Disruptive Technology for Clinical Trials Summit Seminars

7:00AM - 7:50AM

Registration and Networking

7:50AM - 8:00AM

Opening Remarks

Prishu Kagra, Conference Director, AMG World

8:00AM - 8:30AM

Using Predictive Models to Understand Trial Information from ClinicalTrials.gov

  • Overview of the ClinicalTrials.gov website and the value it can create for trials information
  • Leveraging analytics tools to mine data from completed trials
  • Identifying relationships between inclusion and exclusion criteria
  • Enabling meta analyses across trials

Speaker

  • Peter Henstock Machine Learning & AI Lead: Combine AI, Software Engineering, Statistics & Visualization - Pfizer
8:30AM - 9:00AM

Digital Patient Recruitment: Smart Technology and Advanced Analytics to Streamline Recruitment, Retention, and Site Selection for Patients

  • Analyzing medical history, demographics, and health conditions to identify the right patient population for a trial
  • Reaching a broader, more diverse population through digital platforms to enhance the quality of recruitment
  • Improving patient retention in clinical trials with digital patient recruitment and support tools
  • Role of RWD for AI predictive models to enhance performance

Speaker

9:00AM - 9:30AM

Enhancing and Interpreting Clinical Results with Electronic Patient Reported Outcomes (ePROs) and Mobile Apps

  • Monitoring patient adherence to ePROs and mobile apps to ensure correct data collection
  • Providing timely feedback to motivate patients to continue using these tools and guide treatment decisions
  • Incorporating ePROs and mobile apps into routine clinical care to enhance data collection
  • Leveraging data for deeper insights into symptoms, side effects, quality of life, and to guide treatment decisions
  • Ensuring compliance and regulations to ensure privacy and security
9:30AM - 10:10AM

First Technology Demonstrations

This session provides an additional opportunity to meet with our product and solution providers in the exhibition hall to learn more about the products, technology, and services that have been developed to solve some of your unique challenges. The technology demonstrations will last approximately 8 minutes on four cycles with the opportunity to ask questions immediately afterwards over the refreshment break.

10:10AM - 10:50AM

Networking Break and Exhibition

10:50AM - 11:50AM

Roundtable Discussion: Enhancing Clinical Trials through Remote Patient Monitoring: Leveraging Technology and Patient Engagement for Improved Data Management and Analysis

Speaker

11:50AM - 12:20PM

Benefits of Cloud Computing for Clinical Trials Data Storage and Management

  • Integrating cloud-based solutions to scale up and accommodate the increased data storage requirements
  • Reducing capital and operational cost with effective data management
  • Increasing security with limited access to data
  • Optimizing tracking capabilities and visibility of data stored
12:20PM - 1:20PM

Networking Lunch and Exhibition

1:20PM - 1:50PM

Increasing Trust in Sensor Selection for Clinical Trials

  • An overview of regulatory guidelines on what constitutes a medical device
  • Examining the factors for selecting consumer vs. medical-grade devices: Technical verification, algorithms, and economic feasibility
  • Focusing on patient-centricity in clinical trials: Form factor and caregiver considerations
  • Sharing of additional resources for implementing ‘sensors and wearables’ technology

Speaker

1:50PM - 2:50PM

Roundtable Discussion: Advanced Integration of RWD for Efficient Clinical Development

Improving Diversity in Clinical Trials and Patient Centric Outcomes

Speaker

  • Amin Yakubu Associate Director, R&D Neuroscience RWE - The Janssen Pharmaceutical Companies of Johnson & Johnson
1:50PM - 2:50PM

Roundtable Discussion: Comparing Operational and Scientific Value for Using Emerging Technologies for Decentralized Trials

1:50PM - 2:50PM

Roundtable Discussion: Strategies for Analyzing and Interpreting Imaging Data in Trials

Advanced Imaging Techniques such as AI, ML

Speaker

  • Charles Glaus Senior Director, Oncology Precision Medicine - Bayer
2:50PM - 3:30PM

Second Technology Demonstrations

This session provides an additional opportunity to meet with our product and solution providers in the exhibition hall to learn more about the products, technology, and services that have been developed to solve some of your unique challenges. The technology demonstrations will last approximately 8 minutes on four cycles with the opportunity to ask questions immediately afterwards over the refreshment break.

