5pm on Wednesday, August 31st. Crab Trap finalists will be notified the week of 9/5/22. Mandatory virtual pitch coaching for all finalists will take place the week of 9/12/22.

NIH/BHI Seeks Life Science Business Analyst

Click here for more information.

BioHealth Innovation is seeking a Senior Life Sciences Business Strategist

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.

How can your BioHealth business benefit from a review by BHI industry experts? Please register for our next Entrepreneur-In-Residence (EIR) day on July 20th and find out. To sign-up for any of the EIR dates in 2022, please follow this link.

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.

Maryland Inno – TEDCO seeks firm to provide recommendations on creating possible $500M fund

The Maryland Technology Development Corp. is searching for a firm to assess Maryland’s current economic development strategy and make recommendations to help shape the creation of a possible $500 million fund.

TEDCO issued a request for proposal (RFP) for firms to conduct the study earlier this week. The research will be used by TEDCO to help create draft legislation for the Maryland Equitech Growth Fund, which has a recommended minimum of $500 million worth of public investment over a 10-year period. The study is being done at the behest of the Maryland legislature, which called on TEDCO to create the report.

Image: TEDCO, led by CEO Troy LeMaile-Stovall, is searching for a firm to assess Maryland's current economic development strategy. TEDCO

AMPEL BioSolutions' Precision Medicine Breakthrough Predicts Drug Options with RNA Analytics & Machine Learning

AMPEL BioSolutions' Precision Medicine Breakthrough AMPEL BioSolutions' Precision Medicine Breakthrough Predicts Drug Options with RNA Analytics & Machine Learning CHARLOTTESVILLE, Va., July 6, 2022 — AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could modernize the way doctors treat patients across a wide variety of diseases including autoimmunity, infectious disease and cancer. Revealed at the Precision Medicine World Conference in Silicon Valley California, the first-in-class platform technology utilizes RNA analytics and machine learning to characterize an individual’s gene expression and provide clinical decision support to physicians for treatment options for their patients. The technology, only a concept for the last few years, is being utilized to launch a portfolio of 10+ clinical tests over the next five years to provide decision support for diseases that affect more than 50 million Americans.

Jun 27 2022

Love0

514th Edition, June 28, 2022

By admin BHI Weekly Newsletter Archives

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June 28, 2022

FOUNDING MEMBER OF

BioHealth Innovation is seeking a Senior Life Sciences Business Strategist

JOB TITLE – Senior Life Sciences Business Strategist

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.

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

2022 Crab Trap Application

Applications are due by 5pm on Wednesday, August 31st. Crab Trap finalists will be notified the week of 9/5/22. Mandatory virtual pitch coaching for all finalists will take place the week of 9/12/22.

New Mountain Capital Announces Growth Partnership with Emmes

Partnership to Support Emmes' Next Phase of Tech-Enabled Growth NEW YORK and ROCKVILLE, Md., June 21, 2022 /PRNewswire/ — New Mountain Capital, a leading growth-oriented investment firm with more than $37 billion in assets under management and Emmes, a global, tech-enabled full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that they have formed a partnership to support and accelerate Emmes' next phase of growth. Affiliates of New Mountain will acquire the ownership interest of Behrman Capital, the majority investor in Emmes since March 2019, and the ownership interests of Emmes' other investors. The transaction is expected to close in early July and terms were not disclosed.

Emmes is a leading CRO that provides its clients with expertise in biostatistics, technologies and dedicated service required to manage clinical research studies with the highest standards of quality. The company sits at the intersection of the public and private healthcare sectors with clients including biopharmaceutical companies, government agencies, foundations, academic institutions and other non-profit organizations. Emmes is proud to support the research efforts of agencies such as the National Institutes of Health (NIH), Food and Drug Administration (FDA), Department of Defense (DOD), Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA). Emmes' five acquisitions since December 2020 have complemented the company's core operations in the greater Washington, D.C. area, Canada and India, while expanding its international presence throughout Europe.

Aledade Raises $123 Million Series E to Accelerate Growth

BETHESDA, Md., June 06, 2022 (GLOBE NEWSWIRE) — Today, Aledade announced it has closed a $123 million Series E funding round to support investments in value-based care for more seniors covered by Medicare Advantage (MA) and innovation that improves patient care and increases medical cost savings, including expanded offerings through its new health services subsidiary, Aledade Care Solutions (ACS). Returning investor OMERS Growth Equity led the round, which also included Fidelity Management & Research Company and other current investors.

