American Statistical Association (ASA) Biopharm. Section

ASA Biopharm's Podcast

Science EN ↓ 115 episodes

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.

Author

American Statistical Association (ASA) Biopharm. Section

Episodes

Episode 40: Estimands 08.05.2017 56:37

Yuki Ando, Frank Bretz, Rob Hemmings and Tom Permutt discuss estimands and the ICH E9 revisions.

Episode 39: Alex Dmitrienko 14.03.2017 58:08

Alex discusses multiplicity, the FDA’s draft guidance on multiple endpoints, and the BIOP pilot online training program.

Episode 38: Amanda Golbeck 20.02.2017 33:20

Amanda discusses statistical leadership and her book Leadership and Women in Statistics.

Episode 37: Multiregional Clinical Trials 26.01.2017 1:01:14

Aloka Chakravarty, Laurie Letvak and Bill Wang discuss MRCTs and the draft ICH E17 guidance.

Episode 36: Statistical Leadership 21.12.2016 59:54

Sonia Davis, Bill Sollecito and Paula Brown Stafford discuss statistical leadership and leadership training at the University of North Carolina at Chapel Hill.

Episode 35: EFSPI Benefit-Risk Working Group 10.11.2016 44:45

Alexander Schacht and Ian Hirsch discuss benefit-risk and the efforts of the EFSPI working group.

Episode 34: Patient Preferences in Medical Product Evaluation 07.10.2016 45:47

Telba Irony and Martin Ho discuss the important of patient preferences.

Episode 33: Freda Cooner and Ed Luo 06.09.2016 19:54

Freda and Ed discuss what to expect at the 2016 Biopharm Workshop

Episode 32: Marisa Bacchi 17.08.2016 40:16

Marisa Bacchi discusses the first EFSPI workshop on regulatory statistics.

Episode 31: Data Science 14.07.2016 47:00

Marie Davidian, Montse Fuentes & Mladen Vouk define data science, discuss related ASA initiatives and describe the data science program at NC State.

Episode 30: Women in Statistics and Data Science Conference 25.05.2016 33:01

Donna LaLonde, Dalene Stangl & Jiayang Sun discuss the origins and program for the upcoming WSDS conference.

Episode 29: Statistics and Pharmacometrics Interest Group 30.04.2016 34:37

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 25.03.2016 56:58

Nancy Flournoy, Ji-Hyun Lee, Paula Roberson and Jiayang Sun discuss the goals and activities of the caucus.

Episode 27: Veronica Taylor 12.01.2016 34:08

Veronica discusses the Center for Veterinary Medicine at FDA.

Episode 26: Data Transparency 15.12.2015 47:00

Michael Hale, Jonathan Hartzel, Sara Hughes, Ted Lystig & Estelle Russek-Cohen discuss the implications of data transparency for the pharmaceutical industry.

Episode 25: Interview with Greg Campbell 09.11.2015 50:03

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 06.10.2015 37:20

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 18.08.2015 29:15

Wei and Richard discuss the 2015 ASA Biopharmaceutical Section Statistics Workshop. Rima Izem conducts the interview.

Episode 22: Qi Jiang and Olga Marchenko 17.04.2015 23:46

Qi and Olga discuss the first scientific working group of the ASA Biopharmaceutical Section.

Episode 21: Interview with Dionne Price 27.02.2015 20:33

As current Chair for the Biopharmaceutical Section, Dionne discusses her goals for the upcoming year.

Episode 20: Interview with Chrissie Fletcher 06.01.2015 20:42

Chrissie Fletcher discusses EFSPI, the European Federation of Statisticians in the Pharmaceutical Industry.

Episode 19: Interview with Zoran Antonijevic 08.12.2014 22:27

Zoran Antonijevic discusses the DIA Scientific Working Group on Adaptive Designs, and the upcoming Joint Adaptive Design and Bayesian Statistics Conference in Feb 2015.

Episode 18: Interview with Amarjot Kaur 19.11.2014 27:04

Amarjot Kaur discusses the new mentoring program of the ASA Biopharmaceutical Section.

Episode 17: A Conversation with Bob O’Neill 20.10.2014 1:44:02

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 statistic...

Episode 16: Interview with Ted Lystig 29.09.2014 19:47

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.