United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension. The FDA classified the resubmission as a complete, class 2 response to its March 22, 2013 complete response letter, and set a user fee goal date of February 16, 2014.

About United TherapeuticsUnited Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

Normal adult cells have been reprogrammed to become stem cells inside live mice for the first time.

As stem cells can be coaxed into developing into almost any kind of cell, being able to prompt this behaviour in the body could one day be used to repair ailing organs including the heart, liver, spinal cord and pancreas.

"By doing it in situ, the cells are already there in the tissue, in the right position," says Manuel Serrano at the Spanish National Cancer Research Centre in Madrid, and co-leader of the new work.

The University of Maryland and Northrop Grumman will jointly announce the launch of the Advanced Cybersecurity Experience for Students (ACES), the nation's first cybersecurity honors program for undergraduates, at a special event on Wednesday, September 25, 2013, from 10:30-11:30 a.m. in the Stamp Student Union Atrium on the University of Maryland College Park Campus.

The ACES program is designed to educate future leaders in the field of cybersecurity through rigorous, hands-on learning experiences, an intensive interdisciplinary curriculum, collaborative projects, and professional insight from industry and business leaders. The four-year honors program offers students a living-learning experience, giving them the opportunity to collaborate and work closely together as they pursue their advanced program of study in cybersecurity. The inaugural ACES cohort is comprised of 57 students. The ACES program is supported by a major grant from Northrop Grumman. For more information about the program, visit aces.umd.edu.

The INNo program trains research scientists in the entrepreneurial skills needed to bring technology inventions and services to the healthcare market.

Participants in the INNo program learn to:

• Identify and evaluate the commercial potential of intellectual property
• Understand the business fundamentals related to technology start-ups
• Create a value proposition and business concept for a new product, platform, or service
• Articulate investment opportunities persuasively to potential investors and partners
• Develop a network of resources in the Maryland entrepreneurial community

Roche’s move to skip over Inovio’s (NYSE: INO) late stage drugs for cervical cancer and Hepatitis C and make a beeline for its preclinical DNA vaccines for prostate cancer and Hep B was initially a little puzzling. Investors have preferred to park their money further upstream when products are in the clinic and they’ve been derisked. Big pharma is always looking for ways to take costs out of research and development. But the prospect of utilizing new technology with the potential to improve treatment is appealing for drug developers that want to build up and strengthen their drug pipeline.

Two Washington region tech companies — Clarabridge Inc. and Virtustream Inc. — rolled out a combined $120 million in funding on Tuesday, another sign of an improving venture ecosystem. Both rank among the Top 10 biggest D.C. Tech investments thus far in 2013

Not all of the fundings on this list qualify as "venture," of course. Some of the larger ones could just as easily be called private equity, or at least the hybrid term "growth." Like we see with Clarabridge's $80 million, big-ticket financings like these often go partly toward cashing out earlier investors. And not all came from traditional VC. In Virtustream's case, the entire $40 million Series D round came from a single corporate source: SAP AG.

The Abell Foundation underwrote a comparison of Baltimore’s innovation ecosystem with that of Boston. Sean Pool and Matt Van Itallie, of Canterbury Road Partners, undertook the work and their report is telling of the challenges in front of us, but also reveals great promise of the resources we already have and what Baltimore’s innovation ecosystem can become. The full report can be found on the Abell Foundation website.

This video is the first in a series about Startup Shell, the first student-founded, student-run venture incubator at the University of Maryland.

The Startup Shell is a vibrant co-working space at UMD where talented students guide their colleagues through ideation, research and development, product prototyping, business model creation and more.

Startup Shell is located in the Technology Advancement Program (TAP) incubator, an initiative of the Maryland Technology Enterprise Institute (Mtech) in the A. James Clark School of Engineering.

Target has joined one of the growing trends in healthcare: innovation challenges. It announced on Monday two contests: one will seek a solution that helps people make positive lifestyle and prevention choices, while the other will gather ways to help people live well with a chronic condition.

The Target Simplicity Challenge will reward the creators of the winning ideas $25,000 apiece, their own Target-branded flip camera, and a chance to partner with Target to develop the concepts. The deadline for ideas is Oct. 24 and winners will be announced by January.

Maryland entrepreneurs are getting the chance to bring their small business plans directly to a panel of angel investors who could bring those ideas to life.

