ASA Biopharm's Podcast

ASA Biopharm's Podcast

community.amstat.org/BioP/Home
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 i…


69: Non-proportional Hazards
Sep 30 • 50 min
Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.
68: 2019 Regulatory-Industry Statistics Workshop
Aug 30 • 44 min
Judy Li and Renee Rees discuss what’s new and exciting at the 2019 Regulatory-Industry Statistics Workshop.
67: Task Force on Sexual Harassment and Assault
Jul 29 • 51 min
Donna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.
66: Quality Tolerance Limits
Jun 28 • 40 min
Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits.
65: Immuno-oncology
May 31 • 46 min
Inna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development.
64: Biopharmaceutical Software Scientific Working Group
Apr 30 • 52 min
Alex Dmitrienko and Kyle Wathen talk about the development of software for biopharmaceutical applications, the new working group and
63: Platform Trials
Mar 29 • 56 min
Zoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.
62: Qi Tang
Feb 28 • 42 min
Qi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.
61: Richard C. Zink
Jan 31 • 53 min
Richard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.
60: Toshimitsu Hamasaki
Dec 31, 2018 • 28 min
Toshimitsu Hamasaki describes his work at a major research hospital and discusses the regulatory environment in Japan.
59: Alzheimer’s Disease Scientific Working Group
Nov 30, 2018 • 47 min
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.
58: SPAIG (Statistical Partnerships Among Academe, Industry & Government)
Oct 31, 2018 • 26 min
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.
57: Personalized Medicine and Wearable Devices
Sep 28, 2018 • 34 min
Shanthi Sethuraman and Haoda Fu discuss challenges and opportunities in using wearable devices for research in diabetes.
56: Yun Wang and Satrajit Roychoudhury
Aug 27, 2018 • 43 min
Yun and Satrajit discuss the 2018 Regulatory-Industry Statistics Workshop.
55: Data Monitoring Committees
Jul 27, 2018 • 53 min
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.
54: Statistics Without Borders
Jun 29, 2018 • 49 min
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.
53: Abuse Deterrent Opioids
May 31, 2018 • 43 min
Ling Chen and Kunthel By discuss methods related to the development of abuse deterrent opioids.
52: ASA Accreditation
Apr 27, 2018 • 70 min
Zoltan Harsanyi, Janet McDougall, and Theresa Utlaut discuss the PStat® and GStat® accreditations.
51: The Effective Statistician
Mar 28, 2018 • 46 min
Alexander Schacht and Benjamin Piske discuss their new podcast and the many ways statisticians can make themselves more effective.
50: Lisa LaVange
Feb 21, 2018 • 50 min
ASA President Lisa LaVange describes her varied career across industry, government and academia, and discusses the establishment of the ASA Leadership Institute.
49: Heather Thomas
Jan 25, 2018 • 47 min
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.
48: PhUSE, the Pharmaceutical Users Software Exchange
Dec 2, 2017 • 51 min
Stephen Bamford, Chris Hurley and James Johnson discuss the motivation for and initiatives of PhUSE
47: Pediatric Medical Product Development
Nov 6, 2017 • 45 min
Susan Wang and Amy Xia discuss the challenges of pediatric medical product development.
46: Re-Randomization of Subjects Scientific Working Group
Oct 15, 2017 • 53 min
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.
45: Kelly Zou
Sep 19, 2017 • 24 min
Kelly shares her thoughts on real world data and real world evidence in the healthcare and pharmaceutical industry.
44: Weili He and Martin Ho
Aug 17, 2017 • 35 min
Weili and Martin discuss the 2017 Regulatory-Industry Statistics Workshop.
43: 40th Anniversary of PSI
Jul 27, 2017 • 47 min
Andy Grieve, Nigel Howitt, John Lewis and Lucy Rowell reminisce about PSI’s past and look forward to its future.
42: Committee on Minorities in Statistics
Jun 29, 2017 • 47 min
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.
41: Liz Stuart
Jun 5, 2017 • 42 min
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.
40: Estimands
May 8, 2017 • 56 min
Yuki Ando, Frank Bretz, Rob Hemmings and Tom Permutt discuss estimands and the ICH E9 revisions.
39: Alex Dmitrienko
Mar 14, 2017 • 58 min
Alex discusses multiplicity, the FDA’s draft guidance on multiple endpoints, and the BIOP pilot online training program.
38: Amanda Golbeck
Feb 20, 2017 • 33 min
Amanda discusses statistical leadership and her book Leadership and Women in Statistics.
37: Multiregional Clinical Trials
Jan 26, 2017 • 61 min
Aloka Chakravarty, Laurie Letvak and Bill Wang discuss MRCTs and the draft ICH E17 guidance.
36: Statistical Leadership
Dec 21, 2016 • 59 min
Sonia Davis, Bill Sollecito and Paula Brown Stafford discuss statistical leadership and leadership training at the University of North Carolina at Chapel Hill.
35: EFSPI Benefit-Risk Working Group
Nov 10, 2016 • 44 min
