The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five winners of its "Make Your Medical Device Pitch for Kids!" competition who will each receive $50,000 in grant funding and access to the consortium's first-of-its-kind "Pediatric Device Innovator Accelerator Program" led by MedTech Innovator. A panel of expert judges from business, healthcare, regulatory and legal sectors selected the winners based on the clinical significance and commercial feasibility of their medical devices for children. The competition focused solely on advancing care in pediatric orthopedics and spine, a sector that the FDA identified as an emerging underserved specialty which lacks innovation.

The University of Vermont Health Network Ventures and legal firm Wilson Sonsini Goodrich & Rosati recently invested in BioFactura’s $6M Series B Financing Round.

“With the commitment from the UVM fund and WSGR, BioFactura is now securing value-added institutional investors who bring significant financial and business resources to bear as we advance our biopharmaceutical products to the clinic,” said Darryl Sampey, BioFactura’s President and CEO.

In February 2019, the French immuno-oncology diagnostics company HalioDx opened its first laboratory in North America. The five-year-old company, a Qiagen spin-off, selected Richmond, VA, as the location of the lab, in part, because the state’s capital city is only a two-hour drive from the FDA’s headquarters in Maryland.

On Tuesday, May 7, the Center for Biotechnology Education will hold its 14th annual research symposium. During the event at the Johns Hopkins University Montgomery County Campus, biotechnology students and some high school students will participate in a poster session devoted to their research.

Following the poster session, Barry O’Keefe, a scientist at the National Cancer Institute, will give a keynote address about natural product-based drug discovery. O’Keefe is acting chief of the Molecular Targets Program at the Center for Cancer Research and chief of the Natural Products Branch, Developmental Therapeutics Program at the Division of Cancer Treatment and Diagnosis.

For the past five years, Jigar Patel and a group of fellow Roche employees have been quietly developing drug discovery technology at the global pharma company’s outpost in Madison, WI. Now, they’re setting out on their own to see if their approach to identifying promising peptide-based therapies can have an impact on the sector.

Available life science space is dwindling in Maryland's traditional life science core.

• Only six buildings currently offer space larger than 20,000 s.f.
• Space with high ceilings and utility capacity are scarce.
• Investor demand has increased in the last plots of vacant and underutilized land.

LifeSprout, makers of synthetic tissues for aesthetic and reconstructive medicine, is moving from Johns Hopkins‘ East Baltimore innovation hub into a manufacturing accelerator for medical device companies in South Baltimore’s Port Covington.

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.

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.

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.

LifeSprout has eight employees and plans to hire more as it focuses on getting its first product through clinical trials.

The company is seeking to go public just three years after its founding.

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.  

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.

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.

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.

The startup incubator Y Combinator plans to fund more early-stage drug makers, with a partnership designed to bring academic spinouts developing small-molecule drugs into its famed accelerator program. And in a Silicon Valley twist, the compounds it’s backing will often be recommended by an algorithm.

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.

GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.

Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.

A pioneering medical breakthrough that will help organ transplant recipients was announced by the University of Maryland Medical School.

Drone technology was developed by the University’s School of Medicine and Engineering to transport donor organs. The LG-1,000 is the first-ever organ delivery drone and weighs 50 lbs.

With an FDA approval for its pricey CAR-T therapy Yescarta under its belt and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt for a new manufacturing site to fuel those hopes. The company found it in Maryland.

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.

GSK announces that it will spend $100m to expand production capacity for components of Shingrix, amid a US market where demand outstrips supply of its shingles vaccine.

A Santa Monica, Calif.-based biopharmaceutical company plans to open a facility where it will produce cell therapy treatments in Maryland’s Frederick County.

Kite Pharma plans to build the biologics manufacturing facility on a 20-acre site in Urbana, Md., which is located off I-270 south of Frederick.

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.

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.