In this podcast series sponsored by Biopharmaceutical Section of American Statistical Association, key opinion leaders from pharmaceutical industry and regulatory agencies talk about upcoming statistical conferences and events, and discuss current issues in Biopharmaceutical statistics.
American Statistical Association (ASA) Biopharm. Section
John McGready discusses how to prepare future statisticians to succeed in the era of AI.
A look at the life and accomplishments of Nan Laird.
Jürgen Hummel, Hiya Banerjee, Jingyi Liu, Jason Legg, and Henrik Ravn discuss the inaugural STATBOLIC Workshop.
Ian describes how to leverage ChatGPT to accelerate statistical programming in the medical product industry.Related paper available here: https://www.pharmasug.org/proceedings/2024/AP/PharmaSUG-2024-AP-256.pdf
Elaine Hoffman, Rebbecca Wilson, Christina Nurse, and Amy LaLonde discuss the balancing act between family and career.
Scott Clark, Satrajit Roychoudhury, and Michelle Shardell discuss the Statistical Partnerships Among Academe, Industry & Government (SPAIG) Committee.https://community.amstat.org/spaig/home
Amy welcomes Rebbecca to the co-hosting chair while Christina enjoys some time off with her new baby (congrats)! The two discuss Rebbecca's fascinating career thus far and how communication styles differ across male and female leaders.Reference: https://hbr.org/2022/12/research-men-speak-more-abstractly-than-women
Adrian and Wendy discuss imposter syndrome and being confident in your career.
In our first episode of the new year, we interview Steve Ruberg, an ASA fellow with over 35 years of experience in the biopharmaceutical industry and an active proponent of the Tripartite Estimand Approach.
Tian discusses her research in data integration methods and the bias arising from lack of representation.
LaShell discusses diversity, equity, and inclusion in clinical trials.
Elizabeth discusses imposter syndrome and how to manage it in your statistical career.
Dionne talks about her journey in biostatistics and her goals for the ASA when she becomes President in 2023.
This episode introduces new podcast cohosts Amy LaLonde and Christina Nurse! They take over hosting duties starting with Episode 101.
James Buchanan, Judy Li, Melvin Munsaka, and Bill Wang discuss the research of the Safety Scientific Working Group and their recent edited volume "Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches." https://tinyurl.com/2ucyer95
Devan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.
Alan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.
Anna Nevius reflects on her time at the Center for Veterinary Medicine at the FDA and as chair of the Biopharmaceutical Section in 2009.
Bob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.
Amy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.
Bo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.
Joseph Cappelleri and Daniel O'Connor discuss the benefits and challenges in using patient reported outcomes and how to appropriately define clinically-meaningful change.
Haoda Fu, Mengling Liu, Jie Tang, Tian Zheng, and Kelly Zou discuss leadership and the impact of COVID-19 on the workplace.
Karl Peace was chair of the Biopharmaceutical Section in 1990. He discusses his career in the industry, the Jiann-Ping Hsu College of Public Health, and the Biopharmaceutical Applied Statistics Symposium.
Katherine Monti was chair of the Biopharmaceutical Section in 2010. She discusses her career in the industry and how the Section has changed over time.
Scott Evans, Stephanie Omokaro, Janet Wittes, and Zhiheng Xu discuss the importance of storytelling for the modern statistician.
Meg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important.
Weili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.
David shares some of his experiences as the first statistician ever hired at Pfizer.
Kerry Go and Elaine Hoffman discuss vaccine development.
Olga and Natallia discuss their new book Quantitative Methods in Pharmaceutical Research and Development: Concepts and Applications.
This episode features discussions with 3 mentor-mentee pairs from the Biopharmaceutical Section mentoring program. Conversations include Qing Li and Abie Ekangaki (start 1:25), Samson Ghebremariam and Scott Clark (start 44:33), and Carie Kimbrough and Bruce Binkowitz (start 102:29). They discuss the benefits of mentoring and the dynamics of the mentoring relationship.
Yabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.
Nusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.
Dottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.
Nancy Flournoy, Dan Holder, and Jim Rosenberger discuss the mission and history of the National Institute of Statistical Sciences and how it will adapt for the future.
Mouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.
Meijuan Li discusses precision medicine, diagnostic devices, and the importance of parallel development of drugs and diagnostics.
Glen discusses his graduate training in data science in the United Kingdom, vital sign monitoring, the challenges of efficient drug supply, and his healthcare technology podcast, the Pod of Asclepius.
Bruce discusses the Japanese regulatory environment, challenges for statistics departments spread across the globe, and his hopes and plans for the Biopharmaceutical Section in 2020.
Abie discusses opportunities for statisticians in the CRO industry, and we chat about the Scholarship and Leadership-in-Practice Committees of the Biopharmaceutical Section.
Lisa LaVange, J. Jack Lee, and Steve Ruberg about the ASA Statement on p-values, and their recent paper entitled “Inference and Decision Making for 21st-Century Drug Development and Approval” which was featured in the American Statistician in early 2019.
Kate Crespi and Ofer Harel discuss the 2020 International Conference on Health Policy Statistics, and describe current topics of interest in health policy including gun violence and opioids.
Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.
Judy Li and Renee Rees discuss what's new and exciting at the 2019 Regulatory-Industry Statistics Workshop.
Donna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.
Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.
Inna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development.
Alex Dmitrienko and Kyle Wathen talk about the development of software for biopharmaceutical applications, the new working group and LinkedIn group, and talk a little bit about the new YouTube Channel for the Biopharmaceutical Section.
Zoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.
Qi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.