Digital Biomarkers & Digital Measurements Europe

Benjamin (Ben) Vandendriessche is Chief Medical Officer at Byteflies, the Belgian-American company behind Sensor Dot, a powerful platform for 24/7 capture of medical insights to deliver care at home and augment clinical trials with real-world data.

He trained in molecular biology, systems physiology, and data analytics for physiologic waveform and vital sign processing. He completed a PhD in molecular biology at Ghent University as an IWT Fellow, followed by a postdoc in critical care medicine at Case Western Reserve University (CWRU) as a BAEF Fellow. He joined Byteflies in 2016, is adjunct assistant professor at CWRU, and co-chair of the Digital Medicine Society (DiMe) research committee.

Siddharth completed his PhD at the University of Oxford, where he is currently based as a Departmental Lecturer. His research focuses on developing healthcare technologies that can assist with remote detection and monitoring of neurodegenerative diseases. He has been working on a smartphone app that helps assess the symptoms of Parkinson’s disease, by analysing voice/balance/gait/finger tapping/reaction time/rest and postural tremor, which are recorded using the inbuilt smartphone sensors. He has worked with the NHS, and his research has been published in academic journals including Cerebral Cortex, Neurology, Parkinsonism & related disorders, Physiological measurement, Brain communications, Annals of clinical and translational neurology, to name a few. He was the recipient of the Martin Black Prize and the EPSRC Network on Computational Statistics and Machine Learning (NCSML) award. The applications of his work primarily lie in telemedicine and emergency healthcare.

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with
young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the
developers of the Clinpal remote clinical trial platform. Through his involvement in technical,
operational and scientific roles, he has gained deep understanding of broad aspects of the
patient journey in clinical trials from recruitment and engagement through data capture.
Kai brings his innovation mindset and ways of working to support Janssen’s global
regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive
collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and
patient-centric pharmaceutical R&D.

Matteo Lai is co-founder and CEO of Empatica, a digital biomarker and medical devices company based in Boston, Massachusetts, and Milan, Italy. Empatica provides an end-to-end remote health monitoring platform for collecting clinical-quality data in decentralized clinical trials, and develops digital biomarkers that can monitor a range of conditions.

As a technology entrepreneur, Mr. Lai has critically contributed to the invention of the solutions being offered by Empatica. His company has developed the award-winning Embrace, which became the world’s first FDA cleared smart watch for use in Neurology. Its latest EmbracePlus wearable, which he also co-designed, is the world’s smallest and most advanced wearable sensor suite for research.

Matteo studied Engineering, trained as an Architect, and holds a Double MSc degree in Architecture and a Master’s in Innovation Management. He is a contributor to DiMe, and was recently selected by Sifted as one of the top pioneers of the European startup world.  

Katrine has been with Biogen since 2013 and is currently the Head of Payer & Health Ecosystem Value and Strategy in Biogen Digital Health (BDH). She is responsible for ensuring that the payer and health ecosystem perspectives and needs are integral parts of strategies and activities in BDH. For the past 18 years, Katrine has almost uniquely focused on bringing the payer perspective into the pharma industry. Prior to joining the BDH team, Katrine was responsible for securing the European Payer Insights into pipeline assets most prominently gene therapies in ophthalmology, ALS and depression.  In 2018 she was amongst the first to start the preparations for Alzheimer’s Disease treatments Europe, spearheading the system readiness and cross-functional ecosystem preparations. Katrine joined Biogen to support the European launch of two products for Multiple Sclerosis, but has since managed to work on all Biogen marketed products. She has excelled in updating and formalizing internal market access alignment processes; continuously striving to ensure focus on patients and payers.

Throughout her career she has launched 7 products in areas as different as Hodgkin’s Lymphoma and Short Bowel Syndrome to new Insulins, and COPD products. Katrine began her career with the Global Strategic Pricing and Reimbursement team in Novo Nordisk headquarters in Denmark and has since held various positions in Value and Access teams in Nycomed, Takeda and Biogen. Katrine earned a Master of Science in Health Economics and a bachelor’s in International Business, Language and Culture both from University of Southern Denmark

Clare has worked as a mathematician, data scientist and developer in both academia and industry. At the National Physical Laboratory (NPL) she provided statistical data analysis and modelling for a wide range of projects, such as the calibration of micro-thrusters used for steering satellites, optimisation of smart electricity grids, and data fusion for a network of sensors.

