149th Edition – May 5, 2015

BioHealth Innovation, Inc. (BHI), a public-private partnership and innovation intermediary is seeking an energetic and motivated life science professional for the role of an Entrepreneur-In-Residence (EIR) with product development experience and subject matter expertise in the fields of neurology and neuroscience. The EIR will reside within the National Institutes of Health (NIH) and will also support intramural and extramural initiatives on an as needed basis.

The EIR program was established at BioHealth Innovation to:

• Retain and bring entrepreneurial talent to the Maryland ecosystem
• Connect resources including institutions, technology assets, people and capital within Maryland that include federal institutions, labs, academic institutions, small businesses, disease foundations and the investor community
• Build/support sustainable life science startups that will add value within the healthcare system and also build upon the existing infrastructure

The EIR will work with BHI leadership to ensure that the activities and outcomes are aligned with BHIs strategic focus.

Emergent BioSolutions Inc. (EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved IXINITY(R) [coagulation factor IX (recombinant)], an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, >=12 years of age, with Hemophilia B. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.

Gaithersburg company to use funds to add staff and upgrade equipment to meet demand

Angela Graham, President and CEO, accepts check from DED’s Valerie Fremont and Gene Smith Quality Biological, Inc., an industry leader in manufactured ready-to-use biological research tools, has been awarded an EDF Grant by the Montgomery County Department of Economic Development (DED) to support the expansion of their fulfillment operations. The award, funded from the Montgomery County Economic Development Fund (EDF), will be used to upgrade and modernize equipment needed to meet requirements from local and regional customers. The company, headquartered in Gaithersburg, plans to add 10 new jobs as part of the expansion.

Strand Life Sciences, a global genomic profiling company that uses next generation sequencing technology to empower cancer care, today announced it has opened its U.S. operations center in Aurora, Colorado. This opening is in support of the company’s recent launch of the StrandAdvantage pan-cancer genomic profiling service.

Available now to physicians, StrandAdvantage was designed to accelerate the analysis of therapeutically actionable cancer genes and match them to relevant FDA-approved targeted cancer therapies and open clinical trials without the need for multiple tests.

Results Published in Clinical Vaccine Immunology Compares AdVAV Favorably Against Only Currently Licensed Alternative

Vaxin Inc., a clinical stage vaccine development company, today announced that a recently published study demonstrated that utilizing a single vaccination with the company’s AdVAVTM intranasal anthrax vaccine performs as well as the currently licensed Anthrax Vaccine Absorbed (AVA; BioThrax®), which requires two vaccinations. AdVAV is administered via an intranasal route rather than the intramuscular route of AVA. Intranasal delivery is generally believed to be a superior vaccination route because the mucosal immune response is important for protection, particularly against respiratory diseases. The study found that protection from aerosolized anthrax after a single dose of AdVAV was no worse than the protection afforded by multiple doses of AVA. Importantly, AdVAV produced protective antibody titers with earlier onset and greater persistence than AVA, suggesting that AdVAV may offer both rapid and long-lasting protection with just a single dose.

The Company: Noble Life Sciences (Gaithersburg, MD) is a rapidly growing contract research organization (CRO) that provides a continuum of preclinical drug, vaccine and medical device development services, from discovery to GLP-compliant studies for regulatory submissions. The company offers in vitro and in vivo services, including cellular and animal disease model development and experimental design, non-GLP and GLP animal efficacy, toxicity, biodistribution and product release studies in both small and large animals, and vivarium services. The company also offers custom antibody production services and research animal and tissue products.

The Company operates out of two Maryland-based facilities – in Gaithersburg and Woodbine where it operates as Spring Valley Laboratories, a unit of Noble Life Sciences, offering a range of GLP and non- GLP studies with a primary focus on GLP and large animal testing. Noble is AAALACi accredited, USDA licensed, OLAW compliant, FDA inspected and successfully audited by numerous clients.

The Position: The Director Account Development is a key position within the organization with significant prospects for career growth as the company continues to increase the breadth and scope of its business. This position reports directly to the President and is a member of the management team.

Twenty-four Maryland executives were named Maryland regional finalists for EY’s Entrepreneur of the Year.

The annual award program recognizes entrepreneurs who demonstrate excellence in innovation, financial performance and commitment to their businesses. Winners will be announced June 25 at a gala at the Baltimore Marriott Waterfront.

OrderUp Inc. CEO Chris Jeffery, Medifast CEO Michael MacDonald and Goodwill Industries of the Chesapeake Inc. CEO Lisa Rusyniak are among the Baltimore-area business leaders named as finalists.

AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.

Governor Larry Hogan today announced that he will sign into law 10 bills directly related to encouraging economic development and job growth in the state of Maryland. He will sign the bills into law at the next bill signing ceremony, to be held tomorrow, April 28, from 9 to 11 a.m.

