Upcoming Meetings – On Target Is back From Vacation in Santa Fe

 

Target Health is pleased to announce that we will be attending and presenting at the following meetings this month. Please let us know if you will be attending or want additional information.

 

1. Global Clinical Trials – The Fairmont Copley Plaza, Boston, MA, 18 September 2013

 

“An Update on Risk Based Monitoring for Global Clinical Trials.” Deborah Manzo (MScOL), Senior Director, Clinical Business Operations and Transformation, at AbbVie, will moderate the panel and Thomas Haag (IT Systems and Processes, Development QA, Novartis) and Dan White (Vice President, Global Operations, Quintiles) will join Jules Mitchel, MBA, PhD (President of Target Health) on the panel.

 

2. Disruptive Innovations – The Fairmont Copley Plaza, Boston, MA, 19-20 September 2013

 

Jules T. Mitchel, PhD, MBA, President, Target Health and John Orloff, MD, Senior Vice President, Global Development & CMO, Novartis Pharma AG will discuss eSourcing and other technologies to bring innovation to life and how we can use fewer patients in clinical trials.

 

3. Clinical Collaboration Congress – Seaport Hotel, Boston, MA, September 25-27, 2013

 

Presentation: Implementation of eSource and Risk-Based Monitoring in Phase III Clinical Trials. Jules T. Mitchel, PhD, MBA, President, Target Health.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

Sharklet: A Biotech innovative Startup Fights Germs with Sharks

 

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Sharklet CEO Mark Spiecker shows off a sample of his company’s surface coating (in close up, at right), which mimics the texture and anti-bacteria properties of sharkskin.

 

 

Forget chemicals or pills in the fight against nasty bacterial infections. Mark Spiecker, CEO of a six-year-old company called Sharklet Technologies is betting that the secret lies with sharks that just happen to have microscopic textures and patterns on their skin that make them highly resistant to barnacles, algae and, surprisingly, most human 1) ___. Sharklet Technologies has developed technology to copy those mathematical textures and patterns to create germ-deflecting surfaces for everything from 2) ___ devices to computer keyboards. The textures are invisible to the eye — and to the finger. Measured in microns, the surface ridges are about 1/10th the width of a human 3) ___. Depending on the specific bug, the effect is to cut bacterial colonization on surfaces by 90% to 99.99%.

 

Backed by $5.2 million from investors, the 14-employee firm has attracted nine customers, including office furniture maker Steelcase (SCS) and medical device maker Cook Medical, and the company has collected $2.6 million in federal research & development grants. Last year, its sales reached $1 million.

 

Sharklet’s technology sits smack in the middle of a burgeoning field called “biomimicry,” which explores how nature can be copied to solve 4) ___ problems. Bacterial resistance is an especially hot topic, thanks to growing concerns about the rise of antibiotic-resistant 5) ___. In 1976, only 5% of staph infections were resistant. Today, more than half are, meaning they’re tougher to treat and far more deadly. Scientists are studying everything from kangaroo stomachs to leafcutter ants in order to glean the natural world’s antibacterial secrets.

 

If the patterns found in sharkskin actually work in the human medical world, the breakthrough could be big, says Steve Brozak, who tracks the medical 6) ___ industry. “Sharklet’s technology could be important today and could be absolutely necessary tomorrow,” he says.

 

Sharklet’s story began in 2000, when the U.S. Navy asked University of Florida materials science professor Anthony Brennan to find a way to reduce the drag on Navy ships from barnacles and 7) ___. At a Hawaiian conference, Brennan and his fellow researchers stood on a pier by the water talking through the problem. Brennan wondered aloud why whales have barnacles on their skin but sharks do 8) ___. His colleagues brushed off the question, saying that sharks simply swam too fast. The answer didn’t satisfy Brennan. “My friend looked at me and said, ‘I’ll catch a shark for you if you want.“ One month later, as promised, he opened a package containing a mold of shark 9) ___ taken from the shark his buddy had caught and released.

