New hire joins COTA following seven year tenure at FDA
COTA, Inc., an oncology real-world data and analytics company, today announced that a new strategic hire will join their senior leadership team. Laura Fernandes, PhD joins the company after seven years at the U.S. Food and Drug Administration (FDA) as a mathematical statistician focused on hematology and oncology indications. During this time she reviewed clinical trial protocols and directly contributed to FDA guidance on drug development standards. At COTA, Laura and the research and quality team will work to expand the organization’s research footprint and develop enhanced quality and regulatory compliance standards to support healthcare providers and life sciences customers in leveraging real-world data to advance cancer care.
“The COVID-19 pandemic was a watershed moment for real-world data because it highlighted its ability to quickly answer treatment and research questions for stakeholders across healthcare. Recent FDA draft guidance also signals that real-world data will likely play a more significant role in drug reviews moving forward,” said CK Wang, M.D., Chief Medical Officer with COTA. “Laura’s experience at FDA greatly complements the deep research and analytics capability of COTA’s rapidly growing research team and will help inform research protocols and ensure that we are proactively complying with regulatory guidelines as they are developed.”
This most recent hire builds on multiple senior leadership additions at COTA this year, including Ritu Bahal, new chief financial officer who came from Kantar Health; Christine Kawiecki, vice president of life sciences from IBM Watson Health; Paige Whitney, vice president of life sciences, formerly of Aetion; and Miruna Sasu, chief strategy officer who held leadership roles at Johnson & Johnson and Bristol Myers Squibb. With this year’s hires, COTA’s senior leadership team is now 70% women and 80% non-white.
“During my tenure at the FDA, I was excited to see the increased use of real-world data and real-world evidence in clinical trials to improve the efficiency of the drug development process,” said Fernandes. “I was drawn to COTA’s patient-centric mission and their commitment to generating robust, high-quality datasets that can be used in regulatory submissions. I am excited to jumpstart my work at COTA and find new ways to advance the use of real-world data in clinical research.”