Agenda

 

#Blockchain4ClinicalTrials
IEEE Blockchain for Clinical Trials Forum – Europe
13-15 November – Clinical Innovation Zone, Glasgow Scotland
https://blockchain.ieee.org/standards/clinicaltrialseurope18

 

DAY 1: Wearables & Medical IoT Interoperability & Intelligence (WAMIII) Track

Addressing challenges, opportunities and needs for validating data from a clinical-grade IoT and making it interoperable with blockchain and other areas of the medical device ecosystem while empowering the patient to manage, own and access the information derived from the devices.

Time Session Name
8:15 – 9:00 Registration and Breakfast
9:00 – 9:30 Welcome: Why We Are Here
The Roadmap to Adoption for Validated and Effective us of IoTs and Blockchain in Clinical Trials and Research
Speaker: Maria Palombini, IEEE-SA
9:30 – 10:10 Meeting Demands in Hardware and Software for Clinical IoTs to Achieve Interoperability and Stakeholder Satisfaction

Florence DiStefano Hudson
Special Advisor, Trusted CI, The NSF Cybersecurity Center of Excellence at Indiana University; Lead, IEEE-SA Clinical IoT Data Validation and Interoperability with Blockchain Workstream
10:10 – 10:50 Clinical IoTs, Blockchain and the Connected Medical Device System
Susan Ramonat, CEO, Spiritus Partners
10:50 – 11:10 TECH BREAK
11:10 – 11:50 Fixing the Patient Trust Deficit in IoMTs and Healthcare with Blockchain

Nicholas Schmidt
CTO, Embleema
11:50 – 12:30 Layering Intelligence to Clinical Wearable/IoT Data through the Responsible Application of AI

Siddhi Trivedi
Global Strategy Advisor, Lucidium
12:30 – 13:15 INTERACTIVE NETWORKING LUNCH
13:15 – 13:55 Interoperability and Security of Healthcare, Challenges of Current Approaches and Future Solutions

Gilbert Verdian
CEO and Founder, Quant
14:00 – 16:15 PART 1: Development of Building Blocks of Roadmap through Adoption
All participants will contribute, vote and agree on top tier categories for building the roadmap to blockchain adoption. (Guidelines will be provided).

Facilitators: IEEE-SA Team (Maria Palombini, Lloyd Green, Chirag Desai)
16:15 – 16:30 Closing Remarks:
Outcomes of the Part 1 Roadmap Build.
Plan for Day 2
Maria Palombini, IEEE-SA
16:30 – 17:00 Tour of the Clinical Innovation Zone (open to anyone who wants to participate)
17:00 – 18:00 Ice Breaker Reception for Blockchain for Clinical Trials Participants

 

DAY 2: Blockchain for Clinical Trials Agenda

The agenda is currently in development. Session times and titles are subject to change as speakers are added to the program.

Time Session Name
8:15 – 8:45 Attendee Breakfast
8:45 – 9:05 Recap of Day 1 Roadmap Design. Start of Day 2
Maria Palombini, IEEE-SA
9:05 – 9:50 Pilot Study Update:
Advocating to Help Cystic Fibrosis Patients Across the Globe with Blockchain

Speakers:
Jeanne Barnette, Founder, CFTechnology.org
Robert Chu, CEO & Founder, Embleema
9:50 – 10:30 Blockchain for the Clinical Trial Supply Chain – Pfizer’s Latest Global Endeavor for Innovation and Patient Safety

Speaker:
Munther Baara, Head of New Clinical Paradigm, Pfizer
10:30 – 10:50 TECH BREAK
10:50 – 11:50 Interactive Consortia Panel:
Lessons in Progress from POCs and Pilots for Public Patient Blockchain and Clinical Trials
Consortia and working group leaders from IMI Blockchain Enabled Healthcare, PHUSE Blockchain Working Group, OpenPharma Initiative and others will provide insights in progress on developing alliances and establishing multi-organizational governance to enable a patient-centered blockchain for clinical trial efficacy and patient safety.

