Episode 82: Olga Marchenko and Natallia Katenka
Olga and Natallia discuss their new book Quantitative Methods in Pharmaceutical Research and Development: Concepts and Applications .
Oct 30, 2020•49 min
ASA Biopharm's Podcast
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.
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Episodes
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 Kimbrough and Bruce Binkowitz (start 102:29). They discuss the benefits of mentoring and the dynamics of the mentoring relationship.
Sep 30, 2020•1 hr 43 min
Episode 80: 2020 Regulatory-Industry Statistics Workshop
Yabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.
Aug 31, 2020•48 min
Episode 79: Nusrat Rabbee
Nusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.
Jul 31, 2020•1 hr 7 min
Episode 78: Challenges with Pain Assessments
Dottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.
Jun 30, 2020•54 min
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.
May 29, 2020•54 min
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.
Apr 15, 2020•47 min
Episode 75: Meijuan Li
Meijuan Li discusses precision medicine, diagnostic devices, and the importance of parallel development of drugs and diagnostics.
Mar 31, 2020•53 min
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.
Feb 28, 2020•47 min
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.
Feb 03, 2020•45 min
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.
Dec 31, 2019•56 min
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 in early 2019.
Dec 02, 2019•59 min
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.
Oct 31, 2019•46 min
Episode 69: Non-proportional Hazards
Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.
Sep 30, 2019•51 min
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.
Aug 30, 2019•44 min
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.
Jul 29, 2019•51 min
Episode 66: Quality Tolerance Limits
Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.
Jun 28, 2019•41 min
Episode 65: Immuno-oncology
Inna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development.
May 31, 2019•46 min
Episode 64: Biopharmaceutical Software Scientific Working Group
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....
Apr 30, 2019•53 min
Episode 63: Platform Trials
Zoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.
Mar 29, 2019•57 min
Episode 62: Qi Tang
Qi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.
Feb 28, 2019•43 min
Episode 61: Richard C. Zink
Richard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.
Jan 31, 2019•54 min
Episode 60: Toshimitsu Hamasaki
Toshimitsu Hamasaki describes his work at a major research hospital and discusses the regulatory environment in Japan.
Dec 31, 2018•29 min
Episode 59: Alzheimer's Disease Scientific Working Group
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.
Nov 30, 2018•48 min
Episode 58: SPAIG (Statistical Partnerships Among Academe, Industry & Government)
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.
Oct 31, 2018•26 min
Episode 57: Personalized Medicine and Wearable Devices
Shanthi Sethuraman and Haoda Fu discuss challenges and opportunities in using wearable devices for research in diabetes.
Sep 28, 2018•35 min
Episode 56: Yun Wang and Satrajit Roychoudhury
Yun and Satrajit discuss the 2018 Regulatory-Industry Statistics Workshop.
Aug 27, 2018•44 min
Episode 55: Data Monitoring Committees
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.
Jul 27, 2018•53 min
Episode 54: Statistics Without Borders
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.
Jun 29, 2018•49 min
Episode 53: Abuse Deterrent Opioids
Ling Chen and Kunthel By discuss methods related to the development of abuse deterrent opioids.
May 31, 2018•44 min
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