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Title21: Patients not Paperwork

Posted by Jonathan Ting on September 11, 2018

How did Title21 go from being a small Pleasanton-based laboratory software provider, to market leader partnering with the most prestigious healthcare institutions in the world, in just a couple years? “Our technology speaks for itself, and we’re dedicated to our customers and their patients,” says Lynn Fischer, Title21’s CEO.

A Track Record Signaling Tremendous Growth Potential

When we last wrote about Title21 Health Solutions in 2016, Title21 had just pivoted away from its traditional blood center business and released its new Cellular Therapy Solution. The transition strategy was set, and Title21 was positioning itself for growth in this emerging segment. Since then, Title21 has surpassed all expectations and market reception has been outstanding. CEO Lynn Fischer was featured on the cover story of CIO Review’s 20 Most Promising Biotech Technology Solution Providers of 2016, and on the cover of Insights Success business magazine.

Title21 has established itself as the end-to-end solution for leading hospitals and cellular therapy manufacturers. Based on Title21's website, they are in active partnerships with many of the leading healthcare institutions in the country including the largest private cancer center, Memorial Sloan Kettering Cancer Center, Stanford University's Stem Cell Transplantation and Regenerative Medicine Division, Kaiser Permanente and Mayo Clinic. This is an impressive feat for any company, but it is especially remarkable given Title21 has no direct salesforce. Title21 chooses instead to direct its efforts on developing the best quality and most advanced product that healthcare leaders and innovators actually need, and letting the product speak for itself. Going off trade shows and word-of-mouth referrals alone, the company is expected to double its business over the next year.

Digitizing the Clinical Research Workflow

The name Title21 is a reference to the United States Code that contains complex FDA regulations. The name fits perfectly, their solutions allow laboratories to streamline their operations with paperless workflows that adhere to 21 CFR Part 11 regulatory and compliance hoops seamlessly in the background. Title21 currently offers both HIPAA-compliant cloud and on-premise software solutions: Enterprise Quality Management, Blood & Marrow Transplant Data Management, and Electronic Batch Records Systems for the Cell and Gene Therapy sector. This once niche segment of cellular therapy is now becoming mainstream with the recent advances in immunotherapy and the FDA’s fast track approvals.

This Enterprise Quality Management System is designed as an end-to-end platform to manage automated workflows, integrated compliance processes, and continuous quality improvement in laboratory and clinical environments. This product was developed with a robust, modular architecture to support customizable workflows and applications to fit a broad scope of client needs.

Cellular Therapy is Title21’s newest product, a use-case specific platform developed for cellular therapeutics researchers. Features include collections & donor management, processing/manufacturing, product and supplies inventory, quality & compliance management, chain of custody, clinical data and case management, electronic batch records, and more.

Making a Real Difference in Patient Care

Partnered with Wake Forest’s Institute for Regenerative Medicine, Title21 is leveraged to facilitate the process of bioprinting 3D organs for returning wounded warriors. At University of Minnesota’s Molecular and Cellular Therapeutics Unit, Title21 was selected to provide quality management over its biotherapeutic manufacturing facility. University of Pennsylvania is also a Title21 customer where recently FDA-approved advanced pediatric leukemia and lymphoma therapies were brought to market by Novartis.

The company’s ultimate mission is to streamline the translational and clinical research process and bring game-changing medical advancements to the market faster and safely. Title21’s highly configurable platform facilitates the entire operational workflow for laboratories and clinicians; and, by reducing the headaches of excessive paperwork and simplifying compliance procedures that delay the time-to-market, Title21 allows researchers to focus on what really matters, which is developing the next medical breakthrough. The team at Title21 is passionate about the work they do as they understand the significant impact their products have on researchers and patients all across the world.

Tri-Valley Connection

Title21 was awarded as a Best Place to Work in the Bay Area by the San Francisco Business Times for the second year in a row. This award relies exclusively on input from employees, making it an honorable reflection of the company’s leadership. Title21 continues to recruit from the highly talented pool of professionals who live in the Tri-Valley, and although competitive, CEO Lynn Fischer has no problem hiring the right people. The secret sauce? They are passionate about driving medical innovations forward and improving patient outcomes.

Topics: Company Profiles, Tri-Valley Research

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