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ATCC Teams with CDC and Thermo Fisher Scientific on Public Health RT-PCR Assay

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ATCC, the premier global biological materials resource and standards organization, has licensed technology from the Centers for Disease Control and Prevention (CDC) and partnered with Thermo Fisher Scientific to bring a rapid and cost-effective PCR-based method of monitoring HIV drug resistance to resource-limited countries. The ATCC® HIV-1 Drug Resistance Genotyping Kit was optimized for off-the-shelf detection, sequencing, and genotyping of HIV-1 genomic mutations more commonly observed in resource-limited countries, and was attuned to sample collection methods most often employed in developing countries, including dried blood spots. Together, with ongoing CDC programs to train scientists in geographically dispersed regions, such as Sub-Saharan Africa, Central America, and Southeast Asia, this collaboration serves to advance applied public health initiatives to understand the growing problem of HIV drug resistance and, ultimately, improve patient outcomes.

One of the most difficult aspects of supporting resource-limited countries with temperature-sensitive reagents is being able to supply materials under stable conditions. This challenge was addressed by ATCC’s long-standing history and expertise in global cold-chain distribution of biological materials routinely used in research to further advances in human health. “Researchers around the globe rely on ATCC as the leader in the production and distribution of reagents for diseases that impact the world, such as influenza, tuberculosis, and malaria,” said Dr. Ted Mullins, Program Manager for ATCC Biological Services. “The release of these kits to World Health Organization designated and CDC-supported PEPFAR (President’s Emergency Plan for AIDS Relief) genotyping labs for the surveillance of drug resistance in HIV patients demonstrates yet another facet of our commitment to improving global health.”

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Investing in Morgan benefits Maryland – Baltimore Sun

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A few years ago, the Maryland legislature appointed a panel to assess the way it was funding higher education. As part of its scope, the panel evaluated the funding needs of the state’s historically black colleges and universities (HBCUs), paying particular attention to the research infrastructure needs at Morgan State University, which in 2005 had received the coveted Carnegie designation of “Doctoral Research University” without any additional infusion of state resources. It achieved this designation because it annually awarded the requisite number of doctoral degrees and received sufficient external federal research funding to qualify.

The state’s study found that unlike the University System of Maryland research campuses in College Park and Baltimore city and county, Morgan lacked most of the infrastructure components typically found at campuses with a research university label. Morgan’s faculty has much higher than average teaching loads, and its research laboratory space and equipment were inadequate. The study concluded that an investment in Morgan’s research platform would be required to allow it to adequately compete with research campuses with better developed infrastructures. But while state investment in capital facilities at Morgan has improved, its investment in enhancing Morgan’s research mission has not.

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Maryland life sciences innovators showing at BIO International – MDBIZNews

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Potential medical breakthroughs now being developed in Maryland, the fourth largest biopharma cluster in the U.S., will be the focus of the BioMaryland booth at BIO International 2014 at the San Diego Convention Center this week. The innovations range from a surgical tool that can speed and enable heart operations for patients who currently are not candidates for traditional open heart surgery to a simple diagnostic test to reduce the spread of malaria.

The following companies will be presenting their work and research at BIO International on Tuesday:

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Cambridge heavyweights lead dementia fight

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Cambridge UK medical technology heavyweights are in the front line of a battle to speed diagnosis and potential treatment of dementias.

MedImmune, IXICO, Johnson & Johnson Innovation (now with a Babraham base) and the University of Cambridge are in a consortium created by The Medical Research Council in the form of the UK Dementias Research Platform (UKDP) – a £16 million public-private partnership set up to speed up research into dementias.

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From Lab Bench to Bedside: Accelerating the Commercialization of Biomedical Innovations – NIH Extramural Nexus

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We are delighted to announce a new collaboration between the National Institutes of Health (NIH) and the National Science Foundation (NSF) to empower entrepreneurial scientists and advance the Lab-to-Market priorities set forth in the President’s Management Agenda. The Federal government invests over $130 billion on research and development (R&D) each year, and the President’s 2015 budget supports a sustained commitment to accelerate the transfer of promising Federally-funded technologies from the laboratory to the commercial marketplace.

Some academic researchers and entrepreneurs who receive SBIR or STTR funding from NIH will now be eligible to participate in a pilot of the NSF Innovation Corps (I-Corps™) program that is specially tailored for biomedical technologies. First launched in 2011, the NSF I-Corps program is based on the “Lean Launchpad” curriculum developed by entrepreneurship expert Steve Blank to improve how tech start-ups bring their products into the marketplace. This intensive, mentor-driven experience is changing the way that NSF-funded researchers think about the commercialization process, and now it will be available for NIH-funded researchers as well.

