Artificial Intelligence in Clinical Research

Machine Learning and AI to Advance Clinical Operations and Data Management

March 3 - 4, 2021 ALL TIMES EST

Artificial intelligence (AI) and machine learning (ML) have propelled many industries toward a new, highly functional and powerful state. Now they are starting to make their way into the clinical research realm advancing clinical operations, as well as data management. Many pharmaceutical companies and larger CROs are starting projects involving some elements of AI, ML, and robotic process automation in clinical trials. CHI’s 4rd Annual Artificial Intelligence in Clinical Research conference is designed to facilitate the discussion and to accelerate the adoption of these approaches in clinical trials.

Wednesday, March 3

ENHANCING PATIENT-SITE CENTRICITY AND CLINICAL INNOVATION THROUGH TECHNOLOGY

10:55 am KEYNOTE PRESENTATION:

COVID-19: How an External Event Redoubled Janssen’s Culture of Innovation

Darren Weston, Vice President, Integrated Data Analytics & Reporting (IDAR), Janssen

The external threat posed by the pandemic forced Janssen to reckon with longstanding cultural barriers to innovation. Faced with an urgent need to ensure patient safety and continuity of care, Janssen found a way to overcome these barriers and evolve the way they conduct clinical trials. Not only did Janssen minimize overall trial impact, but Janssen’s clinical operations have become more efficient and resilient in the face of future challenges. We will discuss the cultural and operational adaptations Janssen undertook to adapt to the pandemic environment and how we see these actions positioning us for the future.

Steven Sulkin, Founder & CEO, SimuLyve International, Inc.®

Steven Sulkin, CEO, SimuLyve International

Marina Ziehn, PhD, Global Med. Affairs Dir. Neuroscience, Novartis

Markus Krüer, PhD, Head Clinical Project Mgt, Merz

Nico Wegener, PhD, Senior Clinical Project Mgr, Merz

Dave Matthews, Clinical Project Dir., Merz

 

Training worldwide staff on complicated protocols virtually with the added issue of language barriers can seem daunting. Our panel of virtual experts will show you how to perfect virtual skills and enhance virtual meetings.

 

11:20 am KEYNOTE PRESENTATION:

Option 2: New Players and Innovators in Clinical Trials, the Impact of Non-Pharma Entrants...Meet Salesforce and CVS Health

Shwen Gwee, Vice President & Head, Global Digital Strategy, Bristol-Myers Squibb Co.
Gary Gabriel, PhD, Healthcare and Life Sciences Lead, Salesforce
Lou Sanquini, Vice President, Life Sciences Group, CVS Health
11:45 am Tech Break, Transition to Interactive Breakout Discussions
12:00 pm Interactive Breakout Discussions - Visit Our Virtual Exhibit Hall

Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers. View all topics here.


12:30 pm Session Break - Visit Our Virtual Exhibit Hall
Geoff Gill, President, Shimmer Americas, Shimmer Research

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

Bernadette Tosti, Vice President, Patient Experience, Science 37
Lindsay Singler, Director, Research Communications & Engagement, Operations Management Team, Duke Clinical Research Institute

Current events have driven pediatric clinical research to be more flexible and efficient—to increase patient access and enhance the patient experience both during the COVID-19 pandemic and beyond. With increased regulatory support for direct-to-family (decentralized) trials, learn how to leverage technology to safely and efficiently conduct research using a current, real-life example of trial design.

Leon Sun, Chief Science Officer, RA,PV,MD, Beijing Highthink Technology Co., Ltd

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

AI STRATEGY AND CASE STUDIES

1:15 pm

AI-Powered Modelling and Clinical Trial Design Optimization

Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.

This talk will focus on the AI applications in the drug development process, with a focus on designing and executing clinical trials. The discussion will be illustrated by examples and will cover issues, such as data processing and preparation, design of robust AI solutions, and more.

Sharath Bennur, Delivery Director, AI Solutions, IQVIA

Organizations face numerous challenges in driving AI development at scale across organizations. These include identifying valid use cases, building AI solutions adopted by users and proving ROI from AI initiatives. In this talk, we discuss how applying Decision Intelligence can help resolve some challenges and provide a focused path to building AI, that users trust and adopt. The discussion will include use cases and examples from real projects at IQVIA.