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Get paid to swim with sharks

 

 

In laboratory tests, Brennan discovered his theory was right: The sharks’ skin repelled 85% of the algae. But it took another five years before Brennan discovered that the resistance also worked on human pathogens. Serendipitously, a student accidentally tried — and failed — to grow 10) ___ on a sharkskin-patterned petri dish.

 

University officials wanted Brennan to commercialize his discovery, but he didn’t want to be an entrepreneur. Eventually, he called a friend and businessman named Greg Garvis, who came to Florida with a pair of business strategists. The three men were blown away.

 

In October 2007, the four partners started Sharklet Technologies, which was soon financed by $1.2 million from investors. Brennan signed on as chief scientific officer. Bagan became the company’s first CEO. The new startup faced a big problem right away: Getting the patterns to work in the laboratory is one thing, but how do you mass-produce a texture that’s 3 millionths of a meter deep? Sharklet’s executives spent two years searching for people who could help them solve that problem. They visited medical device trade shows, talked to semiconductor manufacturers and met endlessly with experts in photolithography, microreplication and laser etching. At times, they doubted the company would survive.

 

Finally, Spiecker found a Massachusetts company called FLEXCon that agreed to make the tooling to manufacture large sheets of textured plastic. He also found 10x Microstructures in Chicago, which could make tools for molded parts featuring Sharklet’s 12) ___. From there, momentum grew as word spread of the shark-fueled breakthrough. Makers of telephones, countertops and medical devices began calling, and private and institutional investors took notice, backing the idea with another $4 million.

 

Sharklet must still prove its texture will work in human medical trials, but it intends to start manufacturing non-medical products next year. That includes furniture for Steelcase like desks for college classrooms and shared offices. Steelcase vice president Sara Armbruster likes the idea of using something other than chemical coatings to promote wellbeing. “There is a simplicity to it,” Armbruster says. “It’s nontoxic, and it’s coming right out 13) ___.”

 

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Fish Gill-Inspired Design Wins First Prize in Biomimicry Design Competition

 

 

Inspired by 14) ___ gills, newt tadpoles, and human arteries, a team of civil engineering graduate students from the University of Toronto developed a design that could increase water delivery efficiency, decrease water-borne illness, and lower wastewater operating costs. The team won first prize in the first round of the Biomimicry Student Design Challenge, organized by the Biomimicry 3.8 Institute. “We asked students to look at how nature deals with water access and management and apply that knowledge to solve a human design problem,” said Megan Schuknecht, director of university education at the Biomimicry 3.8 Institute. “It’s amazing that by studying a fish gill, this team created a design that could impact water infrastructure on a world-wide scale. The Challenge judges were wowed by their ingenuity and the positive effect this design could have on urban water distribution systems.”

 

In tackling water management, the civil engineering students focused on the challenge that air entrapment plays in the operation of a pipeline system. If not managed effectively, the release of compressed air within a pipeline can be explosive, and surges in pressure can cause fractures and ultimately lead to water loss. Cracks within pipelines also allow for the infiltration of pollutants, a known cause of water-borne epidemics around the 15) ___. Their challenge then, was to find a more efficient design for releasing entrapped air from water pipeline systems. “We looked back and forth between water management issues we were most concerned about and organisms for inspiration until we found an ideal match: a current need that could be solved by nature’s ingenuity” said Rebecca Dziedzic, member of the University of Toronto team. “Fish rely on separating 16) ___ from water in order to breathe. When we looked closely at gills, we realized that the design principles applied by these organisms could be replicated, creating an efficient, adaptable, and multifunctional device.”

 

The University of Toronto team will receive $2,500 for their first place design. Second place prize of $1,000 will be awarded to a team from Artesis University College Antwerp in Belgium for their “Time Capsule” design, which uses evaporative cooling inspired by the honeybee to keep fruits and vegetables fresh at minimal cost and with minimal water use. Third place prize and $500 will go to Pontificia Universidad Catolica de Chile, for their “Fog Farming Dynamic System,” which allows farmers to cultivate plants in the Atacama Desert environment by combining existing fog-capture technology with a unique planting pattern. A special $1,000 award from Autodesk will go to the Universidad Autonoma de Yucatan in Mexico, for their use of resources on the Autodesk Sustainability Workshop website to minimize the environmental impact of their design.

