By Gary Zammit | Forbes Books Author for Forbes Books | AUTHOR POST | Paid Program
Glucagon-like peptide agonists (GLP-1s, like Ozempic, Wegovy, and Mounjaro) have been hailed as breakthroughs. GETTY
From statins to Viagra, occasionally a drug development breakthrough occurs that is considered revolutionary. Most recently, glucagon-like peptide agonists (GLP-1s, like Ozempic, Wegovy, and Mounjaro) have been hailed as breakthroughs. Originally developed to treat people with type-2 diabetes (T2DM), these drugs have proven useful for addressing a range of other conditions, from obesity to sleep apnea.
To the broader public, these moments of scientific revolution might seem like overnight success stories, but anybody who has worked in research and development (R&D) knows they are anything but. What can we learn about the realities of innovation from such revolutionary R&D moments?
How Scientific Revolutions Happen
According to Thomas S. Kuhn’s The Structure of Scientific Revolutions, scientific progress requires time and occurs through predictable cycles. Most daily scientific work is incremental: Scientists work within established paradigms, testing hypotheses that build on current knowledge in a linear, progressive way. Labeled by Kuhn as “normal science,” this approach presumes that research within a particular paradigm will produce meaningful answers.
However, on occasion, scientists encounter anomalies—information that does not fit the existing paradigms. When enough anomalies accumulate, they create what Kuhn calls a “crisis,” a loss of confidence in the status quo because the existing paradigms no longer apply.
As a result of such a crisis, new questions arise and are debated. These questions give rise to new hypotheses, methods, and ways of thinking about the problems we are attempting to address. Ultimately, this can lead to the development of new theories and paradigms that carry science forward. During the transition period that follows, the old and new paradigms coexist, as scientists uncover overlaps and test problems using both frameworks. Eventually, the new paradigm may replace the old.
The Need for an R&D Revolution in Drug Development
Without this pattern of normal science followed by anomaly and crisis, we would not see the revolutionary advances critical to life sciences innovation. Schizophrenia research is a good example. Researchers once believed schizophrenia resulted from maternal behavior, with psychiatrist Frieda Fromm-Reichmann coining the term “schizophrenogenic mother” in 1948. This theory has been debunked. Clinical studies now show that schizophrenia is highly heritable, as approximately 80% of risk has a genetic component.
A similar revolution has occurred in the treatment of obesity and T2DM. Historically, the management of these conditions has emphasized lifestyle changes, including a reduced-calorie diet and increased physical activity, both of which are known to forestall or even reverse the development of T2DM and decrease the risk of cardiovascular disease. Then, over 30 years ago, clinicians began to see the value of incretin-based therapy for T2DM, which led to a plethora of clinical trials confirming that GLP-1 receptor agonists are effective in the management of T2DM. We’ve now witnessed a remarkable paradigm shift, driven by our new understanding that appetite and satiety are regulated hormonally, not just behaviorally, and that the gut-brain axis plays a central role in maintaining energy balance. This shift has led to the emergence of new drug treatments for T2DM, obesity, and cardiometabolic health.
What Will Your Role in the Revolution Be?
In medicine, our revolution focuses on developing better, safer, and more efficacious treatments for patients. We must create our own scientific revolutions in order to make better diagnostic instruments and better drug and device therapeutics. From Alzheimer’s (a disease with no known cure) to depression (a disease where many patients are considered treatment-resistant), there is much work to be done.
Just as it’s tempting to suggest that a breakthrough like GLP-1s happens overnight, the language of revolution also trends toward lionizing a single individual: the mythic revolutionary. However, the truth is that revolutions are rarely achieved by any one person. In drug development, in particular, advances require collaboration across multiple disciplines and organizations, including physicians, patient advocacy groups, research organizations, and patients themselves, among others.
Revolutionary progress, like that ascribed to GLP-1 drugs, happens when many exceptional people work together, following a robust process and supported by advanced systems. Each individual plays a part. The question is, what part will you play? Whether you are a medical student or a seasoned researcher with decades of benchwork behind you, don’t underestimate your role. As Dr. Paul Janssen once said: “The patients are waiting.”
By Gary Zammit, AUTHOR POST | Paid Program. Gary Zammit, PhD, founded Clinilabs in 2000, driven by his vision to improve central nervous system drug and device development through specialized contract research. Now an award-winning entrepreneur, he is widely recognized for his expertise in both neuropsychiatric drug development and sleep medicine. As president and CEO of Clinilabs, Zammit leads a team dedicated to advancing treatments for conditions affecting the central nervous system. He simultaneously serves as a clinical professor of Psychiatry at the Icahn School of Medicine at Mount Sinai in New York and is a distinguished Fellow of the American Academy of Sleep Medicine.
Zammit earned his PhD from the University of Toledo, where his work in biological psychiatry earned him both the Turin Service Award and the Leckie Scholar Award. His postgraduate training included an internship and clinical research fellowship at the New York Hospital-Cornell University Medical College, where he was recognized with the Alumni Award for Excellence. Throughout his career, Zammit has authored two books and over 250 articles and abstracts related to clinical practice, sleep, and CNS drug development. His professional mission remains steadfast: developing innovative drugs and devices to treat psychiatric and neurological disorders, ensuring patients have access to better, more effective, and safer treatments that improve health outcomes and quality of life.
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