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BHI’s next EIR Feedback Day is February 16th

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

 

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

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

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BHI LogoPOSITION 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).

Learn more

Children’s National uses HIFU to perform first ever non-invasive brain tumor surgery – Children’s National

Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. Image provided by Insightec.

Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. Image provided by Insightec.

Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. The advancement of children’s medical devices in the U.S. continues to significantly lag behind adult devices. This is why this milestone marks a significant advance in making pediatric surgery more precise and less invasive.

The hospital is offering this treatment to patients under an ongoing research clinical trial. Children’s National is one of the first pediatric hospitals in the nation to use HIFU for neuro-oncology patients. It’s also the first hospital in the world to use it to treat a pediatric patient with NF. NF is a condition that occurs in approximately 1 in 3,500 births and causes tumors to form in the brain, spinal cord and nerves.

“Using HIFU to treat our pediatric patients is a quantum leap towards non-invasive surgery for kids,” said Robert Keating, M.D., division chief of Neurosurgery and co-director of the HIFU program at Children’s National. “It’s exciting because the future is now here and it’s significantly better for our kids, in terms of non-invasive surgery with lower risk of complications and no exposure to radiation.”

Image: Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. Image provided by Insightec.

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6 Signs It’s Time to Leave Your Job

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Road ends 2021 08 29 08 48 54 utc

At some point, all of us experience moments when we must face the difficult decision to let go of something that formerly offered us purpose. But big decisions, like a career change, should be approached thoughtfully. While sometimes this can be done by reinventing your current work, there are times where the right choice is to strike out on a fresh path.

 

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5 Ways You Can Get Paid Internationally

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International certificate of vaccination 2021 09 01 05 31 33 utc

While domestic sales to American customers are typically cash in advance or on open account, did you know that companies outside of the United States are often accustomed to other methods of payment? Offering attractive and flexible payment terms is an excellent way to win business internationally, but can be risky for your business. It’s important to be well versed in the technicalities so you can prevent payment-related issues before they happen. 

 

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Startup Professionals Musings: 6 Ways To Find Courage For Uncomfortable Discussions

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As a mentor to many entrepreneurs and business owners, I find that many of you have a real fear of uncomfortable interaction situations with individuals on your team, and often delay these discussions endlessly until a crisis occurs. I am often asked for ways to reduce the stress of these impending confrontations, and build up your courage in tackling the inevitable negative conversations.

I’m sure that many of you have some good thoughts on how to deal with difficult situations, but I was very impressed with the summary of recommendations provided in the new book, “Compassionate Leadership,” by Rasmus Hougaard and Jacqueline Carter. Both of these authors come from leadership backgrounds, with much experience in management training and consulting.

Image: https://blog.startupprofessionals.com

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Venture Building: Why the Old Way of Venture Capital Is Dead – Grit Daily News

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In 2020, the failure rate of startups was around 90%. Research showed that 21.5% of startups failed in the first year, 30% in the second year, 50% in the fifth year, and 70% in their 10th year. Stats like these can make a startup founder or a venture capital investor feel like things are a bit bleak, but perhaps there is a better way.

There are ways to avoid failing like setting goals, doing accurate research, loving the work you do and not quitting at the first sign of challenges. These all sound easier said then done, but the recipe for success can be just that simple. Let’s dive into some of the main reasons startups fail.

Image: https://gritdaily.com

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494th Edition, February 8, 2022

 

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February 08, 2022

FOUNDING MEMBER OF

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Geoffrey Lynn, co-founder Avedia, SVP, Synthetic Immunotherapies, Vaccitech, joins BioTalk

Geoffrey Lynn, SVP, Synthetic Immunotherapies, Vaccitech, visits Rich Bendis to discuss his career from NIH, to CEO of Avidea, to their merger with Vaccitech.

Listen now via Apple https://apple.co/3GztBZg, Google https://bit.ly/3gAfHvn, Spotify https://spoti.fi/3GBiaAm, and TuneIn https://bit.ly/3B54Y5V.

