BHI Weekly Newsletter Archives

The company is just so much better known its medical countermeasures against biological threats like anthrax than for its cancer work, and that’s a problem.

United Therapeutics (Nasdaq: UTHR) is selling a voucher designed to speed up approval for rare pediatric disease treatments to Chicago-based pharmaceutical company AbbVie Inc. for a record $350 million.

The Wall Street Journal reports the Silver Spring-based biotechnology company landed the voucher when it received approval from the Food and Drug Administration for Unituxin, its drug designed to treat neuroblastoma.

This event is to gather interested small businesses seeking assistance from the Small Business Innovation Research grants program from the National Institutes of Health. This is a free event brought to you by BioHealth Innovation. Hear from the SBIR managers on current Institute funding priorities. Meet one-on-one with program managers regarding your current project. Learn of SBIR assistance provided by BioHealth Innovation.

Most consumers are familiar with the idea of probiotics — particularly when it comes to gastrointestinal health. But could they actually benefit HIV and AIDS patients?

That’s a question being examined in a medical probiotic product created by Gaithersburg startup ExeGi Pharma LLC. That product, Visbiome, is planned for launch this fall and was originally designed to help the treatment of patients with ailments such as ulcerative colitis or irritable bowel syndrome.

Novartis has agreed to buy all remaining rights to Ofatumumab from Britain’s GlaxoSmithKline for up to $1 billion, boosting the Swiss drugmaker’s stable of multiple sclerosis (MS) treatments.

Basel-based Novartis had previously acquired the rights to Ofatumumab for oncology indications, but it is currently being developed for relapsing remitting multiple sclerosis and other auto-immune conditions.

The world’s first malaria vaccine got a green light on Friday from European drugs regulators who recommended it should be licensed for use in babies in Africa at risk of the mosquito-borne disease.

The shot, called RTS,S or Mosquirix and developed by British drugmaker GlaxoSmithKline in partnership with the PATH Malaria Vaccine Initiative, would be the first licensed human vaccine against a parasitic disease and could help prevent millions of cases of malaria in countries that use it.

Cloud-based data company Inovalon Holdings will acquire D.C. health research and advisory firm Avalere Health in a deal worth $140 million, the companies announced Monday.

The move will enable Bowie-based Inovalon (Nasdaq: INOV) to expand into the pharmaceutical market and fuel growth in the use of big data analytics at life sciences companies, officials said. The deal is expected to close Sept. 1.

September 8th, Cattail Creek Country Club, Glenwood, MD

Biotech execs play for free in the tournament that will benefit The Little Things for Cancer & the Zaching Against Cancer Foundation organizations.

Welcome to the 2015 Biotech Invitational, a DogDenGolf managed event that is being supported by top executives at Medimmune, other Biotechnology companies and Vendors in the region. This year’s event will be held on September 8, 2015, at Cattail Creek Country Club in Glenwood, MD and will determine the Biotech Executive Golfers of the Year.

Proceeds from this event will benefit The Little Things for Cancer, a local non-profit providing support and services to cancer patients, and their caregivers. For detailed information on the programs and services that The Little Things provides, visit their website at www.tlt4c.org.

We are looking for the Most Rockin’ Business in the City!

Is it yours?

The 2nd Annual “Rockin’ in Rockville” Award is set to be handed out at this year’s REDI Resource Meetup (R2M) event in September.

This award, created to highlight the success, community engagement, and innovative practices of a Rockville-based company, is given out during Maryland Economic Development Week.

“The startup scene is starving for seed-stage investment right now.”

If you’ve ever spent time around a startup hub then you’ve probably heard some version of this comment before. Whether it’s currently the case in the D.C. area may be a fair question, and one that we’ve put to venture capitalists from some of the region’s most prominent firms—Revolution, New Atlantic Ventures and New Enterprise Associates.

TOPIC: “Innovating through the U.S. Economic Development Administration”

PRESENTER: Julie Lenzer Kirk, Director Office of Innovation and Entrepreneurship U.S. Economic Development Administration

ABSTRACT: Housed within the U.S. Economic Development Administration, the Office of Innovation and Entrepreneurship (OIE) works to foster a more innovative U.S. economy focused on turning new ideas and inventions into products and technologies that spur job growth and competitiveness while promoting economic development. Ms. Kirk will discuss OIE programs including: • Promoting and supporting high-growth entrepreneurship. • Accelerating commercialization of federally funded research. • Working with other agencies and the White House to collaborate on policies and programs to support entrepreneurship and commercialization. • Supporting the National Advisory Council on Innovation and Entrepreneurship (NACIE), which is chaired by the Secretary of Commerce. • Leading the $15 million 2014 Regional Innovation Strategies Program competition.

BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, is feeling a lot of positive momentum these days as it recently announced an additional $500,000 funding from GE and the NFL, and a host of new appointments intended to move the company forward.

In July, the company announced that it had received an additional $500,000 award from GE and the National Football League (NFL) to further enhance its portable concussion assessment system, as one of six final winners of the GE NFL Head Health Challenge I. In February 2014, Brainscope was selected as one of the initial 16 recipients from more than 400 entries from 27 countries of the up to $10 million Challenge, which was created by GE and the NFL to award entrants for proposals focusing on “identifying breakthrough technologies and approaches that will improve the diagnosis and prognosis of mild traumatic brain injury (TBI).”

Startup Maryland and LAUNCH! Annapolis today announced a teaming relationship under which both organizations present the 2015 Maryland Open Bloody-Mary and Crab-Soup Competitions. Contested over two rounds, the Maryland Open will be held during the Pitch Across Maryland tour and celebration of innovation and entrepreneurship.

Round One begins on Saturday, September 12 during a tailgate at the University of Maryland. Round One continues the following week Saturday, September 19 during a tailgate at the United States Naval Academy. The Final Round will be announced during the Pitch Across Maryland tour.

The WIB-DC/Baltimore Mentors, Advisors, and Peers (MAPs) Committee is thrilled to announce the initiation of our 1:1 Mentoring Program. This program is designed to match mentees in the early stages of their careers to mentors who can help guide them based on different areas of interest. We are looking for volunteers interested in being part of this new program.

Sara Nayeem will participate in the Biotechnology Industry Organization webinar entitled, “Capturing Investor Interest in a Hot Biotech Climate,” on Tuesday, August 18th at 1PM EST. The panel will explore the strong biotech market and answer questions from start-ups seeking funding in their venture.

The biotech market is stronger than ever with more than $5B invested in 2015 so far. With the influx of capital flowing in the biotech pools, the panel will advise startups on what to look for when interviewing investment firms, what due diligence is needed to find appropriate investment partners, and what steps a company should take to ensure that the partnership runs smoothly.

Google Inc. (NASDAQ:GOOG) is a major consumer technology developer and Internet services giant which is involved in an incredibly diverse array of innovative tech fields. The company is best known for its Internet search engine, which processes an average of about 40,000 search queries every second, but in our Companies We Follow series we’ve seen them develop everything from robots with humanoid personalities to medical emergency response drones. We’ve covered Google acquisitions that have pulled the company into the sphere of digital wallet tech as well as patenting activities in the field of autonomous vehicles. It’s clear that the tentacles of the corporate octopus that is Google stretch wide and far away from each other.

With the financial aid of a biotechnology executive whose daughter may need a lung transplant, U.S. researchers have been shattering records in xenotransplantation, or between-species organ transplants.

The researchers say they have kept a pig heart alive in a baboon for 945 days and also reported the longest-ever kidney swap between these species, lasting 136 days. The experiments used organs from pigs “humanized” with the addition of as many as five human genes, a strategy designed to stop organ rejection.

In the May 15, 2014, edition of the journal Nature, Floyd Romesberg’s chemistry lab at San Diego’s Scripps Research Institute published a paper titled “A Semi-Synthetic Organism with an Expanded Genetic Alphabet.” Romesberg and his colleagues had created a bacterium incorporating chemical building blocks that, as far as anybody knows, have never been part of any earthly life form.

There had been previous claims to “creating life.” Genome pioneer Craig Venter led a team that manufactured a genome for a germ that causes pneumonia in cows, but their effort used the familiar chemical bases of DNA, known by the letters A, G, C, and T. Romesberg’s group, on the other hand, added two additional letters, dubbed X and Y. When the bacteria successfully replicated X and Y in succeeding generations, Romesberg’s lab could claim to have made the first living thing with an expanded genetic code.

Bayer HealthCare has launched its own digital health accelerator program in Berlin, Germany called “Grants4Apps,” selecting five digital health startups from around the globe that will advance their business ideas and technology in areas such as hormone tests, patient adherence, breathing patterns, clinical trials and vitamin deficiency. The selected five digital health startups will receive financial support of up to 50,000 Euro and will work out of the company’s pharmaceutical division in Berlin. Over the next four months, the startups will work with Bayer executives and seasoned entrepreneurs

Durham venture capital fund Hatteras Venture Partners plans to announce Monday that it has raised more than $90 million for its fifth investment fund, giving it roughly 60 percent of its $150 million goal.

