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Mission to Protect

By Randy Wells
Photography by Keith Boyer
April 4, 2014
Appeared in the Spring 2014 issue of
IUP Magazine

For John Gilly, the path from IUP led to a successful career in biotechnology, evidenced by the honors he has earned in his field and his receipt last year of the IUP Distinguished Alumni Award.

Ultimately, however, Gilly’s endeavors may win him a loftier, more satisfying achievement: He may eventually improve the health of every person on the planet, now living and for generations to come.

Gilly is a scientist on a quest to find vaccines to prevent cancer, HIV, influenza, and other diseases.

“My interest in biology started in my early years in high school,” in Stroudsburg, eastern Pennsylvania, Gilly said. “I had an interest in living systems and how living systems work. I was definitely more interested in the micro side of biology than field biology or the study of ecology or large animal systems. I was always trying to understand what drove systems to function the way they did.”

That fascination pulled him to the western side of the state, and IUP.

“Part of it was that I was very much ready at that age to get as far from home as I could,” Gilly said. “Indiana was attractive to me not only because it was a very different place from where I lived and grew up, but also that it had a really good reputation for having solid science programs.”

He graduated from IUP in 1979 with a major in biology and a minor in chemistry. The timing put him on the ground floor of the emerging career track of biotechnology.
“It was very much a new field,” Gilly said. “Some of the early [biotech] companies didn’t form until the early 1980s. And they didn’t really develop the first potential therapeutic products or proteins until the very late ’70s and early ’80s. … I had the opportunity to transition from what was a traditional approach to making biologics and vaccines, into the early applications of biotechnology.”

A glance through the 34-year employment history on Gilly’s résumé is a little overwhelming to someone not in the biotechnology field. But Gilly has a layman’s explanation of what keeps him busy: “In simple terms, what we do is try to help researchers take the science they generated in the laboratory and translate that into potential candidate therapeutics that can be tested safely in human beings,” he said.

After graduating from IUP, Gilly first worked for Connaught Laboratories, now Sanofi Pasteur, a major vaccine developer and producer. During his 12 years there, he did analytical testing and assisted in managing the development of new adult and pediatric vaccines.

He next took a position with a start-up biotech company, ImClone Systems, now part of Eli Lilly and Company. His responsibility there was to advance candidate development products that attempted to treat cancer. A main product he worked on while a member of the company’s senior management team is now the marketed drug Erbitux, used to treat colon cancer and head and neck cancer.

He then worked for BioReliance Corporation, which provided services to the government and companies trying to develop novel vaccine products. Its initial focus, post-9/11, Gilly said, was to develop a biodefense vaccine, a new and safer vaccine for smallpox.

He was next offered the chance to head up Premier Research Group, an international clinical research company. While there as chief operations officer, he was responsible for managing clinical trials for the National Institutes of Health and commercial biotech and pharmaceutical companies.

“We had operations in 13 countries,” Gilly said. “After that position, I became interested in not doing so much travel.”

He then went to the Frederick National Laboratory for Cancer Research in Frederick, Maryland, to work for his current employer, Leidos Biomedical Research, which manages that national lab. Gilly is director of the Vaccine Clinical Materials Program.

“Leidos Biomedical is the operations contractor, which means we supply all the researchers and support staff to support the NIH mission objectives for that national lab,” he said.

Gilly talked with Valentina Perepnikhatka, a development associate who studies vaccine processing.

Gilly talked with Valentina Perepnikhatka, a development associate who studies vaccine processing.

According to Gilly, creating new vaccines takes time, talent, and money. “One of the key aspects of developing a new vaccine is to identify a structure or protein called an antigen that when administered to an individual would allow them to independently build a protective immune response to that infection,” Gilly explained. That immune response can come in different forms.

“We all think of making antibodies that would battle the infection, but it’s not always that simple. So part of the research is to understand how the infectious agents work themselves, how they generate an infection, how people can be receptive to being infected, and what mechanisms can be used to prevent  that infection.”

That process, Gilly said, requires many researchers, either at the NIH or an NIH-funded research institute in the US or abroad.

Once a potential candidate therapeutic has been identified, researchers need to develop systems—usually living production systems, like cells—to generate the antigens in a way that maintains their integrity and is sufficiently safe to test in animals, even human beings.

“That could be a process of development that takes three to six years and hundreds of individuals with specialized expertise to engineer production systems,” Gilly said.

The researchers must also know how to test the production systems and how to review the results of the tests with the US Food and Drug Administration so that they can be approved for clinical trials in humans.

The process typically takes millions of dollars. And when the candidate therapeutic is determined safe for testing in humans, more years may be needed to show that the immune system is being turned on as desired and that it’s sufficiently effective in the risk population, Gilly said.

He added that research is under way to develop a universal influenza vaccine, one that would generate an immune response and allow for cross-protection between mutations that occur with the influenza virus each year.

For years, research has also been looking at different components of the HIV virus to see if those components, when presented in the right way, can promote an immune response. Researchers at NIH are looking closely at an antibody, a therapeutic compound, that has been shown to prevent HIV infection.

“So they are studying this compound in both uninfected as well as HIV-infected individuals to see if they can learn more about how HIV infection can be prevented,” Gilly said. “And that research would then form, potentially, the next generation of design for a vaccine.”

Gilly also teaches at Drexel University and the University of the Sciences in Philadelphia, an out-of-the-office activity he finds professionally rewarding.

“Because I teach at the graduate level, these [students] are often individuals who have been in industry or in research 10 to 15 years before they walk in my classroom,” he said. “So it allows me to share with them some of the aspects of novel drug development, how businesses are generating new candidate biotherapeutic products, and how they’re being regulated. It also allows for a very stimulating exchange with these students, who are extremely motivated and highly engaged in advancing their knowledge in the area.”

Gilly has observed that more scientific research is being done by students working directly with faculty mentors, even outside large teaching research institutions. For students, presenting that research should also be part of the equation, he said.

“It’s critical for young scientists to have the opportunity to travel to meetings, to be able to present their work within a forum, not only of other students, but other researchers,” who ask the students questions about their research and provide feedback on questions the students may have.

“To me, that personally has been some of the most stimulating interaction to keep me wanting to do more science,” Gilly said. “With the tightening of grant budgets, it’s more difficult for students to get travel resources to go to conferences and pay registration fees and pay for hotels and transportation.”

<this paragraph relates to sidebar> So Gilly and his wife, Jane McMahon-Gilly, established the Young Life Scientist Opportunity Fund to enable IUP students who generate independent work with a faculty mentor to attend conferences and have travel expenses taken care of.

Attending such conferences, Gilly said, was something he was able to do only after he started working in private industry.

Gilly is also a member of IUP’s Natural Sciences and Mathematics Advisory Board, made up of nine alumni who are leaders in the science field.

While the group may be associated with helping the university to plan a future science and math facility, its true focus is the future of sciences at IUP, Gilly said.

“The committee really is focusing on how to build and attract and retain the best faculty within the sciences and how to identify and create new programs within the school that would continue to attract the best students and be able to grow on core competencies already in existence there.

“From my perspective, the facility would just be a fulfillment of the vision, the next generation vision, for the school.”

Gilly lives in Littlestown, Adams County, and in his free time enjoys traveling with his wife and two adult sons, Ian and Quinn, especially to Washington, DC, Philadelphia, the Finger Lakes, and Savannah, Georgia.

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