A PRECOMPETITIVE CONSORTIA OF EXPERTS WORKING TO LEVERAGE DIGITAL BIOMARKERS AND ENDPOINTS TO DRIVE THE ACCELERATION OF DRUG DEVELOPMENT

Transcription

1 A PRECOMPETITIVE CONSORTIA OF EXPERTS WORKING TO LEVERAGE DIGITAL BIOMARKERS AND ENDPOINTS TO DRIVE THE ACCELERATION OF DRUG DEVELOPMENT CORE THEMES: 1. The State of Digital Biomarkers Today 2. Best Practices for Capturing Source Data for Digital Biomarkers 3. Moving Data from Capturing Source to Internal Data Analytics Systems via Pipelining 4. Best Practices on Analyzing Source Data for Digital Biomarkers 5. Current Landscape of Regulatory Hurdles for Digital Biomarkers that must be overcome Wednesday, June 20 th, :00 09:00 Conference Registration Open in Roche Building 1 Lobby 08:50 09:00 Welcome / Opening Remarks from Roche 09:00 09:10 Welcome Address Basel Area Swiss / Day One Basel Region Industry/Science perspective of Digital Biomarkers Additional speakers TBA

2 09:10 09:35 KEYNOTE PANEL DISCUSSION: The State of Digital Biomarkers Medical impact what are the challenges that we want to address with those endpoints? Where can digital make the best impact? What data does to take to gain insight? Source data? Or derived data? How to begin the process of design thinking what can we conclude from those measures? Christian Gossens, Global Head, Digital Biomarkers, Roche (Chairman) Ashish Atreja, MD, MPH, Assistant Professor and Chief Innovation Officer, Medicine, Icahn School of Medicine at Mount Sinai, NY 09:35 10:05 CASE STUDY: Wearable Lab at Mount Sinai - Identification of Digital Biomarkers Ashish Atreja, MD, MPH, Assistant Professor and Chief Innovation Officer, Medicine, Icahn School of Medicine at Mount Sinai, NY 10:05 10:30 PRESENTATION TBA 10:30 10:50 NETWORKING COFFEE AND REFRESHMENT BREAK 10:50 11:15 PANEL DISCUSSION: BEST PRACTICES OF CAPTURING SOURCE DATA FOR DIGITAL BIOMARKERS Christian Gossens, Global Head, Digital Biomarkers, Roche (Moderator) Jeremy Wyatt, CTO, ActiGraph John Batchelor, Sr. Outcomes Measurement Scientist, Roche Michelle Crouthamel, Digital Platform Leader, GlaxoSmithKline (invited) 11:15 11:35 CASE STUDY: Digital Biomarkers Collected with Smartphones in Clinical Trials: How Relevant Are They? Christian Gossens, Global Head, Digital Biomarkers, Roche

3 11:35 11:50 PRESENTATION TBA 11:50 12:15 CASE STUDY: Matching Clinical Needs to Medical Needs 12:15 12:35 MEDIDATA PRESENTATION Joe Dustin, Principal, Mobile Health, Medidata 12:35 13:15 EXECUTIVE NETWORKING LUNCHEON 13:15 13:40 PANEL DISCUSSION: BEST PRACTICES ON MOVING DATA FROM CAPTURING SOURCE TO SOURCE DATA ANALYTICS VIA PIPELINING Philippe Marc, Global Head, Integrated Data Sciences, Novartis Michelle Longmire, CEO, Medable Kees van Bochove, CEO, The Hyve 13:40 14:00 From Patient Engagement to Insight: Best Practices of Data Pipelining in Direct to Patient Trials Michelle Longmire, CEO, Medable 14:00 14:20 CASE STUDY: Data Pipelining for Clinical Trials Philippe Marc, Global Head, Integrated Data Sciences, Novartis 14:20 14:40 CASE STUDY CO-PRESENTATION: Data Capture & Analytics for Digital Biomarkers in Clinical Research Speaker TBA, JLABS, Johnson & Johnson Chris Economos, VP Business Development, PhysIQ 14:40 15:00 NETWORKING COFFEE AND REFRESHMENT BREAK

4 15:00 15:30 PANEL DISCUSSION: Best Practices on Analyzing Source Data for Digital Biomarkers Applications of AI and Machine Learning A discussion of analytic automation and visualization best practices Transforming clinically relevant symptoms into digitally measurable biomarkers Jonas Dorn, Project Lead, Digital Health, Novartis Kees van Bochove, CEO, The Hyve 15:30 15:50 Is your Big Data Solution Ready for Streaming Data? With the advent of wearables and streaming data in the fold, disparate data in clinical systems create difficulties in understanding how trials will perform. The process, technology, and people will require a transformative approach. We ll review a use case where a cloud-enabled, scalable environment was implemented to perform data lifecycle management, analytics, and intuitive reporting including: Conceptual data landscape and flow of information Look at various analytic solutions and how they are built for various objectives Reflect on learnings and possible innovations Using the right analytic solution that can incorporate your unstructured IoT data provides tremendous benefits including faster time to commercialization and better business and patient outcomes. Nikhil Gopinath, Sr. Product Manager, Saama 15:50 16:10 CASE STUDY: We want to teach a machine to think like a physician, but how do we tell how a physician thinks? Inter- and intra-rater variability severely impact the data quality of clinical trials. If we could teach machine learning algorithms to assess patients like experienced physicians, we would have every patient assessed the exact same way across all the sites in a clinical trial. However, how can we train a machine learning algorithm on data annotated by humans, if we know that those human annotations are unreliable? We will present a framework, and the journey that led us to it, that allows combining the judgments of multiple human raters into one consensus scale and thus provide high quality ground truth, an aspect of machine learning that doesn t always get the attention it deserves. Jonas Dorn, Digital Solutions Director, Novartis

5 16:10 16:35 PRESENTATION TBA 16:35 17:00 CONCLUDING PANEL DISCUSSION: LOOKING AT HURDLES THAT INDUSTRY IS FACING ON DIGITAL BIOMARKERS A discussion by regulatory experts from pharma and their core concerns and objectives How can we take the learnings of the day to move forward in current regulatory environment Discussion of GDPR and how to be prepared Austin Speier, VP of Emerging Technologies, Precision for Medicine Eelko den Breejen, International Health Policy Leader, Roche Sarah Hemsley, Digital Project Leader, NIBR, Novartis 17:00 18:30 EVENING APERO & NETWORKING RECEPTION