Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Book Club Webinar: Atomic Habits - The Science of Getting Your Act Together

The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.

PSI Webinar: Methods and tools integrating clinical trial evidence with historical or real-world data, Bayesian borrowing, and causal inference

This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.

PSI Career Young Virtual Event (Q2 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance

This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day PSI/PHUSE Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

PSI Career Young Virtual Event (Q3 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI/EFSPI Vaccines Statistics Workshop

The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.

PSI Career Young Virtual Event (Q4 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Speaker	Biography	Abstract
Daniel Rooks	Daniel Rooks, PhD is Project Lead of the Mobilise-D consortium and Head, Endpoint Management in Translational Medicine Discovery and Profiling at Novartis, Cambridge, MA, USA. His work focuses on developing and applying methods to reduce variability and improve data quality in clinical outcome assessments of patient function in drug development clinical trials. Prior to his current role, he led the Muscle Diseases and Neuromuscular Diseases groups in Translational Medicine and was the Early Clinical Lead of the bimagrumab program. His work with assessments in clinical trials at Novartis and before that at Harvard Medical School includes traditional pen, paper, and stopwatch and digital measures. He co-developed the SPPB Guide mobile phone app that standardizes administration and scoring of the Short Physical Performance Battery. He is a fellow of the American College of Sports Medicine.	Digital health technologies and digital outcome measures are increasingly used in clinical trials to assess mobility in the real world. In 2019, few digital mobility outcomes had been validated in multiple health conditions. The Mobilise-D consortium, an Innovative Medicines Initiative (IMI) funded public-private partnership, was formed between 22 academic institutions and 12 companies in the pharmaceutical industry to deliver a valid solution for real-world digital mobility assessment that could advance drug development trials. The presentation will provide an overview of several key aspects of the Mobilise-D project.
Wim Dartee	Wim Dartee (Novartis) is Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis and has over 20 years’ experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL), European, US and Global regulatory affairs experience, direct interactions with all major Regulatory agencies (EMA, key EU national health authorities, FDA, PMDA, Swissmedic), and Notified Bodies BSI, TüvSüd. He has worked across a variety of therapeutic areas, both specialized (Oncology, Tropical Medicine) as well as primary care (Respiratory, CNS and Infectious Diseases) and enjoys finding ways to optimize opportunities within the ever-changing regulatory framework. His latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise, capitalizing on opportunities in combining pharma development projects with innovative devices and digital, and with particular focus on enabling the development of digital endpoints in drug clinical development. Wim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception.	The Mobilise-D regulatory journey: key achievements and lessons learned This presentation will focus on the regulatory strategy development and the corresponding various Health Authority interactions that were undertaken to establish what is needed to gain acceptance of digital mobility outcomes as part of the Mobilise-D project.
Igor Knezevic		Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digital biomarkers in clinical trials.
Dr. Arne Mueller	Dr. Arne Mueller, a biologist by training, obtained his PhD in Bioinformatics from the University College London, specializing in protein folding prediction. He gained industry experience through a Marie-Curie fellowship at Aventis Pharma, focusing on Toxicogenomics. Dr. Mueller's career progressed at Sanofi and Novartis, where he transitioned from pre-clinical to clinical research, with a particular focus on digital mobility endpoints.	Technical validation of mobility endpoints How do we know we measure what we think we measure? The technical validation of Mobilise-D compares digital mobility outcomes (DMOs) measured in the patient’s real world from lower limb-worn sensors against reference standards under different experimental conditions and in the patient populations. Challenges and methodologies are presented: Terminology, reference standards (incl. portable a reference), development of a benchmarking framework and the algorithm pipeline for deriving DMOs. Most DMOs can reliably be measured with a lower limb-worn accelerometer, but different algorithms must be deployed for data processing in different population groups.
Julia Chernova	Quantitative data scientist with experience in top-tier U.K. academia and international pharma. She received her PhD in Health Data Science from Cambridge University designing methodology in estimating diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical trials and is always excited to bring innovation in Drug development and post-marketing activities to support data-driven decision making.	Introduction to Mobilise D Clinical Validation Study How do we know what we measure is relevant for patents monitoring of disease progression in drug development? Clinical validation is the next step after technical (analytical) validation in the development of digital measures. The presentation will share the overview of the objectives, design and pre-specified analysis of clinical validation study of Mobilise D program.

