New thinking pushes the pace of drug development

FIU has strengthened its research capacity with a newly outfitted building that completes a dynamic triangle dedicated to investigative medicine. The Center for Translational Science (CTS) is part of a complex in Port St. Lucie, Florida, that also includes a hospital and separate research facility both run by the famed Cleveland Clinic. 

A two-hour drive from the university’s main campus, the CTS serves as a natural extension of FIU’s research prowess at a time when wider partnerships have grown increasingly important. It represents an exceptional opportunity to work creatively, and smarter, in support of scientific advances to more quickly make a difference in patients’ lives. 

The new space lays the ground for a continuum that begins in the lab and includes cooperating with other institutions as well as companies that can run with the resulting discoveries. 

“The days of somebody being able to work in their lab and being able to do everything under one roof is just gone,” says Stephen Black, director of the center and most recently a professor and the chief of the division of translational and regenerative medicine at the University of Arizona. “The fundamental thing is to be willing to collaborate.” 

Black was hired to take charge at the Port St. Lucie facility after its previous owner, a trailblazing inventor and organic chemist, recognized FIU’s unique ability to continue scientific studies in progress while moving forward with new ventures.   

The lightning-fast COVID-19 vaccine rollouts speak directly to the value of concentrated, cross-laboratory synergy, say Black and others. They contend that the same strategy must be applied to cure cancer, Alzheimer’s, lung disease and more. 

“The pipeline for new drugs is empty,” Black says. Developing a new pharmaceutical can take a decade or longer, he explains. “We’re hoping to reduce that. So the potential impact on human health care is fantastically high here.” 

Up and running already are brand-new labs dedicated to brain injury, inflammation and pulmonary vascular disease. Recruitment of experts in the areas of infection/immunity and environmental medicine is ongoing. The four-story building will eventually house as many as 35 research teams, topping out at 300 scientific personnel. 

No more turf wars 
At the core of the new approach lies a commitment to collaboration among investigators across projects. If secrecy and closed doors ruled in the past, openness and interactivity now dominate. 

Nowhere is that more evident than in the newly created laboratories themselves, each of which features approximately 5,000 square feet with rows of stations to accommodate multiple research teams and adjacent rooms filled with specialized equipment. 

Black purposefully exploded the previous tight quarters and individual offices by tearing down walls and building synergy by putting folks with overlapping interests in proximity of one another. The setup, he says, encourages discussions that can lead to cross-pollination that might otherwise never happen. Excitement and ideas grow in good company, and investigations proceed more efficiently as experts with varies experiences contribute. 

Endeavors in Port St. Lucie complement those taking place at FIU’s main campus in areas such as cancer, within the Herbert Wertheim College of Medicine, and environmental toxicology, within the Robert Stempel College of Public Health & Social Work. Most of the researchers working at CTS hold appointments in the latter, and Tomás R. Guilarte, an environmental neuroscientist and the dean of the Stempel College, sees limitless potential for productive connections.  

“Science today is multi-disciplinary,” says Guilarte of the group approach to success. “You need teams rather than individuals.”  

The promise of cooperative efforts encouraged Xugang Xia, a trained medical doctor and respected neuroscientist with multiple patents and papers to his name, to throw in with the CTS. The veteran researcher understands the challenges of helping jump-start such a large undertaking, “but there are also lots of opportunities,” he adds of moving to a new environment. First among them: Bringing folks together on the front lines. 

Looking outward 
The same tactic of putting scientists side-by-side in the lab figures into how FIU works with outside partners, such as the Cleveland Clinic, with a hospital and research institute each within a few walking minutes of the CTS. All three facilities share the common goal of saving lives through groundbreaking discoveries and innovation. 

