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Wed, May 8, 2019, 6:00 PM – 8:00 PM EDT

Inova Center for Personal Health, 8100 Innovation Park Drive, Conference Center, Fairfax, VA 22031

The Titanic represents to many of us the iconic tale of what happens when an unstoppable force meets an immovable object. The tragedy is embodied in that instant when The Ship struck The Iceberg, killing over 1,500 passengers and crew—and the hubris of thinking we can build something too big to fail. But while the iceberg may have represented the killing blow, what many do not realize is that the demise of the Titanic was in fact a result of a series of small decisions and missteps across a number of dimensions.

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Startups may spring from pure academics or from a healthy and heterogenous mixture of science, business experience, and inspired thinking. Rachel King, CEO of GlycoMimetics, and others brought experience to the company. Her cofounder, Dr. John Magnani, brought original science, and an expert team soon joined in response to the inspiration created by the company’s concept. The germ idea was to make a formerly “undruggable” set of disease targets druggable. Deep, careful studies of molecular structures were required, followed by rational drug design to achieve the goal of small molecule therapy mimicking natural carbohydrates critical to the “glycosylation” of cellular proteins.

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Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced the official opening of its new manufacturing facility. Precigen commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs.

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CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.  

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Last week ended with another Friday night blitz of biotech S-1s as a fresh wave of new offerings forms to crash into Nasdaq. Entering the Wall Street spotlight now is one transatlantic operation that is out to develop a new class of meds, a Dallas biotech with a Phase III kidney cancer drug and a startup that in-licensed its lead drug from Novartis.

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Canada’s top universities and research institutes spent $5.7 billion on research and development (R&D), but generated less than $75 million from licensing their innovations in 2017. That’s an average return on investment of 1.3 per cent, according to the latest report from AUTM, which monitors commercialization from academic research in Canada. Institutions filed 687 patents, down from 790 in 2016 and the fewest since 2008.

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Redox, a Madison, Wisconsin-based healthcare technology company that is transforming the way healthcare providers and software vendors share data, announced it has raised $33 million in Series C funding led by Battery Ventures. Also participating in this round is .406 Ventures, RRE Ventures, and Intermountain Ventures. In conjunction with this funding round, Battery general partner Chelsea Stoner is joining Redox’s board.

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United Therapeutics Corporation (Nasdaq: UTHR) today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products XPS™ and STEEN Solution™. This approval means that STEEN Solution, XPS and the accompanying single-use articles are the only medical device products that are approved in the United States for ex-vivo lung perfusion (EVLP) of initially unacceptable donated lungs at body temperature.

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Every two years leader of the life science industry gather from across the state to connect, celebrate, learn, inspire, imagine, and drive forward the development of R&D and commercialization in Virginia in focused ways.

On Thursday May 2, 2019 we expect over 400 attendees - leaders of bioscience companies big and small, research universities, policy makers, innovative health care systems, patient groups, CROs and professionals, and others from across Virginia and beyond to gather in Richmond for THRiVE 2019: Creating the future of bioscience in Virginia.

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Researchers at the Institute for Bioscience and Biotechnology Research (IBBR) recently received $3.5M from the National Institutes of Health (NIH) to advance understanding of the complex process by which the immune system produces highly specialized antibodies. The goal of the project is to design and test novel vaccine candidates that improve the protective antibody response against HIV-1. IBBR Fellow Dr. Yuxing Li (Associate Professor, Department of Microbiology and Immunology, University of Maryland School of Medicine) is principal investigator on the award.

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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).

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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.

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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.

3rd Annual Downstream Purification Symposium

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

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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.

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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.

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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.

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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 »

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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!

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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.

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President and CEO Rich Bendis sits down with industry leaders to talk about the forum and their views on the growth of the region.

In Part 1 his guests are John Trainer, VP and one of the partnering heads at AstraZeneca, Chris Frew, CEO of Workforce Genetics & President of BioBuzz Media, and Alex Philippidis, Senior Editor of Genetic Engineering & Biotechnology News.

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.