Emergent BioSolutions to Acquire – GuruFocus.com

GAITHERSBURG, Md., May 16, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (: EBS) announced today that it has entered into a definitive agreement with Chimerix, Inc. ( 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.

“The addition of TEMBEXA to Emergent’s portfolio of medical countermeasures builds upon our core capabilities and leverages our long and successful history partnering with the U.S. government to address dangerous public health threats,” said Robert G. Kramer, president and CEO of Emergent. “It exemplifies our thoughtful M&A strategy as part of our 2024 growth plan and positions us better to deliver value for our shareholders.”

Maryland might lose out on a new $1 billion federal medical research accelerator – Baltimore Sun

At his State of the Union speech in March, President Joe Biden urged Congress to fund a new federal agency that would “supercharge” breakthrough medical research and “end cancer as we know it.”

Congress responded two weeks later by approving $1 billion for the Advanced Research Projects Agency for Health, or ARPA-H, which will tackle projects that are seen as too costly, risky or time-intensive for the private sector and traditional public research.

In Maryland, research institutions, labs, pharmaceutical companies and biotech startups have long had a close, symbiotic relationship with the numerous federal health agencies already located here, but federal leaders and lawmakers think it might be time now for some distance.

Image: President Joe Biden speaks with researchers and patients about ARPA-H, a new health research agency that seeks to accelerate progress on curing cancer and other health innovations, on March 18 in the South Court Auditorium on the White House campus in Washington. (Patrick Semansky/AP)

Vaccitech’s VTP-300 induced sustained reductions of surface antigen in patients with chronic hepatitis B both as a monotherapy – Bloomberg

Vaccitech’s VTP-300 induced sustained reductions of surface antigen in patients with chronic hepatitis B both as a monotherapy and in combination with a single low dose of anti-PD-1

VTP-300 as a monotherapy and in combination with a single administration of low-dose nivolumab was administered, with no treatment-related serious adverse events and infrequent transient transaminitis.

Meaningful, durable reductions of Hepatitis B surface antigen (HBsAg) were seen in some patients who received VTP-300 as either a monotherapy or in combination with a single low dose of nivolumab at the booster dose. Declines were most prominent in patients with lower baseline HBsAg.

All patients who received VTP-300 monotherapy or in combination with low-dose nivolumab and who had a HBsAg decline greater than 0.5 log[10] had durable reductions of HBsAg until the last measurement (up to eight months after last dose).

Alexandria Real Estate Equities, Inc. Celebrates the Grand Opening of Alexandria LaunchLabs at Columbia to Accelerate the Commercialization of Novel Translational Science to Meet Significant Unmet Medical Needs

NEW YORK, June 22, 2022 /PRNewswire/ — 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, today celebrates the grand opening of Alexandria LaunchLabs® at Columbia, which was created in a strategic collaboration with Columbia University. As the company's second LaunchLabs site in New York City, Alexandria LaunchLabs at Columbia builds upon the success of the flagship LaunchLabs site at the Alexandria Center® for Life Science – New York City, which reached its fifth anniversary this month. The grand opening event marks an important milestone for the unique and leading life science startup platform purpose-built to accelerate innovation and growth for promising early-stage companies. With over 10,000 diseases known to humankind and less than 10% currently addressable with therapies, Alexandria LaunchLabs at Columbia is playing an essential role in catalyzing the translation of scientific research emerging from Columbia University and other leading NYC academic and medical research institutions into treatments and cures to help meet humanity's massive unmet medical need and alleviate patient suffering.

Image: Alexandria LaunchLabs® at Columbia, located on the Columbia University Irving Medical Center campus. Courtesy of Alexandria Real Estate Equities, Inc.

Emergent BioSolutions Announces Publication of CHIKV VLP

GAITHERSBURG, Md., June 21, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that two-year persistence data from its phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate were published in The Lancet Infectious Diseases. The article, Safety and immunogenicity of PXVX0317, an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial, is available online.

“Emergent is pleased that results from our CHIKV VLP phase 2 study have been published and shared with the scientific community in The Lancet Infectious Diseases, a highly esteemed peer-reviewed journal,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “Publication of this body of work highlights the importance of developing ways to address Chikungunya disease, a public health threat for which no vaccine or treatment exists.”

