Registration

The nature of this Forum is to give ALL participants the opportunity to lead discussions, ask questions, and formulate solutions for the critical challenges facing this vested community of technologists, commercialization leads, clinicians, and regulatory leaders. Therefore, the workshop is limited to 100 attendees maximum on first-come basis.

Register Now

 

Fee Schedule

Blockchain for Clinical Trials EuropeSneak Peak OfferOn-Time Rate
  Thru 31 October 2018 After 31 October 2018
Primary Industry and Tech $475.00 $650.00
Industry: IEEE MEMBER $375.00 $550.00

Special discount rates are reserved for government, regulatory, non-profit, and full-time university students. Please note that documents will be requested to verify your affiliation within one of these categories. Accredited press member registrations are limited. To obtain information on any of these opportunities, contact m.palombini@ieee.org.

 

Venue

Clinical Innovation Zone (CIZ)
University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland

The Forum will take place on the 2nd Floor in the Collaboration Zone at the Imaging Centre of Excellence at the Queen Elizabeth University Hospital campus.

Getting to the Queen Elizabeth University Hospital Campus:

  • By Car: The event venue is accessible by car but parking is limited. For those attendees unable to find parking on the main hospital site, there is parking available on Hardgate Road near the Queen Elizabeth Teaching andLearning Centre for £3 per day.
  • By Bus: First Glasgow Hospital Connect services 34A and 77 directly serve the hospital. The new Fastlink bus route provides speedy links from Glasgow City Centre via the Arc Bridge (Squinty Bridge).
  • By Subway: TheGovan Subway station is a 25 minute walk. Buses for hospital grounds are at street level bus stop, not the terminus. The F1, X19 and 26 connect Govan subway to the hospitals.
  • By Train: The hospital is a 25 minute walk from Cardonald Station (just over 1 mile). McGill's bus 17 and First 34 pass the station and call at the hospital.

The CIZ is home to the University’s Imaging Centre of Excellence (ICE), which includes an ultra-high-resolution 7 Tesla MRI scanner – the first of its kind to be fully integrated within a clinical site in the UK. Learn more about the CIZ

Clinical Innovation Zone

Clinical Innovation Zone

Clinical Innovation Zone

Clinical Innovation Zone

 

Hotels

Suggested hotels near the venue:

Glasgow Marriott

Hilton Glasgow

Hilton Glasgow Grosvenor Hotel

Doubletree by Hilton Hotel Glasgow Central

Crowne Plaza Glasgow

 

Speakers

 

Scott AskinScott Askin
Digital Solutions Director, Digital Development, Portfolio, Strategy & Innovation (PS&I), Novartis Pharma AG

Scott Askin is a Digital Solutions Director with Novartis and initially led the company’s digital agenda in the areas of eSource and eConsent. He is a leader of strategic projects such as TeleHealth and BlockChain, and consults on many of Novartis's digitally enabled clinical trials programs. Scott brings with him over 18 years of industry experience in the areas of Data and Digital.

 

 

 

 


 

Munther BaaraMunther Baara
Senior Director, New Clinical Paradigm, Pfizer; Leader, Pfizer Patient Data Donation on Blockchain Project

Munther has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of Clinical Paradigm within the WRD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies. Munther Led the Clinical Aggregation Layer (CAL) implementation of a high-profile, large-scale clinical private cloud of clinical and operational data. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms.

 


 

Jeanne BarnettJeanne Barnett

Jeanne is a well-versed patient advocate with a pioneering sense of the web’s potential to improve health care. Through her broad based experience as a math and computer science teacher and healthcare website developer, she created the first and largest global social media cystic fibrosis patient community in 1996. Jeanne understands the complex issues patients with cystic fibrosis face.

She is an expert in creating effective patient-centered website forums, videos, newsletters, and new technologies for patient education and self-care management.

She is skilled in preparing and delivering comprehensive presentations to varied audiences including Pharma Conferences. She has recently chaired and/or delivered presentations at Digital Pharma East, PanagoraPharma, the World Orphan Drug Summit and eyeforpharma.

Jeanne won the Patient Centricity Award in 2011 from PharmaPhorum. She has a teacher’s patience and curiosity and quickly identifies and addresses the needs of patients requiring innovative technological solutions.

In the patient insights space, she is detail-oriented with proven effectiveness in stimulating the patient base and is proactive in promoting the implementation of remote technology solutions, reducing cross contamination health risks and ultimately reducing chronic care costs.

She is a graduate of Fordham University.

Jeanne is a founding member of the Aurora Project. In her spare time, Jeanne (a birder) explores the neighborhoods, parks, and museums of NYC and its surrounding towns with her husband and grandchildren.