Speaker	Biography	Abstract
Daniel Rooks	Daniel Rooks, PhD is Project Lead of the Mobilise-D consortium and Head, Endpoint Management in Translational Medicine Discovery and Profiling at Novartis, Cambridge, MA, USA. His work focuses on developing and applying methods to reduce variability and improve data quality in clinical outcome assessments of patient function in drug development clinical trials. Prior to his current role, he led the Muscle Diseases and Neuromuscular Diseases groups in Translational Medicine and was the Early Clinical Lead of the bimagrumab program. His work with assessments in clinical trials at Novartis and before that at Harvard Medical School includes traditional pen, paper, and stopwatch and digital measures. He co-developed the SPPB Guide mobile phone app that standardizes administration and scoring of the Short Physical Performance Battery. He is a fellow of the American College of Sports Medicine.	Digital health technologies and digital outcome measures are increasingly used in clinical trials to assess mobility in the real world. In 2019, few digital mobility outcomes had been validated in multiple health conditions. The Mobilise-D consortium, an Innovative Medicines Initiative (IMI) funded public-private partnership, was formed between 22 academic institutions and 12 companies in the pharmaceutical industry to deliver a valid solution for real-world digital mobility assessment that could advance drug development trials. The presentation will provide an overview of several key aspects of the Mobilise-D project.
Wim Dartee	Wim Dartee (Novartis) is Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis and has over 20 years’ experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL), European, US and Global regulatory affairs experience, direct interactions with all major Regulatory agencies (EMA, key EU national health authorities, FDA, PMDA, Swissmedic), and Notified Bodies BSI, TüvSüd. He has worked across a variety of therapeutic areas, both specialized (Oncology, Tropical Medicine) as well as primary care (Respiratory, CNS and Infectious Diseases) and enjoys finding ways to optimize opportunities within the ever-changing regulatory framework. His latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise, capitalizing on opportunities in combining pharma development projects with innovative devices and digital, and with particular focus on enabling the development of digital endpoints in drug clinical development. Wim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception.	The Mobilise-D regulatory journey: key achievements and lessons learned This presentation will focus on the regulatory strategy development and the corresponding various Health Authority interactions that were undertaken to establish what is needed to gain acceptance of digital mobility outcomes as part of the Mobilise-D project.
Igor Knezevic		Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digital biomarkers in clinical trials.
Dr. Arne Mueller	Dr. Arne Mueller, a biologist by training, obtained his PhD in Bioinformatics from the University College London, specializing in protein folding prediction. He gained industry experience through a Marie-Curie fellowship at Aventis Pharma, focusing on Toxicogenomics. Dr. Mueller's career progressed at Sanofi and Novartis, where he transitioned from pre-clinical to clinical research, with a particular focus on digital mobility endpoints.	Technical validation of mobility endpoints How do we know we measure what we think we measure? The technical validation of Mobilise-D compares digital mobility outcomes (DMOs) measured in the patient’s real world from lower limb-worn sensors against reference standards under different experimental conditions and in the patient populations. Challenges and methodologies are presented: Terminology, reference standards (incl. portable a reference), development of a benchmarking framework and the algorithm pipeline for deriving DMOs. Most DMOs can reliably be measured with a lower limb-worn accelerometer, but different algorithms must be deployed for data processing in different population groups.
Julia Chernova	Quantitative data scientist with experience in top-tier U.K. academia and international pharma. She received her PhD in Health Data Science from Cambridge University designing methodology in estimating diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical trials and is always excited to bring innovation in Drug development and post-marketing activities to support data-driven decision making.	Introduction to Mobilise D Clinical Validation Study How do we know what we measure is relevant for patents monitoring of disease progression in drug development? Clinical validation is the next step after technical (analytical) validation in the development of digital measures. The presentation will share the overview of the objectives, design and pre-specified analysis of clinical validation study of Mobilise D program.