Summary of published results This randomized, double-blind, parallel-group, phase 2 study was conducted at three U.S. sites with 415 participants. Eligible participants were healthy CHIKV-naïve adults aged 18–45 years. The primary endpoint was the geometric mean titer of anti-CHIKV neutralizing antibody on day 57 (28 days after the last vaccination). Safety was also assessed.

Maryland Inno – USM creates new pilot program to invest $600,000 in early stage startups

The University System of Maryland this week approved a new pilot program to fund early-stage startups.

The measure, which was approved by the USM Board of Regents on Friday, will allocate $200,000 per year to the Early Capital Pilot fund over three years.

The program will be funded with money currently allocated for the Maryland Momentum Fund, a USM-run venture capital fund that began with $25 million in 2016. The Board of Regents recently authorized an additional $6 million over three years for the program.

Image: The University System of Maryland (USM) approved a new pilot program investing $200,000 a year in early stage startups. Jessica Iannetta/BBJ

NIH seeks industry partners for technology transfer

The National Institutes of Health (NIH) is the world's largest public funder of biomedical research, investing more than $30 billion in taxpayer dollars. However, what is little known about the agency is that its technologies are available for licensing and collaboration, according to Michael Salgaller, PhD, supervisor of the technology analysis and marketing unit at the National Cancer Institute's (NCI) Technology Transfer Center.

The North American Subnational Innovation Competitiveness Index | ITIF

The North American innovation ecosystem is increasingly diverse. In collaboration with Macdonald-Laurier Institute, Fundación IDEA, and the Bay Area Economic Council Institute, ITIF compiled this index to identify economic differences among states and provinces and highlight regions needing more federal attention, identify cross-national innovation performance, and track the continent’s overall competitiveness in the innovation-driven global economy.

Jun 20 2022

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513th Edition, June 21st, 2022

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June 21, 2022

FOUNDING MEMBER OF

BioHealth Innovation is seeking a Senior Life Sciences Business Strategist

JOB TITLE – Senior Life Sciences Business Strategist

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.

Opportunity: Entrepreneur-In-Residence Role with BioHealth Innovation, Inc. and NIH

POSITION DESCRIPTION – Entrepreneur-In-Residence

EIRs will work in collaboration with SEED to mentor innovators and provide guidance to help them de-risk the technical and business elements of their product development projects. EIRs will also help NIH and individual innovators ensure the long-term success of their projects by facilitating connections with investors and strategic partners who can help achieve commercial success and healthcare consumer access. To be successful in this role, entrepreneurial, commercial or product development experience in areas of social impact including wellness & prevention, healthcare access/community health and a wide network in social impact ventures is required.

This position is currently remote (with opportunity for future in-person activities) and part time (20 hrs/week with potential for expansion); occasional travel may be required (when conditions permit).

Synexa Life Sciences Set to Open New Bioanalytics Lab in Rockville, Maryland · BioBuzz

Synexa Life Sciences (Synexa), a global leader in clinical biomarker and bioanalytics research services, recently secured 5,000 square feet of lab space in Rockville, Maryland. The new lab will be located within Inotiv, Inc.’s (Inotiv) Rockville site and is part of a new partnership between Synexa and Inotiv, a leading contract research organization.

For more than 20 years, Synexa has been delivering expert clinical development insights to life sciences organizations via biomarker and bioanalytics solutions, novel modality analytics, innovative technology platforms and custom assay development and validation. The new Rockville lab adds to the company’s global footprint that, up until very recently, included locations in Leiden, The Netherlands, Dublin, Ireland, Berlin, Germany, London, England and Cape Town, South Africa.

Image: https://biobuzz.io/

The Power Players of Washington, D.C., 2022 – Commercial Observer Congrats to Pete Briskman, BHI Chairman Listed

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

Emmes Supports Groundbreaking Anal Cancer Study Sponsored by the National Cancer Institute

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.

Emergent BioSolutions inks deal for smallpox newcomer Tembexa

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.

Children’s National Hospital is #5 in the Nation – Washingtonian

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

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

Supply chain vulnerabilities exist for antimicrobial medicines: USP Medicine Supply Map analysis | Quality Matters | U.S. Pharmacopeia Blog

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.

In Baltimore, a shortage of wet lab space poses an economic bottleneck – Technical.ly

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)

Fewer Financings, Plunging Valuations May Stoke M&A Activity, EY Predicts

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.

The Licensing of Academic Patents Contributed Up to $1.9 Trillion to the US Economy, Supported up to 6.5 Million Jobs in the last 25 Years | AUTM

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.