Alexander Schacht and Ian Hirsch discuss benefit-risk and the efforts of the EFSPI working group.
34: Patient Preferences in Medical Product Evaluation
Oct 7, 2016 • 45 min
Telba Irony and Martin Ho discuss the important of patient preferences.
33: Freda Cooner and Ed Luo
Sep 6, 2016 • 19 min
Freda and Ed discuss what to expect at the 2016 Biopharm Workshop
32: Marisa Bacchi
Aug 17, 2016 • 40 min
Marisa Bacchi discusses the first EFSPI workshop on regulatory statistics.
31: Data Science
Jul 14, 2016 • 47 min
Marie Davidian, Montse Fuentes & Mladen Vouk define data science, discuss related ASA initiatives and describe the data science program at NC State.
30: Women in Statistics and Data Science Conference
May 25, 2016 • 33 min
Donna LaLonde, Dalene Stangl & Jiayang Sun discuss the origins and program for the upcoming WSDS conference.
29: Statistics and Pharmacometrics Interest Group
Apr 30, 2016 • 34 min
Alan Hartford and Matt Rotelli discuss the mission of the group and the importance of communication between statisticians and pharmacometricians.
28: The Caucus for Women in Statistics
Mar 25, 2016 • 56 min
Nancy Flournoy, Ji-Hyun Lee, Paula Roberson and Jiayang Sun discuss the goals and activities of the caucus.
27: Veronica Taylor
Jan 12, 2016 • 34 min
Veronica discusses the Center for Veterinary Medicine at FDA.
26: Data Transparency
Dec 15, 2015 • 47 min
Michael Hale, Jonathan Hartzel, Sara Hughes, Ted Lystig & Estelle Russek-Cohen discuss the implications of data transparency for the pharmaceutical industry.
25: Interview with Greg Campbell
Nov 9, 2015 • 50 min
Greg Campbell discusses his career at the FDA and shares his thoughts on the future of medical product development.
24: International Society for Biopharmaceutical Statistics
Oct 6, 2015 • 37 min
Amit Bhattacharyya, Jie Chen, Frank Fan & Yang Song discuss the mission of the ISBS and the regulatory environment in China.
23: Wei Zhang and Richard Zink
Aug 18, 2015 • 29 min
Wei and Richard discuss the 2015 ASA Biopharmaceutical Section Statistics Workshop. Rima Izem conducts the interview.
22: Qi Jiang and Olga Marchenko
Apr 17, 2015 • 23 min
Qi and Olga discuss the first scientific working group of the ASA Biopharmaceutical Section.
21: Interview with Dionne Price
Feb 27, 2015 • 20 min
As current Chair for the Biopharmaceutical Section, Dionne discusses her goals for the upcoming year.
20: Interview with Chrissie Fletcher
Jan 6, 2015 • 20 min
Chrissie Fletcher discusses EFSPI, the European Federation of Statisticians in the Pharmaceutical Industry.
19: Interview with Zoran Antonijevic
Dec 8, 2014 • 22 min
Zoran Antonijevic discusses the DIA Scientific Working Group on Adaptive Designs, and the upcoming Joint Adaptive Design and Bayesian Statistics Conference in Feb 2015.
18: Interview with Amarjot Kaur
Nov 19, 2014 • 27 min
Amarjot Kaur discusses the new mentoring program of the ASA Biopharmaceutical Section.
17: A Conversation with Bob O’Neill
Oct 20, 2014 • 104 min
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 in…
16: Interview with Ted Lystig
Sep 29, 2014 • 19 min
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.
15: Interview with Cristiana Mayer and Shiowjen Lee
Aug 29, 2014 • 30 min
Cristiana and Shiowjen discuss the 2014 ASA Biopharm Section FDA-Industry Statistics Workshop.
14: Interview with Biopharm Program Chair Ivan Chan
Jul 14, 2014 • 14 min
Ivan Chan discusses Biopharm Section activities at the 2014 Joint Statistical Meetings in Boston.
13: American Statistical Association 175th Anniversary Discussion
Jun 26, 2014 • 23 min
12: Interview with Statisticians in the Pharmaceutical Industry (PSI)
May 20, 2014 • 23 min
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.
11: Interview with ASA Biopharmaceutical Section Chair Matilde Sanchez-Kam
Apr 18, 2014 • 12 min
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.
10: Bayesian Methods
Mar 28, 2014 • 18 min
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.
9: Trends and Innovations in Clinical Trial Statistics Conference
Feb 25, 2014 • 10 min
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.
8: Interview with Nate Silver
Oct 18, 2013 • 17 min
Nate Silver talks prediction, Bayesian methods, communicating statistical ideas to the general public and how to better educate people in statistical thinking.
7: An interview with Ben Locwin
Oct 1, 2013 • 11 min
Ben Locwin discusses data quality and why he thinks statistics is a requirement for good science.
6: Interview With Lily Yue and Bruce Binkowitz
Sep 4, 2013 • 15 min
5: Interview with Estelle Russek-Cohen
Aug 3, 2013 • 6 min
4: Interview with Amit Bhattacharyya
Jul 4, 2013 • 6 min
3: Interview with Stephen Senn
May 3, 2013 • 8 min
2: Interview with Jingyee Kou and Alan Hartford
Sep 6, 2012 • 7 min
Jingyee and Alan discuss the 2012 FDA-Industry Workshop.
1: Special Issue on Nonclinical Biopharmaceutical Statistics
Aug 6, 2012 • 16 min
Interview with Stan Altan & Timothy L. Schofield