Calling in Sick

By Catherine
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Written by Catherine Bolgar

One day, your phone might detect that you have cancer and alert your doctor. It’s among the new diagnostics being developed to spot health problems faster.

Cancer cells, bacteria and certain non-infectious diseases give off volatile organic compounds which the blood eventually transports to our lungs to be expelled into the atmosphere, explains Hossam Haick, professor at Haifa’s Israel Institute of Technology. He is part of a team developing a handheld device with gold nanoparticle sensors that can detect volatile organic compounds in breath samples.

Each disease has a unique breath print, he says. The team’s sensors can detect 23 diseases, including cancers of the lung, breast, ovaries, head and neck, lung, stomach, kidney and prostate, as well as pulmonary hypertension, tuberculosis, and even Parkinson’s disease and Alzheimer’s disease.

Cancer “exists in humans for five to 15 years before we start to see its effects,” Dr. Haick says.

If we want to detect cancer early, we have to do it when people feel good. That’s why we want to detect it by exhaling. It’s painless, so people will be willing to do it.”

Dr. Haick started with lung cancer in 2007. “If you detect lung cancer early, the survival rate is 70%,” he says. “If the cancer is at advanced stages, the survival rate is 9%-15%.”

Today, X-rays and computerized tomography scans detect tumors, but only a biopsy (i.e surgery) can determine if they are malignant—and 96% are not, Dr. Haick says. The sensors can distinguish between benign and malignant cancer, thus reducing the need for biopsies.
Dr. Haick hopes to produce a handheld device for around $800, affordable for clinical doctors. He’s also working with a European consortium to integrate the device into smart phones. “When we speak on the phone we exhale a lot of breath, and we can use that to monitor disease,” Dr. Haick says. The phone would alert the owner’s doctor, who would decide how to manage the results.

Similarly, a team at the Mayo Clinic in Rochester, Minn., is working on a noninvasive screening for several cancers simultaneously, by detecting DNA markers in a blood or stool sample.

While cancer lurks for years, infections can become serious in hours. On TV dramas, doctors examine samples under microscopes and find the solution in minutes. In reality, samples are sent to a lab where they are cultured—which can involve growing bacteria or viruses for six to 24 hours—or undergo polymerase chain reaction (PCR), a complex process that takes about six hours.

Emergency room patients with an infection can’t wait that long, so doctors immediately administer a range of antibiotics. But overuse of antibiotics has led to resistance, and in any case the drugs don’t work on viruses.

Jeong-Yeol Yoon, professor of agricultural and biosystems engineering and biomedical engineering at the University of Arizona in Tucson, has found “a whole new way of doing PCR” utilizing interfacial effects, that’s cheaper, easier and much faster—the whole process takes less than 10 minutes.

Normally, PCR identifies the pathogen by looking at the DNA in the sample. The DNA is first extracted and purified, which can take three or four hours. The amount of DNA is tiny, so it’s amplified by an enzyme and heated and cooled repeatedly. Each cycle doubles the DNA, so “if you repeat the cycle 30 times you’ll have about a million copies, theoretically,” Dr. Yoon explains.

Dr. Yoon’s team instead uses an approach called droplet-on-thermocouple silhouette real-time polymerase chain reaction (DOTS qPCR). The method can identify infection after just three to eight cycles. And the process uses water droplets, which separate contaminants, eliminating the time-consuming step of purifying the sample. The entire process, from sample to answer, can take just five to 10 minutes.

Regular PCR requires expensive equipment and trained lab personnel. But Dr. Yoon hopes to make a fully automated DOTS qPCR device for under $1,000, so it can be used in poorer countries where diseases such as Ebola, MERS, SARS and bird flu require speedy quarantines to prevent epidemics.

Genetics play a key part in other new early diagnostics methods. For example, Stanford University researchers have identified a pattern of gene activity that could lead to a quick blood test for sepsis, which kills 750,000 people annually in the U.S. alone. Meanwhile, a University of Utah team has found DNA anomalies that predict how an ovarian-cancer patient will respond to platinum-based chemotherapy. And scientists at the University of Toronto are using next-generation sequencing to match a sample against a database of thousands of bacteria and viruses, eliminating the need to test one by one.


Catherine Bolgar is a former managing editor of The Wall Street Journal Europe. For more from Catherine Bolgar, contributors from the Economist Intelligence Unit along with industry experts, join the Future Realities discussion.

Photos courtesy of iStock

Optimize Lab Operations with a Unified Platform

By David
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In today’s competitive environment, Life Sciences organizations need to optimize operations by improving efficiency while maximizing quality and adhering to regulations. The drug development process can be expensive, slow and risky.

According to Tufts Center for the Study of Drug Development, the cost to develop and win marketing approval for a new drug is $2.6 Billion and takes more than 10 years to bring to market.