Moderator: Florence Hudson, Special Advisor, Trusted CI, The NSF Cybersecurity Center of Excellence at Indiana University

Panelists:
Scott Askin,
Digital Solutions Director, Digital Development, Portfolio, Strategy & Innovation (PS&I), Novartis Pharma AG
Disa Lee Choun
Director Head of GCSO Innovation, UCB; Co-Lead, phUSE Blockchain Health Working Group
Adama Ibrahim, EMBA, Associate Director, Clinical Operations | WIN UK Chapter Co-Lead Clinical Study Leadership, Biogen UK
Jim Nasr, Vice President, Technology & Innovation, Synchrogenix
11:50 – 12:30 Blockchain and Third-Party Risk Management (TPRM)

Speaker:
Marco Cuomo, Global Lead, EWS Service Operations & Engineering, Novartis
12:30 – 13:15 INTERACTIVE LUNCH
13:15 – 14:15 Interactive Panel:
The Maturation of Blockchain within the Pharmaceutical Framework

Moderator: Siddhi Trivedi, Global Strategy Advisor, Lucidium

Jean-Remy Behaeghel, Sr Director, Clinical, Quality and Manufacturing Systems, Vertex Pharmaceuticals
Marco Cuomo, Global Lead, EWS Service Operations & Engineering, Novartis
Munther Baara, New Clinical Paradigm, Pfizer
14:15 – 16:15 Roadmap to Blockchain Adoption – PART II
Working Group and Ideation Based on Agreed Roadmap Areas
Afternoon Break Coffee, Tea and Treats Served
Working Group 1: Topic and Lead Announced Tuesday Morning
Working Group 2: Topic and Lead Announced Tuesday Morning
Working Group 3: Topic and Lead Announced Tuesday Morning
16:15 – 16:45 Report Out from the Working Groups
16:45 – 17:00 Closing Remarks – Maria Palombini, IEEE-SA
17:00 – 18:00 Networking Reception

 

DAY 3: Blockchain for Clinical Trials Agenda

The agenda is currently in development. Session times and titles are subject to change as speakers are added to the program.

Time Session Name
8:15 – 8:45 Breakfast
8:45 – 9:00 Opening Remarks:
Recap and next steps for Roadmap Design
Plan for Day 2
Speaker: Maria Palombini, IEEE-SA
9:00 – 9:30 Distinguished Presentation
Restoring Patient Trust in Clinical Trials through Digital Empowerment, Integrity and Identity

Estelle Jobson
Patient Advocate;
Communications Manager at the Swiss Clinical Trial Organisation (SCTO)
9:30 – 10:30 Setting a New Standard for Electronic Informed Consent with Smart Contracts– What are we solving?

Panelists:
Dr. Mehdi Benchoufi,
Chef de Clinique Assistant, Département d'Epidémiologie Clinique,
Hôpital Hôtel Dieu

Adama Ibrahim, EMBA,Associate Director, Clinical Operations | WIN UK Chapter Co-Lead
Clinical Study Leadership, Biogen UK

Darpan Ahuja
Co-Founder, Consilx

Moderator:
Scott Askin,

Novartis Digital Solutions Director
Digital Development, Portfolio, Strategy & Innovation (PS&I)
Novartis Pharma AG
10:30 – 10:50 TECH BREAK
TECHNOLOGY IN ACTION SESSIONS
10:50 – 11:20 POC – Review
Decentralised Physician Identity: The New Relationship between patients, clinicians and organisations and what it means for clinical trials.


An overview and live demonstration of a working decentralised physician identity. We will discuss the benefits for clinical trials as well as the challenges of adoption and trust. The session will also cover the open standards of the underlying technologies.

Speaker:
Manreet Nijjar
Co-Founder & CEO, Truu
11:20 – 11:50 Pilot Case Study- Veratrak partnership with Tjoapack
All in One Package: Security, Compliance and Immutability to Secure the Pharmaceutical Supply Chain

Veratrak has partnered with Tjoapack, a pharmaceutical packaging company, on a number of projects that focus on using the properties of blockchain to enable transparent collaboration across multiple pharmaceutical supply chain partners to drive information sharing through a secure digital chain. The Veratrak platform has been built according to GAMP5 guidelines and is compliant with FDA part 11 regulations, making it the first global application of blockchain in a GxP environment working with multiple organisations in the supply chain.

Speaker:
Jason Lacombe, CEO, Veratrak
11:50 – 12:20 POC Review
The Need for Interoperability in Blockchain-Based Initiatives to Facilitate Clinical Trials: A Combined IHE/HL7 Approach

Massimiliano Masi (M.Sc, Ph.D.)
IT Security Architect, Tiani “Spirit” GmbH
12:20 – 13:20 Tech Panel Debate:
What is right blockchain platform for my project?


Moderator: Maria Palombini, IEEE-SA

Panelists:
• Robert Clint, CTO, Spiritus Partners
• Darpan Ahuja, Co-Founder, Consilx
• Manreet Manreet Nijjar, Co-Founder & CEO, Truu
• Jason Lacombe, CEO, Veratrak
13:20 – 13:30 Closing Remarks:
Speaker: Maria Palombini, IEEE-SA
The next steps for publishing and adhering to the roadmap
13:30 Forum Adjourns with Networking Lunch