Senseonics, a privately held medical device company focused on the development and commercialization of the first fully implantable, long-term continuous glucose monitoring (CGM) system, announced that it has raised an additional $20 million of private equity financing.  Senseonics also announced that Mirasol Panlilio, formerly of Abbott Diabetes Care and LifeScan, has joined the company as Vice President of Global Sales and Marketing.  

Current investors Anthem Capital, Delphi Ventures, Greenspring Associates, Healthcare Ventures, New Enterprise Associates and other strategic partners all participated in the financing round.  Senseonics intends to use the proceeds to continue its product development initiatives including completing pivotal trials in Europe, obtaining CE mark, and initiating IDE trials in the United States. “We’re very happy of the continued support from our investors as we near the completion of the product development efforts for our first generation long-term CGM system, “ said Tim Goodnow, CEO and President.  Senseonics has recently begun its European pivotal trials and expect to complete site initiation of all seven European sites before the end of summer.

PETER PRONOVOST: The biggest misperception is certainty. When you receive a diagnosis from a doctor, we don’t always know for 100% sure if it is correct. In reality, medicine is an inexact science. In 2012, Johns Hopkins researchers, including myself, found that in intensive-care units alone, diagnostic errors may account for as many deaths as breast cancer in the U.S.

This is part of a growing body of research highlighting the need to focus on diagnostic accuracy. We need to create health-care systems in which learning is incorporated into daily practice, so that physicians can receive feedback on the accuracy of their diagnoses. We can do this by standardizing care around best practices and standardizing data collection regarding clinicians’ diagnoses and the results they get: Health information technology makes this possible.

DATE: June 13, 2014, 8:30 a.m.-5 p.m.

LOCATION: Institute for Bioscience and Biotechnology Research, University of Maryland, in Rockville, MD

Emerging Strategies for the Production and Characterization of Biosimilars

The biomanufacturing industry faces an unprecedented challenge with the emergence of biosimilars.  The pathway to approval for biosimilars is a fluid process and several key aspects are still not determined.  The University of Maryland and the National Institute of Standards and Technology (NIST) will deliver a one-day symposium on the current trends of characterization and production of biosimilars.  On Friday, June 13, 2014 at 8:30 am join the thought-leaders, policy-makers, and creators of biosimilars as we present current trends, ideas, and predictions.

In the translational medicine space -- where medical research is "translated" into health tools and solutions for patients -- the majority of engaged physicians are either biomedical researchers interested in advancing our understanding of the basic science, or are practicing doctors who want to improve clinical practice while focusing on patient care.

The number of physicians who receive training in understanding this translational research space is few, and even fewer are those who are able to take this skill set into the market to develop new technologies based off this understanding.

At Medgadget we speak with quite a few physicians-turned-entrepreneurs, and one of the most enthusiastic and impressive we’ve known is Dr. Amy Baxter. We first met Dr. Baxter at the AARP conference in Atlanta last October where she was showing off a simple, yet effective tool she developed for pain relief called “Buzzy.” There’s been a lot of, well, buzz about the device ever since she pitched it on Shark Tank and turned down the investors. Informed by her experiences as a pediatric emergency physician, Dr. Baxter took time out of her schedule to answer a few questions we had about the device and why she thinks everyone who experiences pain should have one.

Meet the humble “Magnetosperm,” a tiny, sperm-like robot with incredible potential in the medical world.

It’s approximately six times longer than a human sperm, and scientists at the American Institute of Physics say in a paper that Magnetosperm “technology could be used not only to help with fertilization, but also chemotherapy treatment.”

Disruptive change is now a fact of life for many industries. Healthcare is no exception. Although healthcare has been changing for decades—think about the introduction of diagnosis-related groups (DRGs) or the initial push toward managed care in the 1980s—the Affordable Care Act (ACA) promises to accelerate both the rate of change and the level of uncertainty confronting the industry. Payors face navigating a difficult transition: from an industry in which the customer is often a corporation or small company and the business is paying claims to one in which consumers make healthcare purchasing decisions, the direct provision of care may be necessary for success, and consumer and retail capabilities really matter. Furthermore, payors must make this transition amid regulatory and consumer uncertainty and in a fairly short time frame. This industry and business-model shift is on a scale that few companies and few sectors in the economy have been through.

MdBio Foundation is looking for solutions to build a diverse and highly qualified STEM workforce.  Read the latest from CEO Brian Gaines published in the Washington Business Journal.

