August 27, 2019
In September, here’s why it’s all about data management
Next month, my colleagues at Vineti and I will be speaking, writing, and presenting on a topic of critical importance to cell and gene therapy — data management.
Why focus on data management now? Because in advanced therapeutics, data management is patient management. To support as many patients as possible and grow the field safely and efficiently, our industry needs to master next-gen data management.
Here are just three of the reasons why:
- In a personalized therapeutic paradigm, each patient or donor represents a small manufacturing batch — often a batch of one. And each of those patients/donors, and those batches ,must be considered individually and in the aggregate. This is a higher volume of data and more complexity than ever before.
- In the patient-centric supply chains of cell therapy, gene therapy, and personalized cancer vaccines, the variability of data also increases. There are new process steps, more stakeholders, and different kinds of biology to address.
- Regulators require comprehensive, data-driven applications to review and eventually make approval decisions on these new therapies. And with more than 1,060 advanced therapy trials underway,* the volume of documentation and applications headed toward regulators is enormous. As an industry, we need to standardize our data management and help make this process as streamlined as possible.
With a focus on data management, here’s what we’ll be doing in September:
We are releasing a data management whitepaper, co-authored by myself and Vineti’s Chief Product Officer, Christophe Suchet.
I’m presenting a webinar on “Big Data Strategies for Cell Therapy Manufacturing” with renowned cell therapy scientific leader Dr. Scott Burger on September 17.
I’m speaking in the Clinical Management track on Institutional Readiness at CAR-TCR Summit on September 11, focusing on focusing on strategies for clinical success, including areas related to data management.
At Vineti, our leading software platform helps our partners manage complex cell and gene therapy data flows every day. I’m really looking forward to sharing and learning with the rest of the industry this fall. Together, we can get ready to manage more data — and support more patients — so that the advanced therapy industry continues to grow.
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. If you’d like to learn more about how Vineti’s software platform supports cell therapies as they scale, please contact us to schedule a demo.
*Alliance for Regenerative Medicine, Q2 Quarterly Data Report 2019.