Agenda
The program is currently in development. Please note session times and intervals are not yet final. Continue to check this page to stay current with new speaker additions and topic descriptions.
ALL SESSIONS WILL OCCUR IN THE FOUNDER’S ROOM, LEVEL 3
| 07:00 – 16:00 | Registration |
| 07:30 – 08:00 | Breakfast |
| 08:00 – 08:45 | Breakfast Tech Briefing Presented by IBM Blockchain Why Blockchain for Clinical Trial Matching and Its Importance Data sharing, personal data privacy concerns and patient enrollment in clinical trials are huge medical challenges for contemporary clinical research. Blockchain may be a key to addressing these challenges and should draw the attention of the whole clinical research community. Speed to enrollment is important for clinical trial matching for patients with advanced types of cancer. Understanding the many clinical trials and patient criteria can be a life changing opportunity for patients affected by this deadly disease. Blockchain allows for reaching a substantial level of actual history and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, transparency, ownership and privacy and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders. Panelists: Dr. Alice Landis-McGrath Executive Consultant, IBM Watson Health Oncology Mark Tresbock Associate Partner, Healthcare and Life Sciences, Blockchain, IBM Moderator: Donna Houlne, BSN, MHA, MHRM US Healthcare Leader, Global Business Services, IBM |
| 08:50 – 09:00 | Opening Remarks Speaker: Maria Palombini Director, Communities and Opportunities Development, IEEE Standards Association |
| 09:00 – 09:45 | Keynote Presentation An Integrated and Compliant Healthcare System with Blockchain Keynote Speaker: Dr. Vahan Simonyan Lead Scientist at Food and Drug Administration (FDA) Adjunct Professor, George Washington University |
| 09:45 – 10:30 | The Patient Data Donation Initiative Powered by Blockchain Speaker: Munther Baara Senior Director, New Clinical Paradigm, Pfizer |
| 10:30 – 10:45 | TECH STORY: The Token to Personalized Healthcare Some of the biggest issues holding back the progress of the healthcare sector in the digital age have to do with unmet consumer demands for a level of security and interoperability suitable for sensitive personal data. As more stakeholders, tools and applications interact with our health data, it’s going to be crucial to have a streamlined and secure approach to sharing data, and one that is fully managed by the consumer. Bowhead will present their blockchain-enabled health data management system and their token model to incentivize the sharing of anonymous health data and empower users to test and optimize health. Speaker: Dr. Rhea Mehta CEO, Bowhead Health |
| 10:45 – 11:00 | Morning Break Speak with the technologists developing cutting-edge approaches to utilizing blockchain for advancing innovation in clinical trials operations. |
| 11:00 – 11:45 | The Role of Smart Contracts in Managing E-Consent for Patient Privacy On and Off the Blockchain The challenges and opportunities in utilizing smarts contracts for e-consent on and off the blockchain. Critical legal, technical and compliant questions to be addressed in this session. How to provide e-consent to the patients, need to get the signatures from all the participants involved. This is the process. It’s still in the early stages. Speaker: Basker Gummadi Blockchain Enthusiast, Bayer Pharmaceuticals Speaker: Houman Shadab Professor, New York Law School Co-Director, Accord Project |
| 11:45 – 12:00 | TECH STORY: A Patient “Life Ledger”- the Blockchain Platform for Clinical Trials Imagine a platform connecting all clinical trial participants and key systems to achieve a truly unified trial management system. It enables interoperability, collaboration and work-flow automation, while assuring data privacy and integrity, resulting in enhanced efficiency and compliance across the clinical trial process. LifeLedger™ is patient centered and offers an integrated consent management, patient engagement through real time interaction and clinical supplies tracking in a single application. Speaker: Himanshu Verma Founder & CEO, ConsilX |
| 12:00 - 12:30 | Cross-Industry Blockchain Educational White Paper Progress Update: How Blockchain can Transform Clinical Trials in the Pharmaceutical Industry The Emerging Trends & Technology Phuse Workgroup, comprised of representatives across 7 pharmaceutical & biotechnology companies, have collaborated on this white paper project to serve two purposes: 1) educating and sharing knowledge on what Blockchain is, understanding the landscape in the pharma and healthcare settings, exploring the areas that Blockchain could be used; and 2) presenting two detailed use cases - a. Vendor and Site Oversight; b. Patient Data Access/Transparency- including analysis on regulatory impact, scalability, risks, trade-offs with existing technologies, investment, and change management. The use cases will support future development and implementation for proof of concept testing. Speaker: Adama Ibrahim (EMBA) Senior Manager, Clinical Operations Lead | WIN UK Chapter Co-Lead, Clinical Study Leadership, BIOGEN Member of the phUSE Emerging Technologies Working Group |