3:30PM - 4:00PM

Networking Break and Exhibition

4:00PM - 5:00PM

Roundtable Discussion: Enhancing Diversity in Clinical Trials through Social Intelligence

Amplifying the Patient Voice and Improving Recruitment Strategies

Speaker

  • Michael Durwin Director of Social Media Intelligence & Social Media Communities - ICON
4:00PM - 5:00PM

Roundtable Discussion: NLP Technology: Improving Clinical Trial Design by Analyzing Data and Accurately Predicting Outcomes

Speaker

4:00PM - 5:00PM

Roundtable Discussion: Overcoming Geographical Barriers and Improving Patient Engagement with Telemedicine and Remote Monitoring

4:00PM - 5:00PM

Roundtable Discussion: Site Management Operations in the Age of DCT

Key Considerations for Successful Clinical Trial Implementation

Speaker

  • Tiffany McGinnis Senior Director, North America Site Management Country Head - Bayer
5:00PM - 5:45PM

Panel Discussion: Shaping the Future of Clinical Trials through Smart Technologies to Optimize Patient Experience

Technological advancements and digital innovations have resulted in automated trial processes to improve accuracy, speed, and cost. However, integrating smart technology in trials could be hampered by issues such as data availability, quality, security, and privacy, as well as lack of skills and knowledge.

This panel will look at the fundamentals needed to improve digital trials and maximize the value of emerging technology and digital innovation in clinical research. Our panelists will discuss the common challenges they face and how they have successfully overcome them.

  • Building a data & analytics strategy roadmap to enhance efficiency and outcomes: Governance, quality, storage, standardization and advanced analytics
  • Educating patients and participants to use technical devices such as sensor trackers, wearable medical technology, and mobile apps to ensure accurate data
    collection
  • Developing strategic partnerships and collaborations: Identifying solution providers who can support the journey towards digitally-enabled clinical trials
  • Leveraging appropriate technology and strategies to achieve data security and protection against potential cyber threats
  • Workforce management: Conducting an analysis of technical skills and knowledge gaps to enhance training and ensure proper use of tools and data
  • Identifying use cases, emerging technology and key considerations for organizations stepping into digital transformation and developing their technology
    roadmap

Speakers

  • Jen Yip Associate Director, Digital Trials & Patient Engagement - Novartis
  • Bhaskar Dutta Head of Digital Health & Medical Affairs Technologies - Alexion Pharmaceuticals
  • Jim Hacunda R&D Digital Strategy Lead - Takeda
  • Christopher Lee Strategic Marketing Director - Analog Devices, Inc.
5:45PM - 5:50PM

Close of Conference

5:50PM - 6:50PM

Drinks Reception

All attendees are invited to attend our networking drinks reception at the end of the day’s proceedings. This is our way of saying thank you for your contribution and to create an additional opportunity to continue your discussions in an informal setting.

1:50PM - 2:50PM

Roundtable Discussion: Advanced Integration of RWD for Efficient Clinical Development

Improving Diversity in Clinical Trials and Patient Centric Outcomes

Speaker

  • Amin Yakubu Associate Director, R&D Neuroscience RWE - The Janssen Pharmaceutical Companies of Johnson & Johnson
1:50PM - 2:50PM

Roundtable Discussion: Comparing Operational and Scientific Value for Using Emerging Technologies for Decentralized Trials

1:50PM - 2:50PM

Roundtable Discussion: Strategies for Analyzing and Interpreting Imaging Data in Trials

Advanced Imaging Techniques such as AI, ML

Speaker

  • Charles Glaus Senior Director, Oncology Precision Medicine - Bayer
2:50PM - 3:30PM

Second Technology Demonstrations

This session provides an additional opportunity to meet with our product and solution providers in the exhibition hall to learn more about the products, technology, and services that have been developed to solve some of your unique challenges. The technology demonstrations will last approximately 8 minutes on four cycles with the opportunity to ask questions immediately afterwards over the refreshment break.

3:30PM - 4:00PM

Networking Break and Exhibition

5:00PM - 5:45PM

Panel Discussion: Shaping the Future of Clinical Trials through Smart Technologies to Optimize Patient Experience

Technological advancements and digital innovations have resulted in automated trial processes to improve accuracy, speed, and cost. However, integrating smart technology in trials could be hampered by issues such as data availability, quality, security, and privacy, as well as lack of skills and knowledge.

This panel will look at the fundamentals needed to improve digital trials and maximize the value of emerging technology and digital innovation in clinical research. Our panelists will discuss the common challenges they face and how they have successfully overcome them.