“The following bills all address ways to improve the state’s business climate and make it easier for the hardworking men and women of our state to thrive and succeed,” said Governor Hogan. “The primary focus of my administration is to get Maryland open for business once again and create greater economic opportunity for our citizens, and I am proud to sign these bills into law.”

Given the complexity and difficulty of the challenges that government leaders face, encouraging innovation among their workers can pay dividends. Government-wide employee survey data, however, suggest that much more needs to be done to foster this type of culture at many federal organizations.

As bacterial infections are becoming more difficult to manage, new ways of targeting the pathogens have to be developed. Creating new antibiotics is one approach, but often the real issues is being able to identify which antibiotic will work. Today that takes days and involves guess work that often prevents a powerful early attack against the bacteria. Researchers at Johns Hopkins are now working on a new technology that will allow clinicians to identify the bacteria that is causing the infection and the antibiotic that will treat it.

Gaithersburg molecular diagnostics company OpGen Inc. intends to raise about $18.7 million in its initial public offering expected sometime this week.

That’s less than the $37.5 million the company indicated it would raise when it initially filed to go public last month. In their latest regulatory filing, officials said the company is offering 2.5 million units, each consisting of one share of common stock and one warrant to purchase one additional share of common stock within the next five years. OpGen anticipates an IPO share price of between $5.50 and $6.50.

U.S approval of GlaxoSmithKline’s newest respiratory inhaler continues the global drugmaker’s shift from the blockbuster drug Advair to a suite of drugs that will be assembled at the British company’s Zebulon manufacturing site.

GSK said Thursday the company and business partner Theravance won approval from the Food and Drug Administration to market Breo Ellipta for asthma. The drug had been approved in 2013 for chronic obstructive pulmonary disease, but it failed to win approval for sale to minors as GSK officials had hoped.

Montgomery College offers Summer 2015 classes designed to meet your entrepreneurial needs in support of your business ideas. For Aspiring Entrepreneurs: The Intentional Entrepreneur This one day class helps you identify your entrepreneurial skills and abilities, and addresses any concerns you may have about business ownership. This class is a must for anyone considering starting a business! For Early Stage Entrepreneurs: New Venture Designed specifically for the entrepreneurs in the early stages of business development. Please contact Karen Ambrose, Program Director at 240-567-2592 or e-mail: karen.ambrose@montgomerycollege.edu

CRISPR Therapeutics, a biopharmaceutical company focused on translating CRISPR-Cas9 gene-editing technology into transformative medicines, today announced the closing of a Series A and Series B financing totaling USD 89 million, including USD 35 million of new funding in the Series A and USD 29 million in the Series B. The oversubscribed Series A and Series B financings were led by strategic investors, SR One and Celgene Corporation, respectively, and included new investors New Enterprise Associates (NEA) and Abingworth, alongside the Company’s founding investor, Versant Ventures.

CRISPR Therapeutics has also announced changes to its Board of Directors. Simeon George, SR One, Ali Behbahani, NEA, and Kurt von Emster, Abingworth, will be joining Brad Bolzon, Tom Woiwode, and Chief Executive Officer, Rodger Novak.

When George Scangos took the helm at biotech giant Biogen in 2010, he took a look around the company’s headquarters in the Weston, Massachusetts, suburb of Boston and thought, “What are we doing out here?”

Last year, the company celebrated the return of its headquarters to Cambridge’s Kendall Square, one of the capital cities of the biotechnology industry. The neighborhood’s 2.5 square miles are home to 130 life sciences companies, according to industry group Massachusetts Biotechnology Council, the densest concentration on the planet.

Alexandria is in the enviable position of having a commercial real estate portfolio including embedded development opportunities at the crossroads of the innovation economy – in Cambridge, Massachusetts, San Francisco, and other markets experiencing positive demand. This unprecedented demand from life science and tech tenants is giving ARE significant pricing power – as demonstrated by not only strong SS NOI for the quarter at 7.8% (vs 6.7% Q4 14 and 4.3% Q1 14) but also via the leasing spreads on renewal at 30.8% GAAP and 18.5% cash in Q1 15 and guidance for 2015 leasing spreads at 8-10%. Q1 leasing spreads skewed much higher than guidance given one lease at Tech Square in Cambridge that increased 100%. Given limited supply in Cambridge and the timing of deliveries, ARE may be in a position, as mentioned on the call, to push rents on its Kendall Square development buildings higher than original pro forma. In 2015, ARE is allocating capital 47% Cambridge, 25% Mission Bay/SoMa and 10% Torrey Pines/UTC with the balance in Manhattan and Other.

District investor group NextGen Angels has raised $1 million from 24 of its members to finance expanding to two more cities.

The local angel group, which currently boasts 85 members, has a similar presence in New York City and very recently set up a Boston location. CEO Dan Mindus told me Austin and Chicago are the next two cities on the list, with 10 more cities slated in the next 12 to 18 months. Those include Atlanta, Philadelphia, Seattle, Portland and San Diego.

