DIGITALIZATION DRIVESCOLLABORATIVE

INNOVATIONFOR THE LIFE SCIENCES

Bringing new pharmaceuticals to market is expensive, time consuming and risky, especially in the context of a Life Science industry that is experiencing declining profit margins and a continuous demand for new therapeutics. An information tech-nology landscape littered with data siloes, point solutions and manual processes impedes productivity, collaborative innovation, technology transfer and process optimization while increasing costs and lengthening time to market.

Addressing these challenges requires a significant, end-to-end transformation of enterprise strategies, technologies and opera-tions from research to commercialization. Enterprise R&D, QA/QC and manufacturing organizations can no longer operate in silo’d isolation from one another. Contextualized data must flow freely, back and forth, along a digital continuum connecting all processes to the lifecycle of the medicinal product.

CONNECT THE ENTERPRISE WITH A SCIENCE-ENABLED BUSINESS EXPERIENCE PLATFORM The Dassault Systèmes 3DEXPERIENCE® platform democra-tizes scientific data by making resources and materials findable, accessible, interoperable and reusable in a collaborative, inter-active work environment. By establishing digital connectivity across the enterprise, the platform integrates the workflows of upstream researchers, designers and developers of new com-pounds and formulations with the activities of downstream scaling and manufacturing teams. This helps to eliminate infor-mation silos, decrease process bottlenecks and costs, accelerate collaborative innovation and facilitate technology transfer, while also improving end-to-end quality and reducing regulatory risk.

Working on a flexible and open platform, scientists can lever-age Dassault Systèmes BIOVIA’s industry-leading, role-based Research, Laboratory and Manufacturing Informatics and Quality Management solutions (as well as other Dassault Sys-tèmes brand applications and the customer’s own application stack). The platform’s intuitive interface provides easy-to-use navigation, search and analytics capabilities, connecting and har-monizing end-to-end product and program information from exploration to commercialization.

HIGH-IMPACT OPPORTUNITIESLife Science companies adopting BIOVIA’s Research, Laboratory and Manufacturing Informatics and Quality Management solu-tions are realizing value across a range of activities.

DIGITALIZE THE INNOVATION LIFECYCLE

Scalability and Operational Efficiency↓ 40-60% time searching data ↓ 20-50% time preparing reports

Global Collaboration↑ 50-100% model sharing across functions ↓ 15-40% non-value-added tasks

Decision Support↑ 5% executive insight to inform decisions

↓ 20-30% time to make decisions

Simplified and Standardized IT Environment↓ 15-35% implementation costs↑ 50% reuse of common methods/code

Quality and Compliance Optimization↑ 85% model and data traceability↓ 25-50% cost of audits

BIOVIA BENCHMARK METRICS

SPEED BIOPHARMA PROCESS DEVELOPMENT AND TIME-TO-MARKET

DIGITAL CONTINUITY

Digitally connected, standardized tools and processes with common data structures across the value chain can reduce cycle-times and simplify technology transfer. Streamlined process execution allows Life Science organizations to run multiple concurrent activities and reduce sequential operational dependencies that delay time to market. Closed-loop feedback between upstream development and downstream plants can anticipate and facilitate future development efforts. For example, recipe development typically involves multiple transfers, manual copies, unstructured document libraries and significant data collection, review and reporting efforts. An integrated recipe lifecycle can reduce or eliminate disruptions and accelerate development operations, whether executed in-house or externally.

documented

optimized

approved executed controlled audited

tech transfer

››gxp execution ››mobile device ››data collection ››electronic batch records››deviation documentation

››unit operation››recipe structure››specification››tolerance

››oos/oot events››capas››quality reports››lifecycle management

››text conversion››identification››classification››validation››approval workflow

››multivariate experiment plan

››experiment execution

››data analysis

››review by exception››audit trail››data aggregation››continuous process verification

››collect process parameters

››run statistical analysis

››visualize

unstructured structured

IMPROVE OPERATIONAL EXCELLENCE ACROSS GLOBAL SITESDigital continuity improves end-to-end program management, while also creating significant opportunities for Life Science organi-zations to scale operations, boost operational efficiency and accelerate innovation. By improving oversight of global interdisciplinary teams and complex partner networks, the digital continuum also advances operational excellence and competitive advantage. Life Science organizations can allocate resources and budgets based on automated reporting and real-time information presented in flexible dashboards. Enhanced knowledge sharing, social collaboration and predictive modeling and simulation improve visibility into project and product issues. Decision makers can take corrective action in a timely and even preemptive manner, increasing the likelihood of overall project success.

digital continuum

COLLECT & SHARE IDEAS & RESULTS

REVIEW OVERALL PROJECT HEALTH

MANAGE TASKS & RESOURCES

TRACK BUDGETS, ISSUES & RISK

REVIEW DELIVERABLES

tech transfer

production

contract manufacturingcontract research

research

end-to-end program management

• Accelerate patient-focused innovation

• Increase operational agility

• Shorten time to commercial operations

• Improve partner integration and management

• Harmonize and extend best practices across the global value chain

Strategic Benefits• Reduce effort and time for

commercial development

• Lower tech transfer time and costs

• Improve collaboration efficiency

• Decrease efforts for data aggregation, analysis and reporting

Economic Benefits

Risk Mitigation• Simplify compliance with full

traceability

• Deploy a configuration-based, validation-ready, proven solution

• Reduce investment risks with a scalable, commercial IT solution

IT Impact• Deploy a validation-ready

solution with reduced imple-mentation efforts

• Consolidate applications portfolio on a common platform

• Reduce risk, time and cost with configuration-based implementation

• Decrease administrative support and integration efforts

BIOVIA solutions for Life Science organizations can increase capacity, globalize quality and compliance best practices, lower risk, accelerate collaborative innovation and improve operational excellence in a system that scales to meet the needs of the full product lifecycle today and in the future.

THE CASE FOR CHANGE

Now more than ever, Life Science organizations need a trusted, strategic partner that shares their vision and passion for what is pos-sible in today’s rapidly changing business and technology environment. Dassault Systèmes BIOVIA offers unparalleled experience and a strong track record in the Life Science industry to assist pharmaceutical and biotechnology companies with their business and IT transformation journey.

We look forward to supporting pharmaceutical and biotechnology companies with overall project development, design and deploy-ment to accelerate their transition from evaluation to implementation of an industry-leading digital continuity solution.

THE VALUE OF PARTNERING WITH BIOVIA

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Our 3DEXPERIENCE® platform powers our brand applications, serving 12 industries, and provides a rich portfolio of industry solution experiences. Dassault Systèmes, the 3DEXPERIENCE® Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 190,000 customers of all sizes in all industries in more than 140 countries. For more information, visit www.3ds.com.

Dassault Systèmes CorporateDassault Systèmes175 Wyman StreetWaltham, Massachusetts02451-1223USA

BIOVIA Corporate EuropeBIOVIA 334 Cambridge Science Park,Cambridge CB4 0WNEngland

BIOVIA Corporate AmericasBIOVIA 5005 Wateridge Vista Drive,San Diego, CA 92121USA

Leverage a strategic business partnership with Dassault Systèmes BIOVIA aimed at deploying an enterprise-wide digital continuity solution that enhances operational excellence, drives collaboration, lowers risk and accelerates innovation to market.