BHI Weekly News Archives Archives - Page 13 of 62

523rd Edition, August 30, 2022

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August 30, 2022

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BioBuzz: BioHealth Capital Region Forum 2022 Preview

The past few years in the biotech industry have been filled with challenges and promise.

From the rapid and successful deployment of the COVID-19 vaccine and the explosion of the cell and gene therapy sector to a hiring boom, remarkable advances in tissue engineering and strong biomanufacturing growth, the BioHealth Capital Region (BHCR) has played a pivotal role in it all.

To say a lot has changed is the understatement of the century. The question remains, however: Where is the BHCR headed?

Where are they now? An Update on Former BHI Interns

Since BHI's founding in 2011, the organization has had many interns come through the doors in support of Analytics, Marketing, Communications, Social Media, Business, Legal, Accounting, and more.

BHI wanted to give an update on some names you may remember if you worked with us over the years.

Click here to download the PDF.

BHI Seeks Senior Life Sciences Business Strategist

Currently 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.

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.

Intralytix receives Phase II Fast Track NIH SBIR contract

Intralytix receives Phase II Fast Track NIH SBIR contract to continue development of a universal, scale-independent AI-based platform for manufacturing high titer bacteriophage preparations for clinical applications.

Columbia, Maryland, USA. – August 22, 2022 – Intralytix, Inc. announced today that it has received a Phase II contract in the amount of $1,498,045. This contract is made through the Small Business Innovation Research (SBIR) program from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This project is the continuation of a successfully completed NIAID-funded Phase I contract (see Intralytix, Inc.) and will further leverage Intralytix’s existing proprietary PhageSelector™ program, big data, and manufacturing know-how along with machine learning to advance an artificial intelligence (AI)-based universal manufacturing platform, the PhageEngine™, to deliver methods for producing high titer, high quality bacteriophage preparations suitable for clinical applications. Dr. Alexander Sulakvelidze, President and CEO of Intralytix and the Principal Investigator of the SBIR contract, commented, "We are very pleased to further extend this work with support from NIH after successfully competing Phase I of the project. The resulting technology will significantly increase Intralytix’s capabilities as well as help advance the phage biocontrol and phage therapy fields in general and will ultimately have a very significant positive impact on public health. We look forward to continuing this important project in collaboration with NIH. "

Tonix Pharmaceuticals develops monkeypox vaccine for future by looking at past

Tonix Pharmaceuticals, a company that has a research lab in Frederick, is developing a vaccine to prepare for a future where the monkeypox virus is endemic outside of Africa.

To do that, the company is looking more than 200 years in the past.

The base infrastructure that Tonix researchers use to design vaccines for infectious diseases is based on a virus called horsepox. That’s the same virus Dr. Edward Jenner used when he started developing the first smallpox vaccine in 1796.

Johns Hopkins Applied Physics Lab lands Pentagon RDT&E contract worth up to $10.6B

The Johns Hopkins University Applied Physics Laboratory has been awarded a contract for research, development, test and evaluation of military-related technology that could be worth up to $10.6 billion, the Defense Department announced Monday.

The lab, based in Laurel, Maryland, was awarded a $4.4 billion cost-plus-fixed-fee, indefinite-delivery/indefinite-quantity contract for RDT&E programs throughout the DOD that fall “within its core competency areas including strategic systems test and evaluation; submarine security and survivability; space science and engineering; combat systems and guided missiles; air and missile defense and power projection; information technology, simulation, modeling, and operations analysis; and mission related research, development, test and evaluation,” according to the DOD contract award announcement.

Image: Photo of the Johns Hopkins University Applied Physics Lab's Kossiakoff Center. (Photo courtesy of JHU-APL)

Institute for Bioscience and Biotechnology Research Awarded $6.9M to Design and Test a Vaccine to Combat Hepatitis C

HCV envelope-antibody interaction

The National Institute of Allergy and Infectious Disease (NIAID) awarded a $6.9 million grant to researchers at the Institute for Bioscience and Biotechnology Research (IBBR) to design a vaccine to combat the virus that causes Hepatitis C, an illness that affects an estimated 71 million people worldwide. Hepatitis C Virus (HCV) puts people at heightened risk for severe liver disease, including fibrosis, cirrhosis, and hepatocellular carcinoma (liver cancer). Although treatments are available, an HCV vaccine currently does not exist to help prevent infections and reduce the global burden of the disease.

