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SANTA MONICA, Calif.--(BUSINESS WIRE)--Feb. 10, 2020-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

 

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FREDERICK, Md.--(BUSINESS WIRE)--The Maryland Tech Council (MTC) announced today it has expanded its offices to Frederick to broaden its reach throughout the State of Maryland and to meet the growing needs of its members. The satellite office will be located at 12 West Church Street. Additionally, MTC is planning a move of its Montgomery County satellite office to the Universities at Shady Grove (USG) in Rockville. MTC will continue to utilize its satellite offices in Annapolis and other key life science and tech hubs throughout Maryland.

 

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HHS on Monday launched a new program to spur development and commercialization of technologies that would help the U.S. respond to health security threats and disasters.

The Foundry for American Biotechnology, a public-private partnership, will be jointly managed by the department's Office of the Assistant Secretary for Preparedness and Response—or ASPR—and the New Hampshire technology firm Deka Research and Development Corp.

 

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Feb. 10, 2020 -- Linda Larrimore has been getting chemotherapy every other week for 6 years to treat and manage colon cancer.

The chemotherapy is keeping her health stable, so it’s well worth it to the mother and grandmother to regularly get the treatment. Usually, she spends the 4½ hours every other week reading, watching TV, or chatting.

Image: https://www.webmd.com

New Enterprise Associates reveals steps investors can take on improving diversity and inclusion

New Enterprise Associates Partner Sara Nayeem sat down with Proactive’s Christine Corrado at the BIO CEO & Investor Conference in New York.

The venture capital fund, which has a cumulative committed capital of $20 billion, focuses on investing in across all verticals in healthcare and in technology.

Image: https://www.proactiveinvestors.com

Satish Tamboli

Mtech Ventures, a University of Maryland technology company incubator program, won a $50,000 U.S. Small Business Administration Growth Accelerator Fund competition award to support innovation in federal Opportunity Zones in the Baltimore-Washington metropolitan area.

Through the grant, Mtech Ventures is partnering with the Association of University Research Parks (AURP) and the Center for Accelerating Innovation to organize community-needs roundtables, identify promising innovations, develop entrepreneurs and build awareness of Small Business Innovation Research (SBIR) or Small Business Tech Transfer (STTR) program in low-income census tracts called federal Opportunity Zones (OZ). Maryland has 149 Opportunity Zones, while the District of Columbia has 25. Federal tax incentives for new investments are available in these zones.

 

WASHINGTON – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced today that the application deadline for its annual “Make Your Medical Device Pitch for Kids!” competition is extended one week to Feb. 22 at midnight EST. Innovators and startup companies with devices in the pediatric cardiovascular, orthopedic and spine, or NICU sectors are invited to apply for a share of up to $250,000 in FDA-funded awards and access to a newly created NCC-PDI pediatric device accelerator program led by MedTech Innovator. Applications are being accepted now.

 

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The University System of Maryland Maryland Momentum Fund and the University of Maryland, Baltimore, have invested $350,000 in a medical technology startup, the 11th investment from the fund. University of Maryland BioPark startup ARMR Systems Inc. was awarded $350,000, the first time a BioPark resident has received an investment from the fund. The university investments led ARMR’s ...

 

Derek Lowe

Here’s a useful article that looks at the fate of university-licensed startup (ULS) life sciencecompanies over the last few years. There are more and more such companies (a greater than tenfold increase in their number since 1990), but a comprehensive look at success rates (and how such rates vary according to the universities involved) has been harder to come by. A lot of work went into this overview, and I’m glad the authors were able to assemble it. They spent a lot of time digging through tech-transfer records and contacting universities to make sure that they’d covered everything, checking venture capital announcements and state corporate registrations, and searching through press releases, LinkedIn pages, and more. The data that they have produced look like the best we have on the subject.

 

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The University of Maryland announced Wednesday that it has appointed a new president.

The University System of Maryland Board of Regents appointed Darryll J. Pines to succeed Wallace Loh. Pines’ appointment is effective July 1, and he will be the 34th president of the University of Maryland, College Park.

