BHI Weekly News Archives

Lily Qi, Representative for the 15th legislative district in the Maryland House of Delegates. Joins BioTalk to discuss her career, Biotech in Montgomery County, and being a supporter of the BioHealth Capital Region

Listen now on Google https://bit.ly/3sW3iHE, Apple https://apple.co/3yvdkR4,  Spotify https://spoti.fi/3yxKRdw, TuneIn https://bit.ly/3zz8gww

Read More

Daniela Lecca completed her education in Italy, where she received her Ph.D. in Toxicology from the University of Cagliari for her research on the neuroprotective and immunomodulatory actions of a PPAR-γ agonist in MPTP mouse models of Parkinson’s disease. During her Ph.D. program, she spent a short-term period as a visiting Ph.D. student at the Dept of Neuroscience of the Karolinska Institutet in Stockholm, Sweden. She carried out a project on non-motor symptoms onset in a MPTP chronic model of Parkinson’s disease. After completing her Ph.D., she won a fellowship from her University that allowed her to join as a special volunteer the Synaptic Plasticity section of the National Institute on Drug Abuse in Baltimore, Maryland; here, she worked on a research project on the role of L-DOPA-mediated neuroinflammation in the non-motor symptoms of Parkinson’s disease, by a 6-OHDA mouse model.

Read More

ONLY TWO WEEKS LEFT TO REGISTER

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. Join us for the 7th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

Read More

German-based BioNTech has announced that they will soon be joining Montgomery County, Maryland’s growing list of world-renowned international companies in the “Immunology Capital Next to the Nation’s Capital.” BioNTech is acquiring a Gaithersburg manufacturing facility and cell therapy R&D platform from Kite, a unit of Gilead Sciences, to support the development of BioNTech’s expanding pipeline of novel cell therapies.

Read More

The National Science Foundation (NSF) has selected the University of Maryland to lead one of five multi-institutional hubs that will provide entrepreneurial training to academic researchers in science and engineering in order to foster and maintain U.S. global leadership in innovation.

The $15 million I-Corps Hubs, funded over five years, will extend the foundation’s Innovation Corps, or I-Corps, program that helps researchers commercialize their technologies and translate the impact of their work to the broader public. Each regional hub will include at least eight universities.

Read More

Emergent BioSolutions Inc. is conducting phase clinical 3 trials of its plasma-derived therapy for outpatient treatment of COVID-19, the company announced this week.

The randomized clinical trial will assign participants to receive infusions of either a placebo or the plasma treatment. Emergent is one of two companies providing hyperimmune globulin products for the trial, which plans to enroll 820 patients across the U.S. and abroad.

Read More

Thank you so much for joining us in this interview series. Before we dive in, our readers would love to learn a bit more about you. Can you tell us a bit about your childhood backstory and how you grew up?

I had an introverted childhood growing up in an orthodox Hindu family with my caring parents, two brothers, and paternal grandparents. My father was a bank officer all his life and has been my major inspiration. He had his master’s in mathematics and was a child prodigy at it. He could do 6-digit multiplication and division faster than I could crunch the numbers in a calculator.

Image: https://medium.com

Read More

Home to the National Institutes of Health and operations of nearly every leading biopharmaceutical company, Montgomery County, Maryland, has been on the frontlines of coronavirus vaccine research and other life-saving developments. Its thriving life sciences sector is among the diverse industries that had brought steady population growth to the County. Over the past decade, demand for housing and retail services—as well as land prices—had grown dramatically. In response to growing constituent needs, Montgomery County set out to transform its real estate management.

Read More

State-of-the-art biomanufacturing-ready office space is coming to Frederick County.

Matan Companies recently broke ground on the new Progress Labs at Riverside I in Frederick. Located in Riverside Research Park, the 215,000 square-foot project is adjacent to the National Cancer Institute’s Frederick National Laboratory and just four miles from Fort Detrick.

This project is a significant addition to Maryland’s biohealth cluster, which is home to numerous leading companies and federal agencies and where office and laboratory space for bio companies remains in high demand.

Image: https://open.maryland.gov

Read More

Automating adjudication of events in cardiovascular trials Clinical trials for cardiovascular (CV) disease are time consuming and expensive to run, often requiring large patient populations to meet the statistical requirements needed to demonstrate efficacy.1 These trials require robust data packages to achieve market approvals and registrations in order to get essential new medicines to patients.

Image: https://www.astrazeneca.com

Read More

Since its emergence in December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide, causing a global pandemic (coronavirus disease-19 or COVID-19) with more than 188 million confirmed infections and more than 4 million fatalities (as of July 19, 2021) (https://covid19.who.int). While the majority of the infections are asymptomatic or manifest in mild to moderate forms, a small percentage of people develop severe respiratory illness with a fatal outcome.

Image: Figure 1 Key mutations in the spike protein of SARS-CoV Variants of Concern (VoC) (B.1.1.7, B.1.351, B.1.1.248, and B.1.617.2) and Variants of Interest (B.1.526, B.1.427, and B.1.429). Mutations occur on all spike protein subunits. Mutations in other areas of the genome have been identified and are currently under investigation.  

Read More

Join the National Center for Advancing Translational Sciences (NCATS) in collaboration with the Biotechnology Innovation Organization (BIO) on Wednesday, August 25th, 2021, for a webinar to learn about the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs for researchers and entrepreneurs in translational science.

Read More

The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses with an interest in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application to any of the following Institutes and Centers:

• The National Cancer Institute (NCI SBIR)
• The National Institute on Aging (NIA SBIR)
• The National Heart, Lung, and Blood Institute (NHLBI SBIR)
• The National Institute of Neurological Disease and Stroke (NINDS SBIR)
• The National Institute of Nursing Research (NINR SBIR)
• The National Center for Complementary and Integrative Health (NCCIH SBIR)
• The National Center for Advancing Translational Sciences (NCATS SBIR)
• The National Institute of Environmental Health Sciences (NIEHS SBIR)
• New this cycle! The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD SBIR)
• New this cycle! The National Institute on Alcohol Abuse and Alcoholism (NIAAA SBIR)

Read More

The U.S. government’s announcement that it is investing $3 billion into research on antiviral medicines for Covid-19 is a step in the right direction and comes at a critical moment in the pandemic — though earlier, of course, would have been better.

But based on my experience with drug development, in particular with antivirals, in both government and the private sector, I know that the process takes longer and is more expensive than anyone ever anticipates. I believe that $3 billion in federal funds is not nearly enough, and that at least $10 billion in clinical research funding is needed to discover and develop the new antiviral medicines that patients desperately need and that physicians have been asking for since the start of the pandemic.

Read More

ROCKVILLE, MARYLAND, August 23, 2021 – BioHealth Innovation Inc. (BHI) announces the addition of Diane Ignar, Ph.D., and Dr. Loleta Robinson to the expanding Entrepreneurs-in-Residence (EIR) team. The Entrepreneur-in-Residence Program at BHI ensures that disruptive technologies receive all the resources required to transform the technology from a discovery into a commercially relevant product and eventually have a measurable impact on human health. The program was created to support scientists, early-stage startups, and licensed technologies to provide them with access to these resources. Diane will work with NIH’s National Institute on Aging, and Loleta will work with their Office of Extramural Research.

Image: https://biobuzz.io

Read More

Avian H7N9 influenza viruses cause sporadic outbreaks of human infections and threaten to cause a major pandemic. The breadth of B cell responses to natural infection and the dominant antigenic sites recognized during first exposure to H7 HA following infection are incompletely understood. Here, we studied the B cell response to H7 HA of two individuals who had recovered from natural H7N9 virus infection. We used competition-binding, hydrogen-deuterium mass spectrometry, and single-particle negative stain electron microscopy to identify the patterns of molecular recognition of the antibody responses to H7 hemagglutinin.

Read More

Ranked among the top US states for thriving business climates for over six years, according to Forbes, Utah’s tech prowess, unicorn startups and public-private development makes the University of Utah Research Park the key location to begin the new decade. The University of Utah Research Park, dubbed Bionic Valley in the 1980’s, residing in the region identified as Silicon Slopes, is a sleeping giant housing more than 48 companies alongside 81 academic departments and employs a workforce of more than 14,000 has a staggering annual impact to the regional economy. In addition, the Milken Institute’s 2018 State Technology and Science Index ranked the state of Utah fifth in the US for its “capabilities and broader commercialization ecosystems that contribute to firm expansion, high-skills job creation and broad economic growth”.

Read More

George Mason University boosts the Washington, D.C., metropolitan region economy by supplying an educated, skilled, and multifaceted workforce, by partnering with key employers, and through the Mason-based Virginia Small Business Development Center.

In 2020, the Small Business Development Center network assisted 9,500 businesses, resulting in $86 million in new capital received and 1,167 loans obtained.

Mason incubated and supported or accelerated more than 1,600 Virginia companies in fiscal year 2019.

Investing in our local economy means cultivating Mason’s existing private and public partnerships—and forging new ones—to drive innovation.

Read More

QIAGEN has announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAreach® SARS CoV-2 Antigen Test, which is designed for environments that require a high volume of fast and accurate test results.

The rapid portable test can detect SARS-CoV-2 antigen in people with active infections in 2 to 15 minutes and can process an average of around 30 swab samples per hour, providing digital test results that do not require subjective interpretation. Clinical studies have shown the test to have a sensitivity of at least 80% and a specificity of 98.0%.

Read More

Alexandria Real Estate Equities, Inc. (NYSE:ARE), an S&P 500® company, is an office REIT uniquely focused on collaborative life science and technology campuses in AAA innovation cluster locations, including Greater Boston, San Francisco Bay Area, New York City, San Diego, Seattle, Maryland, and Research Triangle. Alexandria has a longstanding and proven track record of developing Class A properties clustered in life science and technology campuses that provide its innovative tenants with highly dynamic and collaborative environments that enhance their ability to successfully recruit and retain world-class talent and inspire productivity, efficiency, creativity, and success. For more information, please visit www.are.com.

