ASA Biopharm's Podcast
Episodes
Episode 113: RISW: A Look Behind the Curtain
18 Sep 2025
Contributed by Lukas
Erik Bloomquist, Wanjie Sun, Yingwen Dong, and Jonathan Moscovici discuss what occurs behind the curtain at the Regulatory-Industry Statistics Worksho...
Episode 112: Preparing Future Statisticians to Succeed in the Era of AI
04 Apr 2025
Contributed by Lukas
John McGready discusses how to prepare future statisticians to succeed in the era of AI.
Episode 111: Nan Laird
16 Jan 2025
Contributed by Lukas
A look at the life and accomplishments of Nan Laird.
Episode 110: STATBOLIC Cardiometabolic Statistical Workshop
05 Dec 2024
Contributed by Lukas
Jürgen Hummel, Hiya Banerjee, Jingyi Liu, Jason Legg, and Henrik Ravn discuss the inaugural STATBOLIC Workshop.
Episode 109: Ian Sturdy
09 Jun 2024
Contributed by Lukas
Ian describes how to leverage ChatGPT to accelerate statistical programming in the medical product industry.Related paper available here: https://www....
Episode 108: Working Moms
06 May 2024
Contributed by Lukas
Elaine Hoffman, Rebbecca Wilson, Christina Nurse, and Amy LaLonde discuss the balancing act between family and career.
Episode 107: SPAIG Committee
09 Feb 2024
Contributed by Lukas
Scott Clark, Satrajit Roychoudhury, and Michelle Shardell discuss the Statistical Partnerships Among Academe, Industry & Government (SPAIG) Comm...
Episode 106: Rebbecca Wilson
02 Jun 2023
Contributed by Lukas
Amy welcomes Rebbecca to the co-hosting chair while Christina enjoys some time off with her new baby (congrats)! The two discuss Rebbecca’s fascinat...
Episode 105: Adrian Coles and Wendy Martinez
28 Apr 2023
Contributed by Lukas
Adrian and Wendy discuss imposter syndrome and being confident in your career.
Episode 104: Steve Ruberg
17 Jan 2023
Contributed by Lukas
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 ...
Episode 103: Tian Gu
30 Sep 2022
Contributed by Lukas
Tian discusses her research in data integration methods and the bias arising from lack of representation.
Episode 102: LaShell Robinson
03 Aug 2022
Contributed by Lukas
LaShell discusses diversity, equity, and inclusion in clinical trials.
Episode 101: Elizabeth Mannshardt-Hawk on Imposter Syndrome
30 Jun 2022
Contributed by Lukas
Elizabeth discusses imposter syndrome and how to manage it in your statistical career. In collaboration with the ASA's Committee on Career Deve...
Episode 100: Dionne Price, ASA President-Elect
31 May 2022
Contributed by Lukas
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
02 May 2022
Contributed by Lukas
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
30 Mar 2022
Contributed by Lukas
James Buchanan, Judy Li, Melvin Munsaka, and Bill Wang discuss the research of the Safety Scientific Working Group and their recent edited volume &quo...
Episode 97 - Devan Mehrotra
28 Feb 2022
Contributed by Lukas
Devan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.
Episode 96: Alan Hartford
31 Jan 2022
Contributed by Lukas
Alan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.
Episode 95: Anna Nevius
30 Nov 2021
Contributed by Lukas
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
29 Oct 2021
Contributed by Lukas
Bob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.
Episode 93: External Control Arms
30 Sep 2021
Contributed by Lukas
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
17 Aug 2021
Contributed by Lukas
Bo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.
Episode 91: Patient Reported Outcomes
30 Jul 2021
Contributed by Lukas
Joseph Cappelleri and Daniel O’Connor discuss the benefits and challenges in using patient reported outcomes and how to appropriately define clinica...
Episode 90: ICSA Leadership Panel
30 Jun 2021
Contributed by Lukas
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
31 May 2021
Contributed by Lukas
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, a...
Episode 88: Katherine Monti
30 Apr 2021
Contributed by Lukas
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
31 Mar 2021
Contributed by Lukas
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
25 Feb 2021
Contributed by Lukas
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
29 Jan 2021
Contributed by Lukas
Weili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.
Episode 84: David Salsburg
01 Jan 2021
Contributed by Lukas
David shares some of his experiences as the first statistician ever hired at Pfizer.