Pines has been the A. James Clark School of Engineering dean for the past 11 years. He has been with the university for 25 years, starting as an assistant professor in 1995.

Image: https://umdrightnow.umd.edu/news/usm-board-regents-appoints-darryll-j-pines-president-university-maryland-college-park

Todd HAIM,

The NIA Office of Small Business Research (OSBR) team is intrigued by startups and their unique role in research and development. Of course, we’re a bit biased — after all, we lead NIA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) programs, which are designed to help new companies commercialize products and technology to extend the healthy, active years of life.

 

Maryland businesses fight to save millions in tax credits in Annapolis Baltimore Business Journal

Representatives of various industries trekked to Annapolis for a marathon hearing on several bills aimed at generating revenue for public education reforms.

Image: Representatives from the Maryland Department of Commerce said getting rid tax credit programs would send a signal that the state is not committed to growing businesses and supporting economic development. BBJ FILE

IBBR Request for Proposals RFP GMP Biomanufacturing Facility Available Rockville Maryland USA

ROCKVILLE, Md., Feb. 11, 2020 /PRNewswire/ -- The Institute for Bioscience and Biotechnology Research (IBBR) is accepting proposals to lease a bio-manufacturing facility configured to produce biologicals under cGMP conditions in compliance with FDA requirements for phase I/II clinical trials. The facility is also equipped to perform process development research, pre-clinical manufacturing for material necessary to conduct IND-enabling toxicology studies, proof of concept (POC) studies, and process demonstration in advance of Good Manufacturing Practices (GMP) manufacturing. IBBR is a joint research enterprise between the University of Maryland and the National Institute of Standards and Technology (NIST).

Image: https://finance.yahoo.com

Banners and Alerts and Johnson Johnson Announces Collaboration with U S Department of Health Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine Johnson Johnson

NEW BRUNSWICK, N.J., February 11, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.

Image: https://www.jnj.com

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Rebecca Stauffer, Parenteral Drug Association Managing Editor posed the following questions to PDA Letter Article readers in fall of 2019. "What if developers of cell and gene therapies treated their products like software releases? What if the human body could be manipulated like a highly complex computer?"

We invite you to join us for a LIVE and interactive presentation from Jeff Galvin, CEO of American Gene Technologies sharing his passion, vision, and conviction of "reprogramming the human computer."

Image: https://www.eventbrite.com

RYAN DONOVAN

With the coronavirus growing more deadly each day, several companies are racing to produce the first vaccine or antiviral medication to combat the spread of the virus. One company that seems to have made large strides towards finding a vaccine, is Gaithersburg-based Novavax.

The genome of the coronavirus was published last month, which opened the floodgates for potential vaccine attempts. Novavax is most notable for releasing an Ebola vaccine within 90 days of the genome being published in 2015, and they estimate they could have a similar timetable for this vaccine as well.

 

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The streets of Wuhan, China — the epicenter of the coronavirus outbreak — are empty and quiet except for the sound of loudspeakers squawking quarantine instructions to its sheltered-in-place residents. Flights to some Chinese cities have been terminated. A Tokyo, Japan-based travel agency has canceled nearly 20,000 of its Chinese package tours. 

The World Health Organization (WHO) has declared the coronavirus, which has already killed more people than SARS, a global health emergency. There are currently 11 people stricken with the novel virus in the U.S. and over 17,000 are infected globally with numbers jumping exponentially by the day. 

Image: https://biobuzz.io

John Newby column Keep Virginia s life sciences innovation economy strong Columnists richmond com

Citizens across Virginia need health solutions and affordable health care to live full, healthy and productive lives. Lawmakers in the General Assembly are examining a broad range of policies in an attempt to relieve the burden of rising health care costs. But some of the proposals under consideration might have unintended consequences for both patients and Virginia’s innovation economy. As our elected officials consider how to address health care costs, they should ensure that any measure provides meaningful financial relief to patients and preserves the environment for medical innovation in Virginia that delivers groundbreaking treatments and creates thousands of high-paying jobs in the commonwealth.

