Podcasts by ASA Biopharm

Episode 82: Olga Marchenko and Natallia Katenka from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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 ...

Episode 80: 2020 Regulatory-Industry Statistics Workshop from 2021-01-31T22:10:42.023393

Yabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.

Episode 79: Nusrat Rabbee from 2021-01-31T22:10:42.023393

Nusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.

Episode 78: Challenges with Pain Assessments from 2021-01-31T22:10:42.023393

Dottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.

Episode 77: National Institute of Statistical Sciences from 2021-01-31T22:10:42.023393

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.

Episode 76: COVID-19 and Clinical Trials from 2021-01-31T22:10:42.023393

Mouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.

Episode 75: Meijuan Li from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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 Asclepi...

Episode 73: Bruce Binkowitz from 2021-01-31T22:10:42.023393

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.

Episode 72: Abie Ekangaki from 2021-01-31T22:10:42.023393

Abie discusses opportunities for statisticians in the CRO industry, and we chat about the Scholarship and Leadership-in-Practice Committees of the Biopharmaceutical Section.

Episode 71: P-values in Medical Product Development from 2021-01-31T22:10:42.023393

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...

Episode 70: 2020 International Conference on Health Policy Statistics from 2021-01-31T22:10:42.023393

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. 

Episode 69: Non-proportional Hazards from 2021-01-31T22:10:42.023393

Keaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.

Episode 68: 2019 Regulatory-Industry Statistics Workshop from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

Donna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.

Episode 66: Quality Tolerance Limits from 2021-01-31T22:10:42.023393

Rakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits. 

Episode 65: Immuno-oncology from 2021-01-31T22:10:42.023393

Inna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development. 

Episode 64: Biopharmaceutical Software Scientific Working Group from 2021-01-31T22:10:42.023393

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 Chan...

Episode 63: Platform Trials from 2021-01-31T22:10:42.023393

Zoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials.  

Episode 62: Qi Tang from 2021-01-31T22:10:42.023393

Qi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.

Episode 61: Richard C. Zink from 2021-01-31T22:10:42.023393

Richard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.

Episode 60: Toshimitsu Hamasaki from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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.

Episode 58: SPAIG (Statistical Partnerships Among Academe, Industry & Government) from 2021-01-31T22:10:42.023393

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. 

Episode 57: Personalized Medicine and Wearable Devices from 2021-01-31T22:10:42.023393

Shanthi Sethuraman and Haoda Fu discuss challenges and opportunities in using wearable devices for research in diabetes.

Episode 56: Yun Wang and Satrajit Roychoudhury from 2021-01-31T22:10:42.023393

Yun and Satrajit discuss the 2018 Regulatory-Industry Statistics Workshop.

Episode 55: Data Monitoring Committees from 2021-01-31T22:10:42.023393

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.

Episode 54: Statistics Without Borders from 2021-01-31T22:10:42.023393

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.

Episode 53: Abuse Deterrent Opioids from 2021-01-31T22:10:42.023393

Ling Chen and Kunthel By discuss methods related to the development of abuse deterrent opioids.

Episode 52: ASA Accreditation from 2021-01-31T22:10:42.023393

Zoltan Harsanyi, Janet McDougall, and Theresa Utlaut discuss the PStat® and GStat® accreditations.

Episode 51: The Effective Statistician from 2021-01-31T22:10:42.023393

Alexander Schacht and Benjamin Piske discuss their new podcast and the many ways statisticians can make themselves more effective.

Episode 50: Lisa LaVange from 2021-01-31T22:10:42.023393

ASA President Lisa LaVange describes her varied career across industry, government and academia, and discusses the establishment of the ASA Leadership Institute.

Episode 49: Heather Thomas from 2021-01-31T22:10:42.023393

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.

Episode 48: PhUSE, the Pharmaceutical Users Software Exchange from 2021-01-31T22:10:42.023393

Stephen Bamford, Chris Hurley and James Johnson discuss the motivation for and initiatives of PhUSE

Episode 47: Pediatric Medical Product Development from 2021-01-31T22:10:42.023393

Susan Wang and Amy Xia discuss the challenges of pediatric medical product development.

Episode 46: Re-Randomization of Subjects Scientific Working Group from 2021-01-31T22:10:42.023393

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 W...