Sources: ScienceDaily.com, CNNMoneyTech.com, by Jennifer Alsever

 

ANSWERS: 1) bacteria; 2) medical; 3) hair; 4) human; 5) infections; 6) device; 7) algae; 8) not; 9) scales; 10) bacteria; 11) technology; 12) texture; 13) nature; 14) fish; 15) globe; 16) oxygen

Biomimicry, Biomimetics and Bionics

 

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One of the early examples of biomimicry was the study of birds to enable human flight. Although never successful in creating a “flying machine”, Leonardo da Vinci (1452–1519) was a keen observer of the anatomy and flight of birds, and made numerous notes and sketches on his observations as well as sketches of “flying machines”. The Wright Brothers, who succeeded in flying the first heavier-than-air aircraft in 1903, derived inspiration from observations of pigeons in flight.

 

Otto Schmitt, an American academic and inventor, coined the term biomimetics to describe the transfer of ideas from biology to technology. He developed the Schmitt trigger while attempting to replicate the biological system of nerve propagation. The term biomimetics entered Webster’s Dictionary in 1974 and is defined as “the study of the formation, structure, or function of biologically produced substances and materials (as enzymes or silk) and biological mechanisms and processes (as protein synthesis or photosynthesis) especially for the purpose of synthesizing similar products by artificial mechanisms which mimic natural ones”.

 

In 1960, the term bionics was coined by psychiatrist and engineer Jack Steele to mean “the science of systems which have some function copied from nature”. Bionics entered the Webster dictionary in 1960 as “a science concerned with the application of data about the functioning of biological systems to the solution of engineering problems”. Bionic took on a different connotation when Martin Caidin referenced Jack Steele and his work in the novel Cyborg which later resulted in the 1974 television series The Six Million Dollar Man and its spin-offs. The term bionic then became associated with “the use of electronically operated artificial body parts” and “having ordinary human powers increased by or as if by the aid of such devices”. Because the term bionic took on the implication of supernatural strength, the scientific community in English speaking countries largely abandoned it.

The term biomimicry appeared as early as 1982. Biomimicry was popularized by scientist and author Janine Benyus in her 1997 book Biomimicry: Innovation Inspired by Nature. Biomimicry is defined in the book as a “new science that studies nature’s models and then imitates or takes inspiration from these designs and processes to solve human problems”. Benyus suggested looking to Nature as a “Model, Measure, and Mentor” and emphasizes sustainability as an objective of biomimicry.

 

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Nanobiomimicry

 

Biological imitation of nano- and macro-scale structures and processes is called nanobiomimicry. Nature provides a great variety of nano-sized materials that offer as potential templates for the creation of new materials, such as bacteria, viruses, diatoms, and biomolecules. Through the study of nanobiomimicry, key components of nanodevices like nanowires, quantum dots, and nanotubes have been produced in an efficient and simple manner when compared to more conventional lithographic techniques. Many of these biologically derived structures are then developed into applications for photovoltaics, sensors, filtration, insulation, and medical uses. The field of nanobiomimetics is highly multidisciplinary, and requires collaboration between biologists, engineers, physicists, material scientists, nanotechnologists and other related fields. In the past century, the growing field of nanotechnology has produced several novel materials and enabled scientists to produce nanoscale biological replicas.

 

Fabrication

 

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SEM of rod shaped tobacco mosaic virus particles

Biomorphic mineralization is a technique that produces materials with morphologies and structures resembling those of natural living organisms by using bio-structures as templates for mineralization. Compared to other methods of material production, biomorphic mineralization is facile, environmentally benign and economic. Biomorphic mineralization makes efficient use of natural and abundant materials such as calcium, iron, carbon, phosphorus, and silicon with the capability of turning biomass wastes into useful materials. Templates derived from biological nanoparticles such as DNA, viruses, bacteria, and peptides can transform unordered inorganic nanoparticles into complex inorganic nanostructures. Biologically derived nanostructures are typically fabricated using either chemical or physical techniques. Typical chemical fabrication techniques are plasma spraying, plasma immersion ion implantation and deposition, sol-gel, chemical vapor deposition, physical vapor deposition, cold spraying and self-assembly. Physical modification techniques include laser etching, shot blasting, physical plating, and physical evaporation and deposition. Methods of fabrication with high throughput, minimal environmental damage, and low costs are highly sought after.