Image: Kelli Price Photography 

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I made illustration of Corona virus today. 😍 I hope scientists and doctors can find a cure soon and I wish everyone who was affected to get well and recover soon! hashtag#sciart

 

New Members to Add Experience to Board of Directors

ROCKVILLE, MARYLAND, February 12, 2020 BioHealth Innovation, Inc. (BHI) announced that its Board of Directors unanimously has approved the appointments of six new board members:

“I am privileged to welcome these new members to our board,” said Richard Bendis, BHI President and CEO. “The addition of their leadership experience in the BioHealth Capital Region and beyond ensures in BHI’s ability to have our finger on the pulse of innovation and fresh viewpoints. I also would like to thank Rip Ballou of GSK, Robert Caret of the University System of Maryland, Doug Liu of QIAGEN, Ashish Kulkarni, of Avantor, and Beth Meagher of Deloitte Consulting LLP for their many years of service on our Board of Directors.

BioTalk Skyscraper Rich and Andrea

The first BioTalk of 2020 kicks off with Andrea Alms, MS, MBA, Co-Fund Manager of BioHealth Capital Fund as she discusses her background, the world of Angel Investment, and her vision for the Fund

Click here to listen to the podcast.

Andrea Alms is the co-fund manager of BioHealth Capital Fund.  The BioHealth Capital Fund is a venture capital early stage investment fund created by the BioHealth Innovation (“BHI”), located in Rockville, MD, the center of the BioHealth Capital Region. BHI manages a for profit subsidiary BioHealth Innovation Management (BHIM) which owns equity in 27 of the 108 client companies of BHI and has had 3 exits. Our lead investor is Alexandria Real Estate Equities; and, our reference is Joel Marcus.  Andrea is recognized for her abilities in guiding venture capital, private equity, mergers and acquisitions (M&A), and other transactions involving early stage companies. Andrea assists limited partners, general partners, investors, and entrepreneurs as they create, build, and buy or sell businesses, primarily in BioHealth, healthcare, technology, and digital health products industries.

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SOMERSET, N.J. & GOSSELIES, Belgium–(BUSINESS WIRE)–Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, and MaSTherCell Global, Inc., a technology-focused cell and gene therapy contract development and manufacturing organization to leading cell therapy innovators, today announced that Catalent has agreed to acquire MaSTherCell Global, a company backed by Great Point Partners, SFPI-FPIM, and Orgenesis Inc. (NASDAQ:ORGS), for an aggregate of $315 million in cash, subject to a customary adjustments.

 

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As it gears up for expansion in 2020, Baltimore-based Avhana Health is kicking off a partnership with one of Florida’s largest health system, cofounder Noah Weiner said.

The downtown Baltimore-based company is working with AdventHealth to launch its platform that improves electronic health records throughout the system’s network of doctor’s offices.

Image: Avhana Health cofounders and brothers Noah and Nate Weiner. (Courtesy photo)

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BHI is assisting one of its client companies, Medimaps) seeking US sales, customer and marketing support (see position descriptions). Medimaps is an exciting start-up company that is prepared to grow exponentially in the next phase and is looking for dynamic, experienced, and flexible people interested in being a part of this journey. The company is seeking someone who would like to be a critical player to the success of this exciting medtech company. Medimaps Group (MG) is the leader in bone and tissue microarchitecture software analytics. Its proven technology helps doctors make improved clinical decisions for the patients. Over the past several years, Medimaps has developed innovative technology, demonstrated and published clinical efficacy, received regulatory approval, built its network of distributors and partners around the world, and gained worldwide acceptance as standards of care for osteoporosis fracture risk assessment. Medimaps’ premier product, Trabecular Bone Score (TBS) is sold in more than 60 countries. MG currently has 20+ employees between our Headquarters in Geneva Switzerland, our R&D in Bordeaux, France, and our General Office in the US which is expanding. To apply for either position, please send your resume, cover letter, and three professional references to This email address is being protected from spambots. You need JavaScript enabled to view it.

