Accelerating Clinical Trials by Leveraging Blockchain Technology Solutions

About this Event

Data integrity and trial participant safety are among the most critical concerns in clinical trial management, especially from the perspective of regulatory bodies. Ensuring and maintaining data integrity in particular is therefore a significant paint point of clinical trials. Inability to produce accurate, complete, and reproducible data at any time in a trial in particular can lead to significant disruptions and delays in many integrated trial processes, and more importantly, compromise trial approvals.
This webinar explores how blockchain-supported platforms present a solution which can assist with trial data management, but also accelerate clinical trials. Clinical trial management systems—supported by blockchain technology—have the potential to address key pain points and prioritized system requirements. Our panel will discuss the opportunities this technology offers for ongoing and future trials.

Key Topics:
- How can a blockchain-supported platform address pain points in clinical trial management and oversight?
- How are virtual and decentralized trials ensuring that they align with FDA regulations?
- What lessons have we learned during this COVID age that we can apply to improve the management of trials once Coronavirus restrictions begin to be lifted?
This event is brought to you free of charge by our partners Bloqcube.

Meet the Panel:
Dr. Alex Cahana
Chief Medical Officer and EMEA Market Lead at ConsenSys Health
Blockchain (Healthcare) Expert for UN/CEFACT

Earlier this year Alex Cahana, MD, MAS joined ConsenSys Health as its Chief Medical Officer. The former Head of Healthcare and Blockchain at GenesisBlock, also serves as EMEA Market Leader.
Dr. Cahana has worked extensively at the intersection of healthcare and blockchain technology, currently serving as a Blockchain Expert for the European Economic Commission at the United Nations Centre for Trade Facilitation and Electronic Business (UN/CEFACT), an Advisor for Global Blockchain Ventures, and a Theme Developer for Ark Investment.
Dr. Cahana’s extensive academic experience includes serving as Professor and Chief of the Division of Pain Medicine in the Department of Anesthesiology at the University of Washington from 2008-2014 and Head of Interventional Pain Service at the Geneva University Hospital from 2000-2008.

Kyle Faget
Telemedicine, FDA Regulatory and Compliance, Clinical Trials, Healthcare, and Life Sciences Attorney
Foley & Lardner LLP

Kyle Faget is of counsel and a business lawyer with Foley & Lardner LLP. She is a member of the firm’s Health Care, Digital Health, and Life Sciences Industry Teams. Her practice focuses on research, development, and commercialization of pharmaceutical and medical device products. Kyle has extensive experience drafting and negotiating agreements with and for contract/clinical research organizations and site management organizations. She regularly drafts and negotiates License Agreements, Material Transfer Agreements, Clinical Trial Agreements, Informed Consents, and other development agreements on behalf of pharmaceutical and medical device clients She advises clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code. Finally, Kyle has a robust telemedicine practice. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies.

Denis Mir
Director of Clinical Operations
BioMarin Pharmaceutical Inc.

Denis qualified first as a biochemist and later added a statistical degree to his curriculum.
He has been in clinical research for 20 years, developing new treatment options for patients with cancer and rare diseases, in France, England and now in California.
He is currently Director of Clinical Operations at BioMarin Pharmaceutical Inc. focusing on innovations and technology.
During his career, Denis has managed clinical operations teams of various sizes, and was head of clinical operations for BioMarin UK before moving to the US. He retains program oversight in his current role.

Meet the Moderator
Katrina F. Mateo, PhD
Deputy Director, Research & Operations
HITLAB

Katrina F. Mateo, PhD, MPH, is the Deputy Director of Research & Operations at HITLAB and is responsible for directing the development and implementation of HITLAB's digital health innovation research and evaluation studies; providing evidence-based recommendations for further developing, operationalizing, and scaling innovative digital health technologies and platforms; and facilitating partnerships and collaborations between key stakeholders in the digital health ecosystem (i.e. life science/pharma, start-ups, hospitals, private/community clinics, device developers/vendors etc.).