ASA Biopharm's Podcast: Recent Episodes
American Statistical Association (ASA) Biopharm. Section
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.
Rebecca Wilson, Katie Brickey, John Kolassa, Jocelyn Sendecki, Paul Faya, and Mahan Dastgiri discuss the 2025 ASA Biopharmaceutical Section Nonclinical Biostatistics Conference.
Erik Bloomquist, Wanjie Sun, Yingwen Dong, and Jonathan Moscovici discuss what occurs behind the curtain at the Regulatory-Industry Statistics Workshop.
John McGready discusses how to prepare future statisticians to succeed in the era of AI.
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
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
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.
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.
Amy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.
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.
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.
Richard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.
Toshimitsu Hamasaki describes his work at a major research hospital and discusses the regulatory environment in Japan.
Hong Liu-Seifert and Steve Wilson discuss the challenges of developing new treatments for Alzheimer's Disease and the formation of the scientific working group.
Pam McGovern, Willis Jensen, John Kolassa, and Fanni Natanegara talk about collaboration and the Statistical Partnerships Among Academe, Industry & Government Committee, otherwise known as SPAIG.
Shanthi Sethuraman and Haoda Fu discuss challenges and opportunities in using wearable devices for research in diabetes.
Aparna Anderson, David DeMets, Susan Ellenberg, and Janet Wittes discuss the history of data monitoring committees and some of the challenges of implementing them in practice.
Cathy Furlong and Gary Shapiro discuss the history of Statistics Without Borders and how statisticians can use their skills to give back to the community.
Ling Chen and Kunthel By discuss methods related to the development of abuse deterrent opioids.
Zoltan Harsanyi, Janet McDougall, and Theresa Utlaut discuss the PStat® and GStat® accreditations.
Alexander Schacht and Benjamin Piske discuss their new podcast and the many ways statisticians can make themselves more effective.
ASA President Lisa LaVange describes her varied career across industry, government and academia, and discusses the establishment of the ASA Leadership Institute.
Heather discusses her goals for the Biopharmaceutical Section in 2018 and describes the life of a medical product statistician living in a non-traditional area.
Stephen Bamford, Chris Hurley and James Johnson discuss the motivation for and initiatives of PhUSE
Susan Wang and Amy Xia discuss the challenges of pediatric medical product development.
Gheorghe Doros, Anastasia Ivanova, and George Papakostas discuss the Sequential Parallel Comparison Design and the newly-formed Clinical Trial Designs with Re-Randomization of Subjects Scientific Working Group.
Kelly shares her thoughts on real world data and real world evidence in the healthcare and pharmaceutical industry.
Andy Grieve, Nigel Howitt, John Lewis and Lucy Rowell reminisce about PSI’s past and look forward to its future.
Reneé Moore and Janelle Charles discuss the mission and major initiatives of the Committee on Minorities in Statistics and the many ways statisticians can get involved.
Liz discusses the Health Policy Statistics Section (HPSS) of the ASA, the upcoming 2018 International Conference on Health Policy Statistics (ICHPS), as well as some of the major topic areas of focus for health policy statistics.
Yuki Ando, Frank Bretz, Rob Hemmings and Tom Permutt discuss estimands and the ICH E9 revisions.
Alex discusses multiplicity, the FDA’s draft guidance on multiple endpoints, and the BIOP pilot online training program.
Amanda discusses statistical leadership and her book Leadership and Women in Statistics.
Aloka Chakravarty, Laurie Letvak and Bill Wang discuss MRCTs and the draft ICH E17 guidance.
Sonia Davis, Bill Sollecito and Paula Brown Stafford discuss statistical leadership and leadership training at the University of North Carolina at Chapel Hill.
Alexander Schacht and Ian Hirsch discuss benefit-risk and the efforts of the EFSPI working group.
Marie Davidian, Montse Fuentes & Mladen Vouk define data science, discuss related ASA initiatives and describe the data science program at NC State.
Donna LaLonde, Dalene Stangl & Jiayang Sun discuss the origins and program for the upcoming WSDS conference.
Alan Hartford and Matt Rotelli discuss the mission of the group and the importance of communication between statisticians and pharmacometricians.
Nancy Flournoy, Ji-Hyun Lee, Paula Roberson and Jiayang Sun discuss the goals and activities of the caucus.
Michael Hale, Jonathan Hartzel, Sara Hughes, Ted Lystig & Estelle Russek-Cohen discuss the implications of data transparency for the pharmaceutical industry.
Greg Campbell discusses his career at the FDA and shares his thoughts on the future of medical product development.
Amit Bhattacharyya, Jie Chen, Frank Fan & Yang Song discuss the mission of the ISBS and the regulatory environment in China.
Wei and Richard discuss the 2015 ASA Biopharmaceutical Section Statistics Workshop. Rima Izem conducts the interview.
Qi and Olga discuss the first scientific working group of the ASA Biopharmaceutical Section.
As current Chair for the Biopharmaceutical Section, Dionne discusses her goals for the upcoming year.
Chrissie Fletcher discusses EFSPI, the European Federation of Statisticians in the Pharmaceutical Industry.
Zoran Antonijevic discusses the DIA Scientific Working Group on Adaptive Designs, and the upcoming Joint Adaptive Design and Bayesian Statistics Conference in Feb 2015.
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 the past, present, and future of regulatory statistics in an interview format with Dr. Scott Evans. Topics include: Dr. O’Neill’s view of challenging issues of the future, key challenges for the FDA during his tenure, and training in regulatory statistics and decision making.
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 Medical Devices and Diagnostics.
Cristiana and Shiowjen discuss the 2014 ASA Biopharm Section FDA-Industry Statistics Workshop.
Ivan Chan discusses Biopharm Section activities at the 2014 Joint Statistical Meetings in Boston.
The past, current and chair-elect of PSI (Katherine Hutchinson, Robert Cuffe and Mark Morris, respectively) describe the history of the organization and discuss differences in the regulatory experience between the U.S. and E.U.
Biopharmaceutical Section Chair Matilde Sanchez-Kam talks about the challenges of a small pharmaceutical company, volunteering with the section, and building collaborations with other statistics organizations.
Karen Price talks about all things Bayesian in the world of pharmaceutical development: methodology, the DIA Bayesian Scientific Working Group, and the special Bayesian issue of Pharmaceutical Statistics.
Olga Marchenko from Quintiles gives a brief overview of the upcoming Trends and Innovations in Clinical Trial Statistics Conference to take place April 21-23 in Research Triangle Park, North Carolina.
Nate Silver talks prediction, Bayesian methods, communicating statistical ideas to the general public and how to better educate people in statistical thinking.
Ben Locwin discusses data quality and why he thinks statistics is a requirement for good science.