In a bid to keep and grow its flagship biohealth sector, Montgomery County is dramatically streamlining its regulatory review process for industry players who want to build or expand big lab facilities.

A new zoning text amendment, which the County Council unanimously approved Tuesday, will slash the lab entitlement process time from nearly two years to six months in an effort to “roll out the red carpet” for biotech industry leaders, said Councilman Andrew Friedson, D-District 1, who spearheaded the legislation.

Image: Montgomery County Councilman Andrew Friedson, D-District 1, speaks at a county event to unveil a new zoning process change. The Wednesday gathering was held outside of biotech United Therapeutics' Silver Spring campus. DAN BRENDEL

WILMINGTON, Del.--(BUSINESS WIRE)--Amalgam Rx, Inc., a leader in connecting healthcare providers, payers, and life sciences companies through a SaaS-enabled digital marketplace and product platform, and Privia Health Group, Inc., a national physician enablement company, announced a collaboration for multiple EHR-integrated services.

Leveraging Amalgam’s real-time, point-of-care decision support engine, the companies are working together to simplify and enhance the way providers practice value-based care, recruit for clinical trials, and ensure medication safety. Privia Health selected several offerings from Amalgam’s marketplace including:

Image: https://www.businesswire.com

The University of Maryland named Dr. Dean Chang as its new interim chief innovation officer and associate vice president for innovation and economic development of the research division, according to an email Monday from the interim and incoming vice presidents for research.

Chang served as founding associate vice president for innovation and entrepreneurship for this university’s Academy for Innovation and Entrepreneurship over the last nine years. In the position, he worked with more than 41,000 students in all 12 of the university’s colleges and schools in innovation, the email said.

Image: As the interim chief innovation officer, Dean Chang will oversee the Discovery District. (Jordyn Salow/The Diamondback)

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs of the National Institutes of Health (NIH) supported the development of 99 drugs from 1996-2020 — a total that includes 16 percent of all such treatments that made a “significant” advance over available medicines. This finding is just one of the impacts that the National Academies of Sciences, Engineering and Medicine (NASEM) attributes to the program in a new report.

The Ellume COVID-19 Home Test is an over-the-counter, rapid self-test which detects SARS-CoV-2 antigen. The test is suitable for ages 2 years and above for over-the-counter home use in the U.S*. Clinically proven for use for people with and without symptoms, with accurate test results in 15 minutes.

Image: https://www.ellumehealth.com

While COVID has most certainly been top-of-mind for companies working to combat infectious disease, we must not forget the other microbes out there that are still cause for concern. 

Tuberculosis (TB) is a prime example. Most have heard of this disease, but probably in the context of their history classes. You might be surprised to hear, then, that tuberculosis caused an estimated 1.5 million deaths in 2020, making it second only to COVID as the leading cause of death due to an infectious agent.

Image: https://biobuzz.io

BROOKLYN, NY—New York City Economic Development Corporation (NYCEDC) announced a $50 million investment in life sciences at BioBAT to expand their lab space as part of the city’s LifeSci NYC initiative. NYCEDC and BioBAT officials toured the space that will receive funding to build new labs at BioBAT located at the Brooklyn Army Terminal.

Image: Photo courtesy of NYCEDC/Tory Williams

Maryland’s life sciences ecosystem has become a key hub along the eastern shore of the United States due to its position in infectious disease research and vaccine development and manufacturing. While the state saw an infusion of billions of dollars in government financing in the development of vaccines, Maryland’s Biotechnology Investment Incentive Tax Credit, is a tool that has been used to attract venture capital funding in the state.

The tax credit was established in 2005 to incentivize venture capital investment into the state of Maryland. Since 2016, the most recent year for full data, the state has offered more than $70 million in tax credits to 114 different entities. That, in turn, has generated about $140 million in investments into the state’s life sciences ecosystem, the Baltimore Business Journal reported. 

New zoning measure spearheaded by Friedson will accelerate and streamline the regulatory process to develop and spur expansion of biohealth facilities in Montgomery County

On Wednesday, February 16 at 10:30 a.m. Councilmember Andrew Friedson and Montgomery County biohealth and economic development leaders will hold a press conference to reinforce Montgomery County’s commitment to innovation and the biohealth sector at United Therapeutics Corp. in Silver Spring.

Ron Piervincenzi, Ph.D., CEO of United States Pharmacopeia, sits down with host, Rich Bendis, to discuss USP’s growth since his last visit, the nature of their organization, and plans on hosting the 2022 BioHealth Capital Region Forum in person at their beautiful building in Rockville, Maryland.

Listen now via Apple https://apple.co/3JpVTHB, Google https://bit.ly/3JnJfsI, Spotify https://spoti.fi/3JoLig7, and TuneIn https://bit.ly/3BhNcfE.

The University of Maryland Baltimore County has joined the highest ranks of research universities in the country, a milestone for the young school with a reputation for producing scientists and engineers of color.

The 55-year-old university in suburban Baltimore reached Research 1, or R1, status, a distinction for universities with very high research activity.

Image: Trevor Shepard, a chemistry major, works on a viscosity experiment at the University of Maryland Baltimore County in October 2020. (Michael Robinson Chavez/The Washington Post)

Rising to the Top: The Importance of Increasing Diversity in STEM Leadership

Join Young Women In Bio and Winward Academy for a special career panel to learn from the passionate journeys of incredible female leaders in successful science careers.

We'll celebrate the International Day of Women in Science with Dr. Leticia Ferri and Ms. Wendy Clemens of Bristol Myers Squibb, the global pharmaceutical company, and with Ms. Abigail Hata of Horizon Therapeutics.

We'll learn more about their personal journeys and tips for teens interested in science and STEM careers.

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.

Learn more

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/