Monica Luchi, M.D., became a partner with The Bracken Group in December 2020. We talked with her recently about some of the many aspects of her career, particularly her experience in translational medicine.
Q: How would you describe or define translational medicine?
A: Translational medicine is the link between the preclinical space and the clinical space. It was created to try to facilitate that transition and assure optimal use of learnings from preclinical trials to inform development planning for studies in humans. It’s a way to provide a surrogate for clinical endpoints.
Q: What is your experience in the space?
A: I led an area of translational medicine at Novartis for a time. The group was largely focused on biomarkers for a therapeutic area that covered Arthritis/Immunology, Metabolic Bone diseases, Gastroenterology, and Women’s Health.
Q: What questions or problems would you work on in that position?
A: We addressed questions such as, “Should this particular drug be delivered intravenously or orally? Which route seems to provide the optimal exposure to achieve the effect as determined by surrogate markers?” Other typical questions might be, “What biomarkers should our Phase II study include so as to provide insight into potential for on-target and off-target effects? Do we need more non-clinical studies to explore relationships between pharmacokinetics and pharmacodynamics? Should we be concerned in regard to difference in impact based on gender, age, or weight?”
Q: How does translational medicine impact drug development or patient care?
A: Let’s consider the treatment of patients with rheumatoid arthritis (RA). There are many drugs on the market for RA. How should a clinician choose among them? What factors might suggest one choice over another? Someone in the translational medicine field might look at different biomarkers to prospectively identify patients whose genes, demographics or clinical manifestations make them good candidates for one specific therapeutic over another.
Biomarkers are, of course, increasingly important in oncology, as well as other disease areas as we strive to identify what it is about patients—what different characteristics— make them most responsive to the different types of medication available, and which choices would mitigate risk for adverse events.
Q: Could you provide another example of translational medicine in action?
A: We might think back to the unanticipated appearance of avascular necrosis of the jaw or atypical femoral fractures in patients treated with bisphosphonates. Healthcare providers and drug companies were asking, “Where is this coming from? Is it being caused by the drugs? Is there no true causal relationship? If there is a relationship, is there some underlying common thread in patients who suffer these adverse events that might result in additional caution being used in considering this prescription for such patients?” The translational medicine experts would go back and review the pre-clinical studies and resultant data over and over again when new questions arise to try to answer such questions. They take the information provided from the non-human sources and human sources to date and use it to guide what would be the most prudent approach moving forward.
Q: How might expertise in translational medicine be useful to TBG clients?
A: Other than the applications already mentioned, such insights might be useful to drug developers interested in differentiating their product from those already in the marketplace, thereby providing both something new to answer medical needs, and from a business standpoint, a competitive edge. Bottom line is to learn from the data in hand — starting with the non-clinical data and adding the human information gathered to date—and use them to guide development moving forward.