Data management for advanced therapies, Part 8: the benefits of a strategic approach
by Heidi Hagen and Christophe Suchet | February 21, 2020
Note: this post is the eighth 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.
There is no getting around the importance of effective data management in the development, production, and delivery of advanced therapies. A modern data strategy is key to everything from R&D progress and clinical operations to patient safety, compliance, and regulatory success. Handle your data effectively from the start, and you could uncover countless unexpected benefits throughout the value chain.
For the last post in this series, we’ll sum up the benefits that biopharma teams will realize if they implement effective data management strategies.
To read more about these benefits and how to realize them, download our Advanced Therapies Guide: Complex to Controlled.
Improved patient safety, patient care, and compliance
The risks to patient safety reach new levels with personalized treatments. As a result, regulators have required digital, scalable Chain of Identity and Chain of Custody systems to minimize safety risks. The resulting benefits of digital traceability – besides compliance – include more valuable data for analysis, improved patient care during treatment and long-term monitoring, and ultimately more trust from HCPs and patients.
How to strategize: Employ automated solutions to enforce compliant and standardized data collection from across the value chain, while simultaneously improving efficiency and reducing costs. Thinking through a data strategy that maximizes your benefits? Download Vineti’s Advanced Therapies Guide: From Complex to Controlled.
Better product and process understanding
The abundance of data that must be collected for an advanced therapy license application, especially the CMC section, is exponentially higher than a standard pharmaceutical - and provides significant opportunities. Used proactively, data can help identify areas for improvement by providing insight into variabilities or deviations that occur throughout the process. This sets you up for deeper understanding and more useful reporting.
How to strategize: Complete, standardized datasets available in real-time will provide new types of insights and streamline reporting. Work with experienced ecosystem partners to optimize data management and act on new insights.
Collaboration with regulatory agencies
Regulatory filings for advanced therapies are among the industry’s longest, most complex applications. Reliable, timely data for regulators may sound like a basic requirement, but with advanced therapies, this baseline need may be difficult to fulfill. By harnessing data to inform or educate all stakeholders, including regulators, about your product, you can meet filing deadlines and requirements more efficiently.
How to strategize: Arm yourself with high-quality, consistent data sets to support your submission. A digital data management solution will speed up the acquisition and standardization of this information.
Reduced filing timelines and costs
It takes considerable time and expense to prepare regulatory filings, even in the best of scenarios. And in the case of advanced therapies, most of the work goes into the CMC section. Manual data collection and management or disconnected data sources will burn through resources - increasing both time and cost to filing.
How to strategize: Implement solutions that standardize data and provide real-time visibility into operations to help stakeholders manage variability, delays, and data inconsistencies. This will reduce time and costs across all stages of application preparation.
The goal is commercialization, so your infrastructure and processes must be positioned to handle an increase in patients, suppliers, and facilities in the supply chain, as well as new regions with their specific languages, regulations, and requirements. Any expansion will exponentially increase the amount – and complexity – of data, so having technology in place earlier rather than later will accelerate your scalability.
How to strategize: Scalability depends on a convergence of the strategies discussed in the last blog in this series. First and foremost, adopt technology early to avoid obstacles, and tap into your ecosystem to collaborate on strategies for data collection and standardization that will optimize the processes for all stakeholders.
We hope this series on advanced therapy data management has been helpful! If you have further data management questions, please contact us.
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 7: summing up the strategies
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.