Governor Hogan Announces Maryland’s State Small Business Credit Initiative Programs Now Open

ANNAPOLIS, MD—Governor Larry Hogan today announced Maryland programs funded by the State Small Business Credit Initiative (SSBCI) are open. Up to $198 million in federal small business relief is being administered by three state agencies: the Maryland Department of Housing and Community Development (DHCD), the Maryland Department of Commerce, and the Maryland Technology Development Corporation (TEDCO). These agencies will use funds to expand and enhance nine existing state business lending and investment programs.

AstraZeneca Reportedly Seeking Bolt-On Opportunities, could Abandon Vaccines | BioSpace

AstraZeneca CEO Pascal Soriot raised questions Tuesday about the company’s future in vaccines while hinting at potential M&A activity on the near horizon.

In an interview with Reuters, Soriot discussed the company's plans, which he said include building on its portfolio of antibody therapies. AstraZeneca is also considering bolt-on acquisitions in oncology and cardiovascular areas, Soriot said.

Getting out of the COVID-19 Vaccine Business?

Overall, in the COVID-19 space, the company has shifted its resources to antibody therapies.

Image: Pascal Claude Roland Soriot – 23 May 1959 (age 63) France – Wikipedia

Novel Nanotechnology Supercharges Immune System Molecules to Fight Cancer

Researchers from Cytimmune Sciences presented new data at a cancer therapeutics conference in Boston, MA demonstrating the potential of their nanoparticle-based platform to supercharge synergistic immune system stimulators called cytokines.

SUMMARY OF DATA PRESENTED

Data focused on industry leading, first-in-class, multi-cytokine immunotherapies
CYT-IFNg-TNFa (A dual cytokine immunotherapy nanomedicine)
- 100x increase in direct cancer cell killing potency vs native cytokines
- 30x increase in cytokine accumulation in tumor tissue
- Induction of a cancer specific immune response after treatment
Other novel cytokine-based immunotherapies
- Introduction of nanomedicines including combinations of IL-12, IL-2, IL-15 & IL-1b
- 175x increase in potency of IL-12 presented on nanoparticles vs. native IL-12
CYT-6091 (high dose TNF alpha)
- Unpublished preclinical data showing CYT-6091 induces cytotoxic T-Cell tumor infiltration
- Phase 1 clinical safety data and preclinical mechanism of action data

Deloitte remains largest healthcare consulting firm in United States

Deloitte Consulting remained atop Modern Healthcare’s annual ranking of the largest healthcare management consulting firms based in the US.

Deloitte US’ sizable healthcare consulting practice realized $2.698 billion in revenue in 2021, with $962.8 million coming from healthcare providers.

Guidehouse jumped from third place 2020 to second place in 2021, achieving $970 million in healthcare consulting revenue, with approximately half from providers. The firm was boosted a significant industry acquisition in 2021, adding Dovel, an 1,800-person IT consultancy with a focus on health IT, life sciences, and public safety.

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August 30, 2022

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522nd edition, August 23, 2022

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August 23, 2022

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Maryland’s RoosterBio and Seattle’s AGC Biologics Announce Collaboration to Accelerate Manufacturing of Cell and Exosome Therapies

SEATTLE, Aug. 16, 2022 (GLOBE NEWSWIRE) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services.

The partnership creates an end-to-end solution for the development and production of hMSC and exosome therapeutics leveraging RoosterBio’s well-established cell and media products and process development services, coupled with AGC Biologics’ global cell and gene therapy manufacturing capabilities.

