Biohealth Innovation
Cultural fit, bundling potential and a focus on work force optimization.
If your healthcare startup meets all or even two of these criteria, you’ll have a better than average chance of attracting attention from GE Healthcare.
Mike Swinford, President and CEO Global Services at GE Healthcare, explained the thinking behind three recent acquisitions as well as how the companies helped GE make more money.
Johns Hopkins University is among the 50 wealthiest universities across the globe.
The university’s endowment value in 2013 was $2.987 billion — good for 29th on the list of the wealthiest universities, according to higher education website nonprofitcollegesonline.com.
The pharmaceutical industry is regaining its swagger, as companies turn to big and sometimes daring deals to expand and reshape their operations.
On Tuesday alone, pharmaceutical companies announced $74 billion worth of potential deals, including an unorthodox $45.6 billion bid for Allergan, the maker of Botox, and a flurry of swaps and sales between Novartis of Switzerland and GlaxoSmithKline of Britain.
Noble Life Sciences (Gaithersburg, MD) and IBT Bioservices (Gaithersburg, MD) announce a newly optimized cotton rat model for preclinical studies of influenza therapies and vaccines. The companies jointly developed the model of influenza infection in the cotton rat.
Cotton rats are a vital tool to study influenza infection because adaptation of human influenza strains is not required for virus replication in the respiratory tract. Moreover, virus infection results in histopathological lesions in the lungs that are similar to those seen during natural infection of humans.
Before April 16, 2014, NIH permitted one resubmission (A1) of an unfunded application (see NOT-OD-09-016). The extension on the NIH grant number could follow the pattern (A0, A1). A first-time submission is informally referred to as an A0, and the first resubmission is known as an A1. Any virtual A2s would be flagged by the NIH Center for Scientific Review.
For all application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-14-082).
Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140). For more details on the Resubmission Policy, visit the Resubmissions webpage and the Guide Notice, NOT-OD-14-074.
GlaxoSmithKline plc today announces a major 3-part inter-conditional transaction with Novartis AG involving its Consumer Healthcare, Vaccines and Oncology businesses (the “Transaction”). In summary:
Emergent BioSolutions Inc. today announced that it has initiated manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) consistency lots in Building 55, following review by the U.S. Food and Drug Administration (FDA) of the Manufacturing and Non-Clinical Study Protocols submitted by the company supporting the Building 55 comparability program. The goal of the comparability program is to generate data that will show BioThrax manufactured at large scale in Building 55 is comparable to the BioThrax currently manufactured in the approved facility, Building 12. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.
“Emergent is pleased to have reached an agreement with FDA that now enables the final steps towards securing approval of Building 55 for large scale manufacturing of BioThrax. This progress could not have been achieved without the successful collaboration between the company, FDA, and BARDA,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This multi-year effort to expand our manufacturing capability is intended to address the U.S. Government’s stated need for this critical medical countermeasure in the Strategic National Stockpile. We look forward to our continued partnership with the government to bring this program to completion.”
Herndon-based APX Labs has raised $10 million from New Enterprise Associates to bring its software platform for Google Glass and other wearables to manufacturing, health care and other enterprise customers.
The Series A investment from NEA embodies the prediction that the near-future of smart glasses lies in the enterprise, whether that be the sort of heads-up displays offered by Google Glass or more substantial augmented reality overlays provided by ( noticeably less sleek) devices like the Epson Moverio. APX, through its flagship product Skylight, provides both the user interface and the back-end software that could, for example, give assembly line workers data on an individual part as it crossed they field of view.
The impact of federal budget cuts compounded by the challenges of securing funding for biotechnology companies has led to a growing trend of drug development. Scientists are turning to crowdfunding for biotechnology as a way to scrape up money.
A concept for a nonprofit crowdfunding website for medical research hatched at Lehigh Valley StartUp Weekend last fall is moving ahead.
Healthbox, which helps medical startups grow through accelerators in the U.S. and U.K., is expanding its business through a $7 million fundraising.
Healthbox CEO Nina Nashif Healthbox Healthbox and groups like Rock Health and Blueprint Health help entrepreneurs launch businesses in hot markets like health information technology and digital health. Medical software and information services startups raised $297 million in the first quarter, a 130% jump from Q1 of 2013, according to Dow Jones VentureSource.