Read More

In April of 2019, Kite, a Gilead Company, announced their decision to locate to Frederick County, MD and open a new manufacturing facility on a 20-acre site located at the Urbana Corporate Center. A lot of progress has happened since then; Kite finished their brand new 279,000 SF biologics manufacturing facility in April 2021. To learn more, Solash Aviles and Jodie Bollinger from the Frederick County Office of Economic Development met with Chris McDonald, Senior Vice President, Global Head of Manufacturing at Kite and Jim Jackson, Vice President, Manufacturing Operations and Site Head at Kite.

Image: http://www.discoverfrederickmd.com

Read More

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the number of biological samples processed with consumables kits has passed the three billion mark – a record that underlines its leadership in enabling molecular laboratories to gain valuable insights in research, combatting diseases and forensics.

This milestone particularly underscores QIAGEN’s standout position in sample preparation, the most crucial stage of molecular testing at which DNA, RNA or proteins are extracted from human samples. QIAGEN’s sample prep kits have become the gold standard in sample extraction and earned over 200,000 references in academic studies. With more than 500 consumable kits and automated systems such as QIAsymphony, QIAcube Connect, QIAcube HT and EZ1, QIAGEN is the most trusted brand in sample preparation.

Read More

Gaithersburg, MD, August 24, 2021 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company pioneering RNA cell therapy in and beyond oncology, today announced clinical data from the first cohort of an ongoing Phase 1/2a clinical trial of Descartes-08 in patients with generalized Myasthenia Gravis (gMG). Descartes-08 is an mRNA-modified, autologous CAR T-cell product directed against B-Cell Maturation Antigen (BCMA).

The cohort was intended to test safety and tolerability. Descartes-08 was well tolerated, with no cytokine release syndrome (CRS) or other serious product-related adverse events. Of note, all patients experienced at least a full class improvement on the MGFA Clinical Classification. Patients also showed marked improvement on the Myasthenia Gravis Composite (MGC) scale, a standard measure of overall disease severity. About three months after Descartes-08 administration, mean improvement in MGC scale was over 50%.

Read More

Biohealth and Entrepreneur Experts Joins Robust Entrepreneurs-in-Residence (EIR) Team

ROCKVILLE, MARYLAND, August 23, 2021 – BioHealth Innovation Inc. (BHI) announces the addition of Diane Ignar, Ph.D., and Dr. Loleta Robinson to the expanding Entrepreneurs-in-Residence (EIR) team. The Entrepreneur-in-Residence Program at BHI ensures that disruptive technologies receive all the resources required to transform the technology from a discovery into a commercially relevant product and eventually have a measurable impact on human health. The program was created to support scientists, early-stage startups, and licensed technologies to provide them with access to these resources. Diane will work with NIH’s National Institute on Aging, and Loleta will work with their Office of Extramural Research.

 “BHI is pleased to welcome Diane and Loleta to our growing group of EIRs working with the National Institutes of Health,” said Richard Bendis, BHI President, and CEO. “Their backgrounds in healthcare, venture capital, and helping early-stage businesses are key to our mission for the program nationally, and regionally.”

Read More

The exec has been at the helm of the company for 18 years.

Read More

When Joel Marcus, a trained accountant and biotech industry lawyer, started lab real estate giant Alexandria Real Estate Equities in the 1990s, the sure bet many see in biotech wasn’t visible to many. The company’s first leases in San Francisco charged lab tenants just $6 per SF. Now, the REIT’s average tenant pays just shy of $70.

Image: Courtesy of Alexandria Real Estate Equities Alexandria Real Estate Equities Chairman Joel Marcus

Read More

Armed with brilliant ideas, experience and a determination to disrupt, these 50 women are making an impact on society and culture through healthcare, robotics, music, dance, and so much more. It’s the third chapter of our 50 Over 50 project, launched in June and produced in partnership with Mika Brzezinski’s Know Your Value initiative.

Read More

With so many new public biotechnology companies minted in the last 18 months, it has become more difficult to sift out the winners from the losers. During 2020, the biotech industry gave birth to an unprecedented 89 new public companies, and 2021 is on pace to beat this record-setting year. Of all the strong-performing IPOs and biotech companies out there, companies focused on precision medicine, or compounds that directly affect disease-causing genes or proteins, continue to be the subsector getting significant attention, with high valuations being assigned to early- and mid-stage companies.

Read More

BALTIMORE, Aug. 19, 2021 /PRNewswire/ — Empower Therapeutics Inc., a Baltimore-based startup, has secured worldwide, exclusive rights to a simple, reliable brainwave biomarker for pain sensitivity. Empower plans to leverage the technology, which is jointly owned by the University of Maryland, Baltimore (UMB) and the University of Birmingham, U.K., to develop a cutting-edge digital therapeutics platform to determine and modify pain sensitivity for chronic pain therapy.

Read More

A key factor in the success of a developing drug or therapy is the success of early clinical trials. A focus on Good Manufacturing Practice (GMP) standards for phase 1, first-in-human trials is critical to maximize the chances of success from a project’s start. For cell therapy development, where even small errors can make a big difference, it’s even more important.

Read More

Startups with ties to Johns Hopkins ties have contributed significantly to the highest-ever amounts of capital being raked in across Maryland and beyond. For example, three spinout companies raised mega-deals in fiscal 2021, or venture deals worth $100 million or more.

