Life Sciences

The E suite of Ecosystems: E for efficacious

February 28, 2022

Through a series of blogs, we are taking a deep dive into the E suite of Accenture’s Life Sciences ecosystem – examining how the collective power of a harmonized partner community is creating opportunities for biopharma to adopt a more productive, collaborative and innovative R&D model. Many of the ecosystem partners featured through this series are enabled through our INTIENT solution, a platform of platforms and network of services which provides actionable industry insights to those driving the development of New Science and the humanization of healthcare.

In this blog, we focus on how the ecosystem and INTIENT are supporting Cell and Gene Therapy.

E for efficacious

One of the most exciting areas of innovation in medicine today is in the Cell and Gene Therapy (CGT) sector, with many therapies already changing the industry and patients’ lives. CGT is increasingly being viewed as a superior therapy for life-threatening illnesses such as cancer—and in a growing number of indications, it is being used as a first-line therapeutic approach with the potential to cure diseases entirely. While the science that supports CGT is complex, in the simplest of terms, CGT treats the underlying causes of disease by modifying an individual’s cells and/or genes, typically externally, and re-introducing them to the patient to treat the disease.

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One of the most exciting areas of innovation in medicine today is in the Cell and Gene Therapy sector, with many therapies already changing the industry and patients’ lives.

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However, with the fundamental processes of CGT being different than that of traditional biopharma, it doesn’t always fit well with current ways of working, budgeting, and decision-making. Technical complexity, the need for speed, and differences in development, manufacturing, supply chain, and commercialization require new, specialized capabilities—and a shift in the traditional business model.

With the biologic information of the individual being core to the therapy, CGT is an amazing approach to solving complex diseases. With roughly 40% of new drug approvals being for rare diseases, its potential to be a leading technology in biopharma is inarguable.

Still, the pipeline for CGT is fraught with challenges. Some of the biggest pain points across autologous cell journey include:

Lack of end-to-end transparency
No single platform creating a unified experience for all stakeholders
Strict oversight on the chain of identity and custody
Challenges securing patient data throughout the process
Capability gaps and different workflows

For example, an individual treatment center, through which a patient finds access to CGT, may have its own standard for labeling, but that may not be consistent with other labeling further down the pipeline, causing confusion and roadblocks in data transparency. Similarly, couriers and distributors, who orchestrate just-in-time, ultra-cold supply chains, require specialized skills and technologies to ensure safety and efficacy—which was made very evident with the Covid-19 vaccine rollout.

It is estimated that there are roughly 800 applications on file, with an additional 200 expected in the next few years. This decentralization of CGT therapies will bring more challenges to an environment already experiencing significant growing pains. If done effectively, the potential for CGT to revolutionize modern medicine is incredible. The question is: how?

Enabling Cell and Gene Therapy research

With over 1,000¹ongoing clinical trials covering more than 10 therapeutic areas, CGT is positioned to make a significant impact across the social, clinical, and economic spectrum. The FDA has indicated that it expects to approve 10 to 20²new cell and gene therapies between now and 2025, with product sales exceeding $11.96 Billion by 2025.³

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800

Estimated applications on file, with an additional 200 expected in the next few years

1000

Ongoing clinical trials covering more than 10 therapeutic areas

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$33B

The FDA has indicated that it expects to approve 10 to 20 new cell and gene therapies between now and 2025 with product sales exceeding $33 Billion in 2026.

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The life sciences industry has the chance to focus on innovation of technology to match the demand for ongoing support for CGT clinical trials. While off-the-shelf digital solutions exist, they are typically focused on fragments of the overall process. The latter has led to the proliferation of bespoke solutions, creating redundancies in the system. There is a clear need to improve access and coordination of care with reduced complexity and investment per stakeholder—and what the industry needs is a single platform to cut through the complexity and drive efficiency.

Collaboration across the industry is key to ensuring successful progression in cell and gene therapy research, development and commercialization. Biopharma companies are looking to innovative providers to seamlessly orchestrate allogenic and autologous CGT therapies. What does the ideal CGT platform look like?

E2E transparency

Capable of connecting all value chain partners on a single platform with a unified experience for the end-user, whether it’s the C suite or data analytics teams. This will enable trust across partners, encourage smoother operational activities, and compliance adherence.

Cross-manufacturer track and trace

Unambiguously tying the manufacturer and hospital sets of unique identifiers together, while still allowing everyone involved to follow their own processes. This will ensure no unauthorized access and deployment of patient data as all parties will practice their specific sector standards and guidance on governance.

Full-scale capabilities

A low-cost industry utility capable of overcoming off-the-shelf solution gaps through a lightweight and intelligent architecture in one, universal platform. The benefits include versatility, no impact on process or delivery if resources are reduced, and streamlined forecasting and planning.

Diverse Cell & Gene Therapy support

Capable of seamlessly orchestrating allo- and auto- Cell & Gene Therapy. This will help enable the delivery of curative therapies to patients.

As the biopharma landscape grows and evolves, industry leaders are finding new opportunities to raise the standard and personalization of patient care. Accenture helps organizations transform by building intelligent supply chain attributes, co-creating with agility, and scaling with excellence.

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