At the National Physical Laboratory she worked on a large European project to develop the capability for the dynamic calibration of pressure sensors, necessary to accurately measure pressure changes in engines. She developed a computational fluid dynamics model to aid in the design of the shock tube used to perform sensor calibrations and worked on signal processing techniques to calculate the uncertainty associated with the calibration. Clare also led the impact work associated with the project.

As a developer she worked on the creation of a big data platform for a large academic publishing company, pulling together data from multiple sources and generating statistics for an online reference management service.
She has worked with a telematics company and national insurance provider to create a vehicle crash detection algorithm for use on mobile and telematics devices. The algorithm was developed using data from incidents resulting in insurance claims, and uses sensors on a driver’s phone, or the blackbox device fitted to their vehicle, to trigger a real-time alert in the event that a serious crash is detected.

Her research career began at University College London, where she built a fracture-mechanics based model to study observations in seismic activity prior to eruptions at volcanoes with a long repose time.

More recently, at Bangor University, she has worked in the area of real-time summarisation of videos, primarily for the application of summarising daily events captured via wearable devices. Clare’s work at Aparito continues in this field of utilising video to capture data for medical purposes. Her focus is now on automatically rating eating skills from videos of mealtimes, allowing patients to be observed and assessed in their home environment.

I am a biomedical engineer with 5+ years experience in cancer clinical research. I am interested in using mHealth technologies to remotely monitor biological rhythms and symptoms in patients outside the hospital setting. I have developed expertise in large database management, biological time-series collection and analysis from wearables. I have been involved in clinical trials support, design, conduct, monitoring and staff training.

In my current role as Data Scientist at Aparito, I build analytical tools for health data using wearable devices and the Atom5™ platform for rare disease and cancer patients. My tasks involve data collection monitoring, data cleaning and analysis using tailored algorithms. In my most recent project, I focused on the feasibility assessment of remote surveillance of oncological patients during the Covid-19 outbreak – this involved the collection of Covid-related symptoms and physiological data recorded by a wrist-worn wearable device and the Atom5™ Platform. For this project, I was responsible for the assessment of patients’ engagement and adherence, analysis of the time series and the descriptive statistics.

Working at the French National Institute for Health and Medical Research (INSERM), I took part in a National project involving ten industrial, academic and clinical partners, that developed the first mobile platform for the remote multi-dimensional monitoring of chronic diseases [1]. I was responsible for linking the technical developments of the platform with the targeted users, including patients and health professionals; this included, managing the logistics, training, recruiting participants, monitoring the data collection and performing data analysis throughout the pilot tests in cancer patients. In my research role at Warwick Medical School within the Cancer Chronotherapy Team, I was involved in a study aimed at capturing the intra- and inter-variabilities in circadian rhythms of healthy volunteers [2]. The study recruited 30 participants who monitored their circadian rhythms for 1 to 3 weeks using telecommunicating devices such as a chest sensor, a wrist actigraph, and a bodyweight scale.

My further research in healthy volunteers was aimed at predicting the core body temperature from non-invasive physiological measures and questionnaires. I participated in the design of the study and was responsible for the technical support, data monitoring, management and analysis. Forty subjects were recruited and monitored, their core body temperature was measured using an eHealth ingestible pill, physical activity and skin temperature were recorded by a chest sensor during the subject’s daily life for a duration of one week. The subjects self-collected saliva samples for hormone level determination. The prediction model developed, was able to predict core body temperature phase from sex, score from a chronotype questionnaire, and two tele-monitored circadian parameters [3].

I was also involved in a French study that aimed to identify circadian and sleep disruption due to shift work in 200 nurses [paper in preparation]. The nurses provided a general questionnaire including demographics, work and medical history, sleep habits and medication use. They completed a chronotype questionnaire, wore a telemonitoring chest sensor and completed a precise work and sleep diary for a week. I coordinated the circadian rhythms analyses.

In order to find actionable determinants of circadian and sleep disruption in cancer patients, I helped design a multi-centre (5 in UK) observational clinical study. We investigated potential determinants of disruption in a number of tele-monitored circadian parameters, hormones and questionnaires. Patients took part in the study for 1 week of remote monitoring [paper submitted]. I was involved in the study set-up, clinical staff training, and study monitoring as well as the data validation, management and analysis. I developed analytics tools and was responsible for the time series analysis. Outside of work, I enjoy travel and photography.

Carrie Northcott, PhD is a Director/ Project Lead within Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD) at Pfizer.

She leads a driven and diverse team that is evaluating and validating the use of
wearable digital devices to more fully understand and characterize physiological endpoints, such as quantitatively measuring night-time scratch and sleep. Carrie has a diverse scientific background in Pharmacology,
Toxicology, and Physiology which provides unique insight into understanding
how these novel digital endpoints provide meaningful information to patients, doctors and researchers to better treat and understand diseases.