“We’re humbled and gratified that people would continue to have this level of confidence in us,” said Clay Thorp, co-founder and general partner.

Biotech MacroGenics Inc. is growing its footprint, recently leasing 122,000 square feet of wet lab space in the J. Craig Venter Institute in Rockville.

The clinical-stage biopharmaceutical company, which focuses on antibody-based therapies for cancer treatment and other diseases, will use the space for its commercial manufacturing of early clinical stage molecules, CEO Scott Koenig said.

Every year, around 8,000 people die waiting for an organ transplant. There just doesn’t seem to be enough human organs available for those who need them. Biotech company United Therapeutics has been investigating ways to grow pig organs to be used in humans, and in the four years its researchers have been working on it, the company has become the largest commercial backer of xenotransplantation (transplants between species) and has found some initial success.

Mere months after a major venture capital fundraise, Rockville-based biotech RegenxBio Inc. says it’s ready to go public. UPCOMING EVENTS AUGUST 18, 2015 , 11:45AM Washington Business Journal: Lead Generation Seminar

In an initial regulatory filing Monday with the Securities and Exchange Commission, the company said it would trade on the Nasdaq exchange under the ticker symbol RGNX. It has yet to say how much it plans to raise and set either a price for the stock or date for the initial public offering. Morgan Stanley & Co. LLC (NYSE: MS), BofA Merrill Lynch, Piper Jaffray and Chardan Capital Markets LLC will manage the IPO.

Emergent BioSolutions Inc. EBS, -1.75% today announced that the Centers for Disease Control and Prevention (CDC) has exercised options under contract 200-2012-52242 for the supply of Vaccinia Immune Globulin (VIGIV) into the U.S. Strategic National Stockpile. VIGIV is a therapeutic licensed by the U.S. Food and Drug Administration (FDA) for the treatment of complications due to smallpox vaccination. The contract options, valued at $44 million over two years, will require Emergent to collect plasma for future manufacturing in addition to current collection requirements, conduct manufacturing runs, and conduct additional activities in support of maintaining the FDA licensure of VIGIV.

Inovio Pharmaceuticals has begun collaboration and sold the exclusive rights to an HPV types 16 and 18 vaccine to MedImmune, the biologics research and development arm of AstraZeneca, for $700 million, according to a press release.

“[The] collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific, T-cell responses,” David Berman, MD, PhD, senior vice president and head of MedImmune’s oncology medicine development unit, said in the release.

Roche (ROG.VX) is buying U.S. diagnostics firm GeneWEAVE BioSciences for up to $425 million, expanding the Swiss group’s commitment to fighting so-called “superbugs” as the threat from drug-resistant microbes grows.

Roche said on Thursday it would pay shareholders in the privately held Californian company $190 million upfront and up to a further $235 million depending on the future success of its products.

Gliknik Inc., a privately held biopharmaceutical company, today announced that its licensee Pfizer Inc. (NYSE: PFE) has received notification from the U.S. Food and Drug Administration (FDA) that its autoimmune candidate drug GL-2045, a recombinant Intravenous Immune Globulin (IVIG)-mimetic, has been granted orphan drug designation for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

TOPIC: “Innovating through the U.S. Economic Development Administration”

PRESENTER: Julie Lenzer Kirk, Director Office of Innovation and Entrepreneurship U.S. Economic Development Administration

ABSTRACT: Housed within the U.S. Economic Development Administration, the Office of Innovation and Entrepreneurship (OIE) works to foster a more innovative U.S. economy focused on turning new ideas and inventions into products and technologies that spur job growth and competitiveness while promoting economic development. Ms. Kirk will discuss OIE programs including: • Promoting and supporting high-growth entrepreneurship. • Accelerating commercialization of federally funded research. • Working with other agencies and the White House to collaborate on policies and programs to support entrepreneurship and commercialization. • Supporting the National Advisory Council on Innovation and Entrepreneurship (NACIE), which is chaired by the Secretary of Commerce. • Leading the $15 million 2014 Regional Innovation Strategies Program competition.

Aeras announced today a new leadership structure for the nonprofit biotech organization with Jacqueline E. Shea, Ph.D., the current Chief Operating Officer (COO), assuming the role of Chief Executive Officer (CEO), effective August 12. Thomas G. Evans, M.D., will step down as CEO to become Acting Chief Scientific Officer (CSO). Ann M. Ginsberg, M.D., Ph.D., will continue as Chief Medical Officer.

Dr. Evans will serve as Acting CSO while Aeras considers how it wishes to fill the position permanently. “I am extremely happy that Dr. Shea will be leading Aeras as we continue our important work of tuberculosis (TB) vaccine development,” said Dr. Evans. “She is an outstanding choice and I am tremendously pleased to know that Aeras leadership will be in her capable hands. This is the right time for me and the organization to make this change, after five years with Aeras first as CSO, then CEO. As Acting CSO, I will be able to focus on the work I most enjoy. There is much unfinished work for me to do in the science arena, and I am looking forward to having the time to concentrate on a number of exciting TB projects.”

BioMark Diagnostics Inc. (“BioMark” or the “Company”) (CSE:BUX) (FSE:20B), a leader in next-generation diagnostics using metabolites, announces its strategy to expand operations into the U.S. with headquarters in Maryland’s world-class biotechnology center. “Expansion of operations into the U.S. market is a critical step in our growth plan,” said Rashid Ahmed, BioMark’s President and CEO. “This move will support our ability to build upon our leadership position in developing highly sensitive diagnostics that can detect cancer at its very early stages using our proprietary metabolite approach. We are making significant progress in strengthening the clinical validation for our metabolite approach and we are looking to build on the BioMark brand in the U.S. market.”

Scientists throughout are celebrating the scoop that the arena’s first vaccine towards malaria has been authorized by way of the .

The vaccine, named Mosquirix, used to be given the fairway gentle on Friday after , detailed in 230,000 pages of knowledge. It now signifies that the vaccine might be tested via the Global Well being Organisation and, if authorized, may well be administered to youngsters throughout Africa inside of the following few years.

WuXi PharmaTech (Cayman) Inc. (“WuXi” or the “Company”) (NYSE: WX), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries with operations in China and the United States, today announced that it has entered into a definitive Agreement and Plan of Merger (the “Merger Agreement”) with New WuXi Life Science Limited (“Parent”) and WuXi Merger Limited (“Merger Sub”), a wholly owned subsidiary of Parent.

It turns out that bacteria could hold a key to transforming how doctors treat disease — at least that’s what Editas, a privately held company that just raised $120 million from investors including Bill Gates, seems to think.

First, a bit of background Editas was founded in 2013 through $43 million in venture funding from the likes of Flagship Ventures and Polaris Partners and the company is researching a fascinating gene-editing technique based on the immune system of bacteria.

Entrepreneurs who want to pitch their business plan to Steve Case when his Rise of the Rest venture tour comes to Baltimore next month should start preparing now. A pitch competition with a $100,000 prize will be a highlight of the tour’s Sept. 28 stop in Baltimore. The contest starts before entrepreneurs hit the stage — in other cities more than 100 entrepreneurs have applied to the contest. Eight are selected to pitch their business to Case and a panel of local judges.

Announcing the Buzz of BIO: Recognizing the most innovative companies at the 2015 BIO Investor Forum™

Are you an early-stage company looking for your next financing round, or a late-stage private company hoping to make the valuable connection needed to take your product to the next phase? Nominate your company to be the Buzz of BIO at this year’s BIO Investor Forum.

Winners receive complimentary conference registration, a Company Presentation and promotion to industry leaders including a spotlight in BioCentury Extra.

You can now use 3D printing to create items using a wide range of filaments, and not just plastics. Metals, edibles, bio and construction materials are just some of the examples that are being developed for 3D printing.

So it shouldn’t come as a surprise when the U.S. Food and Drug Administration (FDA) approved Spritam, an epilepsy medication made using 3D printers.

Healthcare, agriculture, and manufacturing remain the bread and butter of the private sector in Madison, WI, and the surrounding region, but healthcare IT has arguably become the area’s most buzz-worthy industry.

Today, Xconomy is adding to the conversation about healthtech’s ascent in the local economy. A new analysis of data gathered by the Madison Region Economic Partnership (MadREP) found that there are at least 43 healthtech companies in Dane County employing around 10,000 people. (The list may not be comprehensive, so e-mail us if we missed any companies.)

A new analysis of data from the 2012 National Health Interview Survey (NHIS) has found that most American adults have experienced some level of pain, from brief to more lasting pain, and from relatively minor to more severe pain. The analysis helps to unravel the complexities of a Nation in pain. It found that an estimated 25.3 million adults (11.2 percent) had pain every day for the preceding 3 months. Nearly 40 million adults (17.6 percent) experience severe levels of pain. Those with severe pain are also likely to have worse health status. The analysis was funded by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) and was published in The Journal of Pain.