Dr. Geoffrey Lynn is leveraging his background in synthetic chemistry and cellular immunology to lead Avidea’s efforts to develop precision immunotherapies for treating cancer and autoimmune diseases. Dr. Lynn has expertise in designing, GMP manufacturing and assessing safety, efficacy & MOA of polymer-drug conjugate / nanoparticle technologies for immunotherapeutic applications. Previously, Dr. Lynn was a visiting scientist in the laboratory of Professor Christopher Jewell at the Fischell Department of Engineering at UMD and trained as a post-doctoral fellow with Dr. Robert Seder at the Vaccine Research Center of the National Institutes of Health (NIH). Dr. Lynn attended medical school at Johns Hopkins University; obtained a Ph.D. in Biomedical Engineering from the University of Oxford as an NIH-Oxford and National Science Foundation Graduate Research Fellow; and received his B.S. in chemistry from Elon University, where he was a Goldwater Scholar.

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Immediate Job 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).

Learn more

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How can your BioHealth business benefit from a review by BHI industry experts? Please register for our next Entrepreneur-In-Residence (EIR) day on Feb. 16th and find out.

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

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

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NEXT GENERATION TB TEST DEVELOPED WITH ELLUME TECHNOLOGY RECEIVES APPROVAL FROM KEY GLOBAL REVIEW PANEL FOR USE IN MORE THAN 100 LOW-RESOURCE, HIGH BURDEN COUNTRIES

FREDERICK, Md. and BRISBANE, Australia, Jan. 10, 2022 /PRNewswire/ — Digital diagnostics company Ellume today announced that the QIAreach QuantiFERON-TB test (QIAreach QFT), developed with Ellume technology, and designed to advance the control of tuberculosis (TB) in areas with limited infrastructure, has been approved by the Global Fund’s Expert Review Panel for Diagnostics.  Approval of QIAGEN N.V.’s battery-operated QIAreach QFT means the product will now be available to public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources, as well as through the Stop TB Partnership’s Global Drug Facility (GDF). This development comes after the QIAreach QFT product was launched in October 2021, following CE marking.

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Emmes Supports New Collaboration to Accelerate COVID-19 Research for Children

Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02).  The team, led by the Pediatric Trials Network at Duke University, also includes the Gabriella Miller Kids First Data Resource Center (DRC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

POP02 is one of several cohort studies within the Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID, known as CARING for Children with COVID.  The National Institutes of Health (NIH) initiated the CARING for Children with COVID program to collect clinical data and samples that would advance the understanding of SARS-CoV-2 infections in children.  The program seeks to provide information to help healthcare providers and parents make informed decisions when caring for children infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome).  

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Arcellx Announces Pricing of Initial Public Offering – Arcellx

GAITHERSBURG, Md., Feb. 04, 2022 (GLOBE NEWSWIRE) — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced the pricing of its initial public offering of 8,250,000 shares of common stock at a public offering price of $15.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx, are expected to be approximately $123.8 million. In addition, Arcellx has granted the underwriters a 30-day option to purchase up to an additional 1,237,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Arcellx. Arcellx’s common stock is expected to begin trading on the Nasdaq Global Select Market on February 4, 2022, under the ticker symbol “ACLX.” The offering is expected to close on February 8, 2022, subject to the satisfaction of customary closing conditions.

BofA Securities, SVB Leerink, Barclays and William Blair are acting as joint book-running managers for the offering.

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USP and WHO Renew Official Relations to Continue Strengthening the Global Medicines Supply Chain | LinkedIn

On Saturday, January 29, the World Health Organization (WHO) Executive Board approved the renewal of official relations with the United States Pharmacopeial Convention (USP) through 2023. As an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, USP is honored to continue our longstanding partnership with the WHO and contribute our expertise to shape and advance policies and strategies to improve the health and wellbeing of people around the world.