Funding in the wider category of digital health topped $1.9 billion last year, up 39% from 2012, according to Rock Health.
Two Big Pharma companies with strong ties to the Philadelphia region are the subject of the latest mega-merger rumor in the drug manufacturing industry.
Pfizer Inc. has expressed an interest in acquiring AstraZeneca for $101 billion, according to a report in London's Sunday Times. The two companies declined commenting on the report.
April 30, 2014
Don’t miss this unique opportunity to showcase your products and services to the mid-Atlantic region.
The Universities at Shady Grove is a wonderful venue to showcase your products and services. You can make this a great opportunity for your company and invite clients and guests to attend for FREE! Get started inviting your contacts now.
It will be $700 for a 6' table.
Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax® (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S. This designation provides incentives to the BioThrax PEP Program, including the waiver of the Biologics License Application (BLA) supplemental regulatory filing fee and marketing exclusivity of up to seven years.
“Emergent is pleased with FDA’s Orphan Drug Designation of BioThrax for post-exposure prophylaxis,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This designation will help streamline discussions around regulatory requirements at our pre-BLA meeting with FDA next month. We look forward to discussing our supplemental application for the expanded indication of post-exposure prophylaxis and the role of BioThrax in the treatment of inhalation anthrax.”
Three Johns Hopkins University School of Medicine researchers have been awarded two-year grants for their work on potential treatments for diabetes, Novo Nordisk announced this month. Of the 110 initial submissions to the new Novo Nordisk Diabetes and Obesity Biologics Science Forum Program, only four projects were funded, three of which are led by Johns Hopkins researchers. They are Jonathan Powell, M.D., Ph.D.; G. William Wong, Ph.D.; and Elias Zambidis, M.D., Ph.D.
For as long as I can remember I have been preparing for college.
And not because I wanted to, but because I was “encouraged” (nagged) by my parents. It started in middle school. I had to get good grades so I could get into a good program at my high school, where I had to get good grades so I could get into a good college.
Howard County's Economic Development Authority on Thursday unveiled its newest workspace, a prototyping lab devoted to 3D printing and rapid technology.
The Innovation + Prototyping Lab, located at the Maryland Center for Entrepreneurship's Columbia headquarters on Bendix Road, is an 1800-square-foot space stocked with four 3D printers, computers offering software tutorials and shelves of printed parts.
Disease Diagnostic Group, maker of an inexpensive handheld device that can diagnose malaria in one minute, was named the winner of the 2014 Cupid’s Cup Business Competition, chaired by Under Armour Founder and CEO Kevin Plank. The ninth annual event was April 4 at the University of Maryland’s College Park campus, hosted by the Dingman Center for Entrepreneurship at the Robert H. Smith School of Business. In a last-minute twist to the competition, Disease Diagnostic Group's founder, an engineering student at the Massachusetts Institute of Technology, accepted Plank’s offer of an additional $25,000 in exchange for equity, bringing the company’s grand prize winnings to $100,000.
The equity will be held by Plank’s Cupid Foundation, which funds the annual competition. Plank, a graduate of the University of Maryland, started the competition with the Dingman Center to foster interest in student entrepreneurship. The competition is open to undergraduate and graduate-level students at accredited U.S. colleges and universities, and recent graduates of these institutions.
The rise of corporate venture capital investors, whether at the seed-stage, in the largest financings or into the billion-dollar valuation club, has been reshaping the VC ecosystem as of late. And while some VCs including Fred Wilson have been critical of corporate venture units, others have syndicated dozens of deals with corporate venture arms in just the past few years alone.
Using CB Insights data, we took a look at which VC firms have co-invested in the highest number of deals with a corporate venture unit since 2008 and how their CVC-syndicated deals added up as a percentage of their overall deal activity.
Leaders from 3D printing, fab labs and laser technologies will participate in a Digital Fabrication Summit to open the new Potomac Digital Fabrication Center at BWTech@UMBC in Baltimore, Maryland (US). The event will be held on 6 May 2014 and is being organised by Potomac Photonics, Inc. in cooperation with the non-profit FabLab Hub. The summit will bring together visionaries who are leading the next industrial revolution.