Speaker	Biography	Abstract
Daniel Rooks	Daniel Rooks, PhD is Project Lead of the Mobilise-D consortium and Head, Endpoint Management in Translational Medicine Discovery and Profiling at Novartis, Cambridge, MA, USA. His work focuses on developing and applying methods to reduce variability and improve data quality in clinical outcome assessments of patient function in drug development clinical trials. Prior to his current role, he led the Muscle Diseases and Neuromuscular Diseases groups in Translational Medicine and was the Early Clinical Lead of the bimagrumab program. His work with assessments in clinical trials at Novartis and before that at Harvard Medical School includes traditional pen, paper, and stopwatch and digital measures. He co-developed the SPPB Guide mobile phone app that standardizes administration and scoring of the Short Physical Performance Battery. He is a fellow of the American College of Sports Medicine.	Digital health technologies and digital outcome measures are increasingly used in clinical trials to assess mobility in the real world. In 2019, few digital mobility outcomes had been validated in multiple health conditions. The Mobilise-D consortium, an Innovative Medicines Initiative (IMI) funded public-private partnership, was formed between 22 academic institutions and 12 companies in the pharmaceutical industry to deliver a valid solution for real-world digital mobility assessment that could advance drug development trials. The presentation will provide an overview of several key aspects of the Mobilise-D project.
Wim Dartee	Wim Dartee (Novartis) is Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis and has over 20 years’ experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL), European, US and Global regulatory affairs experience, direct interactions with all major Regulatory agencies (EMA, key EU national health authorities, FDA, PMDA, Swissmedic), and Notified Bodies BSI, TüvSüd. He has worked across a variety of therapeutic areas, both specialized (Oncology, Tropical Medicine) as well as primary care (Respiratory, CNS and Infectious Diseases) and enjoys finding ways to optimize opportunities within the ever-changing regulatory framework. His latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise, capitalizing on opportunities in combining pharma development projects with innovative devices and digital, and with particular focus on enabling the development of digital endpoints in drug clinical development. Wim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception.	The Mobilise-D regulatory journey: key achievements and lessons learned This presentation will focus on the regulatory strategy development and the corresponding various Health Authority interactions that were undertaken to establish what is needed to gain acceptance of digital mobility outcomes as part of the Mobilise-D project.
Igor Knezevic		Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digital biomarkers in clinical trials.
Dr. Arne Mueller	Dr. Arne Mueller, a biologist by training, obtained his PhD in Bioinformatics from the University College London, specializing in protein folding prediction. He gained industry experience through a Marie-Curie fellowship at Aventis Pharma, focusing on Toxicogenomics. Dr. Mueller's career progressed at Sanofi and Novartis, where he transitioned from pre-clinical to clinical research, with a particular focus on digital mobility endpoints.	Technical validation of mobility endpoints How do we know we measure what we think we measure? The technical validation of Mobilise-D compares digital mobility outcomes (DMOs) measured in the patient’s real world from lower limb-worn sensors against reference standards under different experimental conditions and in the patient populations. Challenges and methodologies are presented: Terminology, reference standards (incl. portable a reference), development of a benchmarking framework and the algorithm pipeline for deriving DMOs. Most DMOs can reliably be measured with a lower limb-worn accelerometer, but different algorithms must be deployed for data processing in different population groups.
Julia Chernova	Quantitative data scientist with experience in top-tier U.K. academia and international pharma. She received her PhD in Health Data Science from Cambridge University designing methodology in estimating diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical trials and is always excited to bring innovation in Drug development and post-marketing activities to support data-driven decision making.	Introduction to Mobilise D Clinical Validation Study How do we know what we measure is relevant for patents monitoring of disease progression in drug development? Clinical validation is the next step after technical (analytical) validation in the development of digital measures. The presentation will share the overview of the objectives, design and pre-specified analysis of clinical validation study of Mobilise D program.