 

Biologically Inspired Engineering

 

The use of biomineralized structures is vast and derived from the abundance of nature. From studying the nano-scale morphology of living organisms many applications have been developed through multidisciplinary collaboration between biologists, chemists, bioengineers, nanotechnologists, and material scientists.

 

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Ant Hill

 

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The sacred lotus flower

 

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BP Logo

 

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Gecko’s Climbing Power Using van der Waals Forces

 

Investigational Malaria Vaccine Found Safe and Protective

 

Malaria is transmitted to humans by the bite of an infected mosquito. After the bite occurs, infectious malaria parasites in the immature, sporozoite stage of their life cycle first travel to the liver, where they multiply, and then spread through the bloodstream, at which time symptoms develop.

 

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According to an article published on 8 August 2013 in the journal Science, an investigational malaria vaccine has been found to be safe, to generate an immune system response, and to offer protection against malaria infection in healthy adults. The vaccine, known as PfSPZ Vaccine, was developed by scientists at Sanaria Inc., of Rockville, Md. The clinical evaluation was conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and their collaborators at the Walter Reed Army Institute of Research, Silver Spring, Md., and the Naval Medical Research Center, Bethesda, Md.

 

The PfSPZ Vaccine is composed of live but weakened sporozoites of the species Plasmodium falciparum, the most deadly of the malaria-causing parasites.

 

The Phase I trial, which took place at the NIH Clinical Center in Bethesda, enrolled 57 healthy adult volunteers ages 18 to 45 years who never had malaria. Of these, 40 participants received the vaccine and 17 did not. To evaluate the vaccine’s safety, vaccinees were split into groups receiving two to six intravenous doses of PfSPZ Vaccine at increasing dosages. After vaccination, participants were monitored closely for seven days. No severe adverse effects associated with the vaccine occurred, and no malaria infections related to vaccination were observed.

 

Based on blood measurements, it was observed that participants who received a higher total dosage of PfSPZ Vaccine generated more antibodies against malaria and more T cells — a type of immune system cell — specific to the vaccine.

 

To evaluate whether and how well the PfSPZ Vaccine prevented malaria infection, each participant — the vaccinees as well as the control group that did not receive vaccine — was exposed to bites by five mosquitoes carrying the P. falciparum strain from which the PfSPZ Vaccine was derived. This controlled human malaria infection procedure — a standard process in malaria vaccine trials — took place three weeks after participants received their final vaccination. Participants were monitored as outpatients for seven days and then admitted to the NIH Clinical Center, where they stayed until they were diagnosed with malaria, treated with anti-malarial drugs and cured of infection, or shown to be free of infection.

 

The study found that the higher dosages of PfSPZ Vaccine were associated with protection against malaria infection. Only three of the 15 participants who received higher dosages of the vaccine became infected, compared to 16 of 17 participants in the lower dosage group who became infected. Among the 12 participants who received no vaccine, 11 participants became infected after mosquito challenge.

 

According to the authors, the study showed in principle that sporozoites can be developed into a malaria vaccine that confers high levels of protection and is made using the good manufacturing practices that are required for vaccine licensure.

 

An important challenge in the continued development of PfSPZ Vaccine is that the vaccine currently is administered intravenously — a rare delivery route for vaccines. Previous studies at lower doses have shown that the more common intradermal (into the skin) and subcutaneous (under the skin) routes did not yield as strong an immune response as the intravenous route.

 

A number of follow-up studies are planned, including research to evaluate the vaccine’s different dose schedules, possible protection against other Plasmodium strains and the durability of protection. An evaluation is planned to see whether higher doses administered subcutaneously or intradermally provide the same level of protection as that found in this study.

