ASA Biopharm's Podcast artwork

ASA Biopharm's Podcast

112 episodes - English - Latest episode: 3 months ago - ★★★★★ - 12 ratings

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.

Science statistics asa biopharmaceutical biopharm
Homepage Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed

Episodes

Episode 107: SPAIG Committee

February 09, 2024 16:00 - 27 minutes - 19 MB

Scott Clark,  Satrajit Roychoudhury, and Michelle Shardell discuss the Statistical Partnerships Among Academe, Industry & Government (SPAIG) Committee. https://community.amstat.org/spaig/home

Episode 106: Rebbecca Wilson

June 02, 2023 14:00 - 40 minutes - 27.5 MB

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

Episode 105: Adrian Coles and Wendy Martinez

April 28, 2023 12:00 - 43 minutes - 30.3 MB

Adrian and Wendy discuss imposter syndrome and being confident in your career.

Episode 104: Steve Ruberg

January 17, 2023 18:00 - 1 hour - 42.3 MB

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. 

Episode 103: Tian Gu

September 30, 2022 14:00 - 28 minutes - 19.5 MB

Tian discusses her research in data integration methods and the bias arising from lack of representation.

Episode 102: LaShell Robinson

August 03, 2022 17:00 - 36 minutes - 25.3 MB

LaShell discusses diversity, equity, and inclusion in clinical trials.

Episode 101: Elizabeth Mannshardt-Hawk on Imposter Syndrome

June 30, 2022 18:00 - 45 minutes - 31.5 MB

Elizabeth discusses imposter syndrome and how to manage it in your statistical career.  In collaboration with the ASA's Committee on Career Development (CCD website) . 

Episode 100: Dionne Price, ASA President-Elect

May 31, 2022 13:00 - 37 minutes - 25.6 MB

Dionne talks about her journey in biostatistics and her goals for the ASA when she becomes President in 2023.

Episode 99: Amy LaLonde and Christina Nurse

May 02, 2022 16:00 - 33 minutes - 23.2 MB

This episode introduces new podcast cohosts Amy LaLonde and Christina Nurse!  They take over hosting duties starting with Episode 101.

Episode 98: Safety Scientific Working Group

March 30, 2022 17:00 - 53 minutes - 37 MB

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

Episode 97 - Devan Mehrotra

February 28, 2022 22:00 - 49 minutes - 33.8 MB

Devan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.

Episode 96: Alan Hartford

January 31, 2022 23:00 - 32 minutes - 22.2 MB

Alan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.

Episode 95: Anna Nevius

November 30, 2021 18:00 - 31 minutes - 21.5 MB

 Anna Nevius reflects on her time at the Center for Veterinary Medicine at the FDA and as chair of the Biopharmaceutical Section in 2009.

Episode 94: Bob Starbuck

October 29, 2021 13:00 - 34 minutes - 23.7 MB

Bob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.

Episode 93: External Control Arms

September 30, 2021 16:00 - 53 minutes - 37.1 MB

Amy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.

Episode 92: 2021 Regulatory-Industry Statistics Workshop

August 17, 2021 19:00 - 35 minutes - 24.7 MB

Bo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.

Episode 91: Patient Reported Outcomes

July 30, 2021 10:00 - 1 hour - 42.7 MB

Joseph Cappelleri and Daniel O’Connor discuss the benefits and challenges in using patient reported outcomes and how to appropriately define clinically-meaningful change.

Episode 90: ICSA Leadership Panel

June 30, 2021 20:00 - 31 minutes - 21.8 MB

Haoda Fu, Mengling Liu, Jie Tang, Tian Zheng, and Kelly Zou discuss leadership and the impact of COVID-19 on the workplace.

Episode 89: Karl Peace

May 31, 2021 20:00 - 47 minutes - 32.8 MB

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.

Episode 88: Katherine Monti

April 30, 2021 20:00 - 56 minutes - 39.1 MB

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. 

Episode 87: Storytelling

March 31, 2021 15:00 - 1 hour - 44.7 MB

Scott Evans, Stephanie Omokaro, Janet Wittes, and Zhiheng Xu discuss the importance of storytelling for the modern statistician. 

Episode 86: Pediatric Drug Development Scientific Working Group

February 25, 2021 18:00 - 47 minutes - 32.4 MB

Meg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important.

Episode 85: Weili He

January 29, 2021 20:00 - 40 minutes - 28.1 MB

Weili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.

Episode 84: David Salsburg

January 01, 2021 03:00 - 46 minutes - 31.7 MB

David shares some of his experiences as the first statistician ever hired at Pfizer.

Episode 83: Vaccine Development

November 30, 2020 22:00 - 35 minutes - 24.4 MB

Kerry Go and Elaine Hoffman discuss vaccine development.

Episode 82: Olga Marchenko and Natallia Katenka

October 30, 2020 20:00 - 49 minutes - 34 MB

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

September 30, 2020 21:00 - 1 hour - 70.7 MB

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. 

Episode 80: 2020 Regulatory-Industry Statistics Workshop

August 31, 2020 14:00 - 47 minutes - 32.8 MB

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

Episode 79: Nusrat Rabbee

July 31, 2020 15:00 - 1 hour - 46.3 MB

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

Episode 78: Challenges with Pain Assessments

June 30, 2020 11:00 - 54 minutes - 37.2 MB

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

Episode 77: National Institute of Statistical Sciences

May 29, 2020 20:00 - 54 minutes - 37.3 MB

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

April 15, 2020 16:00 - 46 minutes - 32.1 MB

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

Episode 75: Meijuan Li

March 31, 2020 13:00 - 52 minutes - 36.2 MB

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

February 28, 2020 14:00 - 47 minutes - 32.6 MB

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.  

Episode 73: Bruce Binkowitz

February 03, 2020 15:00 - 44 minutes - 30.6 MB

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

December 31, 2019 20:00 - 56 minutes - 38.5 MB

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

December 02, 2019 14:00 - 59 minutes - 40.7 MB

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. 

Episode 70: 2020 International Conference on Health Policy Statistics

October 31, 2019 13:00 - 45 minutes - 31.3 MB

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

September 30, 2019 13:00 - 50 minutes - 34.9 MB

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

Episode 68: 2019 Regulatory-Industry Statistics Workshop

August 30, 2019 13:00 - 44 minutes - 30.6 MB

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

July 29, 2019 22:00 - 51 minutes - 35.3 MB

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

Episode 66: Quality Tolerance Limits

June 28, 2019 13:00 - 40 minutes - 28 MB

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

Episode 65: Immuno-oncology

May 31, 2019 12:00 - 46 minutes - 21.3 MB

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

Episode 64: Biopharmaceutical Software Scientific Working Group

April 30, 2019 12:00 - 52 minutes - 24.2 MB

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.

Episode 63: Platform Trials

March 29, 2019 04:00 - 56 minutes - 26 MB

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

Episode 62: Qi Tang

February 28, 2019 05:00 - 42 minutes - 19.7 MB

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

Episode 61: Richard C. Zink

January 31, 2019 05:00 - 53 minutes - 24.8 MB

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

Episode 60: Toshimitsu Hamasaki

December 31, 2018 16:00 - 28 minutes - 13.1 MB

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

November 30, 2018 15:00 - 47 minutes - 21.9 MB

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)

October 31, 2018 04:00 - 26 minutes - 12 MB

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.