New York Academy of Sciences, 7 World Trade Center, 40 th Floor, New York, NY CONFERENCE FOCUS: CLINICAL TRIALS MOBILE INNOVATIONS Day One: Tuesday, June 27 th 7:45 9:00 am Conference Registration Open 9:00 9:15 am Opening Remarks from Conference Co-Chairman Spyros Papapetropoulos, VP, Global Development Head, Teva 9:15 10:00 am KEYNOTE PANEL Clinical Trials Mobile Innovations The Next Frontier Mobile, wearable and sensor-enabled devices paired with remote trials and telehealth present an unprecedented opportunity for how clinical trials monitor and work with patients. So what does it mean for the pharmaceutical clinical trial industry where are the best applications for mobile? Gabriel Vargas, Executive Medical Director, Mobile Health, Amgen Alex Simmonds, IT Business Partner Digital Health, Bristol-Myers Squibb Munther Baara, Head of New Clinical Paradigm, Pfizer 10:00 10:25 am The Future of 'Omics: Mapping the Phenome and Why it Matters The next-gen of mhealth data capture is here - Unlock the power of clinical trials with low-cost practical solutions and more actionable data. Focus on 'designed data' with broad consent, high participation rates, and with great data breadth using new data collection tools that are mobile, gamified, elder and youth friendly Pharmaceutical companies & CROs can run studies using a customizable selection of mobile phenomic data points & instruments, ready for IRB approval Leverage cross-platform Apps, unique hardware solutions and data analysis approaches will save you money and simplify any clinical study leading to actionable data and findings Aristides Patrinos, Chief Scientist & Research Director, NOVIM Hannah Bayer, Chief Scientist, The HUMAN Project / CSO, Data Cubed
10:30 11:00 am KEYNOTE: NOVARTIS CASE STUDY: Crawl. Walk. Run Is This Really the Best Way to Innovate? The pharma industry is one of the most innovative industries in the world, yet we have struggled to accelerate meaningful change in the ways we run our clinical trials. We can continue to repeat the past or is it time for us to begin to challenge some of the core principles that have guided us: Should we really crawl walk and then run? Jeremy Sohn, VP, Global Head of Digital Business Licensing, Novartis 11:05 11:25 am Networking Break in Pre-Function Foyer 11:25 11:55 am CASE STUDY: Hear about the latest PoCs from Bristol-Myers Squibb s Digital Health Accelerator Alex Simmonds, IT Business Partner Digital Health, Bristol-Myers Squibb 11:55 12:25 pm CASE STUDY: How the Patient Experience can be Improved by Implementing a BYOD model for Clinical Studies Yet Mui, Director, Product Development, Bracket 12:25 12:55 pm CASE STUDY: mclinical at Pfizer the New Paradigm There is no day passes by where we don t hear about new technology and initiatives helping business bridge the gap and evolve the organization though digital transformation. Will the new digital advancement, Internet Of Things (IoT), mobile, social media, advanced analytics/big data and cloud disrupt savvy companies and transform the way they do business? I will discuss the new paradigm shift, which requires us to move beyond our current thinking and assumptions to find ways to pave the way to transform the way we execute Clinical Trials. Munther Baara, Head of New Clinical Paradigm, Pfizer 12:55 2:00 pm Executive Networking Luncheon
2:05 2:35 pm PANEL DISCUSSION: Using Technology and the Potential of Remote Studies in Clinical Research What are patients saying about the potential of remote studies? What indications and therapy areas are the best fit for remote trials? What it means for patient safety and engagement Hassan Kadhim, IS BP R&DM, Boehringer Ingelheim Gabriel Vargas, Executive Medical Director, Digital Health, Amgen Spyros Papapetropoulos, VP, Global Development Head, TEVA Moderated by Komathi Stem, Founder and CEO, monarc Bionetworks 2:35 3:00 pm INDUSTRY INNOVATION: Patient-Engagement through mobile for clinical trial stakeholders Antidote is a digital health company applying advanced solutions for patients, sponsors and sites. Learn how mobile is core to Antidote and how its platform capabilities can be applied in patient-engaging mobile solutions. How mobile drives Antidote s capabilities Case studies highlighting the role of mobile in patient engagement and recruitment An applied mobile example: Data donation, Real-time Matching, and Block-Chain Tom Krohn, Chief Development Officer, Antidote Munther Baara, Head of New Clinical Paradigm, Pfizer 3:00 3:30 pm CASE STUDY: Innovating Clinical Trials with Mobile Technology: The Clinical Trials Transformation Initiative Mobile Clinical Trials Program Mobile technology offers a powerful tool to improve the quality and efficiency of clinical trials. To increase the adoption and appropriate use of mobile technology in clinical trials, CTTI addresses four key areas: 1) legal and regulatory issues, 2) scientific and technological considerations, 3) developing novel endpoints, and 4) patient and community provider perceptions. In this session we will describe the findings and activities of these projects, including recently released recommendations and tools on developing novel endpoints generated by mobile technology for use in clinical trials. Cindy Geoghegan, CEO, Patients and Partners LLC Lauren Bataille, Assoc. Dir, Research Partnerships, MJF Foundation