Biotech And Drug Development (Audio) – Bloomberg

Dr. Amrie Grammer, co-founder of AMPEL BioSolutions, joins the show to discuss biotech and her company Hosted by Paul Sweeney and Matt Miller.

Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older

If authorized, Novavax' vaccine would be the first protein-based COVID-19 booster for adults
If authorized, the Novavax COVID-19 Vaccine, Adjuvanted could be used as a booster dose for adults aged 18 and older vaccinated with any other currently available COVID-19 vaccine

GAITHERSBURG, Md., Aug. 15, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.

Biotechnology Investment Incentive Tax Credit (BIITC) Accepting 2023 Applications

The fiscal year 2022 program is now closed. The fiscal year 2023 program will begin accepting applications as follows: Commerce will begin accepting Form B QMBC applications on 8/23/2022, and Form A Investor applications on 9/7/2022. Additional information is available under the “Apply” section.

BIITC provides an investor with a refundable State income tax credit for an eligible investment in a Qualified Maryland Biotechnology Company (QMBC). The program supports investment in seed and early stage biotech companies to promote and grow the biotech industry in Maryland.

D.C. Area Life Sciences Market Down to 1.4% Vacancy – Commercial Observer

The Washington, D.C./Baltimore region continued to see a tightening in its life sciences real estate market.

In particular, the region saw a decrease in life sciences vacancy in the second quarter of 2022, dropping from 3.6 percent to 1.4 percent since last year, according to CBRE’s latest national life sciences report.

Image: THE RECENT DEAL FOR THE TWINBROOK OFFICE CENTER HIGHLIGHTS THE DEMAND FOR LIFE SCIENCES SPACE IN THE MARYLAND SUBURBS OF D.C. PHOTO: BY NEWMARK

8 new high priority funding opportunities

We just released 8 new high priority funding opportunities where your company can make a difference in meeting the needs of cancer patients… Please see the solicitation and join our webinar on August 24th….

Technical.ly: 2 new medtech startups will spin out of Johns Hopkins research fund grants

Two new medical startups, focusing on addressing vision loss and catheter-associated urinary tract infections (UTIs), are on the horizon thanks to the $200,000 in grants the research teams received from the Johns Hopkins University’s Louis B. Thalheimer Fund for Translational Research.

14 researchers applied to the Thalheimer Fund, which was created to provide seed funding for proof-of-concept and validation studies of inventions coming out of Hopkins. The awards from the fund range from $25,000 to $100,000.

“We are excited to have received strong applications for disruptive technologies with commercialization potential that can have a future impact on human health and well-being,” Nicole Snell, associate director of ventures at Johns Hopkins Technology Ventures’ (JHTV) FastForward accelerator, which helps university-affiliated founders commercialize their technologies, said in a statement.

Don’t get distracted over ARPA-H fight; let’s win the bigger prize | Maryland Daily Record

Congress has approved a new agency — the Advanced Research Projects Agency for Health (ARPA-H) — that will ‘supercharge’ breakthrough medical research and provide over $1 billion in new research funding.

A fight has broken out, however, over ARPA-H’s headquarters’ location. The Maryland congressional delegation is working to locate it in state, but when a majority in Congress senses a chance to put a prestigious scientific headquarters in their home districts, Maryland likely will not win this battle.

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August 24, 2022

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521st Edition, August 16, 2022

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August 16, 2022

FOUNDING MEMBER OF

BHI Seeks Senior Life Sciences Business Strategist

Currently 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.

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.

Ellume welcomes Congressman David Trone, Senator Ben Cardin, Senator Chris Van Hollen and National Institute of Standards and Technology (NIST) Manufacturing Extension Partnership Director Laurie Locascio

It was a pleasure to welcome Congressman David Trone, Senator Ben Cardin, Senator Chris Van Hollen and National Institute of Standards and Technology (NIST) Manufacturing Extension Partnership Director Laurie Locascio to our new facility in Frederick this week and to see Ellume’s #manufacturing capabilities first-hand.

