BHI Weekly Newsletter Archives

I am clearly on a digital health kick, blog-wise, as I look back on my last few posts. Having spent time at both CES and the JP Morgan Healthcare conference, where digital health was a hot topic, it seems that the subsector is definitely having its day in the sun. I was particularly honored to be named among the 2013 “Top 50 in Digital Health” by a group comprised of Rock Health, Goldman Sachs, Silicon Valley Bank, and Fenwick & West. There are some pretty smart people on the list with me and it is very gratifying to be in such great company (nice article about the list by Wade Roush at Xconomy can be read HERE).

On the other hand, I was feeling a little inadequate being on the list without my own digital health start-up to show for it. I mean, hey, there I am among the actual innovators who dreamed up such cool companies as MC10, Evolent, Pokitdok, Athena Health, and a host of others with only my investment checkbook and blog to show for it. Given that it is the year of the wearables, as anyone who went to CES could readily attest, and that the entrepreneurs in that sector were well represented in the Top 50 list (FitBit’s James Park, Misfit Wearables’ Sonny Vu, etc), I have decided to throw my own hat (wrist?) in the ring on this sector.

These top venture capitalists don’t wait for biotech startups to come to them. They create companies themselves.

The path to greatness in biotechnology runs through a vale of tears. Mark Levin wants to remember that.

Medimmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca (LSE: AZN), has entered into a collaboration to establish a joint lab in Cambridge, UK, with Cancer Research Technology, the commercial arm of Cancer Research UK.

The new laboratory will be the first partnership of its kind of both organizations, and will focus on the discovery and development of biologic cancer treatments over an initial five-year period.

BHI Appoints Shady Grove Adventist Hospital President John A. Sackett to Board of Directors

ROCKVILLE, MARYLAND, April 21, 2014 – BioHealth Innovation, Inc. (BHI) announced today the appointment of Shady Grove Adventist Hospital President John A. Sackett to its Board of Directors. Mr. Sackett is filling a vacancy on the BHI board left by William G. “Bill” Robertson, who recently announced that he was leaving his post as President and Chief Executive Officer of Adventist HealthCare for a position in Washington state.

“The addition of John to the BHI Board of Directors affords us with another strong healthcare leader who provides a perspective from the health system side of the business,” said Rich Bendis, President & CEO, BioHealth Innovation, Inc. “His decades of experience as a healthcare administrator will be an asset to BHI as we work with startups who are seeking to commercialize biohealth products and gain acceptance within the healthcare system.“

In April of 2013, Mr. Sackett became President of Shady Grove Adventist Hospital. He began his career at Boulder Memorial Hospital in 1982. He served as Vice President for General Services from March 1984 until being named President of Avista Adventist Hospital, formerly Boulder Memorial Hospital, in June of 1989. In 1996, when Avista Adventist Hospital became a member of Centura Health, he was named Senior Vice President for Mission and Ministry, in addition to his responsibilities as Administrator for Avista. He most recently served Centura as the Chief Executive Officer for Avista Adventist Hospital in Louisville, Colorado.

A high sugar diet greatly increases the risk of cardiovascular disease regardless of body weight, according to a new study by the American Centers for Disease Control and Prevention.

The study, which is the biggest one of its kind to date and has included more than 10,000 people followed for up to 14.6 years, concludes that people who drink, for example, one soft drink per day increase their risk of cardiovascular disease by one-third.

Download the presentation here

Please join Rich Bendis on Thursday, February 6th, 2014 for the 7th Annual Health IT Day in Annapolis. Learn more about Health Information Technology (HIT) and how it affects you as a consumer today and in the future. Get the chance to meet with district legislators and senators to let them know what needs to be done to further push HIT in Maryland and keep us on the cutting edge of this rapidly evolving field.

“Our goal is absolutely to democratize knowledge,” says Denny Luan. “Modern science has such a rush for fast results – publish or perish, output over process. We’d like to show the greater public that science does not have to be locked up behind monasterial walls. We’d like to change the way science is shared – in an engaging, deliberately beautiful way. Real-time, open-access and with great design.”

Luan is co-founder of what, until this morning, was known as “Microryza” – the site has been renamed “Experiment” as part of a revamped branding strategy – a potentially revolutionary crowdfunding platform that is looking to do for science what Kickstarter has done for the entertainment industry.

ROCK SPRING VENTURES,A LEADING EARLY-STAGE LIFE SCIENCE VENTURE CAPITAL FUND, IS NOW EPIDAREX CAPITAL Our new name is inspired by Epidaurus, the home of ancient Greece’s first hospital and the temple of the Greek God of Medicine. It reflects our focus on innovation in the healthcare sector and our commitment to investing in young life science and health technology companies. Visit www.epidarex.com.

STAY TUNED FOR A NUMBER OF EXCITING ANNOUNCEMENTS THROUGHOUT THE COMING YEAR…

ROCKVILLE AND BALTIMORE, MARYLAND, January 6, 2014 – BioHealth Innovation, Inc. (BHI) and MIMETAS announced today that Todd Chappell, MBA, an Entrepreneur-in-Residence for BHI, has been named General Manager, U.S. Affairs for MIMETAS. A Netherlands-based company, MIMETAS is establishing its offices within BHI’s headquarters in Rockville. MIMETAS and BHI created a U.S. subsidiary of MIMETAS to access the clinical, regulatory and scientific resources available in Central Maryland and to access the U.S. marketplace, the largest life sciences market in the world.

“We’re very pleased to add Todd to the MIMETAS team,” said Jos Joore, Ph.D., Chief Business Officer of MIMETAS. “Todd couples a vast experience in business creation with a profound understanding of biology and disease mechanisms. Most importantly, Todd shares our sense of urgency around enabling better medical treatment by using more predictive cell culture models.”

Previously, Mr. Chappell was the Vice President of Operations for Shape Pharmaceuticals, a portfolio company of HealthCare Ventures, LLC, where he oversaw all day-to-day operations involved in the development of a novel HDAC inhibitor for Cutaneous-T-Cell-Lymphoma. Prior to that, he was at CombinatoRx Inc. for eight years and served as Director of New Products. Mr. Chappell will be combining his role at MIMETAS with his existing EIR position at BHI.