IBM says that Watson, its artificial-intelligence technology, can use advanced computer vision to process huge volumes of medical images. Now Watson has its sights set on using this ability to help doctors diagnose diseases faster and more accurately.

Last week IBM announced it would buy Merge Healthcare for a billion dollars. If the deal is finalized, this would be the third health-care data company IBM has bought this year (see “Meet the Health-Care Company IBM Needed to Make Watson More Insightful”). Merge specializes in handling all kinds of medical images, and its service is used by more than 7,500 hospitals and clinics in the United States, as well as clinical research organizations and pharmaceutical companies. Shahram Ebadollahi, vice president of innovation and chief science officer for IBM’s Watson Health Group, says the acquisition is part of an effort to draw on many different data sources, including anonymized, text-based medical records, to help physicians make treatment decisions.

Emergent BioSolutions Inc. (NYSE:EBS) today announced that its Board of Directors has authorized management to pursue a tax-free spin-off of the company’s Biosciences business into a separate, stand-alone publicly-traded company. The spin-off is expected to create two independent public companies with distinct strategic plans, growth strategies, and operational and development priorities.

The new Biosciences company, to be named at a later date, will focus on providing novel oncology and hematology therapeutics to meaningfully improve patients’ lives. The core technology of the Biosciences company will be its ADAPTIR platform applied to immuno-oncology. Emergent BioSolutions will continue to operate as a global specialty biopharmaceutical company whose core business is focused on providing specialty products for civilian and military populations that address intentional and naturally emerging public health threats.

Gaithersburg-based biotech MedImmune entered an exclusive license agreement to work on vaccines targeting cancers caused by human papillomavirus, or HPV.

Under the agreement, announced Monday, MedImmune — the biologics research and development arm of U.K. pharmaceutical giant AstraZeneca (NYSE: AZN) – will collaborate with immunotherapy company Inovio Pharmeuticals. Inovio’s “INO-3112” immunotherapy generates killer T-cell responses to destroy tumors associated with HPV. It is in Phase I and II clinical trials for cervical, head and neck cancers.

In response to a request from the Congress, NIH is developing a 5-year NIH-wide Strategic Plan to advance its mission to support research in pursuit of fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to extend healthy life and reduce illness and disability. Senior leadership and staff from all 27 Institutes, Centers, and Offices (ICOs) are contributing to the proposed direction and content of the Strategic Plan, with input from the Advisory Committee to the Director, NIH. The framework below identifies crosscutting areas of research exemplifying the breadth of ICOs’ priorities and aims to outline a set of unifying principles to guide NIH in pursuit of its mission. The goal of this larger NIH-wide strategic plan is not to outline the myriad of important research opportunities for specific disease applications (as that is covered in the strategic plans from each of the ICOs, which will be referenced appropriately), but to highlight major trans-NIH themes. The Strategic Plan is due to the Congress in late December 2015.

MedImmune, a global biologics R&D arm of AstraZeneca, has entered into an exclusive clinical trial collaboration with Mirati Therapeutics, US-based oncology firm focusing on genetic and epigenetic drivers of cancer.

As part of the deal, a Phase I/II trial will be conducted to evaluate the safety and efficacy of MedImmune’s durvalumab (MEDI4736) in combination with Mirati’s mocetinostat in patients with non-small cell lung cancer (NSCLC), with the potential to explore additional indications in the future.

We told you Tuesday about the first-ever White House demo day on Tuesday, which featured 32 early- to growth-stage companies sharing their personal stories and demonstrating their technologies.

And now, some prizes: Six Greater Washington accelerators were awarded prizes from the Small Business Administration, the SBA announced. It was part of a $4.4 million national program encouraging entrepreneurship, according to the SBA.

Blood is one of those things Americans take for granted.

Here, when patients are rushed to the hospital after an accident and are losing a lot of blood, we assume the hospital will have units of donated blood ready to hook up when the ambulance arrives. We don’t think about how much each unit of blood costs — yes, it has a price — because we have health insurance that pays the bill.

Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, and BioChain, an early cancer diagnostic company with operations in both USA and China and Epigenomics’ exclusive strategic commercialization partner in China, today announced that testing based on the proprietary Septin9 biomarker was included in the Chinese Guideline on Screening, Endoscopic Diagnosis and Treatment of Early Colorectal Cancer (CRC).

After 10 years as a successful veterinarian, Ignacio “Nacho” Pino decided to dedicate himself to work that could bring state-of-the-art biotechnology research to his home of Puerto Rico.

CDI Laboratories—a company he founded in 2008 along with Johns Hopkins University researchers Heng Zhu and Seth Blackshaw, JHU professor emeritus Jef Boeke, and two others (Dan Eichinger and Joe Bonaventura)—aims to produce research-grade protein and antibody products that support scientific research on cancer, autoimmunity, and infectious diseases. The company is one of more than 30 startups being showcased in Washington, D.C., today as part of the first-ever White House Demo Day, which will highlight the work of a diverse group of entrepreneurs from across the country.

AstraZeneca Plc and Isis Pharmaceuticals Inc. will work together, expanding an earlier collaboration, to seek gene therapy treatments for diseases affecting the heart, kidneys and the body’s metabolism.

AstraZeneca agreed to pay Isis an upfront fee of $65 million plus development and regulatory milestones for each program that the London-based drugmaker advances to clinical development, the companies said in a statement. Isis, based in Carlsbad, California, will earn tiered double-digit royalties on annual sales of each program.

Bye bye, ‘burbs. Vasoptic Medical is officially a city company now.

The medical device startup, which is making a device that allows primary-care doctors to give diabetes patients eye exams rather than making an extra trip to the eye doctor, completed its move from Columbia to Locust Point. The company’s new office is within Mindgrub’s climbing-wall-outfitted space near McHenry Row.

Secretary of Commerce Penny Pritzker announced the launch of the Economic Development Administration’s (EDA) 2015 Regional Innovation Strategies (RIS) Program competition to spur innovation capacity-building activities in regions across the nation. Under the 2015 announcement, SBA will commit $10 million for two funding opportunities:

Positive results of Symbiomix Therapeutics’ first pivotal trial for lead drug candidate SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV), were presented today at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting in Portland, Oregon. The results from the multi-center, randomized Phase 2 trial showed that a single oral dose of SYM-1219 met the trial’s primary endpoint of Clinical Outcome Responder and was well tolerated for the treatment of BV. Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company plans to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA). A second pivotal trial of SYM-1219 is currently enrolling patients, with targeted completion by the end of 2015. If the second pivotal trial is successful, an NDA could be submitted in mid-2016.

Originally the national headquarters for WIB, the “Washington DC/Baltimore” chapter officially became its own chapter in October 2011. Located along the I-270 Corridor in Maryland and also covering DC, Northern Virginia and the greater Baltimore area, this setting is central to what Governor Martin O’Malley called, “one of the largest bioscience clusters in the nation, perhaps in the world.”

The WIB-Washington DC/Baltimore Chapter community is dedicated to creating opportunities and careers for women in the life science industry and to encouraging women in our region to translate novel discoveries into products. Our chapter symbolizes the significance of promoting the dynamic women in the biotechnology and life sciences industry in this area and globally. Our membership consists of professionals at leading pharmaceutical, biotechnology, device and diagnostics companies, non-profits, academic institutions, and support service companies, including law firms, consultants, and financial service firms.

GSK and Save the Children have launched their third annual $1 million healthcare innovation award that rewards innovations in healthcare that have helped to reduce child deaths in developing countries.

Organisations from across developing countries can nominate examples of innovative health approaches they have implemented till September 7, 2015. These approaches must have resulted in tangible improvements to under five child survival rates, be sustainable and have the potential to be scaled-up and replicated.

Illumina, Inc. ILMN, today announced Illumina Accelerator—the world’s first business accelerator focused solely on creating an innovation ecosystem for the genomics industry—has selected three new startups for its second funding cycle. Selected from a competitive pool of highly qualified applicants, the new startups from across the globe are spurring genomics innovation in healthcare, agriculture, and the winemaking industry.