 


 

Jean-Remy BehaeghelJean-Remy Behaeghel
Sr Director, Clinical, Quality and Manufacturing Systems, Vertex Pharmaceuticals

 

 

 

 

 

 


 

Mehdi BenchoufiMehdi Benchoufi
Chef de Clinique Assistant, Département d’Epidémiologie Clinique, Hôpital Hôtel Dieu

Mehdi Benchoufi is an Assistant Professor in Epidemiology in Clinical Epidemiology Center, at Hôtel Dieu Hospital, with Pure Mathematics and Computer Science background. His main interests are on the augmentation of healthcare by new technologies, and Open Science as an inclusive tool to improve research processes. He most recently (2017) co-authored a groundbreaking white paper on Blockchain for improving research quality. See the research paper on the NCBI website

 

 


 

Disa Lee ChounDisa Lee Choun
Director of Head Data Acquisition, UCB Pharma; phuse Emerging Technology Working Group on Blockchain Healthcare

Disa has 15+years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation within the Global Clinical Sciences & Operations (GCSO) group at UCB, she is responsible for evaluating, piloting, and implementing innovative solutions in clinical trials. Prior to joining the pharmaceutical industry, she was a co-founder of an IT company. She has an EMBA and B.S. in Pharmaceutical Chemistry. Disa started a cross-industry collaboration on blockchain via PhUSE where presently she is one of the co-leads. She is also a member of other blockchain consortiums. Her passion is on closing the gap for patients with unmet needs and exploring the right technologies (Blockchain, Internet of Things, Artificial Intelligence/machine learning, robotics, data discovery tools, and others) to accelerate the implementation of end-to-end patient solutions.

 


 

Robert ChuRobert Chu
CEO, Embleema

Recognizing the considerable potential of cloud and blockchain technologies in the healthcare industry and the need for better solves for care continuum and pervasive cyber-security issues, Robert founded Embleema in 2017 after a distinguished career at IBM and QuintilesIMS. Robert worked for IBM in Europe and the US for more than 15 years, serving in key technical and management positions such as Global Wireless Solutions Executive in the US and Director of Telecommunications, Media & Utilities Sector for IBM France. In June of 2007, Robert joined IMS Health France and served as the General Manager of the affiliate in 2011. He then moved to Shanghai in China in 2013 to run the Asia Pacific and China operations for IMS Health. Robert was subsequently promoted in 2015 to Senior Vice President, Global Technology Solutions, responsible for the management of a 1,400 employees and $800 million business, delivering SaaS solutions for the healthcare and life sciences industries globally. Robert graduated with a Master's Degree in Engineering from the Ecole Polytechnique in Paris, France in 1988 and obtained a Master's in Computer Sciences shortly thereafter from Ecole Nationale Superieure des Telecommunications in 1990.

 


 

Bob ClintBob Clint
Co-Founder & CTO, Spiritus Partners

Bob builds state-of-the art data analytics solutions that turn insights into operational action plans.

His primary expertise includes big data, analytics and enterprise transformation - from concept and architectural design to engineering and implementation.

Former Director and Global Audit Analytics Leader at Ernst and Young, he previously acted as Senior Partner and National Analytics Practice Manager at CSC. He served in similar positions at IBM, KPMG and MphasiS. Bob received his BA in International Relations from the University of Minnesota.

 


 

Marco CuomoMarco Cuomo
Global Lead, EWS Service Operations & Engineering, Novartis

Marco is a senior Digital Solutions Architect, responsible for exploring, engineering and implementing new technologies such as Blockchain, IoT and API Management. He has been with Novartis since 2005. For the last two years, his focus has been on Blockchain and exploring various use cases for Pharma. He began his career as a programmer in 1988 and has held various positions of increasing responsibilities in software development, engineering, operations, service management and solution design.

 

 


 

Adama IbrahimAdama Ibrahim
Associate Director, Clinical Operations, Biogen UK; IEEE-SA Smart Contracts for Informed Consent Workstream Leader

An innovation award winning operational strategy expert and patient engagement thought leader with over 17 years in the NHS on commission by the Department of Health and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). Member of the DIA Patient Engagement Voluntary Community Leadership team and the PHUSE Emerging Technologies working group on adoption of Blockchain technology in the pharmaceutical industry. Currently an R&D Transformational Change Champion.

Experience across various therapeutic areas and phases of trials in drug development include creation and execution of successful strategies for research protocols and CRO oversight, expertise in technologies such as eCOA and IVRS, creation of optimal drug packaging and administration concepts, mapping the patient journey, planning and executing effective global site and patient engagement campaigns using direct to patient methods, leading and coaching remote and complex global teams. Completed an Executive MBA consulting report on ‘Implementing Patient Engagement at a Biotechnology Company.

 


 

Estelle JobsonEstelle Jobson
Patient Advocate; Communications Manager, Swiss Clinicals Trial Organisation (SCTO)

Estelle Jobson is a trained patient advocate who believes in the patient mantra: Nothing about us, without us. She is engaged on-line and off-line: with endometriosis awareness and patient engagement between patient organizations and healthcare providers in Switzerland, and with international online patient forums. As a patient, she has experienced different health care systems in South Africa, Italy, and Switzerland.

With a background in editing and writing in educational and academic publishing, Estelle has a particular interest in developing accessible information for patients, including digital resources. Only with clear information, increasing step by step in complexity, can patients can be empowered to make sound, informed decisions. In 2016, she completed the “Patient Experts in Medicines’ Research & Development” training run by the European Patients’ Academy (EUPATI). She now serves on the Executive Board of EUPATI Switzerland and works as Communications Manager at the Swiss Clinical Trial Organisation (SCTO), Bern.