Ellume's Frederick facility provides a sustainable U.S. domestic industrial base for #diagnostics production and stands ready to respond to any future surge in #COVID19 demand, while accelerating #innovation to develop solutions for future public health needs. A multimillion-dollar automation program is underway to further enhance the production capability of the facility.

Alexandria Real Estate Equities and the Transformation of Life Science Real Estate | Nareit

A quarter century after it began life as a garage start-up, Alexandria Real Estate Equities, Inc.’s (NYSE: ARE) decision to focus on the niche segment of life science real estate looks sounder than ever as demand for sophisticated lab space across major U.S. markets sits at an all-time high.

Pasadena, California-based Alexandria is the only publicly traded, pure-play office/laboratory REIT. The company, led by founder and Executive Chairman Joel Marcus, focuses exclusively on highly specialized lab space used for research and development in the booming life science industry.

Image: Lilly Institute for Genetic Medicine, 15 Necco Street, Seaport Innovation District, Greater Boston. Photo courtesy Alexandria Real Estate Equities, Inc.

NSF Awards $10M To UMBC To Expand Successful Initiative Developing Underrepresented Postdocs In STEM – UMBC: University Of Maryland, Baltimore County

UMBC will expand its work boosting diversity in academia from Maryland to the national level through a new NSF INCLUDES Alliance: Re-Imagining STEM Equity Utilizing Postdoc Pathways (RISE UPP). The RISE UPP Alliance, anticipated to officially launch in fall 2022, is modeled after the AGEP PROMISE Academy, a high-impact initiative co-led by UMBC that supports faculty diversification in the biomedical sciences across University System of Maryland (USM) institutions.

Image: Albin O. Kuhn Library (Marlayna Demond '11/UMBC)

Chancellor's Message: VISION 2030 — From Excellence to Preeminence

VISION 2030: From Excellence to Preeminence

This summer, the University System of Maryland unveiled a new 10-year strategic plan—Vision 2030: From Excellence to Preeminence. The plan reflects 18 months of in-depth analysis. It coalesces intense discussions among dozens of groups of people with a stake in Maryland’s public universities—people with different opinions on higher education’s main objectives and different ideas on how to achieve them.

But one theme emerged across all groups: That students must serve as our starting point. They must set our agenda. They must center our work.

Click here to view the PDF

Q32 Bio and Horizon Therapeutics Announce Collaboration in Autoimmune Diseases

WALTHAM, Mass. and DUBLIN, Aug. 15, 2022 /PRNewswire/ — Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that they have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases.

ADX-914 is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. Q32 has recently completed a biomarker-enabled Phase 1 study characterizing pharmacokinetics, pharmacodynamics and safety of ADX-914 that demonstrated pharmacological effect on T cells in healthy volunteers. Q32 expects to initiate a Phase 2 trial in atopic dermatitis later this year and is planning to initiate a Phase 2 trial in a second autoimmune disease next year.

DC Inno – How 3 women-led life sciences startups thrive with TEDCO

Maryland is home to a number of STEM entrepreneurs with quality projects and the skills to succeed. What entrepreneurs often lack are the right connections and access to funding, which is especially true for women-led life sciences start-ups.

“In 2021, women founders raised just 2% of venture capital money and only 23% of biotech CEOs are women said Margia Argüello, formerly with the Maryland Department of Commerce’s Office of Life Sciences.

Image: The three busy female founders of innovative life science startups CarrTech, NasaClip and PerSoN Clinic took time to share what TEDCO’s Builder Fund and other TEDCO resources have meant to their companies.

Ellume COVID test plant in Frederick starting to add automation to manufacturing | Coronavirus | fredericknewspost.com

Five months after the Australian-based biopharmaceutical company Ellume opened its first U.S. location in Frederick, the facility is scaling up its production of at-home COVID-19 tests by starting to automate the manufacturing process.

U.S. Rep. David Trone and U.S. Sens. Chris Van Hollen and Ben Cardin visited the sprawling campus along Executive Way on Tuesday afternoon for a tour of the company’s production capabilities and a town hall meeting with its employees.