  • Building a data & analytics strategy roadmap to enhance efficiency and outcomes: Governance, quality, storage, standardization and advanced analytics
  • Educating patients and participants to use technical devices such as sensor trackers, wearable medical technology, and mobile apps to ensure accurate data
    collection
  • Developing strategic partnerships and collaborations: Identifying solution providers who can support the journey towards digitally-enabled clinical trials
  • Leveraging appropriate technology and strategies to achieve data security and protection against potential cyber threats
  • Workforce management: Conducting an analysis of technical skills and knowledge gaps to enhance training and ensure proper use of tools and data
  • Identifying use cases, emerging technology and key considerations for organizations stepping into digital transformation and developing their technology
    roadmap

Speakers

  • Jen Yip Associate Director, Digital Trials & Patient Engagement - Novartis
  • Bhaskar Dutta Head of Digital Health & Medical Affairs Technologies - Alexion Pharmaceuticals
  • Jim Hacunda R&D Digital Strategy Lead - Takeda
  • Christopher Lee Strategic Marketing Director - Analog Devices, Inc.
5:45PM - 5:50PM

Close of Conference

5:50PM - 6:50PM

Drinks Reception

All attendees are invited to attend our networking drinks reception at the end of the day’s proceedings. This is our way of saying thank you for your contribution and to create an additional opportunity to continue your discussions in an informal setting.

7:30AM - 7:55AM

Registration and Networking

7:55AM - 8:00AM

Opening Remarks

Prishu Kagra, Conference Director at AMG World

8:00AM - 8:30AM

What’s Happening with AI: Current Reality & Future Opportunities

Integrating AI within the early stages to accelerate and optimize clinical trial design
Exploring how AI technology can be implemented within minor areas to enhance overall clinical outcomes
Analyzing technical skills and knowledge gaps to enhance training and ensure proper use of tools and data
Will AI replace people or train people?

Speaker

  • Andrew LeBlanc Associate Director, Digital Health - Alexion Pharmaceuticals
8:30AM - 9:00AM

Understanding Global Feasibility and Analytics for Enhanced Decision-Making

  • Finding the Right Places: Figuring out the right countries and sites to conduct your clinical trial
  • Understanding Local Factors: Considering patient population, healthcare infrastructure, and regulatory environment in different countries
  • Leveraging real world data to support recruitment of diverse populations
  • Enhanced analytics for decision making: role of predictive modelling, and new AI technologies

Speaker

9:00AM - 9:30AM

Empowering Patient-Centric Outcomes: The Synergy of ePRO, Wearables, and Patient Engagement in Clinical Trials

  • Implementing tailored strategies to foster active participation and feedback from patients throughout the trial duration
  • Automating Collection of Patient Outcomes: Ensuring the integrity and reliability of collected data through quality control measures and leveraging advanced analytics
  • Adhering to regulatory standards and Integrating ePRO and wearable data streams to gain a comprehensive understanding of patient experiences, behaviors, and health outcomes.
  • Future-Proofing Research Methodologies: Adapting to emerging technologies to continuously enhance patient-centricity

Speaker

9:30AM - 10:15AM

Technology Demonstrations

This session provides an additional opportunity to meet with our product and solution providers in the exhibition hall to learn more about the products, technology,
and services that have been developed to solve some of your unique challenges. The technology demonstrations will last approximately 8 minutes on four cycles
with the opportunity to ask questions immediately afterwards over the refreshment break.

10:15AM - 10:45AM

Networking Break & Exhibition

10:45AM - 11:20AM

Implementing Technology for Remote Consent to Enhance Participant Engagement

  • Effective informed consent management for standardized and ethical clinical trials
  • Reducing participant burden through digital accessibility, real-time support, and easy-to-use applications
  • Assessing Site Readiness: Ensuring that platform aligns with the needs & preferences of trial sites and participants
  • Optimizing consent documentation & ensuring compliance with regulatory standards
11:20AM - 12:20PM

Roundtable Discussion: Are Decentralized Clinical Trials Even Good? Evaluating the Reality of DCTs and Reasons Why People Are Avoiding this Term

Speaker

  • Jen Yip Associate Director, Digital Trials & Patient Engagement - Novartis
11:20AM - 12:20PM

Roundtable Discussion: Driving Clinical Trial Diversity and Equity through Digital Accessibil- ity Standards, Ensuring Inclusive Participation for Individuals with Disabilities

Speaker

11:20AM - 12:20PM

Roundtable Discussion: Listening to your Customers’ Needs: Developing Agile, Adaptable & Tailored Clinical Trial Technology Solutions

11:20AM - 12:20PM

Roundtable Discussion: Utilizing Participant Feedback to Transform Decentralized Clinical Trials: eConsent, Telemedicine, Home Nursing & Transportation Services