Episode 83: Vaccine Development
30 Nov 2020
Contributed by Lukas
Kerry Go and Elaine Hoffman discuss vaccine development.
Episode 82: Olga Marchenko and Natallia Katenka
30 Oct 2020
Contributed by Lukas
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
30 Sep 2020
Contributed by Lukas
This episode features discussions with 3 mentor-mentee pairs from the Biopharmaceutical Section mentoring program. Conversations include Qing Li and A...
Episode 80: 2020 Regulatory-Industry Statistics Workshop
31 Aug 2020
Contributed by Lukas
Yabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.
Episode 79: Nusrat Rabbee
31 Jul 2020
Contributed by Lukas
Nusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.
Episode 78: Challenges with Pain Assessments
30 Jun 2020
Contributed by Lukas
Dottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.
Episode 77: National Institute of Statistical Sciences
29 May 2020
Contributed by Lukas
Nancy Flournoy, Dan Holder, and Jim Rosenberger discuss the mission and history of the National Institute of Statistical Sciences and how it will adap...
Episode 76: COVID-19 and Clinical Trials
15 Apr 2020
Contributed by Lukas
Mouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.
Episode 75: Meijuan Li
31 Mar 2020
Contributed by Lukas
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
28 Feb 2020
Contributed by Lukas
Glen discusses his graduate training in data science in the United Kingdom, vital sign monitoring, the challenges of efficient drug supply, and his he...
Episode 73: Bruce Binkowitz
03 Feb 2020
Contributed by Lukas
Bruce discusses the Japanese regulatory environment, challenges for statistics departments spread across the globe, and his hopes and plans for the Bi...
Episode 72: Abie Ekangaki
31 Dec 2019
Contributed by Lukas
Abie discusses opportunities for statisticians in the CRO industry, and we chat about the Scholarship and Leadership-in-Practice Committees of the Bio...
Episode 71: P-values in Medical Product Development
02 Dec 2019
Contributed by Lukas
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 ...
Episode 70: 2020 International Conference on Health Policy Statistics
31 Oct 2019
Contributed by Lukas
Kate Crespi and Ofer Harel discuss the 2020 International Conference on Health Policy Statistics, and describe current topics of interest in health po...
Episode 69: Non-proportional Hazards
30 Sep 2019
Contributed by Lukas
Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.
Episode 68: 2019 Regulatory-Industry Statistics Workshop
30 Aug 2019
Contributed by Lukas
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
29 Jul 2019
Contributed by Lukas
Donna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.
Episode 66: Quality Tolerance Limits
28 Jun 2019
Contributed by Lukas
Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.
Episode 65: Immuno-oncology
31 May 2019
Contributed by Lukas
Inna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development.
Episode 64: Biopharmaceutical Software Scientific Working Group
30 Apr 2019
Contributed by Lukas
Alex Dmitrienko and Kyle Wathen talk about the development of software for biopharmaceutical applications, the new working group and LinkedIn group, a...
Episode 63: Platform Trials
29 Mar 2019
Contributed by Lukas
Zoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.
Episode 62: Qi Tang
28 Feb 2019
Contributed by Lukas
Qi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.
Episode 61: Richard C. Zink
31 Jan 2019
Contributed by Lukas
Richard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.
Episode 60: Toshimitsu Hamasaki
31 Dec 2018
Contributed by Lukas
Toshimitsu Hamasaki describes his work at a major research hospital and discusses the regulatory environment in Japan.
Episode 59: Alzheimer's Disease Scientific Working Group
30 Nov 2018
Contributed by Lukas
Hong Liu-Seifert and Steve Wilson discuss the challenges of developing new treatments for Alzheimer's Disease and the formation of the scientific...
Episode 58: SPAIG (Statistical Partnerships Among Academe, Industry & Government)
31 Oct 2018
Contributed by Lukas
Pam McGovern, Willis Jensen, John Kolassa, and Fanni Natanegara talk about collaboration and the Statistical Partnerships Among Academe, Industry &...
Episode 57: Personalized Medicine and Wearable Devices
28 Sep 2018
Contributed by Lukas
Shanthi Sethuraman and Haoda Fu discuss challenges and opportunities in using wearable devices for research in diabetes.
Episode 56: Yun Wang and Satrajit Roychoudhury
27 Aug 2018
Contributed by Lukas
Yun and Satrajit discuss the 2018 Regulatory-Industry Statistics Workshop.