Image: https://www.linkedin.com/

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Baltimore Fishbowl | University of Maryland, Baltimore County reaches nation’s highest level as research university –

The University of Maryland, Baltimore County has received a Carnegie Classification, the nation’s highest designation for research universities.

Two other universities in Maryland – Johns Hopkins University and the University of Maryland – share the classification.

The Carnegie Classification of Institutions of Higher Education ranked UMBC in the R1 category, which signifies “very high research activity.”

UMBC is one of only 146 R1 institutes nationally, including 107 public universities and 39 private universities.

“This is an amazing accomplishment by faculty, staff, and administrative leaders who have built a research culture that nurtures undergraduate and graduate students,” said UMBC president Freeman Hrabowski in a news release.

Image: Photo via the University of Maryland, Baltimore County

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Gain Therapeutics Announces Additional Details on its February 4th Virtual R&D Day

BETHESDA, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”), a biotechnology company transforming the drug discovery paradigm with structurally targeted allosteric regulators identified with its proprietary computational discovery platform, today announced additional details on its R&D Day being held virtually on Friday, February 4, 2022 from 10:00 am – 12:00 pm Eastern Time.

The R&D Day Event, entitled “Neuroscience and Beyond: Harnessing Computational Technology and Allosteric Modulators to Drug the Undruggable” will feature presentations from several Key Opinion Leaders (KOLs):

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Altimmune Announces FDA Clearance Of Pemvidutide (ALT-801) IND For Obesity

January 31, 2022 at 7:00 AM EST

Enrollment in 48-week Phase 2 clinical trial expected to begin in Q1 2022

GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial.

“This Phase 2 trial in obesity represents an important milestone toward developing a safe and effective treatment option for people with obesity,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Results from a recently completed Phase 1 study of pemvidutide in Australia showed that 12 weekly subcutaneous doses of pemvidutide at the 1.8 mg dose level resulted in an average weight loss of 10.3% in overweight and obese subjects. Importantly, there were no study discontinuations due to adverse events. We believe these results rank among the best in terms of the rate and magnitude of weight loss and tolerability among drugs in development for obesity.”

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MaxCyte Signs Strategic Platform License with Intima Bioscience to Advance Tumor Infiltrating Lymphocytes Programs

Intima Bioscience to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its solid tumor cell-therapy candidates NEW YORK and GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

Under the terms of the agreement, Intima obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

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2021 Global life sciences sector outlook | Deloitte

Navigating the pandemic has been an all-encompassing, once-in-a-lifetime challenge. Globally, life sciences companies responded with leadership and are emerging stronger. How will life sciences companies continue to respond and what areas can they build resiliency going forward?

The life sciences sector has played a pivotal role amid the COVID-19 pandemic. To cope with the global crisis, traditional competitors partnered to accelerate research and develop the fastest novel vaccine in the history. Governments, health systems, payers, retail pharmacies, and nonprofits are now working collaboratively with the sector to provide widespread distribution and administration.

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How Johns Hopkins Inventors’ Vision for Early Cancer Detection Got a $2.1B Boost – Johns Hopkins Technology Ventures

Johns Hopkins researchers Nickolas Papadopoulos, Ken Kinzler and Bert Vogelstein have spent their careers working on ways not just to treat cancer but to detect it before it becomes a threat. The goal: a blood test for the earlier detection of cancer incorporated into routine medical care. Their dream is closer to reality thanks in part to a $2.15 billion acquisition of their company, Thrive Earlier Detection Corp., one year ago by Exact Sciences Corp., a global leader in cancer-detection testing.

The heart of the researchers’ work is the liquid biopsy, a test done on a blood sample to look for signals derived from cancer cells circulating in the blood. In 2011, they invented SafeSeqS, a next-generation gene sequencing technology that simultaneously and individually analyzed millions of DNA molecules to identify mutations in the bloodstream more accurately than other methods.

