Shows
ASA Biopharm's PodcastEpisode 104: Steve RubergIn 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. 2023-01-171h 01ASA Biopharm's PodcastEpisode 101: Elizabeth Mannshardt-Hawk on Imposter SyndromeElizabeth discusses imposter syndrome and how to manage it in your statistical career. In collaboration with the ASA's Committee on Career Development (CCD website) . 2022-06-3045 minASA Biopharm's PodcastEpisode 100: Dionne Price, ASA President-ElectDionne talks about her journey in biostatistics and her goals for the ASA when she becomes President in 2023.2022-05-3137 minASA Biopharm's PodcastEpisode 96: Alan HartfordAlan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.2022-02-0132 minASA Biopharm's PodcastEpisode 95: Anna Nevius Anna Nevius reflects on her time at the Center for Veterinary Medicine at the FDA and as chair of the Biopharmaceutical Section in 2009.2021-11-3031 minASA Biopharm's PodcastEpisode 94: Bob StarbuckBob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.2021-10-2934 minASA Biopharm's PodcastEpisode 93: External Control ArmsAmy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.2021-09-3053 minASA Biopharm's PodcastEpisode 92: 2021 Regulatory-Industry Statistics WorkshopBo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.2021-08-1735 minASA Biopharm's PodcastEpisode 91: Patient Reported OutcomesJoseph Cappelleri and Daniel O’Connor discuss the benefits and challenges in using patient reported outcomes and how to appropriately define clinically-meaningful change.2021-07-301h 02ASA Biopharm's PodcastEpisode 90: ICSA Leadership PanelHaoda Fu, Mengling Liu, Jie Tang, Tian Zheng, and Kelly Zou discuss leadership and the impact of COVID-19 on the workplace.2021-06-3031 minASA Biopharm's PodcastEpisode 89: Karl PeaceKarl 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.2021-05-3147 minASA Biopharm's PodcastEpisode 88: Katherine MontiKatherine Monti was chair of the Biopharmaceutical Section in 2010. She discusses her career in the industry and how the Section has changed over time. 2021-04-3056 minASA Biopharm's PodcastEpisode 87: StorytellingScott Evans, Stephanie Omokaro, Janet Wittes, and Zhiheng Xu discuss the importance of storytelling for the modern statistician. 2021-03-311h 04ASA Biopharm's PodcastEpisode 86: Pediatric Drug Development Scientific Working GroupMeg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important.2021-02-2547 minASA Biopharm's PodcastEpisode 85: Weili HeWeili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.2021-01-2940 minASA Biopharm's PodcastEpisode 84: David SalsburgDavid shares some of his experiences as the first statistician ever hired at Pfizer.2021-01-0146 minASA Biopharm's PodcastEpisode 83: Vaccine DevelopmentKerry Go and Elaine Hoffman discuss vaccine development.2020-11-3035 minASA Biopharm's PodcastEpisode 82: Olga Marchenko and Natallia KatenkaOlga and Natallia discuss their new book Quantitative Methods in Pharmaceutical Research and Development: Concepts and Applications. 2020-10-3049 minASA Biopharm's PodcastEpisode 81: Mentor-Mentee Pairs from the BIOP Mentoring ProgramThis 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. 2020-09-301h 42ASA Biopharm's PodcastEpisode 80: 2020 Regulatory-Industry Statistics WorkshopYabing Mai and Thomas Birkner discuss the 2020 Workshop and the changes necessary to go virtual.2020-08-3147 minASA Biopharm's PodcastEpisode 79: Nusrat RabbeeNusrat discusses biomarker analysis throughout clinical development and her recent book Biomarker Analysis in Clinical Trials with R.2020-07-311h 07ASA Biopharm's PodcastEpisode 78: Challenges with Pain AssessmentsDottie Brown, Ciprian Crainiceanu, and Jean Recta discuss how pain is quantified in human and animal trials.2020-06-3054 minASA Biopharm's PodcastEpisode 77: National Institute of Statistical SciencesNancy 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.2020-05-2954 minASA Biopharm's PodcastEpisode 76: COVID-19 and Clinical TrialsMouna Akacha, Yongming Qu, and Aileen Ward discuss COVID-19 and the operational and statistical effects on clinical trials.2020-04-1546 minASA Biopharm's PodcastEpisode 75: Meijuan LiMeijuan Li discusses precision medicine, diagnostic devices, and the importance of parallel development of drugs and diagnostics. 