Image: Johns Hopkins Technology Ventures operates several FastForward startup accelerator programs for student-led ventures and other growing spinout companies. KAITLIN NEWMAN

Read More

I’m pleased to share with you JHTV’s annual report for Fiscal Year 2021. The pandemic made FY21 an unusual one, but the JHTV team made it an extraordinary one, as the report demonstrates. We took full advantage of the momentum that had been building prior to the pandemic and used our digital connectivity to continue bringing the benefits of academic discovery to the world. Among our FY21 achievements:

Read More

BOSTON – July 27, 2021 – Boston Properties, Inc. (NYSE: BXP), the largest publicly traded developer, owner, and manager of Class A office properties in the United States, announced today that it has agreed to purchase the Shady Grove Bio+Tech Campus in Rockville, Maryland. The property includes seven existing buildings comprising approximately 435,000 square feet across 31 acres in the Shady Grove life sciences cluster, a highly desirable location for leading and emerging companies in the biotechnology sector.

Read More

The MDC Studio is pleased to announce the spin-out of the company, Sonosa Medical, Inc., as an independent entity. Founded in 2019, Sonosa Medical is developing next-generation devices poised to transform the diagnosis and treatment of obstructive sleep apnea (OSA). The company is led by Dr. Stephen Restaino as Chief Executive Officer, Dr. Jeffrey Wolf as Medical Advisor, and Dr. Gil Blankenship as Chairman of the Board. Dr. Restaino and his team have been developing novel technology for the detection and treatment of OSA using a wearable device. Their work has been funded by a $3.35 million Phase II Small Business Innovation Research (SBIR) award from the Defense Advanced Research Projects Agency (DARPA).

Read More

Since the precise 3D structure of a protein is essential for its function, misfolding can result in significant downstream consequences. If this misfolding occurs to an enzyme, oftentimes the catalytic reaction can no longer take place, leading to substrate accumulation to toxic levels and subsequent cellular dysfunction.

There are many reasons why enzymes misfold. The most obvious is a genetic mutation in which a change to the amino acid sequence leads to an incorrect folding pattern. However, there are other causes of misfolding that can affect even wildtype enzymes, including states that increase cellular stress such as aging and inflammation.

Read More

The appointments are just the latest in a series of additions the company has made throughout the pandemic.

Image: Stanley Erck is president and CEO of Novavax.

Read More

“This is USG” is a video podcast series launched by the Universities at Shady Grove (USG) in October 2020. The series features Dr. Anne Khademian, USG’s Executive Director, interviewing guests who are closely connected to USG and the greater community. Guests include students; alumni; staff; faculty; members of the USG Board of Advisors; business, community and university leaders; and others.

https://youtu.be/0pe8g47_f-o

Read More

August 11, 2021 (Washington, D.C.) – A bold new public-private partnership to prevent future viral outbreaks from becoming pandemics has moved one step closer to realization, as the Greater Washington cross-sector nonprofit, Connected DMV, has announced the formal launch of a Global Pandemic Prevention and Biodefense Center (GPPBC). The Center will serve as a vehicle to foster greater collaboration among pandemic prevention stakeholders to deliver on strategic projects needed to advance pandemic preparedness and avoidance. The signature initiative of the Center accelerates the development of human monoclonal antibodies (mAbs) to treat the world’s top 100 pathogens across 25 pathogen families most likely to result in disease outbreaks.

Read More

In this episode of #ThisIsUSG, BioHealth Innovation President and CEO Rich Bendis joins Dr. Anne Khademian for a discussion about BioHealth Innovation’s role in advancing the biotechnology/life sciences industry in Montgomery County and the capital region as a whole.

https://www.youtube.com/watch?v=0pe8g47_f-o

Read More

RIVERDALE, Md., Aug. 12, 2021 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, today announced it has raised $7.4 million in private equity to support its growing product line and development of its lead surgical candidate for clinical evaluation. The financing includes the sale of Series A Preferred stock as well as common stock based, in part, from certain investors benefitting from a Maryland Investment Incentive Program.

“Medcura has reached a pivotal point in our growth,” said Larry Tiffany, CEO of Medcura. “Our products are positively impacting the lives of patients and our community. With these funds we can accelerate product development, expand our commercial footprint and bring the company’s potentially lifesaving technology to operating rooms and battlefields worldwide.”

Read More

On August 6th, 2021, FDA released an update on various matters related to COVID-19. Among these topics was an update on Emergent BioSolutions, a manufacturer who has come under fire for their mishandling production of COVID-19 vaccines.

However, FDA has now approved certain lots of the AstraZeneca vaccine made at the facility suitable for export. While the AstraZeneca vaccine is not approved for use within the United States, it is used by various countries overseas.

Read More

HILDEN, Germany & WALTHAM, Mass. & GERMANTOWN, Md.–(BUSINESS WIRE)–QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) and OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel.

Read More

One of the top questions that employers in the Life Sciences community within the Capital Region are asking is how companies are approaching bringing employees back to the office. That’s why we asked nearly 30 top employers in the area to share their strategies in a recent survey conducted by BioBuzz Media.