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Amalgam named Best SaaS-Enabled Digital Health Platform!

Global Health & Pharma recently presented their seventh annual Biotechnology Awards and named Amalgam the Best SaaS-Enabled Digital Health Platform. The Global Health & Pharma Biotechnology Awards are given strictly on merit, so we’re extremely honored to be among those whose innovation, determination and outstanding levels of care have earned them this prestigious recognition.

Contact us today for a capabilities demonstration to see how we can enable success for your digital solution, clinical decision support, or patient ID needs.

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Key lawmaker: ARPA-H won’t be part of NIH – STAT

WASHINGTON — A new research agency aimed at developing breakthrough medical technologies won’t be housed within the National Institutes of Health, a key lawmaker said on Wednesday.

Instead, the agency, known as ARPA-H, will exist as a distinct unit within the Department of Health and Human Services, said Rep. Anna Eshoo (D-Calif.).

Image: https://eshoo.house.gov/about-anna/biography

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Fresh Off Best Year Ever, Lab Giant Alexandria To Venture Into New Territory

The leading developer of life sciences properties rode the industry’s wave last year, recording 4.1M SF of leases signed between October and December, more than double its best total for any quarter in Alexandria Real Estate Equities’ nearly 30-year history.

Its pace of activity is spurring the Pasadena, California-based real estate investment trust to venture into new territory — it is paying $402M for a nearly 1M SF life sciences campus in Texas, it disclosed in its quarterly earnings release this week.

Image: Courtesy of Alexandria Real Estate Equities Vaccine-maker Moderna inked one of the year’s biggest deals with Alexandria Real Estate Equities for a new Kendall Square headquarters.

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The Clues to the Next Variant Surge Are All Around Us

When scientists in South Africa noticed an uptick in Covid-19 cases in the Gauteng Province last November, they began investigating the source. These researchers and others in Botswana quickly discovered the Omicron variant and heroically shared their discovery with the rest of the world. And yet it was still too late — Omicron was already rapidly infecting people across the globe.

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American Gene Technologies’ HIV Clinical Trial Shows Blood Markers of Efficacy in Two More Patients

ROCKVILLE, MD. (PRWEB)  FEBRUARY 02, 2022

Data from a Total of Five Patients Demonstrates Critical Markers of the Company’s HIV Cure Gene & Cell Therapy American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached another important milestone for its HIV cure program. Five participants were treated with AGT103-T and are stably engrafted with genetically modified cells.

Laboratory studies confirmed substantial increases in virus-specific T cells consistent with improved immunity against HIV in all participants. The early data addresses key trial endpoints and is aligned with the objective of restoring natural immunity against HIV.

“These latest laboratory studies of clinical material are extremely encouraging,” said AGT CEO Jeff Galvin. “To see these markers in all five trial participants indicates that prospects are bright for a potential one-and-done therapy to functionally cure HIV. This milestone brings us another step closer to our goal of returning people living with HIV to a normal life without the side effects of ART and having no further consequences of HIV.”

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2 technologies of which hospitals should be wary

Blockchain and “connected health” technology are two trends hospitals should not rush to adopt, according to two hospital innovation executives.

Discussions of blockchain have been increasingly prominent in the technology industry in recent years, and it shows potential for healthcare applications. However, it can be tricky for hospitals to figure out how to deploy the technology, Michelle Stansbury, vice president of IT innovation at Houston Methodist, told Becker’s.

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493rd Edition, February 1, 2022

 

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February 01, 2022

FOUNDING MEMBER OF

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BioHealth Innovation Announces Updates to its Board of Directors

Board of Directors Elects New Chair, Vice-Chair, and Two New Members

ROCKVILLE, MARYLAND, January 31, 2021  The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Peter S. Briskamn, Executive Managing Director and Mid-Atlantic Life Sciences Practice Co-Lead for JLL, and Christine Dingivan, M.D., President and Chief Executive Officer for Emmes as the new Chair and Vice-Chair in 2022. In addition, Ronald C. Kurz, Senior Director/GM for Canon Virginia, Inc. (CVI), and Dr. Tyrell Rivers, Executive Director of Corporate Development & Ventures at AstraZeneca, will be joining the Board as new members.