2020-03-3152 minASA Biopharm's PodcastEpisode 74: Glen Colopy and the Pod of AsclepiusGlen 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. 2020-02-2847 minASA Biopharm's PodcastEpisode 73: Bruce BinkowitzBruce discusses the Japanese regulatory environment, challenges for statistics departments spread across the globe, and his hopes and plans for the Biopharmaceutical Section in 2020.2020-02-0344 minASA Biopharm's PodcastEpisode 72: Abie EkangakiAbie discusses opportunities for statisticians in the CRO industry, and we chat about the Scholarship and Leadership-in-Practice Committees of the Biopharmaceutical Section.2019-12-3156 minASA Biopharm's PodcastEpisode 71: P-values in Medical Product DevelopmentLisa 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. 2019-12-0259 minASA Biopharm's PodcastEpisode 70: 2020 International Conference on Health Policy StatisticsKate 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. 2019-10-3145 minASA Biopharm's PodcastEpisode 69: Non-proportional HazardsKeaven Anderson, Pralay Mukhopadhyay, and Satrajit Roychoudhury discuss non-proportional hazards in a regulatory setting.2019-09-3050 minASA Biopharm's PodcastEpisode 68: 2019 Regulatory-Industry Statistics WorkshopJudy Li and Renee Rees discuss what's new and exciting at the 2019 Regulatory-Industry Statistics Workshop.2019-08-3044 minASA Biopharm's PodcastEpisode 67: Task Force on Sexual Harassment and AssaultDonna LaLonde, Kristian Lum, and Leslie McClure discuss the ASA Task Force on Sexual Harassment and Assault.2019-07-3051 minASA Biopharm's PodcastEpisode 66: Quality Tolerance LimitsRakhi Kilaru and Olgica Klindworth discuss risk-based monitoring and quality tolerance limits. 2019-06-2840 minASA Biopharm's PodcastEpisode 65: Immuno-oncologyInna Perevozskaya and Bo Huang discuss the changing landscape in oncology clinical development. 2019-05-3146 minASA Biopharm's PodcastEpisode 64: Biopharmaceutical Software Scientific Working GroupAlex 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.2019-04-3052 minASA Biopharm's PodcastEpisode 63: Platform TrialsZoran Antonijevic, Robert Beckman, Scott Berry & Richard Simon discuss the current application and future of platform trials. 2019-03-2956 minASA Biopharm's PodcastEpisode 62: Qi TangQi talks about the benefits and challenges of applying deep learning methodologies to electronic medical records.2019-02-2842 minASA Biopharm's PodcastEpisode 61: Richard C. ZinkRichard discusses the importance of the Biopharmaceutical Section and describes what he hopes to accomplish as Chair in 2019.2019-01-3153 minASA Biopharm's PodcastEpisode 60: Toshimitsu HamasakiToshimitsu Hamasaki describes his work at a major research hospital and discusses the regulatory environment in Japan.2018-12-3128 minASA Biopharm's PodcastEpisode 59: Alzheimer's Disease Scientific Working GroupHong Liu-Seifert and Steve Wilson discuss the challenges of developing new treatments for Alzheimer's Disease and the formation of the scientific working group.2018-11-3047 minASA Biopharm's PodcastEpisode 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. 2018-10-3126 minASA Biopharm's PodcastEpisode 57: Personalized Medicine and Wearable DevicesShanthi Sethuraman and Haoda Fu discuss challenges and opportunities in using wearable devices for research in diabetes.2018-09-2834 minASA Biopharm's PodcastEpisode 56: Yun Wang and Satrajit RoychoudhuryYun and Satrajit discuss the 2018 Regulatory-Industry Statistics Workshop.2018-08-2743 minASA Biopharm's PodcastEpisode 55: Data Monitoring CommitteesAparna 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.2018-07-2753 minASA Biopharm's PodcastEpisode 54: Statistics Without BordersCathy Furlong and Gary Shapiro discuss the history of Statistics Without Borders and how statisticians can use their skills to give back to the community.2018-06-2949 minASA Biopharm's PodcastEpisode 53: Abuse Deterrent OpioidsLing Chen and Kunthel By discuss methods related to the development of abuse deterrent opioids.2018-05-3143 minASA Biopharm's PodcastEpisode 52: ASA AccreditationZoltan Harsanyi, Janet McDougall, and Theresa Utlaut discuss the PStat® and GStat® accreditations.2018-04-271h 10ASA Biopharm's PodcastEpisode 51: The Effective StatisticianAlexander Schacht and Benjamin Piske discuss their new podcast and the many ways statisticians can make themselves