Image: https://www.fredericknewspost.com – Staff photo by Ric Dugan

Alexandria – 940 CLOPPER ROAD – GAITHERSBURG, MARYLAND – AVAILABLE 1Q23 – 8,867 RSF OF LABORATORY/OFFICE SPACE

TENANT AMENITIES

• 8,867 RSF lab/office suite available 1Q23

• Dedicated suite entry

• Energy efficient HVAC

• Loading dock

• Ample parking

• Complimentary access to the Alexandria FitLab

fitness center (located at 910 Clopper Road)

• On-site asset management

• Proximate to major amenities, including

restaurants, retail, lodging, and banking

Click here for more information.

CHIPS Act Authorizes Unprecedented Support for Tech Transfer

The arc of the technology transfer profession can be tied to the Bayh-Dole Act of 1980 in the United States and similar enabling legislation from across the globe. This week a new transformational law was passed – the CHIPS and Science Act – supporting U.S. semiconductor production and catalyzing research and development in many key technology areas and in new innovation regions of the country. Most importantly, this new law has a key provision titled “Planning and Capacity Building Awards” (Sec. 10391), which authorizes an unprecedented $3.1 billion to support technology transfer capacity building for research institutions.

Copyright AA(C) BioHealth Innovation 2022
All Rights Reserved.

August 16, 2022

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520th Edition, August 9, 2022

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August 9, 2022

FOUNDING MEMBER OF

BARDA Director Gary L. Disbrow, Ph.D., Joins Rich Bendis on the BioTalk Podcast

Gary L. Disbrow, Ph.D., Director of the Biomedical Advanced Research and Development Authority (BARDA), visits BioTalk to discuss his career, advancing research, development, and collaboration in BioHealth.

Listen to the podcast now via Apple https://apple.co/3zCsbMl, Google https://bit.ly/3p2aAIP, Spotify https://spoti.fi/3p2V0Ne, and Amazon https://amzn.to/3BSQWqf.

BioBuzz: BioHealth Capital Region Forum Crab Trap Winners: Where Are They Now?

The BioHealth Capital Region Forum and Investment Conference are right around the corner on September 20th and 21st, 2022, respectively. And that means great networking opportunities, engaging panel discussions, valuable investor interaction and the celebrated and highly anticipated 7th annual Crab Trap competition.

The Crab Trap competition brings together entrepreneurs with innovative diagnostics, medical devices, therapeutics or other transformative health solutions to compete for a prize package valued at $50,000, which includes cash rewards and a one-year residency at JLABS @ Washington DC. Crab Trap finalists will earn the chance to make an in-person pitch at the BioHealth Region Investment Conference.

Johns Hopkins spinout Emocha Health closes $6.2M series A for video-based medication adherence

Emocha Health, a Johns Hopkins University spinout tackling medication adherence with an asynchronous video platform, has announced a $6.2 million series A round led by Claritas Health Ventures.

Like many other health technology startups recently, the company’s latest raise comes after months of pandemic-boosted growth. Emocha said in its announcement that revenue has increased 300% over the last year alone, due in part to the accelerated acceptance of virtual technologies in healthcare.

Image: Emocha Health has patients record videos of themselves taking a medication and asking questions about their treatment, which are then reviewed by a live team to ensure adherence and resolve any issues. CEO Sebastian Seiguer said it's a more effective approach than others that rely on financial incentives or prescription refill rates. (emocha Health)

Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma Member Discounts – Maryland Tech Council

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.

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.

Emergent BioSolutions unveils 7th pandemic CDMO contract, this time for Humanigen's late-stage antibody hopeful | Fierce Pharma

Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.

Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.

Image: Emergent recently completed a new filling line at its Camden plant in Baltimore, pictured above. (Emergent BioSolutions) (Emergent Biosolutions )

Jos Joore – MImetas CEO and BHI’s first International soft landing company

This interview is part of a series of conversations with the people working at Mimetas. The 'I' in Mimetas focuses on the personal side of the scientists that drive our world. Today we have a chat with Jos Joore, CEO and co-founder of Mimetas.

