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.

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.

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.

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.

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.

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.

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.

MAY 7-8, 2015 • BETHESDA NORTH MARRIOTT HOTEL & CONFERENCE CENTER

Sessions on cancer immunotherapeutics, RSV vaccines, HIV, TB, and malaria vaccines, and models for regional synergy in vaccine development all await you at the Atlantic Vaccines and Immunotherapeutics Summit on May 7-8 at the Bethesda North Marriott. Renowned speakers will be leading sessions highlighting local innovation that is having a global impact. We are excited to announce that Stanley Erck, President and CEO of Novavax, will be leading a session titled, “The Next Billion Dollar Vaccine.” Mr. Erck was named President and Chief Executive Officer of Novavax in April 2011. He became a Novavax Director in June 2009 and beginning in February 2010, served as its Executive Chairman of the Board. From 2000 to 2008, Mr. Erck was President and Chief Executive Officer of Iomai Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company, and through the development of a late-stage infectious disease product candidate. Prior to Iomai, Mr. Erck served as President and Chief Executive Officer of Procept, a publicly traded immunology company; as Vice President, Corporate Development at Integrated Genetics (now Genzyme), and in management positions within Baxter International. Mr. Erck currently sits on the Board of Directors of BioCryst Pharmaceuticals, MaxCyte, Inc., and the MdBio Foundation. 

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.

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.

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.

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.

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.

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

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: This email address is being protected from spambots. You need JavaScript enabled to view it.

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.

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.

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.

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.

he world's first malaria vaccine, produced by GlaxoSmithKline, could be approved by international regulators for use in Africa from October.

The final trial data showed that the shoe, called RTS, S offered partial protection for children for up to four years.

AstraZeneca and its global biologics research and development arm, MedImmune, announced that they have entered into an exclusive collaboration agreement with Celgene Corporation, a global leader in haematological cancers, for the development and commercialisation of MEDI4736 across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.

MEDI4736 is an investigational immune checkpoint inhibitor, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. Within the collaboration, MEDI4736 will be assessed both as monotherapy and in combination with other AstraZeneca and Celgene potential and existing cancer medicines. Over time, the collaboration could expand to include other assets.

ASTRAZENECA has paid $250m for the rights to develop an antibody that could help in the fight against cancer.

The pharmaceutical firm's research and development arm MedImmune, which is based in Cambridge, has entered into an agreement with Innate Pharma that will allow it exclusive access to the company's anti-NKG2A antibody.

Real estate firms, which have traditionally been slow to innovate, are beginning to embrace new technologies to find clever solutions to old problems. This newfound openness comes as millennials start to enter the workforce, creating a need for tools that appeal to a tech-savvy customer base.

“It’s pretty fascinating when you think about we’re 75 percent millennials in maybe a dozen years. Clearly technology’s going to have an incredibly important impact on real estate; the operation of real estate and what the tenants do and how they do it,” said Joel Marcus, the CEO of Alexandria Real Estate Properties, an REIT that specializes in science campuses.

Among this year’s Mentors-in-Residence at Johns Hopkins Technology Ventures are a senior-level biomedical executive, a chief executive at a company developing novel treatments for neurodegenerative diseases, a two-time medical device industry Most Valuable Thought Leader and an American Pain Foundation chairperson.

These are just four of the 14 entrepreneurial leaders serving at Johns Hopkins as Mentors-in-Residence in 2015, the second year of the program. All 14 mentors this year are business leaders, entrepreneurs and development-driven experts with a passion for innovation and growth.

Since 2003, the Johns Hopkins Alliance for Science and Technology Development has brought faculty members and investors together for an annual daylong meeting to foster important biotechnical and pharmaceutical developments.

This year, 14 faculty members or teams of faculty members from The Johns Hopkins University and seven from the University of Maryland, Baltimore, presented work, as did eight startups affiliated with each university. Four Johns Hopkins University researchers received monetary awards for translational development of their inventions at the April 20 annual joint meeting of the alliance and the University of Maryland, Baltimore’s Commercial Advisory Board.

United States-based New Enterprise Associates (NEA), which last week raised $3.1 billion in the world's largest venture capital fund, is looking to step up investments in India after going slow over the past two-three years. The venture capital fund, which has backed start-ups such as daily deals firm Groupon and online storage service Box in the US, has said that it will look to sharpen its focus on technology related themes.

Wed, May 6, 2015 2:00 PM - 3:00 PM EDT

This is an educational webinar on the NHLBI Phase IIB Bridge and Small Market funding opportunities to support continued development of SBIR/STTR Phase II projects focused on heart, lung, blood, or sleep technologies. The Small Market Awards support projects focused on rare diseases or for pediatric indications.

Phase IIB Bridge RFA-HL-16-009: http://1.usa.gov/1Deb9h5 Phase IIB Small Market RFA-HL-14-012: http://1.usa.gov/1p2cvbi

Presenters: Jennifer Shieh, PhD - NHLBI Small Business Coordinator Gary Robinson, PhD - NHLBI Business Development Advisor

The University of Maryland (UMD) and MakerBot, a global leader in the desktop 3D printing industry, will be holding a grand opening of the new MakerBot Innovation Center at UMD on April 23, 2015. UMD is the first in the Big Ten, and the first in the Baltimore-Washington Metropolitan area, to launch a MakerBot Innovation Center – a large-scale 3D printing installation that is designed to empower university faculty, students and organizations to innovate faster, increase collaboration and compete more effectively. Grand opening festivities will begin at 2:00 p.m., Thursday, April 23, at the University of Maryland, Technology Advancement Program Building, 387 Technology Drive, College Park, Maryland, with speeches from university staff and representatives from MakerBot.

Virginia will create a new online portal where researchers can post information about their biotech projects — information employers can then use for recruitment and investment opportunities, Gov. Terry McAuliffe said Thursday.

It’s among several specific investments the state needs to make to create a stronger life sciences industry, McAuliffe said. He was at the THRiVE 2015 conference, which attracted 350 bioscience leaders from across the state, to talk about how to better merge the commonwealth’s strength in big data with its growing biotech industry. The portal was among multiple ideas raised by an eager group of business leaders who sought more support from the state in their efforts to commercialize their work.

George Mason University unveiled its new $40 million Advanced Biomedical Research building Thursday, signaling its expansion in genomics and precision medicine research.

The university simultaneously renamed its Manassas campus its Science and Technology campus.

How much venture capital money is out there for healthcare start-ups?

Apparently, quite a bit.

According to a recent article in the Wall Street Journal, medical start-ups in the United States raised around $3.9 billion in venture capital during the first quarter of this year. Here are eight key trends from the report: