CORE THEMES: 1. 2. 3. 4. 5. The State of Connected IoT Devices & Digital Endpoints in Today s Landscape Best Practices for Digital Endpoint Development Strategies with Current Technology How to Leverage Existing Internal Data Analytics Systems for New Digital Endpoints Learning to Improve Standardization for AI & Machine Learning to be Effective Why Data Ownership & Patient Engagement are Imperative to Drive Drug Development Day One Wednesday, November 7th 8:00 9:00 am Conference Registration Open in Pfizer Lobby, KSQ2 9:00 9:05 am Welcome Address from Pfizer Sandeep Menon, VP, Head of Early Development, Pfizer 9:05 9:15 am Opening Remarks from Conference Chairman Joe Mather, Executive Director, Digital Medicine, Pfizer 9:15 10:00 am KEYNOTE PANEL: Digital Endpoints & IoT to Support Clinical Trials The Next Frontier The internet of things, mhealth, wearable and sensor-enabled devices paired with remote trials and telehealth present an unprecedented opportunity for how clinical trials monitor, communicate and work with patients. What does it mean for the clinical trial industry? Timothy McCarthy, Head, Digital Medicine & Translational Imaging, Pfizer Deborah Slipetz, Executive Director, Digital Technologies & Analytics, Merck Ieuan Clay, Group Lead Digital Endpoints NIBR, Novartis Georgia Mitsi, Sr. Director, Search & Evaluation, Digital Healthcare, Sunovion Moderated by Joe Mather, Executive Director, Digital Medicine, Pfizer
10:00 10:20 am CASE STUDY: Improving Patient Experience in Clinical Trials using Mobile Clinical trial dedicated mobile apps can improve patient experience in clinical trials and increase data collection and yield Key considerations in clinical trial mobile patient engagement: HIPAA compliance, data collection & analysis Deanna Lennon, Director of Business Development, Medable 10:20 10:50 am NOVARTIS CASE STUDY: From Data to Insights: Measuring Morning Pain and Stiffness in Arthritis Arthritis-related pain and stiffness are often most acute in the morning, yet by the time the patient makes it to the doctor s office for assessment, the symptoms are much improved. We explored the utility of a wrist-worn actigraphy device for quantifying the effect of morning pain and stiffness on function. Patients were asked to perform a five times sit-to-stand test every other morning after waking, while wearing a three-axis accelerometer on their wrist. We present learnings from our actigraphy data analyses, demonstrating that the patients performed the unsupervised test correctly at home and that test duration was robustly related to the selfreported morning pain & stiffness. Jonas Dorn, Digital Solutions Director, Novartis 10:50 11:15 am NETWORKING BREAK 11:15 11:40 pm PFIZER CASE STUDY: Considerations and Lessons Learned from a Regulatory Interaction for a Parkinson s Disease Trial with Digitally Collected Data Kelley Erb, Director, Digital Medicine, Pfizer 11:40 12:05 am CASE STUDY: Using Novel Digital Endpoints within Decentralized Trials Growth in the use of mobile technology, and increasing focus on decentralized clinical trials, present numerous opportunities for the development of novel digital endpoints for trials, including new forms of Electronic Clinical Outcomes Assessments, new digital biomarkers, and new data collection strategies. This talk will cover examples of how novel digital endpoints can be incorporated into trials, and how these will dovetail with modern decentralized research programs. Adam Butler, SVP Strategic Development, CRF Bracket
12:05 12:30 pm BAYER PERSPECTIVE: After Evaluation of Implementing mhealth Technology in Trials, where are our current challenges? Hear an update on the last year of mhealth evaluation programs at Bayer Challenges with regards to organizational structure and streamlining of business processes for scaled deployment with the goal of focusing on digital endpoints Raj Pallapothu, mhealth Ecosystem Global Lead, Bayer 12:30 1:45 pm EXECUTIVE NETWORKING LUNCHEON 2:00 2:45 pm PANEL DISCUSSION: The State of Remote & Virtual Studies in Clinical Research What are the latest success stories, and failures that we can learn from? What are patients saying about their experience with remote studies? What indications and therapy areas are the best fit for remote trials? What it means for patient safety, HCP engagement, and lines of communication Raj Pallapothu, mhealth Ecosystem Global Lead, Bayer Melissa Ceruolo, VP Software Engineering & Data Products, MC10 Ching Tian, General Manager, Digital Accelerator, Novartis Adam Butler, SVP Strategic Development, CRF Bracket Hassan Kadhim, Head of IT Clinical Trials Planning & Mgmt, Boehringer Ingelheim Moderated by Joe Mather, Executive Director, Digital Medicine, Pfizer 2:45 3:05 pm CASE STUDY: Moving beyond Actigraphy: Using AI to make sense of Multi-Parameter Wearable Sensor Data Wearable biosensors offer the opportunity to simultaneously reduce the length of clinical trials while expanding the insights generated. Both of these attributes are a product of the vast quantity of data captured when patients are continuously monitored in the real world. That said, achieving these objectives is impossible without sophisticated physiology analytics to extract the signal from the noise of real world data. PhysIQ will share examples of how they are applying FDA-cleared analytics to data captured through their accelerateiq platform to demonstrate physiological changes of patients enrolled in clinical trials. Chris Economos, VP of Business Development, PhysIQ 3:05 3:30 pm PFIZER CASE STUDY: Detecting Symptoms of Respiratory Illness from Mobile Phone Voice Recordings Paul Wacnik, Director, Digital Medicine, Pfizer
3:30 4:00 pm NETWORKING BREAK 4:00 4:25 pm 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 on the fly, 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. Amit Gulwadi, SVP Clinical Innovations, Saama Karim Damji, SVP Product and Marketing, Saama 4:25 5:00 pm NOVARTIS / MIT CASE STUDY: Emerald - Wireless, 3D Tracking Technology in the Home Self-reporting, examinations, and diagnostics drive clinical trial outcomes across the industry. However, these data largely overlook information generated where our patients live their lives at home. Over the last year, Novartis and MIT have engaged in a strategic partnership to validate the utility, suitability, and capability of Emerald, a wireless 3D tracking technology for use in at-home settings, to discover, develop, and deploy clinically meaningful endpoints. Eli Goldberg, Data Scientist, Innovative Digital Endpoints Analytics, Novartis Ieuan Clay, Group Lead Digital Endpoints NIBR, Novartis 5:00 6:30 pm NETWORKING DRINKS RECEPTION 6:30 pm CONCLUSION OF DAY 1 Day Two Thursday, November 8 th 8:00 9:00 am Conference Registration Open in Pfizer Lobby, KSQ2 9:00 9:05 am Chairman s Day One Recap and Opening Remarks Joe Mather, Executive Director, Digital Medicine, Pfizer
9:05 9:40 am MORNING PANEL: Let s Talk About It Can Chatbots Enhance Clinical Trial Experience? Whether you think that chatbots in clinical trials are either hypothetical or hype othetical, serious efforts are underway to determine their potential value. Building on the previous presentation, this panel discussion will feature industry experts sharing their perspectives, and opening the conversation to audience participants, as we all try to assess if and how to embrace this technology. Shwen Gwee, General Manager, Digital Accelerator, Novartis Richard Burton, CMR Tech, Business Consultant, GlaxoSmithKline Amir Lahav, Digital Biomarkers & Clinical Innovation Lead - Rare Diseases, Pfizer Mitch Lawrence, EVP Sales, Verint Moderated by: Bill Tobia, Lead Clinical Research Instructor, GlaxoSmithKline 9:40 10:05 am NOVARTIS CASE STUDY: Are Healthbots the Future of Healthcare Engagement? Healthcare, and in particular the biopharma industry, has struggled with patient engagement for a very long time. With our strict regulations, extended timelines for review of materials, and the need for only sharing scripted, pre-approved content, even our most personalized engagements like human-led call centers can often sound robotic and impersonal. With the rise of AI, machine learning and new conversational platforms like Facebook Messenger and Alexa, could chat/voice-bots become more engaging and more personalized than humans can ever be in this industry? Is there an opportunity for us to change the current clinical trial experience by utilizing healthbots? Shwen Gwee, General Manager, Digital Accelerator, Novartis 10:05 10:30 am GSK CASE STUDY: Thinking of Launching a Chatbot for Clinical Trials? Here s How to Do It! During the conduct of a clinical trial, investigators, monitors, and study participants all need access to specific information contained within the protocol. Easier said than done, as many protocols can be over 100 pages long. How do you go about choosing the key elements of the protocol that will be most needed by each of these listeners? What technology platform do you use for deployment? Where do you start, and how do you progress your idea through the many layers of your organization? This session will provide answers to these questions, by sharing insights from real-world experiences at a major pharma company. Bill Tobia, Lead Clinical Research Instructor, GlaxoSmithKline Richard Burton, CMR Tech, Business Consultant, GlaxoSmithKline 10:30 10:50 am The Value of collecting Digital Endpoints - from the Patient s perspective Technology is revolutionizing the way we design and conduct clinical trials across the world. In this presentation and sit down chat, we will take a look at how collecting digital endpoints through a number of existing and emerging means can affect the patient experience. We will also explore some best practices to consider that keep patients in mind when developing a strategy for collecting digital endpoints in Clinical Trials. Joe Dustin, Director, Mobile Heath / ecoa, Medidata Solutions Alicia Staley, Sr. Director, Patient Engagement & Patient Advocate, Medidata Solutions
10:50 11:15 am NETWORKING BREAK 11:15 11:40 am PANEL DISCUSSION: Best Practices on Using Technologies to Collect Better Patient Data Patient data is coming in from every direction and source on the market today how can the industry collaborate to identify what is most important? Can a focus on user experience and participant engagement with technology lead to better outcomes? Jyoti Shah, Sr. Scientist, Scientific Data Strategy, Merck Dorian Tisdale, Head, Shared Solutions, Janssen Jeremy Wyatt, CTO, ActiGraph Jonas Dorn, Digital Solutions Director, Novartis Moderated by: Hannah Bayer, Chief Scientific Officer, Data Cubed 11:40 12:05 pm JANSSEN CASE STUDY: Digital Endpoints at Janssen Business Processes to Support Digital Health An overview of DHALI (Digital Health Action Learning Initiative) current vs. future A look at the landscape within Janssen - understanding what the digital health needs are for clinical research therapeutic areas How Janssen is sharing best practices with internal stakeholders to improve communication & productivity Dorian Tisdale, Head, Shared Solutions, Janssen 12:05 12:45 pm PANEL DISCUSSION: How to Give Patients Control of their Own Data to Improve Clinical Research for All Stakeholders Shwen Gwee, General Manager, Digital Accelerator, Novartis Marissa Dockendorf, Principal Scientist, Digital Analytics & Technology, Merck Deanna Lennon, Director, Business Development, Medable Alicia Staley, Sr. Director, Patient Engagement & Patient Advocate, Medidata Solutions Moderated by: Joy Chen, Sr. Manager, Digital Medicine, Pfizer 12:45 2:00 pm EXECUTIVE NETWORKING LUNCHEON 2:00 pm END OF CONFERENCE