Accelerating Cell & Gene Therapy Development: From Concept to Patient
Delivering on the promise of personalized medicine is no easy feat, but the rewards to be reaped are enormous. Cell and gene therapies offer life – changing solutions for many suffering ruthless, relentless and previously untreatable diseases. By harnessing the power of our own immune systemes or leveraging the human genome to fight these diseases, we now can now truly deliver on the promise of personalized medicine.
Six Steps to Digitally Transform Cell & Gene Therapy Manufacturing
Conquer digitalization and achieve success to accelerate your transformation journey in this rapidly growing and expansive market
Realizing the potential of cell and gene therapies requires the convergence of science and technology to create advanced novel therapeutics, and a game-changer scientific and business platform that enables sustainable innovation and fosters operation excellence in order to accelerate the delivery of the breakthroughs that improve the patient & physician experience
The area of cell and gene therapy is undergoing rapid growth with billions of dollars being invested and product development pipelines expanding quickly. However, in order for Life Sciences companies to leverage the full potential of this market, there are a number of challenges they need to overcome:
- Accelerating therapeutic discovery, research and design while driving down costs by effective knowledge transfer and collaboration to facilitate the exchange of scientific information to swiftly advance best candidates to clinical trials.
- Delivering safe, affordable and high quality products by leveraging an integrated framework for compliant innovation, embedding quality and regulatory best practices early in development and providing end-to-end traceability throughout the patient and product lifecycle.
- Expediting the transition from development to manufacturing with agile and smart practices, shifting to more predictive and adaptive approaches to scale-up and scale-out, meeting market demand while reducing costs.
- Optimizing the Supply Chain to maximize shareholder return with a networked and digitally connected value chain and adopting open innovation as a core business strategy to drive agility with global scale.
- All of the above requires digitalization to transform business processes and will involve the collecting, controlling and leveraging of huge quantities of data generated from a variety of processes for the patient and product journeys. Virtual twin technology can improve agility and flexibility to optimize manufacturing output. Predictive Analytics will find factors and risks associated with a disease or predict which patient would respond best to an experimental treatment.
The 3DEXPERIENCE® platform and our extensive portfolio of solutions enable Life Sciences companies to address each of the challenges associated with bringing cell and gene therapies to the market, from concept to patient – satisfying unmet medical needs and allowing patient access to the right treatment at the right time.
With Dassault Systèmes, Life Sciences companies can:
- Make Research and Development labs more efficient, compliant and collaborative for faster product and process development by integrating people, resources, processes, data and interfaces.
- Advance cell & gene therapy development, regulatory approval, manufacturing, and supply, in a global landscape by leveraging an extensive, connected and comprehensive regulatory and quality platform.
- Accelerate clinical trials by collaborating with all stakeholders to increase statistical confidence in trial results for indications where randomized control groups are impractical or infeasible using a reliable synthetic control arm.
- Reduce costs & deliver therapies to smaller patient populations, with a modular, predictive, digitalized approach, optimizing and virtually testing CGT processes before a new plant is built or before an existing plant undergoes improvements.
- Identify and make adjustments on out of control manufacturing trends before failures occur through identification of critical process parameters, quality attributes and monitoring production processes.
- Gain operational excellence against volatile and rapidly changing production schedules across many different sites/CDMOs with dynamic and intelligent planning and scheduling.
- Utilize big data analytics to integrate information from both internal and external sources, and provide dashboards that deliver actionable insights to all stakeholders in a secure and auditable manner.
Drive Possibility Forward
MEDIDATA Acorn AI believes in propelling the innovators - the heroes - of the scientific world to overcome the impossible and realize what is possible. We do this by arming you with the data, tools and insight you need to reimagine clinical trials, rededicate patient data to develop critical therapies and to rethink the limits around human data science
50% reduction in total turnaround time in the development lab
35% cost savings by shortening clinical trial timelines
Up to 80% reduction in total turnaround time for manufacture of treatment
40-50% reduction in correct response time to Out-of-Specification/Out-of-Trend results
Up to 15% improvement of manufacturing productivity
Up to 60% time saved on planning
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