Avi Reichental, chief executive officer (CEO) of 3D Systems Corporation, will deliver the keynote, “Manufacturing the Future.” 3D Systems has been at the forefront of digital fabrication since company founder Chuck Hull invented stereo-lithography in 1983. Reichental has been one of those responsible for the dramatic shift from a technology for specialised applications to tools for mainstream markets. Potomac is an authorised 3D Systems equipment reseller and service provider and is creating a 3D printing equipment showcase in the new facility.
The exuberance of last year's record D.C. region venture totals waned somewhat in the first three months of 2014, with 43 companies raising a collective $217.5 million, according to the MoneyTree report released Friday by PricewaterhouseCoopers and the National Venture Capital Association.
The total represents an 18 percent drop compared with the same period last year, and a 31 percent fall from the fourth quarter of 2013.
Today Healthbox announces it has closed $7 million in funding to expand on its accelerator model and launch three new business verticals that will continue to drive actionable innovation through collaboration between entrepreneurs and the healthcare industry.
This is a bold vision for a healthcare accelerator. Healthbox closed the $7 million from a collaborative group of leading healthcare organizations to form Healthbox Global Partners, LLC, representing the common need to find and implement transformative solutions that will improve health outcomes.
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:
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.
In the winter of 1996, as part of my new position as president of the Baltimore Development Corp., I searched for evidence of the city’s technology scene.
There wasn’t much to see.
I first visited the BDC’s “incubator,” housed in an old — but not historic — building at 1444 Key Highway in South Baltimore. It was the only incubator in the region. As I met with the staff, I observed that several buckets had been strategically placed to catch water leaks (a seemingly insurmountable problem, as I was told).
Join us as we bring together the major players in Maryland’s startup ecosystem to celebrate entrepreneurism and award nearly $1,000,000 in prizes to the state’s most promising early-stage companies.
Who will win the Cyber, Life Sciences, IT and General Industry Categories? Join us May 19th to find out!
Sarah Bergbreiter is an assistant professor of mechanical engineering at the University of Maryland, and she and her team build tiny robots.
Just how tiny? Bergbreiter calls it “ant-scale,” but said, “That’s really just a PR term. Our robots are built on the millimetre scale, less than 1 centimeter.”
Horizon Pharma, Inc. today announced the appointment of H. Thomas Watkins, former director, president and chief executive officer of Human Genome Sciences, to its board of directors. Additionally, Jean-Francois Formela, M.D. has resigned from the Horizon board of directors.
"Tom brings valuable industry experience to our board as a highly regarded biotechnology leader," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "As we continue to grow our commercial business and build our organization through in-licensing and acquisitions, his strategic insights and pharmaceutical leadership experience will be important at this critical juncture for Horizon. Also, I would like to thank Jean-Francois for his years of service and counsel as a member of our board. Jean-Francois joined the Horizon board in 2010 in connection with our acquisition of Nitec and has been a valuable member of the board in helping us develop and implement the strategic direction of the Company."
The Executive Director supports the Senior Advisor for Enterprise Development to the University President in directing and managing the short and long term critical priorities, initiatives and activities that relate to current entrepreneurship, commercialization, innovation, and translational efforts at Johns Hopkins University. The Executive Director represents the Senior Advisor to the President and ensures effective communication, coordination, and integration across various initiatives and programs where appropriate.
The most fundamental way for a nation to build its strength in innovation is to invest in its research universities because this investment brings forth new knowledge and human capital – two key aspects that help accelerate innovation, according to Dr. L Rafael Reif, President of the Massachusetts Institute of Technology (MIT).
“New knowledge is the foundation of all truly important innovation while human capital helps in transforming knowledge into new technologies, solutions, companies and jobs,” explained Dr. Reif, who was delivering a talk titled, ‘Science, Technology and Education: Research Universities as Engines of a Modern Economy’ at Masdar Institute in Abu Dhabi. A large number of staff and faculty members with students and other stakeholders attended the event that was organized as part of the Masdar Institute of Science and Technology’s Distinguished Lecture Series program.
Qiagen has acquired an exclusive worldwide license to a promising biomarker that could aid the diagnosis of a group of blood disorders.
The biomarker calreticulin (CALR) has been found to present mutations in an estimated 15 percent of cases of myeloproliferative neoplasms, a group of blood disorders involving overproduction of blood cells that can cause severe complications.