Speaker

12:20PM - 1:20PM

Networking Lunch & Exhibition

1:20PM - 1:50PM

Role And Impact Of Digital Health Technologies In Decentralized Clinical Trials

Speaker

  • Jie Shen Director Digital Science - AbbVie
1:50PM - 2:50PM

Roundtable Discussion: Considering Regulatory Landscape According to Emerging Trends of Technological Advancement in Drug Development

Speaker

1:50PM - 2:50PM

Roundtable Discussion: Testing Usability of Medical Devices to Ensure they Meet the Needs of Users and Are Safe and Effective

Speaker

1:50PM - 2:50PM

Roundtable Discussion: Tracking Patient Adherence To Epros And Mobile Apps To Ensure Correct Data Collection

1:50PM - 2:50PM

Roundtable Discussion: What Causes Studies to Fail? Understanding Causal Drivers of Operational Success Using Technology

Speaker

2:50PM - 3:20PM

Implementing a Direct-to-Patient Application to Recruit Diverse Patients and Collect Real-World Data

  • Developing targeted outreach strategies leveraging social media and digital platforms to engage underrepresented communities in clinical trials
  • Implementing user-friendly interfaces and providing necessary support to enhance digital literacy among participants
  • Tailoring questionnaire design to accommodate diverse cultural backgrounds to reduce potential biases in data collection
  • Combining structured and unstructured data from EHRs, and community health surveys with modern data fusion algorithms to create patient profiles

Speaker

3:20PM - 3:50PM

Networking Break & Exhibition

3:50PM - 4:50PM

Roundtable Discussion: Best Practices to Prepare IRB: Guidelines and Regulatory Requirements to Ensure Successful Submission

Speaker

  • Dana Immerso Director of Strategic Partnerships - Avrok Biosciences
3:50PM - 4:50PM

Roundtable Discussion: Developing Digital Biomarkers: Using Wearables, Apps, and Machine Learning for Validated Digital Endpoints

Speaker

  • Hao Zhang Director, Digital Healthcare Innovation - Mitsubishi Tanabe Pharma America
3:50PM - 4:50PM

Roundtable Discussion: Executing Decentralized Clinical Trials: Theory vs Reality

Speaker

  • Bob Bois Innovation Program Director - Novartis
3:50PM - 4:50PM

Roundtable Discussion: Key Considerations for Organizations Stepping Into Digital Transformation and Developing their Technology Roadmap

4:55PM - 5:40PM

Panel Discussion: Evaluating the True Impacts from Decentralized Trials: Do they Reduce or Increase Burden?

As the healthcare landscape continues to evolve, decentralization promises to reduce burden on both healthcare facilities and patients alike. However, there is also a danger that new challenges will emerge, potentially increasing burden in new areas. Therefore, it is critical to consider the quality and consistency of data collected across multiple sites, the different regulatory requirements, and the level of training and support required for staff and participants.


This discussion will explore the implications and opportunities of decentralized trials to determine whether they truly present the best ROI.


Site Accessibility: How does the decentralization of clinical trials impact the accessibility of research sites for patients?
Are decentralized trials facilitating or hindering patient recruitment efforts compared to traditional centralized or hybrid trials?
Which group of stakeholders possesses the most potential to broaden acceptance of decentralized trials? Sponors/Sites/Patients/Tech vendors?
Patient Engagement: How does the DCT’s influence patient engagement and retention throughout the study?
Data Quality, Accuracy and Standardization: What measures are in place to ensure data quality and integrity in decentralized trials, and how does this affect the
overall burden on patients and sites?
Have Health Authorities provided enough guidance on the conduct of decentralized trials?

Speakers

  • Dana Immerso Director of Strategic Partnerships - Avrok Biosciences
  • Stephen Framil Corporate Global Head of Accessibility - Merck
  • Bob Bois Innovation Program Director - Novartis
  • Martina Endzhova Global Category Lead for Clinical Trial Technologies - Bayer
5:40PM - 5:45PM

Close of Conference

5:45PM - 6:45PM

Drinks Reception

All attendees are invited to attend our networking drinks reception at the end of the day’s proceedings. This is our way of saying thank you for your contribution and to create an additional opportunity to continue your discussions in an informal setting

7:55AM - 8:00AM

Opening Remarks

Prishu Kagra, Conference Director at AMG World

8:00AM - 8:30AM

What’s Happening with AI: Current Reality & Future Opportunities

Integrating AI within the early stages to accelerate and optimize clinical trial design
Exploring how AI technology can be implemented within minor areas to enhance overall clinical outcomes
Analyzing technical skills and knowledge gaps to enhance training and ensure proper use of tools and data
Will AI replace people or train people?