U.S. legislators recently released a discussion draft of the medical innovation bill known as the 21st Century Cures Initiative. The legislation aims to hasten the discovery, development, and delivery of new medical devices and drugs, particularly for the treatment of thousands of diseases for which there are no cures.

The proposals in the draft include ways to revamp how agencies such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) foster and regulate medical innovation in the U.S.

Having secured a funding boost for the National Institutes of Health in the 21st Century Cures legislation, House Democrats now say the Food and Drug Administration would be ill-equipped to handle the new burdens under the bill without more resources.

Rep. Frank Pallone (D-N.J.), the ranking member of the House Energy and Commerce Committee, raised the matter during a hearing Wednesday on the latest iteration of the legislative package, which is intended to accelerate the pace of innovation in medical drug and device development.

Fresh from unveiling a $3.1B fund, New Enterprise Associates is the sole investor in a $3 million Series A round by MORE Health. The health IT startup wants to connect Chinese doctors and their patients with U.S. specialists across areas such as oncology, neurology, cardiology and pediatrics.

As part of its investment, Xiaodong Jiang, managing director for NEA China, will take a seat on the company’s board of directors. NEA has been in the China market for 12 years and has invested about $400 million in 20 companies there.

The Federal Laboratory Consortium for Technology Transfer (FLC) is pleased to offer you a sneak peak at its new and improved branding. While the official unveiling of the new branding will take place at the 2015 national meeting, the FLC is eager to share exclusive insights into the new logo design and refreshed brand message with its members.

As the FLC looks forward to its 30th year after being chartered, the organization wanted to portray a more modern look and feel that reflects the progressive achievements and innovations of its member laboratories and research centers.

How well do you understand science?

Jon D. Miller, director of the International Center for the Advancement of Scientific Literacy at the University of Michigan at Ann Arbor, has been asking people in the United States and abroad that question since 1988.

The American Telemedicine Association (ATA) today released an update to two critical state policy reports which identified gaps in coverage and reimbursement, and physician practice standards and licensure.

“After ATA issued the State Telemedicine Gaps Reports last September, many state regulating bodies responded by looking at how their laws and regulations impact healthcare delivery in their state,” said Jonathan Linkous, CEO of ATA. “As a result of state actions across the nation, ATA reevaluated the indicators for each state and issued new reports. As before, we anticipate that these reports will serve as an incentive to increase the utilization of telemedicine to improve the accessibility, affordability and quality of healthcare.”

At DC Inno we are constantly on the look out for the next innovative local company. Over the past several months, one of the most interesting industries we have had the opportunity to cover is the virtual reality (VR) sector. Virtual reality is immensely cool and as a medium, it offers a host of exciting applications and uses. In the past, the technology was so expensive that it offered little to many consumers, but that is now changing. With the proliferation of new, consumer-targeted devices—like the Oculus Rift, Samsung Gear and Google Cardboard—more people are finally getting the opportunity to experience VR.

Bungalow Insurance won the $30,000 Perlman Grand Prize of the 2015 Wharton Business Plan Competition. The prize was awarded at the Wharton School’s annual Venture Finals on April 30, 2015, where student finalists received more than $128,000 in combined cash prizes and in-kind legal/accounting services.

Call it serendipity. When the management team behind Foundation Medical Partners decided to shift their investment strategy away from medical devices and therapeutics in favor of health IT, the name change to Flare Capital Partners coincided with an exit. IBM Watson snapped up its portfolio company Explorys in a big announcement at HIMSS this month. Explorys, a Cleveland Clinic spinout, is a predictive analytics company that amassed a huge amount of data to develop cognitive insights for clinical decision support.

“The timing was nice” but entirely coincidental, according to Flare Capital General Partner Michael Greeley who spoke to MedCity News in a phone interview Wednesday night.

1776 has made its second acquisition.

Just weeks after the surprise announcement of its Disruption Corp. purchase, the Washington, D.C., accelerator has acquired San Francisco-based Hattery, a co-working space that will give the company a foothold on the West Coast.

Women in tech in D.C. aren’t going anywhere. We’ve spent some time on these pages covering some amazing founders over the past two and a half years—Donna Harris, Carla Valdes, Glennette Clark, Shavanna Miller, Sara Capra and Veronica Eklund, Denise Tayloe, Elizabeth Bennett, and many, many others.

Here are three more Superwomen in Tech—a social marketer for one of D.C’s hottest startups, the president of DC Web Women, and the assistant director for open innovation in the White House Office of Science and Technology Policy—that “get it.” They know that they are working in male-dominated industries. They go to work every day and do their jobs. They network. But they take the time to connect with other people—particularly other women, sometimes in a volunteer capacity—to ensure that the people they meet get what they need. And the tech scene is better because of them.