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Health Care Accelerator Raises $7M for New Initiatives

Nina Nashif

Nina Nashif (healthbox.com)

17 April 2014. Healthbox Global Partners LLC, a Chicago-based business accelerator in the health care industry, says it raised $7 million to fund its operations in six cities in the U.S. as well as support new business models for encouraging innovation. Healthbox is a joint venture of Intermountain Healthcare, a health delivery system in Utah; Health Care Service Corporation, a health insurance company operating several Blue Cross Blue Shield plans in the U.S.; and health care investment company Chicago Pacific Founders that contributed to the financing, along with other undisclosed investors.

Healthbox offers a four-month training, business development, and financing process for start-ups in the health care industry. The company says since it began in 2012, Healthbox established relationships with 20 industry organizations, investing in some 50 new companies. Its portfolio includes start-ups aiming to improve operational efficiency of health care providers, consumer wellness, evidence-based decision-making, and complex disease management. Other companies are working in patient-centered medical practices, data infrastructures, telehealth, and new models for care.

Nina Nashif, founder and CEO of Healthbox, notes in a company statement, “We provide the necessary access and insight for serious health care entrepreneurs to grow businesses in this complex industry and for the industry to source the solutions that they need to improve care delivery and outcomes.”

The new financing is expected to support Healthbox’s creation of regional accelerators in Boston, Tampa, Salt Lake City, London, and Nashville, as well as Chicago, all in 2014. The company says the new accelerators will expand Healthbox’s reach to another 50 start-up enterprises.

In addition to its geographic expansion, Healthbox plans to use the new funding to offer three new types of business services:

- A marketplace known as Healthbox Solutions, to help its portfolio companies introduce and market their new products and services to early adopters in the health care industry

- Adapting its business development curriculum to internal operations of current health care companies and organizations, in a service called Foundry, to encourage entrepreneurial solutions and commercialization of innovative ideas

- Partnering with health care organizations to offer financial support for new models in innovation, a service that remains largely undefined at this stage.

Healthbox says it is now accepting applications for its regional accelerator programs, beginning in Boston in July 2014.

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Football Head Hits May Need More Than Off-Season to Heal

Diffusion tensor image of brain

Diffusion tensor image of brain showing white matter connections (NIBIB/NIH)

17 April 2014. Researchers at University of Rochester in New York found college football players may need more than the standard six months from the end of one season to the start of the next for their brains to recover from blows to the head. The team led by Rochester’s Jeffrey Bazarian, a professor emergency medicine, published its findings yesterday on the online journal PLoS One.

A concussion is a type of traumatic brain injury caused by blows to the head or even the body — typical in the course of the game of football — that cause the head and brain to rapidly move back and forth, causing the brain to bounce and twist inside the skull. The sudden movement can stretch the brain, causing damage to brain cells and chemistry.

Recent revelations of an association between concussions and and long-term degenerative brain conditions, sometimes with tragic outcomes, sparked a debate among players and coaches at all levels about ways to reduce concussions. Even without concussions, the stress from these hits can make the brain more vulnerable to further damage until the initial recovery is complete.

Bazarian and colleagues — from Rochester, Cleveland Clinic, and Hamilton College — studied 10 football players at University of Rochester, a division 3 NCAA team, as well as 5 male non-athletes for comparison. The participants under went a series of physiological, cognitive, and balance tests, at the beginning and end of the 201-20121 season, and after six months of no-contact rest. The football players wore accelerometers inside their helmets supplied by Riddell, a helmet manufacturer, that tracked every hit.

The study participants were also given diffusion tensor imaging scans of their brains, a type of MRI. Diffusion tensor imaging can produce detailed two- and three-dimensional images of connective tissue in the brain known as white matter.

The researchers found the 10 football players sustained between 431 (running back) and 1,850 (center) head blows during the course of season, covering both daily practices and game action, but none causing a concussion. The hits ranged from mild jolts incurred during practice to dangerous rotational acceleration hits that can result in a concussion.

