DAY 1|2nd June 2021
Stream A
8:00 am Sponsor Oversight in Managing Real Time Data
Understanding the collaboration between trial management, data management and eClinical. Maintaining data standards to allow for data integration, data sharing and meta-analysis. How to make data available for the sponsor to maintain sponsor oversight in clinical trials and programs
Max Horneck
Head of Clinical Data Management and eClinical Systems
Medac GmbH
8:30 am Place Holder Session
9:00 am CRO Oversight: Where is the sweet spot?
- Consolidated review of how to oversee a CRO doing Data Management work for a sponsor
- Commonalities, differences and best practise of oversight processes in the industry
- Practical considerations for Clinical Data Managers
Pieter Voermans
Head Clinical Data Management
SOBI
9:30 am Reserved For e-Clinical Solutions
Break
10:20 am Roundtable Breakout Sessions
Roundtable 1: Reserved for CMED
Roundtable 2: Streamline clinical workflows with intelligent, predictive insights
Facilitators: Gary Shorter, Senior Director, Data Science, IQVIA Technologies and Wendy Morahan, Senior Director, Clinical Data Analytics, IQVIA Technologies
- Go beyond descriptive analysis by applying intelligent analysis to subject data investigations, risk management, and performance metrics
- ML-enhanced analytics identify more predictive and previously hidden insights to help stakeholders make smarter decisions
- Accelerate time to market for new medications and improve patient experiences across the trial journey
11:00 am Implementing Centralised Monitoring Processes To Support Current Trials
Jacqueline Gough
Director Centralized Monitoring and Data Surveillance
Astellas Pharmaceuticals
11:30 am Bench to Market in Record Time with Virtualizing Technology
Prior to the pandemic, decentralized or virtual clinical trials were more a vision of the future than a current imperative for sponsors and CROs. But on the heels of the COVID-19 pandemic, the industry is witnessing a digital era that opens up new opportunities for companies to develop highly efficient operating models, and this has allowed contract research organizations to offer new services that ultimately enable delivery of therapies to patients faster, and with lower barriers to entry to increase recruitment, patient diversity, and retention. These modernized technologies and processes offer companies the ability to radically improve both the patient and the site experience, thereby enabling greater access and interest for both patients and sites. Changing the paradigm of study conduct to enable virtualization of clinical trials, for both patients and sites, has become the industry’s new focus. Multiple solutions exist to enable remote patient participation, however there has been a growing need for virtualizing solutions to be incorporated in daily site operations, including monitoring and oversight.
Anthony Costello
SVP, President, Patient Cloud
Medidata
Lisa Moneymaker
VP, Product Management
Medidata
12:00 pm Panel: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity
- Vulcan is an HL7 FHIR Accelerator that brings together stakeholders across the translational and clinical research commu-nities in order to bridge existing gaps be-tween clinical care and clinical research, strategically connect
- industry collaboratives, maximize collec-tive resources, and deliver integrated tools and resources.
- Following the example of other HL7 Accel-erators, Vulcan has brought together re-search academia, industry groups, govern-ment agencies, technology vendors, and patient advocates in order to bridge exist-ing gaps, maximize use of collective re-sources, and deliver standards and tools necessary to connect healthcare data with clinical and translational research.