(1776) Dr. Michelle McMurry-Heath, BIO 2022 Tuesday Keynote: BIO Unbound, Clip 3 – YouTube

Dr. Michelle McMurry-Heath, BIO 2022 Tuesday Keynote: BIO Unbound, June 14, 2022 SHOW LESS

View on Youtube: https://www.youtube.com/watch?v=cZUM7wBvdSg

MDUFA V – progress!

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.

SNUBH opens K-BioHealth regional center < Bio < 기사본문 – KBR

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)

Jun 14 2022

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512th Edition, June 14th, 2022

By admin BHI Weekly Newsletter Archives

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June 14, 2022

FOUNDING MEMBER OF

BioHealth Innovation Announces Additions

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.”

BHI Supports Maryland's showcase of life science assets at BIO International in San Diego

A delegation of Maryland companies and organizations is heading to San Diego June 13-16 for the BIO International Convention. At BIO, the life sciences industry’s leading trade show, Maryland will showcase the unparalleled life science assets within the state.

The Maryland Department of Commerce, in collaboration with the Maryland Tech Council, will exhibit at Booth #5013. The Maryland Department of Commerce, Maryland Tech Council and various sponsors are supporting a delegation of 15 Maryland life sciences companies’ attendance at the show. Companies in the Maryland delegation receive premium access to BIO, including its exhibit hall, educational program, and one-on-one partnering to meet with potential partners and investors. Companies in the Maryland delegation include:

BHI Attends BLUE KNIGHT Symposium 2022

BHI was pleased to join our partners at today's BLUE KNIGHT Symposium 2022 hosted at JLABS @ Washington, DC. Thanks to BARDA, Johnson & Johnson and all of the entrepreneurs and innovative minds who are strategizing today for tomorrow's public health challenges.

How can your BioHealth business benefit from a review by BHI industry experts? Please register for our next Entrepreneur-In-Residence (EIR) day on June 15th and find out. To sign-up for any of the EIR dates in 2022, please follow this link.

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

Novavax CEO Stanley Erck talks Covid-19 vaccine, FDA meeting — and what comes next – Washington Business Journal

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

QIAGEN CEO details how company tracks the spread of COVID through wastewater testing

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.

United Therapeutics and 3D Systems shoot for 3D printed lung scaffold trials within five years – 3D Printing Industry

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.

Deka Biosciences, Inc is Growing

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

Image: https://www.linkedin.com

Abu Dhabi Cements the Long-Standing Partnership with the Children's National Hospital in Washington DC

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.

WIB-Capital Region: HERstory Gala 2022, April 21, 2022 – Women In Bio

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

Life Sciences Research Talent 2022 | CBRE – BHCR #2

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.

Maryland Inno – Proposed USM program would fund early stage startups

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

Healthcare Innovators Nurturing the Next Great Breakthroughs | Johnson & Johnson

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/

Inventions of the Year: UMD, JHU Researchers Develop AI-Enhanced Digital Otoscope for Diagnosing Pediatric Ear Disease | Division of Research

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

FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older

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."

Jun 06 2022

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511th Edition, June 7, 2022

By admin BHI Weekly Newsletter Archives

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June 7, 2022

FOUNDING MEMBER OF

BHI and KOSME welcome a new US market entry cohort to the BioHealth Capital Region

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

Brian Castleberry, of the Maryland Department of Commerce & Robin Wiener of Get Real Health Guest on BioTalk

Brian Castleberry, Maryland Department of Commerce Regional Manager – Middle East, Africa and India, Office of International Investment and Trade, and & Robin Wiener, President, Get Real Health, Join Rich Bendis on BioTalk to discuss International Collaborations, Maryland Biotech, and Collaborations.

Listen now via Google https://bit.ly/3xjyLau, Apple https://apple.co/3GU4UIP, Spotify https://spoti.fi/3MrBJ0R, Amazon https://amzn.to/3H0rL5F, and TuneIn https://bit.ly/38Ry0vV

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

Novavax Initiates Phase 3 Trial of its COVID-19 Omicron Strain Vaccine as a Booster

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.

United Therapeutics Provides an Update on Its Organ Printing Programs

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.

UMD Research Scientist Tapped to Lead New Federal Health Agency – UMD

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.

GSK to Acquire Affinivax for Up to $3.3B, Bolstering Vaccine Portfolio

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)

Richmond Inno – Richmond med-tech company lands spot in national pitch competition

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.