Bert is an experienced Senior Director and Innovation Leader. He leads transformational
innovation projects that have the goal to shape the future of clinical trial execution, improve
the clinical trial experience and position Janssen as a role model in patient-centered clinical
research.
Bert is an international industry expert in Clinical Research and Digital Health. He graduated
in Biomedicine and obtained a PhD in Medicine from Utrecht University. He worked in
Clinical Operations-, QA- and IT-management before joining Janssen’s Clinical Innovation
team in 2015.
His main focus today is developing capabilities for digital health in clinical trials, including
harmonization of digital outcome measures and technologies for remote patient monitoring
and engagement.

“Doina Sirbu is a Medical Device Innovation Lead at UCB, where her focus is to support the development of novel digital biomarkers and build strategies that would lead to their integration in clinical settings. She is an active member of Digital Medicine Society (DiMe) and a contributor to the Nocturnal Scratch digital measure development collaboration.

During her career, Doina acquired extensive experience in innovation in the pharmaceutical industry as well as in the field of start-ups. This double hatting allows her to work very closely with start-ups and tech companies while exploring collaborations with pharmaceutical companies to ultimately embed new technologies in a clinical environment.

Doina holds an engineering degree in Pharmaceutical Industry, a PhD in Medicinal Chemistry and a master’s in Business Innovation and Entrepreneurship.”

Ariel V. Dowling, PhD is a Director of Digital Strategy within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, Ariel oversees the strategy, assessment, and deployment of digital devices and decentralized clinical trials across the organization. She was previously a Senior Clinical Data Scientist at Biogen Inc where she managed the wearable sensors deployed in clinical trials for Parkinson’s Disease. Ariel was the algorithm team lead at MC10 Inc and a senior research scientist at BioSensics LLC. Ariel holds an MS and PhD in Mechanical Engineering from Stanford University and an AB and BE in Mechanical Engineering from Dartmouth College. She currently serves on the Strategic Advisory Board of the Digital Medicine (DiMe) Society.

Marco Viceconti is full professor of Industrial Bioengineering in the department of Industrial Engineering of the Alma Mater Studiorum – University of Bologna, and Director of the Medical Technology Lab of the Rizzoli Orthopaedic Institute. In the IMI-funded Mobilise-D project he serves as academic lead of the regulatory workpackage, which is pursuing the regulatory qualification of digital mobility outcomes from wearable sensors as drug development tools.

Aude Clement, PharmD is a Global Program Regulatory Director within Novartis Global Drug Development organization. In this role, Aude contributes to the internal capability building and global regulatory policy efforts to embed the use of digital technologies and data in regulatory decision making for medicines. She provides strategic regulatory support to novel digital endpoints development programs.  Aude previously worked at Roche, Sanofi and Pfizer, where she held various regulatory affairs roles supporting global drug development and registration across therapeutic areas and modalities.

Dr. Roozbeh Ghaffari is CEO and co-Founder of Epicore Biosystems, a digital health solutions company commercializing wearable microfluidic sensors and analytics for tracking and managing hydration, nutrition, and metabolic health biomarkers.

His contributions in soft bioelectronics, microfluidics and neuroscience have been recognized with the MIT100K Grand Prize, IEEE Spectrum Emerging Technology Prize, and the MIT Technology Review Magazine’s Top 35 Innovators Under 35.

He has published over 100 academic papers and is inventor on over 50 patents issued.  Dr. Ghaffari graduated from MIT with BS and MEng degrees in Electrical Engineering and received his PhD in biomedical engineering from the Harvard-MIT Division of Health Sciences and Technology.

Stefan Avey is a Principal Data Scientist at Janssen R&D where he focuses on data analytics to further development of digital biomarkers and digital measurements for the Immunology therapeutic area.

Stefan has broad experience in setting digital health strategy, implementing digital health technologies in non-interventional and interventional clinical trials, digital health technology vendor management, and FDA/EMA regulatory interactions. He is a member of the Digital Medicine Society (DiMe) and contributor to the nocturnal scratch digital measures development project (https://www.dimesociety.org/tours-of-duty/digital-measures-nocturnal-scratch/). In addition, Stefan represents Janssen as the industry lead of the statistical inference, design, and learning work package for the IMI IDEA-FAST project (https://idea-fast.eu/).

Stefan holds a Ph.D. in Computational Biology & Bioinformatics from Yale University and dual Bachelor of Science degrees in Biomedical Mathematics and Computational Biology from The Florida State University.