Google turned heads last week when it disclosed that its workforce includes a troublingly low rate of women and minorities. We applaud Google for its leadership in sharing this data. The disclosure sparked national questions about the hiring practices at our most innovative companies.

The U.S. National Institutes of Health has awarded $25 million to the J. Craig Venter Institute to back an initiative to study infectious diseases like malaria and influenza at the genetic level to help find better treatments and preventive measures.

The institute, with offices in Maryland and California, will use the 5-year grant from NIH to establish the Genome Center for Infectious Diseases to study the genetic secrets of a wide range of bacteria, viruses and parasites, officials said on Thursday.

A biotech entrepreneur wants to arm physicians with an electronic companion diagnostic tool to help hospitals reduce hospital-acquired infections.

Last year, antibiotic-resistant infections caused more than two million illnesses and 23,000 deaths in the U.S. alone, according to the Centers for Disease Control. About 70 percent of those antibiotic-resistant infections were caused by hospital-acquired infections.

The Association of University Research Parks (AURP) and the Biotechnology Industry Organization (BIO) are pleased to invite you to attend the 2014 BIO International Convention to be held June 23-26, 2014 in San Diego. 

BIO 2014 is the largest venue for private company-to-company meetings ("partnering") in the world and offers tech transfer, licensing, and intellectual property professionals with unparalleled access to pharmaceutical and biotech companies, investors, and other potential partners from around the globe. According to the Campbell Alliance's Deal Makers' Intentions report from 2013, partnering events such as BIO 2014 drive the majority of successful deals in the biopharma industry.

Ventana Medical Systems, Inc. (Ventana), a member of the  Roche  Group and MedImmune, the global biologics research and development arm of AstraZeneca, today announced they are jointly developing a PD-L1 (SP263) immunohistochemistry assay to enroll patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This includes the recently commenced MEDI4736 ATLANTIC trial that will enroll only patients who express PD-L1 as determined by the VENTANA assay.

MEDI4736 is an investigational, engineered, human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1).   Signals from PD-L1 help tumors avoid detection by the immune system.   It is believed that by targeting PD-L1, MEDI4736 may block this ligand from sending out signals to T-cells to 'ignore' tumor cells, thereby countering cancer's immune-evading tactics.  

The University of Maryland, Baltimore County and the Chesapeake Innovation Center are teaming up to teach cyber entrepreneurs how to pitch to investors.

The seven-week program — Perfect Pitch — is scheduled to begin in September and conclude at the end of October. The program will end just before the start of the CyberMaryland Conference on Oct. 29.

Early June is Health Datapalooza time, and this year’s event was again a whirlwind of energy, insights, and over 2,000 very motivated and passionate health data enthusiasts (health datapaloozers doesn’t sound right). The hallway conversations provided tons of of pragmatic, productive and engaging conversations, inspired by keynotes and presentations from Todd Park, Bryan Sivak, Jeremy Hunt, Atul Gawande, Steve Case, Jerry Levin, Vinod Khosla, Kathleen Seblius, Dwayne Spradlin, Francis Collins, Fred Trotter, and many more (if you haven’t heard of some of them, look them up, it’s worth your time).  

The University Economic Development Association (UEDA) is currently seeking nominations for its annual Awards of Excellence program, which recognizes cutting edge university-based economic development initiatives from across the country. The Awards of Excellence Program recognizes higher education institutions and their partners who are transforming their campuses into engines of economic prosperity through creative initiatives in five categories:

1. Community Connected Campus: initiatives that promote the physical development of quality connected campuses and their surrounding communities;
2. Research and Analysis:  initiatives that enhance the capacity of colleges and universities to provide new forms of research and tools for community, economic and workforce development practitioners;
3. Leadership and Collaboration: initiatives that support the development of collaborative economic development strategies and the leaders required to implement them;
4. Innovation and Entrepreneurship: initiatives designed to support startups, high-growth companies and clusters within a region; and
5. Talent Development: initiatives that promote the development of 21st-century skills.

ERIC KING, 30, of Northern Liberties, is founder and CEO of Grand Round Table, a startup on 3rd Street near Market that develops software to help doctors make complicated diagnoses. GRT, which launched in 2012, is getting the correct diagnoses about 70 percent of the time. The company, which was part of the first DreamIt Health accelerator in 2013, has three full-time employees and has raised $110,000 from the Wharton Venture Initiation Program and Ben Franklin Technology Partners.