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Montgomery College’s Workforce Development and Continuing Education (WDCE) Program will offer a program for budding entrepreneurs in Montgomery County to gain start-up business resources and get newly created businesses registered. The program, named LaunchCamp, starts April 7 and is a 12-week sprint for entrepreneurial-minded students to turn their ideas into registered businesses with identified customers.

Funded through the Montgomery College Foundation Innovation Fund, this start-up business accelerator is an easy-to-apply program that requires just a 1-page business plan, called the Lean Canvas.

 

Beth Meagher

Now that we have stepped over the threshold into 2020, what has the research community learned that will propel progress and how can we enable changes that can move health and science forward?

Here’s a look a 10 trends and big ideas we are watching as this new decade unfolds:

1.   Making patients the priority: Retail, banking, and other consumer-focused industries have placed the consumer in the center.

 

George Mason University starts the search for developers for its Amazon inspired Arlington campus expansion Washington Business Journal

George Mason University is now looking for private partners to help it build its Amazon-inspired expansion of its Arlington campus, outlining preliminary plans for a building with 225,000 square feet of academic space and 135,000 square feet of private office and retail.

University officials released a request for proposals Tuesday, looking for developers interested in teaming up with Mason to build a new home for the Institute of Digital Innovation on its Virginia Square property. The building is set to include a mix of uses across its 460,000 square feet, with room for classes and research labs alongside space for companies big and small looking to partner with the university.

Image: https://www.bizjournals.com

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BALTIMORE, United States of America, February 6, 2020/APO Group/ -- Hemafuse, a surgical autotransfusion device, will revolutionize blood access across Africa. Hemafuse is designed to salvage and recycle whole blood from cases of internal bleeding. The device can be used in both emergencies and scheduled procedures to recover blood from where it pools inside of a patient, into a blood bag, where it is immediately available to be re-transfused back to that same patient.

 

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Developing medication, devices, and products for children is not a matter of “shrinking” down the adult version. Delivering solutions to our littlest patients requires a long-term approach that deliberately centers children in all stages of innovation – from ideation to incubation, from clinical trials to market.

 Join Chief Innovation Officer of Children’s National Health System Kolaleh Eskandanian and experts in pediatric medical device innovation for a candid discussion on the challenges and opportunities upon designing innovation with children in mind.

 

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Herndon, VA, Feb. 04, 2020 (GLOBE NEWSWIRE) -- The Center for Innovative Technology (CIT) today announced the appointment of Greg Feldmann, President of Skyline Capital Strategies, an affiliate of Woods Rogers, PLC, as CIT GAP Funds Venture Partner. CIT GAP Funds and affiliated Virginia Founder’s Fund (VFF) are committed to identifying viable start-up investment opportunities in all parts of the Commonwealth. As a Venture Partner, Feldmann will provide outreach services to cultivate new and existing sources of deal flow and early-stage investment capital in the Roanoke-Blacksburg corridor, Southside Virginia, Lynchburg and Far Southwest Virginia.“CIT recognizes the wealth of technology and strong entrepreneurial spirit of the Roanoke-Blacksburg corridor and adjacent geographies,” said Tom Weithman, Managing Director of CIT GAP Funds. “A critical part of harnessing those assets to create economic development benefit for the Commonwealth turns on mobilizing capital to drive development of emerging companies.

Image: https://www.streetinsider.com

John George

Merck & Co. Inc. unveiled plans Wednesday to spin off products from its women’s health and biosimilars businesses, along with certain legacy brands, into a new independent and publicly traded company.

Going forward, Merck (NYSE: MRK) will focus on its oncology, vaccines, hospital medicine and animal health segments.

Merck expects the spinoff to be completed by the first half of 2021. The pharmaceutical giant anticipates cost savings of more than $1.5 billion — primarily in areas such as manufacturing and sales staff costs — by 2024. In addition, Merck said by continuing to increase investments in its key growth drivers and pipeline assets, it is targeting operating margins to grow to more than 40% in 2024.