Biohealth Innovation
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The Human Immunome: Small Moves Become a Movement
“We’re basic scientists. We did not set out initially just to make drugs. That’s not what it was about when we started. I’ve just always been interested in how the human immune system even recognizes a virus,” says James E. Crowe, Jr., a well-known infectious disease expert who directs the Vanderbilt Vaccine Center in Nashville, Tennessee. “Now we can study how the body works and have curiosity about that, but also have drugs in the pipeline. It’s the unexpected benefit we get by delving deeply into the human immune system.” Crowe is one of the recipients of the 2020 Golden Goose COVID-19 Recognition for his decades-long pursuit of a better understanding of the human immune system, which is now paying dividends in the fight against COVID-19.
Unless you’ve been living on private island (send invite immediately!), it’s no secret that the pandemic has changed the way manufacturers operate and run their businesses in order to survive these challenging times.
At least that’s what we at the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP) have heard from manufacturers over 11 virtual listening sessions we call the “National Conversation with Manufacturers.”
When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.
Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent.
Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins.
Though it began like any other year, 2020 has proven to be one of the most difficult and frustrating periods of our lifetime. This was especially true for our business community, which faced numerous new obstacles including shifting consumer needs, new safety requirements and a general uncertainty about what lay ahead.
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics' investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics' next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.
The university licenses its original patent to the company to develop the product and conduct early-stage clinical trials.
Image: Michael Keidar, a mechanical engineer by training, is a professor of engineering at George Washington University. WILLIAM ATKINS
We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.
Image: U.S. Senator Birch Bayh (ret.)
The COVID pandemic has certainly forced us to re-think the whole paradigm of conducting clinical trials. From design, site and CRO selection, patient recruitment, data management, to execution, the world of clinical trials has been altered significantly in 2020… and most likely beyond.
Here are some relevant questions you should be asking yourself and that we will be asking our panelists in today’s webinar:
ROCKVILLE, Md., Dec. 14, 2020 /PRNewswire/ -- Emmes today announced that it has conducted the data and statistical analysis for the second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2). The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.
Baricitinib, produced by Eli Lilly and Company, has been used to treat adults with moderate to severe rheumatoid arthritis. Baricitinib, in combination with remdesivir for COVID-19 patients, received Emergency Use Authorization on November 19.
AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.
The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.
Image: KRISTOFFER TRIPPLAAR/SIPA/AP
AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.
The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.
Image: KRISTOFFER TRIPPLAAR/SIPA/AP
Qiagen, an international life sciences company that provides molecular sample and assay technologies, is expanding its United States headquarters in Germantown to accommodate increased production of testing products for COVID-19 and other diseases. The company, which is based in the Netherlands, has already spent over $7 million on new equipment and improvements to its 146,000-square foot ...
Baltimore, Md. (Dec. 11, 2020) – The University System of Maryland (USM) COVID Research and Innovation Task Force is bringing together people, expertise, and resources from its 12 universities to rapidly advance solutions to challenges presented by the COVID-19 pandemic. With the generous support of several local organizations, the Task Force is inviting members of the USM community to take part in a multimedia, Public Health Challenge seeking creative submissions that highlight ways for USM students, members of the broader university community, and all Marylanders to stay safe and healthy while waiting for a vaccine to become available.
Scott Gazelle, MD, PhD, MPH, FACR Appointed to Board of Directors and Damon Kuehl, MD, FACEP Joins Scientific Advisory Board
RICHMOND, Va. (December 8, 2020) ‐ BRAINBox Solutions today announced the initial closing on a $23 million Series A financing to support the clinical development of the company’s BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate.
“The BRAINBox TBI test has enormous potential to significantly improve patient care as an aid to objectively diagnosing and managing the treatment of concussion patients,” said Marc Goldberg, BioVentures Investors Co-Founder and Managing Partner. “The company has made great progress, particularly in this challenging COVID-19 environment, in advancing the development of the BRAINBox TBI testing system, including laying the groundwork for the pivotal, HeadSMART II clinical trial and securing ‘Breakthrough Designation’ from the FDA.” He noted there are more than five million patients evaluated in emergency rooms annually for mild TBI as well as additional patients in urgent care settings.