Read More

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

Read More

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

On the heels of Silicon Valley’s branding as one of the world’s largest tech hubs, the BioHealth Capital Region aims to brand the DMV region as one of the most prominent BioHealth clusters in the Mid-Atlantic. BioHealth Innovation, Inc. was founded 11 years ago in an effort to drive ideas from labs into markets through innovation-driven economic development organizations and initiatives.

Galvin and Bendis discuss the abundance of opportunities for growth within the region as it is home to a wide variety of research institutions, top scientists, and annual grants. Additionally, they discuss how BioHealth Innovation, Inc. cultivates success for companies within the competitive region.

Read More

Brand new office / lab suites. Flexible suites that can be combined for larger uses. Full third floor available for customization.

Approximately 47,000 BRSF.

Click here to download a brochure.

Read More

OVERVIEW:

• Free, half-day virtual event.
• Hear from inventors from the National Cancer Institute and the Frederick National Laboratory about technologies primed for commercialization and/or collaboration; great opportunity for biotech stakeholders and companies of all sizes, including start-ups.
• Panel sessions focused on technology commercialization.
• Lightning Pitch & Poster Session highlighting additional NIH technologies available for licensing and collaborative development presented by the NCI Technology Transfer Ambassadors Program.

Read More

As a trifecta of crises upended life in 2020, the need for a diverse scientific and medical community grew ever more clear. George Floyd’s murder elicited worldwide protests against racial injustice. COVID-19 affected all of our lives and had an outsize impact on Black and brown communities. And COVID-19’s economic fallout only exacerbated extreme wealth inequality.

Read More

We’re taking a closer look at each of the 50 winners of our 2021 Inno on Fire honorees.

Read More

Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.

The FDA’s fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.

The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.

Drugmakers pay these fees to ensure the FDA responds to applications within 10 months for standard applications and within six months for expedited reviews.

Read More

FZata, Inc. is developing our ground-breaking “Live Biologics In A Pill” platform for oral delivery of live biologics. Live Biologics In A Pill will open up a new route of oral administration for innovative live biologic therapeutics. FZata is pleased to announce that our lead drug, FZ002, has advanced to manufacturing stage and IND-enabling studies. FZ002 is a first-in-class live biotherapeutic product (LBP) yeast for the treatment of Clostridioides difficile (C. diff) infection. C. diff bacteria can cause life-threatening diarrhea. Infections occur most often in people who have taken antibiotics for other conditions. It is the most common healthcare-associated infection and the CDC has labeled it at the highest urgent threat level.

Image: https://biobuzz.io

Read More

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

Read More

This is what it is ALL about – the largest 3D printed hydrogel. This lung model can be perfused and ventilated and this blueprint replicates the entire conducting airway and large vasculature of the lung. Blueprint by Gregory Hurst. BioInk Formulation by Aman Kaur. Huge #DreamTeam Effort!

Looking to be on one of UT’s dream teams? Look no further: https://bit.ly/2QIqx6m

Read More

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

You can also listen to the audio only version via Apple https://apple.co/37wc6Kk, Google https://bit.ly/2XbLe0v, Spotify https://spoti.fi/3yCWhxE, and TuneIn https://bit.ly/3AqYkoR.

Click here to view the video interview between Jeff and Rich.

Read More

ROCKVILLE, Md.–(BUSINESS WIRE)–Aug. 4, 2021– GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King. Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company’s pipeline.

Read More

Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 – UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

Read More

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

Read More

ARLINGTON, Va., Aug. 9, 2021 /PRNewswire/ — Sands Capital held a first and final closing of its second life sciences dedicated fund, Sands Capital Life Sciences Pulse Fund II, L.P. (“Pulse II”), raising $560 million. This close increases total Pulse Strategy assets under management to more than $950 million, including Sands Capital Life Sciences Pulse Fund, L.P. (“Pulse I”) and related vehicles. The team will continue investing with the same emphasis on private therapeutics, diagnostics, and life sciences tools businesses. The strategy’s mission is to help transform how diseases are defined, diagnosed, and treated.

Read More

GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent’s Bayview manufacturing facility to resume production of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan.

“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” said Emergent chief executive officer, Robert Kramer. “We are in the unique business of producing life-saving medications for catastrophes that we hope never occur like anthrax attacks, opioid overdoses, and Covid-19.”

Read More

COLLEGE PARK, Md. – The Quantum Startup Foundry (QSF) at the University of Maryland (UMD) today announced that Ernst & Young LLP (EY US) is a founding member of the QSF and will help the foundry advance its mission of accelerating leading-edge quantum technologies and driving the second quantum revolution.

EY is the first professional services firm and overall organization to work with the foundry on programs that connect the virtual and physical resources needed to support quantum entrepreneurs and startups. Additionally, EY will provide insight, mentorship, customer and investor introductions, and other services to companies cultivated through the QSF.

Read More

The Bacteriophage (Phage) Therapy (PT) market is growing rapidly in the U.S. The rise of antibiotic resistant bacteria and multidrug-resistant bacteria (MDRs) across the globe has increased the value and industry acceptance of a phage approach, which can help combat bacteria that cannot be effectively treated by antibiotics. What’s more, the phage modality is a great fit for targeted personalized medicine approaches.

Read More

Hospitals and health systems across the U.S. are pushing forward digital transformation efforts by creating new tools and launching innovative programs. 