Episode 55: Data Monitoring Committees
27 Jul 2018
Contributed by Lukas
Aparna Anderson, David DeMets, Susan Ellenberg, and Janet Wittes discuss the history of data monitoring committees and some of the challenges of imple...
Episode 54: Statistics Without Borders
29 Jun 2018
Contributed by Lukas
Cathy Furlong and Gary Shapiro discuss the history of Statistics Without Borders and how statisticians can use their skills to give back to the commun...
Episode 53: Abuse Deterrent Opioids
31 May 2018
Contributed by Lukas
Ling Chen and Kunthel By discuss methods related to the development of abuse deterrent opioids.
Episode 52: ASA Accreditation
27 Apr 2018
Contributed by Lukas
Zoltan Harsanyi, Janet McDougall, and Theresa Utlaut discuss the PStat® and GStat® accreditations.
Episode 51: The Effective Statistician
28 Mar 2018
Contributed by Lukas
Alexander Schacht and Benjamin Piske discuss their new podcast and the many ways statisticians can make themselves more effective.
Episode 50: Lisa LaVange
21 Feb 2018
Contributed by Lukas
ASA President Lisa LaVange describes her varied career across industry, government and academia, and discusses the establishment of the ASA Leadership...
Episode 49: Heather Thomas
25 Jan 2018
Contributed by Lukas
Heather discusses her goals for the Biopharmaceutical Section in 2018 and describes the life of a medical product statistician living in a non-traditi...
Episode 48: PhUSE, the Pharmaceutical Users Software Exchange
02 Dec 2017
Contributed by Lukas
Stephen Bamford, Chris Hurley and James Johnson discuss the motivation for and initiatives of PhUSE
Episode 47: Pediatric Medical Product Development
06 Nov 2017
Contributed by Lukas
Susan Wang and Amy Xia discuss the challenges of pediatric medical product development.
Episode 46: Re-Randomization of Subjects Scientific Working Group
15 Oct 2017
Contributed by Lukas
Gheorghe Doros, Anastasia Ivanova, and George Papakostas discuss the Sequential Parallel Comparison Design and the newly-formed Clinical Trial Designs...
Episode 45: Kelly Zou
19 Sep 2017
Contributed by Lukas
Kelly shares her thoughts on real world data and real world evidence in the healthcare and pharmaceutical industry.
Episode 44: Weili He and Martin Ho
17 Aug 2017
Contributed by Lukas
Weili and Martin discuss the 2017 Regulatory-Industry Statistics Workshop.
Episode 43: 40th Anniversary of PSI
27 Jul 2017
Contributed by Lukas
Andy Grieve, Nigel Howitt, John Lewis and Lucy Rowell reminisce about PSI’s past and look forward to its future.
Episode 42: Committee on Minorities in Statistics
29 Jun 2017
Contributed by Lukas
Reneé Moore and Janelle Charles discuss the mission and major initiatives of the Committee on Minorities in Statistics and the many ways statistician...
Episode 41: Liz Stuart
05 Jun 2017
Contributed by Lukas
Liz discusses the Health Policy Statistics Section (HPSS) of the ASA, the upcoming 2018 International Conference on Health Policy Statistics (ICHPS), ...
Episode 40: Estimands
08 May 2017
Contributed by Lukas
Yuki Ando, Frank Bretz, Rob Hemmings and Tom Permutt discuss estimands and the ICH E9 revisions.
Episode 39: Alex Dmitrienko
14 Mar 2017
Contributed by Lukas
Alex discusses multiplicity, the FDA’s draft guidance on multiple endpoints, and the BIOP pilot online training program.
Episode 38: Amanda Golbeck
20 Feb 2017
Contributed by Lukas
Amanda discusses statistical leadership and her book Leadership and Women in Statistics.
Episode 37: Multiregional Clinical Trials
26 Jan 2017
Contributed by Lukas
Aloka Chakravarty, Laurie Letvak and Bill Wang discuss MRCTs and the draft ICH E17 guidance.
Episode 36: Statistical Leadership
21 Dec 2016
Contributed by Lukas
Sonia Davis, Bill Sollecito and Paula Brown Stafford discuss statistical leadership and leadership training at the University of North Carolina at Cha...
Episode 35: EFSPI Benefit-Risk Working Group
10 Nov 2016
Contributed by Lukas
Alexander Schacht and Ian Hirsch discuss benefit-risk and the efforts of the EFSPI working group.