This paper is a final project from the NIH Foundation for Advanced Education in the Sciences course — TECH 566: Biotechnology Management

Starting up a company is a risky endeavor. From listening to the FAES 566’s course panel discussions this semester, it is clear that there are many challenges a Chief Executive Officer (CEO) will face and try to overcome while starting up and exiting his/her company. Fortunately, we also learned that there are numerous resources available to assist new entrepreneurs in developing strategies for management, funding, technology transactions, and approaches to exit, to name a few.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices:

• Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice
• (NOT-OD-15-128) National Institutes of Health
• Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards): Updated Notice
• (NOT-OD-15-129) National Institutes of Health|
• Findings of Research Misconduct
• (NOT-OD-15-131) National Institutes of Health
• Subscribe to Receive NIH eRA Service Information
• (NOT-OD-15-132) National Institutes of Health
• Notice to Modify RFA-RM-13-006 “NIH Pioneer Award Program (DP1)” regarding the Award Budget, Biographical Sketch, and Research Strategy
• (NOT-RM-15-015)NIH Roadmap Initiatives
• Notice to Modify RFA-RM-13-007 “NIH Director’s New Innovator Award Program (DP2)” regarding Biographical Sketch and Research Strategy
• (NOT-RM-15-016) NIH Roadmap Initiatives

Program Announcements:

• Discovery of Genetic Basis of Monogenic Heart, Lung, Blood, and Sleep Disorders (X01)
• (PAR-15-314) National Heart, Lung, and Blood Institute
• Application Receipt/Submission Date(s): October 20, 2015; June 15, 2016; June 15, 2017; June 15, 2018 , by 5:00 PM local time of applicant organization.

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

During a tour to Paris, Bruce Springsteen explained that his dream was for the US to adapt a Swedish style welfare state. The famous musician is far from alone in idealizing Nordic policies. The four Nordic nations (Denmark, Finland, Norway and Sweden) are often regarded as prime role-models the policies to be emulated by others. Internationally, advocates of left of centre policies view these countries as examples of how high tax social democratic systems are viable and successful. Paul Krugman, for example, has said: “Every time I read someone talking about the ‘collapsing welfare states of Europe’, I have this urge to take that person on a forced walking tour of Stockholm”.

Baltimore will be the first stop for billionaire investor and entrepreneur Steve Case, who in September kicks off a $1 million investment round.

Case, CEO of the Washington, D.C., venture firm Revolution, plans to invest $1 million in startups in cities that are off the beaten path for most venture capitalists. The Rise of the Rest bus tour kicks off Sept. 28 in Baltimore and will make stops in Philadelphia, Buffalo and Manchester and Portland, Maine.

Mobile health tools will be “a powerful equalizer” in terms of geographic health disparities, according to executives from the Aetna Foundation.

Aetna Foundation leaders Dr. Garth Graham, MaryLynn Ostrowski and Alyse Sabina said in a post on the Health Affairs blog:

Ever heard of a hospital setting up a digital health operation within a single center of excellence? We hadn’t, either, until this week, when the Temple Lung Center at Temple University Health System in Philadelphia announced the establishment of the Center for Digital Health.

Dr. Gerard Criner, founding chair of Temple’s Department of Thoracic Medicine and Surgery, which started up in February, leads the Center for Digital Health. He also founded and continues to serve as chairman of HGE Health Care Solutions, a Temple spinoff that has built a mobile app that helps clinicians manage patients with chronic obstructive pulmonary disorder.

Apparently, requiring scientists to state their objectives ahead of time makes a big difference.

Around 2000, the U.S. government ordered researchers conducting clinical trials with federal money to announce ahead of time which medical question they were hoping to answer.

Relevant Health, a newly launched innovative health technology startup accelerator focused on bringing products to market, announced that it is now accepting applications from health tech startups for its Fall 2015 class. Additionally, the accelerator launched its website and the portal to its streamlined application process. U.S. and international startups are encouraged to apply.

Relevant Health’s five-month program involves an intensive product-focused curriculum that gives founders of health tech startups the skills to define, develop, position and launch a viable health tech product. The new accelerator will be based out of a brand-new cowork space in the Rockville Innovation Center, centrally located in the heart of the Montgomery County (Maryland) life sciences corridor. Companies admitted to the accelerator will have access to the cowork facility along with other support that includes up to $50,000 in funding, mentorship, development support from a pool of software engineers, and access to the local health tech ecosystem.

Emergent BioSolutions Inc. (NYSE:EBS) today announced that it is launching a ruggedized, military-grade auto-injector device, known as Emergard™, which is designed for intramuscular self-injection of antidotes and other emergency response medical treatments that can address exposure to certain chemical agents and other similar emerging threats. Emergard is not approved by the U.S. Food and Drug Administration (FDA) and is not currently marketed in the U.S., although the company intends to pursue FDA approval of the device. The company has received preliminary interest for Emergard from countries outside the U.S. and anticipates making its first deliveries in limited quantities in Q4 2015.

Tom Sadowski, president and CEO of the Economic Alliance of Greater Baltimore, joins the Baltimore Metropolitan Council (BMC) Board of Directors as a representative appointed by Governor Larry Hogan.

“It is imperative that our planning efforts complement economic development activity as we work to promote prosperity in the Baltimore region,” said Michael B. Kelly, executive director of the Baltimore Metropolitan Council. “In Tom Sadowski, BMC’s Board of Directors gains a wealth of knowledge and experience – especially in fostering and maintaining regional partnerships and promoting positive economic development initiatives. We look forward to working with him.”

Chevy Chase-based New Enterprise Associates ranked among the VC firms with the best exits (meaning biggest acquisitions and initial public offerings) between 2009 and 2015, according to a new report from CB Insights.

Silicon Valley firms Sequoia Capital and Accel Partners were also included at the top of the list.

MedImmune has received a state award recognizing the company’s commitment to environmentally conscious practices.

Maryland’s Green Registry announced Thursday that MedImmune was one of its five 2015 Leadership Award winners.

A gel being developed in the lab at Johns Hopkins University is designed to make all signs of wounds disappear.

Gemstone Biotherapeutics, which focuses on wound care, grew out of the research of Hopkins engineering professor Sharon Gerecht. The winner of Hopkins’ first-ever President’s Frontier Award, Gerecht’s work is focused on tissue repair.

GenArraytion, Inc., is pleased to announce a manufacturing license agreement with Chemring Detection Systems, Inc. (“CDS”), a subsidiary of Chemring Sensors & Electronic Systems (CSES) and part of Chemring Group PLC (“Chemring”), in support of the development of the Commercial-Off-the-Shelf (COTS) Athina Consumable Cartridge product. GenArraytion will provide a highly multiplexed molecular assay panel on Luminex magnetic beads that will detect multiple biological warfare agents in a single reaction as part of the Athina Consumable Cartridge solution.

CDS was awarded a $14,934,533 cost-plus-incentive-fee incrementally funded JBTDS contract with options last month. The Athina product technology is the basis for the awarded JBTDS solution. Fiscal year 2015 research, development, testing and evaluation funds in the amount of $4,456,639 were obligated at the time of the award. CSES was granted the contract after an evaluation and selection process that began in early 2014.

MedImmune Gaithersburg CampusMedimmune Way Gaithersburg, MD 20878

Thursday, August 20, 2015 from 3:00 PM to 5:00 PM (EDT)

Event is open to Post-Docs & Professional Scientists currently work in the Therapeutic Areas of:

• Oncology
• Respiratory, Inflammation & Autoimmunity
• Cardiovascular & Metabolic Diseases
• Infectious Diseases & Vaccines
• Related scientific disciplines

Business roles who support the groups above should also register!

Event will include music, lawn games, hors d’oeuvres, and drinks

Newt Fowler, a longtime advisor and business planner for Baltimore entrepreneurs and investors, has been named chair of the Maryland Technology Development Corp.

Fowler, a business transactions partner with Baltimore’s Womble Carlyle LLP, is among four officers elected by the 15-member board of directors.

Silver Spring-based United Therapeutics’ quarterly sales got a boost from its newest treatment for pulmonary arterial hypertension, while higher research and development costs, and a bigger payroll, dragged down the bottom line.

United Therapeutics had second quarter revenue of $347.2 million, up 7.5 percent from $322.8 million in revenue in the same quarter a year earlier. Net income was $99.2 million, or $1.91 per share, compared to net income of $111.9 million, or $2.10 per share a year ago.

The term ‘translational sciences’ means different things to different people. For MedImmune, the global biologics research and development arm of AstraZeneca, the term refers to our expertise in accelerating drug development through the careful selection of the right patients in early clinical trials. As recently shared by Dr. Bahija Jallal, Executive Vice President, AstraZenenca, and Head of MedImmune at the recent ‘ON Helix’ translational research conference hosted by One Nucleus, translational science is a mind-set that’s embedded throughout MedImmune.

The federal government is attempting to ensure that doctors don’t inadvertently compromise patient data when they use smartphones to access electronic health records.

The National Institutes of Standards in Technology this week released a step-by-step guide for hospitals and IT professionals, listing ways to secure the connection between devices and electronic health records.

Maryland Technology Development Corp.’s new board chair, Newt Fowler, is stepping in as the investment agency’s responsibility grows five-fold.

TEDCO this year will take over disparate investment programs from Maryland’s Department of Business and Economic Development, most notably the state’s Maryland Venture Fund. All told, the shift will put an additional $100 million under TEDCO’s management beginning Oct. 1.

