According to the World Health Organization estimates, 50% of immunizations used worldwide are unsafe. Among the world’s poorest nations, reusing needles up to 150 times is not unheard of, as well as collection of used needle syringes from garbage dumps that are washed, and repackaged so that they appear to be new again. Perhaps because of knowledge of this danger, or simply because of fear (in the US, 1/3 of adults and 2/3 of children avoid immunization because of the needle), the world faces challenges around providing clean and safe vaccinations. This avoidance can have widespread consequences not only for the health of the individual—particularly infants and children who require basic immunization to have a healthy start in life—but for entire societies, as up to 20 pathogens can be spread from person to person through needle-stick and re-use. It is clear that a better approach is necessary.
Heather Callender-Potters, a Claremont McKenna alumnus, has taken on the challenge, in partnership with her mother Kathy Callender, a healthcare professional—creating a simple, inexpensive, and safe method of needle-free immunization, called PharmaJet. While at CMC, Potters received a degree in International Management, and had great and formative interaction with Professor Haley and Professor Roth and others, that she knows has influenced her career path and PharmaJet development as she works to spread the needle-free application throughout the world.
Needle-free injection is not a new concept. Jet injection, which is the concept of using fluids to create a force powerful enough to penetrate material surfaces, was conceptualized as long ago as the late 1800s. In the 1960s, a pneumatic force jet injector known as the Ped-o-Jet was developed and used widely for immunization globally, and particularly. was instrumental in the eradication of diseases such as smallpox, and for 10’s of millions of influenza shots during the pandemic of 1977 in the United States. The force of the injector created a “liquid needle”, but was too strong and painful. It was ultimately declared unsafe, because the metal tip was difficult to clean it increased the risk of contributing disease pathogens from patient to patient. Ultimately it was banned from use in the 1980s, after studies showed that the device was a large factor in the spread of Hepatitis.
The World Health Organization issued a call for an improved device that could take its place, a needle-free technology that was single use, inexpensive, and did not require an external power source, so that it could be used anywhere in the world. Enter Callender, the mother of Potters. Early prototypes of her technology, soon to be called “PharmaJet,” was tested in Cuba and the US But she needed monetary support to help fund further research and distribution of her new technology. Potters, with her investment and private equity background, decided begin investing in support of her mother’s innovation. Soon, however, she found herself drawn in by the powerful potential of the technology. “I looked back at the things that were the most meaningful to me in my fund investments, and they were things that created a paradigm shift,” says Potters. “They were not only a good investment that generated a return but also benefitted an economy in an emerging market. I liked the global outlook that we could do well and do good.” Potters became the sole advisor for PharmaJet and contributed all the assets from her mother’s original efforts into a new company, forming PharmaJet, and embarked in in public advocacy and fundraising, while investing further herself. With some initial full-time science, engineering and regulatory hires, she and her mother developed a new device, which was ultimately given FDA marketing clearance in 2009.
At first, Callender & Potters reached out to specific organizations: vaccine developers, the Gates Foundation, GAVI, and the World Health Organization. Over time, credibility, data, and user feedback around the technology grew; more regulatory approvals and new devices were advanced, and today PharmaJet has reached a level where its technology has a global footprint of use that spans more than 130 countries, including becoming the first needle-free technology prequalified by the WHO for public health purchases through UNICEF procurement.
The benefits of needle-free injection are numerous. The device helps reduce the global spread of disease through more sterile inoculation methods. Accidental needle-stick spreads pathogens from patients to nurses (or vice versa), a problem that is eradicated with PharmaJet. Vaccines can be administered without fearful avoidance, particularly for infants who have a series of 6-13 necessary vaccines within the first years of life. There is also potential for new vaccines for diseases that do not yet have a cure, such as Dengue Fever, to find an effective mode of prevention through PharmaJet technology. Recent studies have even demonstrated that immune responses in humans can be enhanced when needle-free technology is used, so that vaccines administered in this manner work more effectively than when classic needle injections are used. Some of this development around their intradermal injection technology may enable the reduction of vaccine volume needed to reach protective immunity levels, and/or reduce the number of injections needed, and/or sometimes make vaccines work that may not work well with traditional needle-injection.
Potters now serves on the board for the Center for Human Rights Leadership at CMC. Her work came full circle while she was living in Warsaw and investing in the Central & Eastern European and CIS countries, when Professors John Roth and Jonathan Petropolis contacted her about a visit. They were bringing a group of students to Poland to study the Holocaust, they explained, and would she be willing to organize a dinner so that they could all catch up? She did, and at the dinner Potters learned about what Petropolis and Roth were doing with the Center for Human Rights at CMC. The Center was still in its early days and the focus was predominantly on Holocaust issues. Living in Poland, the epicenter of the Holocaust, Potters found that this mission resonated with her, and she decided to become more involved. “And it has grown from there,” Potters says, “It has become such a wonderful pillar in my life.” She watched the Center evolve and change its name to take on a broader focus, lauded it as it added internship possibilities that allowed students to learn through first-hand experience rather than just from book knowledge, empowering them to make a contribution in the world. With PharmaJet, Potters is setting an example for students who wish to make this kind of tangible contribution.
Potters is aware that her project will take time, that addressing the 2.5 billion market for annual immunizations will take years before PharmaJet’s full potential is utilized. “You can’t conquer the world in a day,” Potters explains. But in true CMC fashion, she seems determined to try.
–Nora Studholme, ’14