Episode 34: Patient Preferences in Medical Product Evaluation
07 Oct 2016
Contributed by Lukas
Telba Irony and Martin Ho discuss the important of patient preferences.
Episode 33: Freda Cooner and Ed Luo
06 Sep 2016
Contributed by Lukas
Freda and Ed discuss what to expect at the 2016 Biopharm Workshop
Episode 32: Marisa Bacchi
17 Aug 2016
Contributed by Lukas
Marisa Bacchi discusses the first EFSPI workshop on regulatory statistics.
Episode 31: Data Science
14 Jul 2016
Contributed by Lukas
Marie Davidian, Montse Fuentes & Mladen Vouk define data science, discuss related ASA initiatives and describe the data science program at NC Stat...
Episode 30: Women in Statistics and Data Science Conference
25 May 2016
Contributed by Lukas
Donna LaLonde, Dalene Stangl & Jiayang Sun discuss the origins and program for the upcoming WSDS conference.
Episode 29: Statistics and Pharmacometrics Interest Group
30 Apr 2016
Contributed by Lukas
Alan Hartford and Matt Rotelli discuss the mission of the group and the importance of communication between statisticians and pharmacometricians.
Episode 28: The Caucus for Women in Statistics
25 Mar 2016
Contributed by Lukas
Nancy Flournoy, Ji-Hyun Lee, Paula Roberson and Jiayang Sun discuss the goals and activities of the caucus.
Episode 27: Veronica Taylor
12 Jan 2016
Contributed by Lukas
Veronica discusses the Center for Veterinary Medicine at FDA.
Episode 26: Data Transparency
15 Dec 2015
Contributed by Lukas
Michael Hale, Jonathan Hartzel, Sara Hughes, Ted Lystig & Estelle Russek-Cohen discuss the implications of data transparency for the pharmaceutica...
Episode 25: Interview with Greg Campbell
09 Nov 2015
Contributed by Lukas
Greg Campbell discusses his career at the FDA and shares his thoughts on the future of medical product development.
Episode 24: International Society for Biopharmaceutical Statistics
06 Oct 2015
Contributed by Lukas
Amit Bhattacharyya, Jie Chen, Frank Fan & Yang Song discuss the mission of the ISBS and the regulatory environment in China.
Episode 23: Wei Zhang and Richard Zink
18 Aug 2015
Contributed by Lukas
Wei and Richard discuss the 2015 ASA Biopharmaceutical Section Statistics Workshop. Rima Izem conducts the interview.
Episode 22: Qi Jiang and Olga Marchenko
17 Apr 2015
Contributed by Lukas
Qi and Olga discuss the first scientific working group of the ASA Biopharmaceutical Section.
Episode 21: Interview with Dionne Price
27 Feb 2015
Contributed by Lukas
As current Chair for the Biopharmaceutical Section, Dionne discusses her goals for the upcoming year.
Episode 20: Interview with Chrissie Fletcher
06 Jan 2015
Contributed by Lukas
Chrissie Fletcher discusses EFSPI, the European Federation of Statisticians in the Pharmaceutical Industry.
Episode 19: Interview with Zoran Antonijevic
08 Dec 2014
Contributed by Lukas
Zoran Antonijevic discusses the DIA Scientific Working Group on Adaptive Designs, and the upcoming Joint Adaptive Design and Bayesian Statistics Confe...
Episode 18: Interview with Amarjot Kaur
19 Nov 2014
Contributed by Lukas
Amarjot Kaur discusses the new mentoring program of the ASA Biopharmaceutical Section.
Episode 17: A Conversation with Bob O’Neill
20 Oct 2014
Contributed by Lukas
A recording of A Conversation with Bob O'Neill which took place during a recent ASA Boston Chapter meeting. Dr. O’Neill discusses aspects of ...
Episode 16: Interview with Ted Lystig
29 Sep 2014
Contributed by Lukas
Ted Lystig discusses some of the unique challenges present in the development of medical devices, and the recent formation of the new ASA Section on M...
Episode 15: Interview with Cristiana Mayer and Shiowjen Lee
29 Aug 2014
Contributed by Lukas
Cristiana and Shiowjen discuss the 2014 ASA Biopharm Section FDA-Industry Statistics Workshop.
Episode 14: Interview with Biopharm Program Chair Ivan Chan
14 Jul 2014
Contributed by Lukas
Ivan Chan discusses Biopharm Section activities at the 2014 Joint Statistical Meetings in Boston.