Improving health literacy and patient engagement and developing alternative ways to appraise apps and physicians are among the ideas that have reached the finals of a Robert Wood Johnson Foundation competition. The people and companies behind these ideas are vying for the opportunity to get funding as part of a program to fund transformative innovations in healthcare.

Among the judges are Angel investor Esther Dyson (@edyson), PatientsLikeMe Co-Founder and President Ben Heywood (@patientslikeme), Rhode Island School of Design President John Maeda(@johnmaeda), IDEO Life Sciences Chief Strategist Rodrigo Martinez(@rodrigoatcg), Games for Health Co-Founder Ben Sawyer (@bensawyer), Fast Company Staff Writer Ben Schiller(@btschiller) and NPR Science Correspondent Shankar Vedantam(@hiddenbrain).

Cydan, LLC, an orphan drug accelerator that identifies and de-risks programs with therapeutic and commercial potential, today announced that the company has expanded its initial round of financing, bringing its total financing raised to $26 million. Cydan launched in April 2013 with a $16 million financing from New Enterprise Associates (NEA), Pfizer Venture Investments and Alexandria Venture Investments. New investors Lundbeckfond Ventures and Bay City Capital led the $10 million expansion of this round of financing and were joined by Cydan’s previous investors NEA and Alexandria Venture Investments. In conjunction with this investment, Lundbeckfond Ventures Managing Partner Mette Kirstine Agger, MBA and Bay City Capital Investment Partner and Managing Director Carl Goldfischer, M.D., are joining Cydan’s Board of Directors.

Sequencing the human genome seemed like a discovery so important that it couldn’t be overhyped—we had, after all, transcribed the blueprint for human life—but biotech executives somehow managed the trick. William Haseltine, the founder of Human Genome Sciences, predicted in 2000 that he would halve the time and money required to bring a drug to market. Randy Scott of Incyte Genomics claimed that, “In 10 years, we will understand the molecular basis for most human diseases.”

Not quite. The cost of bringing a drug to market has increased dramatically, quibbles about accounting methods notwithstanding. The process still takes more than a decade. We already had a thorough understanding of diseases linked to single genetic sequences, such as Huntington’s and cystic fibrosis, but if anything, exploring the genome has taught us how complicated the relationship between genes and diseases really is. Last year, for example, researchers in Canada linked 71 genetic regions to inflammatory bowel disease, bringing the total to 163 and counting.

An early-stage investment fund founded by Revolution has raised $200 million in commitments, blowing past its $150 million goal. The new fund, Revolution Ventures, will invest in technology firms, mostly under $10 million in revenue, that are seeking to disrupt traditional industries.

“We are doing the things that we’ve been doing for the last decade,” Revolution co-founder Steve Case said. “Trying to find early-stage companies that are using technology to disrupt traditional industries, create new business models and have all kinds of different aspects that we find interesting.”

As the Managing Director at a tech accelerator, I face a dilemma. I need to fund the most talented people, because they’ll be most likely to build great companies. But I also need to find the hidden gems.  I’m the sort of person who’s always looking for the best deals.  Let me tell you, great deals almost always come from unexpected sources.

Here’s the problem: If I look for talent in the same places everyone else does — at Stanford, Harvard, and MIT — I’ll have to fight crowds of investors and even other accelerators who are trying to do the same thing I am. I don’t like lines, and I hate waiting, so I don’t go with the crowd. I try to create value where others don’t recognize it.

Emergent Biosolutions, the maker of the only FDA-licensed anthrax vaccine, is expanding its footprint in Montgomery County, with a little bit of financial help from the state and county. Emergent is taking 50,000-square feet (the precise number was reported by the Washington Business Journal earlier this month) at 400 Professional Dr., a 129,360-square foot, five-story building here, owned by Corporate Office Properties Trust. It will be moving 112 of its current employees to the building in early 2015. Emergent plans to purchase building, which is adjacent to its current research and development facility located at 300 Professional Dr.

What is interesting about the deal is the rare glimpse it reveals about the type of state and county incentives available for such transactions: the State of Maryland contributed $2 million, Montgomery County $750,000 and the City of Gaithersburg $250,000.

These days, having a strategic investor or partner has become almost a matter of survival for healthcare startups.

Corporate investing and partnering has really taken off over the last few years as pharma and medical device companies have opened their doors and wallets to find innovation outside of their four walls.

Anyone can have a great business idea, and now students don’t have to be enrolled in the business school to get help making their ideas a success.