more effective.2018-03-2846 minASA Biopharm's PodcastEpisode 50: Lisa LaVangeASA President Lisa LaVange describes her varied career across industry, government and academia, and discusses the establishment of the ASA Leadership Institute.2018-02-2150 minASA Biopharm's PodcastEpisode 49: Heather ThomasHeather discusses her goals for the Biopharmaceutical Section in 2018 and describes the life of a medical product statistician living in a non-traditional area.2018-01-2547 minASA Biopharm's PodcastEpisode 48: PhUSE, the Pharmaceutical Users Software ExchangeStephen Bamford, Chris Hurley and James Johnson discuss the motivation for and initiatives of PhUSE2017-12-0251 minASA Biopharm's PodcastEpisode 47: Pediatric Medical Product DevelopmentSusan Wang and Amy Xia discuss the challenges of pediatric medical product development.2017-11-0645 minASA Biopharm's PodcastEpisode 46: Re-Randomization of Subjects Scientific Working GroupGheorghe 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.2017-10-1553 minASA Biopharm's PodcastEpisode 45: Kelly ZouKelly shares her thoughts on real world data and real world evidence in the healthcare and pharmaceutical industry.2017-09-1924 minASA Biopharm's PodcastEpisode 44: Weili He and Martin HoWeili and Martin discuss the 2017 Regulatory-Industry Statistics Workshop.2017-08-1735 minASA Biopharm's PodcastEpisode 43: 40th Anniversary of PSIAndy Grieve, Nigel Howitt, John Lewis and Lucy Rowell reminisce about PSI’s past and look forward to its future.2017-07-2747 minASA Biopharm's PodcastEpisode 42: Committee on Minorities in StatisticsReneé 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.2017-06-2947 minASA Biopharm's PodcastEpisode 41: Liz StuartLiz 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.2017-06-0542 minASA Biopharm's PodcastEpisode 40: EstimandsYuki Ando, Frank Bretz, Rob Hemmings and Tom Permutt discuss estimands and the ICH E9 revisions.2017-05-0856 minASA Biopharm's PodcastEpisode 39: Alex DmitrienkoAlex discusses multiplicity, the FDA’s draft guidance on multiple endpoints, and the BIOP pilot online training program.2017-03-1458 minASA Biopharm's PodcastEpisode 38: Amanda GolbeckAmanda discusses statistical leadership and her book Leadership and Women in Statistics.2017-02-2033 minASA Biopharm's PodcastEpisode 37: Multiregional Clinical TrialsAloka Chakravarty, Laurie Letvak and Bill Wang discuss MRCTs and the draft ICH E17 guidance.2017-01-261h 01ASA Biopharm's PodcastEpisode 36: Statistical LeadershipSonia Davis, Bill Sollecito and Paula Brown Stafford discuss statistical leadership and leadership training at the University of North Carolina at Chapel Hill.2016-12-2159 minASA Biopharm's PodcastEpisode 35: EFSPI Benefit-Risk Working GroupAlexander Schacht and Ian Hirsch discuss benefit-risk and the efforts of the EFSPI working group.2016-11-1044 minASA Biopharm's PodcastEpisode 34: Patient Preferences in Medical Product EvaluationTelba Irony and Martin Ho discuss the important of patient preferences.2016-10-0745 minASA Biopharm's PodcastEpisode 33: Freda Cooner and Ed LuoFreda and Ed discuss what to expect at the 2016 Biopharm Workshop2016-09-0619 minASA Biopharm's PodcastEpisode 32: Marisa BacchiMarisa Bacchi discusses the first EFSPI workshop on regulatory statistics.2016-08-1740 minASA Biopharm's PodcastEpisode 31: Data ScienceMarie Davidian, Montse Fuentes & Mladen Vouk define data science, discuss related ASA initiatives and describe the data science program at NC State.
2016-07-1447 minASA Biopharm's PodcastEpisode 30: Women in Statistics and Data Science ConferenceDonna LaLonde, Dalene Stangl & Jiayang Sun discuss the origins and program for the upcoming WSDS conference.2016-05-2533 minASA Biopharm's PodcastEpisode 29: Statistics and Pharmacometrics Interest GroupAlan Hartford and Matt Rotelli discuss the mission of the group and the importance of communication between statisticians and pharmacometricians.2016-04-3034 minASA Biopharm's PodcastEpisode 28: The Caucus for Women in StatisticsNancy Flournoy, Ji-Hyun Lee, Paula Roberson and Jiayang Sun discuss the goals and activities of the caucus.2016-03-2556 minASA Biopharm's PodcastEpisode 27: Veronica TaylorVeronica discusses the Center for Veterinary Medicine at FDA.2016-01-1234 minASA Biopharm's PodcastEpisode 27: Veronica TaylorVeronica discusses