MIT professor Yael V. Hochberg revealed the most effective startup accelerators in the country Tuesday at SxSW in Austin. DreamIt Health showed up in slot #15 and was the only health focused accelerator on the list.

Hochberg is a professor of Finance at the Sloan School of Management at the Massachusetts Institute of Technology. She and professor Susan Cohen of the University of Richmond and the Batten Institute at the University of Virginia’s Darden School of Business, used original research and data from CrunchBase to rank the 15 accelerators.

MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca,…

In order to access this content you need to be logged into the site and have an active subscription or trial subscription. Please login, take a free trial or subscribe in order to continue reading.

– Representatives from Sigma-Tau Pharmaceuticals Inc., Alexandria Real Estate Equities, Inc., and Deloitte Consulting LLP Take New Board Seats – 

– Charles Morton Becomes New Venable LLP Representative on Board while Mike Baader Stays on as Board Member (Now as Greenspring Associates Representative) –

ROCKVILLE AND BALTIMORE, MARYLAND, August 11, 2014 – BioHealth Innovation, Inc. (BHI) announced today the appointment of four new members to its Board of Directors. Dave Lemus, Chief Executive Officer, Sigma-Tau Pharmaceuticals Inc.; Joel S. Marcus, Chairman, Chief Executive Officer, and Founder, Alexandria Real Estate Equities, Inc. (Alexandria Venture Investments); and Beth Meagher, Principal, Deloitte Consulting LLP, have joined the BHI Board of Directors, effective August 7, 2014, based upon their organizations’ newly committed support of BHI. Charles “Chuck” Morton now represents Venable LLP on the Board, as another new Board member, while Mike Baader, formerly with Venable, will continue to hold a seat on the Board, but now as a representative of Greenspring Associates. Cynthia L. Collins, CEO, Clarient, who had served on the BHI Board since early 2013, is stepping down from her Board position after relocating to the West Coast

“The expansion of and continued diversity within the BHI Board, based upon new key industry and service provider representatives who are all deeply involved in life sciences, is a testament to the positive impact BHI has made on the Central Maryland biohealth community to date,” said Richard Bendis, BHI President & CEO. 

“We look forward to the contributions from the new Board members representing these organizations. We’re also pleased to welcome a new Venable representative to the Board and that Mike Baader will continue to add value to the organization now that he is on the Greenspring Associates team,” said Douglas Liu, Chair, BHI Board of Directors, and Senior Vice President of Global Operations for Qiagen. “And, on behalf of the BHI staff and Board, I would also like to offer gratitude to Cynthia Collins for her service and contributions to the BHI Board over the last year and half.”

Each year, Speakers Platform recognizes five speakers within ten popular topic areas. Excellence in speaking is based on: expertise, professionalism, client testimonials, presentation skills and original contribution to the field. The only substantive requirement is that the candidates’ standard keynote presentation fee be under $30,000USD. Once the nominees are chosen, online voters determine the final Top5 honorees. Women secured more honoree slots this year than any year in the past – almost sweeping some categories such as “Communication / Diversity”. Job well done!

Over 12,000 votes were received at Speaking.com for the initial 165 nominees- from business leaders, educators, association members and others from around the world. Many voters praised the nominees for having a profoundly positive impact on their lives; a living testament to the far reach and valuable work of all the nominees. Please join us in congratulating your 2014 honorees!

Richard Bendis was listed in the top 5 in the Innovation / Creativity category. Thanks to all those who voted and helped spread the word! —Ed.

As we go into the last few weeks of the year, my office is busy working up the final numbers on application data for this year. Although the complete set of application data, tables, and graphs will not be available until later in January, I thought I would provide an early snapshot on success rates for 2013 competing research project grant (RPG) applications and awards.

We received 49,581 competing RPG applications at NIH in fiscal year 2013, slightly declining compared to last year (51,313 applications in FY2012).

The disease detectives at the Centers for Disease Control and Prevention named the top five global health threats they expect to tackle in 2014:

1. The emergence and spread of new microbes

While it’s rare, CDC scientists do come across new diseases each year. In 2013, the new Heartland virus carried by ticks was confirmed in northwest Missouri. Federal health investigators collected samples in the state after two farmers from St. Joseph were sickened by the virus that carried a novel genetic profile.

After vanquishing humans on Jeopardy!, IBM says its Watson computer is ready to help save human lives. The company on Thursday announced it has created a new business unit specifically to advance Watson and deliver its artificially intelligent wisdom to research organizations, medical institutions and businesses so that they can process “big data” for detailed answers to complex questions. They won’t actually own a Watson computer—instead its services will rendered via a network connection (the “cloud computing” model).

IBM doesn’t launch new business units every day—or even every decade—chief executive Ginni Rometty noted during the Watson Group announcement. Indeed, the company is making a calculated bet—to the tune of more than $1 billion—on cognitive computing and the role it will play in making big data useful.

Gov. Martin O’Malley on Wednesday unwrapped his eighth and final budget, a $39 billion plan that increases spending on tax credits for cyber security, biotechnology and research and development while holding the line on taxes.

For fiscal 2015, O’Malley has proposed hiking the biotech and life sciences tax credit by 20 percent, to $12 million. He wants to increase the cyber tax credit by 33 percent, to $4 million and raise the credit for research and development by 12.5 percent, to $9 million.

– BHI offers program that guides biohealth startups in securing federal funding –  

ROCKVILLE AND BALTIMORE, MARYLAND, June 10, 2014 – BioHealth Innovation, Inc. (BHI) announced today that two local biohealth companies to which it has provided strategic assistance, N5 Sensors, Inc. and BioDatomics, have secured Small Business Innovation Research (SBIR) awards. N5 Sensors, a BHI client, received two awards: one from the Enivronmental Protection Agency (EPA) and one from the National Science Foundation (NSF). BioDatomics, which participated in a federal funding assistance program offered by BHI, secured an SBIR grant from the National Institutes of Health (NIH)1.  The U.S. federal government’s SBIR program encourages domestic small businesses to engage in federal research and development that has the potential for commercialization. The SBIR program empowers these companies to develop their trade and provides a path to profitability.  