Schizophrenia and Bipolar Disorder Share Common Genetic Variation

 

The largest genome-wide study of its kind, performed by the Psychiatric Genomics Consortium (PSG), has determined how much five major mental illnesses are traceable to the same common inherited genetic variations. The study, published online in the journal Nature Genetics (11 August 2013), found that the overlap was highest between schizophrenia and bipolar disorder; moderate for bipolar disorder and depression and for ADHD and depression; and low between schizophrenia and autism. Overall, common genetic variation accounted for 17-28% of risk for the illnesses.

 

Earlier this year, PGC researchers — more than 300 scientists at 80 research centers in 20 countries — reported the first evidence of overlap between all five disorders. People with the disorders were more likely to have suspect variation at the same four chromosomal sites. But the extent of the overlap was unclear. In the new study, the authors used the same genome-wide information and the largest data sets currently available to estimate the risk for the illnesses attributable to any of hundreds of thousands of sites of common variability in the genetic code across chromosomes. They looked for similarities in such genetic variation among several thousand people with each illness and compared them to controls — calculating the extent to which pairs of disorders are linked to the same genetic variants.

 

The overlap in heritability attributable to common genetic variation was about 15% between schizophrenia and bipolar disorder, about 10% between bipolar disorder and depression, about 9% between schizophrenia and depression, and about 3% between schizophrenia and autism. According to the authors, the newfound molecular genetic evidence linking schizophrenia and depression, if replicated, could have important implications for diagnostics and research. While the authors expected to see more overlap between ADHD and autism, but the modest schizophrenia-autism connection is consistent with other emerging evidence.

 

The study results also attach numbers to molecular evidence documenting the importance of heritability traceable to common genetic variation in causing these five major mental illnesses. Yet this still leaves much of the likely inherited genetic contribution to the disorders unexplained, including any non-inherited genetic factors. For example, common genetic variation accounted for 23% of schizophrenia, but evidence from twin and family studies estimate its total heritability at 81%. Similarly, the gaps are 25% vs. 75% for bipolar disorder, 28% vs. 75% for ADHD, 14% vs. 80% for autism, and 21% vs. 37% for depression.

 

Among other types of genetic inheritance known to affect risk and not detected in this study are contributions from rare variants not associated with common sites of genetic variation. However, the authors indicated that their results show clearly that more illness-linked common variants with small effects will be discovered with the greater statistical power that comes with larger sample sizes.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area

 

Abraxane Approved for Late-stage Pancreatic Cancer

 

Pancreatic cancer is the fourth leading cause of cancer death in the United States. An estimated 45,220 patients will be diagnosed and 38,460 will die from the disease in 2013, according to the National Cancer Institute. Surgery is the only option to permanently remove or cure pancreatic cancer, but it usually is too late for surgery by the time the cancer is diagnosed.

 

The FDA has just expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer. Abraxane is a chemotherapy drug that can slow the growth of certain tumors and is intended to be used with gemcitabine, another chemotherapy drug, in patients with pancreatic cancer that has spread to other parts of the body.

 

The FDA reviewed the new use for Abraxane under the agency’s priority review program, which provides for an expedited review of drugs. Abraxane was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition.

 

The safety and effectiveness of Abraxane for pancreatic cancer were established in a clinical trial with 861 participants who were randomly assigned to receive Abraxane plus gemcitabine or gemcitabine alone. Participants treated with Abraxane plus gemcitabine lived, on average, 1.8 months longer than those treated with gemcitabine alone. Additionally, participants who received Abraxane plus gemcitabine experienced a delay in tumor growth (progression-free survival) that was, on average, 1.8 months later than the participants who only received gemcitabine.

 

Common side effects observed in Abraxane plus gemcitabine-treated participants include a decrease in infection-fighting white blood cells (neutropenia), a low level of platelets in the blood (thrombocytopenia), fatigue, nerve damage in the arms and legs (peripheral neuropathy), nausea, hair loss (alopecia), tissue swelling (peripheral edema), diarrhea, fever (pyrexia), vomiting, rash and dehydration. The most common serious side effects were fever (pyrexia), dehydration, pneumonia and vomiting. Other clinically important serious side effects included bacterial infection of the blood stream (sepsis) and inflammation of the lung tissue (pneumonitis).