What small things in life make you happy?

That's an interesting one. I would say it's, in particular, the small things that make me happy. Being out in nature, taking a run, being with family. People need a firm, happy basis to cope with challenges like setting up and running a company. That basis is made up of all the small things in life that are, in fact, the most important.

What does #USPVerified mean?

What does #USPVerified mean? It means that you can trust that what's on the label is what's in the bottle. The USP Verified Mark has appeared on more than 880 million bottle labels, making quality visible so you can choose dietary supplements with confidence. Learn more about USP Verified products at quality-supplements.org #NoDoubtAboutIt

IPO market in a ‘wait-and-see period,’ EY Americas IPO leader says

EY Americas IPO Leader Rachel Gerring joins Yahoo Finance Live to discuss the U.S. IPO market, navigating through recessionary fears, inflation, supply chain woes, volatility, and the outlook for IPOs.

Video Transcript BRIAN SOZZI: Companies are pumping the brakes on public debuts with the number of IPOs in the US plunging by 75% in the first half of this year compared to last year according to new data from EY. Joining us now to break down the latest in the IPO space is EY Americas IPO leader Rachel Gerring. Rachel, good to see you here this morning. Have we reached a bottom yet?

Image: From Video

U.S. Department of Commerce Announces Winners of American Rescue Plan $500 Million Good Jobs Challenge to Expand Employment Opportunities | U.S. Economic Development Administration

WASHINGTON – Today, U.S. Secretary of Commerce Gina Raimondo announced grant awards to 32 industry-led workforce training partnerships across the country as part of the $500 million Good Jobs Challenge funded by President Biden’s American Rescue Plan. The Good Jobs Challenge is administered by the Commerce Department’s Economic Development Administration and will enable communities across the country to invest in innovative approaches to workforce development that will secure job opportunities for more than 50,000 Americans.

“BioTalk with Rich Bendis” Podcast Featured in BioBuzz Podcasts to Follow Now

In a job market that’s become increasingly competitive and employer-driven, it’s imperative for both active and passive job candidates to do their homework. Understanding national biotech market trends and how those forces are impacting regional biohubs and the market at large could be a key differentiator between job seekers.

If you’re a job seeker in the BioHealth Capital Region (BHCR) or Greater Philadelphia, there are a host of valuable resources for job market research that can help target your search. The weekly BioBuzz Newsletter and Job Board, BioHealth Innovation’s newsletter, the Maryland Tech Council’s Biohub Maryland Pathways website, and Big4Bio are all just a few of the great sources of information and job opportunities.

Add to that LinkedIn and local in-person networking events, and there are many ways for job seekers to educate themselves on market conditions, specific job qualifications, and where one might fit within the overall talent market.

REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II

FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024
Pivotal program is active and enrolling patients
RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II
Internal cGMP manufacturing process expected to support BLA

ROCKVILLE, Md., Aug. 3, 2022 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome. The Company also announced that a pivotal program for RGX-121 is active and enrolling patients. RGX-121 is an investigational, one-time AAV Therapeutic using the NAV AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme.

"We are pleased to share that our recent discussions with the FDA support our plans to submit a BLA for RGX-121 in 2024 using the accelerated approval pathway, which was created to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "We believe RGX-121 for the treatment of Hunter Syndrome has demonstrated emerging positive impact on neurodevelopmental function, and we intend to advance this program as quickly as possible with the aim of providing a much-needed new treatment option for the MPS II community."

NIH Applicant Assistance Program Accepting Applications

The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses who have never received NIH SBIR/STTR funding in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application.

The goal of this program is to increase participation in the SBIR program by socially/economically disadvantaged small businesses, women-owned small businesses, and small businesses located in under-represented states.

The AAP application portal will be opening on August 5th, 2022 and information about the program is available at the NIH Application Assistance Program website. For more information about the AAP, be sure to attend the AAP Informational Webinar on August 5th at 3:00 PM ET and the Q&A Office Hours on September 15th at 2:00 PM ET. All applications must be submitted no later than September 22nd, 2022 at 5:00 PM ET.