“BHI is dedicated to supporting start-up biohealth companies in Central Maryland in their submission of competitive SBIR applications,” said Ethan Byler, Director, Innovation Programs, BioHealth Innovation, Inc. “We congratulate N5 Sensors and BioDatomics on receiving SBIR grants from the EPA, NSF and the NIH, respectively.”

N5 Sensors of Rockville, which is developing a new generation of chemical sensors that can detect harmful chemicals mixed in air in very small quantities, recently announced that the EPA has issued a SBIR Phase I grant to the company for its low-power, small form-factor benzene sensors for exposure monitoring using mobile devices. The $100,000 grant will support N5’s work developing sensors that can detect small amounts of benzene in the air. A University of Maryland, College Park spin-off, N5 Sensors, Inc. has engaged BHI to support its commercial strategy. N5 has also recently been awarded a Phase I SBIR from the NSF to develop chip-scale carbon monoxide and ammonia sensors.

Thomas Kucharski (IEDC) – Ethan Byler (BHI) – William C. Sproull (IEDC)

BioHealth Innovation, Inc. (BHI) was selected as an International Economic Development Council (IEDC) Excellence in Economic Development Silver Award recipient. BHI is receiving the award in the Public-Private Partnerships category for its work to assemblethe partnership that sponsored DreamIt Health IT Baltimore accelerator program. The award, which recognizes outstanding and innovative development projects that have significantly enhanced the economic revitalization of distressed communities, states, or regions, was formally presented to BHI on Monday, October 20, during the 2014 IEDC Annual Conference in Fort Worth, TX.

“BHI is honored to be acknowledged with this award for our work with DreamIt Health in support of the DreamIt Health Baltimore program in 2014,” said Richard Bendis, BHI President & CEO. “This reinforces the dedication to entrepreneurship and innovation in the biohealth arena that we are constantly striving for in Central Maryland.”

Maryland’s efforts to build out the local cybersecurity economy seem to be working. Cybersecurity startup Luminal recently announced a move to Maryland from West Virginia, and will be rewarded by a $600,000 investment from InvestMaryland, the state’s venture fund. With this investment, Luminal closed a total of $3.82 million in a Series A round of funding including Core Capital Partners and New Enterprise Associates.

As CivSource has reported Maryland has launched several initiatives aimed at growing the local cybersecurity economy, including tax incentives, investments and a research partnership leveraging local universities and the military. Maryland is building on its proximity to a number of critical defense assets and the federal government to attract new cybersecurity entrants. The state of Virginia is also working on a similar effort.

Originally published in the Baltimore Business Journal

By Brian Darmody

Where’s the nation’s second largest concentration of academic, federal and private sector research spending? California? Massachusetts? According to the National Science Foundation, it’s Maryland, equating to billions of dollars in research investment in the Maryland economy. First place New Mexico has a relatively small rural population and presence of two major federal nuclear research labs.

But Maryland has something New Mexico doesn’t — proximity to Washington, D.C.

Washington is home to the nation’s government, but also the National Academies, technology trade associations, international corporations, embassies, media, regulatory agencies, foundations, and science agencies.

Happy New Year! This week’s Top of the List is from our first-ever List of “Largest incubators, accelerators and co-working spaces in Maryland,” ranked by current number of members or tenants.

Here they are, counting back from No. 5:

One way pharma giant Johnson and Johnson stays ahead of the competition is via its network of Innovation Centers where researchers are working on new approaches to cardiovascular issues, infectious diseases, neuroscience, and more.

The centers are located in San Francisco, Boston, London, and Shanghai – and this week the company announced that Israel was joining the family, in the form of an incubator J&J will be opening in Rehovot, near the Weizmann Institute. Working together with several other partners, the company said, the new incubator “is the latest in a series of recently announced collaborations to fuel entrepreneurship in the world’s scientific hot spots.”

ROCKVILLE AND BALTIMORE, MARYLAND, September 30, 2014 – BioHealth Innovation, Inc. (BHI), a regional private-public partnership focusing on commercializing market-relevant biohealth innovations and increasing access to early-stage funding in Central Maryland, announced today that venture capitalist, Tania Fernandez, Ph.D., has joined the BHI team as a strategic advisor. Dr. Fernandez will be a member of the management team for a new BioHealth Gap Fund, which will provide up to $50 million in seed and early-stage equity investments to therapeutics, medical device, diagnostics, and health IT companies in Maryland. Additional BioHealth Gap Fund management team members include Richard Bendis, Ram Aiyar, Todd Chappell, and Ken Malone, who each bring domain knowledge and industry access to the fund.

Just what is a “National Cybersecurity Center of Excellence,” anyway?

I’ve heard this question muttered repeatedly, in one form or another, in the course of covering the ongoing bio vs. cyber dispute over the future of the William Hanna Center for Innovation at Shady Grove.

– Effort designed to help revolutionize access to genomic interpretation services in hospitals, molecular diagnostics companies and academic medical centers throughout the U.S. –

ROCKVILLE AND BALTIMORE, MARYLAND, MARCH 25, 2014 – Strand Genomics Inc. (Strand) and BioHealth Innovation, Inc. (BHI) today announced a strategic partnership designed to expand the Strand Centers for Genomics & Personalized Medicine into the U.S. This effort is intended to help revolutionize access to genomic interpretation services in cardiovascular disease, oncology, rare diseases, and many other indications. Strand Genomics is a wholly owned subsidiary of Strand Life Sciences, a Bangalore, India-based bioinformatics, clinical genomics, and diagnostics company.

Strand operates clinical genomics and diagnostics laboratories in India that perform end-to-end clinical genomics services, such as testing and diagnostics, to healthcare systems in that country. Strand now provides diagnostic tests based on next-generation sequencing to more than 50 major hospitals in India. Strand is expanding globally and is actively seeking partnerships with hospitals, molecular diagnostic companies and academic medical centers looking to offer genomics-based diagnostics tests. In December 2013, Strand had announced its collaboration with El Camino Hospital in Mountain View, CA. BHI, a Maryland-based innovation intermediary, will be integral in supporting the market penetration of Strand’s services into the U.S. healthcare system by connecting Strand with key market channels, thus providing access to genomic services to more patients and healthcare providers.