 


 

Jason LacombeJason Lacombe
CEO, Veratrak

Jason Lacombe is the CEO of Veratrak, a blockchain company focused on the pharmaceutical supply chain. Jason first became interested in blockchain technology while on a fully-funded PhD scholarship at the University of Oxford, where he held an executive role with the blockchain society. Most recently, Jason was selected as a blockchain influencer in a recent report led by the All Party Parliamentary Group on Blockchain and appointed an Executive Advisor for Pharmaceuticals for the Blockchain Research Institute. In a past life, Jason had exposure to the pharmaceutical industry as an Expert Advisor to the European Parliament, Member of the World Health Organisation Collaborating Centre, and, as a health economist.

 


 

Massimiliano MasiMassimiliano Masi, M.Sc, Ph.D.
IT Security Architect, Tiani “Spirit” GmbH

Massimiliano Masi (M.Sc, Ph.D.) is IT Security Architect at Tiani “Spirit” GmbH. He participated in the design and planning of security measures and requirements of several nationwide projects (e.g., Austrian ELGA, eHR.ZA in South Africa, Consent2Share in USA).

Dr. Masi was the coordinator of the Core team of the epSOS.eu Security Expert Group and in the e-SENS.eu architectural board, while coordinating all the national eHealth pilots.

Masi has been a member of the OASIS and IEEE, and is also the editor of the IHE ITI profile XCF, and participated in the evaluation of the IHE profiles related to security (e.g., XUA, XUA++, SeR, Access Control White Paper, and ATNA).

Dr. Masi has been a consultant for the ENISA, currently for the EU Commission, and the Austrian Federal Ministry of health. Together with the Hyper e-Health team is promoting and implementing blockchain-based initiatives.

 


 

Jim NasrJim Nasr
VP of Technology & Innovation, Synchrogenix

Jim Nasr is the VP of Technology & Innovation at Synchrogenix, a Certara company. Jim leads strategy and implementation of emerging technologies—including: blockchain, open APIs, real-time data services and machine learning—to improve patient outcome and transform life sciences.

Prior to joining Synchrogenix, Jim was the Chief Software Architect at the US Centers for Disease Control (CDC). Jim led a number of initiatives around modernization of CDC’s public health systems, through design and implementation of interoperable software (based on microservices and modern DevOps), data as a service, blockchain and open source software. Prior to CDC, Jim was the CEO and co-founder of Armedia, a technology firm focused on building enterprise solutions for managing unstructured data.

Jim has more than twenty years of experience in the technology industry, with over a decade as a founder/entrepreneur profitably growing Armedia from inception to over 100 employees, and a 5-time Inc. 5000 awardee. Jim has co-authored several technology books, guest lectured for a number of universities and spoken globally at numerous industry events, including many in recent months on blockchain and open technologies.

Jim is a Technical Fellow at pioneering digital identity, non-profit EP3 Foundation, co-chair of (the healthcare standards accreditation) EHNAC Blockchain Workgroup, on the Industry Advisory Board of the College of Computer Engineering at Kennesaw State University, a mentor for the machine learning accelerator Cyberlaunch, and on advisory for a number of blockchain startups. He has an MBA from the University of Connecticut, a BS in Computer Science and Statistics from Coventry University and resides in Atlanta, GA.

 


 

Manreet NijjarManreet Nijjar
Co-Founder and CEO, Truu

Manreet Nijjar is trained as a Consultant Physician in Infectious Diseases and Internal Medicine and has over a decade of frontline clinical experience in the UK’s National Health Service.

He is also the co-founder of Truu and the team have been leading the way in Decentralised/ Self sovereign identity in the healthcare field, working on a solution for the past three years. The initial focus has primarily been to develop a trusted digital identity for doctors. Learning the complexity of various identity and credentialing authorities has lead Dr. Nijjar to engage with multiple institutions and gain a unique understanding of the importance of governance when creating a blockchain identity solution. Through this time the team have learnt the enablers and importance of what a physician controlled digital identity can do in both current and future healthcare ecosystems, such as its use in clinical trial recruitment and data collection. The team believe the new world requires a new relationship where individuals, clinicians and organsiations are treated as equals, this can be facilitated by the trusted peer to peer ecosystem they are helping to create.

Dr Nijjar is currently an NHS clinical entrepreneur fellow and has spoken about digital identity in healthcare internationally most recently at the My Data 2017 conference, European Identity Conference 2018, Healthcare and Blockchain congress London 2018, and the Internet Identity workshop.

 

 

Sponsors

Supporting and Partners Sponsors

With our sponsors and partners, we could not make this initiative (advancing the adoption of viable blockchain applications) possible. A special thanks to:

Spiritus PartnersConsilx

 

Venue Sponsor

ICE Imaging Centre of Excellence

 

If you are interested in joining this growing list of supporters and partners, contact helen.scott@ieee.org or m.palombini@ieee.org.

 

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