Amy Cramer
Director of eSource
Pfizer
12:30 pm Keynote: Measuring eClinical Data Challenges and Performance
- Understanding the collaboration between trial management, data management and eClinical
- Maintaining data standards to allow for data inte-gration, data sharing and meta-analysis
- How to make data available for the sponsor to maintain sponsor oversight in clinical trials and programs
Break
1:10 pm Roundtable
Roundtable 1: Reserved for CMED
Roundtable 2: Maximize the long-term value of clinical data
Facilitator: Tim Riely, Vice President – Clinical Data Analytics, IQVIA Technologies
- The explosion of data sources and volumes requires intelligent technology to harness the power of trial data
- Explore how sponsors can increase the value of data and improve outcomes by applying intelligent insights within and across trials
- Cloud data management platforms and advanced data analytics help shape future study design, study planning, and risk management
1:50 pm Reserved for Axiom Real-Time Metrics
2:20 pm Q&A: Considerations When Working With Multiple Sites and Collecting Study Data
Patrick Zbyszewski
Director, Data Management and Programming
Endo Pharmaceuticals
2:50 pm Considerations Needed When Implementing Risk Based Quality Management To Improve Operational Efficiency
- Pre planning in advance to ensure you have the right processes in place
- Assessing any risk based
Terry Katz
Sr Director, Biostatistics and Data Management Planning and Functional Excellence
Daiichi Sankyo
3:20 pm Outlining the necessary procedure to prepare for FDA submission for MedDevice
- Data manager’s role from IDE Submission to PMA approval
- Partnering with the FDA to ensure successful study outcomes
- Leveraging available and emerging technologies
- Hybrid model of a decentralized clinical study
Frances Rubenstein
Director, Database Management
Nevro Corporation
3:50 pm Convergence of Big Data and Artificial Intelligence in Augmenting Drug Discovery, Development and Supply Chain Management
- Introduction to big data: Sources, applications and challenges
- Reviewing big data analytics & cloud computing: players, collaborative models, data integration and representation
- Implications of AI, data analytics and robotic process automation (RPA) in digital health, medical devices, wearable and supply chain management
- Running intelligent clinical trials and supply chain operation using advanced analytics, machine learning, AI, smart labeling and tracking
Prasun Mishra
Founder CEO
Agility Pharmaceuticals
4:20 pm Capturing Data More Efficiently In Patient Centric Trials
- Having effective data capturing tools available for patients
- Outlining time frames to ensure patient data is being uploaded effectively
- Creating a central hub to analysis the captured data efficiently
Conclusion of Conference
Stream B – e-Clinical Innovations
8:00 am How CDISC is Using Standards and Technology to Boost Automation of Clinical Data Processes
- New standards content that make better standards automation possible
- New technology that makes standards-based automation simpler, including the CDISC Library and other software applications
- New tools for managing standards
Sam Hume
Vice President, Data Science
CDISC
8:30 am Reserved for Genomoncology
9:00 am Considerations Needed When Digitalising Your Clinical Trial
- Managing tele visits expectations in advance to avoid any shortages of devices of patient participation
- Assessing sites to determine if remote monitoring is possible
- Checking Privacy regulations for international trials to avoid any GDPR issues
Krishna Mankala
Executive Director
SK Life Science
9:30 am Place Holder Session
Break
10:20 am Roundtable
Roundtable 1: Reserved for CMED
Roundtable 2: Streamline clinical workflows with intelligent, predictive insights
Facilitators: Gary Shorter, Senior Director, Data Science, IQVIA Technologies and Wendy Morahan, Senior Director, Clinical Data Analytics, IQVIA Technologies
- Go beyond descriptive analysis by applying intelligent analysis to subject data investigations, risk management, and performance metrics
- ML-enhanced analytics identify more predictive and previously hidden insights to help stakeholders make smarter decisions
- Accelerate time to market for new medications and improve patient experiences across the trial journey
11:00 am Collaborate to Scale: The Path to Global Adoption of Decentralized Trials
- Understand the challenge in the way of scaled global adoption of decentralized research
- Explore the collaborations underway meant to help address adoption barriers
- Detail the specific pain points best suited to collaboration as a solution
Craig Lipset
Co-Chair
Decentralised Trials and Research Alliance
11:30 am Bench to Market in Record Time with Virtualizing Technology
Prior to the pandemic, decentralized or virtual clinical trials were more a vision of the future than a current imperative for sponsors and CROs. But on the heels of the COVID-19 pandemic, the industry is witnessing a digital era that opens up new opportunities for companies to develop highly efficient operating models, and this has allowed contract research organizations to offer new services that ultimately enable delivery of therapies to patients faster, and with lower barriers to entry to increase recruitment, patient diversity, and retention. These modernized technologies and processes offer companies the ability to radically improve both the patient and the site experience, thereby enabling greater access and interest for both patients and sites. Changing the paradigm of study conduct to enable virtualization of clinical trials, for both patients and sites, has become the industry’s new focus. Multiple solutions exist to enable remote patient participation, however there has been a growing need for virtualizing solutions to be incorporated in daily site operations, including monitoring and oversight.
