Optimize Lab Operations with a Unified Platform

By David

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.

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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

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.

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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.

The logic of biologics

By Catherine

Written by Catherine Bolgar

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Biologics have long been the great hope in the fight against non-communicable diseases. Cancer, cardiovascular and chronic respiratory diseases, diabetes and mental health account for 63% of all deaths world-wide. According to a 2011 World Economic Forum report, these diseases will cost some $47 trillion in lost global output over the next two decades. Unsurprisingly, biologics are grabbing an increasing share of the blockbuster drugs market; in 2014 they represented six of the world’s 10 best-selling pharmaceuticals.

Unlike conventional chemical-based drugs, biologics are organic and consist of larger molecules, with thousands of times more atoms. Their greater complexity, however, means that “the regulatory pathway is more cumbersome,” notes Ranjith Gopinathan, program manager, life sciences in the European health-care practice of Frost & Sullivan, a global market research and consulting firm. Of the 41 new drugs approved by the U.S. Food and Drug Administration in 2014, only 11 were biologics.

Never the less, biologic drugs that have been approved have made a huge and rapid impact. Take Sofosbuvir (sold by Gilead as Solvaldi), an anti-viral medication that helps cure hepatitis C. With some 150 million sufferers world-wide, the drug became a global best seller within its first year on the market.

One of the hottest areas in biologics is the development of monoclonal antibodies. These mimic the body’s natural antibodies and have proven to be particularly effective in cancer treatment. They can make cancer cells more visible to the immune system, block growth signals, prevent new blood vessel formation in tumors, and deliver radiation or chemotherapy to cancer cells.

Trastuzumab (sold by Roche as Herceptin), for example, is a monoclonal antibody that targets the HER2+ receptor in breast cancer, a genetic variation found in 15% of  breast cancer patients. When used with other chemotherapy drugs, Herceptin increases survival rates 37%. Roche has come up with other biologics—pertuzumab (sold as Perjeta) and trastuzumab emtasine (sold as Kadcyla)—that can further improve Herceptin’s results, says Barbara Gilmore, a senior industry analyst at Frost & Sullivan.

Close lookAnother monoclonal antibody, launched on the U.S. market in March 2015, is dinutuximab, (marketed by United Therapeutics as  Unituxin). Containing mouse and human components, it helps the immune system find and destroy cancer cells by targeting a substance found on the surface of neuroblastoma tumor cells. Neuroblastoma cancer starts in the nervous system and typically afflicts children under five.

Monoclonal antibodies are key to the success of targeted therapeutics, a process that attacks diseases without affecting healthy cells and tissues. Meanwhile, advances in companion diagnostics and genetic profiling would bolster personalized medicine.

“The growth will be in personalized medicine and targeted therapeutics,” says Mr. Gopinathan. “More efficient drug-development processes based on the disease pathophysiology and genetic risk factors would be game-changers in the industry.” He predicts: “Biologics will continue to outpace overall pharma growth.”

Another promising growth area lies in non-brand versions of biologics, known as “biosimilars.” These are analogous to the $261 billion generic drugs market that replicates conventional drugs whose patents have expired.

One such biosimilar, developed by Novartis, is Zarxio , a version of Amgen’s filgrastim (sold as Neupogen), which helps prevent infection during chemotherapy. Amgen is also developing six of its own biosimilar drugs.  “Here’s a biotech company that makes biotech drugs, and even though they have a robust pipeline, they’re also making biosimilars,” says Ms. Gilmore. “It’s very smart. There’s money to be made there.”

Frost & Sullivan forecases a 60% compound annual growth in the biosimilar market between 2012 and 2019. A RAND Corp. study estimates  that biosimilars could reduce spending on biologic drugs in the U.S. by $44 billion over the next decade, while Spain’s University of the Basque Country forecasts €20 billion savings in Europe through 2020.

iStock_000029461972_SmallHowever, getting biosimilars into the market remains a major challenge. Biologics’ complexity makes them hard to replicate because they use biological processes or living organisms to create the drugs’ molecules.

The European Union has approved only 19 biosimilar drugs since 2006, and the U.S. approved its first biosimilar, Zarxio, in March 2015. Herceptin lost its patent protection last year in Europe and will lose its U.S. patent in 2019, but no biosimilars have yet been approved in those jurisdictions, an indication of how difficult the process is.

Moreover, unlike generics, biosimilars are not much cheaper than their originals to produce. Mr. Gopinathan calculates that “the price reduction is, at most, 30%.” Health care’s great hope will still come at a price.

 

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



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