Speaker

  • Andrew LeBlanc Associate Director, Digital Health - Alexion Pharmaceuticals
8:30AM - 9:00AM

Understanding Global Feasibility and Analytics for Enhanced Decision-Making

  • Finding the Right Places: Figuring out the right countries and sites to conduct your clinical trial
  • Understanding Local Factors: Considering patient population, healthcare infrastructure, and regulatory environment in different countries
  • Leveraging real world data to support recruitment of diverse populations
  • Enhanced analytics for decision making: role of predictive modelling, and new AI technologies

Speaker

9:00AM - 9:30AM

Empowering Patient-Centric Outcomes: The Synergy of ePRO, Wearables, and Patient Engagement in Clinical Trials

  • Implementing tailored strategies to foster active participation and feedback from patients throughout the trial duration
  • Automating Collection of Patient Outcomes: Ensuring the integrity and reliability of collected data through quality control measures and leveraging advanced analytics
  • Adhering to regulatory standards and Integrating ePRO and wearable data streams to gain a comprehensive understanding of patient experiences, behaviors, and health outcomes.
  • Future-Proofing Research Methodologies: Adapting to emerging technologies to continuously enhance patient-centricity

Speaker

9:30AM - 10:15AM

Technology Demonstrations

This session provides an additional opportunity to meet with our product and solution providers in the exhibition hall to learn more about the products, technology,
and services that have been developed to solve some of your unique challenges. The technology demonstrations will last approximately 8 minutes on four cycles
with the opportunity to ask questions immediately afterwards over the refreshment break.

10:15AM - 10:45AM

Networking Break & Exhibition

10:45AM - 11:20AM

Implementing Technology for Remote Consent to Enhance Participant Engagement

  • Effective informed consent management for standardized and ethical clinical trials
  • Reducing participant burden through digital accessibility, real-time support, and easy-to-use applications
  • Assessing Site Readiness: Ensuring that platform aligns with the needs & preferences of trial sites and participants
  • Optimizing consent documentation & ensuring compliance with regulatory standards
12:20PM - 1:20PM

Networking Lunch & Exhibition

1:20PM - 1:50PM

Role And Impact Of Digital Health Technologies In Decentralized Clinical Trials

Speaker

  • Jie Shen Director Digital Science - AbbVie
2:50PM - 3:20PM

Implementing a Direct-to-Patient Application to Recruit Diverse Patients and Collect Real-World Data

  • Developing targeted outreach strategies leveraging social media and digital platforms to engage underrepresented communities in clinical trials
  • Implementing user-friendly interfaces and providing necessary support to enhance digital literacy among participants
  • Tailoring questionnaire design to accommodate diverse cultural backgrounds to reduce potential biases in data collection
  • Combining structured and unstructured data from EHRs, and community health surveys with modern data fusion algorithms to create patient profiles

Speaker

3:20PM - 3:50PM

Networking Break & Exhibition

4:55PM - 5:40PM

Panel Discussion: Evaluating the True Impacts from Decentralized Trials: Do they Reduce or Increase Burden?

As the healthcare landscape continues to evolve, decentralization promises to reduce burden on both healthcare facilities and patients alike. However, there is also a danger that new challenges will emerge, potentially increasing burden in new areas. Therefore, it is critical to consider the quality and consistency of data collected across multiple sites, the different regulatory requirements, and the level of training and support required for staff and participants.


This discussion will explore the implications and opportunities of decentralized trials to determine whether they truly present the best ROI.


Site Accessibility: How does the decentralization of clinical trials impact the accessibility of research sites for patients?
Are decentralized trials facilitating or hindering patient recruitment efforts compared to traditional centralized or hybrid trials?
Which group of stakeholders possesses the most potential to broaden acceptance of decentralized trials? Sponors/Sites/Patients/Tech vendors?
Patient Engagement: How does the DCT’s influence patient engagement and retention throughout the study?
Data Quality, Accuracy and Standardization: What measures are in place to ensure data quality and integrity in decentralized trials, and how does this affect the
overall burden on patients and sites?
Have Health Authorities provided enough guidance on the conduct of decentralized trials?

Speakers

  • Dana Immerso Director of Strategic Partnerships - Avrok Biosciences
  • Stephen Framil Corporate Global Head of Accessibility - Merck
  • Bob Bois Innovation Program Director - Novartis
  • Martina Endzhova Global Category Lead for Clinical Trial Technologies - Bayer
5:40PM - 5:45PM

Close of Conference

5:45PM - 6:45PM

Drinks Reception

All attendees are invited to attend our networking drinks reception at the end of the day’s proceedings. This is our way of saying thank you for your contribution and to create an additional opportunity to continue your discussions in an informal setting