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ETC Hosts Entrepreneurship and Innovation European Delegation

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The ETC (Emerging Technology Centers: http://www.etcbaltimore.com) — Baltimore City’s award-winning technology innovation center–welcomed last week a European Delegation of entrepreneurs, policy makers and Members of Parliament who were invited to the United States under the auspices of the Department of State’s International Visitor Leadership Program and coordinated by the World Trade Center Institute (WTCI) in Baltimore, Maryland. Two weeks ago, the ETC hosted another European Delegation led by Dr. Rob de Wijk, Director of The Hague Security Delta.

“At ETC, we have always been pioneers,” said Deb Tillett, ETC’s President. “We work hard every day to innovate and move forward. We are so pleased that these distinguished delegations chose to visit us to see how we do what we do in Baltimore and how we stay on the leading edge of technology and best practices to help our emerging companies grow and become successful, all business is global these days and our companies are always looking for the next customer and opportunity,” she added.

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Medtronic-Covidien Merger Not Great News For Startups, VCs Say – Venture Capital Dispatch – WSJ

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Medtronic Inc., an active acquirer and financial backer of new medical technologies, has moved its tax domicile overseas with the $42.9 billion acquisition of rival Covidien PLC, a deal that Medtronic says will free up billions of dollars that can be more easily and flexibly deployed to technologies being developed in the U.S.

Medtronic headquarters in Minneapolis Bloomberg News But investors in these U.S.-based technologies see things differently. The merger means that the medical-technology industry is consolidating, several venture capitalists said, which takes options off the table for young companies struggling to bring new treatments onto the market.

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Why Medical Devices and Technologies Fail? The Importance and Implications of Proper Design – SOPE Event

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Tuesday, July 8, 2014 6:00 PM – Johns Hopkins University Montgomery County Campus, Rockville, MD

Guest Speakers:  

GAUTAM GULATI, MD, MBA, MPH
Dr. Gulati is the Chief Medical Officer and Head of Product Innovation for Physicians Interactive Holdings, where he leads a world-class team to ideate, design, build, and deploy disruptive solutions for a health audience. In addition to his executive role, he serves as an Adjunct Professor of “Medical Innovation and Entrepreneurship” at Johns Hopkins University Carey Business School, sits on numerous company boards, and speaks at a variety of events around the world.  

Over his 20+ year career, Dr. Gulati has been combining his diverse experiences, creative juices, and passionate voice to help take on a bigger challenge…to treat our troubled health system.  He has earned an impeccable reputation for his ability to transform organizations – both big and small – to meet the future innovative demands of the health industry. Along this journey, he has been dubbed both a “health hooligan” and “physician artist”, encapsulating the creative characteristics that allow him to meld his various vantage points as a clinician, executive, designer, professor, advisor, entrepreneur, speaker, and technology advocate.

PAUL FEARIS, CEO Clinvue

Mr. Fearis obtained Masters Degrees in both mechanical engineering and industrial design and as a consequence has been involved in product development throughout his career. An entrepreneur at heart, with his partners, Mr. Fearis formed Clinvue, a company which marries his passion for innovation with his love of understanding people and solving worthwhile problems.

Peter Davis, JD

Mr. Davis is a partner in Whiteford, Taylor & Preston’s Technology and Intellectual Property Practice, located in Baltimore, Maryland. He is a former U.S. Patent Examiner, and for the last 23 years he has balanced his time between patent prosecution, patent litigation, and strategic patent counseling for many of the world’s best-known companies. He has worked in virtually all areas of technology, including biotechnology, pharmaceuticals, medical devices, electronic devices, software, light and heavy machinery, and automotive. He can speak the languages of both the inventor and the layman, translating inventions into terms that patent examiners, judges and juries find compelling. Mr. Davis received his bachelor’s degree from Cornell University (1987) and his JD from Catholic University (1993).

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Qiagen

US FDA approves Qiagen’s artus CMV RGQ Mdx kit for human cytomegalovirus

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Qiagen, a Netherlands based holdings company announced that its artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the US Food and Drug Administration (US FDA) under a full premarket approval (PMA). The test is the only FDA-approved PCR-based assay optimised for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests. artus CMV RGQ MDx runs on Qiagen’s Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is a member of the QIAsymphony modular family of automated instruments.

“We are very pleased to add yet another FDA approved diagnostic kit to our menu of FDA approved or cleared content for a core element of our flagship QIAsymphony modular family of automated instruments. This flexible platform is driving the dissemination of molecular diagnostics by delivering efficient, reliable workflows in low- to mid-throughput settings, which represent the largest market opportunity in terms of placements,” said Peer M. Schatz, chief executive officer of Qiagen. “Our artus CMV assay is the fastest test approved for quantifying CMV viral loads in organ transplant patients. In addition to helping save lives with its clinically proven usefulness, the FDA-approved artus test creates economic value by reducing the time and money many labs and hospitals currently must spend validating lab-developed CMV tests and analyte-specific reagents. More than one million CMV tests are performed on US transplant patients each year and we believe the artus CMV kit will provide significant value for laboratories, patients and the healthcare system.”

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