ASA Biopharm's Podcast
112 episodes - English - Latest episode: 3 months ago - ★★★★★ - 12 ratingsIn 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.
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Episodes
Episode 107: SPAIG Committee
February 09, 2024 16:00 - 27 minutes - 19 MBScott 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
June 02, 2023 14:00 - 40 minutes - 27.5 MBAmy 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
April 28, 2023 12:00 - 43 minutes - 30.3 MBAdrian and Wendy discuss imposter syndrome and being confident in your career.
Episode 104: Steve Ruberg
January 17, 2023 18:00 - 1 hour - 42.3 MBIn 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
September 30, 2022 14:00 - 28 minutes - 19.5 MBTian discusses her research in data integration methods and the bias arising from lack of representation.
Episode 102: LaShell Robinson
August 03, 2022 17:00 - 36 minutes - 25.3 MBLaShell discusses diversity, equity, and inclusion in clinical trials.
Episode 101: Elizabeth Mannshardt-Hawk on Imposter Syndrome
June 30, 2022 18:00 - 45 minutes - 31.5 MBElizabeth 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
May 31, 2022 13:00 - 37 minutes - 25.6 MBDionne 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
May 02, 2022 16:00 - 33 minutes - 23.2 MBThis 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
March 30, 2022 17:00 - 53 minutes - 37 MBJames 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
February 28, 2022 22:00 - 49 minutes - 33.8 MBDevan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.
Episode 96: Alan Hartford
January 31, 2022 23:00 - 32 minutes - 22.2 MBAlan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.
Episode 95: Anna Nevius
November 30, 2021 18:00 - 31 minutes - 21.5 MBAnna 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
October 29, 2021 13:00 - 34 minutes - 23.7 MBBob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.
Episode 93: External Control Arms
September 30, 2021 16:00 - 53 minutes - 37.1 MBAmy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.
Episode 92: 2021 Regulatory-Industry Statistics Workshop
August 17, 2021 19:00 - 35 minutes - 24.7 MBBo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.
Episode 91: Patient Reported Outcomes
July 30, 2021 10:00 - 1 hour - 42.7 MBJoseph 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
June 30, 2021 20:00 - 31 minutes - 21.8 MBHaoda 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
May 31, 2021 20:00 - 47 minutes - 32.8 MBKarl 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
April 30, 2021 20:00 - 56 minutes - 39.1 MBKatherine 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
March 31, 2021 15:00 - 1 hour - 44.7 MBScott 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
February 25, 2021 18:00 - 47 minutes - 32.4 MBMeg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important.
Episode 85: Weili He
January 29, 2021 20:00 - 40 minutes - 28.1 MBWeili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.
Episode 84: David Salsburg
January 01, 2021 03:00 - 46 minutes - 31.7 MBDavid shares some of his experiences as the first statistician ever hired at Pfizer.
Episode 83: Vaccine Development
November 30, 2020 22:00 - 35 minutes - 24.4 MBKerry Go and Elaine Hoffman discuss vaccine development.
Episode 82: Olga Marchenko and Natallia Katenka
October 30, 2020 20:00 - 49 minutes - 34 MBOlga 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
September 30, 2020 21:00 - 1 hour - 70.7 MBThis 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
August 31, 2020 14:00 - 47 minutes - 32.8 MBYabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.
Episode 79: Nusrat Rabbee
July 31, 2020 15:00 - 1 hour - 46.3 MBNusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.
Episode 78: Challenges with Pain Assessments
June 30, 2020 11:00 - 54 minutes - 37.2 MBDottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.
Episode 77: National Institute of Statistical Sciences
May 29, 2020 20:00 - 54 minutes - 37.3 MBNancy 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
April 15, 2020 16:00 - 46 minutes - 32.1 MBMouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.
Episode 75: Meijuan Li
March 31, 2020 13:00 - 52 minutes - 36.2 MBMeijuan 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
February 28, 2020 14:00 - 47 minutes - 32.6 MBGlen 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
February 03, 2020 15:00 - 44 minutes - 30.6 MBBruce 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
December 31, 2019 20:00 - 56 minutes - 38.5 MBAbie 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
December 02, 2019 14:00 - 59 minutes - 40.7 MBLisa 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
October 31, 2019 13:00 - 45 minutes - 31.3 MBKate 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
September 30, 2019 13:00 - 50 minutes - 34.9 MBKeaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.
Episode 68: 2019 Regulatory-Industry Statistics Workshop
August 30, 2019 13:00 - 44 minutes - 30.6 MBJudy 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
July 29, 2019 22:00 - 51 minutes - 35.3 MBDonna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.
Episode 66: Quality Tolerance Limits
June 28, 2019 13:00 - 40 minutes - 28 MBRakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.
Episode 65: Immuno-oncology
May 31, 2019 12:00 - 46 minutes - 21.3 MBInna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development.
Episode 64: Biopharmaceutical Software Scientific Working Group
April 30, 2019 12:00 - 52 minutes - 24.2 MBAlex 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
March 29, 2019 04:00 - 56 minutes - 26 MBZoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.
Episode 62: Qi Tang
February 28, 2019 05:00 - 42 minutes - 19.7 MBQi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.
Episode 61: Richard C. Zink
January 31, 2019 05:00 - 53 minutes - 24.8 MBRichard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.
Episode 60: Toshimitsu Hamasaki
December 31, 2018 16:00 - 28 minutes - 13.1 MBToshimitsu Hamasaki describes his work at a major research hospital and discusses the regulatory environment in Japan.
Episode 59: Alzheimer's Disease Scientific Working Group
November 30, 2018 15:00 - 47 minutes - 21.9 MBHong Liu-Seifert and Steve Wilson discuss the challenges of developing new treatments for Alzheimer's Disease and the formation of the scientific working group.
Episode 58: SPAIG (Statistical Partnerships Among Academe, Industry & Government)
October 31, 2018 04:00 - 26 minutes - 12 MBPam McGovern, Willis Jensen, John Kolassa, and Fanni Natanegara talk about collaboration and the Statistical Partnerships Among Academe, Industry & Government Committee, otherwise known as SPAIG.