The results show about half the players experienced changes in the white matter of their brains, which suggest mild traumatic brain injuries occurred during the season. However, the brain trauma that the players suffered during the season, although mild, did not completely return to the preseason state after six months without contact. In addition, higher levels of inflammation biomarkers in blood tests among the players also correlated with the lack of complete recovery during the six-month off-season.

“At this point we don’t know the implications, but there is a valid concern that six months of no-contact rest may not be enough for some players,” says Bazarian in a university statement. “And the reality of high school, college and professional athletics is that most players don’t actually rest during the off-season. They continue to train and push themselves and prepare for the next season.”

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Early Trial Shows Immunotherapy Evidence With Some Tumors

Lymphocyte (National Cancer Institute)

Lymphocyte (National Cancer Institute)

16 April 2014. A clinical trial of a cancer vaccine developed by biopharmaceutical company Celldex Therapeutics Inc. in Hampton, New Jersey shows it generated an immune response which affected the growth of tumors in some patients with advanced stages of cancer. The early-stage trial, conducted with researchers from seven university or research institute labs appears in today’s issue of the journal Science Translational Medicine (paid subscription required).

The clinical trial tested the safety and tolerability of Celldex’s vaccine code-named CDX-1401 at various dosage levels, but also recorded evidence of clinical benefit. The vaccine contains an antibody to stimulate the immune system targeting receptors of dendritic cells presenting antigens to T cells, the lymphocytes or white blood cells that fight infections or cancer. In this case the immune response aims specifically at cancers expressing the protein NY-ESO-1, associated with a number of cancer types: bladder, breast, ovary, non-small cell lung cancer, myeloma (plasma cells), sarcoma (soft tissue), and melanoma (skin).

The study enrolled 45 patients with advanced cases of cancer who had not responded to previous therapies, of which 42 completed the treatments. The patients were given CDX-1401 injections in various doses, along with drugs supporting the immune system Hiltonol and resiquimod, over six weeks. The researchers report no patients suffered serious adverse effects from the treatments. The most frequent side effects were  fatigue, nausea, and chills, as well as reactions at the site of the injections.

Most of the patients receiving the treatments — nearly 8 in 10 (79%) — showed at least some immune system response. A little more than half (52%) showed a high immune response to the treatments and one-third (33%) had a very high response. Moreover, the cancer in 13 of the patients stabilized, where the growth of the tumor stops but the tumor still remains. Patients with a specific T cell immune response to the NY-ESO-1 protein showed a higher stable disease state (46%) compared to those who did not have that response (13%). In addition, two patients with melanoma experienced a shrinkage of about 20 percent in their skin lesions.

The study included a two-year follow-up with patients, including 6 melanoma patients also receiving treatments with ipilimumab — marketed as Yervoy by Bristol Myers Squibb — and 2 non-small cell lung cancer patients receiving an experimental checkpoint inhibitor that makes the cancer cells more susceptible to therapies. Of the 6 melanoma patients receiving ipilimumab, 4 experienced reductions in tumor size. Both of the non-small cell lung cancer patients also showed reductions in tumor size. The researchers report all 6 of the patients experiencing a smaller tumor response also had tumors expressing the NY-ESO-1 protein, with most of those showing an immune response to that protein.

Celldex Therapeutics says it plans two more studies of CDX-1401 in combination with other drugs later this year.

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IT Firm, University Partner on Alzheimer’s Research Platform

Illustration of brain (NIDA)

(National Institute of Drug Abuse)

16 April 2014. Parabon Computation in Reston, Virginia is creating a crowd-sourced computer network to provide the analytical power for two research studies on Alzheimer’s disease conducted in-house and with George Mason University in nearby Fairfax. The initiative, called Compute Against Alzheimer’s Disease, aims to tap into unused capacity of idle computers donated for this effort.

Compute Against Alzheimer’s Disease will support two research projects developing genetic diagnostics and simulations of chemical activity in the brain associated with the disorder. Ellen McRae, Parabon’s bioinformatics manager, is leading one study to identify genetic biomarkers that predict an individual’s risk of developing Alzheimer’s disease. McRae and colleagues will conduct in-depth analysis of data from the Alzheimer’s Disease Neuroimaging Initiative, an effort that detects and tracks Alzheimer’s disease in its earliest stages and tracks with biomarkers its progression over time.

