MCEDC learns how Pat’s love for science drove her to found a company in Montgomery County, MD that delivers the cutting-edge buildings innovators need to make the world healthier.

Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).

Illumina has added four genomics startups to its accelerator program, marking its ninth funding round, the company said on Tuesday.

Today, the U.S. Department of Commerce’s National Institute of Standards and Technology announced 15 key findings from a final version of a new “green paper” on maximizing U.S. innovation from government-funded research.   

Kite Pharma, a California-based biopharmaceutical company that develops innovative cancer immunotherapies, announced plans today to open a new biologics manufacturing facility in Frederick County that will produce innovative cell therapies for people with cancer. A Gilead company, Kite will open the new facility on a 20-acre site in the Urbana Corporate Center, with plans to create a significant number of job opportunities.

GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health. The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

Bio‑Rad welcomes you to attend the 3rd Annual Downstream Purification Symposium at Institute for Bioscience and Biotechnology Research. This event will include discussion of new developments in purification of biologics and key industry regulatory topics. Thursday, May 9, 2019

9:00 AM–5:00 PM

Location

Institute for Bioscience & Biotechnology Research

9600 Gudelsky Drive

Rockville, MD 20850

The Small Business Administration (SBA) has statutory authority to establish federal Government-wide policies to implement the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. SBA recently issued a significantly revised final SBIR/STTR Policy Directive, which is effective May 2, 2019. See 84 FR 12794. Below we highlight the major changes implemented in the revised policy directive.

Most recently, the biotech executive helmed one of the fastest-growing public companies in Baltimore last year.

An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces 12 finalists that will present at the “Make Your Medical Device Pitch for Kids!” competition on April 30, 2019 at the University of Maryland, College Park. The finalists, all innovators in the orthopedic and spine sector, have a chance to win up to $50,000 in grant funding and access to the newly created NCC-PDI “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.

Are you excited about the work you do in the biohealth industry? How did you get to where you are? Would you like to be connected to the newest career ready talent pool?

Join us for a Happy Hour with post docs from NCI and other NIH institutes who have expressed interest in transitioning to our exciting industry! Help them learn about your work and opportunities in the field. You may find one of your best future hires in the process!

These events are being cohosted by BioHealth Innovation, American Gene Technologies and SciPhD. The events are free but registration is required.

Postdoc Industry Connections Happy Hour 

5/8 – 5-6:30 p.m. – American Gene Technologies

9640 Medical Center Dr Rockville, MD 20850

Register Now »

Were you unable to attend the 2019 BioHealth Capital Region Forum? Are you looking to stay updated on what is happening with Companies/Organizations/Institutions in the BHCR throughout the year? Be sure to bookmark http://www.biohealthcapital.com/ in your internet browsers today to keep yourself in the loop. From a look back at the Forum Agenda to News on Companies in the Region, the BHCR website is one of your go-to pages along with http://www.biohealthinnovation.org/.

Do you have news to share in the region? Be sure to let us know by tagging on social media! @BiohealthCR on Twitter. We can also be found on Facebook and LinkedIn!

GlycoMimetics, Inc. (NASDAQ: GLYC) today announced the publication of a paper in Nature Cell Biology that describes how tumor cells engage specific stromal components, most notably E-selectin, for propagation and outgrowth.1 The paper provides further scientific support for the clinical trial in breast cancer patients with bone metastasis that was recently announced by GlycoMimetics.

The Food and Drug Administration (FDA) on Friday announced that it granted final approval to the first generic naloxone hydrochloride nasal spray, which can be used to reverse opioid overdoses.

The Golden State is living up to its nickname, with California ranking as the most innovative economy in America.

That’s according to Bloomberg’s newest U.S. State Innovation Index based on six equally-weighted metrics: research and development intensity, productivity, clusters of companies in technology, “STEM” jobs, populous with degrees in science and engineering disciplines, and patent activity.

Elon Musk’s tunneling startup, aptly-named The Boring Company, has taken a step towards its proposed loop system in the East Coast. In an announcement on Wednesday, the Transportation Department stated that the project had completed its environmental assessment, a draft of which will be available for public comment for the next 45 days.

It has four chambers, blood vessels and it beats — sort of.

In a first, scientists have 3D printed a heart using human tissue. Though the heart is much smaller than a human's (it's only the size of a rabbit's), and there's still a long way to go until it functions like a normal heart, the proof-of-concept experiment could eventually lead to personalized organs or tissues that could be used in the human body, according to a study published Monday (April 15) in the journal Advanced Science.

Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, life-threatening autoimmune disease affecting the central nervous system.

If asked “What’s the most talent competitive city in the U.S.?” few Americans would name the top of our global list: Washington, D.C. (1). Often considered to be a (political) quagmire, the greater metropolitan area actually has a tremendous amount to offer. With an excellent environmental quality, major universities, an impressive number of physicians in the area and, of course, the presence of international global organisations, the greater Washington area provides a complete environment for talent competitiveness.

A nascent project launched by the Health and Human Services Department aims to spur innovation and help solve an expensive health crisis plaguing millions of Americans: kidney disease.

