Data management for advanced therapies, Part 7: summing up the strategies
by Heidi Hagen and Christophe Suchet | February 19, 2020
Note: this post is the seventh in an eight-part series on data management strategies for personalized therapeutics, such as cell therapies, gene therapies, or neoantigen cancer vaccines. You’ll find the prior installment, on data and supply chain efficiencies, here.
Personalized therapies require a very distinct manufacturing process and supply chain. As we’ve discussed throughout this series, this results in a myriad of unique data requirements and challenges. Understanding these is a key first step towards successful clinical trials and commercial launch.
An important second step is creating a modern data management program that minimizes these obstacles, helps streamline operations, and ensures compliance. As part of our work in industrializing cell and gene therapies, Vineti has identified six fundamental data management strategies.
We’ve summarized each below. Or, for a more in-depth review, download a copy of Vineti’s Advanced Therapies Guide: From Complex to Controlled.
Download the Guide
There is no room for error when it comes to collecting, managing, and applying data in personalized therapeutics. The success of your drug product depends on efficient, accurate, and compliance handling at every point in the process. Automating processes and data management significantly increases all three aspects.
Why automation? By automating processes with intelligent technologies and cloud-based solutions, you can improve the quality of data, streamline collaborative workflows, and ensure compliance. All stakeholders will be able to work faster and more effectively saving time and resources in the process.
Adopt technology early
While there is no exact right time to implement a digital solution, earlier is typically better. Collecting and managing data manually will limit scalability and increase risk of error. A digital solution will not only reduce these risks, but will save time and money -- and support automation of additional activities across the ecosystem.
When to adopt a technology solution? The right time to adopt a solution will depend on a therapy’s scale and complexity. The threshold could be as low as 10 or 20 patients for an exceptionally complex process being conducted frequently.
Employ ecosystem expertise
As we are still in the early days of this field, personalized therapeutics are very specialized and complex. The manufacturing process requires high levels of expertise in a number of supporting industries beyond the core of biopharma, such as logistics orchestration and software development. Employing the experience of your ecosystem partners will maximize compliance and productivity across the supply chain.
How to identify technology experts? Identify partners who specialize in digital solutions for biopharma and other highly regulated industries, combined with a deep knowledge of the operations and compliance requirements of real-time biological supply chains. Look to configurable, off-the-shelf solutions built for these unique use cases.
Successful data management will mean getting all stakeholders – and the data they produce – on the same page. Since data standards for advanced therapies are not yet universal, it falls on each sponsor to standardize processes and harmonize data across the supply chain.
What stands in the way of standardization? It is unlikely that all the stakeholders in your supply chain are using the same reporting systems or data standards, which will result in a variety of datasets. Disparate data sets or formats create many challenges for all aspects of your progress, including compliance, overall clinical operations, cost control, and regulatory filings.
All stakeholders in your supply chain are working toward the same goal: a successful therapy. The disparity between functions, levels of expertise, and geography, however, can make it difficult to work together. Technology is key to efficient collaboration across all the people, processes, and systems involved.
How does an integrated supply chain create value? By providing real-time visibility into operations across the supply chain, stakeholders can prepare and adjust for changes in production, such as delayed deliveries or increased capacity needs(?). This also supports traceability for regulatory review and internal analysis.
Optimize analysis and reporting
A complete, high-quality dataset does more than satisfy the CMC section of your application and regulatory inspection requirements. It can provide insight into product and operational performance and patient safety, therefore potentially leading to enhancements in product quality and improving the clinical trial experience for patients and health care providers.
How to make data work for you? Data should be readily available in real-time. Not only will this better support compliance, but it will also help quickly identify issues in manufacturing processes or the supply chain. In addition, many advanced therapy patients require long-term monitoring, so your strategy should accommodate the collection and analysis of large patient datasets over long periods of time.
Next in this series, we’ll sum up the benefits of next-gen data management. If you have data-related questions for us in the meantime, please contact us.
Successful data management requires a combination of digitally enabled strategies. Want to understand how to implement the strategies above?
Download Vineti’s Advanced Therapies Guide: From Complex to Controlled.
Data management for advanced therapies series:
Part 1: the need for new strategies
Part 2: unique data features
Part 3: working with living cells
Part 4: working with multiple stakeholders
Part 5: traceability
Part 6: efficiencies across the supply chain
Part 8: the benefits of a strategic approach
Heidi Hagen is the Chief Strategy Officer and a Co-founder of Vineti. Over the course of her career, she has overseen the operations and delivery for more than 100,000 doses of cell therapy. Christophe Suchet is the Chief Product and Compliance Officer of Vineti, and previously led IT systems for cell therapy pioneer Kite Pharma. If you'd like to see how Vineti's Personalized Therapy Management (PTM) platform can help you solve your advanced therapy data challenges, please contact us to schedule a demo.