For nearly a year and a half, there has been word that Cambridge Innovation Center (CIC) — the Massachusetts-based coworking space and business incubator for early-stage startups — would expand and open an office in Baltimore.
As Technical.ly Baltimore reported in July 2013, current plans for CIC Baltimore situates the incubator at 873 W. Baltimore St. near the University of Maryland BioPark. At the time real estate consulting firm Cross Street Partners told Technical.ly Baltimore that the Baltimore-based innovation center — a development project of Wexford company — would be roughly 44,000 square feet when construction is completed in late 2014.
MidAmerica Healthcare Venture Forum, to take place April 22-23 in Chicago, unites active investors with corporate business development executives to facilitate investment opportunities with promising Mid-America based startups.
The event showcases emerging innovation and technology dealflow originating in the Midwest, and has earned the reputation as the premier healthcare investing conference.
The Montgomery County Department of Economic Development is looking for a senior level professional to formulate and implement the County's economic development strategy related to the growth of the life sciences and health IT industry sectors and to provide policy advice on technology issues in these strategic sectors. The position will foster partnerships and manage projects designed to attract new companies to the County, to enhance the presence of companies in these sectors within the County and to foster a pipeline of new companies in these sectors.
This position will evaluate and make recommendations on the technology policy issues relevant to Montgomery County, and implement creative programs that will expand the County's technological presence in the global marketplace. This position affects the County's economic well-being through the number of additional jobs created, number of companies established, capital raised, and commercial space occupied through new company attraction, retention and growth of existing companies, and a pipeline of startups. The candidate will work collaboratively with DED teammates to build the capabilities and competencies of the Department.
Cultivating Cultures for Ethical STEM (CCE STEM) funds research projects that identify factors that are effacacious in the formation of ethical STEM researchers in all the fields of science and engineering that NSF supports. CCE STEM solicits proposals for research that explores the following: ‘What constitutes ethical STEM research and practice? Which cultural and institutional contexts promote ethical STEM research and practice and why?' Factors one might consider include: honor codes, professional ethics codes and licensing requirements, an ethic of service and/or service learning, life-long learning requirements, curricula or memberships in organizations (e.g. Engineers without Borders) that stress social responsibility and humanitarian goals, institutions that serve under-represented groups, institutions where academic and research integrity are cultivated at multiple levels, institutions that cultivate ethics across the curriculum, or programs that promote group work, or do not grade. Do certain labs have a ‘culture of academic integrity'? What practices contribute to the establishment and maintenance of ethical cultures and how can these practices be transferred, extended to, and integrated into other research and learning settings?
When Kathleen Sebelius took the helm of one of the largest civilian departments in the federal government, the first thorny issue on her desk was responding to the H1N1 flu virus, a new pandemic flu strain that seemed to target otherwise healthy young people. After less than week on the job her first public speech focused on how the Department of Health and Human Services (HHS), which oversees the Centers for Disease Control and Prevention and Food and Drug Administration, was responding to the public health emergency. She released millions of antiviral drugs from the national stockpile and warned against fake flu cures while calling for continual investment into research to stay ahead of future flu outbreaks. Talks about women’s and children’s health, obesity and AIDS soon followed.
Emergent BioSolutions Inc. today announced successful completion of the last licensure-enabling study in its BioThrax® (Anthrax Vaccine Adsorbed) Post-Exposure Prophylaxis (PEP) program. This clinical study, also known as the non-interference study, was designed to evaluate the pharmacokinetic profile of the antimicrobial ciprofloxacin when administered prior to and following the administration of a three-dose series of BioThrax. It was also designed to evaluate the immune response to BioThrax when administered with or without ciprofloxacin. The primary endpoints were the ratio of the maximum concentration (Cmax) and area under the curve (AUC) for ciprofloxacin and the secondary endpoint was the ratio of the geometric mean titer of the antibody response to BioThrax two weeks following the last dose. The study met the prospectively defined success criteria for both the primary and secondary endpoints. Data from this study show no interaction between ciprofloxacin and BioThrax.
Emergent has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA). Results from this study will be used to support a supplemental Biologics License Application (sBLA) seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. BioThrax is currently licensed for a pre-exposure prophylaxis indication only.