Developers hope it will one day be used as a model not only for introducing innovators to government, but for addressing other high-cost diseases.

The BioHealth Capital Region (BHCR) is rapidly becoming an industry hub for companies that are developing next-generation therapeutics that focus on personalized and regenerative medicine for the treatment and potential cure of unmet medical needs. Autolus, Inc., a CAR T-cell therapy company, and REGENXBIO, a gene therapy company focused therapies for rare diseases, are two examples of emerging leaders in the personalized medicine field making their imprint on the region.

Children's National today announced a $30 million gift from the United Arab Emirates (UAE), marking a major milestone in the creation of its new Research & Innovation Campus. The gift will help drive pediatric discoveries that save and improve the lives of children in the Washington, D.C. region and around the world.

Scientists at Tel Aviv University (TAU) have printed the world’s first 3D vascularized engineered heart using a patient’s own cells and biological materials. Their findings appear (“Printing of Personalized Thick and Perfusable Cardiac Patches and Hearts”) in Advanced Science.

In honor of the new JLABS @ Washington, DC – a 32,000 square foot facility located on the new Children’s National Research and Innovation Campus from Johnson & Johnson Innovation, LLC in partnership with Children’s National Health System[1] (“Children’s National”) - Johnson & Johnson Innovation – JLABS announces the JLABS @ Washington, DC Children’s QuickFire Challenge.

Visionaries within the fields of pediatric oncology, pediatric surgery and influenza are invited to submit innovative ideas for a total of up to $150,000 in grant funding*; one year of residency at JLABS @ Washington, DC with the use of a bench, workstation, and access to the JLABS @ Washington, DC community; and mentorship from experts at the Johnson & Johnson Family of Companies.

Emergent BioSolutions Inc. (NYSE:EBS) today announced results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle (CHIKV-VLP) vaccine candidate across a series of dosing regimens. The interim analysis has shown that with a single dose administered, up to 98% of study participants produced a neutralizing antibody response against the chikungunya virus (CHIKV) by Day 7. Further, the immune response was shown to be persistent through the six-month visit, including in the one-dose regimen.

Paragon Bioservices, the leading private equity-backed biologics contract development and manufacturing organization (CDMO) with proven expertise in gene therapy and next-generation vaccines, celebrated this morning the grand opening of its new, world-class and state-of-the-art 200,000 square-foot GMP gene therapy biomanufacturing facility in Maryland’s Anne Arundel County. The event brought together state and regional political and biopharmaceutical industry leaders. Distinguished guests and speakers at the event included:

Is it possible to be successful in business and not fulfilled? The answer is a resounding yes today, and I’m convinced that it will be even more true tomorrow, as young idealistic entrepreneurs try to adapt to the long-standing business culture if success is only measured in the money you make for yourself and your business.

Catalent, Inc. (NYSE: CTLT), the leading global diversified provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Paragon Bioservices, Inc., a leading viral vector development and manufacturing partner for gene therapies, today announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.

In mid-November 2018, Amazon grabbed headlines when it announced it will build part of its new headquarters in Northern Virginia.1 The site for HQ2 had been long-awaited after a national "beauty contest." Amazon decided to place major new office complexes in the Crystal City section of Arlington, which is being renamed National Landing. This will rejuvenate an area filled with office buildings that were developed in the 1970s, and once housed the U.S. Patent and Trademark Office and various patent law firms that have now relocated to Alexandria.

QIAGEN N.V. (NYSE:QGEN; Frankfurt Prime Standard:QIA) today announced the U.S. launch of its novel therascreen® FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib), developed by Janssen Biotech, Inc. (Janssen). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3) gene. The U.S. Food and Drug Administration co-approved the new test with BALVERSA™, as announced today by Janssen.

For a second year in a row, D.C. metro area venture capital funding in the first quarter dropped when compared to the previous quarter. In the first quarter of 2019, venture capital activity in the D.C. metro area totaled $323 million invested in 47 deals, according to data from a recent PwC/CB Insights MoneyTree report.

Alexandria Real Estate Equities is accepting applications for two $125,000 Alexandria LaunchLabs Innovation Prizes for entrepreneurs who can win support for their emerging businesses and a year’s worth of space at the Cambridge, MA, startup facility by showing what the urban life-sciences real estate investment trust says is excellence in early-stage science, leadership, and business strategy.

The uptake of continuous manufacturing, a faster and more flexible production process, has lagged in the risk-averse pharma and biotech industries.

Still, a number of the larger companies have dipped their toes in the water, including GlaxoSmithKline, Vertex, Johnson & Johnson and Eli Lilly. In addition to its collaboration with CPI, GlaxoSmithKline is working with the Center for Structured Organic Particulate Systems at Rutgers University to expand its knowledge of continuous manufacturing.

Generally speaking the aim of active stock picking is to find companies that provide returns that are superior to the market average. Buying under-rated businesses is one path to excess returns. For example, long term QIAGEN N.V. (NYSE:QGEN) shareholders have enjoyed a 94% share price rise over the last half decade, well in excess of the market return of around 47% (not including dividends). On the other hand, the more recent gains haven’t been so impressive, with shareholders gaining just 27%.