BioHealth Innovation and its Board of Directors would also like to thank outgoing Chair Jarrod Borkat for his leadership as he will remain with the Board. The Board would also like to thank Rebecca Farkas, Ph.D., for her contributions as she departs GSK and moves into a new role with CEPI.

 “We are proud to announce Pete and Christine as our new Chair and Vice-Chair on the BHI Board of Directors,” said Richard Bendis, BHI President and CEO. “Their experience and industry knowledge, plus the additions of Ron and Tyrell are important pieces to not just BHI, but the continued growth of the BioHealth Capital Region.”

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Immediate Job 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).

Learn more

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BHI’s next EIR Feedback Day is February 16th

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.

Read More

Entrepreneurial Development | Seed

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

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Cartesian Therapeutics Doses Patient with First Allogeneic RNA Cell Therapy for Multiple Myeloma – Cartesian

Gaithersburg, Md., January 25, 2022 – Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, today announced that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma.  To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years.  Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory® cell manufacturing platform.  This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

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QIAGEN Completes U.S. Federal Contract to Equip Local Public Health Authorities with QIAcuity Digital PCR System for COVID-19 Surveillance | BioSpace

HILDEN, Germany, & GERMANTOWN, Md.–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has completed a U.S. government contract to equip public health laboratories across the country with the QIAcuity digital PCR system to monitor the spread of the COVID-19 pandemic by testing wastewater for the presence of SARS-CoV-2 pathogens.

QIAGEN has shipped more than 35 QIAcuity systems to state and local health laboratories as part of a multi-million-dollar contract with the U.S. National Institutes of Health (NIH) to supply COVID-19 instruments and consumables through the end of 2021.

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Pandemic Preparedness: The next best time to act is now – Emergent BioSolutions

Global public health is at a critical inflection point. Do we learn the lessons of this pandemic and build a modern public health infrastructure to prepare us for the next one? Or do we repeat the mistakes of the current and past pandemics?

This week, Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr released a bipartisan draft bill aimed at evolving America’s pandemic preparedness commensurate with the challenges we face. The bill adds to the important public policy conversation ongoing in Washington, which includes President Biden’s ambitious $65 billion initiative for preparedness.

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Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

 NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant strains

GAITHERSBURG, Md., Jan. 31, 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 has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.

“We’re extremely proud of the work of our teams and we look forward to FDA’s review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “I’d like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today’s milestone of EUA request submission.”

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Novavax and Israel Announce Advance Purchase Agreement for Supply of COVID-19 Vaccine

The Novavax vaccine would be the first protein-based alternative available in Israel

GAITHERSBURG, Md., Jan. 28, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Israel’s Ministry of Health today announced an agreement for the purchase of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.

“Israel has been at the forefront of the fight against COVID-19 and has demonstrated strong leadership throughout the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the Israeli Ministry of Health for their commitment to providing a protein-based COVID-19 vaccine option, based on well-understood technology, to the people of Israel.”   

Under the advance purchase agreement, Novavax will provide an initial 5 million doses of its protein-based vaccine with an option for Israel to purchase an additional 5 million doses. Novavax will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel pending regulatory approval.

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CoapTech Awarded Seed Fund Grant from Pennsylvania Pediatric Device Consortium

BALTIMORE, Jan. 27, 2022 /PRNewswire/ — CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded a $50,000 grant by the Children’s Hospital of Philadelphia-based Pennsylvania Pediatric Medical Device Consortium (“PPDC”) for its PUMA-G Peds System, a device designed to provide a safer way to place feeding tubes in children.