The Parabon study aims to make stronger connections between genetic factors and risks of contracting Alzheimer’s disease. The findings are expected to offer earlier identification of people at all ages at risk of the disorder, which can encourage regular screenings and plan for changes in lifestyle and other environmental factors associated with Alzheimer’s disease.

The second research project is headed by Dmitri Klimov, a systems biologist at George Mason University. Klimov’s team is creating computer simulations of the effects of various peptides associated with the onset of Alzheimer’s disease on neurons, or brain cells. This research is looking into the damage that occurs when these peptides interact with the surface membranes of neurons, an undertaking that requires immense amounts of computing power. Understanding these interactions can help develop more effective therapies.

In December 2013, Parabon and Klimov were awarded a Small Business Technology Transfer grant from National Institute on Aging to develop new processes for simulations of molecular dynamics associated with Alzheimer’s disease, and write algorithms representing these dynamics to be offered as an online software service. The company earlier in 2013  received another small business research grant to develop software services supporting genetics research, this one with Dartmouth University.

To participate in Compute Against Alzheimer’s Disease, volunteers download a small application that activates when the computer is idle. Parabon then aggregates this volunteered capacity for the two research projects. The application also lets volunteers monitor the progress of the research projects for which their idle capacity is being used. The software runs on Windows, Mac OS, and Linux systems.

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Blood Glucose Control Drug Approved for Type 2 Diabetes

Diabetes Test (NIH)

(National Institutes of Health)

15 April 2014. The U.S. Food and Drug Administration approved the drug albiglutide to help adults with type 2 diabetes control their blood glucose levels. Albiglutide is marketed in the U.S. under the brand name by Tanzeum by the global pharmaceutical company GlaxoSmithKline.

Diabetes is a chronic condition where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. Type 2 diabetes is a disorder where the pancreas produces some, but not enough insulin, or the body cannot process insulin, and accounts for some 90 percent of all diabetes cases. Type 1 diabetes is an autoimmune condition where the body is tricked into producing little or no insulin. According to the International Diabetes Federation, diabetes affects 382 million people worldwide, of which 24,2 million are in the U.S.

Albiglutide is in a class of drugs known as glucagon-like peptide-1 receptor agonists, which are hormones that generate a greater insulin response, and thus help regulate blood glucose levels. The drug is administered once a week with an injector pen device.

FDA’s approval was based on a series of eight clinical trials testing albiglutide alone and in combinations with other drugs. The trials recruited some 5,000 patients, of which 2,000 were given albiglutide. The most common side effects experienced by patients in clinical trials treated with the drug were diarrhea, nausea, and injection site reactions.

The agency is requiring GlaxoSmithKline conduct post-marketing studies to evaluate safety, dosing, and efficacy of albiglutide for pediatric patients, as well as a trial to determine cardiovascular outcomes of the drug for patients with a high baseline risk of cardiovascular disease.

The company is also required to keep a registry for at least 15 years of patients to track any increase in medullary thyroid carcinoma. Thyroid gland tumors were reported in studies with lab animals given some glucagon-like peptide-1 receptor agonists. The drug is required to carry a warning about the risk of thyroid cancer associated with the drug.

GlaxoSmith Kline says it expects to have Tanzeum on the market in the U.S. during the third quarter of 2014. Albiglutide was approved last month in Europe, marketed under the brand name Eperzan.

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Intelligent Liner Aims to Improve Prosthetic Limb Comfort

Leg amputee

(Veterans Health Administration)

15 April 2014. Engineers in the U.K. at University of Southampton and Chas A Blatchford & Son Ltd. in Basingstoke are designing a liner with sensors for lower-limb prosthetic devices that improve the fit and comfort of those devices for their wearers. The team is developing a prototype device that they aim to have available for patients in the U.K.’s National Health Service in about three years.

The prototype device will help identify and measure the forces pressing and pulling from the prosthetic socket on the wearer’s stump. “Socket fit is the single biggest factor determining whether prosthesis will be successful for a patient,” says Southampton engineering lecturer Liudi Jiang in a university statement. “If we had a simple way to accurately measure the load at the socket-stump interface and determine the best possible fit for that limb, it would completely transform the socket fit experience for amputees.”