“The one thing we want to do is bring your story back with us,” said Mike Binko, founder and co-chair of Startup Maryland. “We want to put a big spotlight and a big megaphone in your hands to tell your story in your words.”

Harvard University has partnered with several venture capital firms to launch The Experiment Fund.  The Experiment Fund is starting with $10 million and was co-founded by Harvard alumni Patrick Chung (New Enterprise Associates) and Hugo Van Vuuren.  Accel Partners and Polaris Ventures is also associated with The Experiment Fund.

Two of the world’s most prolific technology entrepreneurs, Bill Gates and Mark Zuckerberg, are known for being Harvard University dropouts.  Why did they drop out?  Possibly due to lack of resources at the University.  Mark Zuckerberg moved to Silicon Valley from Harvard University to raise VC funding for Facebook in May 2004 and never looked back.

University System of Maryland increased the number of new companies formed out of university technology by 29 percent in fiscal 2013 and is aiming to keep up the pace this year.

The university system credits the growth in new businesses in part to its heightened focus on entrepreneurship and transforming university research to commercial technology. Assistant Vice Chancellor for Information Technology Suresh Balakrishnan said the university system will look to continue adding new companies by looking for new ways to support startups, such as an investment fund.

The Johns Hopkins University edged closer to the top 10 of national universities on the U.S. News and World Report annual rankings, which were released Tuesday.

U.S. News moved Hopkins up one spot to No. 12, just behind Dartmouth University and tied with Northwestern University, in the most-often cited of numerous college rankings. It was the highest ranking for Hopkins in 14 years. As expected based on prior rankings, Princeton, Harvard and Yale remained in the top three spots, in that order.

Biotech venture capitalists, as a group, haven’t had much to cheer about the past few years. But this is shaping up to be the year the storyline changes, thanks to the ripple effect from the biotech IPO class of 2013.

The story of biotech venture capital over the past few years, as many readers know well, has been mostly about struggle. Many firms haven’t been able to scrape out returns, and they’ve reacted by grasping for new investment models, pushing partners out, veering into other sectors, or shutting their doors. The historic shift, which came about a decade after the genomics bubble, left only a few firms with the desire and capability to make the edgiest, riskiest, and potentially most innovative investments in life sciences.

I visited cardiologist Eric Topol at the Scripps Green Hospital in La Jolla, California, one day this summer. He’d had a busy morning seeing patients and, by about noon, was claiming to have already saved the medical system tens of thousands of dollars using his iPhone and a pocket-sized ultrasound machine. Then he pointed to the stethoscope in his pocket and said he hasn’t used it in three years. “I should just throw it out,” he said. “This is basically a worthless icon of medicine.”

Topol is perhaps the most prominent advocate in the U.S. of how digital technology can lead to less expensive health care, and he invited me to see the savings in action. As we lope toward the exam room, Topol, slightly hunched and repeatedly turning to deal with questions flying at him from his staff, seems slightly rattled by the commotion and barrage of demands, but a calm sets in the moment he enters the exam room. He folds his arms across his chest as a young colleague updates him on the patient’s history. Topol introduces himself to the 85-year-old man, who has been tiring easily as of late, and then the doctor immediately pulls out his iPhone.

While U.S. job growth was less than economists expected in August – increasing by 169,000 – the healthcare sector remained a bright spot, adding 32,700 jobs, according to the Bureau of Labor Statistics’ jobs report issued Friday.  

In the healthcare sector, ambulatory healthcare services had the most growth, with 26,600 added jobs. Hospitals saw the least growth, adding only 900 jobs in August. Home healthcare services and nursing and residential care facilities continued to be solid, adding 9,500 jobs and 5,200 respectively.

The Center for Innovative Technology (CIT) announced today it will host an event with Virginia Governor Bob McDonnell launching the MACH37™ Cyber Accelerator on Thursday, September 12, 2013. The Accelerator is a program designed to facilitate the creation of the next generation of cybersecurity companies in Virginia. Supported by Governor McDonnell, the General Assembly appropriated $2.5 million to CIT to start and operate the Accelerator for two years, after which the Accelerator will secure private funding. MACH37 is the nation’s first public-private sector Cyber Accelerator program

Kicking off the fall semester, the University of Maryland is giving the thousands of innovative minds across campus new ways to share and explore their fearless ideas. Starting today, the university is expanding its popular "Innovation Fridays," which give students the opportunity to meet with experienced innovators and entrepreneurs, get free and impartial advice, brainstorm strategies, and learn about available resources and funding.

