For all organizations within the cellular therapy and regenerative space, the paramount challenge is to manage the vast amount of critical patient data generated throughout their processes and also meeting regulatory and accreditation requirements. The industry has also been slow to adopt the existing technology due to the increased burden and disruption of the workflow associated with many solutions. As a result, organizations have continued to rely on paper-based systems and spreadsheets, manually integrating data from one system to another. This reduces their operational efficiency and increases the risk of human errors.
“Our passion is to support the leading healthcare institutions and biotech companies with easy-to-use technology that helps them deliver innovative treatments to patients more quickly and safely.”
Lynn Fischer has had almost 25 years long participation in strategy, general management, and marketing as a leader. Therefore, she is well-acquainted with the heavy burden of endless paperwork and the potential for human errors. Among all, her passion for improving patient safety and overall quality of the U.S. health system led her to co-found Title21 Health Solutions. It is a patient-centric healthcare technology company that offers a robust yet flexible software platform that removes the need for paper and manages all critical and complex information about patients, processes, and products. Since 2001, Title21 has been delivering world-class integrated healthcare technology to improve quality and compliance. It is headquartered in the Bay Area of California and has recently opened an office in Phoenix, Arizona.
“We stay close to our customers to advance our technology and continue to add value to their quality and cell therapy programs,” says Lynn Fischer, co-founder, and CEO of Title21 Health Solutions. “At Title21, we make a difference in healthcare by innovating for this rapidly growing cell therapy and regenerative medicine market.”
Lynn Fischer, Co-founder & CEO, Title21 Health Solutions
Streamlining data management
The purpose of this software is to support the leading health science organizations with easily adaptable and flexible software solutions, so that they can scale their cell therapy programs to serve more patients and save more lives. They provide top institutions with a complete solution that safely and securely manages all the critical patient, product and process-related data in one integrated platform translating these innovative therapies from the bench to the bedside. Title21’s technology makes the future of healthcare safer by improving compliance, safety, and quality of the data and workflows.
“We have no direct competitors because our technology is much more advanced than the competitive set. Moreover, we are the only software provider that offers a flexible, integrated technology in a single integrated platform that is easy to use,” says Fischer. “One would have to purchase about 12 different software systems to compare to Title21 and of course the systems would not naturally talk to one another. Title21 has many modules to serve all the needs in the regulated healthcare environment and specifically to support enterprise quality management and immunotherapy programs.”
Industry leaders rely on Title21’s technology to digitize manufacturing, ISBT 128 labeling, supplies and reagents, equipment maintenance, chain of custody, finished product inventory, CIBMTR\AGNIS integration, outcomes analytics, EHR integration and more. Some of their notable clients include Mayo Clinic, Memorial Sloan Kettering, Sanford, Stanford Health Care, Penn Medicine, Fred Hutch Cancer Research Center, Kaiser Permanente, and others. This is remarkable considering that Fischer built the company from scratch and rapidly grew it mainly through referrals and word of mouth. “Ironically, we have no salespeople on our team. Our current customers share their experiences with our technology and our team to their colleagues and our work speaks for itself,” states Fischer. Further, her strategic initiatives have led Title21 to become the end-to-end solution for integrated data management in health sciences.
Driven by passion
Fischer contributes this success to the team and the culture at Title21. She says, “The Title21 team is driven by their passion for making a difference in patient safety and quality to support improving patient outcomes.” She believes that a great culture is fundamental in achieving great things, because it is all about aligning one’s passion with the company’s mission and vision. “The patient is our true north. That philosophy is fundamental to everything we do. Title21’s mission is to support improved patient safety and care through enterprise cloud software solutions. We have developed and delivered technology that enables our customers to provide life-saving therapies while gaining efficiencies, ensuring compliance and improving patient outcomes. I value that everything we do every day is for the patient,” says Fischer. “This mission brings focus and perspective to our work on a daily basis and allows us to take our technology and services to new heights.”
Challenges and successes
Although Title21 has successfully positioned itself as a major player in the industry the firm is never short of challenges. The biggest challenge they face is that the protocols and their requirements continue to change rapidly and frequently as they are developed.
Title21’s team tackled this challenge by developing an extensible software platform that would meet the diverse and specific requirements of their consumers while maintaining a single code base. Integrating data management in a single software system reduces double-data entry, minimizes the risk of transcription errors, and facilitates high-quality output. It was quickly decided that it was best to initiate an implementation with their leading solution and then make minor configuration refinements to that solution. It was important that their software reflected how their customers operate for maximum benefit. That way, they managed to reduce both cost and time and didn’t end up just re-inventing the wheel.
In addition, Title21 leverages the experience and the expertise that they have in the FDA- regulated environment, as well as, in cell therapy and blood marrow transplant programs to the benefit of their partners. Likewise, Title21’s software solutions also support compliance with regulations and standards of ISO, CLIA, CAP, AABB, FACT, and more.
Today Fischer reports that Title21 has the technology that will soon place the revisions in trained and certified users’ hands and make way for real-time changes to the electronic batch records system. This advanced technology will help speed up innovation in translational medicine.
As for the shift towards personalized medicine, developing and designing of curative therapies for individual patients. Fischer is convinced her approach will help Title21 stay ahead of the game. She says, “Our technology is on-trend and can help many life science firms gain regulatory approvals and help serve more patients faster and more safely.”
Outside work, she enjoys theatre and loves to spend her time traveling around the globe, dancing, cooking, writing, and mentoring young people who are just commencing their higher education and career. If given an opportunity Fischer expressed her desire to share the dinner table with Emily Whitehead. “She was diagnosed with acute lymphocytic leukemia and was the first pediatric patient at age seven to enroll in a clinical trial investigating chimeric antigen receptor (CAR) T-cell in 2012. This innovative therapy saved Emily’s life and later was then approved by the FDA in the fall of 2017. Emily is a pioneer in cancer research and an extremely brave young woman,” shares Fischer.
Making a difference
Finally, Fischer through her work hopes to serve as many patients as possible. In addition, she says, “We hope to support a cure for cancer in our lifetime. And along the way, I hope that I inspire someone to go beyond what they thought they could achieve when they began.”