Maryland has a new strategy for growing biotechnology business: Roll out the welcome mat for international companies.

International bio companies looking to break into the American market must first get approval from the U.S. Food and Drug Administration. The FDA regulates medical devices and drugs. The approval process can be complicated even for American companies that are somewhat familiar with the agency.

Niall O’Donnell fancies himself an archaeologist of the pharmaceutical persuasion. His firm, RiverVest Ventures, is scoping out the failed and forgotten drugs of big pharma, building companies to repurpose these benched meds for new indications.

The aim is to find drugs that have passed for safety in clinical trials, but may have shown limited efficacy in the initial disease they aimed to treat.

Today, Under Armour (NYSE:UA), the global leader in sports performance and innovation, announced plans for the 2014 Under Armour Future Show: The Connected Fitness Innovation Challenge, which asks innovators to submit concepts for the next generation of game-changing digital experiences, through apps and wearable technology, while utilizing the MapMyFitness software. Finalists will present their concepts to the Brand's executive team in October, 2014 at Under Armour's global headquarters in Baltimore, MD for a chance to win the Grand Prize of $50,000. Winners may then be eligible for an additional investment of up to $150,000. Innovators can now submit their ideas and innovations at idea.underarmour.com for consideration.

Entering its fourth year, Under Armour's Future Show rewards the Brand's innovation-inspired consumer base, incentivizing them to design new products that align with the Brand's forward-thinking vision. The 2014 Future Show will identify the most creative minds in engineering and software development who can implement wearable, wireless and embedded apparel-based technology addressing one or more of the following needs: fitness assessment and training, readiness and recovery, sleep analysis or other novel usages that will help make athletes better.

After stepping up their R&D spending last year, biotechnology companies worldwide must deploy that capital to create more value from their research, EY concluded in this year’s 28th annual edition of its industry report, released Tuesday at the Biotechnology Industry Organization (BIO)’s 2014 International Convention in San Diego.

Beyond Borders: Unlocking Value focused on three strategies for creating more value—“Adaptive” clinical trials that allow biotechs to tweak their hypotheses and shift R&D spending based on clinical data; “Precision medicine” that identifies patient subgroups most likely to benefit from a new therapy; and cross-industry collaborations during precompetitive phases, spearheaded by big pharma.

Cyber entrepreneur Mike Binko is launching a second Innovation Sandbox to give exposure to small startup companies.

The program will connect health care, medical and life science organizations with small vendors that are interested in working with the health care sector, said Binko, CEO of cloud services provider Kloudtrack.

May 18 was a glorious Sunday in the Boston area. Tens of thousands of families and friends descended on one of the nation’s best-known education corridors to celebrate the class of 2014. My husband and I were among the happy crowds joined by my family from Shanghai for our son Andrew’s graduation from Tufts University.

We fully immersed ourselves in the joy of gathering, cheering, listening, reflecting and photo snapping—including some selfies. Our weekend of celebration culminated with Andrew’s commencement speech on behalf of the Sociology Department. In a mother’s unbiased opinion, his 5-minute speech was brilliant, perceptive, and entertaining, an affirmation of the value of his college education in shaping his outlook on self and the society. Surrounded by family, I cheered and laughed as I listened to him. It was a moment of pure joy and pride that no other accomplishments of my own could possibly match.

Scientific excellence is an integral part of any pharmaceutical company’s success. By paying attention to staff training and development at all levels, it is possible to embed vital life-long skills and behaviours into the scientists and professionals responsible for discovering and developing new medicines to treat patients.

MedImmune is the global biologics R&D arm of AstraZeneca and is committed to scientific innovation and medical progress. Our state-of-the-art facilities at Granta Park are home to over 550 members of the 2,500-strong global MedImmune team. To support its ambitions to help save lives and improve people’s health, MedImmune works hard to ensure that all employees, across all functions, are given the training they need to excel in their roles and work alongside their colleagues. MedImmune’s Cambridge site is therefore very pleased that it has recently been awarded Gold Standard Status for Training in Life Sciences by Cogent, the organisation responsible for skills in the life sciences sector and connected to government policies in this area.

Kyushu University and the University System of Maryland exchanged memorandums of understanding on Tuesday to work together on cybersecurity education and research. It will be the first cooperation between a Japanese and U.S. university in the area of cybersecurity.

Setsuo Arikawa, the president of Kyushu University, visited Maryland to sign the memorandums with William Kirwan, the chancellor of the University System of Maryland, to create a partnership with the University of Maryland, Baltimore County.

Johns Hopkins University is one of eight Baltimore universities and hospitals that today joined Mayor Stephanie Rawlings-Blake to sign a pledge to work together to grow and revitalize the city and to help solve some of its most pressing challenges.