the Center for Veterinary Medicine at FDA.2016-01-1234 minASA Biopharm's PodcastEpisode 26: Data TransparencyMichael Hale, Jonathan Hartzel, Sara Hughes, Ted Lystig & Estelle Russek-Cohen discuss the implications of data transparency for the pharmaceutical industry.2015-12-1547 minASA Biopharm's PodcastEpisode 25: Interview with Greg CampbellGreg Campbell discusses his career at the FDA and shares his thoughts on the future of medical product development.2015-11-0950 minASA Biopharm's PodcastEpisode 24: International Society for Biopharmaceutical StatisticsAmit Bhattacharyya, Jie Chen, Frank Fan & Yang Song discuss the mission of the ISBS and the regulatory environment in China.2015-10-0637 minASA Biopharm's PodcastEpisode 23: Wei Zhang and Richard ZinkWei and Richard discuss the 2015 ASA Biopharmaceutical Section Statistics Workshop. Rima Izem conducts the interview.2015-08-1829 minASA Biopharm's PodcastEpisode 22: Qi Jiang and Olga MarchenkoQi and Olga discuss the first scientific working group of the ASA Biopharmaceutical Section.2015-04-1723 minASA Biopharm's PodcastEpisode 21: Interview with Dionne PriceAs current Chair for the Biopharmaceutical Section, Dionne discusses her goals for the upcoming year.2015-02-2720 minASA Biopharm's PodcastEpisode 20: Interview with Chrissie FletcherChrissie Fletcher discusses EFSPI, the European Federation of Statisticians in the Pharmaceutical Industry.2015-01-0620 minASA Biopharm's PodcastEpisode 19: Interview with Zoran AntonijevicZoran Antonijevic discusses the DIA Scientific Working Group on Adaptive Designs, and the upcoming Joint Adaptive Design and Bayesian Statistics Conference in Feb 2015.2014-12-0822 minASA Biopharm's PodcastEpisode 18: Interview with Amarjot KaurAmarjot Kaur discusses the new mentoring program of the ASA Biopharmaceutical Section.2014-11-1927 minASA Biopharm's PodcastEpisode 17: A Conversation with Bob O’NeillA 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 statistics and decision making. 2014-10-201h 44ASA Biopharm's PodcastEpisode 16: Interview with Ted LystigTed 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.2014-09-2919 minASA Biopharm's PodcastEpisode 15: Interview with Cristiana Mayer and Shiowjen LeeCristiana and Shiowjen discuss the 2014 ASA Biopharm Section FDA-Industry Statistics Workshop.2014-08-2930 minASA Biopharm's PodcastEpisode 14: Interview with Biopharm Program Chair Ivan ChanIvan Chan discusses Biopharm Section activities at the 2014 Joint Statistical Meetings in Boston.2014-07-1414 minASA Biopharm's PodcastEpisode 13: American Statistical Association 175th Anniversary Discussion2014-06-2623 minASA Biopharm's PodcastEpisode 12: Interview with Statisticians in the Pharmaceutical Industry (PSI)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.2014-05-2023 minASA Biopharm's PodcastEpisode 11: Interview with ASA Biopharmaceutical Section Chair Matilde Sanchez-KamBiopharmaceutical 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.2014-04-1812 minASA Biopharm's PodcastEpisode 10: Bayesian MethodsKaren 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.2014-03-2818 minASA Biopharm's PodcastEpisode 9: Trends and Innovations in Clinical Trial Statistics ConferenceOlga 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.2014-02-2510 minASA Biopharm's PodcastEpisode 8: Interview with Nate SilverNate Silver talks prediction, Bayesian methods, communicating statistical ideas to the general public and how to better educate people in statistical thinking. 2013-10-1817 minASA Biopharm's PodcastEpisode 7: An interview with Ben LocwinBen Locwin discusses data quality and why he thinks statistics is a requirement for good science.2013-10-0111 minASA Biopharm's PodcastEpisode 6: Interview With Lily Yue and Bruce Binkowitz2013-09-0415 minASA Biopharm's PodcastEpisode 5: Interview with Estelle Russek-Cohen2013-08-0306 minASA Biopharm's PodcastEpisode 4: Interview with Amit Bhattacharyya2013-07-0406 minASA Biopharm's PodcastEpisode 3: Interview with Stephen Senn2013-05-0308 minASA Biopharm's PodcastEpisode 2: Interview with Jingyee Kou and Alan HartfordJingyee and Alan discuss the 2012 FDA-Industry Workshop.2012-09-0607 minASA Biopharm's PodcastEpisode 1: Special Issue on Nonclinical Biopharmaceutical StatisticsInterview with Stan Altan & Timothy L. Schofield2012-08-0616 min