Here are the organizations that announced pilots of new innovation programs or expansions to existing programs during June and July, as reported by Becker’s Hospital Review.

1. Worcester, Mass.-based UMass Memorial Health expanded care beyond hospital walls with the recent rollout of its tech-powered hospital-at-home program. 

Read More

The FAES Academic Programs at NIH offers a unique Advanced Studies in Technology Transfer to persons with a Bachelor’s degree in science or engineering or a related field. Courses are offered in the evenings, making it convenient for working professionals and postgraduate Fellows to gain expertise and experience in patenting, licensing, collaborative agreements, and other fundamental intellectual property transactions. The technology transfer profession field employs more than 10,000 professionals in the U.S., with many practicing their trade in the greater Washington, D.C. metro area.The course instructors are leading practitioners in the field, so students can simultaneously gain the necessary knowledge and build professional networks.

Read More

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques. People both inside the pharmaceutical industry and outside share many common concerns about the state of the pharma supply chain. Interruptions caused by the COVID-19 pandemic, global unrest, severe weather catastrophes, and other events stand to disrupt the supply of essential ingredients and products; these challenges have pharma professionals, government leaders, and others looking for ways to shore up the supply chain and avoid interruptions.

Read More

GAITHERSBURG, MD, 9 August 2021 – MaxCyte, Inc. (Nasdaq: MXCT) (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the signing of a clinical and commercial license with Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on creating and delivering engineered cells as medicines.

Under the terms of the agreement, Sana Biotechnology 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.

Read More

Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 – UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

Read More

The chief executive of AstraZeneca has underscored the importance of multilateral cooperation in the fight against COVID-19 as well as other systemic global challenges such as climate change, calling global warming “the biggest threat to humanity”.

In a wide-ranging and exclusive interview, Pascal Soriot expressed unease over what he saw as an excessive focus on Western nations in the context of vaccinations. He told IMD’s President Jean-François Manzoni: “The whole discussion is about [the] US and Europe, but there are 7 billion people outside of those two regions.”

Read More

GAITHERSBURG, Md., July 29, 2021 /PRNewswire/ — MaxCyte, Inc., (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the pricing of its upsized offering of 13,500,000 shares of common stock at an initial offering price of US$13.00 per share (the “Offering”).

MaxCyte has granted the underwriters a 30-day option to purchase up to 2,025,000 additional shares of common stock at the initial offering price per share of common stock less underwriting discounts and commissions.

The closing of the Offering is expected to occur on August 3, 2021, subject to customary closing conditions.

Read More

Maryland biotech company Emergent BioSolutions said on Thursday that it was approved by the U.S. Food and Drug Administration (FDA) to resume manufacturing of Johnson & Johnson’s COVID-19 vaccine at its Bayview plant in East Baltimore. The Gaithersburg-based company, which serves as a contract manufacturer for pharma companies, has an agreement with J&J to provide doses of its one-shot vaccine.

Image: Emergent Biosolutions’ Bayview facility. (Courtesy photo)

Read More

Emergent Biosolutions’ vaccine manufacturing plant in Baltimore has been the subject of many headlines this past year for its’ role in producing several COVID-19 Vaccines. However, the history of this facility goes back more than two decades.

For the past 25 years, this Baltimore biopharmaceutical facility has played a significant role in Maryland’s life sciences ecosystem. Over the course of its life, the building has gone from being home to vaccine and small molecule manufacturing to the development of countermeasures for biologic threats, including COVID-19.

Image: https://biobuzz.io

Read More

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

Read More

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it has appointed Steve Sang Young Park and Robert V. Ahlgren as new members to its Board of Directors, expanding the board to eight members.

“We are pleased to welcome Steve and Robert to Immunomic’s Board. Our scientific platform, financial acumen and growth strategies are strengthened by their wealth of knowledge and leadership experience,” commented Dr. William Hearl, CEO of ITI. “Each brings deep and diverse expertise across global financial markets and large healthcare companies that will be meaningful to us as we advance our immunotherapy pipeline and strategic vision.”

Read More

George Mason University bioengineering professor Michael Buschmann and a team of scientific collaborators have devised improved lipid nanoparticle technologies to deliver mRNA that could make mRNA vaccines such as the COVID-19 vaccines less costly, with fewer side-effects and more available worldwide.

Image: Michael Buschmann (seated) and his team that includes (l to r) Aarthi Narayanan, Mikell Paige and Caroline Hoemann have developed improved technology that could help make COVID-19 vaccines better and more readily available. Not pictured: Pat Gillevet. Photo by Evan Cantwell/Creative Services

Read More

A large interlaboratory study of adeno-associated virus (AAV), an important tool in gene therapy, will be led by USP and NIST in collaboration with NIIMBL.

Rockville, MD, July 27, 2021 —The United States Pharmacopeia (USP), the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have announced a research collaboration to assess analytical methods and develop standards for adeno-associated virus (AAV), an important mechanism for delivering gene therapies.