Anthony Costello
SVP, President, Patient Cloud
Medidata
Lisa Moneymaker
VP, Product Management
Medidata
12:00 pm Expanding Upon The Utility and Versatility of Decentralized Clinical Trials Through the Use of Digital Endpoints
Vanja Vlajnic
Senior Manager, Statistics and Data Insights
Bayer
12:30 pm Innovative AI technologies for data-driven forecasting & monitoring patient recruitment & trial operational design
- Predictive analytic modelling to maximize patient recruitment
- Optimal operational design, sites/countries selection given costs & time constraints
- Data-driven re-projection and optimal adjustment to increase probability to meet target
- Advances in risk-based data monitoring and forecasting trial performance
- Forecasting various operational processes (event’s counts, specific sites,..)
Vladimir Anisimov
Data Scientist
Amgen
Break
1:10 pm Roundtable
Roundtable 1: Reserved for CMED
Roundtable 2: Maximize the long-term value of clinical data
Facilitator: Tim Riely, Vice President – Clinical Data Analytics, IQVIA Technologies
- The explosion of data sources and volumes requires intelligent technology to harness the power of trial data
- Explore how sponsors can increase the value of data and improve outcomes by applying intelligent insights within and across trials
- Cloud data management platforms and advanced data analytics help shape future study design, study planning, and risk management
1:50 pm Artificial Intelligence and Machine Learning Technologies For Proactive Data Cleaning
We are at the start of what is likely to be a rapid evolution within data management; we are embracing technologies which will provide overall efficiency gains in terms of cost as well as faster high-quality data to support analyses. These processes require effective collaboration between human and machine; both in the design and integration into existing processes and in the effective and successful application to data management activities.
When the
In this session we will describe how PHASTAR is applying machine learning to historic manual queries across different studies, in order to create an understanding of the common issues across and within studies, thus enabling a targeted approach to process optimisation for clinical data cleaning. Through the application of AI and rule-based approaches we will demonstrate how, working closely with the study experts, the machine can auto-detect potential data inconsistencies and anomalies. We explore the potential efficiency gains from such an approach, the vital role of the human expert, particularly where free text is involved, and the progress and challenges integrating such a method into the existing data query process.
We will outline the first steps towards an automated system as we look to build the foundations of a system that ultimately will learn, through expert feedback, how to identify data anomalies – providing a mechanism to drive increased time and cost efficiencies and empowering data managers to use such technology to their advantage.
Learning outcomes
- How AI can effectively be applied to clinical meta-data
- Understand potential areas for efficiency gains in data management
- Understand the interplay between human expert and machine in the application of advanced analytics
Sheelagh Aird
Senior Director, Data Operations
Phastar
2:20 pm Deep Dive: Analysing Data For Diverse Patient During A Pandemic
- Breakdown of patient categories to see where they have been lost
- Assessing what can be done to encourage diverse population back into trial studies
2:50 pm Panel: Decentralising Your Clinical Trials But Achieving Optimum Results
Join our panel experts, where they will dive into to the evolvement of digital health in the clinical trial space and assess tools like remote monitoring
Swapna Bapat
IT Manager
Janssen
Derk Arts
Founder & CEO
Castor
Valerie Balosso
Head Data Management RDC US, GlaxoSmithKline Vaccines
3:20 pm Fireside Chat: Analysing Digital Devices In Harnessing Real World Data
- Outlining the current digital devices available to sponsors
- Assessing protocols to measure efficacy and real world data
Aman Thukral
Head of Digital Operations and eCOA
AbbVie
3:50 pm Measuring Clinical Data De-Identification For Enabling Secondary Research and Drug Discovery
Gian Prakash
Associate Director, R&D Information Research
AbbVie
4:20 pm An Analytical Overview on Decentralized trials and Where The Industry Is At
Revati Tatake
PhD, Global Director of Databases and Analytics
GlobalData
Conclusion of Conference