Monday 9:00 AM EDT Title: Modelling the COVID-19 Pandemic Presenter: Lisa LaVange, University of North Carolina at Chapel Hill Abstract: Biostatisticians contribute to advancements in public health and medical research through active collaborations with colleagues from a variety of disciplines. Studies resulting from research collaborations may be designed to support the discovery and development of therapies addressing an important unmet medical need, to determine best practice guidelines for a disease or indication, or to combat a pandemic or other public health crisis on short notice. Settings such as these are often associated with time and resource constraints that may benefit from innovative ideas and novel solutions to non-standard problems. Since 2016, the need for innovation in complex trial designs, in model-informed drug development, and in the use of real-world data to generate real-world evidence has been codified through the Prescription Drug User Fee Act (VI) and the 21st Century Cures Act. Today, statisticians in academia, the pharmaceutical industry, and government agencies are in a position to foster innovation and positively impact the success of research collaborations. I will draw on my experience working in all three sectors to highlight aspects of statistical leadership that can enhance our abilities to succeed in this quest and ultimately benefit patients and the general public. References: Ronald L. Wasserstein, Allen L. Schirm & Nicole A. Lazar (2019) Moving to a World Beyond “p < 0.05”, The American Statistician, 73:sup1, 1-19, DOI: 10.1080/00031305.2019.1583913 Bio: Lisa LaVange, PhD is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. She is former director of the department’s Collaborative Studies Coordinating Center (CSCC), overseeing faculty, staff, and students involved in large-scale clinical trials and epidemiological studies and serving as coordinating center principal investigator (PI) for large-scale studies in a variety of disease areas, including pulmonary and cardiovascular medicine, schizophrenia, chronic lower backpain, severe asthma, and HIV/AIDS. From early 2020 to date, she has been involved in the NIH public-private partnership Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV), collaborating on master protocol design and implementation. From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). There, she oversaw more than two hundred statisticians and other staff members involved in the development and application of statistical methodology for drug regulation. She was a leader in developing and assessing the effectiveness and appropriateness of innovative statistical methods intended to accelerate the process from drug discovery to clinical trials to FDA approval and patients’ benefit. She continues to advise the CDER Director on strategic initiatives today. Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President. |
BASS XXXI
31st Annual Biopharmaceutical Applied Statistics Symposium