Small businesses with NHGRI grants were instrumental in contributing to the completion of the human genome sequence, redefining the future of genomics.

When Kelvin Liu began his doctorate degree in biomedical engineering at Johns Hopkins University in 2004, he knew his resume was unusual. His previous work painted him as more of an inventor and entrepreneur than an academic. Even before starting his doctoral research, Liu already had two patents under his name. Now, he has eight. Less than two years after graduating with his Ph.D., he became CEO of Circulomics, a biotechnology startup in downtown Baltimore. 

Image: https://www.genome.gov/news/news-release/NIH-funded-startups-are-fueling-the-era-of-genome-completeness

While COVID-19 infections rates are on a downturn, the viral threat is expected to become an endemic concern, which means at-home testing will remain a booming sector in the industry. With its newly authorized at-home antigen test, Rockville’s MaximBio expects to carve out a significant share of the market.

At the end of January, the U.S. Food and Drug Administration granted Emergency Use Authorization to MaximBio’s ClearDetect COVID-19 Antigen Home Test, which has been designed to be as user-friendly as possible. MaximBio Chief Operating Officer Jonathan Maa believes that the company’s ClearDetect test will differentiate itself from other tests on the market due to its simplicity and the strength of the company’s proven Lateral Flow Assay (LFA) technology. In an interview with BioBuzz, Maa said at-home testing is an urgent need in the United States and that need “will exist for some time.”

Image: https://biobuzz.io

The Universities at Shady Grove (USG) – with nine partner universities offering a wide range of life-changing academic programs on one convenient campus in Montgomery County – has been an innovative model for higher education delivery since its inception in 2000.

After two decades of growth, evolution and success, it’s time for the USG community to now build on the solid foundation it has established by charting a solid course for “USG 2.0.” It’s time for us to develop our first-ever Strategic Plan, to help shape the future direction of a unique University System of Maryland institution that is the largest and most comprehensive of the state’s regional higher education centers.

Image: https://shadygrove.umd.edu/about-usg/leadership-governance/office-of-the-executive-director/usg-2.0

Looking to make connections and identify partners in the life sciences industry? Use the Maryland Life Sciences Directory, a free tool for exploring more than 1,000 profiles of companies active in Maryland’s robust life science markets, including biotechnology, medical technology, pharmaceuticals, digital health, manufacturing, regulatory services, and related subsectors. Explore company profiles for an overview of business activities, products, and services, and to connect with potential partners.  

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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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.

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.

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. 

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

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

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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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.

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.

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.

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.

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

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.

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."

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).  

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

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.

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/

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.

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.

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.”

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):

Zoe Cournia, PhD (Biomedical Research Foundation Academy of Athens) will discuss the role of supercomputing in novel allosteric target discovery. Samuel Broder, MD (former Director of the National Cancer Institute and Scientific Advisor of Gain Therapeutics) will discuss the role of allosteric drug discovery in targeting undruggable proteins in Oncology. Tiago Fleming Outeiro, PhD (University Medical Center Göttingen) will discuss protein misfolding in neurodegenerative diseases. Ricardo A. Feldman, PhD (University of Maryland School of Medicine) will present recent data generated in patient-derived iPSCs with Gain Therapeutics’ structurally targeted allosteric regulators for the treatment of GBA1-associated neurodegeneration in Parkinson’s and Gaucher Disease. Joanne Taylor, PhD (former Director of Neuroscience at Eisai and Scientific Advisor of Gain Therapeutics) will serve as moderator. The Gain Therapeutics management team will present on the following topics:

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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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.

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.

- 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."

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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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.