Speaker	Biography	Abstract
Daniel Rooks	Daniel Rooks, PhD is Project Lead of the Mobilise-D consortium and Head, Endpoint Management in Translational Medicine Discovery and Profiling at Novartis, Cambridge, MA, USA. His work focuses on developing and applying methods to reduce variability and improve data quality in clinical outcome assessments of patient function in drug development clinical trials. Prior to his current role, he led the Muscle Diseases and Neuromuscular Diseases groups in Translational Medicine and was the Early Clinical Lead of the bimagrumab program. His work with assessments in clinical trials at Novartis and before that at Harvard Medical School includes traditional pen, paper, and stopwatch and digital measures. He co-developed the SPPB Guide mobile phone app that standardizes administration and scoring of the Short Physical Performance Battery. He is a fellow of the American College of Sports Medicine.	Digital health technologies and digital outcome measures are increasingly used in clinical trials to assess mobility in the real world. In 2019, few digital mobility outcomes had been validated in multiple health conditions. The Mobilise-D consortium, an Innovative Medicines Initiative (IMI) funded public-private partnership, was formed between 22 academic institutions and 12 companies in the pharmaceutical industry to deliver a valid solution for real-world digital mobility assessment that could advance drug development trials. The presentation will provide an overview of several key aspects of the Mobilise-D project.
Wim Dartee	Wim Dartee (Novartis) is Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis and has over 20 years’ experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL), European, US and Global regulatory affairs experience, direct interactions with all major Regulatory agencies (EMA, key EU national health authorities, FDA, PMDA, Swissmedic), and Notified Bodies BSI, TüvSüd. He has worked across a variety of therapeutic areas, both specialized (Oncology, Tropical Medicine) as well as primary care (Respiratory, CNS and Infectious Diseases) and enjoys finding ways to optimize opportunities within the ever-changing regulatory framework. His latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise, capitalizing on opportunities in combining pharma development projects with innovative devices and digital, and with particular focus on enabling the development of digital endpoints in drug clinical development. Wim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception.	The Mobilise-D regulatory journey: key achievements and lessons learned This presentation will focus on the regulatory strategy development and the corresponding various Health Authority interactions that were undertaken to establish what is needed to gain acceptance of digital mobility outcomes as part of the Mobilise-D project.
Igor Knezevic		Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digital biomarkers in clinical trials.
Dr. Arne Mueller	Dr. Arne Mueller, a biologist by training, obtained his PhD in Bioinformatics from the University College London, specializing in protein folding prediction. He gained industry experience through a Marie-Curie fellowship at Aventis Pharma, focusing on Toxicogenomics. Dr. Mueller's career progressed at Sanofi and Novartis, where he transitioned from pre-clinical to clinical research, with a particular focus on digital mobility endpoints.	Technical validation of mobility endpoints How do we know we measure what we think we measure? The technical validation of Mobilise-D compares digital mobility outcomes (DMOs) measured in the patient’s real world from lower limb-worn sensors against reference standards under different experimental conditions and in the patient populations. Challenges and methodologies are presented: Terminology, reference standards (incl. portable a reference), development of a benchmarking framework and the algorithm pipeline for deriving DMOs. Most DMOs can reliably be measured with a lower limb-worn accelerometer, but different algorithms must be deployed for data processing in different population groups.
Julia Chernova	Quantitative data scientist with experience in top-tier U.K. academia and international pharma. She received her PhD in Health Data Science from Cambridge University designing methodology in estimating diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical trials and is always excited to bring innovation in Drug development and post-marketing activities to support data-driven decision making.	Introduction to Mobilise D Clinical Validation Study How do we know what we measure is relevant for patents monitoring of disease progression in drug development? Clinical validation is the next step after technical (analytical) validation in the development of digital measures. The presentation will share the overview of the objectives, design and pre-specified analysis of clinical validation study of Mobilise D program.

