The healthcare industry is now in the midst of the most change its ever seen in its history. The technology wave that has disrupted so many other industries has now descended on healthcare. One such organization at the forefront and leading this change is Title21 Health Solutions. Title21 has risen to a leadership position in the immunotherapy, regenerative, and cell and gene therapy domains with their flexible, end-to-end integrated software platform. Lynn Fischer, CEO of Title21 Health Solutions, has some interesting insights to share from their successful journey.
For nearly 20 years, Title21 has been providing easy-to-use, HIPAA-compliant software solutions targeting the FDA-regulated domains. Having started with a suite of quality management solutions for the blood industry, Title21 pivoted into the Cellular Therapy market and has invested extensively to develop a leading platform targeting both academic and cGMP manufacturing programs. These market segments are demanding as they each require highly flexible solutions to accommodate their complex and unique workflows. The Title21 system allow laboratory, clinical, and manufacturing entities to be relieved of the many of the paperwork burdens normally found in complex biologic processing, allowing them focus on higher-value work, serving more patients with better safety, quality and efficiency. Programs that implement Title21’s solutions find they can take products from bench to bedside with less resources and higher throughput than ever before.
The Right Mix of Solutions
Title21’s product roadmap has been largely driven by their customers and their need to meet cGMP\cGLP requirements. In addition to supporting core Cell and Gene Manufacturing processes such as Lab Processing, Collections, Reagent Manufacturing, CAR- T workflows, Chain of Custody/Identity and Product Inventory, Title21 also offers a complete Enterprise Quality Management system that includes Document Control, Error Management and Learning and Competency Management, Audit, Corrective and Preventive Action, Supplies, Equipment Maintenance and Calibration. Title21 enables manufacturing and healthcare teams to have patient, manufacturing and quality data accessible in one system. With out-of-the-box integrated modules, Title21 eliminates double-data entry, validates data and provides quick access to any Batch record. Title21’s comprehensive interoperability capabilities allow for data sharing with external systems like EPIC, Cerner, SAP and others to provide seamless data flow across complex and disparate systems.
The Driving Factor
Title21 is aligned to the same drivers as their customers; serving patients to the very best of their abilities. With customer relationships built on this shared foundation of placing patient care first, Title21 has developed many long-standing and strategic partnerships that bring safety and innovation to the forefront. This approach has positioned Title21 in the marketplace as a “go-to” solution for hospitals, Cell and Gene Therapy Laboratories, and cGMP manufacturing facilities.
The Road Ahead
Title21’s mission is to serve the many patients and their families who face life-threatening diseases by supporting the leading healthcare institutions and biotech companies with powerful tools that help them deliver innovative treatments. Every team member at Title21 is dedicated to supporting the lifesaving work of these institutions and helping them deliver on the promise of a new generation of curative therapies.