A recent Kauffman Foundation study found that year-over-year startup activity in the U.S. increased in 2015 for the first time in five years and showed the largest increase in more than 20 years. This is particularly good news from an employment perspective because new firms create the vast majority of net new jobs. And, fortunately for the Greater Baltimore market, Maryland is recognized as a leader in innovation. When compared to other Northeast Corridor metros, Greater Baltimore has historically had a greater startup rate than Boston and Philadelphia.

The Pentagon today awarded its years-in-the-making multibillion contract to upgrade its electronic health records system, to defense IT firm Leidos, which partnered with electronic health record vendor Cerner and Accenture Federal.

The Defense Healthcare Management Systems Modernization contract’s base value is $4.3 billion over 10 years, with an expected 18-year lifecycle value of $9 billion, and will put Leidos in charge of building a next-generation health records system responsible for DOD’s 9.6 million beneficiaries.

Three American universities are set to conduct wide-ranging research on cryptocurrencies using roughly $3m in grant funding from the National Science Foundation, a US government agency that supports and funds scientific research.

Cornell, the University of Maryland and the University of California Berkeley will focus on developing new cryptocurrency systems that, according to principal investigator Elaine Shi, will address “pain points” attributed to bitcoin and other existing networks.

Three venture firms stand out in a new study by CB Insight of who consistently enjoyed the biggest exits — IPOs or sales — of their portfolio companies.

Sequoia Capital, Accel Partners and New Enterprise Associates had at least five of the top exits in two windows used in the study. They were the only ones to be in the top five for both periods used in the CB Insights research.

Three Maryland colleges cracked the top 100 of the 2015 Forbes’ Top Colleges list.

The schools and their rankings on the list are:

No. 27: U.S. Naval Academy No. 62: Johns Hopkins University No. 93: University of Maryland, College Park

The world population is continuing to grow for various reasons, and it’s growing fast.

A recent report released by the United Nations revealed that the current world population is 7.3 billion, is expected to reach 8.5 billion by 2030, 9.7 billion in 2050 and 11.2 billion in 2100.

Today Startup Maryland announced updates to the schedule (September 12 – October 2) and the rough route for the Pitch Across Maryland, the fourth annual state-wide tour and celebration of entrepreneurship and high-growth startup companies.

The Pitch Across Maryland tour will again traverse the state all in the name of celebrating Maryland’s diverse communities of venture building. A sampling of details, key data and results from previous tours follow:

Developing lab research into the foundations of a profitable biotech company has always been a high-risk, high-reward business.

Deerfield Management, a New York-based healthcare investor with more than $5 billion under management and two decades of experience, has created a new $550 million fund that targets early stage science from academic medical centers and hospitals. The fund is specifically focused on innovative treatments for genetic disorders, cancer, and orphan diseases.

Relevant Health, a newly launched innovative health technology startup accelerator focused on bringing products to market, announced that it is now accepting applications from health tech startups for its Fall 2015 class. Additionally, the accelerator launched its website and the portal to its streamlined application process. U.S. and international startups are encouraged to apply.

Relevant Health’s five-month program involves an intensive product-focused curriculum that gives founders of health tech startups the skills to define, develop, position and launch a viable health tech product. The new accelerator will be based out of a brand-new cowork space in the Rockville Innovation Center, centrally located in the heart of the Montgomery County (Maryland) life sciences corridor. Companies admitted to the accelerator will have access to the cowork facility along with other support that includes up to $50,000 in funding, mentorship, development support from a pool of software engineers, and access to the local health tech ecosystem.

Baxalta Incorporated, a $6 billion global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has completed the acquisition of the Oncaspar (pegaspargase) portfolio from Sigma-Tau Finanziaria S.p.A.

The acquisition includes Oncaspar, an important biologic treatment for patients with acute lymphoblastic leukemia (ALL), the novel investigational biologic calaspargase pegol, and established global clinical and commercial resources. Baxalta previously announced plans to acquire the portfolio for approximately $900 million.

MedImmune, the global biologics research and development arm of AstraZeneca, and the University of Sheffield announced today that they have entered into a multi-project research collaboration to generate breakthrough research in cell factory technology, the process by which living cells can be controlled and manipulated to make specific proteins with therapeutic benefits.

As part of the five-year collaboration, MedImmune will provide funding and in-kind contributions to support University of Sheffield post-doctoral and doctoral research projects to address key challenges in cell engineering. The aim is to produce tools to ensure that manufacturing success is “designed in” from a much earlier stage than occurs with current screening-based strategies, to improve the development and production of biologic medicines. The collaboration will focus on harnessing expertise from both MedImmune and the world-leading group in the University’s Advanced Biomanufacturing Centre to advance research specifically in mammalian cell factories.

Vaxin Inc. today announced that it has added key patents to its expanding Intellectual Property (IP) portfolio. The clinical stage vaccine and immunotherapeutics company confirmed that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for two patents that protect important elements of its Densigen platform technology for immunotherapeutic treatment of Hepatitis B virus infection, and its RespirVec non-invasive adenoviral vector influenza vaccine. The patents include U.S. Application Serial No. 13/977,265 (the ‘265 application) entitled “Fluorocarbon-Linked Peptide Formulation”, and U.S. Application Serial No. 13/426,037 (the ‘037 application) entitled “Rapid and Prolonged Immunologic-Therapeutic”.

A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. Vaxin now has 37 patents protecting its products in 13 countries.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:Notices:

• Request for Information (RFI): Inviting Comments and Suggestions on the Environmental influences on Child Health Outcomes (ECHO) Program (the National Children’s Study Alternative)
• (NOT-OD-15-117) National Institutes of Health

Request for Applications:

• Collaborative Projects to Accelerate Research in Organ Fibrosis (R01)
• (RFA-HL-16-003)
• National Heart, Lung, and Blood Institute
• Application Receipt Date(s): October 22, 2015 and October 21, 2016, by 5:00 PM local time of applicant organization.
• Sickle Cell Disease Implementation Consortium (SCDIC): Using Implementation Science to Optimize Care of Adolescents and Adults with Sickle Cell Disease (U01)
• (RFA-HL-16-010)
• National Heart, Lung, and Blood Institute
• Application Receipt Date(s): November 12, 2015
• Data Coordinating Center for Sickle Cell Disease Implementation Consortium (SCDIC): Using Implementation Science to Optimize Care of Adolescents and Adults with Sickle Cell Disease (U24)
• (RFA-HL-16-011)
• National Heart, Lung, and Blood Institute
• Application Receipt Date(s): November 12, 2015
• Facile Methods and Technologies for Synthesis of Biomedically Relevant Carbohydrates (U01)
• (RFA-RM-15-007)
• NIH Roadmap Initiatives
• Application Receipt Date(s): October 15, 2015
• Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and their Functions (R21)
• (RFA-RM-15-008)
• NIH Roadmap Initiatives
• Application Receipt Date(s): October 15, 2015
• Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and their Functions (U01)
• (RFA-RM-15-009)
• NIH Roadmap Initiatives
• Application Receipt Date(s): October 15, 2015

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

I’m a huge fan of R&D collaborations between pharma and academia, so I should be thrilled by Sanofi’s latest tie-up with seven top-tier centers – so why do I have mixed feelings?

On first glance, there’s a lot to like: Sanofi has committed $2.4M per year to seven top centers, including Johns Hopkins, Brigham and Women’s Hospital, and Columbia, to fund about 20-25 seed projects annually, with no strings attached and a wide-open scope. Who knows what will emerge – but it won’t take much for this to look like a pretty good investment for Sanofi.

The truism about biopharma being a global industry has never been truer than when it comes to the top 20 IPOs for the first half of this year.

The U.S. had exactly half of the therapeutic, diagnostics, and tools/tech IPOs that were completed or began trading their first shares on public markets during January-June 2015. The rest of the world accounted for the other half, with Europe being home to seven of the 10 ex-U.S. top IPOs, followed by China, Canada, and Bermuda with one each.

Jobs in science, technology, engineering and mathematics (STEM) represent some of the best opportunities for workers in today’s economy. The work can be rewarding as well as coming with high pay and good benefits (like a 401(k) and health insurance). Diversity in STEM, however is a problem, one that has captured the attention of CEOs like Jeff Bezos and policymakers including the president himself.

Synthetic Biologics, Inc. (nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares in the offering are to be sold by Synthetic Biologics. The Company intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the share amount sold to cover over-allotments, if any. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The White House is getting ready to honor five years since the creation of Challenge.gov — the central web portal for government competitions intended to spur innovation and solve problems — with a forward-looking celebration.

Touting the $72 million in prizes awarded across 400 challenges in the last five years, the Office of Science and Technology Policy announced a special event this fall that will highlight some of the major breakthroughs and civic issues solved through the program.

The University of Maryland students who join the Startup Shell incubator are all working hard to turn their ideas into successful businesses. As the new executive director of Startup Shell, 20-year-old Chris Szeluga is working just as hard to help make that possible. Now in his third year at UMd, the finance major has been involved in helping grow Startup Shell since it began, during his freshman year. His new role puts a new responsibilities on him though, making Startup Shell rather more than just a club or hobby.