Stu Solomon, President & CEO, Connected DMV joins BioTalk to discuss formation of the Strategic Renewal Task Force, their Covid-19 Pandemic Pivot, the Global Pandemic Prevention and Bioterrorism Center, and much more.
Listen now on Apple https://apple.co/3gqmJlB, Google https://bit.ly/3mVtled, Spotify https://spoti.fi/3mO0j05, and TuneIn https://bit.ly/37FMf2t.
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.
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.
Are you and early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Learn more about whether or not federal or state non-dilutive funding makes sense for you. Discuss potential strategies for success. Sign up for a free 1:1 advice and feedback regarding non-dilutive funding strategy and applications with BHI staff who have helped companies secured SBIR, STTR and other awards—at twice the national average win rate.
Click here to schedule a time.
Children’s National Hospital today performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely. The 3D images provide surgeons with better visualization, allowing them to continue improving patient care and outcomes.
Matthew Oetgen, M.D., division chief of Orthopaedic Surgery at Children’s National, is overseeing the first use of this 3D imaging technology in orthopaedic procedures.
ROCKVILLE, Md., Dec. 1, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the first patient has been dosed in the Phase I/II trial of RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I). RGX-111 is an investigational one-time gene therapy designed to deliver the α-l-iduronidase (IDUA) gene directly to the central nervous system (CNS) using the NAV AAV9 vector.
MPS I is a rare, autosomal recessive genetic disease caused by deficiency of IDUA, an enzyme required for the breakdown of the polysaccharides in lysosomes. These polysaccharides, called glycosaminoglycans (GAGs), accumulate in tissues of MPS I patients, resulting in characteristic storage lesions and diverse clinical signs and symptoms including in the central nervous system (CNS), which can include excessive accumulation of fluid in the brain, spinal cord compression, and cognitive impairment.
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) announced today its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in transgenic mouse models as compared to 0% survival in the two control groups in studies conducted at the University of Georgia Center for Vaccines and Immunology.
Scientists at the University of Georgia working in conjunction with CEL-SCI’s scientific team conducted a challenge study in human(h) ACE2 receptor transgenic mice infected with a dose of SARS-CoV-2 (the causative agent of COVID-19 disease) virus sufficient to cause death in all animals within 8 days. This transgenic animal model is useful to study COVID-19 disease because the mice express the molecule that provides entry for the SARS-CoV-2 virus into human cells. Virus infection is optimized in this animal model providing an ideal system to determine vaccine induced immune protection or therapy against a SARS-CoV-2 infection of humans.
The effort to develop a COVID-19 vaccine is continuing to create new demand for life sciences space in Montgomery County, with one of the leading vaccine developers taking over a former industrial building and land previously planned for mixed-use development.
Novavax, a biotech company that has received $2B in funding for its COVID-19 work, announced Monday it signed a 122K SF lease at 700 Quince Orchard Road in Gaithersburg.
The Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC) Combines Innovation and Education – a smart choice for co-location.
The BioHealth Capital Region has come to be known for its unique blend of Industry, Government, and Academia from Baltimore to Charlottesville. Unlike many of the other Biotech Hubs across the United States, the geographic spacing, which at times has been seen as a challenge in the region, has created new opportunities.
Image: https://biobuzz.io/
PASADENA, Calif., Dec. 1, 2020 /PRNewswire/ -- Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, today announced that it has been recognized as the #1 real estate company in the world in the Global Real Estate Sustainability Benchmark (GRESB) 2020 Science & Technology sector for its leadership in championing sustainability initiatives that promote the health and well-being of its tenants and employees and enhance local communities. Alexandria also earned the #1 global ranking and a 5 Star Rating—the highest GRESB Rating—in its Diversified Listed Peer Group for its highly sustainable development work and green building initiatives, as well as an "A" disclosure score for the third consecutive year. GRESB is one of the leading global environmental, social and governance (ESG) benchmarks for real estate and infrastructure investments across the globe.
