After 30 years in the industry, Eric Fluhler values the strong relationships he has built the most.
By Mark Crawford
Eric Fluhler, Ph.D., is president of Bioanalytical Compliance Associates, a consulting firm he started in 2016 after leaving Pfizer as part of a reorganization. During his time with Pfizer, he served as executive director of global bioanalytical and compliance and executive director and compliance lead for pharmacokinetics, dynamics, and metabolism. Currently Fluhler is working with Glenmark Pharmaceuticals to develop several innovative biologic compounds.
Although Glenmark is a large pharma company, its innovation group in the U.S. has fewer than 200 employees. This is a refreshing change for Fluhler, compared to big pharma.
“What’s great about a small group like this is that you know everybody,” he says. “For example, I get to interact with the president of research on a regular basis. In my short time here, I have already been in two meetings with the CEO. Although small companies demand flexibility in various roles, you also get a greater sense of empowerment.”
Fluhler began his career in the pharmaceutical industry almost 30 years ago. For the first few years he focused almost exclusively on pharmacokinetics and modeling before expanding into regulated bioanalysis. “Although these two subdisciplines of drug development may seem distinct, my Ph.D. in biophysical chemistry gave me a broad enough base to contribute in both areas early on,” he says.
These contributions helped develop a number of drugs that made it to market and have improved patient lives around the world—for example, Enbrel, Effexor, Bosulif, Protonix, Tygacil, Rapamune, Sonata, Mylotarg, Benefix, Duavee, Pristiq, and Xeljanz. And, as meaningful as these accomplishments are for a pharmaceutical scientist, what matters most to Fluhler are the strong relationships he has built over the years with his codevelopers.
“Having had to manage through several downsizings late in my career, these relationships are what got me through,” says Fluhler. “These lifelong friendships are what I value most—and many of them have been made through AAPS [the American Association of Pharmaceutical Scientists].”
LEADERSHIP STARTS WITH CLEAR EXPECTATIONS
Over his long pharmaceutical career, Fluhler has witnessed many different styles of leadership. “Early in my career, I was fortunate to work under some great leaders with very different styles,” he says. “This allowed me to develop my own style of leadership.”
Fluhler believes the most important factors for successful leadership are being genuine and setting clear expectations. “People will rally around leaders or causes if they believe the leaders are sincere, and if they can understand where the leaders want to take them,” he says. “This is easier to achieve if the leaders are honest and passionate, communicate clearly, and are comfortable being who they are.”
Leadership starts with becoming a true expert in your own discipline, which allows you to impart immediate value and influence. As time goes on, Fluhler advises gaining a broader view of the drug development process. This is best accomplished by participating in project teams. “When I was serving on drug-development project teams, it gave me the opportunity to understand the complete drug development process, while still advancing my career in bioanalysis and pharmacokinetics,” states Fluhler.
Being involved in the drug development process is essential for understanding how departments collaborate (or don’t) and for learning how to deal with the corporate politics that sometimes disrupt the process and cause frustration.
“Project management develops important leadership skills in every team member,” says Fluhler. “Ultimately it teaches you people skills that are outside your normal sphere of influence. On the technical front, the things you learn from other disciplines help tremendously in solving your own problems, as well as broader team issues. It is hard to imagine all the work that goes into an investigational new drug, or new drug application, until you have participated in a project team. Seeing how preclinical; clinical; chemistry, manufacturing, and controls; and regulatory all work together is inspiring and delivers the broader understanding required for effective decision making.”
To broaden leadership skills, Fluhler also recommends being an active participant in professional groups and associations. He has been an active member of the AAPS Bioanalytical focus group (BFG) and the AAPS Analysis and Pharmaceutical Quality section for many years (BFG steering committee, past BFG chair, current Awards Committee member). “This has afforded me opportunities to improve my communication and networking skills, as well as provided meaningful leadership opportunities I would not have otherwise had in the pharmaceutical industry,” says Fluhler. “AAPS has also fostered the creation of the current bioanalytical and drug metabolism and pharmacokinetics communities, which directly influence best practices and enable the sharing of diverse opinions and approaches. Collectively these have afforded me greater understanding and even visibility in the pharmaceutical industry.”
PURSUING HIS PASSION
Fluhler intends to spend the last decade or two of his career working on challenging drugs, new technologies, and most important, continuing to build great relationships with his fellow scientists and researchers. “This combination is what makes work fun,” Fluhler says. “There’s a point in your career where the kind of work you do, and the people you do it with, are most important,” he says. “I’m there.”
Fluhler continues to work on the development of the biologics portfolio at Glenmark Pharmaceuticals. Although the company is best known for its generics, it also has an innovative pharmaceutical group that is developing some bispecific oncology drugs (along with other monoclonal antibody therapies). Given their apparent high potency and associated low doses, these molecules pose significant challenges from a bioanalytical perspective. One interesting approach is applying new immunocapture liquid chromatography mass spectrometry techniques to drug pharmacokinetics. “These techniques have been used mostly for biomarker work in the past,” says Fluhler. “But we are now attempting to apply them to bioanalysis for pharmacokinetics, which has a higher bar for overall quality. We are pushing these techniques to new limits that will hopefully bring these drugs to market.”
Another passion for Fluhler is contributing to organizations that promote education and advancement of the bioanalytical sciences. These include the AAPS BFG and the University of Wisconsin Land O’Lakes Bioanalytical Meeting Steering Committee.
“These groups have given me the opportunity to work with great people in industry, academia, and the Food and Drug Administration to promote high-quality programming,” says Fluhler. “Hopefully our efforts will influence the establishment of sensible quality standards in bioanalysis.”
Mark Crawford is a science and technology freelance writer based in Madison, Wis.