PRESENTER:

Karen Ambrose, Program Director, Business, Professional Licensure and Certification Programs
Montgomery College, Workforce Development and Continuing Education

ABSTRACT:

Montgomery College has joined with the world renowned Kauffman Foundation in support of current and future business owners before, during, and after the start-up process. Our plethora of courses is designed to meet the entrepreneurial needs of the aspiring business person and those who dream of business ownership.

Free monthly program offered through the Gateway to Innovation: Montgomery County Welcome Center for Federal and Academic Tech Transfer. For more information and additional calendar items, please visit TechTransferConnection.com. 

Engage with others in the tech transfer field by joining the Gateway to Innovation LinkedIn Group.

Johns Hopkins biomedical engineering students have designed a lightweight, easy-to-conceal shirtlike garment to deliver lifesaving shocks to patients experiencing serious heart problems. The students say their design improves upon a wearable defibrillator system that is already in use and should help persuade patients at risk for sudden cardiac arrest to wear the system around the clock.

"In two studies, up to 20 percent of patients who received the defibrillator garment that's already available did not keep it on all the time because of comfort and appearance issues, problems sleeping in it, and frequent 'maintenance alarms,' which occur when the device does not get a good signal from sensors on the patient's skin," says Sandya Subramanian, who led the undergraduate team that built the new prototype. "We set out to address these issues and design a device that heart patients would be more likely to wear for longer periods of time—because their lives may depend on it."

Rockville-based CytImmune Sciences Inc. has raised $400,000 from the Maryland Venture Fund, Montgomery County and an unnamed venture investor to push Aurimune — a drug that pairs a decades-old tumor-fighting agent with gold nanoparticles — into phase 2 trials.

The Maryland Venture Fund led the round with $200,000, with another $100,000 coming from the Montgomery County Department of Economic Development and the unidentified investor.

GSK, formerly Glaxo SmithKline, and the Philadelphia Foundation have announced a $5 million grant package available to non-profits which will lead to healthier lives.

It’s called the GSK IMPACT Grant. IMPACT stands for Innovative, Measured, Partnered, Accountable, Community Centered and Transformative. Katie Loovis is GSK’s director of Community Relations.

Simeon Taylor, MD, PhD, a seasoned pharmaceutical executive who has served in senior positions with Eli Lilly and Bristol-Meyers Squibb, has joined the University of Maryland, Baltimore (UMB) as industry liaison with its Center for Clinical Trials and Corporate Contracts (CCT).

In his new role for CCT, he will assist faculty in developing research strategies that will maximize corporate partnering and funding opportunities, and the possible creation of valuable intellectual property. CCT is part of the University's Office of Research and Development, and the part-time consultancy is funded in keeping with the University's 2011-2016 Strategic Plan

In this Hangout, we will discuss when a small business should contact the FDA, and what formal and informal mechanisms exist for device, drug, biologic, and diagnostic developers to obtain early advice from the FDA.

Mobile devices are revolutionizing the health care system for patients and medical providers. Using this new technology wisely and securely is the goal of the health information technology experts who talked about trends in the field during a Health IT Forum at the Johns Hopkins University Montgomery County Campus.

The Health IT Forum series, held four times a year, is a community partnership co-sponsored by Montgomery County Department of Economic Development, the TechCouncil of Maryland and the Montgomery County Chamber of Commerce. The May forum, titled “mHealth: Bring Your Own Device,” attracted dozens of IT experts from the region.

After a lengthy and somewhat contentious markup, the House Science, Space and Technology Committee approved the Frontiers in Innovation, Research, Science, and Technology (FIRST) Act (H.R. 4186) by a vote of 20-16 on May 28th. As discussed in previous editions of Capitol Update, the bill reauthorizes and prioritizes federal investments at the National Science Foundation (NSF) and the National Institute of Standards and Technology (NIST) by funding research and development (R&D) to address national needs. The bill also sets priorities to drive the nation's investments in science, technology, engineering and math (STEM) education programs.

The FIRST Act would require that the NSF publish a justification of each grant's scientific merits and relevance to the broad national interest in order to meet minimum standards of public accountability and transparency in its grant funding decisions. The FIRST Act does not change NSF's peer review process. Provisions of the FIRST Act also broadens the definition of STEM education to include computer science and supports student participation in nonprofit competitions, out-of-school activities and field experiences related to STEM.

More than a decade has passed since scientists completed the Human Genome Project, a worldwide effort to decode our DNA. That DNA sequence contains instructions for making all of the proteins that our bodies need to function.