1:55 pm

Meet the AbbVie DevBot Family: Intelligent Process Automation Bots Helping Accelerate, Scale, and Hone the Operation of Clinical Trials


Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie

In order to improve productivity throughout the clinical trial execution process, AbbVie is developing a family of Intelligent Process Automation ‘bots’ that execute operational processes in order to free up our teams to work on higher value activities. These bots assist in trial operations tasks such as document quality checks, extraction of statistical data from PDF sources, and more. In this talk I will introduce the audience to five of our family members - Blizzard, Bert, Mater, Ernie, and CeSaR. I will explain how these bots give time back to our teams and walk through how they were developed and deployed.

Siddharth Karia, Principal, Life Sciences, Deloitte Consulting LLP
Bill Baker, Specialist Leader, Life Sciences, Deloitte Consulting LLP

The traditional data flow across the clinical trial lifecycle is often siloed and manual. AI can automate data management by creating structured, standardized, and digital data elements from different input sources. Through ML, these data elements can be intelligently interpreted and transformed to set up downstream systems, auto-populate reports and analyses, and generate content for key trial artifacts. This streamlined interoperability can accelerate trials–from protocol to submission.

2:35 pm

AI in Drug Development: Opportunities and Pitfalls

Faisal Khan, PhD, Executive Director, Advanced Analytics & AI, AstraZeneca Pharmaceuticals, Inc.

This presentation will cover some of the numerous exciting applications of AI in drug development, as well as pitfalls to watch out in order to make sure best practices are being followed for robust AI results.

2:55 pm

Using AI and Analytics to Reduce Clinical Development Timelines

Jade C. Dennis, Advisor, Design Hub, Eli Lilly and Company

Using AI and analytics, we can speed clinical trial enrollment, accelerate overall clinical development timelines, and reduce costs. An integrated set of advanced analytical tools and processes was developed that allows users to identify trends and make broader inferences about clinical trial feasibility and facilitates more robust and reliable clinical development plans.

3:15 pm

CAI Machine Learning to Automate the CDISC SDTM Data Preparation for Analysis and Regulatory Submissions

Gian Prakash, Associate Director, Data Engineering, Information Research, AbbVie Inc.
The preparation of the CDISC SDTM compliant datasets is one of the critical and time-sensitive pre-requisites for completing the analysis and regulatory submissions for drug approval. The current approach for creating a CDISC SDTM compliant datasets is based upon the manual technique of mapping source datasets one at a time, which is time-consuming and prone to error. This presentation aims at utilizing machine learning to automate the preparation of CDISC SDTM compliant datasets to improve efficiency and quality.
3:35 pm Close of Day

Thursday, March 4

MOVING TOWARD PLATFORM THINKING TO TRANSFORM PHARMA

9:00 am

Moving toward Platform Thinking: Creating a More Seamless Front-End and Back-End to Future-Proof and Advance Digital Transformation in Pharma

Panel Moderator:
Adama Ibrahim, Director, Digital Solutions & Technology & Platforms, Data & Digital Global Drug Development, Novartis Pharma AG

COVID has been a reality check for the biopharma industry and it is evident we should be focused on future proofing. We operate through webs of legacy systems, complex org charts and entrenched 'resistance to change' cultures. Platform thinking is the opposite. Imagine a patient or physician able to find, learn about and participate in clinical research similar to the way we all interact with our own financial services companies through apps and sophisticated yet simple technology solutions! This can be possible through common enterprise thinking and approaches that are adopted across the industry.

Panelists:
Mohammed Ali, VP Digital Analytics & Performance, GlaxoSmithKline
Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol-Myers Squibb Co.
Craig Lipset, Founder & Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Disa Lee Choun, Head, GCSO Innovation, UCB Pharma

AI FOR DATA MANAGEMENT AND CLIN-OP DECISIONS

9:30 am

The Application of Artificial Intelligence and Machine Learning to the Analysis of Clinical Trials: Deriving Further Insight

Vanja Vlajnic, Senior Manager, Statistics and Data Insights, Bayer Science Fellow, Bayer Pharmaceuticals
Fabrizio Messina, Senior Statistician, Bayer Pharmaceuticals

The talk will focus on a survey of several AI/ML approaches to the analysis of clinical trial data, with a particular focus on methods appropriate for survival analysis. Case studies involving neural networks and clustering methodologies will be shown.

