ASA Biopharm's Podcast

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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


    • Apr 4, 2025 LATEST EPISODE
    • monthly NEW EPISODES
    • 40m AVG DURATION
    • 112 EPISODES


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    Latest episodes from ASA Biopharm's Podcast

    Episode 112: Preparing Future Statisticians to Succeed in the Era of AI

    Play Episode Listen Later Apr 4, 2025 15:51


    John McGready discusses how to prepare future statisticians to succeed in the era of AI. 

    Episode 111: Nan Laird

    Play Episode Listen Later Jan 16, 2025 49:59


    A look at the life and accomplishments of Nan Laird. 

    Episode 110: STATBOLIC Cardiometabolic Statistical Workshop

    Play Episode Listen Later Dec 5, 2024 27:39


    Jürgen Hummel, Hiya Banerjee, Jingyi Liu, Jason Legg, and Henrik Ravn discuss the inaugural STATBOLIC Workshop.

    Episode 109: Ian Sturdy

    Play Episode Listen Later Jun 9, 2024 33:32


    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

    Play Episode Listen Later May 6, 2024 37:09


    Elaine Hoffman, Rebbecca Wilson, Christina Nurse, and Amy LaLonde discuss the balancing act between family and career.

    Episode 107: SPAIG Committee

    Play Episode Listen Later Feb 9, 2024 27:32


    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

    Play Episode Listen Later Jun 2, 2023 40:00


    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

    Episode 105: Adrian Coles and Wendy Martinez

    Play Episode Listen Later Apr 28, 2023 43:59


    Adrian and Wendy discuss imposter syndrome and being confident in your career.

    Episode 104: Steve Ruberg

    Play Episode Listen Later Jan 17, 2023 61:33


    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

    Play Episode Listen Later Sep 30, 2022 28:15


    Tian discusses her research in data integration methods and the bias arising from lack of representation.

    Episode 102: LaShell Robinson

    Play Episode Listen Later Aug 3, 2022 36:45


    LaShell discusses diversity, equity, and inclusion in clinical trials.

    Episode 101: Elizabeth Mannshardt-Hawk

    Play Episode Listen Later Jun 30, 2022 45:48


    Elizabeth discusses imposter syndrome and how to manage it in your statistical career. 

    Episode 100: Dionne Price, ASA President-Elect

    Play Episode Listen Later May 31, 2022 37:10


    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

    Play Episode Listen Later May 2, 2022 33:46


    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

    Play Episode Listen Later Mar 30, 2022 53:45


    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

    Episode 97 - Devan Mehrotra

    Play Episode Listen Later Feb 28, 2022 49:11


    Devan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.

    Episode 96: Alan Hartford

    Play Episode Listen Later Jan 31, 2022 32:12


    Alan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.

    Episode 95: Anna Nevius

    Play Episode Listen Later Nov 30, 2021 31:16


     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

    Play Episode Listen Later Oct 29, 2021 34:29


    Bob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.

    Episode 93: External Control Arms

    Play Episode Listen Later Sep 30, 2021 53:53


    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

    Play Episode Listen Later Aug 17, 2021 35:51


    Bo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.

    Episode 91: Patient Reported Outcomes

    Play Episode Listen Later Jul 30, 2021 62:04


    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

    Play Episode Listen Later Jun 30, 2021 31:38


    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

    Play Episode Listen Later May 31, 2021 47:43


    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

    Play Episode Listen Later Apr 30, 2021 56:50


    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

    Play Episode Listen Later Mar 31, 2021 64:59


    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

    Play Episode Listen Later Feb 25, 2021 47:09


    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

    Play Episode Listen Later Jan 29, 2021 40:52


    Weili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.

    Episode 84: David Salsburg

    Play Episode Listen Later Jan 1, 2021 46:01


    David shares some of his experiences as the first statistician ever hired at Pfizer.

    Episode 83: Vaccine Development

    Play Episode Listen Later Nov 30, 2020 35:25


    Kerry Go and Elaine Hoffman discuss vaccine development.

    Episode 82: Olga Marchenko and Natallia Katenka

    Play Episode Listen Later Oct 30, 2020 49:29


    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

    Play Episode Listen Later Sep 30, 2020 102:56


    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.

    Episode 80: 2020 Regulatory-Industry Statistics Workshop

    Play Episode Listen Later Aug 31, 2020 47:42


    Yabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.

    Episode 79: Nusrat Rabbee

    Play Episode Listen Later Jul 31, 2020 67:24


    Nusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.

    Episode 78: Challenges with Pain Assessments

    Play Episode Listen Later Jun 30, 2020 54:05


    Dottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.

    Episode 77: National Institute of Statistical Sciences

    Play Episode Listen Later May 29, 2020 54:15


    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.

    national institutes statistical sciences
    Episode 76: COVID-19 and Clinical Trials

    Play Episode Listen Later Apr 15, 2020 46:44


    Mouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.

    Episode 75: Meijuan Li

    Play Episode Listen Later Mar 31, 2020 52:39


    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

    Play Episode Listen Later Feb 28, 2020 47:20


    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

    Play Episode Listen Later Feb 3, 2020 44:30


    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

    Play Episode Listen Later Dec 31, 2019 56:02


    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

    Play Episode Listen Later Dec 2, 2019 59:08


    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.

    Episode 70: 2020 International Conference on Health Policy Statistics

    Play Episode Listen Later Oct 31, 2019 45:32


    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

    Play Episode Listen Later Sep 30, 2019 50:47


    Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.

    Episode 68: 2019 Regulatory-Industry Statistics Workshop

    Play Episode Listen Later Aug 30, 2019 44:26


    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

    Play Episode Listen Later Jul 29, 2019 51:20


    Donna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.

    Episode 66: Quality Tolerance Limits

    Play Episode Listen Later Jun 28, 2019 40:40


    Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.

    Episode 65: Immuno-oncology

    Play Episode Listen Later May 31, 2019 46:25


    Inna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development.

    Episode 64: Biopharmaceutical Software Scientific Working Group

    Play Episode Listen Later Apr 30, 2019 52:39


    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.

    Episode 63: Platform Trials

    Play Episode Listen Later Mar 28, 2019 56:38


    Zoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.

    Episode 62: Qi Tang

    Play Episode Listen Later Feb 27, 2019 42:47


    Qi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.

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