Now researchers have cataloged the vast majority of those proteins, creating a dynamic map of the human body called the proteome.

Before coming into the program I would highly stress putting together a comprehensive product roadmap for the duration of the program as well as 2 months after. Start by splitting the upcoming 3 months into individual weeks & writing out goals both for the tech side (development, design, ux etc.) of the company as well as the business side (sales, fund raising, partnerships etc.). If possible have them written on a huge calendar for everyone in the company to see & be aware of.

Then go more granular and translate those weekly goals into individual tasks using any project management software, here I’d recommend Trello since its very intuitive, has great array of browser plugins to support different styles of task management & it’s totally free.

Qiagen announced a collaboration with Eli Lilly and Co. to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types. The agreement includes the development of tests that will be based on Qiagen’s multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and biomarkers in a single test.  

GlaxoSmithKline ($GSK) has already made some moves to sell off some of its older meds. But now, it's making more that could end up much, much bigger.

As Sky News reports, the pharma giant has solicited bids from a handful of private equity firms--Advent International, Blackstone and KKR included--for some or all of the 50 or so drugs in its established products portfolio, worth up to £7.5 billion ($12.6 billion). A spokesman for GSK told Sky the company is currently evaluating its options.

The University of Maryland's commitment to expanding science opportunities on campus could not be any more clear having now acquired a five-year, $1.2 million grant to further undergraduate science education from the Howard Hughes Medical Institute.

The College Park institution plans to use the grant to develop a new living-learning program for students enrolled in the biological and chemical sciences. It will include a residence hall with integrated support mentoring programs, community-building activities, co-enrollment in introductory science courses and advanced access to stellar hands-on research opportunities.

Once a year, all of the tech world stops to listen to what influential analyst Mary Meeker has to say. According to Meeker, current trends show a slight dip in internet user growth but she highlights that emerging markets are showing the fastest growth in terms of internet usage. This growth can be seen more rapidly in what she calls “difficult to monetise developing markets” like India, Indonesia and Nigeria.

Meeker, a partner at VC company Kleiner Perkins Caufield Byers (KPCB), unveiled her annual trends report at the Code Conference this week. The report highlights the disruption that is underway in areas like media consumption, education, healthcare, commerce, security, mobile and consumer apps. We have picked some key trends that we thought were worth highlighting.

GlaxoSmithKline (GSK.L) has invited private equity firms to consider making offers for a range of its older drugs sold in Western markets, according to three people with direct knowledge of the matter.

The move is part of a reshaping of the drugmaker's business, which also involves a major asset swap deal struck last month with Novartis (NOVN.VX).

Microsoft Ventures, Microsoft's startup investment arm, is to set up its first accelerator dedicated solely to companies in the cybersecurity area.

The four-month programme aims to provide startups with tools to succeed in business, from mentorship to help with development to marketing expertise. Companies that get through the program will have an opportunity to get $1m in funding, courtesy of Jerusalem Ventures Partners (JVP), which has partnered with Microsoft Ventures on the project.

The University of Maryland at College Park has a new Ferrari of a supercomputer, and it’s students who are taking it for a test drive.

Some 60 students enrolled in the university’s high-performance-computing boot camp, now in its second of two weeks, are the first to make use of Deepthought2, the newest supercomputer in higher education. The $4.2-million machine has a processing speed of about 300 teraflops, meaning it can complete up to 300 trillion operations per second, and it has a petabyte of storage. It is the equivalent of 10,000 laptops working together simultaneously, university officials say.

June 10, 2014 08:00 AM – 10:00 AM
Bethesda North Marriott Hotel & Conference Center

Maryland is home to the most innovative and fast growing life science companies in the world. Two of these companies have recently made a huge splash – Amplimmune and GlycoMimetics. Hear from the CEOs of each company about why being homegrown and staying in Maryland is a key ingredient to success and what their achievements through IPO and acquisition can mean for your company and our life science community as a whole.

Discussion topics include:

• The challenges faced – the stories behind the stories
• Choosing your path and having the path choose you
• Planning for adaptation
• IPO vs. acquisition

Graduates and current tenants of Baltimore accelerator the Emerging Technology Centers contribute almost $174 million in direct economic impact in Baltimore, according to a new report commissioned by the city.

About 63 percent of the ETC’s 76 graduate companies have stayed in Baltimore and generate about $108.5 million in economic activity. Those 48 companies employ 311 workers.