"We are committed to cultivating a community of innovators on campus," says Dean Chang, UMD's associate vice president for innovation and entrepreneurship. "Similar to Google's 20 percent time, which gave the world innovations like Gmail by encouraging employees to spend one day a week pursuing bold projects that were not necessarily related to their job description, we want to encourage students to take one day a week—Fridays—to pursue their own fearless ideas. The expansion of Innovation Fridays will allow more students across all disciplines to do just that."

High Level Overview - Recapped

• The National Institutes of Health (NIH) has a significant portfolio of inventions available for licensing.  The Center for Advancing Innovation (CAI) has evaluated many of them to identify those with the strongest commercial viability
• The Avon Foundation, the NIH, and CAI are launching a start-up Challenge to exploit these opportunities

Challenge Phases

• Letter of Intent (LOI): Teams provide information regarding the members of their team and indicate how team members meet eligibility requirements.  Teams also outline their intent to participate in the Challenge
• Business Plan (BP): Teams develop a 10-page business plan or business model canvas; a five minute "live" pitch; and a one minute elevator speech via recorded video
• Start-up (SU): Teams incorporate their start-up and apply for seed funding and the NIH start-up license or a license from the Clemson University Research Foundation (for this invention). In order to complete these three activities,the teams should refine their commercialization plan, development plan, regulatory strategy and comprehensive view of their management team and board of advisors

Stanford University is going to start directly investing in students’ companies. Stanford is also giving a $3.6 million grant to StartX, a non-profit startup accelerator for Stanford-affiliated entrepreneurs.

StartX founder and CEO Cameron Teitelman tells me Stanford will only invest in StartX companies and alumni companies.

University spokesperson Lisa Lapin tells me Stanford’s investment fund will have an uncapped size. Vice President for Business Affairs Randy Livingston and his office will oversee the school’s investments, and Stanford will not take a lead role in funding rounds.

There has been a sharp increase in venture capital funding of life sciences companies in the second quarter of 2013, according to a new report from PriceWaterhouseCoopers and the National Venture Capital Association.

San Diego companies were the third-most invested in, following San Francisco and Boston.

Dr. Michael M. Gottesman has spent nearly four decades as a highly respected scientist at the National Institutes of Health (NIH), conducting important studies on how cancer cells resist destruction by several widely used chemotherapy drugs.

As chief of the laboratory of cell biology at the National Cancer Institute (NCI), Gottesman is the country’s premier researcher on the interaction of cancer and medications. He has developed molecular tools to define the drug-resistance genes found in individual cancers, information that is used to predict a patient’s response to therapy.

Governor Martin O’Malley today via video kicked off the 2nd annual InvestMaryland Challenge, a national business competition that supports Maryland startups and strengthens a climate of innovation and entrepreneurship that has been ranked #1 in the country by the U.S. Chamber of Commerce for two years in a row. The Maryland Department of Business and Economic Development (DBED), through the Maryland Venture Fund and the BioMaryland Center, will award $400,000 in top prizes spread across four categories — Life Sciences, IT, General Industry and a new Cybersecurity category — as well as secondary prizes and awards from partners and sponsors. DBED is continuing its partnership with Inc. magazine to promote the Challenge to a national audience of entrepreneurs and small business owners. The application period opens immediately and will close December 6 and applications are available here.

Startup Maryland (www.startupmaryland.org), an initiative driven By Entrepreneurs ... For Entrepreneurs, today announced that UNDER ARMOUR® (NYSE: UA) has agreed to be the host venue for the 2013 Pitch Across Maryland™ Last Stop ... Innovation Celebration.

The 2013 edition of the Pitch Across Maryland is the second annual state-wide tour and celebration of entrepreneurship and innovation communities.

"Referred to by FOX News affiliate WBOC-TV 16 as Opportunity on Wheels, the inaugural Pitch Across Maryland tour was an overwhelming success last year and this year's offering is about to hit the road on September 9 with the first Stop on the Boardwalk in Ocean City, MD," stated Julie Lenzer Kirk, Startup Maryland co-chair.

September 5, 2013 marks Emergent BioSolutions’ 15th year of operations. Emergent BioSolutions is a global specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Celebrate 15 years of innovation and growth with them by learning about their beginnings and their commitment to their mission – to protect life.

