IASOTransforming the Patient Experience

LIFESCIENCES

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IASO

Due to the high cost of bringing a single new therapeutic to the market, Life Sciences companies have greater pressure to maximize revenue while staying ahead of the competition. Considering that programs for innovative products are high-risk/high-reward, many companies continue to focus their activities on developing First-in-Class treatments. The most innovative among them are turning to novel formulation strategies and delivery systems that can vastly improve the patient experience—the next frontier in drug development.

Nowhere is innovation to enhance the patient experience more critical than with these novel large molecules and the required high-volume injections to deliver them. Thus, high-tech large-volume wearable injectors in the form of combination products are sure to play a critical role in the future success of these new therapeutics by shifting the Point-of-Care (PoC) from hospitals and clinics to the patients‘ homes.

IASO, named after the Greek goddess of recovery, is a Life Sciences showcase for the lifecycle of a combination product in oncology. From upstream thinking through to commercialization, IASO demonstrates the value that Dassault Systèmes and the 3DEXPERIENCE® platform can deliver to stakeholders challenged with bringing innovation to market in the form of combination products that transform the patient experience.

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THE PATIENT JOURNEY WITH IASO

The patient comes out of the hospital with a patch installed on their arm for three main purposes:

• To secure the catheter that has been positioned inside the vein which will be used for the IV injection of a drug.

• To attach the injector + cartridge when the treatment needs to be administered.

• To monitor the efficacy of the treatment in real time + collect and analyze data to generate analytics.

The patient will receive a refrigerated box that contains the injector + the different drug cartridges at home via digital prescription.

When the patient is notified through their mobile phone to proceed with the injection, they will lock the injector and the appropriate cartridge together, and then plug in the combination product on the patch that is fixed to their arm.

The patient will then press the Play button on the IASO screen to launch the injection.

Once the injection is over, the IASO screen will inform the patient. The patient will then unplug the injector from the patch and store it for the next injection.

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Biologic drugs are a driving force in the Life Sciences industry to treat complex diseases. The success of biologics is driven by superior efficacy, safety, pricing, exclusivity—and most importantly—the ability to satisfy previously unmet medical needs. But, their delivery can be complex and they require high-tech, high-volume, wearable injectors to enable patients to receive drug delivery in the comfort of their own homes.

The Dassault Systèmes 3DEXPERIENCE platform fosters collaborative innovation in the initial stages of combination product development in the following areas:

• Research Project Scope Definition

• Social Marketing Intelligence

• Social Collaboration & Ideation

• Industrial Design Innovation

• Design Experience & Validation

COLLABORATIVE INNOVATION

Did you know?

The global market for biologics is expected to grow to US$375 billion by 2022

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BENEFITS OF USING THE 3DEXPERIENCE PLATFORM FOR COLLABORATIVE INNOVATION

• Increases innovation potential to deliver more enriching product experiences for patients faster than ever before.

• Accelerates ideation processes and industrial design workflows using social collaboration between an organization's internal and external ecosystems.

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In the last 35 years, the focus of drug discovery and development has gradually shifted away from small, well-defined chemical molecules to large, complex molecular entities called therapeutic biologics. These biotherapeutics are now playing an increasingly prominent role in combating cancer, diabetes and autoimmune diseases.

The fundamental challenge facing the Life Sciences industry is how to optimize R&D efficiency and productivity for these biotherapeutics from early-stage discovery to commercial manufacturing. To reduce time and costs in R&D, there is a growing focus—especially during early-phase discovery and development—toward earlier decision making to identify quality therapeutic candidates and ensure the lower quality candidates “fail early”.

The 3DEXPERIENCE platform facilitates early decision making to increase efficiency and productivity in design and development in the following areas:

• Target Identification & Validation

• Epitope Characterization

• Biologics Lead Identification & Optimization

• Lab Tests

• Molecular Dynamics Simulation

• Assess Developability Properties

• High Content Screening (HCS)

• Biologics Process Development

THERAPEUTICS DESIGN & DEVELOPMENT

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• Enables scientists to work in partnership and efficiently share scientific results, accelerating decision support to move the best candidates forward.

• Provides robust predictive analytics tools that leverage existing experimental results to rapidly optimize therapeutic efficacy and safety.

• Provides analytics to allow an early prediction of potential downstream manufacturability issues, to guarantee rapid formulation of efficacious, stable therapeutics and speed up time-to-market.

BENEFITS OF USING THE 3DEXPERIENCE PLATFORM FOR THERAPEUTIC DESIGN & DEVELOPMENT

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The delivery of new and novel biologic therapeutics to patients is complicated as they can be viscous and must be delivered in large volumes. Thus, the design of the device used to administer these is critical.