This semester, the business school’s Dingman Center for Entrepreneurship expanded its Innovation Fridays program to reach students of all majors. The program, which used to be advertised only to business school students, gives student entrepreneurs free consultations with successful business owners to get advice for starting their own small businesses, promoting social causes or creating new technology.

Earlier this year Sun Yat-sen University, a well-regarded institution in Guangzhou in the Guangdong province of China, announced that the university and affiliated hospitals were entering into a novel collaboration with Johns Hopkins Medicine. The agreement would see Hopkins faculty working bilaterally with Sun Yat-sen’s medical faculty both in China and at Hopkins in order to help the university become a world-class biomedical research institute. The deal has significant implications for U.S. hospitals because, facing declining revenues, international collaborations like these offer a new path for growth.

It was the 30th major, revenue-producing, international healthcare collaboration for Johns Hopkins Medicine, with several more currently under negotiation — when the rest of the world combined has perhaps a few dozen similar partnerships. One reason Hopkins is outpacing others is because it created an agile satellite unit – Johns Hopkins Medicine International (JHI) – within the much larger parent organization solely dedicated to these projects.

Bureaucracy is one of the dirty words in business. Nobody wants to publicly admit their company is bogged down with too many layers of management, or needs a dozen committees to sign off on every little decision. For a couple years now, I’ve been hearing entrepreneurs complain about suffocating bureaucracy in pharma.

So I started asking people to name names by answering this question:

GL-2045 is Gliknik’s Lead Recombinant Stradomer™ Designed to Improve on Pooled Human Intravenous Immunoglobulin

Gliknik Inc., a privately held biopharmaceutical company, today announced that it has entered into an exclusive worldwide licensing agreement with Pfizer Inc. for GL-2045, Gliknik’s recombinant stradomer™, a drug candidate that is designed to replace and improve on pooled human intravenous immunoglobulin (IVIG). GL-2045 has shown promising results in a broad range of preclinical tests and is being developed as a potential treatment for a wide variety of autoimmune diseases, including those in which IVIG is clinically used.

“GL-2045 is the first of several innovative drug candidates Gliknik is advancing for people with autoimmune diseases and cancer,” said Gliknik CEO David S. Block. “We selected Pfizer as our partner to progress GL-2045 from among several interested and capable parties because of its exceptional development, manufacturing and commercial capabilities.”

Bureaucracy is one of the dirty words in business. Nobody wants to publicly admit their company is bogged down with too many layers of management, or needs a dozen committees to sign off on every little decision. For a couple years now, I've been hearing entrepreneurs complain about suffocating bureaucracy in pharma.

Anyone can have a great business idea, and now students don't have to be enrolled in the business school to get help making their ideas a success. This semester, the business school's Dingman Center for Entrepreneurship expanded its Innovation Fridays program to reach students of all majors. The program, which used to be advertised only to business school students, gives student entrepreneurs free consultations with successful business owners to get advice for starting their own small businesses, promoting social causes or creating new technology.

These days, having a strategic investor or partner has become almost a matter of survival for healthcare startups. Corporate investing and partnering has really taken off over the last few years as pharma and medical device companies have opened their doors and wallets to find innovation outside of their four walls.

BALTIMORE, MARYLAND, September 30, 2013 – Gliknik Inc., a privately held biopharmaceutical company, today announced that it has entered into an exclusive worldwide licensing agreement with Pfizer Inc. for GL-2045, Gliknik's recombinant stradomer™, a drug candidate that is designed to replace and improve on pooled human intravenous immunoglobulin (IVIG). GL-2045 has shown promising results in a broad range of preclinical tests and is being developed as a potential treatment for a wide variety of autoimmune diseases, including those in which IVIG is clinically used.

Northrop Grumman Corporation (NYSE:NOC) and the University of Maryland, Baltimore County's Research Park Corporation - also known as bwtech@UMBC - hosted a ceremony today for the first graduating class of the Cyber Cync Program: AccelerEyes, Five Directions and Oculis Labs.

The event also marked the expansion of bwtech@UMBC's Cyber Incubator program, a sign of the program's success and the positive economic impact both initiatives are making on the region.

A new investment fund structured by JPMorgan Chase & Co. (NYSE:JPM) and the Bill & Melinda Gates Foundation will, for the first time, allow individual and institutional investors the opportunity to finance late-stage global health technologies that have the potential to save millions of lives in low-income countries.