BioHealth Innovation, Inc. (BHI) announced today that Roche Pharma Research and Early Development (pRED) and BHI have entered into an agreement to advance healthcare technologies coming from academic institutions, federal laboratories and startups based in Central Maryland. Under the terms of the agreement, BHI will identify health technologies that Roche will evaluate for potential research, development and commercialization opportunities. Priority areas of interest will include oncology, neuroscience, ophthalmology, rare diseases, immunological and infectious diseases. Financial terms for the agreement were not disclosed.

The agreement was initiated through Roche pRED Academic Relations and Collaboration (ARC) group, which is led globally by Juan Carlos Lopez. “Sourcing of technologies from academia, federal labs and early-stage startups can be a challenging and lengthy process,” said Lopez. “As we seek to expand our capabilities to source and screen technologies aligned with our strategic interests, BHI is an ideal partner to support identification of external opportunities in a broad, systematic fashion.”

Montgomery County Executive, Ike Leggett, has named Sally Sternbach Acting Director for the Department of Economic Development effective January 3, 2015.

Health Canada has accepted US-based Sucampo Pharmaceuticals’ New Drug Submission (NDS) for Amitiza (lubiprostone), 24mcg capsules, to treat chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

The pharmaceutical giant Roche has paid an undisclosed price to acquire Bina Technologies, a bioinformatics company. The move sees Roche expand further into the life sciences sector.

On Thursday, January 15, 2015 from 4-6:30 pm there will be an open house for the spring courses in the “Advanced Studies in Technology Transfer” program at the Foundation for Advanced Education in the Sciences (FAES) Graduate School at NIH in the new Classroom & Bookstore complex in NIH Building 10 / B1 level. For the semester beginning on January 26, 2015 there will be 14 courses offered with details available in the new 2014-15 course catalog ( www.faes.org ). The Advanced Studies in Technology Transfer is an open enrollment program with class credits transferable into various university MBA & MS degree programs. The technology transfer classes will be held at the offices of the NIH Office of Technology Transfer in Rockville as well as the NIH main campus in Bethesda.

United Therapeutics Corporation (NASDAQ: UTHR) announced today the signing of an agreement with DEKA Research & Development Corp. for the development of a potential technology breakthrough in the subcutaneous delivery of Remodulin® (treprostinil) Injection to patients with pulmonary arterial hypertension (PAH) via a pre-filled semi-disposable pump system.

SHUTTLE Pharmaceuticals, a privately held company, today announced it has been awarded a fast-track Phase I/II contract #HHSN261201400013C by the National Institutes of Health (NIH) under its Small Business Innovation Research (SBIR) program. The $ 1.62 million contract will fund the initial development of IPdR (5-iodo-2-pyrimidinone-2-deoxyribose), a prodrug of the radiation sensitizer IUdR (5-iodo-2-deoxyuridine). The contract is to determine the scientific merit, feasibility and potential for commercialization of oral IPdR for use as a radiation sensitizer for the treatment of rectal cancers. The NIH contract provides funds to cover a portion of the costs for initiating a Phase I trial in GI cancers and development of companion diagnostics for analyzing clinical specimens from Phase I patients.

Roche Holding AG said US health regulators have approved its Ebola test for emergency use in response to the world’s worst outbreak of the disease in West Africa.

The US Food and Drug Administration (FDA) has approved Roche’s LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection, the Swiss drugmaker said in a statement.

Two-thirds of a wide variety of cancer kinds are largely rooted in undesirable genetic luck and not simply the benefits of traits passed down from parents or risk components like smoking or diet program, according to a new study. Random mutations in DNA are largely accountable for the majority of cancers in humans, according to researchers at Johns Hopkins University in Baltimore.

Outgoing D.C. Mayor Vincent Gray gave the city’s tech scene some love as one of his final acts, signing a somewhat controversial tax cut into law. The capital gains tax on returns from investments in certain tech companies was lowered to 3 percent.

Here are a few thoughts on the cut from techs I spoke with…

Anne Arundel County’s economic development chief took to LinkedIn in search of a new executive director of the Chesapeake Innovation Center — and he’s dangling a big carrot.

Robert L. Hannon, president and CEO of Anne Arundel Economic Development Corp., is spreading the word that he’s looking for an executive director for the agency’s technology incubator who has a background in small-business/technology development, technology commercialization, entrepreneurship and five years professional work experience. The position’s salary will range from $110,000 to $130,000, with an estimated benefits

The CMS Innovation Center paid $2.6 billion through September to hospitals, doctors and others through nearly two dozen programs that tested new ways to deliver healthcare and pay for it.

Here are my 10 crucial pieces of advice for students who aspire to a career in pharmaceutical labs:

1. You need a solid foundation in science. Master the basics, and learn how to apply that knowledge.

Biotechnology will have a strong year in 2015, but it can’t get any better than 2014, biotech investor G. Steven Burrill says in his annual year-end report.

“The unprecedented IPO (initial public offering) and M&A (mergers and acquisitions) activity this year will make 2014 one for the record books and unlikely to ever be surpassed,” Burrill said.

With 41 novel drug approvals under the regulators’ belts last year, 2014 represented an 18-year high for the Food and Drug Administration – including a record number of okayed meds for orphan diseases, the Associated Press says…

A new business incubator in Baltimore’s Inner Harbor will cater to startup companies launched through universities.

The Institute of Marine & Environmental Technology in January is opening a 4,300-square-foot incubator in its offices at the Christopher Columbus Center in Baltimore’s Inner Harbor.

Campus Technology is looking for innovative colleges and universities that have deployed unique technology solutions to campus challenges.

Nominations are now open for our tenth annual Campus Technology Innovators Awards, recognizing institutions, technology project leaders and vendor partners that have used technology in new ways to support teaching, learning, administration and operations. The deadline for entries is Feb. 17.