Episode 45: Kelly Zou from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

Weili and Martin discuss the 2017 Regulatory-Industry Statistics Workshop.

Episode 43: 40th Anniversary of PSI from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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.

Episode 41: Liz Stuart from 2021-01-31T22:10:42.023393

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 foc...

Episode 40: Estimands from 2021-01-31T22:10:42.023393

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

Episode 39: Alex Dmitrienko from 2021-01-31T22:10:42.023393

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

Episode 38: Amanda Golbeck from 2021-01-31T22:10:42.023393

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

Episode 37: Multiregional Clinical Trials from 2021-01-31T22:10:42.023393

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

Episode 36: Statistical Leadership from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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

Episode 34: Patient Preferences in Medical Product Evaluation from 2021-01-31T22:10:42.023393

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

Episode 33: Freda Cooner and Ed Luo from 2021-01-31T22:10:42.023393

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

Episode 32: Marisa Bacchi from 2021-01-31T22:10:42.023393

Marisa Bacchi discusses the first EFSPI workshop on regulatory statistics.

Episode 31: Data Science from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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

Episode 29: Statistics and Pharmacometrics Interest Group from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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

Episode 27: Veronica Taylor from 2021-01-31T22:10:42.023393

Veronica discusses the Center for Veterinary Medicine at FDA.

Episode 26: Data Transparency from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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

Episode 22: Qi Jiang and Olga Marchenko from 2021-01-31T22:10:42.023393

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

Episode 21: Interview with Dionne Price from 2021-01-31T22:10:42.023393

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

Episode 20: Interview with Chrissie Fletcher from 2021-01-31T22:10:42.023393

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

Episode 19: Interview with Zoran Antonijevic from 2021-01-31T22:10:42.023393

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 from 2021-01-31T22:10:42.023393

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

Episode 17: A Conversation with Bob O’Neill from 2021-01-31T22:10:42.023393

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...

Episode 16: Interview with Ted Lystig from 2021-01-31T22:10:42.023393

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.

Episode 15: Interview with Cristiana Mayer and Shiowjen Lee from 2021-01-31T22:10:42.023393

Cristiana and Shiowjen discuss the 2014 ASA Biopharm Section FDA-Industry Statistics Workshop.

Episode 14: Interview with Biopharm Program Chair Ivan Chan from 2021-01-31T22:10:42.023393

Ivan Chan discusses Biopharm Section activities at the 2014 Joint Statistical Meetings in Boston.

Episode 13: American Statistical Association 175th Anniversary Discussion from 2021-01-31T22:10:42.023393

Episode 12: Interview with Statisticians in the Pharmaceutical Industry (PSI) from 2021-01-31T22:10:42.023393

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 experi...

Episode 11: Interview with ASA Biopharmaceutical Section Chair Matilde Sanchez-Kam from 2021-01-31T22:10:42.023393

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 or...

Episode 10: Bayesian Methods from 2021-01-31T22:10:42.023393

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 Sta...

Episode 9: Trends and Innovations in Clinical Trial Statistics Conference from 2021-01-31T22:10:42.023393

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.

Episode 8: Interview with Nate Silver from 2021-01-31T22:10:42.023393

Nate Silver talks prediction, Bayesian methods, communicating statistical ideas to the general public and how to better educate people in statistical thinking.

Episode 7: An interview with Ben Locwin from 2021-01-31T22:10:42.023393

Ben Locwin discusses data quality and why he thinks statistics is a requirement for good science.

Episode 6: Interview With Lily Yue and Bruce Binkowitz from 2021-01-31T22:10:42.023393

Episode 5: Interview with Estelle Russek-Cohen from 2021-01-31T22:10:42.023393

Episode 4: Interview with Amit Bhattacharyya from 2021-01-31T22:10:42.023393

Episode 3: Interview with Stephen Senn from 2021-01-31T22:10:42.023393

Episode 2: Interview with Jingyee Kou and Alan Hartford from 2021-01-31T22:10:42.023393

Jingyee and Alan discuss the 2012 FDA-Industry Workshop.

Episode 1: Special Issue on Nonclinical Biopharmaceutical Statistics from 2012-08-06T00:00

Interview with Stan Altan & Timothy L. Schofield