3:30 3:45 pm Networking Break in Pre-Function Foyer 3:45 4:20 pm CASE STUDY: Moving Beyond Pilots: Implementation of a Biometric Solution for Remote and Continuous Monitoring of Motor Symptoms in a Ph2 Clinical Trial The objective is to implement quantification of motor dysfunction in a Huntington disease (HD) clinical trial using machine learning algorithmic analysis derived from biometric monitoring through a smartphone and wearable sensor combination. Motor symptoms in Huntington Disease (HD) are typically evaluated by clinicians using rating scales, such as the Unified Huntington s Disease Rating Scale total motor score (UHDRS-TMS). The use of biometric solutions could enable objective, real-time monitoring of motor dysfunction for both clinical research and patient care purposes. Spyros Papapetropoulos, VP, Global Development Head, TEVA 4:20 4:40 pm ALZHEIMER S ASSOCIATION CASE STUDY: How Mobile Technology can be a Compliment to the Services of Patient Organizations Jed Levine, Executive Vice President, CaringKind (formerly Alzheimer s Association, NYC Chapter) 4:40 5:15 pm PANEL DISCUSSION: Mobile Technology Driving Adherence to Change Behavior and Improve Outcomes Hear pharma and technology providers improving adherence using mobile tech & understand the patient / caregiver perspective. Where can tech fill in the gaps? Matthew Moyer, Director, Clinical Supply Technology, Merck Victor Morrison, SVP Healthcare, Next IT Healthcare Jenny Rozbruch, Founder / CEO, GreyMatters Moneshia zu Eltz, Head of Strategic Alliances, Philips Healthtech Moderated by Jeff Lee, CEO, mprove Health 5:15 6:30 pm Networking Drinks Reception Day Two: Wednesday, June 28 th 8:00 9:00 am Day Two Registration Open 9:00 9:10 am Chairman s Day One Recap and Opening Remarks Moe Alsumidaie, Chief Data Scientist, Annex Clinical
9:10 9:50 am MORNING KEYNOTE: econsent Implementation and Scaling How traditional pharma has baby stepped into Digital Healthcare Innovation, and how econsent can be scaled within an enterprise Exploring best practices for implementing an econsent program Opportunities & Challenges in the era of Digital Innovation Hassan Kadhim, IS BP RD&M, Boehringer Ingelheim Anthony Costello, CEO, Mytrus Maya Hardigan, Director, Clinical Innovation, Pfizer Cami Gearhart, CEO, Kinetiq Moderated by Bill Tobia, Lead Clinical Research Instructor, GSK 9:50 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 10:20 10:50 am REGULATORY UPDATE: Hear about the Industry s Top Concerns around mhealth in Clinical Trials PanAgora Pharma has polled top industry minds to gather questions that the industry is struggling with. Precision for Medicine will address these key concerns with relevant research. Austin Speier, Dir. Emerging Technologies, Precision for Medicine 10:50 11:10 am Networking Break 11:10 11:30 am CASE STUDY: How the Michael J Fox Foundation is Making it s Wearable and Device Research Data Open Source to Promote Collaboration Why the MJF views providing open-source datasets with digital data in Parkinson s disease could be a game changer for disease research Hear about the research strategy to connect stakeholders to accelerate development of advancements in Parkinson s disease research Hear about available grants to incentivize researchers to dive in! Lauren Bataille, Assoc. Dir, Research Partnerships, MJF Foundation
11:30 11:55 pm Driving the Uptake of New Technologies at the Grassroots Level Now more than ever, much is expected of clinical research professionals. New technologies are entering the market at a dizzying pace. Regulators are changing the landscape in ways almost unimaginable even a few years ago. Protocols are constantly becoming more complex. In each case,there are new things to learn and new challenges to address.this session will discuss methods to drive the implementation of new technologies at the site level. Jim Kremidas, Executive Director, ACRP 11:55 12:20 pm Driving Healthcare Innovation from within: Opportunities & Challenges How traditional pharma perceives the Digital Healthcare Innovation? Exploring best practices for implementing a Digital Healthcare Strategy Opportunities & Challenges in the era of Digital Innovation Georgia Mitsi, Sr. Director Search and Evaluation, Digital Healthcare Initiatives, Sunovion Pharmaceuticals 12:20 1:00 pm LESSONS LEARNED: Sensor and New End Point Capture in Clinical Trials As Pharmaceutical companies and regulators focus on patient centric clinical trials, the opportunity for capturing patient data via new technology has never been better. Learn practical tips for implementing sensors and mobile technology in your study. Learn ways to add new end points in your clinical trial and hear what s coming next. Karin Beckstrom, Sr. Manager, Innovation Lab, ERT 1:00 2:30 pm Executive Networking Luncheon 2:30 pm End of Conference