Improving Drug Development Efficacy Through Operational Efficiency

By David
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The drug development process has become increasingly expensive and focused on improved returns on investment. With average development taking 12 – 15 years, only one in 25 drug programs are released to the commercial market.  Yet, after all this time and investment, the patent expires after only 20 years.  Meanwhile, the time needed for drug discovery is lengthening and becoming more costly as well. Companies are facing high operational costs and high development failure, leading to fewer, lesser quality candidates entering clinical phases.

Another challenge is the move towards ‘personalized medicine’, as research indicates these therapies are more effective. This is forcing a shift from blockbuster drugs to targeted solutions for smaller populations. Pharmaceutical companies have opportunity here, but must also find a way to deliver new types of therapeutics while reducing costs and time-to-market.

New drug development requires a combination of innovation and operational efficiency. To achieve new levels of productivity, Life Science companies must learn to capture and build-upon their existing knowledge base by harvesting and sharing the data that already exists within their organizations.

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Putting Big Data to Work

As in all industries, there has been a vast increase in data generated by Life Sciences organizations, which will help the industry become more efficient and effective. If data was aggregated and disseminated to its potential, predictive modeling of biological processes and drugs could become more sophisticated and commonplace. This would enable better identification of probable candidate molecules that could be developed into a successful drug. The wealth of new data and improved analytical techniques will enhance future innovation and fuel the drug-development pipeline.

Tools for analyzing and interpreting this data have not been developed and implemented at the same rate, and data without analysis are worthless. Pharmaceutical companies must find ways to mine, integrate and gain knowledge from all this data to improve analytical capabilities.

Eliminating the Silos

Leveraging the existing information that is created, and then stored during drug development, requires the ability for contributors across the enterprise to collaborate and have access to common knowledge.  Departmental silos of data must be eliminated so that digital data is captured and shared between functions. This requires a flexible process and system that can capture, manage and document all the data.  This level of visibility and collaboration sets the foundation for predictive analytics, which can provide the insight needed to accelerate and improve innovation.

Optimizing Therapeutic Development

Dassault Systèmes Designed to Cure Industry Solution Experience provides a business and scientific platform that can deliver collaborative virtual design, knowledge-driven innovation, as well as the predictive analytics needed to address current industry challenges.

Based on the unique BIOVIA portfolio, the solution integrates the diversity of science, experimental processes and information requirements across R&D, QC and manufacturing.  This solutions supports data-driven insight that is key to accelerating and improving innovation. Utilizing a highly integrated, streamlined information gathering and processing system, multi-disciplinary teams can connect to the high quality information at any time, from any location. By unifying siloed applications and enabling seamless data management, Designed to Cure enables scientists within a collaborative global ecosystem to achieve better insights and deliver safe and efficacious drug candidates faster.

 

To learn more about Designed to Cure Industry Solution Experience provided by Dassault Systèmes, download the solution brief.

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.

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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
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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.

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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.



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