Finding funds for early stage companies has always been a great challenge. In past venture financing cycles, it’s been the gap between the first venture financing (Series A) and the growth capital or mezzanine financing that many emerging companies were unable to bridge. This gap, called the “valley of death,” was attributed to a number of factors, but that valley of death has shifted in important ways in the recent past.

U.S. drug approvals in 2014 hit their highest level in 18 years and recommendations in Europe also came at a rapid rate, driven by expensive new treatments for cancer and rare diseases.

U.S. News & World Report is pleased to announce the 2014 STEM Leadership Hall of Fame, honored during the U.S. News STEM Solutions conference. In choosing the honorees, U.S. News sought out leaders who, among other things, have achieved measurable results in the science, technology, engineering, and math fields; challenged established processes and conventional wisdom; inspired a shared vision; and motivated legions of aspiring STEM professionals.

Governmental agencies face a wide spectrum of challenges in creating mHealth apps, ranging from a changing development culture to potential litigious issues, revealed a new report published in the Journal of Medical Internet Research.

Last spring Laura Murphy, then 28 years old, went to a doctor to find out if a harmless flap of skin she had always had on the back of her neck was caused by a genetic mutation. Once upon a time, maybe five years ago, physicians would have focused on just that one question. But today doctors tend to run tests that pick up mutations underlying a range of hereditary conditions. Murphy learned not only that a genetic defect was indeed responsible for the flap but also that she had another inherited genetic mutation.

Ah, the elevator pitch. A favorite tool of the networking masses. A rite of passage of sorts. You’ve heard the scenario: you step into an elevator and go up one floor. The elevator doors open and in walks the client of your dreams. They start some small talk and ask, “What do you do?” and you’ve got the rest of the elevator ride to respond. How do you answer that in 20 seconds in such a way that gets them interested? The answer is simple. You need an elevator pitch for your elevator pitch.

In 2014, wearable health tracking devices continued to get more creative, going far beyond simple fitness tracking. The K-Goal, a “Fitbit for your vagina,” promised to help women do kegel exercises correctly, while the Emotiv EEG headset offered the prospect of mental acuity, measured by a device that tracks the brain’s concentration.

The year in biotechnology began with a landmark event. A decade after the first human genome was decoded at a cost of about $3 billion, the sequencing-machine company Illumina, of San Diego, introduced a new model, the Hyseq X-10, that can do it for around $1,000 per genome.

Medical technology developer Medtronic, Inc. recently completed an application submission to the U.S. Food and Drug Administration (FDA) regarding the pre-market approval of their SynchroMed II implantable drug infusion system, which includes a new catheter design. The system is intended to be used by pulmonary arterial hypertension (PAH) patients for the intravenous delivery of the drug Remodulin (treprostinil), which is being developed by the United Therapeutics Corporation.

Imagine, a quick pinprick on the sidelines of a football game that could tell athletes whether they’ve concussed. Arizona startup BioDirection is developing a point-of-care device that diagnoses minor brain injury quickly – in 60 to 90 seconds – with just a single drop of blood.

Friday, January 9, 2015

Learn How to Get Seed Funding Investment for Your Business from the Government! Improve your Federal Contractor procurement postion from the same program–Small Business Innovation Research Funds (SBIR). Featuring SBIR program managers from leading Federal agencies including DOD, NIH, NCI, NASA, DOE and NSF! Network with the SBIR program managers during an Expo and meet other business owners. Get tips on how to win awards and hear about changes in the agencies’ funding and procurement programs. If you are considering applying for an SBIR grant in 2015, or have already won and need to learn updates directly from SBIR program managers, this event is for you!

BioHealth Innovation, Inc. (BHI), a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together among other things management, funding, and markets, is seeking an experienced life science professional with entrepreneurial experience to serve as an Entrepreneur-in-Residence (EIR).

The EIR will lead in the evaluation of early-stage technologies and corporations with a priority focus on those associated with Funding Partners and those that best fit with the strategic direction as set by BHI’s CEO and Director of EIR Programs. The EIR will perform any reasonable task which will forward the goals of BHI. 

A new business incubator in Baltimore’s Inner Harbor will cater to startup companies launched through universities.

The Institute of Marine & Environmental Technology in January is opening a 4,300-square-foot incubator in its offices at the Christopher Columbus Center in Baltimore’s Inner Harbor.

Tao Yu, a graduate student in the Department of Biomedical Engineering, talks about his internship with Biohealth Innovation, through the Johns Hopkins University School of Medicine’s Biomedical Careers Initiative (BCI).

Biotechnology will have a strong year in 2015, but it can’t get any better than 2014, biotech investor G. Steven Burrill says in his annual year-end report.

“The unprecedented IPO (initial public offering) and M&A (mergers and acquisitions) activity this year will make 2014 one for the record books and unlikely to ever be surpassed,” Burrill said.

Marriott International Inc. is launching a restaurant incubator competition, hoping to tap the world’s growing cadre of food and beverage entrepreneurs to bring a new level of cool to its hotels.

The Bethesda hotel giant bills the competition, called Canvas, as a “global concept lab for food and beverage ideas.” The winners will get up to $50,000 each and six months to operate and prove their concepts.

In a world’s first, a double-amputee, with arms missing at shoulder level, received two prostheses, each of which he is able to control intuitively with his mind and manipulate different joints to control a total of 30 degrees of motion.

The system installed at the Johns Hopkins University Applied Physics Laboratory relies on surgically connecting electrodes to existing nerves that used to lead to the different part of the arm and hand.

In 2014, wearable health tracking devices continued to get more creative, going far beyond simple fitness tracking. The K-Goal, a “Fitbit for your vagina,” promised to help women do kegel exercises correctly, while the Emotiv EEG headset offered the prospect of mental acuity, measured by a device that tracks the brain’s concentration.

The year in biotechnology began with a landmark event. A decade after the first human genome was decoded at a cost of about $3 billion, the sequencing-machine company Illumina, of San Diego, introduced a new model, the Hyseq X-10, that can do it for around $1,000 per genome.