Speaker	Biography	Abstract
Daniel Rooks	Daniel Rooks, PhD is Project Lead of the Mobilise-D consortium and Head, Endpoint Management in Translational Medicine Discovery and Profiling at Novartis, Cambridge, MA, USA. His work focuses on developing and applying methods to reduce variability and improve data quality in clinical outcome assessments of patient function in drug development clinical trials. Prior to his current role, he led the Muscle Diseases and Neuromuscular Diseases groups in Translational Medicine and was the Early Clinical Lead of the bimagrumab program. His work with assessments in clinical trials at Novartis and before that at Harvard Medical School includes traditional pen, paper, and stopwatch and digital measures. He co-developed the SPPB Guide mobile phone app that standardizes administration and scoring of the Short Physical Performance Battery. He is a fellow of the American College of Sports Medicine.	Digital health technologies and digital outcome measures are increasingly used in clinical trials to assess mobility in the real world. In 2019, few digital mobility outcomes had been validated in multiple health conditions. The Mobilise-D consortium, an Innovative Medicines Initiative (IMI) funded public-private partnership, was formed between 22 academic institutions and 12 companies in the pharmaceutical industry to deliver a valid solution for real-world digital mobility assessment that could advance drug development trials. The presentation will provide an overview of several key aspects of the Mobilise-D project.
Wim Dartee	Wim Dartee (Novartis) is Global Lead Regulatory Affairs, Devices/Sensors in Clinical Development at Novartis and has over 20 years’ experience in Regulatory Affairs and Pharmaceutical Industry. He has local (3 years NL), European, US and Global regulatory affairs experience, direct interactions with all major Regulatory agencies (EMA, key EU national health authorities, FDA, PMDA, Swissmedic), and Notified Bodies BSI, TüvSüd. He has worked across a variety of therapeutic areas, both specialized (Oncology, Tropical Medicine) as well as primary care (Respiratory, CNS and Infectious Diseases) and enjoys finding ways to optimize opportunities within the ever-changing regulatory framework. His latest role at Novartis has focused on medical devices and combination products to prepare the organization regulatory-wise, capitalizing on opportunities in combining pharma development projects with innovative devices and digital, and with particular focus on enabling the development of digital endpoints in drug clinical development. Wim has been the Regulatory Industry Co-Lead for the Mobilise-D Consortium since inception.	The Mobilise-D regulatory journey: key achievements and lessons learned This presentation will focus on the regulatory strategy development and the corresponding various Health Authority interactions that were undertaken to establish what is needed to gain acceptance of digital mobility outcomes as part of the Mobilise-D project.
Igor Knezevic		Igor will be sharing his experience of EMEA regulatory discussions related to utilisation of digital biomarkers in clinical trials.
Dr. Arne Mueller	Dr. Arne Mueller, a biologist by training, obtained his PhD in Bioinformatics from the University College London, specializing in protein folding prediction. He gained industry experience through a Marie-Curie fellowship at Aventis Pharma, focusing on Toxicogenomics. Dr. Mueller's career progressed at Sanofi and Novartis, where he transitioned from pre-clinical to clinical research, with a particular focus on digital mobility endpoints.	Technical validation of mobility endpoints How do we know we measure what we think we measure? The technical validation of Mobilise-D compares digital mobility outcomes (DMOs) measured in the patient’s real world from lower limb-worn sensors against reference standards under different experimental conditions and in the patient populations. Challenges and methodologies are presented: Terminology, reference standards (incl. portable a reference), development of a benchmarking framework and the algorithm pipeline for deriving DMOs. Most DMOs can reliably be measured with a lower limb-worn accelerometer, but different algorithms must be deployed for data processing in different population groups.
Julia Chernova	Quantitative data scientist with experience in top-tier U.K. academia and international pharma. She received her PhD in Health Data Science from Cambridge University designing methodology in estimating diet and physical activity to predict health outcomes. She is focused on analysis and integration of data from wearables/sensors in clinical trials and is always excited to bring innovation in Drug development and post-marketing activities to support data-driven decision making.	Introduction to Mobilise D Clinical Validation Study How do we know what we measure is relevant for patents monitoring of disease progression in drug development? Clinical validation is the next step after technical (analytical) validation in the development of digital measures. The presentation will share the overview of the objectives, design and pre-specified analysis of clinical validation study of Mobilise D program.

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