“I consider Startup Shell to be pretty much my full-time job,” Szeluga said. “I definitely spend at least 30 to 40 hours a week working on it in some way.”

Venture-backed biotechs continue their blistering pace of funding. According to the latest MoneyTree Report from PricewaterhouseCoopers (PwC) and the National Venture Capital Association (NVCA), with data from Thomson Reuters, over $2.1B was invested in biotech companies in 2Q 2015, bringing the year to date total to almost $4B(covered here, here). Four of the last five quarters are amongst the largest record-setting quarters in ten years.

It’s one of the best periods for biotech funding in the history of the industry, offering an opportunity for emerging companies to scale and develop their pipelines more significantly than ever before.

It is no secret that 2015 has been a highly active year for deal-making in the life science space. However, what is often overlooked is exactly where in the space those deals are taking place. Life Science Nation’s financing rounds database contains detailed information on over 250 of these rounds that have taken place since January 1 of 2015. We track this data from a variety of sources however as many companies and investors chose not to disclose this information this should be viewed as a sample of the entire data set of financings. With this article will highlight what our data tells us about the rounds that have taken place thus far in 2015 for therapeutics companies around the globe.

Johns Hopkins University tops the list of private, non-government employers in the Baltimore region, although three of the top five Baltimore-area employers are health systems — an unsurprising fact given that most workers in the Baltimore area are in health care or education.

Health care and education employees make up 19 percent of workers in the Baltimore area, more than any other supersector, according to May data from the U.S. Bureau of Labor Statistics. Still, there are large employers of many different industry types in the Baltimore area. Subscribers can check out the full list here.

The shift from fully integrated pharmaceutical companies (FIPCOs) to virtually integrated pharma companies (VIPCOs) has made biopharmas more reliant on external R&D. Often, that external R&D comes from startups nurtured through the venture funds of biopharma giants.

This year’s List offers three significant changes since last year’s ranking of corporate venture funds. One is the exclusion of Novo Ventures and Novo Seeds from the list, since the funds do not invest for the benefit for Novo Nordisk, but for its holding company Novo A/S.

Bioscience companies up to 7 years old can now apply for state funding that was formerly available only to younger companies.

BioInnovation Connecticut, managed by Connecticut Innovations, a state financing entity, invests in bioscience companies to speed the path to commercialization through its CT Bioscience Innovation Fund. Until July 1, only companies 3 years old and younger were eligible to apply, said Margaret Cartiera, vice president and fund manager for BioInnovation CT.

Since Medicaid’s creation in 1965, it’s become the largest health insurer in the country, covering more than 70 million Americans. Initially covering only poor, single parents and their children, the program now also offers government-subsidized insurance to disabled people, able-bodied adults without kids and some elderly.

The program’s expansion may slow down a bit, but it’s not likely to stop anytime soon, and there’s a whole lot of reform going on, along with major shifts in coverage.

It was Coney Island in the early 1900’s. Beyond the Four-Legged Woman, the sword swallowers, and “Lionel the Lion-Faced Man,” was an entirely different exhibit: rows of tiny, premature human babies living in glass incubators.

Barkers, including a young Cary Grant, called out to passersby, enticing visitors to come see the preemies.

Researchers who are developing miniature models of human organs on plastic chips have touted the nascent technology as a way to replace animal models. Although that goal is still far off, it is starting to come into focus as large pharmaceutical companies begin using these in vitro systems in drug development.

“We are pretty excited about the interest we get from pharma,” says Paul Vulto, co-founder of the biotechnology company Mimetas in Leiden, the Netherlands. “It’s much quicker than I’d expected.” His company is currently working with a consortium of three large pharmaceutical companies that are testing drugs on Mimetas’s kidney-on-a-chip. At the Organ-on-a-Chip World Congress in Boston, Massachusetts, last week, Mimetas was one among many drug and biotechnology firms and academic researchers showing off the latest advances in miniature model organs that respond to drugs and diseases in the same way that human organs such as heart and liver do.

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) awards a two-year $19.7M contract to Emergent Biosystems (NYSE:EBS) to develop and manufacture cGMP (current good manufacturing practice) lots of three Ebola monoclonal antibodies in CHO (Chinese hamster ovary) cell lines at a scale of 2,000 liters.

Mayo Clinic in Jacksonville, Florida, and United Therapeutics Corporation (NASDAQ: UTHR) today announced a collaboration to build and operate a lung restoration center on the Mayo campus. The goal is to significantly increase the volume of lungs for transplantation by preserving and restoring selected marginal donor lungs, making them viable for transplantation. The restored lungs will be made available to patients at Mayo Clinic and other transplant centers throughout the United States.

The Francis Crick Institute, the UK’s newest biomedical research facility, and GSK, the UK’s largest pharmaceutical company, are to partner on an open innovation collaboration exploring new avenues of medical research and drug discovery across a broad range of diseases, with a view to achieving breakthroughs in the understanding of human disease.

This is the first collaboration to be established between the Crick and a pharmaceutical company.

We are excited to be returning to Growlers in Gaithersburg this month for BioBuzz MoCo with our Sponsor Maryland Innovation Initiative (MII), a TEDCO program, as we host one of their “Meet TEDCO Program Managers Happy Hour“. The networking event will feature a short presentation followed by happy hour allowing you to network with program managers and your peers. MII is designed to foster the transition of promising technologies with significant commercial potential from the Maryland academic research institutions: Johns Hopkins, Morgan State, and University of Maryland College Park, Baltimore and Baltimore County campuses. The program is designed to promote commercialization of research conducted in the partnership universities and to leverage each institution’s strengths.

Johns Hopkins works not only to foster startups whose products have the potential to improve the well-being of people all over the world, but also to produce savvy investors with business acumen and a strong sense of market dynamics.

Earlier this year, a team of Johns Hopkins University graduate student investors-in-training won the Entrepreneurs’ Choice award at the 2015 mid-Atlantic regional final of the Global Venture Capital Investment Competition (VCIC), during which judges evaluate the competencies of teams of student venture capitalists.

William (Brit) Kirwan has been a top university administrator over nearly three decades of vast change in higher education.

During that time he’s seen the rise of online learning, a change in the funding dynamic of public colleges, an increased emphasis on obtaining a college education and much, much more. The 77-year-old Kirwan retired last month from his 13-year chancellorship of the University System of Maryland.

Symptoms associated with Parkinson’s disease include tremor, muscle stiffness, and slowed movement that make it difficult to execute such simple tasks as holding an eating utensil steady, and patients currently have few options for relief outside of a hospital or clinic. Some medications can help, but over time they tend to become less effective. To give Parkinson’s patients another in-home option, a research team of Johns Hopkins University graduate students have invented a headband-shaped device that delivers noninvasive brain stimulation to help suppress symptoms.

Last fall, David Narrow and his colleagues reached a critical juncture in the development of their fledgling medical technology company, Sonavex. As Narrow puts it, their brainchild needed nurturing, and a suitable—and affordable—environment for it to happen in.

The company’s core concept, he says, was worth the TLC. Narrow and Johns Hopkins Hospital plastic surgeon resident Devin O’Brien Coon, who met while studying in Johns Hopkins’ biomedical engineering graduate program in the Whiting School’s Center for Bioengineering Innovation and Design, had identified a clinical problem that needed addressing. Each year, more than 550,000 people in the United States undergo medical procedures—soft-tissue reconstruction, organ transplants, bypass surgeries—in which arteries or veins are surgically connected, exposing the patient to the risk of a blood clot. Detecting the clot in a timely manner, before it blocks the vessels and leads to catastrophic complications, becomes paramount. What’s needed, Narrow says, is a real-time clot-monitoring device that can be used by nurses post-surgery.

The May 15 groundbreaking ceremony for Johns Hopkins Technology Ventures’ new FastForward East location at 1812 Ashland Ave. was about more than just the much-needed additional space the new location will provide the innovation hub.

The ceremony represented the robust growth of the Johns Hopkins innovation culture that is driving economic development in Baltimore, and it signified Baltimore’s strong prospects for becoming a home for tech-savvy companies, offering a wide range of new jobs to Baltimore residents and cultivating a booming, technology-based economy.

American companies continued to attract eye-watering sums of money from venture capitalists in the last quarter, according to a report released Friday.

U.S. firms picked up more than $17 billion in 1,189 deals through the second quarter of 2015, the highest amount since 2000, according to the report by PricewaterhouseCoopers and the National Venture Capital Association, which is based on data from Thomson Reuters.

Sharath Mekala’s two-person tech startup isn’t a textbook government contractor.

Village Defense, spawned through a startup incubator called 1776, develops a free app that lets neighbors send real-time alerts to one another if they notice suspicious activity. A premium version, which costs $125 a month, is designed for homeowners associations.