Here are my 10 crucial pieces of advice for students who aspire to a career in pharmaceutical labs:

1. You need a solid foundation in science. Master the basics, and learn how to apply that knowledge.

Faced with diminishing returns on R&D investments, large pharmaceutical companies are searching for innovative ways to successfully identify, develop, and market products with financial viability. Yet small discovery companies and biotechs continue to outpace large pharma in the approval of NMEs (new molecular entities).

Rampaging animal spirits have given birth to a biotechnology unicorn. It’s apt that a stellar year for initial public offerings in the sector will be capped by its biggest float ever. Juno Therapeutics is a year old and revenue free, but its cancer fighting technology is hot. At nearly a $2 billion valuation, the company shows capitalism’s ability to catalyze investors’ hopes and resources.

Whether a startup makes or breaks depends on if you have the right people on the team. How can you know? During my start-up journey as an early employee of an online education startup, co-founder of a social enterprise, and sole founder of my health technology company, ClickMedix, I’ve been through and witnessed the birth, growth, decline, and eventual end of startups.

Medical technology developer Medtronic, Inc. recently completed an application submission to the U.S. Food and Drug Administration (FDA) regarding the pre-market approval of their SynchroMed II implantable drug infusion system, which includes a new catheter design. The system is intended to be used by pulmonary arterial hypertension (PAH) patients for the intravenous delivery of the drug Remodulin (treprostinil), which is being developed by the United Therapeutics Corporation.

Amgen Inc. announced an agreement Monday to become a sponsor of LabCentral, a biotech incubator in Cambridge, Mass.

The Thousand Oaks pharmaceutical company can nominate up to two biotech startups a year for residence in LabCentral’s facilities. The lab has 28,000 square feet and can house 28 early stage companies. Other sponsors of the project include Massachusetts Life Sciences Center, MIT and Johnson & Johnson Innovation.

Evolva Holding SA (“Evolva”, SIX: EVE) today announced that Emergent BioSolutions Inc. (“Emergent”, NYSE: EBS) has acquired Evolva’s anti-bacterial programme, the EV-035 series. The lead compound in the EV-035 series is the broad-spectrum antibiotic GC-072, which is being developed with US government biodefense funding. For Evolva, this transaction is worth up to USD 70.5 million plus royalties.

United Therapeutics (Nasdaq: UTHR) announced two senior executive promotions as well as changes to Martine Rothblatt, Ph.D’s compensation program.

Much of the talk these days regarding HR technology revolves around big data, wearable devices and bring-your-own-device policies. Such current technological concerns could be mere child’s play compared to cyberconsciousness and how it could alter the workforce of the future. This obscure concept is brought to you courtesy of Martine Rothblatt, an unrelenting force in business.

Friday, January 9, 2015

Learn How to Get Seed Funding Investment for Your Business from the Government! Improve your Federal Contractor procurement postion from the same program–Small Business Innovation Research Funds (SBIR). Featuring SBIR program managers from leading Federal agencies including DOD, NIH, NCI, NASA, DOE and NSF! Network with the SBIR program managers during an Expo and meet other business owners. Get tips on how to win awards and hear about changes in the agencies’ funding and procurement programs. If you are considering applying for an SBIR grant in 2015, or have already won and need to learn updates directly from SBIR program managers, this event is for you!

From Steve Silverman, Directory, Montgomery County Department of Economic Development:

As 2014 draws to a close, I want to sincerely thank our 33,000-plus local businesses for all you do to support the local economy! Montgomery County benefits so much from our diverse, dedicated business community. I also applaud the many support organizations and entities that work with our Department, state and local governments to make sure you succeed.

Shareholders in British drugmaker GlaxoSmithKline (GSK.L) have approved a planned deal with Switzerland’s Novartis (NOVN.VX), which will see the two pharmaceutical groups trade more than $20 billion (12.7 billion pounds) of assets.

Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The trial is expected to begin patient enrollment in early 2015.

The Swiss firm, which this week filed a melanoma combination drug for US approval, spent $10bn on research into new products, ahead of rivals such as Novartis, which spent $9.8bn and the $8.2bn spent by Johnson & Johnson (J&J).

Let’s be clear: Martine Rothblatt is just plain more of a lawyer than anybody else in this town.

The 60-year-old grandmother and CEO of United Therapeutics, the Silver Spring-based biotech she founded to help save her younger daughter’s life, banked $38 million last year. It made her the nation’s highest-paid female executive. It also made her the nation’s highest-paid transgendered person, as she had sex reassignment surgery in 1994.

Healthcare workers treating Ebola victims are at a great danger of contracting the disease, as recent events in western Africa have shown. Currently available protective suits tend to require complicated procedures when putting on and taking off, are difficult to breathe in, and obscure the clinician’s face. A team at Johns Hopkins has developed, and just won a grant from the U.S. Agency for International Development (USAID) to further perfect, a new protective suit for use when treating highly infectious patients.

Maryland is not waiting for the new year or a new governor to start taking applications for a program intended to boost business development around colleges and universities.

The state is now taking applications for its new Regional Institution Strategic Enterprise Zone program(called the “Rise Zone” program for short). It requires two application stages.

With new articles published in journals every week and scores of labs constantly at work, scientists at this university stay productive.

And a new ranking has found that university researchers live up to that standard — when it comes to science research, this university is one of the most prolific in the world.

University of Massachusetts President Robert Caret will take over as University System of Maryland’s fourth chancellor in July.

The Agency for Healthcare Research and Quality (AHRQ) has awarded a five-year contract to the Johns Hopkins Evidence-based Practice Center (JHU EPC) to help the Center continue to promote evidence-informed decision-making in clinical practice and public health policy. JHU EPC was established in 1997 as a charter member of the EPC Program supported by AHRQ’s Effective Healthcare Program (EHC). Today there are a total of 13 EPC’s.

