Title21 Helps Partners Battle Covid-19

Life Science Company Calls Patients the True North

By Tim Hunt

PLEASANTON—When the COVID-19 pandemic hit the United States, Lynn Fischer had one goal for her company—support her customers so they can serve their patients.

Title21 Health Solutions’ customers are a virtual who’s who of the leading health care institution and research organizations. They’re on the front line of battling the coronavirus as well as doing the cutting edge research on both treatments and a vaccine. Some key customers are:  Mayo Clinic, Stanford Health Care, Kaiser Permanente, the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Sanford Health and the Wake Forest Institute of Regenerative Medicine.

Title21’s robust and integrated software platform supports a variety of digital functions for their institutions.

Lynn and her leadership team had decided to disperse her employees to work remotely a few days before the shelter-in-place orders were imposed on Alameda County and then statewide in California. So, they were well-positioned to respond when their clients did the same with their groups.

One immediate impact was customers needed more software licenses for their dispersed workforce. So, Fischer immediately doubled the software licenses at no cost for her customers.

“They’re on the front line. So, we need to support them and we’ve gotten some just lovely feedback from our customers,” she said.

One customer sent a hand-written thank you note saying that five transplants took place because of Title21’s support.

Another key customer group for Title21 is blood banks, which was the first sector of the health care industry they set out to serve when the company was founded in 2001. With the need for plasma expected to soar to serve patients fighting the virus, blood banks are playing a key role.

The Title21 platform also features a robust training module that Lynn is using with a consortium of experts in regenerative medicine to equip them to retrain and certify a new workforce.

“This is a mechanism that is basically free for them to use so workers can pivot their career into cellular therapy and regenerative medicine,” she said. “It’s such an emerging market and we don’t have enough trained workers in that area.”

She brings an unusual professional background to her CEO role. She’s been the CEO of Title21 Health Solutions since 2012 after joining the firm as a co-founder in 2001. She holds an undergraduate degree in English Writing and Communications from the University of Pittsburgh and, after a short copywriting stint, earned her MBA in marketing and strategic planning.

That led to a move to California and senior marketing positions with EJ Gallo, Dreyer’s Grand Ice Cream, and its joint venture with Mars plus The Wine Group in Livermore. After giving birth to her third child, she was planning to move into consulting and Title21 wanted her skills. That consulting led to a role as co-founder and director of sales and marketing.

Thanks to her deep background in consumer marketing, she and her entire team keep one thing in their laser-focus: their customers or Title21’s case, the patient.

Her business card reads “The patient is our True North.”

“Ultimately it’s all for the patient. As part of the corporate culture, it makes all the difference. You’re doing what you’re doing for the kid who is fighting leukemia. It makes everything seem like, well, nothing’s too hard. We can help be part of the team to support the doctors, the clinicians, the cell biologists, the researchers and make their life easier and help them. You have the data accessible, being able to trend things, all the analytics reporting, then that’s the least we can do,” Fischer said.

Title21’s name stems from the federal regulation code that covers food and drugs. In short, it’s designed for any company that is regulated by the FDA in the health sciences sector.

“We can have the greatest impact with trying to get these curative therapies to the patient faster and help a biotech company or research institution go from research on the bench protocols through the phase one and phase two clinical trials to commercialize to ultimately manufacturing,” she said.

The company started in 2001 focused on supporting blood banks. They intentionally stayed away from being a blood bank computer system that is subject to FDA approval. Instead, their system deals with the quality management with modules on document control, error management, corrective and preventative action, competency management, audit, equipment supplies and more. It all operates off the same platform so it’s easy to scale and modify.

The Great Recession struck in 2008-2009 sparked a consolidation of community blood banks with a few big companies taking over the business. In that time, a client hospital approached Title21 about using their system to help develop a cancer vaccine. (This was before cell therapy was even called cell therapy, Lynn said). The work is highly regulated and using Title21 gave leaders confidence that they met FDA rules.

The next big step came when Sloan Kettering Memorial approached Title21 asking for help after another major company could not meet their needs. Title21 provided the software and other systems to manage the inventory of frozen stem cells.

“They know exactly where that product is so that, God forbid, a patient gets a relapse of cancer, they know exactly where their stem cells are for their bone marrow transplant,” Fischer explained.

That led to other clients such as Stanford University and Stanford Health Care, Penn Medicine, Kaiser Permanente, and Fred Hutchinson Cancer Research Center.

In fact, Fischer said, their impressive list of clients has approached Title21 after learning about its capabilities from colleagues. The company has no employees working in sales, which is amazing for a firm that is growing at double-digit rates.

Their biggest challenge, she said, is finding the talent to scale the company. To meet that challenge, they’ve opened a second office in the Phoenix area where a key client, Mayo Clinic, has a facility and Arizona State University produces top-quality potential employees.

They’ve targeted her hometown of Pittsburgh, PA, which has a strong medical structure as well as a university, for another office. She’s hopeful that the two new sites will allow the company of 25 employees to rapidly scale to even 20 times larger—she believes the market is there. They have been limiting growth in customers because they do not have enough employees to serve them.

She loves Pleasanton and the Tri-Valley and the company will remain headquartered here.

“There’s a very unique person who works for us. Every single person on our team is dedicated to the patient and doing the best work every day for that patient. I always tell our team that you’re like the Navy SEALs of software because they are so skilled and so dedicated and so good at what they do,” she said.

In the nearly 20-year history, they’ve never laid off an employee. In fact, Lynn knows every employee personally and each one has a personal development plan.

They’ve had to constantly innovate to meet their clients’ needs. When the FDA approved T-cell therapies to treat leukemia and lymphoma, that dramatically increased the need to improve digital tracking. Some hospitals were still using Excel spreadsheets to manually enter data. The Title21 software tracks and traces all the interactions that a product has and stores it in a readily accessible database.

Today, clients continue to identify needs and ask Title21 if it can help.

“We don’t stand still as a company because that’s where we are partnering with the leaders in the industry and innovators. They will say, ‘Hey, will you do this? Can you do that? And so, we’ll say let’s give it a try and literally partner with them,” she said.

“What’s different about us is we don’t want any typical vendor-customer relationships. We want long term, strategic partnerships. We’re their technology partner, so they come to us with a problem or a challenge. And then we like to solve for that, and that’s how every module of our integrated platform has been built.”

All of their partners are customers who are paying for Title21’s software on an annual basis. Title21 fronts the cost of the innovation or upgrades.

In recent years, there’s been lots of work with immunotherapy and regenerative medicine. One customer asked if they could help with electronic batch records in a bone marrow transplant facility. In cellular therapy, that batch can concern one patient, but with many data points.

Title21 has experience with a cancer transplant research institution so it was asked if their batch software could support 3D bio-printing of organs at the Wake Forest Institute of Regenerative Medicine. Their system has the capability to manage a complicated protocol that can be 25 pages or more with the need to automate steps throughout the process.

Title21 systems can operate on-site at the company or health care facility or in a private cloud.

Title21 has been bootstrapped since the start with only one small, silent investor. Lynn owns 51 percent of the privately held firm. She declined to discuss annual revenues.

The key question for Title21 moving forward is how effectively the leadership can staff up the new offices so the company can serve more partners while keeping its True North focus on the patient.

https://www.title21.com/