 

Abraxane is also approved to treat breast cancer (2005) and non-small cell lung cancer (2012) and is marketed by Celgene, based in Summit, N.J. Gemcitabine is marketed by Indianapolis-based Eli Lilly.

Santa Fe Confetti Salad

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What is it about Santa Fe that pulls us back each August?  This was our 21st vacation, there, and one of the best yet. Coming from the totally vertical dynamic cityscape of Manhattan, the contrast of cultures is great. The airport in Albuquerque is adobe, Pueblo, and charming; everyone is helpful and friendly.

 

The drive from the airport to Santa Fe is the first glimpse of mostly horizontal landscape lines of soft brown and green, which instills an air of calm and relaxation. We reach an altitude of 7,000 miles above sea level, which brings the puffy white clouds closer. We welcome this complete change from the Big Apple.

 

Although, a tiny city compared with other U.S. capitols, Santa Fe has the most concentrated cultural advantages to be found, other than Manhattan. The beautiful open-air (with dramatically designed roof) Santa Fe Opera, perched on a mountain top, attracts the best (and the same) international singers, as the Metropolitan Opera in NYC; the Santa Fe Chamber Music Festival in the Lensic Theater (one block from our hotel) is world-class (a New York family renovated the Lensic); curvaceous Canyon Road is dotted for miles with the most charming art galleries showing local as well as international art; and our favorite little art museum on the planet, SITE Santa Fe, always provides the most cutting edge shows, we could imagine. The last show there was a profoundly wrenching and beautiful installation by the Cuban artist (and one-time physicist) Enrique Martinez Celaya, that we will never forget. The extraordinary contemporary installations presented here always cut right through me, leaving lasting impressions as well as educating and uplifting my spirit.

 

And, so, now back in our beloved Big Apple, but wanting to hang on to some of the loveliness of Santa Fe, we want to share a few recipes with our friends.

 

Ingredients

 

2 cups soy cheddar cheese, grated

1 pint of low fat sour cream

1 avocado cut up

1 large ugli or beefsteak tomato, cut into small pieces

1 box frozen corn kernels, or shuck 2 ears of cooked corn

Juice of 2 or 3 garlic cloves (throw pulp away)

2/3 cup fresh cilantro, chopped up well

2 15-ounce cans black beans, drained and well-rinsed (or only 1 can).

1/2 red bell pepper chopped into small squares

1/2 orange pepper, chopped into small squares

1/2 yellow pepper, chopped into small squares

1/2 green pepper, chopped into small squares

1 onion, chopped into a small dice

Juice of one lime

3 Tablespoons olive oil

1/2 teaspoon ground cumin

3/4 teaspoon salt

1/2 teaspoon agave or honey

1/2 teaspoon turmeric

 

Directions

 

Into a large salad bowl, mix the black beans, all of the fresh peppers cut-up, corn, avocado, tomato and chopped onion. In a separate, smaller bowl, whisk remaining ingredients (olive oil, lime juice, garlic juice, cilantro, cumin, salt, agave, turmeric) into a vinaigrette. Ideally, you’ll have approximately 1/2 cup of dressing. Pour it over the bean mixture, toss it well and adjust seasonings to taste. Serve, on the side, low or no-fat sour cream and grated soy cheddar. Also serve tortilla chips and salsa.

 

This salad would go well with any fish and I am making some lovely fragrant saffron rice, as well. When you make your rice, consider boiling it in chicken stock/broth, which improves the flavor. Into the chicken stock, throw in a generous pinch of saffron, stir, and add your rice. (I use jasmine).

 

Serve your ice cold favorite beer, sangria or well-chilled white wine, and you’re all set for a lovely meal, including an outdoor barbecue with friends.

 

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Enjoy!

 

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Our hotel in Santa Fe and the Santa Fe Opera House (partial view)

 

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Santa Fe Opera House, partial view

 

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Lensic Theater for the Arts, Santa Fe, NM

 

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Coyote Cafe, near our hotel

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SITE Santa Fe Contemporary Art Museum