With the 3DEXPERIENCE platform, in the device design and development stage of IASO development, social ideation is done using See What You Mean (SWYM) Communities that gather all actors and users involved in the product definition. Ideas are captured in the Ideation Funnel and are efficiently sorted, discussed, evaluated and refined to determine the short list of strongest candidates. At the requirements stage, the requirements are created, edited and reviewed directly from the 3DEXPERIENCE web dashboard in an intuitive manner.

Dassault Systèmes SOLIDWORKS® enables 3D design, delivers powerful, easy-to-use design features and provides tightly integrated tools for every area of product development.

For systems engineering, the 3DEXPERIENCE platform allows companies to better manage and simplify multi-disciplinary collaboration and to accelerate the design and validation process within different disciplines.

DEVICE DESIGN & DEVELOPMENT

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The 3DEXPERIENCE platform enables users to leverage multiphysics simulation and high-performance computing to explore and optimize real-world behavior.

For the IASO device design, the following multiphysics simulations were completed on the 3DEXPERIENCE platform.

Drop Test Fluidic Test

Skin Adhesion Test Electro Magnetic (EM) Test

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• Reduces cycle times.

• Accelerates design and development processes.

• Improves productivity.

• Minimizes cost of design errors.

• Decreases cost of quality.

BENEFITS OF USING THE 3DEXPERIENCE PLATFORM FOR DEVICE DESIGN & DEVELOPMENT

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Ensuring therapies are produced ‘As designed’ and ‘As registered’ is a continuous challenge for the Life Sciences industry. The 3DEXPERIENCE platform allows complete visibility for quicker data-driven decision making, shorter time-to-market, traceability and total quality outcomes in each of the following domains:

• Digital Manufacturing

• Production Planning

• Lean Operational Management (Six Sigma)

• Manufacturing Execution System

• Batch Process Analytics

MANUFACTURING EXCELLENCE

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• Allows complete visibility across the enterprise.

• Informs data-driven decision making.

• Promotes quicker, more informed decisions.

• Reduces time-to-market.

• Provides total quality through visibility and traceability.

BENEFITS OF USING THE 3DEXPERIENCE PLATFORM FOR MANUFACTURING EXCELLENCE

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ENTERPRISE OPERATIONAL EXCELLENCE

Today, for a therapeutic solution, drug or medical device, and more specifically for a combination product, product information is managed through highly fragmented processes and systems that pose obstacles many companies face everyday.

This causes multiple challenges including:

• Risk of non-compliance and non-quality

• Lack of end-to-end traceability and transparency

• Inefficient project execution and poor productivity, resulting in loss of time and money

To achieve quality that positively impacts the organization, Life Sciences companies need to take a holistic end-to-end approach to the product lifecycle. This is even more critical in the context of a combination product such as IASO.

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The 3DEXPERIENCE platform enables digital continuity among many disciplines which include the following.

Project Management Design Review

Change Request Tracking Change Implementation

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• Enables impact analysis for post-approval change management.

• Enables global closed-loop process and project management.

• Delivers greater traceability and control of changes.

• Allows for impact assessment with “where-used” capabilities.

• Fosters improved collaboration and assignment of dedicated stakeholders and experts.

• Promotes regulatory intelligence.

• Presents a unified dashboard-driven view of change-related information.

BENEFITS OF USING THE 3DEXPERIENCE PLATFORM FOR ENTERPRISE OPERATIONAL EXCELLENCE

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3DEXPERIENCE THE BUSINESS EXPERIENCE PLATFORM

The market opportunity for large volume injectable devices alone is estimated to be $8 billion by 2025, and biological drugs now account for more than 40% of pharmaceutical R&D pipelines. These novel biologic solutions, dosed with connected, wearable and reusable delivery devices, are transforming the patient experience by shifting the Point-of-care from clinics to the patient’s home.

To capture the market and leapfrog the competition, Life Sciences companies embracing these industry trends must adopt a comprehensive global approach to quality, regulation and compliance. To ensure enterprise-wide data integrity, consistency and reliability, a unified quality solution is required providing a Single Source of Truth (SSOT). The Dassault Systemes 3DEXPERIENCE platform connects sys-tems, people and data among disciplines including Research, Development, Process Engineering, Quality Compliance, Regulatory Affairs, Manufacturing and Commercialization.

This business experience platform ensures that Product Lifecycle Management (PLM) will not be just another disparate application or viewed as a limited or incomplete solution. Rather, it will demonstrate how to deliver collaborative innovation and operational excellence through complete digital continuity.

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AmericasDassault Systèmes175 Wyman StreetWaltham, Massachusetts02451-1223USA

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Our 3DEXPERIENCE® platform powers our brand applications, serving 11 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 250,000 customers of all sizes in all industries in more than 140 countries. For more information, visit www.3ds.com.

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For further information on IASO, please request a demonstration from the Life Sciences team experts:

https://ifwe.3ds.com/life-sciences

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