Jiang, an electrical engineer, is designing the pressure sensors to be built into a liner worn over the lower-limb stump. Many prosthetic devices now have liners to cushion the device on the stump. No two stumps are the same size or shape, however, and in some cases the stumps can even change in shape over the course of a day. Pressures building up on an ill-fitting stump can cause sores and tissue damage.

Dan Bader, a biomedical engineer at Southampton on the development team, is designing sensors to assess the health of the tissue on the stump. The liner is expected to be worn over the stump, as is done today, but the sensors would make it possible for clinicians to to make immediate adjustments in the prosthetic device to improve comfort for the wearer.

In addition, the liner would monitor changes in socket fit over time, feeding a stream of data from the prosthetic device to a wireless receiver. The monitoring of the device’s fit would enable clinicians to make adjustments sooner than is done today, thus avoiding pressures to build up and cause skin sores. This function alone could make the liners a low-cost solution to a common problem for amputees, requiring frequent returns to rehabilitation centers and extra costs.

The university team is collaborating on the project with Chas A Blatchford & Sons, a manufacturer of prosthetic devices. Company staff are expected to help integrate the sensors into thin liners that work with sockets of any size. The researchers believe their technology can be extended to shoe insoles to prevent diabetic foot ulcers and with mattresses and wheel chairs to prevent bed sores with immobile patients.

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Microparticle Solution Devised to Identify Genuine Goods

Patrick Doyle

Patrick Doyle (Mass. Institute of Technology)

14 April 2014. Engineers at Massachusetts Institute of Technology and the affiliated Lincoln Laboratory developed a process for adding minute particles into materials that can be encoded and sensed by inexpensive readers to detect counterfeit goods from the originals. The team from the lab of chemical engineering professor Patrick Doyle published its findings yesterday online in the journal Nature Materials (paid subscription required).

The problem of counterfeiting ranges from knockoff fashion garments and electronic goods to currencies and phony medications with life-threatening implications. OECD estimates counterfeit goods account for 2 percent of all international trade, calculated at more than $250 billion in 2007. To combat counterfeiting, legitimate manufacturers and distributors use additional labels or electronic tags, yet these too can be counterfeited, or are unreliable and too expensive.

Doyle and colleagues in 2006 designed a system for making microscale particles — measured in increments of microns or one-millionth of a meter — that employs photolithography and microfluidics to imprint shapes into chemical components that make up more complex polymer materials like those found in many plastics. When exposed to ultraviolet light, the microfluidic stream of components reacts and forms into polymer particles.

The researchers today adapted that process to create new particles about 200 microns long imprinted with nanocrystals — measured in billionths of a meter — containing traces of rare earth elements ytterbium, gadolinium, erbium, and thulium. The imprinted nanocrystals form into colored stripes; the researchers report producing nine colors so far, but they say many more colors are possible.

The microscale particles can then be configured with combinations of these colored stripes to represent a unique identifier, in much the same way a bar code works. With combinations of six colors, up to 1 million unique identifiers are possible. Adding more microscale particles expands the potential number of identifiers exponentially.

In the Nature Materials paper, the researchers demonstrated these identifying particles in materials simulating pharmaceutical packaging, objects like glass made at high temperatures, and biocompatible materials. The tests embedded the particles into two different types of polymer materials, one that attracts water and one that repels water. The colors generated are identical in both types of polymer.  The team also reports tests of the particles show they can withstand extreme temperatures, exposure to the sun, and heavy wear.

Inexpensive technologies widely available today can read the encoded particles. When illuminated by near-infrared light, like that put out by a laser pointer say the researchers, the particles shine brightly. The illuminated particles can then be read by a smartphone camera with 20-times magnification. Doyle and colleagues are working on a smartphone app to read, process, and interpret the encoded particles.

The authors in March 2013 filed two provisional U.S. patents for this technology.

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On the Road Again

Airport rush (TSA.gov)

(TSA.gov)

9 April 2014. Science & Enterprise is taking a brief hiatus, while I travel for the remainder of this week, 10-12 April. The blog will return on Monday, 14 April.