Please note that this service is NOT available to support preparation of a Fast-Track or Phase II application. Companies who have a current SBIR/STTR application under review with the same scope of work are not eligible for AAP support.

Click here for more information.

GSK enters agreement with 12 EU countries – BioProcess InsiderBioProcess International

GlaxoSmithKline (GSK) has signed an agreement to reserve, produce, and supply its influenza vaccine Adjupanrix to 12 European countries.

Under the terms of the deal, GSK has signed a contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA), for the reservation of future manufacture of 85 million doses of Adjupanrix (split virion, inactivated, adjuvanted).

Biotech & Beer -NOVA – Registration

You are invited to our exclusive Biotech & Beer networking event at The Black Sheep Restaurant on August 16th from 4:30-6:30pm, where we will bring together our Northern Virginia life science community from academia, industry, and healthcare.

Learn about new resources available in Virginia to grow your research and development capabilities. Also, come hear about the latest in the life sciences by exchanging in conversation with with old and new friends!

Register to attend for free at: https://members.vabio.org/events/biotech-and-beer–nova/register

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August 8, 2022

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519th Edition, August 2, 2022

By adminBHI Weekly News Archives

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August 2, 2022

FOUNDING MEMBER OF

BioHealth Innovation Announces New Life Sciences Business Strategist Kelly Murphy

ROCKVILLE, MARYLAND, July 5, 2022 – BioHealth Innovation Inc. (BHI) is pleased to welcome Kelly Murphy, M.S., as a new Life Sciences Business Strategist. In this role, Murphy will evaluate the commercial potential of clients’ emerging technologies and assist start-ups with their go-to-market strategies. Her work will also focus on helping biohealth companies to secure non-dilutive funding.

Murphy is a recent graduate of the Masters of Biotechnology Program at Northwestern University. During her time at Northwestern, she gained professional experience in government affairs, project management, and corporate strategy at two life sciences companies. Prior to earning her graduate degree, she received her BS from the University of Nevada, Reno in neuroscience and chemistry.

Arcellx inks deal for Rockville expansion – Washington Business Journal

The newly minted public company has signed a lease for 60,000 square feet.

Image: 800 King Farm Blvd. will be converted from traditional office to lab space. BANYAN

Council Approves New Zoning Measure to Expand Biohealth in Urbanizing, Transit-Oriented Locations – EIN Presswire

ROCKVILLE, Md., July 29, 2022—The Montgomery County Council voted Tuesday to approve a new zoning measure introduced by Councilmember Andrew Friedson that will help attract and retain biohealth companies in Montgomery County and spur economic development, particularly in transit-oriented locations. The new zoning measure continues the Council’s ongoing efforts to support innovation and the biohealth sector, which is an essential part of Montgomery County’s economic engine.

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.

VerImmune Inc Announces Closing of Seed Financing to Further Develop Novel Virus-inspired Particle Immunotherapies

Financing led by SeedFolio, an early-stage high-tech biotech venture investment firm with participation from Ulu Ventures, Proxima VC, NuFund Venture group, Gaingels, Mana Ventures, and others.

WASHINGTON, D.C. (PRWEB) JULY 27, 2022

VerImmune, Inc. (“VerImmune”), a biotechnology company developing new therapeutic modalities that aim to redirect the body’s pre-existing immunity toward cancer, announced today the close of $2.5 million in Seed funding. The round was led by SeedFolio, a seed series venture capital firm focused on innovative, early-stage companies with game-changing impact potential. The round also included participation from US and global investment venture firms such as Ulu Ventures, and Proxima VC as well as leading private investment syndicate funds such as the NuFund Venture group (previously Tech Coast Angels- San Diego), Gaingels, Mana Ventures, and others.

2022 Crab Trap Application

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.

Children's National Hospital Innovation Day 2022

Children's National Innovation Day features the hospital's life science and healthcare projects that are looking for strategic partnership, co-development, and licensing opportunities. The event will also showcase startup companies whose mission is aligned with our quest to bring novel pediatric products to patients and families.