The Baltimore City Anchor Plan targets four priority areas—public safety, local hiring, local purchasing, and quality of life in the city. In a memo introducing the plan, Rawlings-Blake said that the signing institutions, which are among the city's largest employers, are integral to her goals of attracting new families to Baltimore and increasing jobs and investment.

The BioMaryland Center is pairing up with a French life science organization to support a business venture between two companies.

BioMaryland and Medicen Paris Region will each invest $200,000 in a commercialization project between Opticul Diagnostics in Rockville and the French company Diafir. Each company will also put $200,000 toward the project for a total investment of $800,000.

Johns Hopkins University affiliate Jhpiego has been awarded a five-year, $500 million contract to lead a federal global health program.

The Baltimore nonprofit organization will lead the Maternal and Child Survival Program, which targets preventable maternal and child deaths in 24 countries in Africa, Asia, the Caribbean and the Middle East that have the highest mother and child death rates. The award is from the U.S. Agency for International Development (USAID).

BIO BizLink is an online platform that connects life sciences companies with an unparalleled community of pre-clinical and clinical R&D service vendors

BIO BizLink is a portal to an unparalleled community of R&D vendors – including pre-clinical and clinical Contract Research Organiza­tions (CROs), Contract Manufacturing Organizations (CMOs), and regulatory consultants – and a platform to take the administrative hassle out of RFP, vendor, and project management.

User on the platform can explore the community to find specific services and expertise; review company profiles and key personnel; start conversations about prior experiences; invite vendors to submit proposals; and execute confidentiality agreements. BIO BizLink was developed and launched as a cooperative effort among BIO, its State and Regional Affiliates and OnDeckBiotech.

The University of Maryland School of Medicine's Maryland Psychiatric Research Center (MPRC), a research center in the School's Department of Psychiatry, was awarded a $10.7 million grant from the National Institutes of Health (NIH) to establish a Silvio O. Conte Neuroscience Research Center that will examine the causes of schizophrenia and search for possible new treatments. Schizophrenia is a devastating psychiatric disease, affecting one percent of people worldwide. Although its roots have been traced to abnormal early brain development, the cause remains a mystery, and current treatments are limited.

The five-year NIH grant*, one of only two awarded this year nationwide, will enable researchers to conduct breakthrough research, combining laboratory and clinical studies of a key chemical called kynurenic acid, a major breakdown product of the amino acid tryptophan. Kynurenic acid levels are increased in the brain of individuals with schizophrenia, and appear to contribute especially to the cognitive abnormalities, which are core symptoms of the disease and a major reason for the inability of people with the disorder to lead productive and fulfilling lives.

Emergent BioSolutions Inc. - Product Pipeline Review - 2014 is a new market research publication announced by Reportstack. This report provides an overview of the Emergent BioSolutions Inc.’s pharmaceutical research and development focus.

This report provides comprehensive information on the current therapeutic developmental pipeline of Emergent BioSolutions Inc.’s, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. It also reviews latest updates, and featured news and press releases, along with special features on late-stage and discontinued projects.

Sept. 18 - 19

Baltimore Marriott Inner Harbor at Camden Yards

Baltimore, MD USA

The AUTM 2014 Eastern Region Meeting will gather more than 200 technology transfer professionals in Baltimore, MD to discuss best practices and strategies for industry-academia partnerships that culminate in successful product commercialization through company formation or licensing and other agreements.

Healthbox, a leading business accelerator focused on healthcare technology and technology-enabled companies, today confirmed it is taking its accelerator program to Salt Lake City this August. Through partnerships with innovative organizations Intermountain Healthcare and HealthEquity, in addition to Zion's Bank and BD (Becton, Dickinson and Company), Healthbox is sourcing companies, regardless of development stage, that meet the needs of a rapidly changing healthcare industry. The companies selected for the 16-week program will have unique access to Healthbox strategic partners, gaining an understanding of the key challenges plaguing these organizations and how to adapt their solutions to truly solve these challenges.

“We are thrilled to expand to Salt Lake City and build relationships with the local community. Utah has one of the fastest growing economies, and we believe there is a large opportunity to elevate the recognition of the area's talented healthcare entrepreneurs,” says Nina Nashif, founder and CEO of Healthbox. “As Healthbox continues to grow, it is important that we commit to communities with both strong local health economies and an interest in advancing innovation.”

The A. James Clark School of Engineering and the Maryland Technology Enterprise Institute (Mtech), an international leader in technology entrepreneurship education and venture creation, seeks a teaching faculty member to join its award-winning team.

