Biohealth Innovation
What would you say about a technology commercialization system that kept on performing even through the worst pandemic in over a century? How about if it improved its performance over the previous year and was a critical factor in developing desperately needed therapies to protect people around the world? Would it seem reasonable that this was something that all of us should highly value and want to protect? You might think so, but some in Washington apparently don’t agree.
Join us on September 30th for the 6th year of the Women Building Bio conference. Don’t miss an event where women converge to advance the industry with all stakeholders, men and women, front and center joining forces.
Our half-day hybrid conference will offer full virtual attendance or the option for in-person viewing at one of 5 regional locations across our state. In-person requires pre-registration at a specific location and space is limited, so do not delay!
Regardless of molecule, the goal of biopharmaceutical downstream processing is to reduce process- and product-related impurities while maintaining the highest possible process yield. However, emerging modalities such as those based on gene-edited human cells, transgenes carried by viral vectors, and proteins transferred by exosomes all are pointing out limitations in current downstream strategies, which by and large have been developed around purification of monoclonal antibodies (MAbs). This year's nominees in the BPI Readers' Choice downstream category highlight technologies and processing strategies that biopharmaceutical developers and manufacturing organizations are developing to address the separation and purification demands raised by innovative therapies.
On August 23, 2021, BARDA's Division of Research, Innovation, and Ventures (DRIVe) opened a new area of interest (AOI) under the EZ Broad Agency Announcement (EZ-BAA) solicitation to expand the capabilities of existing next-generation sequencing diagnostics to agnostically detect any pathogenic respiratory RNA virus including new, emerging and existing viruses.
Next-generation sequencing diagnostics have been established for oncology and some genetic disorders, and such technology also is needed for infectious diseases due to growing health security challenges and threats. In a viral outbreak or pandemic, having agnostic tests – especially those which can detect any respiratory RNA virus and can be implemented rapidly without the need for additional regulatory approvals – is crucial.
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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.
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.
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.
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
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.
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
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.
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
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.
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.
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
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:
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.
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.
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.
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
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.
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%.
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".
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.
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
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.
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%.
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.
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.
The exec has been at the helm of the company for 18 years.
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.
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.”
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.
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
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.