No one illustrates the promise of cell therapy better than a little girl named Emily Whitehead. She was just 5 years old when she got sick with a common type of childhood cancer called acute lymphoblastic leukemia. Roughly 98 percent of children go into remission within weeks of treatment, but Emily relapsed repeatedly despite several rounds of chemotherapy.
Running out of options, her parents enrolled her in an experimental cell therapy trial at The Children’s Hospital of Philadelphia (CHOP) in early 2012. CHOP doctors collected a type of Emily’s white blood cells called T lymphocytes — the immune system’s SWAT team — and edited their DNA so they would recognize Emily’s cancer. When doctors injected the modified lymphocytes back into her body, they multiplied and wiped out the disease. She’s been cancer-free since.
Everyone in the cell therapy community knows Emily’s story. They want to start telling others. “She’s the poster child and also the reminder that we need to move faster,” says Rowan Chapman, head of healthcare investing for GE Ventures. “The results in trials have been astounding, but the treatment process today is highly resource-intensive and frighteningly manual. It still involves a lot of handwritten labels, clipboards and Sharpie pens throughout the process. We need to inject speed and scale, and we have to figure out ways to take out cost.”
That’s why GE Ventures teamed up with Mayo Clinic and launched Vitruvian Networks last April, an independent technology company that uses advanced manufacturing and data analytics software to industrialize cell therapy. “Cell therapy today is mostly a very localized process taking place in a single hospital,” says Heidi Hagen, who leads global operations at Vitruvian Networks. “Things will need to change when these therapies are commercially approved and need to scale. Our software provides secure and digital transparency throughout the entire process. We will be working collaboratively with partners to develop critical industry standards and to set high quality benchmarks.”
To be sure, Vitruvian Networks is not in the actual therapy business. It’s the digital connective tissue that brings the pieces together for companies like Kite Pharma, Juno Therapeutics, Novartis and other big players in the field. “We use software to arrange different players, including hospitals, blood banks, couriers and therapy manufacturers, like an orchestra,” Hagen says. GE projects the cell therapy industry to reach $10 billion by 2021.
Cell therapy has many moving and dependent parts. The links between them have to be executed flawlessly and quickly since many patients have very little time to spare, and speed and precision are often a matter of life and death. “If you want to commercialize these therapies, you need to build a national and even global system that will allow you to seamlessly track and connect everything from cell collection and transportation logistics to DNA modification and treatment results,” Hagen says.
Here’s why. The type of therapy that Emily received is called autologous immunotherapy. Physicians first collect the patient’s own blood at a blood center. The step is similar to dialysis and lasts several hours. Doctors then use special machines to strip out T lymphocytes and send them to a manufacturing facility where their DNA can be edited to attack the patient’s blood cancer and the cells grown in volume inside bioreactors. This step takes anywhere from three to six weeks. After that, the reengineered immune cells travel to the hospital, where they are injected back into the patient. “You have to have total assurance and quality control,” says Amy DuRoss, executive director of new business creation at GE Ventures. “Your own cells are a ‘living drug.’ If you receive someone else’s cells by accident, the results could be deadly.”
Vitruvian’s solutions will help “orchestrate” and monitor everything from logistics and manufacturing to ordering, scheduling and quality control. “Right now most nurses coordinate appointments and receive updates over the phone or by fax, which is inefficient and not the best use of their valuable time,” DuRoss says. “But because of our digital connectivity, Vitruvian’s technology will streamline a lot of the complexities behind the scenes, so that patients, providers and therapy manufacturers can enjoy a smooth, reliable experience that starts from ordering all the way through therapy administration. Our system is more like a nexus between Amazon and FedEx. It will provide, in real time, optimal scheduling windows, updates on the status of a patient’s cells and data insights into how certain cell characterizations may affect treatment times and decisions.”
Mayo Clinic will supply Vitruvian with data and expertise related to biomarkers, processes and outcomes to help guide further development of personalized therapies. The company will also draw on know-how from GE Healthcare’s own cell therapy business, as well as software GE is already developing for the Industrial Internet to monitor and optimize everything from jet engines to power plants.
Vitruvian Networks will start by focusing on hard-to-treat blood cancers like the one that afflicted Emily. “It’s a very specific subset of blood cancer patients who’ve failed existing lines of treatment and are at the end of the road,” says GE Ventures’ Chapman. “But the potential is enormous — there are many future application opportunities within personalized medicine, all of which is great news for patients.”