Day One Wednesday, November 7 th. 9:15 10:00 am KEYNOTE PANEL: Digital Endpoints & IoT to Support Clinical Trials The Next Frontier

Transcription

1 CORE THEMES: 1. The State of Connected IoT Devices & Digital Endpoints in Today s Landscape 2. Best Practices for Digital Endpoint Development Strategies with Current Technology 3. How to Leverage Existing Internal Data Analytics Systems for New Digital Endpoints 4. Learning to Improve Standardization for AI & Machine Learning to be Effective 5. Why Data Ownership & Patient Engagement are Imperative to Drive Drug Development Day One Wednesday, November 7 th 8:00 9:00 am Conference Registration Open in Pfizer Lobby 9:00 9:15 am Opening Remarks from Conference Chairman Joe Mather, Executive Director, Innovation Research Lab, 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? Craig Lipset, Global Head, Clinical Innovation, Pfizer Lisa Shipley, VP Digital Technologies & Analytics, Merck Jake LaPorte, Global Head of Digital Development, Novartis Moderated by Joe Mather, Executive Director, Innovation Research Lab, Pfizer

2 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 Michelle Longmire, CEO, Medable 10:25 10:45 am CASE STUDY: Walk This Way: Case study on Real-World Gait Behaviour Due to advances in technology, our ability to capture data in clinical settings is better than ever. How we ensure that we are extracting the relevant information from that stream of data in a robust & sensitive way is the focus of our research. We will present examples and discuss how we are tackling these challenges in a case study focusing on assessing realworld walking behaviors using wearable inertial sensors, and look at how tailored analytic solutions are helping us gain insight in clinical settings. Speaker TBA, Digital Endpoints and Evidence, Novartis 10:45 11:15 am NETWORKING BREAK AT PFIZER INNOVATION RESEARCH LAB 11:15 11:45 am BAYER S 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 Pallopothu, mhealth Ecosystem Global Lead, Bayer 11:45 12:15 pm CASE STUDY: Lower the Patient Burden: How to Deliver a Unified Mobile Tech Experience Jeff Lee, President, ecoa and Patient Engagement, Bracket Global 12:15 12:45 pm PRESENTATION TBA

3 12:45 2:00 pm EXECUTIVE NETWORKING LUNCHEON 2:00 2:25 pm CASE STUDY: Digital Endpoints Success Stories at Pfizer A look at how digital tools and innovations can better improve connections in the clinical research triad - the patient, treating physician and investigator - to ease the burden of clinical trial participation. Craig Lipset, Global Head, Clinical Innovation, Pfizer 2:25 2:55 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 Craig Lipset, Global Head, Clinical Innovation, Pfizer Raj Pallopothu, mhealth Ecosystem Global Lead, Bayer Ching Tian, General Manager, Digital Accelerator, Novartis Additional Panelists TBA! 2:55 3:15 pm CASE STUDY: Merck s 'Smart Trials' Initiative: Enabling Patient-Centricity and More Informed Decisions in Clinical Trials through Digital Smart Trials is a cross-functional innovation project at Merck focused on leveraging digital and new technologies to improve data quality and enrich datasets by accessing clinical endpoints in the outpatient setting. Pilot studies are conducted to evaluate clinical trial readiness of new technologies in three primary areas: smart sampling, smart dosing, and smart analytics (methods to collect, integrate, and visualize data in real-time). Results from two recent clinical studies will be presented together with key learnings and future opportunities. Jyoti Shah, Sr. Scientist, Scientific Data Strategy, Merck Marissa Dockendorf, Principal Scientist, Merck (TBC) 3:15 3:40 pm PRESENTATION TBA 3:40 4:00 pm NETWORKING BREAK AT PFIZER INNOVATION RESEARCH LAB

4 4:00 4:30 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 cloudenabled, 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. Karim Damji, SVP Product, Saama 4:30 5:00 pm CASE STUDY: Leveraging Digital and Connected Devices Across the Enterprise Blockchain. Biosensors. Internet of Things. Can all these innovative technologies truly help us improve clinical trial operations or have we diluted the term innovation into nothing more than a buzzword that represents coming up with new ideas? Shwen Gwee, General Manager, Digital Accelerator, Novartis 5:00 6:30 pm Tours of Pfizer Innovation Research Lab & Networking Drinks Reception Day Two Thursday, November 8 th 8:00 9:00 am Conference Registration Open in Pfizer Lobby 9:00 9:15 am Chairman s Day One Recap and Opening Remarks Joe Mather, Executive Director, Innovation Research Lab, Pfizer

5 9:15 9:50 am MORNING PANEL: Hearing the Voice of the Patient How Ambient Listening Devices Can Improve the Clinical Trial Experience The healthcare industry, and in particular, the clinical research sector, has recently focused its attention on achieving patient-centricity. Driven by the desire to better engage clinical trial volunteers, coupled by the need to demonstrate value-added medical products, this has become much more than the latest buzz word. Within the planning stages of clinical research, we are seeing physicians and patients actively contribute to protocol design. However, once the trial begins, the patient oftentimes may feel isolated in the process; quite simply, they need to ask questions and receive answers that they can understand. Lisa Shipley, VP Digital Technologies & Analytics, Merck Megan McBride, Associate Director, RDO-Innovation, Janssen (TBC) Shwen Gwee, General Manager, Digital Accelerator, Novartis Additional Panelists TBA! Moderated by: Bill Tobia, Lead Clinical Research Instructor, GSK 9:50 10:20 am From Data Quality to Data Privacy: Overcoming Challenges to Adoption of Digital Biomarkers in Clinical Research The collection of digital biomarker data is presenting new data management challenges for sponsors and technology providers alike. Traditional clinical data management may consist of thousands of discrete data endpoints per subject during the course of a clinical study. With the introduction of smart devices and sensors, there is an exponential jump in the volume of data that can be collected resulting in perhaps millions of data points for each subject. Developing methods for ensuring the quality of the data is not an insignificant effort. Combined with evolving international regulations in the protections of patient rights, sponsors must work closely with technology partners to ensure that design of data management tools is sufficient to manage the data collection, analysis, protection and rights governance models sufficient to meet tomorrows trials. Joe Dustin, Principal, Mobile Health, Medidata 10:20 10:50 am PRESENTATION TBA 10:50 11:15 am NETWORKING BREAK AT PFIZER INNOVATION RESEARCH LAB 11:15 11:40 pm 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? Jyoti Shah, Sr. Scientist, Scientific Data Strategy, Merck Paul Glimcher, CEO, Data Cubed Jeffrey Arnett, CTO, ActiGraph

6 Moderator TBA 11:40 12:20 pm PRESENTATION TBA 12:20 1:00 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 Austin Speier, VP, Emerging Technologies, Precision for Medicine Michelle Longmire, CEO, Medable Additional Panelists TBA! Led by: Craig Lipset, Global Head, Clinical Innovation, Pfizer 1:00 2:15 pm EXECUTIVE NETWORKING LUNCHEON 2:30 pm END OF CONFERENCE