AAVs are particularly useful for gene therapies because they are not known to cause human disease and cannot replicate on their own. AAV-based therapies are currently used to treat a type of inherited retinal dystrophy that causes blindness and spinal muscular atrophy in children, and treatments for many more diseases are currently being developed. However, to use AAVs most effectively, scientists need to accurately measure attributes related to their quality. These attributes include the purity of the AAV product and the relative number of virus particles that contain the full genetic payload.

Read More

ROCKVILLE, Md., July 29, 2021 /PRNewswire/ — Shuttle Pharmaceuticals Holdings, Inc (Shuttle Pharma), a Maryland-based developer of new drugs for cancer treatment, was awarded US Patent No.: 11,034,667 B2 for “Selective Histone Deacetylase Inhibitors for the treatment of Human Disease.” These non-cytotoxic, highly selective inhibitors target the histone deacetylase 6 (HDAC6) enzyme to stimulate the immune system for applications in the treatment of cancers, neurological diseases and immunological disorders.

Lead inventor Scott Grindrod, PhD describes histone deacetylase (HDAC) inhibitors as “a novel class of drugs that target enzymes involved in regulation of critical cellular functions that can inhibit cancer growth and activate cellular immunity. These are key target functions to improve cancer treatment. HDAC6 regulates the innate immune system and will be tested to activate an anti-cancer immune response to increase the effectiveness of chemotherapy and radiation therapy. The molecules in this patent enhance Shuttle Pharma’s platform technology of selective inhibitor discovery for cancer treatment.”

Read More

ROCKVILLE, Md. and CHESTERBROOK, Pa., July 26, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunologic, immuno-oncologic and rare genetic disorders, today announced positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody, in adult patients with moderate to severe Crohn’s disease (CD). Crohn’s disease is a disorder affecting as many as 780,000 people in the United States.

Read More

Each quarter we bring you an update from our Johnson & Johnson Innovation – JLABS Portfolio of ompanies across our 13 sites, from San Diego to Shanghai. Beyond news of our companies milestones, we also report on the diversity of our JLABS Portfolio leadership as we seek to reflect the patients we serve.

This past quarter JLABS @ Washington, DC opened its doors and welcomed the inaugural class of residents with areas of focus ranging from health equity to broad-spectrum antivirals. Housed at the new Children’s National Research & Innovation Campus, JLABS @ Washington, DC also serves as the BLUE KNIGHT™ hub in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). You can read more about our newest site in Fierce Biotech and you can always find our latest stats and companies via our JLABS Portfolio Navigator. Finally, don’t forget to register to virtually join the JLABS @ Washington, DC Grand Opening celebration on September 22!

Read More

Boston Properties (BXP) is set to acquire the Shady Grove Bio+Tech Campus, a seven-building, 435,000-square-foot office park in Rockville, Md., for $116.5 million, from Lantian, the company announced.

The deal is expected to close in the third quarter of this year.

The 31-acre property, located at 9600 Gudelsky Drive, is situated within the Shady Grove life sciences cluster, home to a host of companies in the biotechnology sector. It is also currently home to the Universities at Shady Grove, a biomedical and tech-focused university that is part of the University System of Maryland.

Image: PETE OTTENI. PHOTO: BY BXP

Read More

The rapidly spreading Delta variant is forcing employers to rethink their strategies for handling the pandemic. Policies they should reconsider include encouraging or requiring employees to be vaccinated, whether to hold off on having remote workers return to company facilities, rules for social distancing and wearing masks at job sites, ventilation, testing, travel restrictions, communicating exposures, and support for mental health care. This article offers advice on how to think through these issues.close

Read More

The delta variant spreads much faster than other Covid-19 strains—and scientists may now know why.

People infected with the delta variant have more than 1,260 times the viral load—the concentration of viral particles in the body—than those with the original strain found in China, a group of scientists has reported in a preprint paper. A higher viral load can have many implications such as more severe disease. Its most significant contribution is to a virus’s higher transmissibility.

Image: https://qz.com

Read More

Jeff Boyle, President of Ellume USA, joins Rich Bendis on BioTalk to chat about his history, their Flagship U.S. Manufacturing Facility in Frederick, MD, and why BioHealth Capital Region is a right fit for their company goals.

Listen now on Google https://bit.ly/3i0XFUO, Apple https://apple.co/2TDD1kg, Spotify https://spoti.fi/3kWwP1P, and TuneIn https://bit.ly/3BGPDrP

Read More

GAITHERSBURG, Md., July 26, 2021 /PRNewswire/ — MaxCyte, Inc., (LSE: MXCT) (LSE: MXCN), a leading provider of platform technologies for cell engineering, today announced the commencement of an underwritten offering of 12,000,000 shares of common stock (the “Offering”) at an expected offering price between $11.50 and $13.50 per share. All shares to be sold in the Offering will be offered by MaxCyte. In addition, MaxCyte intends to grant the underwriters a 30-day option to purchase up to 1,800,000 additional shares of common stock.

Read More

The extension follows a tumultuous time for the Gaithersburg company, making it unclear if the government would proceed with deals as normal.

Read More

German-based BioNTech has announced that it will soon be joining Montgomery County’s growing list of world-renowned international companies in the “Immunology Capital Next to the Nation’s Capital.” BioNTech is acquiring a Gaithersburg manufacturing facility and cell therapy research and development platform from Kite, a unit of Gilead Sciences, to support the development of BioNTech’s expanding pipeline of novel cell therapies.