Wednesday, July 22, 2015, 10:00am – 12:30pm

Throwing a perfect pitch to potential investors is a skill. Learn how to develop a concise description of your business along with some tips for presenting it. This is an interactive workshop where you will have the opportunity to present and pitch. Fee: $25.

Wednesday, July 22, 2015, 04:30pm – 06:30pm

Dr. Gordon Dammann, DDS, founder of the National Museum of Civil War Medicine (NMCWM), will be available to discuss the importance of Frederick both strategically and medically in the Civil War. He will also offer a brief history of the NMCWM. The museum exhibits will be open to visit during the event.

July 14-15, 2015 – Bethesda, MD

MedCity ENGAGE has quickly become a destination for fresh thinking and the latest solutions for patient engagement and healthcare delivery. That’s due in large part to speakers who are both established and up-and-coming leaders, and includes those in the trenches of healthcare.

Here are just some of the ENGAGE speakers, who will cover an array of topics that will make you better able to implement your own patient engagement solutions.

Trophogen, Inc., a U.S.-based emerging biotechnology company founded in 2001, today announced that it was awarded the second year of its Phase 2 Fast Track component of $756,000 for a Small Business Innovation Research (SBIR) Award from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop novel VEGF analogs for targeted imaging of undifferentiated thyroid cancer. The two principal investigators, Dr. Mariusz W. Szkudlinski, Vice-President & CSO and Dr. Bruce D. Weintraub, President and CEO, have now brought their total NIH and FDA highly competitive SBIR funded grants to 10 for a total of nearly $10 million.

The Government of the Republic of Equatorial Guinea announced an agreement with industry partners, Marathon Oil Corporation, Noble Energy Inc. and AMPCO, to sponsor the clinical development of Sanaria® PfSPZ Vaccine against malaria, including a series of clinical trials from 2015 until 2018.

Malaria is one of the leading causes of infant and childhood mortality in the world, particularly in Africa. The World Health Organization estimated that in 2013 there were 198 million clinical cases and 584,000 deaths caused by malaria, primarily by Plasmodium falciparum malaria. Malaria directly reduces the Gross Domestic Product of African countries by at least 1 percent annually. This economic impact is estimated based on lives lost, healthcare costs, reduced learning capabilities by students, loss of worker productivity, and a range of other factors.

Baltimore gene analysis firm Personal Genome Diagnostics Inc. has raised $4.32 million in a larger financing round underway.

The new funding is a convertible note that is part of a Series A financing round the company expects to complete later this year. Officials declined to give details about investors, the total amount the company seeks to raise or a timeline for closing the round.

Southern Research has been awarded a seven-year contract of up to $22 million to support research that could contribute to the cure of HIV disease. Under this contract, Southern Research will develop and standardize assays that quantitate latent reservoirs of HIV.

“This is a revolutionary area in HIV research that is opening up new avenues for us in infectious diseases,” said Southern Research President and CEO Art Tipton, Ph.D. “It supports our 24-year legacy in HIV drug discovery and development for government and pharmaceutical clients.”

BD (Becton, Dickinson and Company) and Guidepoint today announced BD & Guidepoint Mentor, a new program providing selected start-up healthcare companies with free access to Guidepoint’s expert network services.

BD is currently mentoring several start-ups that are developing cutting-edge technologies to improve healthcare delivery and outcomes and, with the help of a dedicated Guidepoint research manager, each start-up entrepreneur will be able to directly engage with industry experts across the entire healthcare ecosystem, gaining insights that help them shape their strategic plans.

GlaxoSmithKline is bringing on board the University of California, San Diego School of Medicine and Moores Cancer Centre to work on a programme aimed at eradicating cancer stem cells to treat leukaemia and other diseases.

The bench-to-bedside project is part of GSK’s Discovery Partnerships with Academia programme, where academic partners become core members of drug-discovery teams to expedite promising basic research into drug discovery and development.

The Johns Hopkins University Applied Physics Laboratory (APL) has provided critical contributions to critical challenges with systems engineering and integration, technology research and development, and analysis. Our scientists, engineers, and analysts serve as trusted advisors and technical experts to the government, ensuring the reliability of complex technologies that safeguard our nation’s security and advance the frontiers of space. We also maintain independent research and development programs that pioneer and explore emerging technologies and concepts to address future national priorities.

The U.S. House of Representatives voted overwhelmingly today in favor of a bipartisan bill that would speed the development of lifesaving drugs and medical devices and provide additional funding for biomedical research.

The bill, called the 21st Century Cures Act, includes provisions that attempt to make the drug approval process less unwieldy and also calls for an additional $8.75 billion in funding for the National Institutes of Health. The bill passed by a 344-77 vote on Friday morning; it now moves to the Senate.

Learn about the Target Product Profile (TPP) – a tool used by many biomedical innovators to define, stage, and allocate resources to different aspects of product development work, to frame discussions with stakeholder groups, and to track regulatory interactions and milestones.

Ask questions via the chat window during the live event!

Dina Link may not be a household name, but she holds one of the most important jobs in the American economy: high school science teacher. At Northwest High School in Germantown, Md., she helps mold the next generation of scientists so that they can compete for jobs in an economy dominated by science, technology, engineering and math, or STEM.

The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System is now accepting proposals for its “Make Your Medical Device Pitch for Kids!” competition. Two top prizes of $50,000 each will be awarded to the winning presentations at the Third Annual Pediatric Surgical Innovation Symposium in October.

The competition invites proposals from innovators – researchers, entrepreneurs, clinicians, and patient families – who have identified a significant, yet unmet medical device need within the pediatric population. For competition details, click here.

Secretary of Commerce Mike Gill is looking for an energetic and focused individual to lead the State’s activities in the life sciences arena. This is a highly collaborative role. Its objective is to advance Maryland as the premier center for biotechnology innovation and entrepreneurial vitality in the nation. The position is based within the Department of Business and Economic Development, and reports to the Managing Director of Business and Industry Sector Development.

We are excited to be returning to Growlers in Gaithersburg this month for BioBuzz MoCo with our Sponsor Maryland Innovation Initiative (MII), a TEDCO program, as we host one of their “Meet TEDCO Program Managers Happy Hour“. The networking event will feature a short presentation followed by happy hour allowing you to network with program managers and your peers. MII is designed to foster the transition of promising technologies with significant commercial potential from the Maryland academic research institutions: Johns Hopkins, Morgan State, and University of Maryland College Park, Baltimore and Baltimore County campuses. The program is designed to promote commercialization of research conducted in the partnership universities and to leverage each institution’s strengths.

This morning as the House considers H.R. 6, the 21st Century Cures Act, more than 100 patient groups and organizations are voicing their support for the bill’s Innovation Fund to help boost research and support scientists. Chairman Fred Upton (R-MI) has led this effort for a year and a half, keeping patients at the forefront from the beginning. Speaking in support of the bill last night, Upton said, “There is not a single person in this chamber or watching at home today who has not been touched by disease in some way. And it’s time we did something about it.” H.R. 6 is that something. The patient groups listed below voiced their opposition to any attempts to undermine these investments.

Tuesday, July 14th, 12 p.m. ET

In Silicon Valley, Big Data drives decisions. In health care, half the country runs on paper charts. In Silicon Valley, the biggest tech companies collaborate to drive innovation. In health care, applications barely talk to each other.

According to athenahealth EVP and COO, Ed Park, that needs to change. In this special webinar event, he’ll discuss:

Relevant Health, a newly launched innovative health technology startup accelerator focused on bringing products to market, announced that it is now accepting applications from health tech startups for its Fall 2015 class. Additionally, the accelerator launched its website and the portal to its streamlined application process. U.S. and international startups are encouraged to apply.

Relevant Health’s five-month program involves an intensive product-focused curriculum that gives founders of health tech startups the skills to define, develop, position and launch a viable health tech product. The new accelerator will be based out of a brand-new cowork space in the Rockville Innovation Center, centrally located in the heart of the Montgomery County (Maryland) life sciences corridor. Companies admitted to the accelerator will have access to the cowork facility along with other support that includes up to $50,000 in funding, mentorship, development support from a pool of software engineers, and access to the local health tech ecosystem.

MedCity ENGAGE has quickly become a destination for fresh thinking and the latest solutions for patient engagement and healthcare delivery. That’s due in large part to speakers who are both established and up-and-coming leaders, and includes those in the trenches of healthcare.

Here are just some of the ENGAGE speakers, who will cover an array of topics that will make you better able to implement your own patient engagement solutions.

Johns Hopkins University and University of Maryland, College Park, will this month open a shared $30 million high-power data center.

The 3,786-square-foot facility, called Maryland Advanced Research Computing Center (MARCC) will be used by researchers from the two universities for work involving big data and is expected to be fully functional by the end of July. The facility, located near Johns Hopkins Bayview Medical Center in Baltimore, was paid for with $30 million in state funding. Hopkins and University of Maryland will share ongoing costs for maintenance, staffing and power.

