The path from innovation to implementation

Penn’s infrastructure in both supporting clinical research and forging commercial partnerships smooths the way from idea to approval.

In August 2017, the Food and Drug Administration approved Kymriah, the first cellular immune therapy for cancer, that had been developed at Penn, which faculty and staff celebrated with an iconic flash mob. John Swartley reflects that ten years earlier, Carl June had been struggling to find funding for this phase one study—the study that eventually became the New England Journal of Medicine article that kicked off the CAR T revolution.

Swartley was hired into Penn’s Center for Technology Transfer (CTT), a “more or less traditional, transactional tech transfer group” that managed the patenting and licensing processes for any intellectual property developed university-wide. Gradually, he helped to transform it into the Penn Center for Innovation (PCI), which still serves those functions but is now equally focused on building relationships between faculty innovators and the private sector.

Carl June with a microphone in the Penn Medicine atrium with the celebratory flash mob.
Carl June, at the flash mob celebration of the FDA approval of the CAR T cell therapy he developed, in August 2017. (Image: Courtesy of Penn Medicine Magazine)

“Faculty know to disclose big discoveries to us, but also to come to us if they’re looking for sponsored research or thinking that maybe they should start their own company—whatever’s the best way to take their program forward and get it to patients,” says Swartley, who today is associate vice provost for research at Penn and PCI’s managing director.

The expansion of PCI—now about three times the size of its predecessor, the CTT—has empowered researchers to accelerate the advancement of their discoveries by positioning them as active research and development partners with pharmaceutical and biotech companies.

“We’re no longer just a contracting entity whose work ends with throwing a discovery over the fence. We’re officially joint developers of our own technologies, especially when it’s something like a groundbreaking cell or gene therapy, because without our faculty members’ skills and expertise, these types of transformative innovations don’t work,” Swartley explains.

While PCI manages all of the intellectual property coming out of Penn as a whole, Penn Medicine has its own resources for supporting faculty research efforts as they push new therapies through the pipeline. The dozen staff members on the PSOM Office of Clinical Research’s (OCR) regulatory team, all of whom have regulatory backgrounds and graduate degrees in biomedical science, guide researchers in designing their projects with a view toward FDA approval—offering know-how that doesn’t exist in most academic organizations, according to Emma Meagher, senior vice dean for clinical and translational research, who oversees PSOM’s clinical research infrastructure.

No matter how far down the testing and development pathway an investigator’s project perseveres, Meagher says it demands doggedness and drive to navigate the laboratory, clinical, and entrepreneurial routes involved in drug discovery: “It takes a combination of incredible passion for and curiosity in the science, an unbelievable sense of optimism, and being able to take the knocks—to have an inherent resilience to bounce back up again even if nothing is ever going to go the way you want it to go.”

Except sometimes, eventually, things do go the way a researcher wants—like they did for June. Two years after first lamenting to Swartley about his lack of funding, June secured just enough private funding to treat three patients in an initial trial. Then, in 2012, two years after those remarkable first results were published—with support from Swartley and his team—Penn signed an agreement with Novartis to accelerate research, development, and commercialization of CAR T cell therapies.

Five years after that, their voices joined the chorus of cheers at the CAR T approval flash mob event.

Read the full story in Penn Medicine Magazine.