Much like the American Dream, entrepreneurship is a national ideal of the United States representing a belief that prosperity and success can be achieved through hard, tireless work. Developing a technological innovation that will change the world for the better is what it’s all about these days, especially for young people trying to make a name for themselves on college campuses. Students arrive on school grounds driven by two thoughts – fear of failure and desire for success – both of which naturally lead down the road to entrepreneurship.

Another one to file under the Science is Awesome category: Johns Hopkins University’s Applied Physics Laboratory has engineered prosthetic arms that can be controlled with the mind.

The University of Maryland is recruiting Ken Ulman to transform College Park into a tech hub for incubators and startups, according to The Washington Post.

Ulman, a former Howard County executive who made an unsuccessful bid for lieutenant governor in November, will announce Monday he is forming a consulting firm called Margrave Strategies. Its first client will be the university’s fundraising arm, according to the report.

A coalition of geneticists and computer programmers calling itself the Global Alliance for Genomics and Health is developing protocols for exchanging DNA information across the Internet. The researchers hope their work could be as important to medical science as HTTP, the protocol created by Tim Berners-Lee in 1989, was to the Web.

The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about. “Our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel drugs in 2014 compared to 27 in 2013,” FDA commissioner Margaret Hamburg wrote on the agency’s FDA Voice blog.

The world of technology is growing at a rapid pace, nothing new, but next year could involve some major cashing in for some health tech industries. With the help of some leading analyst firms, Business Insider put together a list of the trends that are predicted to be really booming next year.

Ebola dominated the news in the second half of the year. Other important news was the debate on maintenance of certification, the first baby born after uterine transplant, and the change in HHS leadership.

Cathal Garvey used to work in cancer research. Now he is the scientific director of IndieBio, a biotech accelerator based in Cork, Ireland which is about to open a branch in San Francisco. Garvey originally studied genetics. “I got into genetics after seeing a documentary about it when it was quite young.” he says.”I had already decided that I was going to be a biologist at an even younger age. And then I thought ‘Oh my God, living things operate on a code.’”

Boards aren’t working. It’s been more than a decade since the first wave of post-Enron regulatory reforms and, despite a host of guidelines from independent watchdogs such as the International Corporate Governance Network, most boards aren’t delivering on their core mission: providing strong oversight and strategic support for management’s efforts to create long-term value.

Nearly every state added jobs in 2014, and 14 states experienced an employment increase of 2 percent or more, according to a Stateline analysis of Bureau of Labor Statistics data released Friday.

University System of Maryland Chancellor William E. Kirwan, who announced in the spring his plans to step down, said this week that he will likely remain in his post at least through February as the search continues for his successor.

Pieris AG announced today the initiation of a Phase I clinical trial with PRS-080, an anti-hepcidin Anticalin® therapeutic protein designed to treat anemia. The trial is a placebo-controlled, single ascending dose evaluation of the compound’s safety and tolerability in healthy volunteers. Conducted in Germany, the trial is underway and patients from the first cohort have been dosed.

Bedsores, diabetic ulcers and other chronic wounds cost the U.S. health care system $30 billion a year. Why? At least in part because the primary tool doctors and nurses use to track wounds is a basic ruler.

A ruler can measure the size of a wound, but does little to track other important qualities, such as changes in shape and tissue color. Consider that patients are usually cared for by a rotating team of nurses, who may each interpret a wound’s appearance differently, and it’s easier to see how so much money is spent tending to preventable (or at least treatable) conditions.

When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.

The University of Maryland is now integrating the Lean LaunchPad® into standard innovation and entrepreneurship courses across all 12 colleges within the University. Over 44 classes have embedded the business model canvas and/or Customer Discovery including a year-long course taken by every single one of its bioengineering majors.

An advanced protective suit for healthcare workers who treat Ebola patients, devised by a Johns Hopkins team, has been selected as a winning design in a global competition aimed at quickly getting new tools into the field to combat this deadly disease.

Recent efforts between the University of Maryland (UMD) and Bethesda-based Weinberg Medical Physics LLC (WMP) have led to a new technique to magnetically deliver drug-carrying particles to hard-to-reach targets. The method has the potential to transform the way deep-tissue tumors and other diseases are treated.

Chairwoman of the Senate Appropriations Committee and the Commerce, Justice, Science (CJS) Appropriations Subcommittee, today announced the Consolidated and Further Continuing Appropriations Act of 2015 provides increased funding to support American jobs and innovation, including funds for trade and economic development programs, and investment in scientific research and exploration.

Stem cell-derived blood and platelet products have the potential to meet critical medical needs. Remaining challenges exist in both the manufacturing process and additional discovery research. The manufacturing process needs to be made more efficient and cost-effective while assuring the effectiveness and safety of the blood products and enable their commercial viability. RFA-HL-15-022 supports R01 grants to address the basic or early translational research needs whereas RFA-HL-15-029 and RFA-HL-15-030 support small business awards to enable further advances in the manufacturing processes (tools and technologies) to take advantage of the existing knowledge and recent advances in the field to produce safe and functional blood and platelet products at reduced costs.

NHLBI is soliciting applications from small businesses to develop and validate novel in vitro human cell-based tools for predicting the responses of individual patients to cystic fibrosis transmembrane conductance regulator (CFTR)-directed therapeutics for cystic fibrosis (CF) lung disease. Proposed research projects are expected to focus on the development of highly innovative cell-based systems that recapitulate a patient-specific CFTR phenotype to create a personalized study platform to examine response to CFTR-directed therapeutics. The models developed must be based on live cells from humans harboring CFTR mutations associated with CF. While the primary goal of this initiative is to promote precision medicine and optimization of treatment at the personal level, it may also yield as a secondary benefit the ability to select appropriate treatments for CF at an earlier age.

ATCC, the premier global biological materials resource and standards organization, and LGC, a leading global producer and distributor of reference materials and proficiency testing (PT) programs, announce a new agreement to provide high-quality proficiency testing programs supporting the food, beverage, animal feed, and pharmaceutical quality control markets in the United States.

Johns Hopkins University’s Applied Physics Laboratory says it has experienced record growth for initiatives to move its scientific discoveries into the commercial sector in 2014.