With $94 million committed by a pioneering group of investors – including anchor support from Grand Challenges Canada (funded by the Government of Canada), the German Ministry for Economic Cooperation and Development (acting through KfW) and the Children’s Investment Fund Foundation – the Global Health Investment Fund (“GHIF” or the “Fund”) will help advance the most promising interventions to fight challenges in low-income countries such as malaria, tuberculosis, HIV/AIDS and maternal and infant mortality. To help mitigate the risk of investing in the clinical development of new technologies, the Gates Foundation and the Swedish International Development Cooperation Agency have committed to partially offset potential losses in the Fund, which will seek a financial return for investors by targeting high-impact technologies with public health applications in both developed and emerging markets.

President Obama signed the Jumpstart Our Business Startups (JOBS) Act into law on April 5, 2012.  BIO advocated strongly for this new law, which includes several important policies designed to stimulate capital formation for growing businesses, including those in the biotech industry.  Some of the new policies were self-effectuating, while others are awaiting rulemaking at the SEC.  Below is a summary of the relevant provisions in the new law, along with a status update on the implementation process for each.

Newt Fowler looked across Baltimore’s Renaissance Hotel ballroom and noted who was missing from the tables.

Sure, there are plenty of leaders in today’s innovation economy in Baltimore, Fowler told the crowd Thursday at the Greater Baltimore Committee’s Economic Outlook Conference.

“They’re just not in this room today,” he said.

What we’ve got in our corner: Everything from good schools to a really funky music scene.

What we need to do: Everything from reform our corporate tax structure to rearrange our offices.

What’s at stake: The economic drivers who will keep Baltimore, and Maryland, competitive with the rest of the country and the rest of the world.

Baltimore’s Sage Growth Partners sees opportunity where others see a headache.

Over the past few years Sage, a health care technology consulting firm, has seen business pick up as more health care providers look for help installing and managing the new electronic record systems. CEO Don McDaniel declined to disclose the company’s revenue but said Sage has seen 50 percent annual growth for the past five years. That’s a trend he expects to continue as the company makes a move to break into consulting for startup companies in the health IT sector.

Companies spent $294 billion on research and development performed in the United States during 2011, compared with $279 billion during 2010 (table 1). Funding from the companies’ own sources was $222 billion during 2010 and $239 billion during 2011; funding from other sources was $57 billion in 2010 and $55 billion in 2011 (table 2). Data for this InfoBrief are from the Business R&D and Innovation Survey (BRDIS), which was developed and cosponsored by the National Science Foundation and Census Bureau.

The National Institutes of Health is making available approximately $3.7 million for awards to enhance training opportunities for graduate students and postdoctoral scholars to prepare them for careers in the biomedical research workforce that could take them outside of conventional academic research.

The first set of NIH Director’s Broadening Experience in Scientific Training (BEST) awards are supported through the NIH Common Fund’s Strengthening the Biomedical Research Workforce program.

University of Maryland, Baltimore and MedImmune are pairing up for a five-year, $6 million collaboration on bioscience research.

The Gaithersburg-based drug company and the university will both put money and scientists toward joint research projects. The projects will focus on medical conditions and diseases in MedImmune’s wheelhouse, such as cardiovascular disease, respiratory problems and inflammation.

The success of MenAfriVac shows vaccines can be developed outside Big Pharma's walls, but, in most cases, the cost of late-phase trials is too great for charities. Recognizing this, JPMorgan Chase and the Bill & Melinda Gates Foundation have set up a Big Pharma-backed investment fund. 

GlaxoSmithKline ($GSK), Merck ($MRK) and Pfizer's ($PFE) foundation are among the investors in the fund, which will back late-stage development of technologies to fight disease in low-income countries. Having raised $94 million from its initial backers, the Global Health Investment Fund (GHIF) will now start trying to give vaccines and other technologies the financial clout to navigate Phase III trials.

The National Institutes of Health has launched a major initiative to improve how basic science advances and discoveries are translated into commercially viable products that improve patient care and advance public health.

The NIH Centers for Accelerated Innovations (NCAIs), funded by the NIH’s National Heart, Lung, and Blood Institute (NHLBI), will target technologies to improve the diagnosis, treatment, management, and prevention of heart, lung, blood, and sleep disorders and diseases. 

Venture capital for early-stage medical device companies is drying up. At Advamed 2013, I was able to sit down and talk to Paul Grand, managing director at Research Corporation Technologies Ventures, a life sciences firm focused primarily on medical devices. When I asked him what the three main mistakes startups make when pitching him, he sighed. His first response: “Only three?”

