The R Adoption Series
This is a new series of webinars focused on the adoption of R. Each session will include a case study and often include panels or discussions to enable those starting their journey to ask questions.
Upcoming Webinar
Location:
Virtual
Date:
March 30, 2023 at 8 AM PST/ 11 AM EST
Summary:
The R Validation Hub will review the implementation of risk-based approaches to assess R package accuracy within a validated infrastructure and present our learnings from applied case studies. The discussion reflects the thinking of the R Validation Hub working group, which is a cross-industry initiative funded by the R Consortium. Our mission is to enable the use of R by the bio-pharmaceutical industry in a regulatory setting, where the output may be used in submissions to regulatory agencies.
Speaker
Juliane Manitz, Senior Expert Biostatistician at EMD Serono
Juliane Manitz is a statistician in the pharmaceutical industry who currently works in the field of immuno-oncology at EMD Serono, MA USA. In this role, she works on statistical methodology, innovation, and technology. She has contributed to various R packages and is a member of the R validation Hub executive committee working on software validation for usage in pharmaceutical trials.
Breakout Room Leads
Doug Kelkhoff has been supporting the adoption of R in the pharmaceutical space for the past 6 years. During his time at Roche, he has pushed the adoption of R through pilot clinical trials, showcasing the benefits of using R by crafting internal tools and building services that embed the R Validation Hub’s guidance as part of our software development lifecycle. He is passionate about making the use of open source tools in a regulated setting a viable path not just for large pharmaceutical companies, but for lean startups and the public sector by addressing challenges through open initiatives
Uday Preetham Palukuru is a Standards lead at Merck &Co., providing leadership to develop and maintain global standards for ADaM implementation, R package development, Open Source package qualification, Computing Platform enhancements and compliance management tools. He has contributed to various internal and external R packages and is a member of the R Validation Hub Executive committee. He actively promotes the use of open source software in clinical trial data analysis via forums and paper publications. He has a PhD in Bioengineering from Temple University.
Archived Webinars – Full Recordings Available
Teal: An R-Shiny Framework to Unlock the Power of Interactive Data Exploration
Chendi Liao, Principal Statistical Programmer Analyst, Roche Canada • Dony Unardi, Principal Data Scientist, Genentech
Ben Arancibia, Data Scientist – Senior Manager At GSK • Yoni Sidi, Director of Modeling and Simulation at Sage Therapeutics
Mark Hornick, Senior Director, Oracle Machine Learning • Sherry LaMonica, Consulting MTS, Oracle Machine Learning
Claudio T. Rebelo, Model Validation Actuary for Group Risk Management at Swiss Re • Georgios Bakoloukas, Head Model Development & Analytics, Risk Management at Swiss Re • Daniela E. Damm, Divisional Operational Officer for Group Risk Management at Swiss Re
Christina Fillmore, Data Scientists and R developer at GSK • Yujie Zhao is a Senior Scientist (Biostatistics) at Merck & Co., Inc. • Keaven Anderson, Scientific Assistant VP of Methodology Research in the Biostatistics and Clinical Research Decision Sciences group at Merck
Hye Soo Cho, Statistical Analyst, FDA/CDER • Tae Hyun (Ryan) Jung, Ph.D., Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVI • Paul Schuette, Scientific Computing Coordinator, FDA • Ning Leng, Director, Product Development Data Sciences, Roche • Coline Zeballos, R Strategy Lead, Roche
Michael Rimler, Head of Technical Excellence and Innovation at GlaxoSmithKline • Mike Stackhouse, Chief Innovation Officer at Atorus
Gabriel Becker, Statistical Computing Consultant
Kieran Martin, R Enablement Lead: PD Data Sciences at Roche • Tadeusz Lewandowski, Pan-Pharma collaboration product lead at Roche • Adrian Waddell, Chief Engineer NEST Project
Paulo R. Bargo, Ph.D., Head of R&D Data and Advanced Analytics, Ethicon • Dan Hofstaedter is a statistical programmer within the Janssen Clinical & Statistical Programming group • Gayathri Kolandaivelu has over 13 years of experience in the pharmaceutical industry
Andy Nicholls, Head of Data Science within GSK Biostatistics