TITLE

General Manager

INDUSTRY

Life Sciences

COMPANY/PROGRAM

Jacksonville’s Lung Bioengineering facility in collaboration with the Mayo Clinic Transplant Center

“No one grows up wanting to be an Ex Vivo Lung Perfusion Specialist (EVLP),” says Brandi Zofkie, General Manager of Jacksonville’s Lung Bioengineering facility in collaboration with Mayo Clinic Transplant Center. Brandi holds a BS in Biochemistry as well as MS degrees in both Public Health and Human Donation Science. Brandi initially used these skills and education in a non-profit space, serving in a procurement transplant coordinator role before making the transition into this aspect of biomedicine. Brandi has been on staff with United Therapeutics for seven years in an exciting career that saw her working in the Midatlantic, receiving training in Canada, and “transplanting” to Jacksonville.

Brandi’s current role can be traced to a scholarly project for a master’s program, which led her to make contact with a company to request some information and leading to a ventilator, pig lungs, and a dome to support her presentation. After beginning her career in the non-profit world, the relationships formed during the class project resulted in a hiring offer with United Therapeutics and six months of training at Toronto General Hospital, which created this niche within the biomedical space. United Therapeutics has the first EVLP service in the United States, including Brandi.

Organ procurement was Brandi’s focus, so this career transition to biomedicine initially felt risky. She wanted to ensure that she could still derive satisfaction from knowing that “every day, I did something to save someone’s life.” Brandi was used to working closely with families and transplant recipients seeking a variety of organs, so she was concerned the role would feel impersonal. However, fulfillment is still part of the work. To date, Brandi has helped ensure that well over 100 patients have received lifesaving lung transplants. She generates impactful results, but success is realized differently.

To best understand Brandi and her work with the Mayo Clinic via United Therapeutics, it helps to understand the context of this very innovative company for which she works, United Therapeutics. Dr. Martine Rothblatt, founder and CEO of United Therapeutics also founded what is now SiriusXM Satellite Radio. An attorney by trade, Dr. Rothblatt became an entrepreneur and later pursued her PhD in medical ethics after her daughter was diagnosed with Pulmonary Arterial Hypertension (PAH). This patient population was too small to develop and sell medicines to assist those with PAH, so pharmaceutical companies were not willing to develop a drug that was just sitting on a shelf. Dr. Rothblatt started United Therapeutics to develop that drug now with multiple routes of administration (i.e., pump, inhalation, oral medication) to help patients like her daughter live. The next step after developing these drugs was to help influence more patients being able to receive lung transplants.

Less than 20 percent of all donor lungs are suitable for transplant. The EVLP process allows specialists like Brandi to support, maintain, and monitor donor lungs, as well as generate and analyze data to provide more information for decision making by the lung transplant program. The lungs are perfused with a blood-free solution and ventilated for several hours. A colleague of Brandi’s explains that the option to use EVLP can “help turn a ‘no’ into a ‘maybe’” regarding the availability for transplant of a donor lung, since these lungs would otherwise not have been used. Even lungs that fail may do so on the EVLP system rather than in the patient.

Donated lungs can be well-traveled before being transplanted. For example, a lung could be ex-planted from a donor on the west coast, sent to a Lung Bioengineering facility in Silver Spring, Maryland for evaluation, and then sent on to be transplanted at a center in other states including Illinois, Tennessee, or Florida’s Mayo Clinic. The company’s research studies are designed to show that lungs can come from anywhere in the continental United States.

Not only does Brandi need to understand the physical aspects of maintaining the lung, interpreting data, and providing information for physicians to make critical decisions about the use of the lung, but her role also involves non-medical, yet critical work creating inventory systems, writing standard operating procedures, and creating the structure for the department in their brand-new facility, expected to be live for transplants this fall. She also makes connections and develops relationships with the other providers that make operating a biomedical facility possible.

Brandi is excited for the potential of the industry, particularly as it relates to technology as a therapy platform to improve lungs that are currently unusable. Biomedical advances through future research could result in the rehabilitation and modification of lungs in the future, essentially making EVLP’s the “fixer uppers” of lungs to “flip” them to new owners. Brandi says, “We’re in startup mode. You wear a lot of hats and have to strike a balance to be successful. It’s really just about hard work and being dedicated to your mission. But, passion must be behind it. Don’t get into it without passion for it.” Good news for students in Northeast Florida? This field is growing rapidly, so the need for internships and a skilled workforce will only increase.

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