Ouch. So be sure to avoid these blunders when pitching VCs, startup CEOs:

With the enforcement of the HIPAA Omnibus final rule starting this week, health IT companies face liability for breaches of patients’ protected health information that they may never have faced before. It’s also making issues like Bring Your Own Device even mores stressful for CIOs as they figure out how to make any instances of PHI on these devices secure enough to withstand an audit if the devices get lost or stolen. Although the strategy is not without risks, providers and payers are turning to cloud-based solutions from data security companies to ensure HIPAA compliance.

Here are a few health IT companies taking this approach. Their data security measures are designed to help providers serving as covered entities and HIT companies who are business associates comply with HIPAA.

Covidien President and CEO Joe Almeida said in a little more than a decade, sub-Saharan Africa could be the big opportunity for medical device companies’ solution investments.

“It is a 10- or 15-year play. . . . The middle class will rise and you will have an opportunity,” Almeida said during the CEOs Unplugged series at Advamed 2013.

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:

NIH Guide Notices (NOT):

• NOT-OD-13-117: Review of Grants Information for Fiscal Year 2013
• NOT-OD-13-116: New Program Certifications Required for SBIR and STTR Awards
• NOT-OD-13-115: Notice of Intent to Publish the Reissuance of the Funding Opportunity Announcement Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (Parent T32)

Requests for Applications (RFAs):

• RFA-RM-13-014: Defining A Comprehensive Reference Profile of Circulating Human Extracellular RNA (U01)

Program Announcements (PA):

• PAR-13-358: Opportunities for Collaborative Research at the NIH Clinical Center (U01) (expires March 21, 2015 )
• PAR-13-357: Pre-application: Opportunities for Collaborative Research at the NIH Clinical Center (X02) (expires November 21, 2014)

At Rock Health, entrepreneurs are developing innovative products to keep us healthier, and lower medical care costs.

Ten health startups in Rock Health’s current accelerator class presented to a roomful of investors and the press today. Rock Health is a startup accelerator that focuses on health care technology.

The current class of startups are tackling huge challenges in health care, such as cancer treatment or eating disorders.

mHealth advocates are giving good early reviews to the U.S. Food and Drug Administration's final guidance document on the regulation of mobile medical apps, with one expert calling it "an expansive document that truly seeks to deregulate our nimble and innovative industry, while ensuring patient safety."

"The guidance goes much further than I thought it would," said Robert Jarrin, senior director of government affairs for Qualcomm, who noted that the agency has taken a new and novel approach in launching a consumer-facing website with an adjoining list of regulated apps that may be updated on a regular basis. In addition, he said, the FDA is creating a team that will be tasked with answering public inquiries about mobile medical apps submitted through This email address is being protected from spambots. You need JavaScript enabled to view it..

October 1 and 2, 2013 8:00pm ET/5:00pm PT

Now on its eighth run, the NIH SBIR Phase I Program for First-Time Applicants is a very practical step-by-step, four-hour online "How-To" workshop over two evenings to help researchers, faculty members, graduate students, post-docs and entrepreneurs create a SBIR company and apply to the NIH SBIR program in December of 2013. This workshop includes a post-course review of the applicant's proposed SBIR application by our experts before submission to the NIH. As an added benefit, your SBIR companies will be included on NCET2's newsletters that is sent out to VCs, angel investors, Global 1000 companies, and government funders.

The NIH SBIR/STTR program is one of the federal government's best mechanisms to continue funding innovative life science research after traditional research funding has been exhausted. The objective of the program is to dramatically increase the impact of innovations derived from original federally funded R&D, and as such is an ideal program to fund university commercialization of research through new university/faculty/student startup companies. Phase I can be for up to $150,000 for 6 months. Phase II can be for up to $1 million for 2 years. After Phase I and II, the company should have eliminated enough technical and scientific risk of the original research that the company is ready for outside investor funding or product sales in the company sustainability final Phase III of the SBIR program.

Something as mundane and common as giving and receiving compliments may be a serious challenge if you are an immigrant.

Over the years, I have learned, often the hard way, the essential importance of receiving and giving compliments, at home, at work, and in social or semi-social environment. Generally speaking, East Asian cultures tend to be more reserved in expressing appreciations or affection toward others compared to the American culture (some generalization here).  We have all heard of such jokes about Asian parents singling out the only “B” in the child’s report card amidst all other “A”s and demand to know why the child had failed to get straight “A”s, while American-born parents would emphasize on the progress or efforts rather than the outcome.

Health IT groups and mobile application developers' reaction to FDA's release of final guidance for mobile health apps is mixed, the Baltimore Sun reports (Wells/Clarke, Baltimore Sun, 9/23).

Details of Final Rule

According to the final guidance issued Monday, FDA will focus oversight on apps that:

• Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or 
• Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 9/23).