Read More

MAINZ, Germany & SANTA MONICA, Calif.–(BUSINESS WIRE)–BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Kite, a Gilead Company (Nasdaq: GILD, “Kite”) today announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD. The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

Image: https://biobuzz.io

Read More

Montgomery County is set to consider plans for the first phase of a five-building life sciences project in Rockville.

An affiliate of life sciences giant Alexandria Real Estate Equities filed plans for a 200K SF research and development building as part of an 18-acre project on Darnestown Road. The Montgomery County Planning Board is scheduled to hear the plans on July 29.

Image: Montgomery County Planning Department A rendering of the 200K SF lab building on Darnestown Road in Rockville.

Read More

Matan Companies breaks ground on Progress Labs at Riverside I The City-based project will feature 215,000 square feet of biomanufacturing-ready space — including a 96,000 square foot existing building, which is available for immediate occupancy, as well as a 118,000 square foot expansion building, which will be delivered in June 2022.

Read More

Come join the Virginia Tech Corporate Research Center for Game Changer Week! Game Changer Week, set for August 23-27, 2021 will bring together industry disruptors, entrepreneurs, innovators, and researchers for a variety of online and in-person events. Events include webinars, happy hours, start-up mentoring, special guests, open houses, and more!

Read More

The Endless Frontier bill, now incorporated into the U.S. Innovation and Competition Act, made progress in the U.S. Senate while parallel legislation in the House also advanced to create a Technology Directorate in the NSF. Congress and the Administration also advanced through the budget process and other Congressionally authorization bills billions of dollars to create new tech hubs, advanced manufacturing, increased tech transfer, test beds, and applied research. Collectively this is one of the largest investments in applied research and tech based economic development undertaken by the federal government.

Read More

ROCKVILLE, MD, July 15, 2021 /Globe Newswire/ — American Gene Technologies (AGT) announced today that the Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV cure program without modification, after safety analysis of the participant’s data revealed no adverse effects from the treatment. AGT’s Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease, is designed to induce durable viral suppression by delivering therapeutic genes to the recipient’s immune cells. The cells are collected by leukapheresis, modified outside the body, then re-infused. Once infused, the cells are expected to durably suppress the virus at undetectable levels without the need for antiretroviral treatment.

Image: https://www.americangene.com

Read More

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields. The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as “World Expert”. Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

Read More

The biomedical research ecosystem has delivered advances that not long ago would have been inconceivable, exemplified by highly effective COVID-19 vaccines developed by global partners and approved in less than a year. The United States stands at a moment of unprecedented scientific promise and is challenged to ask: What more can we do to accelerate the pace of break-throughs to transform medicine and health? Toward that end, President Biden recently proposed to create a new entity, the Advanced Research Projects Agency for Health (ARPA-H), within the National Institutes of Health (NIH) “to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer,” requesting $6.5 billion in the fiscal year 2022 budget.

Read More

The US National Institutes of Health (NIH) are the largest public supporter of basic life science in the world.

With an FY2020 budget of $42 billion, most of their expenditures are university grants supporting either new discoveries or early-state clinical studies of promising treatments and diagnostic tests.

Since 1982, Congress has mandated that a fraction of the total annual NIH budget be put to work via grants or contracts to small life science and biotech companies rather than academic institutions.

Image: Photo by National Cancer Institute on Unsplash

Read More

You have invested the time, expertise, and financial resources to develop a therapy that changes patient lives for the better. After all of your hard work and dedication, how can you ensure your product reaches patients? What are the key commercialization considerations for healthcare innovators, large and small? Learn how to unlock product potential in this step-by-step guide to making the most of your commercialization investments.

Read More

The German firm hopes to expand its cancer treatments with the purchase.

Image: BioNTech is buying a Gaithersburg manufacturing facility on Clopper Road from Kite Pharma. GOOGLE STREET VIEW

Read More

If you are interested in pediatric medical device innovation or alternative solutions to surgery such as focused ultrasound, these two topics will merge at the Pediatric Device Innovators Forum, July 22, from 2 – 3:30 p.m. This free livestream event, hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), features clinical, regulatory and reimbursement experts discussing the topic “Focused Ultrasound for Pediatric Indications.”

Image: https://medcitynews.com

Read More

DNA-modified cells can behave unpredictably in the body and there is a risk that they could proliferate uncontrolled, cause severe toxicities, and even survive unchecked for months or years. Cartesian uses its platform technology to engineer RNA into cells, making time-controlled changes. The company is developing treatments for cancer, respiratory conditions, and autoimmune diseases such as myasthenia gravis. We spoke to Murat Kalayoglu, president and CEO of Cartesian, about its RNA-engineered cell therapies, how they work and how the company is pushing the use of cell therapies beyond cancer.

Image: https://globalgenes.org

Read More

President Biden will nominate Laurie E. Locascio to lead the federal agency in charge of promoting innovation and technology, the National Institute of Standards and Technology.

Driving the news: Biden will name Locascio, currently vice president for research at the University of Maryland, as Undersecretary for Standards and Technology at the Department of Commerce.

Image: https://news.yahoo.com

Read More