BHI Seeks Senior Life Sciences Business Strategist

Currently 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.

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.

The Galien Foundation Announces 2022 Prix Galien USA Nominees for "Best Digital Health Solution," "Incubators, Accelerators and Equity," and "Prix Galien Startup" – DEKA Nominated

NEW YORK, July 28, 2022 /PRNewswire/ — The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, today announced the 2022 Prix Galien USA Award nominees for "Best Digital Health Solution," "Incubators, Accelerators and Equity," and "Prix Galien Startup." Winners will be announced during the Prix Galien USA Awards Ceremony on October 27, 2022, at the American Museum of Natural History in New York City.

"The Prix Galien Awards have become the most coveted prizes for those who dedicate their lives to the development of meaningful drugs and innovations," said Bernard Poussot, Director, Roche Holding, Former Chairman & CEO, Wyeth, Prix Galien Startup, Digital Health and Incubators, Accelerators and Equity Committee Chairman. "Members of the Awards Committees applaud the unwavering commitment of each nominee in their quest to provide a healthier future for the next generation."

Image: https://www.prnewswire.com

Incubator “Cheat Sheet” for Life Science Entrepreneurs in the BioHealth Capital Region · BioBuzz

The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region aims to be in the top three biohealth clusters in the country by 2023. Whether it’s Kite Pharma‘s new facility in Frederick County, MD, companies like ATCC scoring contracts for critical vaccines, or recent moves to the area by companies like Synexa Life Sciences, it’s evident that the BHCR is thriving.

Image: https://biobuzz.io

Apply for the Maryland Global Consulting Program

Expand your company's reach to international markets with the University of Maryland – Robert H. Smith School of Business Global Consulting Program!

Develop your export capabilities and find new customers with a team of 3-5 business graduate students advised by top-rated Maryland Smith faculty, along with the Maryland Department of Commerce's Office of International Investment and Trade.

Applications close on Thursday, August 4. Learn more at: https://lnkd.in/eFfddjsA

Medical Device I-Corps

The Fischell Institute is working with University of Maryland (UMD) I-Corps representatives to plan a Medical Device I-Corps program, targeting dates in November. I-Corps is a National Science Foundation (NSF) program designed to foster, grow, and nurture innovation ecosystems regionally and nationally. UMD is the lead institution of the NSF I-Corps Hub: Mid-Atlantic Region and a member of the larger National Innovation Network.

UMD’s Introduction to I-Corps Course is a short, intense, bootcamp-style cohort. Participants work closely with teammates, other teams, and with mentors and instructors to develop business models around their innovations. Courses are approximately two weeks in duration, with the cohort meeting three or four times during the two-week span.

Copyright AA(C) BioHealth Innovation 2021
All Rights Reserved.

August 2, 2022

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518th Edition, July 26, 2022

By adminBHI Weekly News Archives

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July 26, 2022

FOUNDING MEMBER OF

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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July 25, 2022

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517th Edition, July 19, 2022

By adminBHI Weekly News Archives

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July 19, 2022

FOUNDING MEMBER OF

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.

Register Now! Accepting 2022 Crab Trap Applications

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

July 18, 2022

Love0

516th Edition, July 12, 2022

By adminBHI Weekly News Archives

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July 12, 2022

FOUNDING MEMBER OF

Accepting 2022 Crab Trap Applications

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.

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

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.

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

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.

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.

July 12, 2022

Love0

515th Edition, July 6, 2022

By adminBHI Weekly News Archives

Trouble Viewing This Email: Click Here

July 6, 2022

FOUNDING MEMBER OF

2022 Crab Trap Application

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.

NIH/BHI 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.

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.

July 5, 2022

Love0

514th Edition, June 28, 2022

By adminBHI Weekly News Archives

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June 28, 2022

FOUNDING MEMBER OF

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.

2022 Crab Trap Application

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.

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.

June 27, 2022

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