San Diego-based BioMed Realty Trust Inc. has sold a 289,900-square-foot bio-manufacturing facility at 9911 Belward Campus Drive for $322.5 million to private equity firm GI Partners.

The selling price translates into a whopping $1,112 per square foot.

Aris Melissaratos is batting around the idea of making Stevenson University’s Maryland Rising economic development forum an annual event.

Can you blame him? The first conference, held Monday, drew big-name speakers and generated a buzz other economic development confabs probably envy.

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 Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

(NOT-OD-15-026) Office of the Director, NIH

Reminder for the Extramural Scientific Community: Implementation of the Genomic Data Sharing Policy Begins January 25, 2015

(NOT-OD-15-027) Office of the Director, NIH

Notice of Office of Laboratory Animal Welfare Policy on Shared Animal Welfare Concerns

(NOT-OD-15-028) Office of the Director, NIH

NIH Modification to Guidance on Marking Changes in Resubmission Applications

(NOT-OD-15-030) Office of the Director, NIH

Update: New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After May 25, 2015

(NOT-OD-15-032) Office of the Director, NIH

Notice of NHGRI Participation in PA-14-015 “Ruth L. Kirschstein NRSA Institutional Research Training Grants (Parent T32)” and Establishment of New Training Program in the Ethical, Legal and Social Implications of Genetic and Genomic Research

(NOT-HG-15-004)
National Human Genome Research Institute

Notice of Additional Due Date and Correction for RFA-HG-14-005 “Revisions to Add Biomedical Big Data Training to Active Institutional Training Grants (T32)”

(NOT-HG-15-009)
National Human Genome Research Institute

Notice of Change to Instructions for Senior/Key Personnel in the Overall and Project Components of PAR-13-316 “NHLBI Program Project Applications (P01)”

(NOT-HL-14-242)
National Heart, Lung, and Blood Institute

Request for Information (RFI): Challenges and Opportunities for Exploring and Understanding the Epitranscriptome

(NOT-RM-15-007)
NIH Roadmap Initiatives

Requests for Applications:

Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator- Directed Therapeutics (R41)

(RFA-HL-15-026)
National Heart, Lung, and Blood Institute
Application Receipt Date(s): February 9, 2015 and November 9, 2015

Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator- Directed Therapeutics (R43/R44)

(RFA-HL-15-027)
National Heart, Lung, and Blood Institute
Application Receipt Date(s): February 9, 2015; November 9, 2015; and November 9, 2016

Sometime soon a slender robot that looks like Casper the ghost and works like Skype on wheels may visit the bedside of an Ebola patient in West Africa, as a doctor nearby instantly transmits data to other researchers over a portable Wi-Fi network.

Falls Church-based Northrop Grumman Corp. has named Kenneth Bedingfield as its next chief financial officer.

Bedingfield will succeed James Palmer, who retires next year.

GlaxoSmithKline (GSK) has for the fourth consecutive time been ranked No 1 among global pharmaceutical companies assessed for their efforts to improve access to medicine in developing countries.

Released on 17th November by the Access to Medicine Foundation, the 2014 Access to Medicine (ATM) Index gives GSK a composite score of 3.3 out of a possible 5, following an in-depth evaluation of company activities in seven areas that are germane to enhancing access to medicine in developing countries.

A rich new Credit Suisse report, “Global Biotechnology – An Outlook for 2015,” was flush with cool data about trends in the biotech industry. The analysis lists out 10 key themes for 2015. Here’s the highlight reel:

Building a biotechnology startup is a lot like getting a private university education: To make progress, you have to get past the high-cost barrier to entry.

First and foremost, biotech requires expensive clinical studies and the use of state-of-the-art manufacturing facilities.

The U.S. Senate gave final passage on Saturday to an overdue spending bill for the 2015 fiscal year that provides modest increases for research, while holding education spending mostly flat.

As reported in a story earlier this morning, Oregon is preparing to join 15 states that have implemented rules to let businesses raise money through investment crowdfunding.

On October 9, 2014, the Investment Advisory Committee of the SEC issued its much awaited recommendations on the “Accredited Investor” definition of Regulation D of the ’33 Act. This is in response to the SEC’s Request for Comments on the definition of “Accredited Investor” in its release relating to Proposed Rules for Regulation D and Form D, which mainly related to general solicitation (for the full text of that release, see here).

Healthcare giant McKesson Corp. plans an aggressive move into venture capital funding for healthcare technology, expecting to commit several hundred million dollars to the effort over the next five to eight years, and hiring long-time venture capitalist Tom Rodgers as managing director of strategic venture capital operations.

As an offshoot of PatentStat, I’ve assembled a set of graphs of patent inventor locations, focusing in 33 industry sectors.

Hospitals are on the hunt for new ideas to transform health care, and some are looking to reality television for inspiration.

Several health care institutions recently have tested TV’s “Shark Tank” approach to seeking out innovation — gathering a panel of pros to hear invention ideas from startups.

This source of strategic partnership offers a synergistic relationship that combines monetary and functional resources, capabilities, and core competencies for the purpose of technology commercialization. Entrepreneurs who are looking to accelerate the growth of their businesses often realize they can capture a greater bang for their buck when they collaborate with CVCs who offer value beyond the dollar.

California has been associated with risk-taking, entrepreneurship and innovation since the Gold Rush. Today, California is still an innovation engine in such varied sectors as agriculture and the Internet. But only one homegrown industry can stake a claim as a leading contributor to our state’s economy and the health of people around the world: the life sciences sector.

Louis Brandeis famously characterized states as laboratories for democracy, but cities could be called labs for innovation or new practices. With far fewer resources than states or the federal government and responsibilities to people on a daily basis, cities have to be scrappy and creative when it comes to delivering services and running their operations.

A flood of new health care IT companies has been pouring into the U.S. health care market. The cause of this torrent: the recognition that as market and regulatory forces alter incentives in health care, IT companies will play a powerful role in combating the overemployment and declining productivity that has plagued this industry and in helping providers improve the quality of care.

How do you turn a genetic disorder into a money-making empire? Grumpy Cat has done it, but is it only acceptable because she is a funny looking feline instead of a human?