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MRSA Toxicity Predicted Through Genomic Sequencing

MRSA bacteria emerge from dead white blood cells (Frank DeLeo, NIH)

MRSA bacteria emerge from dead white blood cells (Frank DeLeo, NIH)

9 April 2014. Researchers in the U.K., U.S., Sweden, and Turkey developed a technique based on genomic sequencing to predict the pathogenic severity of methicillin resistant Staphylococcus aureus or MRSA bacteria, an antibiotic-resistant microbe often found in health care facilities. The team led by University of Bath biologist Ruth Massey published its findings today online in the journal Genome Research.

The Centers for Disease Control and Prevention says the number of cases of MRSA infections are declining in U.S. hospitals and clinics, but remains a serious problem. A CDC study published last year in the American Medical Association’s journal Internal Medicine reports life-threatening MRSA infections declined by more than half (54%) between 2005 and 2011. The same study reported nearly 31,000 fewer MRSA infections from 2005 to 2011, with 9,000 fewer hospital deaths.

Nonetheless, the study reported more than 80,000 cases of life-threatening MRSA infections in 2011, with more than three-quarters of these cases (78%) diagnosed either while in the hospital or soon after release. A 2007 study estimated the direct economic burden on hospitals of MRSA infections between 1999 and 2005 at more than $6 billion, which does not include indirect costs related to patient pain, illness, and time spent in the hospital.

The MRSA microbe is a complex organism, which the authors note, may require a more sophisticated and nuanced response than many current approaches. Massey and colleagues sequenced the genomes of 90 pure MRSA cultures and identified 125 genetic mutations that made each culture either high or low in toxicity.

The team was then able to find a common genetic signature for the high-toxicity cultures. Knowing this signature, say the authors, makes it possible to predict the cultures most likely to be toxic and cause severe cases of MRSA infection.

These findings, says Massey, make it possible to develop a diagnostic technique based on sequencing a swab sample from the patient and personalized to the individual’s infection. “Clinicians will then be able to tailor the treatment to the specific infection,” notes Massey in a university statement. “This technique can tell them which combination of antibiotics will be most effective, or tell them which drugs to administer to dampen the toxicity of the infection.”

The university says the researchers are extending this technique to other virulent MRSA strains as well as other bacterial pathogens.

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UC-San Francisco Launches Brain Disease Trial Registry

Brain visualization image

(Univ of California, San Francisco)

9 April 2014. University of California in San Francisco opened an online registry that aims to reduce the time and cost of recruiting participants in clinical trials for disorders of the brain, such as Alzheimer’s and Parkinson’s disease and traumatic brain injuries. The Brain Health Registry is led by UC-San Francisco radiology professor Michael Weiner, who founded the registry, and psychiatry professor Scott Macklin, with collaboration from a number of companies.

The pharmaceutical industry is increasing its use of online tools to reduce the costs of clinical trials, which account for a large proportion of the development cost of medications. Services like MyClinicalTrialLocator.com and TrialReach.com act as search engines for trials, while PatientsLikeMe uses the community/social media model to encourage people with disease to discuss their experiences and volunteer for clinical studies.

The registry asks volunteers to provide a brief personal medical history and take a few online neuro-psychological tests to provide an outline of visitors’ mental functions. From this first pool, some participants will be asked to provide saliva or blood samples, and take part in clinical trials. All data, says the university, will be protected according to federal privacy laws and the highest medical ethics standards.

Brain Health Registry is seeking volunteers initially from the San Francisco Bay area, and hopes to enroll some 100,000 participants by 2017; about 2,000 already enrolled during the site’s testing phase. The registry’s collections are expected to offer researchers data on brain capabilities through the aging process and help develop diagnostic tools, as well as provide a pool of potential clinical trial volunteers.

The registry is partnering with Lumiosity, a San Francisco company that offers online brain training games. Lumiosity is providing a series of assessments included in the registry’s brain performance tests, as well as recruiting volunteers. Other collaborating companies are Johnson & Johnson Innovation Center and Cogstate, an Australian company developing cognitive testing tools.

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