Entrepreneurial Development | Seed Program

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

Venture Capitalists’ Soaring Pay Is Tempting Fate – The Washington Post

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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May 31 2022

Love0

510th Edition, June 1, 2022

By admin BHI Weekly Newsletter Archives

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June 1, 2022

FOUNDING MEMBER OF

United Therapeutics Announces FDA Approval of Tyvaso DPI™ | United Therapeutics Corporation

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.

CAR T-cell Therapy Continues to Show Promise for Myasthenia Gravis

Descartes-08, Cartesian Therapeutics’ investigational CAR T-cell therapy, appears generally safe and markedly lessened symptom severity in the first five patients with generalized myasthenia gravis (gMG) enrolled in a Phase 1b/2a clinical trial.

“I am very encouraged by the interim analysis findings,” as the therapy “appears safe and well tolerated, and the extent of clinical improvement seen in our early participants is remarkable,” Volkan Granit, MD, the trial’s principal investigator at the University of Miami, said in a press release.

George Mason Biotech Startup Virongy Continues to Expand in Northern Virginia

After making striking advancements in HIV and COVID-19 research, Virongy, a biotechnology company in Prince William County, Virginia, has set its sight on tackling even more viruses. With millions of people being afflicted by viral illnesses worldwide each year, Virongy’s objective addresses an ever-increasing market need.

“Our goal is to create advanced diagnostics so that doctors can promptly prescribe treatments to patients,” said Brian Hetrick, chief scientific officer of Virongy.

How can your BioHealth business benefit from a review by BHI industry experts? Please register for our next Entrepreneur-In-Residence (EIR) day on June 20th and find out. To sign-up for any of the EIR dates in 2022, please follow this link.

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

TEDCO to Receive up to $50 Million from State Small Business Credit Initiative · BioBuzz

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.”

HHS Secretary Becerra Establishes ARPA-H within NIH, Names Adam H. Russell, D.Phil. Acting Deputy Director | HHS.gov

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.

Save Ukrainian Lives: Provide Access to Blood by FINCA International

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

U.S. Treasury awards first round of funding for State Small Business Credit Initiative – Financial Regulation News

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.

Which SARS-CoV-2 Variant Will Cause the Next Wave? An AI Tool Predicts

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?

Legal & General Capital makes first U.S. investment, with seed capital for $4Bn platform to fund major life-science and technology assets across multiple regional U.S. markets | News Direct

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.

These Are The Leading And Lagging States For Female-Founded Startups

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

TEDCO’s Strategic Plan Sets Bold Path for the Future | TEDCO

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

Home – Quantum World Congress (Nov 29 – Dec 1)

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.

Advancing and Commercializing Longevity Market Innovations — Leveraging Seed Funding, Foundational, and Accelerator Support To Advance Innovations for Older Adults – BIO International Convention | BIO

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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May 23 2022

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509th Edition, May 24, 2022

By admin BHI Weekly Newsletter Archives

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May 24, 2022

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Linshom Medical, Inc. Closes $1.5 million Series A Round with Investment from Maryland Momentum Fund and Current Investors

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.

BHI Congratulates SISU Global!

Sisu Global is a 2022 TiE50 Winner! TiE50 is TiE Silicon Valley's premier annual awards program, contested by thousands of early to mid-stage startups worldwide.

"Sisu Global is grateful to be a part of the TiE50 community this year. We are looking forward to the opportunity of working together and our expansion into India." President & Co-founder, Gillian Henker

Visit the link in the comments below to learn more about TiE50.

Deka Biosciences – Daikine Platform Explanation

Dr. John Mumm explains the Diakine™ platform developed by Deka Biosciences.

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

Maryland Stem Cell Research Commission Announces Over $7 Million in Awards to Accelerate Cures | TEDCO

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.

Johns Hopkins neuroscientists find brain mechanism tied to age-related memory loss | Hub

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

SBIR Matching Fund | Technology Commercialization Office | The George Washington University

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

Landscaping the DMV Region: A Hotbed for Innovation | by Michael Nestor | Bioeconomy.XYZ | Medium

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)

The National Institutes of Health, a Technology Transfer Wellspring · BioBuzz

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.

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.

ARMI Seeks: Director, Education and Workforce Development – Manchester, NH – Advanced Regenerative Manufacturing Institute Inc Jobs

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.

The Real Estate Problem Holding Back NYC's Life Sciences Industry

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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