The University of Maryland, Baltimore (UMB) strives to support the entrepreneurial talents of its students, faculty, staff, and alumni as it works to improve the human condition and serve the public good.
To this end, the University System of Maryland (USM) continues to aid entrepreneurs at UMB and throughout the state with the $10 million Maryland Momentum Fund (MMF).
When it comes to virtual reality, truly immersing someone in another space requires a lot of things to be just right. For one, there’s a question of visuals. The objects have to be three-dimensional enough to look like they’re in front of a player, and a character has to be able to move around to see those objects to the right or left.
Image: VR on the RMI Manufacturing Day demo floor in 2017. (Courtesy photo)
Pitch Perfect: The Art and Science of Communicating with Investors Before AND After Funding Communicating with investors before AND after funding is both an art and science. Learn best strategies at this truly informative webinar.
This free webinar is brought to you by the Society of Physician Entrepreneurs and the George Washington University Technology Commercialization Office.
Among the front-runners racing to deliver a Covid-19 shot, AstraZeneca PLC has the least vaccine experience. But it has promised the world the most doses—more than three billion.
The company has assembled an unprecedented network of manufacturing and distribution partners spanning the globe, complementing a series of deals with governments that have sought to lock in vaccine supplies for their countries.
Seven start-up companies and university research projects across a range of therapeutic areas and geographical locations form latest intake for life science incubator BioInnovation Institute
COPENHAGEN, Denmark, 2nd December – BioInnovation Institute (BII), a Novo Nordisk Foundation initiative incubating and accelerating world-class life science research, today identifies its latest cohort of program participants. Comprising a pan-European spread of start-up companies and university research projects in countries including Denmark, Sweden and the UK, the seven ventures are developing revolutionary science across BII’s three sector specialised areas – therapeutics, bioindustrial and health tech.
Chevy Chase, MD – May 22, 2019 – New Enterprise Associates, Inc. (NEA), a leading global venture capital firm, today announced the appointment of Scott Gottlieb, M.D., as a Special Partner on the firm’s healthcare investment team. Dr. Gottlieb was a Venture Partner at NEA from 2007 to 2017 before being appointed the 23rd Commissioner of the U.S. Food and Drug Administration (FDA), where he served from 2017 to 2019.
Under Dr. Gottlieb’s leadership, the FDA advanced new policies for the safe and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs, and digital health devices; implemented new reforms to standardize drug and medical device reviews; and promoted policies to reduce death and disease from tobacco, improve food innovation and safety, promote better nutrition, and aggressively confront addiction crises.
TEDCO's 2019 Entrepreneur Expo took place on October 29, 2019, at The Hotel At The University of Maryland! See what Maryland has to offer entrepreneurs.
Image: https://www.tedcomd.com
Hilden, Germany and Germantown, Maryland, December 7, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today the launch of its QuantiFERON SARS-CoV-2 RUO solution that can detect T-cell responses of the human immune system to the pathogen that causes COVID-19, which could help researchers find out more about immunity levels and disease progression.
Studies suggest that T-cell response to SARS-CoV-2 declines much more slowly than antibody response, which presents several benefits to researchers who want to push beyond the existing detection of active infections to screen for potential courses of the illness and long-term immune responses to it. QIAGEN’s QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution could be a valuable tool in this research.
The agency's decision is expected to drop Dec. 18.
Image: MacroGenics is led by CEO and co-founder Scott Koenig. JOANNE S. LAWTON
Jennifer Doudna PhD, the UC Berkeley biochemist who shared the 2020 Nobel Prize in Chemistry with Emmanuelle Charpentier PhD, was the recent guest of honor for the final episode in the “Women in Science” web series, co-organized by GEN and the Rosalind Franklin Society.
In 2012, the Doudna and Charpentier labs teamed up to publish a landmark paper in which they adapted the CRISPR microbial anti-viral defense system to create a programmable method for genome targeting. The work laid the foundation for CRISPR genome editing, which has become not only a ubiquitous research tool but also applied in clinical gene therapy, diagnostics, agriculture, and many other applications.
Image: https://www.genengnews.com