While we’ve seen how 3D printing has dramatically revolutionized the medical industry by allowing surgeons to print replicas of organs and their surrounding areas in order to better understand them before an actual surgical procedure, the next evolutionary step is to look into 3D printing the organs themselves to replace a patient’s existing failing organ.

Chancellor of the University System of Maryland William “Brit” E. Kirwan is serving his last day of his 13-year tenure Tuesday before Robert L. Caret takes over on July 1.

Caret is returning to Maryland after serving as president of the University of Massachusetts system. He was president of Towson Univeristy from 2003 to 2011.

Montgomery County Department of Economic Development offers a program that provides free one-on-one business assistance to entrepreneurs, business owners, and start-ups.

A business development specialist will be available at locations throughout Montgomery County to meet directly with business owners. Experts will provide information about county financial initiatives and other programs, make introductions and identify the connections your business needs.

This program is open to any entrepreneur and/or business located within Montgomery County. Montgomery County works hard to support local businesses and has a variety of resources including industry sector experts in IT, cybersecurity, life sciences, green, international, government contracting, and more. Support is also available for navigating the county procurement and Local Small Business Reserve Program.

REDI…SET…WATCH…5 Questions with Michael Stiefvater, Business Development Manager at Rockville REDI

The University of Maryland is part of the reason that Maryland, as a state, is producing some really innovative entrepreneurial talent. Their student-run incubator and co-working space Startup Shell (shell, because the UMD mascot is the Terrapin -very clever, guys), which opened in 2012, is home to a lot of really interesting student-led projects. Most of the startups focus on students’ issues or problems related to fields that students are studying.

Has your lab had a successful technology partnership or program experience with its state or local government office? If so, we want to hear about it! The Federal Laboratory Consortium for Technology Transfer (FLC) is now accepting submissions for its 2015 edition of the Federal Laboratories & State and Local Governments: Partners for Technology Transfer Success publication.

The goal of this publication is to highlight the value that state and local government entities can obtain for their regions by forming strategic partnerships with federal laboratories. Federal labs play a significant role in creating technology-based regional economic development. The State & Local Government (S&LG) publication works to raise awareness about the impact federal labs can have on their surrounding areas.

Innovator of the Year was created in 2002 to honor Maryland businesses and/or individuals who have had a positive effect and tremendous impact in Maryland.

To nominate someone for this prestigious award, please submit a short description addressing how your nominee meets the criteria.

Nominations are due July 10, 2015.

A process that accelerates the separation of bacteria could be the answer to the food industry’s prayers.

Food contamination, which refers to the presence of unwanted chemicals and bacteria in food, has been plastered across the news lately. Dozens of products have been recalled in the past 60 days. For example, Blue Bell Creameries had a massive recall of all ice cream products due to an April listeria outbreak, according to the FDA’s website.

Over the past two weeks, in their respective FY 2016 Labor, Health and Human Services, and Related Agencies appropriations bills (known as Labor-H), House and Senate appropriators have shown support for biomedical research funding by recommending NIH budget levels higher than even the Administration had requested. But controversy still reigns over other parts of the bill, particularly patient-centered outcomes research associated with the Affordable Care Act.

eHealth Initiatives’s iTHRIVE Innovation Challenge, August 12-13 in Washington DC, is a competition and event that convenes business leaders, government officials, innovators, investors and promising entrepreneurs looking to shape how health technology can improve the quality, safety, and efficiency of healthcare. The Challenge invites startups from around the world to submit proposals that tackle healthcare system problems head-on, focusing on three critical areas of the eHealth Initiative 2020 Roadmap: consumer-oriented health IT; population health management; and interoperability between providers, payers and across the delivery system.

If you have an idea about how health technology can improve the quality, safety and efficiency of healthcare, notice gaps in the system that offer easy fixes, or wish to share your vision for better healthcare delivery, join the competition and the conversation.

External models of R&D innovation are the rage in Pharma today, as they should be – the future of our industry depends on a great deal more rather than less collaboration.

In a very healthy way, lots of experiments are being done across the ecosystem and the final scorecard for what worked and what didn’t is years from being tallied up; however, the early biomarkers are positive and it’s a widely-held belief that a critical element of exceptional R&D organizations in the future will be creative BD engagement. In short, great BD and R&D are becoming synonymous with each other.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest: Notices:

Notice of Correction to PAR-15-280 “Multidisciplinary Studies of HIV/AIDS and Aging (R01)”(NOT-AG-15-009) National Institute on Aging Notice of Correction to PAR-15-282 “Multidisciplinary Studies of HIV/AIDS and Aging (R21)”(NOT-AG-15-011) National Institute on Aging Program Announcements:

Pre-application: Opportunities for Collaborative Research at the NIH Clinical Center (X02)(PAR-15-286) Eunice Kennedy Shriver National Institute of Child Health and Human Development Application Receipt/Submission Date(s): December 15, 2015; December 15, 2016; December 15, 2017, by 5:00 PM local time of applicant organization. Opportunities for Collaborative Research at the NIH Clinical Center (U01)(PAR-15-287) Eunice Kennedy Shriver National Institute of Child Health and Human Development Application Receipt/Submission Date(s): April 11, 2016; April 11, 2017; April 11, 2018, by 5:00 PM local time of applicant organization.Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

AstraZeneca has joined forces with the University of Cambridge for three more joint schemes designed to develop the next generation of world-class scientists.

The schemes will support more than 80 PhD scholarships and eight clinical lectureships over the next five years spanning translational science, basic and clinical research.

Proteus Digital Health won FDA approval for what the company calls “the only device with an FDA-sanctioned claim for measuring medication adherence.” Proteus technology, the development of which we’ve been covering for a number of years now, uses tiny injestible sensors attached to drug tablets and a patch that can detect when they’ve been swallowed. The patch then uses its built-in Bluetooth antenna to share when every pill was swallowed with the matching smartphone app, which in turn passes the readings to family, caretakers, and the patient’s physician.

When Milton Wright III got his third cancer diagnosis, he cried until he laughed. He was 20 and had survived leukemia twice before, first when he was eight and again as a teen. Each time he’d suffered through years of punishing chemotherapy.

But now he had checked himself in to Seattle Children’s Hospital. An aspiring model, he had taken a fall before a photo shoot and found he couldn’t shake off the pain in his ribs. When the doctors started preparing him for a spinal tap, he knew the cancer was back. “I said, Oh, man, they are going to tell me I relapsed again,” he recalls. “They’re going to give me my six months.”

The State Entrepreneurship Index tracks core trends and reflects states’ entrepreneurship environments, growth in business formation and technological innovation. Each state index is calculated by comparing five key economic components and determining how much their performance deviate above or below the “median state,” which is assigned a value of 1.0.

Medicare and Medicaid, the two mainstays of government health insurance, turn 50 this month, having made it possible for most Americans in poverty and old age to get medical care. While the Affordable Care Act fills the gap for people who don’t qualify for help from those two programs, there are important improvements still needed in both Medicare and Medicaid.

At the time the two programs were enacted in July 1965, advocates of Medicare, which today covers 46 million Americans over the age of 65 and nine million younger disabled people, expected that it would expand to cover virtually all Americans. Although polls between 1999 and 2009 showed consistent majorities in favor of expanding Medicare to people between the ages of 55 and 64 to cover more of the uninsured, it never happened.

Scientists may apply online until September 22, 2015 at http://www.openinnovationinscience.at for the ‘Lab for Open Innovation in Science’ continuing studies programme taking place in Vienna.

Health sciences’ two greatest challenges are the lack of incentives for investigating new research questions and the complexity of current research findings, according to a recent survey of international researchers and scientists conducted by the Ludwig Boltzmann Gesellschaft (LBG). These findings provided the impetus for launching the LBG’s Tell us! crowdsourcing project in their Open Innovation in Science initiative. This initiative invites patients, families, and professionals to actively contribute to the development of scientific research questions in the field of mental illness. Findings from this unique research approach will impact the world’s first educational programme for the application of Open Innovation in science, known as ‘Lab for Open Innovation in Science’ (LOIS).

Chinese investment in the Puget Sound region is about to go beyond real estate.

A Chinese venture capital group wants to open an office in the Seattle area so it can invest in the region’s tech and biotech industries, the director of the city of Seattle’s economic development office Brian Surratt confirmed Wednesday.

The corridor between NYC and Washington DC is rich in life science talent, technical know-how and business development expertise. Although many regions throughout the country vie to attract talent and capital, the unique ecosystems that exist in the east coast’s major metropolitan cities, including Washington DC, New York, and Boston, mean that health tech founders can immediately access resources and build the strategic partnerships to support their rapid growth.

This event will focus on New York City and Washington, DC, two key areas offering a number of advantages for health tech founders. The event will be an opportunity to learn from people leading region-wide initiatives in NYC and Washington DC as well as network with peers building health technology startups. Come join us to learn more about unique opportunities and funding in the NYC and DC regions focused on supporting the transformation of healthcare.