By Jacques Galipeau, MD
Traditionally, drug development arises from a university discovery for which a pharmaceutical company acquires the rights and thereafter navigates the path to market approval. This process of shepherding a therapeutic discovery to become a U.S. Food and Drug Administration (FDA)approved drug costs hundreds of millions of dollars. Historically, due to mission and structural reasons, universities simply have not been involved in drug development and manufacturing. Rather, they relied on industry to pick technologies and bear the burden and risk of developing blockbusting winners.
Today, the advent of cellular therapy has changed the constraints of that paradigm, as informed by the revolution of living cells used as drugs. Academic medical centers, including the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health, now can take ownership of developing their own innovations for the greater good.
Bone marrow transplantation, like blood transfusion and solid organ transplantation, is a “practice of medicine,” and blood and tissues are not considered “drugs” according to state and federal regulatory agencies. Any properly accredited hospital can provide these services. However, if cells or tissues are “more-than-minimally manipulated” by laboratory handling or gene engineering, they are considered to be “drugs” and are subject to exacting safety and manufacturing oversight by the FDA. Indeed, FDA-regulated cell therapies are emerging as a positive force in achieving a cure for cancer and alleviating suffering for vexing health problems that have been inadequately addressed by traditional methods.
More than half a century ago, Dr. Fritz Bach, then a faculty member at the SMPH, discovered a means for performing successful bone marrow transplantation. His work led to the ﬁrst-ever cure of a toddler with an otherwise lethal bone marrow disease in 1968. Bone marrow transplantation is now routinely curing adults and children with cancer. Similarly, two decades ago at UW-Madison, Dr. James Thomson launched the ﬁeld of modern stem cell regenerative medicine. As these examples show, UW-Madison historically has been a thought leader in transformative discoveries in cell therapies.
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