| 12:30 – 13:15 | Networking Lunch Attendee Mingle Time. Speak with the experts including the technology companies and speaker faculty. |
| 13:15 – 14:00 | Blockchain, a Path to Better Clinical Trials Quality Blockchain is a generic technology allowing data consistency, because of its cryptographic-oriented protocol, and empowerment of users, due to its distributed nature. A wide range of Blockchain applications in healthcare have been envisioned and are currently being tested: from user-centric health data-sharing platform, nation-wide EHR to Clinical Trials (CT). On this latter point, Blockchain may have a decisive impact. Clinical research is tainted with low reproducibility and questionable quality; clinical trials are full of "Bugs". Blockchain is a powerful tool to track and construct an indelible memory of all the complex events streams occurring in clinical trials, avoid after-facts modifications and streamline some procedures by automation due to Smart Contracts. Speaker: Mehdi Benchoufi Assistant Professor, Epidemiology in Clinical Epidemiology Center, Hôtel Dieu Hospital |
| 14:00 – 14:15 | TECH STORY: Increasing Clinical Research Integrity and Throughput Through Blockchain and Distributed Ledger Technologies The reproducibility crisis in clinical research impacts patients, providers and payers. MyIRE will present a case study of blockchain technology combined with easy to use tools and its impact on research integrity. We will also demonstrate how this approach empowers doctors to participate in research as part of their daily practice. Speaker: Mark Graves CEO & Co-Founder, MyIRE, Inc. |
| 14:15 – 15:45 | Taking Sides: Uses and Challenges for Blockchain in Clinical Trials Attendees will split up into three groups to discuss an application of interest. At the end of the session each mentor will present the findings of the group and suggested next steps. Side A: Incentivizing the Patient on Blockchain Tech Mentor: Robert Chu Founder, Embleema Side B: The Many Sources of Patient Data: IoT, Blockchain and more Tech Mentor: Dr. Michele Longmire Founder, Medable Side C: Combining the Power of AI, Robotic Automation and Smart Contracts for e-Consent Tech Mentor: Basker Gummadi Blockhain Enthusiast, Bayer Pharmaceuticals Each side will be led by a tech mentor. Each mentor will have 5 minutes to present their side outcomes to the attendees. AFTERNOON BREAK WILL BE SERVED DURING THIS SESSION |
| 15:45 – 16:00 | TECH STORY: Re-Engineering Clinical Trials In today’s connected world, the aggregation of large volumes of complete longitudinal medical records of an individual, together with their unique genomic data in an accessible database, requires bullet proof privacy, security and access controls for the individual clinical records. The challenge becomes, how can longitudinal personal health information be safely and securely stored and used, to discover new insights that may lead to breakthrough diagnostic and clinical treatment developments? Speaker: Oskar Buhre Co-Founder, E-Nome |
| 16:00 – 16:45 | Blockchain in Context of IRB and Regulatory Oversight of Multi-Site Clinical Research This session will summarize goals and challenges of IRB and regulatory oversight in multi-site clinical research, highlighting the pre-blockchain trust models that inform relationships between investigators, subjects, sites, public and private sector sponsors, CROs, peer-reviewed journals, IRBs, and regulators. Briefly cites examples of current-state applications of blockchain/DLT to health and life sciences research. Explores opportunities for blockchain to positively impact multi-site clinical research by study phase (initiation, participant recruitment, etc.), stage of clinical development (safety, efficacy, etc.), and intended level of evidence (from RCTs to RWE). Describes use-cases for public blockchains, hybrid and interoperable blockchains, and private/permissioned distributed ledger technologies, along with architectural and compliance considerations, referencing representative IRB data management and privacy requirements. Places broader adoption of blockchain technology in research in context of its dynamic oversight and regulatory framework, including potential disruption of IRBs and the GDPR's entry into force in May 2018. Speaker: Heather L. Flannery CEO, Obesity PPM |
| 16:45 – 17:00 | Closing Remarks Next Steps for the Moving the Initiatve Forward Speaker: Maria Palombini IEEE-SA |
| 17:00 – 18:00 | The Blockchain for Clinical Trials White Board Challenge Networking Reception The winner of the Blockchain for Clinical Trials White Board Challenge will be announced by: Dr. Ramesh Ramadoss, Chair, IEEE P2418 Blockchain Working Group Attendee time to mingle while enjoying an array of beverages and hor d'oeuvres. |
