Introduction The coronavirus 19 (COVID-19) pandemic triggered a simultaneous global demand for preventative vaccines, which quickly became a high priority among governments as well as academia and the pharmaceutical industry. Within less than a year after COVID-19 was declared a pandemic, vaccines had received emergency approvals and vaccination campaigns were initiated. Areas covered We discuss the several factors that led to the unprecedented, accelerated development and approval of COVID-19 vaccines, which includes optimization of processes by regulatory authorities, redesign of sequential development processes, learnings from previous pandemics, and prior development of novel vaccine platforms. Expert Opinion Despite unanticipated and complex challenges presented by real-time vaccine development in the context of the evolving COVID-19 pandemic and subsequent ever-changing landscape of public health measures and recommendations, important milestones were reached within extraordinarily short periods and, following roll-out to billions worldwide, the approved vaccines have proven to be well tolerated and effective. Whilst this is an exceptional feat and an example of what can be achieved with collaboration and innovation, there are lessons that can still be learned, including the need for further harmonization between regulatory authorities, modes to react to the pandemic’s ever-evolving challenges, and ensuring equitable vaccine access among low-income countries.

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Cell-free DNA (cfDNA) and circulating tumor cell (CTC) enumeration and profiling serve as sources of tumor material to guide treatment decisions. Use of blood-based biomarker assays requires an understanding of factors outside the laboratory where the assay is performed that can influence the final reported result. The factors include preanalytical variables related to specimen acquisition, delivery and storage, and patient context variables. To address this question, our group activated an IRB-approved protocol to study the effect of variables associated with the factors mentioned above, including: (i) the order of blood being drawn in a single collection, (ii) collections done at different times of the day, (iii) collections repeated 1-14 days apart, (iv) patient fasting status, and (v) glucocorticoid use as an antiemetic. Our focus is on validated assays spanning different contexts of use in metastatic prostate cancer management, including: 1) a nuclear localized AR-V7 assay in circulating tumor cells (CTCs) as response indicator to androgen receptor (AR) signaling inhibitor vs. taxane based chemotherapy in the second line of therapy (Epic Sciences®, San Diego, CA); 2) a change in CTC number from any pretherapy value to zero post-therapy as a response indicator (CellSearch®, Menarini Silicon Biosystems); and 3) the detection of somatic mutations and copy number alterations in the AR pathway as resistance mechanism to abiraterone acetate in castration-resistant prostate cancer patients. Our pilot data currently include a cohort of 12 patients on which we aimed to study the effect of draw order on (i) the counts of CTC and ARV7 expression assessed by EpicScience® and (ii) the quality and quantity of cfDNA and mutation detected assessed by the analytically validated ThermFisher Oncomine® Pan-cancer cfDNA assay (Waltham, MA). Our initial analysis showed that the CTC and cfDNA results are mostly consistent across different draw orders, with slight variation at levels close to or below the limit of detection of the assay involved (such as 0.1% variant allele frequency of the ThermoFisher Oncomine® assay). We are expanding the sample size to further validate these results, perform additional statistical analysis, and include data from the Food and Drug Administration (FDA) cleared, CellSearch® CTC enumeration assay and MSK-ACCESS (Analysis of Circulating cfDNA to Examine Somatic Status), an ultrasensitive 129-gene cfDNA profiling assay that was developed internally at Memorial Sloan Kettering Cancer Center, recently approved by the New York State Department of Health, and launched in our Clinical Laboratory Improvement Amendment (CLIA)-certified molecular diagnostic laboratory. The results of this study will provide evidence to inform the design of preanalytical sample collection and inform how to use these tests in clinical practice. Citation Format: Dana Tsui, Ethan S. Barnett, Kelli Bramlet, Joseph Schonhoft, Ruben Rizzi, Howard I. Scher. Evaluation of preanalytic variables in liquid biopsy tests for prostate cancer: Specimen acquisition and patient context factors that impact results [abstract]. In: Proceedings of the AACR Special Conference on Advances in Liquid Biopsies; Jan 13-16, 2020; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(11_Suppl):Abstract nr A60.