ASA Biopharm's Podcast
Science & Ideas
About
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.
Episodes
- Episode 115: Steven Novick
Biopharmaceutical Section Chair Steven Novick discusses goals for the section.
- Episode 114: 2025 Nonclinical Biostatistics Conference
Rebecca Wilson, Katie Brickey, John Kolassa, Jocelyn Sendecki, Paul Faya, and Mahan Dastgiri discuss the 2025 ASA Biopharmaceutical Section Nonclinical Biostatistics Conference.
- Episode 113: RISW: A Look Behind the Curtain
Erik Bloomquist, Wanjie Sun, Yingwen Dong, and Jonathan Moscovici discuss what occurs behind the curtain at the Regulatory-Industry Statistics Workshop.
- Episode 112: Preparing Future Statisticians to Succeed in the Era of AI
John McGready discusses how to prepare future statisticians to succeed in the era of AI.
- Episode 111: Nan Laird
A look at the life and accomplishments of Nan Laird.
- Episode 110: STATBOLIC Cardiometabolic Statistical Workshop
Jürgen Hummel, Hiya Banerjee, Jingyi Liu, Jason Legg, and Henrik Ravn discuss the inaugural STATBOLIC Workshop.
- Episode 109: Ian Sturdy
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
- Episode 108: Working Moms
Elaine Hoffman, Rebbecca Wilson, Christina Nurse, and Amy LaLonde discuss the balancing act between family and career.
- Episode 107: SPAIG Committee
Scott Clark, Satrajit Roychoudhury, and Michelle Shardell discuss the Statistical Partnerships Among Academe, Industry & Government (SPAIG) Committee. https://community.amstat.org/spaig/home
- Episode 106: Rebbecca Wilson
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. Ref…
- Episode 105: Adrian Coles and Wendy Martinez
Adrian and Wendy discuss imposter syndrome and being confident in your career.
- Episode 104: Steve Ruberg
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.
- Episode 103: Tian Gu
Tian discusses her research in data integration methods and the bias arising from lack of representation.
- Episode 102: LaShell Robinson
LaShell discusses diversity, equity, and inclusion in clinical trials.
- Episode 101: Elizabeth Mannshardt-Hawk on Imposter Syndrome
Elizabeth discusses imposter syndrome and how to manage it in your statistical career . In collaboration with the ASA's Committee on Career Development ( CCD website ) .
- Episode 100: Dionne Price, ASA President-Elect
Dionne talks about her journey in biostatistics and her goals for the ASA when she becomes President in 2023.
- Episode 99: Amy LaLonde and Christina Nurse
This episode introduces new podcast cohosts Amy LaLonde and Christina Nurse! They take over hosting duties starting with Episode 101.
- Episode 98: Safety Scientific Working Group
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 Appro…
- Episode 97 - Devan Mehrotra
Devan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.
- Episode 96: Alan Hartford
Alan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.
- Episode 95: Anna Nevius
Anna Nevius reflects on her time at the Center for Veterinary Medicine at the FDA and as chair of the Biopharmaceutical Section in 2009.
- Episode 94: Bob Starbuck
Bob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.
- Episode 93: External Control Arms
Amy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.
- Episode 92: 2021 Regulatory-Industry Statistics Workshop
Bo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.
- Episode 91: Patient Reported Outcomes
Joseph Cappelleri and Daniel O’Connor discuss the benefits and challenges in using patient reported outcomes and how to appropriately define clinically-meaningful change.
- Episode 90: ICSA Leadership Panel
Haoda Fu, Mengling Liu, Jie Tang, Tian Zheng, and Kelly Zou discuss leadership and the impact of COVID-19 on the workplace.
- Episode 89: Karl Peace
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.
- Episode 88: Katherine Monti
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.
- Episode 87: Storytelling
Scott Evans, Stephanie Omokaro, Janet Wittes, and Zhiheng Xu discuss the importance of storytelling for the modern statistician.
- Episode 86: Pediatric Drug Development Scientific Working Group
Meg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important.
- Episode 85: Weili He
Weili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.
- Episode 84: David Salsburg
David shares some of his experiences as the first statistician ever hired at Pfizer.
- Episode 83: Vaccine Development
Kerry Go and Elaine Hoffman discuss vaccine development.
- Episode 82: Olga Marchenko and Natallia Katenka
Olga and Natallia discuss their new book Quantitative Methods in Pharmaceutical Research and Development: Concepts and Applications .
- Episode 81: Mentor-Mentee Pairs from the BIOP Mentoring Program
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 K…
- Episode 80: 2020 Regulatory-Industry Statistics Workshop
Yabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.
- Episode 79: Nusrat Rabbee
Nusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.
- Episode 78: Challenges with Pain Assessments
Dottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.
- Episode 77: National Institute of Statistical Sciences
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.
- Episode 76: COVID-19 and Clinical Trials
Mouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.
- Episode 75: Meijuan Li
Meijuan Li discusses precision medicine, diagnostic devices, and the importance of parallel development of drugs and diagnostics.
- Episode 74: Glen Colopy and the Pod of Asclepius
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.
- Episode 73: Bruce Binkowitz
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.
- Episode 72: Abie Ekangaki
Abie discusses opportunities for statisticians in the CRO industry, and we chat about the Scholarship and Leadership-in-Practice Committees of the Biopharmaceutical Section.
- Episode 71: P-values in Medical Product Development
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…
- Episode 70: 2020 International Conference on Health Policy Statistics
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.
- Episode 69: Non-proportional Hazards
Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.
- Episode 68: 2019 Regulatory-Industry Statistics Workshop
Judy Li and Renee Rees discuss what's new and exciting at the 2019 Regulatory-Industry Statistics Workshop.
- Episode 67: Task Force on Sexual Harassment and Assault
Donna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.
- Episode 66: Quality Tolerance Limits
Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.