Michaela Gack, a virologist and the scientific director of Cleveland Clinic Florida Research and Innovation Center (FRIC), which formally opened in 2020, sees the benefit of sharing of what she calls “complementary infrastructure and core facilities.” She envisions, for example, giving FIU researchers access to spaces such as the FRIC’s high-containment biological lab — a state-of-the-art facility in which infectious viral agents can be studied — and to the “biobank” of tissue samples currently being established. 

Already researchers at the two institutions have been meeting and, in one case, have submitted an NIH grant together, the first of many to come, Gack says. She wholeheartedly promotes mutually beneficial relationships in the interest of science. 

“Cleveland Clinic really has a knack for making that work,” she says. “That [approach] could really profit not only FIU and us but, honestly, the whole region.” 

And critical to arriving in a timely fashion at the other end of the translational science spectrum — the actual delivery of life-impacting therapeutics — FIU has an incentive to work with business partners. While funding for foundational research comes primarily from the National Institutes of Health — expectations are that grant totals for work at the CTS will reach between $45 million and $50 million annually by fiscal year 2026 — getting to human trials generally requires an infusion of private capital. 

“There’s got to be a commercialization bent to the research,” says Ronald J. Shebuski, president and CEO of Patmos Therapeutics, a Florida-based biotech startup, of pursing scientific inquiry to a consequential end. “It's paramount that there be a valid medical reason you’re doing it.”

A former senior scientist at Merck, former director at what is today Pfizer and former two-term adviser to the Center for Drug Evaluation at the FDA, Shebuski well understands current pharmaceutical gaps and the millions of dollars needed to fill them. 

Recognizing the high-level work coming out of Black’s lab specifically — Shebuski is most excited about the promising identification of new molecular “targets” involved in respiratory illnesses and for which drugs can be developed — he and the FIU researcher together will soon apply for an NIH Small Business Technology Transfer grant to fund testing to validate the research. Once the latter is completed, Shebuski can seek investors to propel FIU’s patented discoveries through human trials and the regulatory process to, eventually, the marketplace. 

Taking the long view 
As FIU knows best, building human infrastructure remains even more important to long-term success than acquiring new buildings. Educating the up-and-coming generation of researchers is crucial to ensuring that future projects reach fruition. Such young investigators include people like post-doctoral associate Alejandro Garcia Flores, who works in Black’s lab on several studies related to pulmonary disease, among them one on ventilator-induced lung injury. (The latter work began pre-pandemic but for obvious reasons has taken on greater importance since.) 

“It’s a very exciting opportunity for me for growth,” says Garcia, who marvels at the seamless integration between teams that Black has facilitated. “If we have an idea for an experiment, we can right away discuss it with others, especially if it’s the first time for me doing a certain [procedure],” he says, giving the examples of tests that might require a particular kind of analysis. “We don’t have to communicate with a far-away place that specializes in this,” Garcia adds. Instead, he seeks out his sources within the CTS to ask, “What do you think? What are the [necessary] conditions?” 

The opportunities extend to those even earlier in their careers, such as Tasleem Robinson, who in 2019 earned a bachelor’s degree in biology and returned home to Port St. Lucie to decide on her next move. Working as a research assistant at CTS, she is being mentored by seasoned investigators even as she considers applying to FIU for a Ph.D. program. 

“I’m just looking to learn as much as I can,” says Robinson, whose work involves detecting the presence and size of specific protein molecules associated with acute lung injury, “and to just be a vital part of this research.” 

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Even as Black and the others at CTS take advantage of synergies that make possible a pace once unheard of in the world of research, he remains steadfast in his commitment to the old-school concept of integrity. It is the foundation upon which everything else rests. 

“It’s an honor to be trusted with these resources,” he says of the many moving parts that together comprise a brave new world in the university’s scientific exploration. 

“I’m thinking about legacy,” the trained molecular biologist continues. “So I can leave a dynamic research environment and have, hopefully, trained more people that can keep this vision going. My goal is to recruit people who are smarter than I am, smart people who can interact. And I think if we can do that, then we’re going to be very successful.”