Enhancing Clinical Trial Outcomes through Effective Data 
Integration, Standardization and Compliance

15th February 2022

Day One - 15th February 2022

9:00 am - 9:45 am GMT Accelerating Clinical Trial Workflows with AI – Beyond the Hype, a Real-World Use Case

Nigel Hughes - Scientific Director, Janssen
Dr. Christopher Pettengell - Chief Medical Officer, Pentavere

Join Janssen Scientific Director, Nigel Hughes, Pentavere Chief Medical Officer Dr. Christopher Pettengell for a fireside chat on the challenges surrounding clinical trial data, and how innovative collaborations between pharma and AI companies, such as Janssen’s collaboration with Pentavere, are driving efficiencies so patients can access treatment sooner. This session will address:

• Increasing complexity of clinical trial data is a key factor impacting clinical trial success, and COVID is accelerating these challenges

• Need for clinical trial data management innovation, which is often overlooked in comparison to AI applications for drug discovery

• A leading real-world use case of Janssen & Pentavere’s successful collaboration using AI to accelerate and de-risk clinical trial data management


img

Nigel Hughes

Scientific Director
Janssen

img

Dr. Christopher Pettengell

Chief Medical Officer
Pentavere

10:00 am - 10:45 am GMT Understanding How Clinical Data Managers and Clinical Data Scientists Roles are Evolving

Narayan Lebaka - Senior Director of Clinical Data Management, Rgenix Inc.


• Let’s talk about the definition of data management to kick off our conversation today 

• What is the ideal definition of a data scientist, and does that apply to data management? 

• What is the role of a clinical data manager?

• How can we handle data processes and what tools can be utilised on the front end to help data analysis 

• When it comes to assess the challenges of assessing data, can we touch on quality not quantity and data cleaning?

• Guidance on data management is imperative, how do we overcome the challenge and handling of protocol deviations?

• The format of data is incredibly important – can you talk to me about why and how we can standardise this approach? 

• Discussing the challenges and best practices in the evolution of data managers acquiring new skills, adopting new technologies and employing new working methodologies in Clinical Data Management 

• Assessing how machine learning and artificial intelligence can be applied to the practice of data management, review and data quality and how that may transform the function to data sciences

img

Narayan Lebaka

Senior Director of Clinical Data Management
Rgenix Inc.

11:00 am - 11:45 am GMT Streamlining Business Operations to Ensure Reliable and Timely Data

Fausto Artico - Global R&D Data and AI Strategy Leader, Argenx

All the people and processes involved in a trial tirelessly work with one goal in mind: to obtain complete, reliable and timely data for objective decision-making by drug developers, medical staff, investors, and regulators. In other words, clinical trial data should be valued like gold dust, not coal dust. This session will address: 


• What is the role of statistics in the creation of a clinical trial plan and in the interpretation of its data?

• How can the digitalization of clinical trials streamline data collection processes?

• How can we reliably aggregate and collect data in a timely fashion during clinical trials? 

• How can we declutter data but preserve quality data from which generate useful insights? 

• How can we leverage Artificial Intelligence and Machine Learning in the clinical trial domain?



img

Fausto Artico

Global R&D Data and AI Strategy Leader
Argenx