In addition, pharmaceutical companies face major challenges including patent expirations, increased FDA inspections, as well as increasing competition in the global marketplace and decreasing margins. In order to contribute to corporate directives, laboratories also need to remove inefficiencies and compliance risks from processes as well as provide a collaborative environment that fosters innovation.

In any industry, the best way to be successful is by doing the right project and by doing projects right. This means that scientific processes for product R&D as well as Quality and Operations must be aligned with business goals, requiring visibility across the enterprise. Organizational silos, which hinder business efficiency and agility, must be eliminated and, instead, integrated through a single information hub.


Single Solution for a Unified Laboratory:

The Dassault Systèmes ONE Lab industry solution experience integrates people, resources, processes, and data, providing interfaces from research, development, and quality labs on a single platform. It is designed to address today’s market challenges by improving operational excellence through collaboration that shortens time to market.

Integration Hub Based on One Foundation:

ONE Lab works as an integration hub for BIOVIA and third-party applications and instruments. It allows seamless data transfer between the different domains from research to manufacturing, as well as with external collaborators and integrates lab processes like resource or data lifecycles based on a common foundation.

Standardized Approach:

ONE Lab provides a standardized approach for all laboratory processes including the usage of lab equipment, materials and procedures. It also addresses the management of procedures, recipes, and resources and handles the execution of lab workflows. This allows the lab to increase efficiency by eliminating paper and manual processes, and improve process knowledge through visualization and analytics.

Role-based User Experience:

ONE Lab speaks in the language of each user, offering a unified role-based user experience for all scientists and managers involved in the laboratory process.  Users can develop and execute methods, recipes and processes with domain-specific templates configured to deliver the appropriate information for each particular role.

Digital Lab Experience:

Through shared access to digital information, One Lab helps eliminate disconnected and paper-based processes that tend to be error-prone. Compliance is improved through templates, standard work practices and rapid reporting with all information aggregated and standardized from one source.

Knowledge Capture:

The ONE Lab solution connects lab-to-plant workflows and information across the product lifecycle from ideation to commercialization supporting research, product development and production. Through Knowledge Management, Life Sciences companies can improve operational excellence and collaboration and shorten time to market.

Access and sharing of common, relevant data throughout the research, development and manufacturing lifecycle is key in reducing research, development and production times, identifying non-promising product potentials sooner in the process, optimizing the drug development process and accelerating the product release while maintaining quality. This requires collaboration from inception through product commercialization that is reliant upon a single data foundation.  To learn more, download the solution brief.

Optimize Your Therapeutics Production Process

By David
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The life sciences industry is the driving force behind major medical breakthroughs and therapies that ensure public health. The sustainability of a competitive, innovative biopharmaceutical sector depends on collaboration across enterprise to overcome bottlenecks and address key challenges.

Pharmaceutical companies typically are linked to a complex network of other organizations requiring partners adapt to meet changing regulatory compliance, as well as manage collaboration. In order to master the complex relationships that exist between process development, manufacturing, and quality operations as well as outsourced operations, companies must learn to flawlessly execute processes, leverage internal and external knowledge, conform to regulatory agencies and minimize risk while simultaneously facing pressure to reduce costs.

To meet these challenges, manufacturers need a business framework that integrates all areas of the extended enterprise so that every unit can leverage the same information. Additionally, real-time visibility into manufacturing and process data will provide the insight needed to understand critical process parameters so that manufacturers can quickly adapt operations for continuous improvement.

Dassault Systèmes’ Made to Cure for BioPharma provides a collaborative environment that helps speed time-to-market and maximize profitability. This solution enables pre-emptive action by providing visibility into process operations, quality and compliance risks, helping to optimize product quality as well as the production process of therapeutics.


Data Driven Insights for Business Improvement

Process development, manufacturing and quality functions generate an abundance of data, which needs to be presented in a user-friendly, organized form to be leveraged. Made to Cure for BioPharma provides all key stakeholders with self-service, on-demand access to process and quality data from disparate databases and paper records from one location helping users to gain process knowledge and improve production operations.

The access to timely and reliable analyses and reports helps support business as well as compliance requirements. The automatic aggregation and contextualization of the data delivers near real-time insight into operations enabling companies to quickly identify, understand, monitor and improve process and product variability. Data can be reused and shared across global operations internally and externally, thereby quickly spreading insights and knowledge to improve decision making.

Optimize Performance for Improved Profitability

Therapeutics manufacturing can be costly and ineffective management of regulatory actions can lead to additional filings costing both time and money. Poor tech transfer from lab to in-house and outsourced operations can result in inadequate therapeutics process design that failed to learn from prior experience. A collaborative validated business framework can help reduce operational disruptions that occur with disconnected systems and units that can lead to regulatory recalls that could potentially damage the brand in the marketplace.

By  easily aggregating and contextualizing data and providing role-based visibility of critical production process and product parameters, Dassault Systèmes’ Made to Cure for BioPharma can shorten process development times, enable tech transfer , and bring quality products to market with lower risk and improved profitability. To learn more, download the solution brief.

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