10:10 am LIVE PANEL DISCUSSION:

AI to Advance Novel Approaches in Clinical Research 

Panel Moderator:
Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.
Panelists:
Faisal Khan, PhD, Executive Director, Advanced Analytics & AI, AstraZeneca Pharmaceuticals, Inc.
Neal Grabowski, Director, Safety Data Science, AbbVie
Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie
Vanja Vlajnic, Senior Manager, Statistics and Data Insights, Bayer Science Fellow, Bayer Pharmaceuticals

THE TOKENIZATION OF TRIAL PARTICIPANTS, SOCIAL DETERMINANTS OF HEALTH (SDOH) & MOVING TOWARD PLATFORM THINKING TO TRANSFORM PHARMA

11:25 am KEYNOTE PRESENTATION:

Option 1: Tokenization of Our Clinical Trial Participants

Kyle Holen, Head, Development Design Center, AbbVie Inc.

Unique, encrypted patient identifiers allow you to match the world's data with the people that participate in your clinical research studies.  The opportunities to learn more from the study participants are endless; however, there are significant legal and privacy concerns that need to be addressed.  This presentation will walk you through how to address these concerns, the implications to the consent and protocol, and how to implement at sites.

11:25 am KEYNOTE PRESENTATION:

Option 2: Social Determinants of Health (SDoH) and Its Relevance to Clinical Trials

Laurie Myers, Director, Global Health Literacy, Merck & Co Inc

It is well documented that clinical trials have struggled to achieve equitable participation of racial-ethnic minorities and women. However, the role of social determinants of health (SDOH) on participation and retention rates of research participants in clinical trials has not been well studied. Additionally, there are a few studies that suggest SDOH may have an impact on clinical trial results, highlighting the importance for more studies to consider the SDOH as another dimension when developing clinical programs.

11:50 am Session Break - Visit Our Virtual Exhibit Hall

AI APPLICATIONS CASE STUDIES

12:10 pm

Application of Deep Learning Methods to Optimize Site Monitoring in Clinical Operations

Bhargava Reddy, PhD, Director, Advanced Insights, Janssen

Conduct of clinical trials are costly. Significant portion of the cost in a clinical trial is attributed to site monitoring related activities such as source data verification/review during the conduct of the trial. Studies have shown that traditional onsite monitoring at a fixed intervals have resulted in suboptimal efficiencies.  Therefore, exploration of alternate approaches such as evidence-based decision making to optimize the cost and quality have become increasingly important

12:30 pm

Implementing Intelligent Automation Technologies for Individual Case Safety Reporting

Neal Grabowski, Director, Safety Data Science, AbbVie

TransCelerate’s solutions help identify ways intelligent automation technologies can support and improve the execution of pharmacovigilance (PV) activities and processes. Using the Individual Case Safety Reporting (ICSR) process as a case study, we will introduce foundational terminology, attitudes toward intelligent automation, applicable technologies, and validation considerations.


12:50 pm

Propelling into a New Era of Trial Optimization for Operational Success with Data Science-Infused Analytics and Technology

Miruna Sasu, PhD, Executive Director Global Development Feasibility & Advanced Analytics, Johnson & Johnson

The Janssen Global Development Feasibility team has built a sustainable global model to support every trial with data science and technology at an industrial scale. This presentation will focus on briefly showcasing several tools and algorithms that were built internally to bring unfathomable value and data-driven solutions to trial teams that aids them in making solid decisions on how to operationalize each trial for ultimate success and decreased patient and site burden.

1:10 pm Tech Break, Transition to Live Q&A
1:30 pm LIVE PANEL DISCUSSION:

Pandemic-Proof Trials of 2030: Applying Lessons Learned from COVID-19

Panel Moderators:
Pamela Tenaerts, MD, MBA, Executive Director, Clinical Trials Transformation Initiative (CTTI)
Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

For many clinical trials, survival during the pandemic has centered on transitioning to remote practices midstream. What have we learned from these remote experiences that should carry forth into future trials? How do we approach trial design and conduct in new ways to ensure the next generation of research is resilient? This panel will discuss lessons learned from the COVID-19 pandemic, provide recommendations for improved future trials, and outline a system-wide vision for clinical trials in 2030.

Panelists:
Janice Chang, Chief Operating Officer, TransCelerate Biopharma Inc.
Patricia Hurley, Director, Center for Research & Analytics, American Society of Clinical Oncology
Angie Botto-Van Bemden, PhD, Patient Advocate, Musculoskeletal Research International
1:50 pm SCOPE Summit 2021 Adjourns





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