The PUMA System™ is a new category of minimally invasive devices, enabling ultrasound procedures in hollow organs of the body where previously it was impossible or unsafe to do so. The PUMA-G Peds System is being developed to allow ultrasound-based placement of gastrostomy tubes in pediatric patients as an alternative to traditional endoscopic or fluoroscopic procedures. Endoscopic procedures cannot “see through” tissue which can result in organ damage or other complications. Fluoroscopic procedures require the use of ionizing radiation which presents long term risk of cancer. The PUMA-G Peds System uses ultrasound to visualize tissue and organs in real time without ionizing radiation. It is designed to operate like the currently available adult PUMA-G System, with modifications to accommodate the pediatric patient population. 

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Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma :: Immunocore PLC

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, Wednesday, January 26, 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

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Looking Back with Pride—and Forward with Purpose

At the University System of Maryland, January brings with it the chance to reflect on a year of accomplishment and anticipate a year of impact. Because, despite the challenges of the past several months, we’re still doing the work we were built to do. Our students are excelling. Our scholarship is making change. Our research is solving problems. Our service is improving lives.

This is a direct credit to the people of the USM. As COVID upended our academic enterprise and administrative operations, our people kept working harder, with a clarity of purpose and a devotion to mission that is, to me, breathtaking. The achievements and ambitions I share here honor their dedication.

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Maryland life science & digital health companies drive record VC investment. | Maryland Business News

In 2021, venture capitalists invested $2.27 billion in Maryland companies, according to the initial figures from the PitchBook-NVCA Venture Monitor Report. VC investment in 2021 shattered the record set in 2020 of $1.24 billion, and marks the third consecutive year of record-setting investment in Maryland companies. 

Given the high concentration of life sciences and digital health companies located in Maryland, it’s no surprise that investors turned their eyes, and their dollars, here last year. Significant local investments are fueling innovation across nearly every field, from cancer research to healthcare analytics. Below are some themes from Maryland’s banner year in venture capital. 

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Trends in Talent Acquisition, COVID Edition · BioBuzz

The pandemic, now approaching year three in full force, has impacted nearly every facet of the life sciences’ job market. A talent shortage existed pre-pandemic and has only accelerated since then. For life sciences employers, finding and securing talent will continue to be a major challenge throughout 2022. 

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5 Cities Emerging As Future Hubs For Life Sciences Development

The current boom in life sciences development mirrors the tech industry, especially geographically; there is an incredible concentration of jobs and investment in the top markets, in this case Boston, San Diego and the Bay Area and challenges finding support and funding anywhere else.

Image: Courtesy of Bill Timmerman A lab at 850 PBC, a Wexford lab development in downtown Phoenix.

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Vaccitech CEO Bill Enright Joins Rich Bendis on First BioTalk of 2022

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Ron Kurz

Ron Kurz

Sr. Director of Business Development, Business Innovation Group (BIG), Canon U.S.A. Inc.

Ron Kurz

Ronald C. Kurz is the Senior Director / GM at Canon Virginia, Inc. (CVI), the Canon manufacturing, engineering, recycling and technical support center for the Americas located in Newport News, Virginia.  Serving in a dual role, Ron is responsible for CVI’s Medical business including Sales, P&L, and Strategy. In addition, Ron is also responsible for the Business Development Division, including the development of strategic partnerships that leverage Canon Technology and Manufacturing Know-how. Prior to this position, he led the R&D division in the design and development of medical products for Canon BioMedical, Inc., which was a newly created Canon company.  Ron has worked for Canon Virginia for more than 23 years.

Prior to joining Canon, Ron served as a Mechanical Design Engineer for nVIEW Corp, responsible for video projector design and as a Product Design Engineer for GE Aircraft controls, responsible for mechanical design and thermal / vibration analysis of Flight and Engine controls.

Ron holds multiple patents and has previously served on the Old Dominion University’s College of Engineering and Technology Advisory Board. He received his Bachelor of Science in Mechanical Engineering from Binghamton University.

 

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