Leveraging their experiences in technology entrepreneurship, the faculty member will teach approximately five courses per year, with an emphasis on undergraduates. Key topics may include customer discovery, marketing strategy, new product design and development, design for manufacturing, industrial design, concurrent engineering, and/or market development and commercialization.

The lecturer will be expected to use innovative teaching approaches to include collaborative learning, project based learning, flipped classroom, online learning, and civic engagement. This person will play an active role in collaborating with student entrepreneurs to launch new ventures.

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.”

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.

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:

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.

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.

When Mike Oberst walks through the doors of MedImmune in Gaithersburg each day, he resumes his important work on developing a newer, promising type of cancer treatment.

The scientist has focused his attention on immunotherapy as a way to eliminate cancer cells in patients. The treatment aims to harness the power of one’s immune system to fight cancer.

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.

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.

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).

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.”

The FLC invites you to submit images of your lab’s work for its 2015 planner! Why keep all of that hard work to yourself? Share it with the more than 10,000 planner recipients throughout the FLC community, including members of Congress, scientists, tech transfer professionals, and members of academia and industry. The FLC planner features an array of images displaying the innovative research and development that occur daily in our nation’s federal labs.

To submit images of your lab’s work, carefully read the submission criteria below. You also may want to coordinate your submission with, or through, your agency’s FLC representative or public affairs office.

Top pharmaceuticals face a dilemma in that many blockbuster drugs are losing patent protection and existing pipelines may not compensate for lost revenues. The choice for many is layoffs, office closings, downsizing or to innovate with new products. Most companies will do the former if they must but prefer the latter. Rather than the megamergers that achieve big cost savings through layoffs and factory closings, most drug companies are aiming for transactions that grow their bottom line. In the last few years, this trend has resulted in a complex series of deals and transactions, ranging from complete buyouts to licensing transactions to a variety of collaborative arrangements.

The Nasdaq Biotechnology Index (NBI) has been on a wild ride in 2014 with a 20 percent gain in the first two months, a 24 percent drop from late February to mid-April, and a rebound of 16 percent off April lows by early June. This recent sell-off follows a 130 percent gain over the last three years and the debut of 100 biotech IPOs, leading some investors to ask if the recent sell-off is the start of a bubble bursting.

Indeed, the biotech sector has been hot for the last couple of years, but there is very little evidence to support that biotech has been forming a bubble ready to pop.

Over the last two and a half years the National Science Foundation I-Corps has taught over 300 teams of scientists how to commercialize their technology and how to fail less, increasing their odds for commercial success.

After seeing the process work so well for scientists and engineers in the NSF, we hypothesized that we could increase productivity and stave the capital flight by helping Life Sciences startups build their companies more efficiently.

Just how valuable is "technology transfer" for universities?   This question is addressed in "More than Money: The Exponential Impact of Academic Technology Transfer," an article from the National Academy of Inventors (NAI) that examines the impact of landmark 1980 legislation that facilitated technology transfer from the academic inventors' "bench" to commercialization and the far-reaching and beneficial changes for universities and communities that have resulted.

A collaboration between the National Science Foundation (NSF) and the National Institutes of Health will give NIH-funded researchers training to help them evaluate their scientific discoveries for commercial potential, with the aim of accelerating biomedical innovations into applied health technologies.

I-Corps at NIH is a pilot of the NSF Innovation Corps (I-Corps) program specially tailored for biomedical research. Academic researchers and entrepreneurs with Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Phase I awards – awards that establish feasibility of proof of concept for commercializable technology – from participating NIH institutes will be eligible to apply to I-Corps at NIH. NIH will begin outreach to the small business research community with a June 25 program briefing at the 2014 BIO International Convention in San Diego, and a webinar on July 2.

The U.S. Food and Drug Administration on Tuesday issued proposed guidelines for the pharmaceutical and medical device industries for posting information on social media networks and correcting misinformation posted by others.

The long-awaited guidance would effectively limit the amount of product advertising a company can do on sites where character space is limited, such as Twitter.

At Novartis’s research lab in Cambridge, Massachusetts, a large incubator-like piece of equipment is helping give birth to a new era of psychiatric drug discovery. Inside it, bathed in soft light, lab plates hold living human stem cells; robotic arms systematically squirt nurturing compounds into the plates. Thanks to a series of techniques perfected over the last few years in labs around the world, such stem cells—capable of developing into specialized cell types—can now be created from skin cells. When stem cells derived from people with, say, autism or schizophrenia are grown inside the incubator, Novartis researchers can nudge them to develop into functioning brain cells by precisely varying the chemicals in the cell cultures.