We Know Precision Medicine is a series of blog posts and articles about the people of PierianDx and how we know precision medicine through our expertise and personal experiences. In this article, Shalini Verma, Laboratory and Medical Director, discusses her role at PierianDx and how our products and services will help make precision medicine a routine component of healthcare.
What is your role at PierianDx?
I serve as Laboratory and Medical Director at PierianDx. In my role as Laboratory Director, I oversee the PierianDx clinical molecular diagnostics laboratory. We offer next generation sequencing (NGS)-based testing for cancer evaluation. In my role as Medical Director, I provide medical oversight for all of the PierianDx products and services and render medical affairs support for their market positioning. I also head our Interpretation Services Team, which assists our clinical geneticist and molecular pathologists clients in the professional sign-out of NGS based cancer tests.
What does a typical day entail?
A typical day for me starts early with meetings with our Interpretation Services team. I go over any issues they encountered during the previous day and assist with planning for incoming cases and any other administrative items. Then, I spend time working closely with staff in our molecular diagnostic laboratory and overseeing laboratory operations, performing sign-out of clinical cases. Each day I also work with our product team to inform the direction of our products and services. At PierianDx, we are not just a software company -- we provide expert, end-to-end scientific services to enable NGS-based clinical testing.
What excited you about working at PierianDx?
Back in 2011, when NGS testing was just making its way into a clinical setting, I was a Molecular Genetics Pathology fellow at the MD Anderson Cancer Center. At that time, I was introduced to Rakesh Nagarajan, PierianDx founder, because our team at MD Anderson wanted to learn about the clinical NGS dry bench workflow that he and his laboratory had implemented at Washington University. The way that he had operationalized clinical NGS, and particularly the dry bench component, was--and still to this day--is very novel. I was also introduced to what is called the Clinical Genomics Workspace, or CGW in that period. CGW is a genomic information management system that molecular pathologists and clinical geneticists can use to call, annotate, classify, and interpret genomic variants while maintaining an end-to end (sample accessioning to clinical report sign off) integrated workflow. I was inspired to learn about this innovation. I also realized that in the future as NGS based clinical testing enters standard clinical practice, a software system like CGW and robust bioinformatics would become critical components for any clinical laboratory intending to adopt NGS based testing. Thus, when I got this unique opportunity to work at PierianDx, I was thrilled. In my opinion, PierianDx is unparalleled in its capabilities and talent. I am fortunate to be here.
What do you think is the biggest obstacle to making precision medicine mainstream?
Precision medicine in oncology implements clinical screening and tissue molecular profiling to characterize the genetic makeup of the patient and of the tumor. The knowledge derived from both a patient’s phenotypic and molecular profile has the potential to support individualized clinical decision-making by understanding the likely benefits and risks of a particular treatment. This approach enables the identification and validation of treatments to reduce side effects and improve outcomes.
I think there is a set of interdependent factors that are impeding adoption of precision medicine. One is the lack of powerful data showing clinical utility of this approach. This in itself is a big challenge and would require the development of a highly collaborative, sound data infrastructure allowing all stakeholders to share and analyze clinical/genomic/phenotypic data to demonstrate clinical need for a personalized approach. Second is the high cost of genomic testing which is further compounded by reimbursement structures that fail to incentivize precision medicine. Last but not the least is the gap in the patient, physician and payor education about the data that support precision medicine.
How will PierianDx help overcome these obstacles?
I think that PierianDx is well positioned to overcome many of these obstacles. First of all, CGW provides a data infrastructure that allows users to share and analyze large amounts of molecular data in a clinically meaningful way. CGW is designed to make the process of analyzing large amounts of genomic data and assigning it biological and clinical significance more efficient and straightforward. Likewise, the PierianDx KnowledgeBase that is integrated with CGW enables more expedient clinical interpretation of genomic data by providing a rich set of curated and rationalized content of medical interpretations, clinical practice guidelines, FDA approved therapeutics and clinical trials. Since PierianDx customers share clinical interpretations of genetic variants as part of the “partner sharing network” there is perpetual learning and exchange.
Additionally, all of our services enable customers to internalize NGS-based genomic testing. Internalizing, or bringing NGS testing in house, enables clinical laboratories and hospital systems to take control of the cost1 and quality of genetic testing. It also allows access to patient molecular data, in compliance with existing regulations. And when these data are combined with phenotypic data, we have additional opportunities to improve patient care as well as demonstrate the utility of precision medicine.
PierianDx is also actively participating in sharing and spreading knowledge about clinical standards and practice guidelines for the interpretation of genomic data and standing up high-quality and cost-efficient NGS-based testing programs.
Why is precision medicine so important to you?
My parents are both physicians -- one of them a surgeon and the other a gynecologist -- so I grew up hearing about their work. From an early age, I learned about different diseases and conditions and often the “dinner discussions” left me wondering about such things as when two patients have the same form of cancer, why does one of them get better and one not? Even in the context of non-cancer patients, I was fascinated with how uniquely managing an individual’s care always made such a difference in their quality of life and outcome.
Seeing my parents care for their patients but also wanting to understand the underpinnings of disease made me want to pursue a career in medicine that was focused on pathology and genetics. So, soon after I received my medical degree in India, I traveled to the United States to pursue advanced medical training. When I got here, I started as a research fellow at the Children’s Hospital Los Angeles where I had the great fortune to be mentored by one of the most prominent thought leaders in Neuropathology. He understood my academic inclinations and asked me to study histologic features in childhood medulloblastoma (a cancerous tumor) and see if I could find feature/s presence/absence of which affected survival rates for patients. Indeed, we were able to identify certain histopathological features whose presence in the tumor predicted better survival. This became highly successful research that also influenced the clinical practice.
My work with medulloblastoma solidified my belief that an accurate diagnosis and in-depth disease understanding is key for better treatment outcomes. This was further engraved in my mind in the first and second years of pathology residency during my Hematopathology rotations. It became clear that the more I understood about the patient’s clinical history, histopathology and genetics of disease, the better diagnosis I could provide for the managing physician. These events truly propelled me on my path to become a Molecular Genetics Pathologist and made precision medicine my professional pursuit. I went on to complete fellowships and my residency training at the University of Texas MD Anderson Cancer Center, Houston (Molecular Genetic Pathology); Weill Cornell Medical College/New York Presbyterian Hospital, New York (Hematopathology); and the Los Angeles County/University of Southern California Medical Center in Los Angeles (Anatomic & Clinical Pathology).
What do you like to do in your free time?
When I’m not working, I like to spend time with my family in nature, engaging in some type of outdoor activity such as hiking or taking long walks on the beach. I also enjoy reading about different cultures and their history.
Don’t miss our upcoming webinar on August 28, in which Shalini joins Karl Voelkerding, MD, FCAP to discuss the CAP Distributive Model.
ReferencesNagarajan, R. and Loo, E. (2018). Bringing NGS Testing In-House. [online] Info.pieriandx.com. Available at: https://info.pieriandx.com/bringing-ngs-testing-in-house [Accessed 17 Aug. 2018].