My name is Dee Luo, and I am a rising senior at the University of Pennsylvania working towards a degree in the Biological Basis of Behavior from the College of Arts and Sciences and a minor in Healthcare Management from the Wharton School of Business. This summer, I am working with Dr. David Brindley, Dr. David DiGiusto, Anthony Davies, and Kirk Trisler to investigate regulation strategies in regenerative medicine.
My past research encompasses both clinical and benchwork experience. As an independent student researcher under Dr. David Asch and Dr. Ben Roman at the Leonard Davis Institute of Health Economics under Dr. David Asch and Dr. Ben Roman, I was able to conduct an investigation on the effective use of Positron Emission Tomography combined with Computed Tomography (PET/CT) scans to detect reoccurring tumors as a patient management tool. In today’s medical climate, advancements in medical imaging technologies show great therapeutic promise, but the accompanying price tags pose an increasingly more difficult obstacle in the effort to reduce healthcare expenditures in the United States. One such costly new imaging modality, PET/CT scans, showed promise in detecting reoccurring tumors. However, at the time of discovery, there wasn’t enough data to either prove or disprove the efficacy of the scans. The Centers of Medicare and Medicaid Services (CMS) therefore conditionally covered the usage of such scans in an effort to accumulate data. However, when a formal evaluation two years later showed there is little evidence to support the effectiveness of PET/CT to detect reoccurring tumors, the technology was already widely incorporated into clinical practice and attempts to withdraw coverage for the procedure was met with so much physician backlash that CMS revised their decision to allow three PET/CT scans per cancer patient.1
We sought to determine whether physician rationaleeasons for supporting low value care could be explained by sufficient perceived benefit of PET/CT and/or loss aversion. Content analysis proceeded through several stages, resulting in the identification ofa 7 main reasons. The results are currently being analyzed, with prominent trends such as loss aversion promising some surprising results that could tie health economics more closely with business models.
The research I conducted on the inefficiencies in healthcare policy made me realize the crucial importance regulation has on the ability of medicine to help patients. If guiding policy is outdated or misinformed, a therapy might never pass regulations, and the patient population will continue to suffer. On the other hand, if a promising technology is released into market that doesn’t measure up, the entire healthcare economy has to shoulder that expense. This interest in regulation drew me to SENS Research Foundation, because the cutting edge research being conducted in regenerative medicine at SRF is exactly where regulatory science research is needed.
My benchwork stems from an acknowledgement that all policy suggestions should come from a background based in science. As a current assistant researcher under Dr. Gordon Barr at the Children’s Hospital of Pennsylvania Department of Anesthesiology and Critical Care Management, I study acute and chronic pain management from a developmental perspective. When infants are admitted into intensive care, they undergo painful tests and procedures that utilize anesthetic opiates such as morphine.2 Infant models for morphine withdrawal are currently unstudied. I am investigatinge the novel mechanisms for infant pain management through formalin-induced c-fos expression in areas associated with pain perception, namely the periaqueductal gray of the midbrain, of model rats.3 I have high hopes that this research will break grounds in the standard of care in the neonatal intensive care unit.
An Evaluation of Market Dynamics in Regenerative Medicine
My research with SRF at Stanford University, supervised by Dr. David Brindley and Dr. David DiGiusto, will focus on the regulatory environment for combinational therapies in regenerative medicine. Regulatory science is an interdisciplinary field that focuses on standardization and optimization of healthcare innovations. The recent advances in highly promising yet extraordinarily expensive stratified medicines offer unique challenges for developing regulation. There are groundbreaking combinational therapies that attack the root of previously incurable diseases, such as breast cancer, but regulations can often limit the innovation of such drugs or create such a high cost that the price is unsustainable for the healthcare economy. Therefore, my research investigating the areas of regulation that can be improved will have vast influence on the ability of the pharmaceutical industry to develop crucial therapies.
Figure 1. Companion diagnostic development and regulation concomitant with drug therapy development.
This is a basic overview of the regulatory approval pathway for co-developing a therapeutic and its companion diagnostic. The relationship and timeline between drug and diagnostic as shown by the purple double arrows is an approximation.
I plan to identify the regulatory barriers in regenerative medicine by examining the market dynamics of breakthrough combination therapies. Combinational therapies consist of a drug therapy and a diagnostic, a model that is similar to many regenerative medicine therapeutics, which require a cellular component and a device. By examining such criteria as the attrition rates, target population sizes, and prices, I hope to identify novelew relationships between the two components of combination therapies. Then, I plan to examine regenerative medicines on the market based on the same criteria and suggest improvements to the regenerative medicine regulatory process. Because the advent of regenerative medicine is relatively recent, and regulation of these therapeutics is still under development, this research is timely.
Through understanding the factors that influence the availability of combinational therapies currently on the market, I hope to construct a regulatory decision support tool that will help academic innovators improve or develop a regulatory strategy for regenerative medicine.
I hope to continue conducting impactful research and apply to medical school an undecided number of years after I graduate. I believe that for medicine to improve, there has to be more interaction between the stakeholders in healthcare. Therefore, I hope to continue conducting research in clinical management, while gaining a solid understanding of the field from a physician’s perspective, and eventually use my background in the two perspectives to create innovative solutions. Along the way, I hope to continue developing my skills as an avid dancer and writer.
1. “Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4”. The Centers for Medicare and Medicaid Services. Washington.
2. Barr, GA. “Formalin-induced c-fos expression in the brain of infant rats.” J Pain. (2011): 263-71.
3. Meadows, NA, Morrison, A, Brindley, DA. “An evaluation of regulatory and commercial barriers to stratified medicine development.” The Pharmacogenomics Journal. (2014): 1-7.