Stanford University produces more alumni entrepreneurs than any other university, and now it’s created its first fund to invest directly in those early-stage companies emerging from the university community.

Stanford has established a three-year partnership with Stanford Hospital & Clinics and StartX, an accelerator for students, faculty, alumni and staff, under which the institutions will support the accelerator and create a fund called the Stanford-StartX Fund.

We are currently enjoying a much needed resurgence in the biotechnology industry. The industry has been the best performing sector in the stock market for the last two years and it appears it will be again this year. This performance has enabled companies to raise capital, either publicly or privately, in record amounts. We expect the industry to raise more than $4 billion this year. The performance of the stock of companies that have executed initial public offerings is quite impressive. The average stock prices of the 23 life science IPOs through July are up over 50 percent from their offering price (on average) with only four trading below their offer price.

Governor Dannel P. Malloy today signed new legislation creating a $200 million Bioscience Innovation Fund during a ceremonial event at the University of Connecticut Health Center (UCHC). The fund will make investments over the next 10 years in the form of grants, equity investments, loans and loan guarantees to foster innovation in smaller companies.

"Over the last two and a half years, we've taken great steps forward in reinventing our economy," said Governor Malloy. "With the addition of Jackson Laboratories and the investments we are making in our flagship university, we are positioning Connecticut to be a leader in the creation of 21st Century jobs. The Bioscience Innovation Fund will allow us to build on the tremendous progress that's being made across our state. Little by little, we are turning around years of stagnation and growing jobs for our residents."

NovoBioPharma, a global biopharmaceutical firm with locations in Cambridge, MA, Delaware, and Philadelphia, and UPstart at the University of Pennsylvania announced today that they entered into a synergistic collaboration in which NovoBioPharma provides critical guidance and strategic direction to select life science UPstart companies embarking on the commercialization of early stage opportunities.  UPstart provides support for Penn inventors interested in pursuing entrepreneurial endeavors through ventures formed in partnership with Penn. NovoBioPharma will assist companies within UPstart to develop scientific and financially sound development plans to take these entities from proof of concept and beyond. 

The education establishment is in a twit over the phenomenon called "summer slide." "Summer slide" is the loss of knowledge/competence in the summer months, according to research done by the RAND Corporation and Johns Hopkins University. "Summer slide" disproportionately plagues poor kids of color, so the recent, alarmingly low scores recorded by urban students on the Common Core tests heightened sensitivity around this issue.

Rather than acknowledging the corrosive effects of poverty, or conceding that the testing and accountability era has been a failure and has driven lousy practices, the answer is to make the least privileged kids work longer and harder while their more affluent peers summer in the Hamptons or South of France.

The NFL, Under Armour and GE on Wednesday launched Head Health Challenge II, an open innovation challenge to award up to $10 million for new innovations and materials that can protect the brain from traumatic injury and for new tools for tracking head impacts in real time. The challenge is part of the Head Health Initiative, a collaboration to help speed diagnosis and improve treatment for mild traumatic brain injury.

Kevin Plank, Founder and CEO of Under Armour said: "As longstanding partners of the NFL and in collaboration with GE, we take great pride in our participation in the Head Health Challenge II. We are excited to harness the power of innovation and assemble the best minds in the world towards an effort to make the field of play safer across all sports and for all athletes."

This graph is a good visual depiction of how aging baby boomers, advances in technology and shifts in the way healthcare is delivered under reform may influence jobs in the healthcare sector.

In a Labor Day article, PBS directed us to interesting data published last year by U.S. Bureau of Labor Statistics in its Occupational Outlook Handbook (h/t @VentureValkyrie). Seventeen of the 30 occupations expected to grow the quickest between 2010 and 2020 are healthcare and medicine-related.

With all the concern (and liability) hospitals and their partners face to keep patient medical data secure and private, one new biometric security innovation could offer an interesting alternative to the typical password. This wristband grants users access to their devices by identifying the wearer by their heartbeat.

Image Courtesy of dream designs / FreeDigitalPhotos.net

Johns Hopkins University's Whiting School of Engineering said Tuesday it will partner with Campbell & Co., a Baltimore-based investment firm, in a teaching and internship program.

Staff from Campbell will teach an investment science course at Hopkins during the fall semester and offer paid internships to as many as three Hopkins students during the year.