8 October 2024 Seminars
Opening Remarks
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
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
Stephanie Vakaljan Director, Clinical Operations Planning - GSK
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
Wessam Sonbol Founder, CEO - Delve Health

Technology Demonstrations with Evidation and Mushroom Solutions
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.
Networking Break & Exhibition
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
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
Driving Clinical Trial Diversity and Equity through Digital Accessibil- ity Standards, Ensuring Inclusive Participation for Individuals with Disabilities
Exploring the Transformative Impact of Clinical Trials Operations Automation (CTOps): Enhancing Clinical Trials Through Advanced Automation
Speaker
Srinivas Kommalapati CEO - Mushroom Solutions
Roundtable Discussion: Exploring the Transformative Impact of Clinical Trials Operations Automation (CTOps): Enhancing Clinical Trials Through Advanced Automation
Sponsor
Srinivas Kommalapati CEO - Mushroom Solutions
Utilizing Participant Feedback to Transform Decentralized Clinical Trials: eConsent, Telemedicine, Home Nursing & Transportation Services
Speaker
Lani Hashimoto Associate Director, Patient Engagement - Novartis
Networking Lunch & Exhibition
Role And Impact Of Digital Health Technologies In Decentralized Clinical Trials
Speaker
Jie Shen Director Digital Science - AbbVie
Considering Regulatory Landscape According to Emerging Trends of Technological Advancement in Drug Development
Overcoming Hurdles in Clinical Trials: From Recruitment to Retention
Sponsor
Meghann Dryer General Manager, Consumer - Evidation Health
Testing Usability of Medical Devices to Ensure they Meet the Needs of Users and Are Safe and Effective
Speaker
Miles Alexander Welbourn Senior Associate Digital Health Technology - Pfizer
What Causes Studies to Fail? Understanding Causal Drivers of Operational Success Using Technology
Speaker
Martina Endzhova Global Category Lead for Clinical Trial Technologies - Bayer
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
Yuwei Zhang VP, Innovative Digital Health - Northern Medical Center
Networking Break & Exhibition
Best Practices to Prepare IRB: Guidelines and Regulatory Requirements to Ensure Successful Submission
Speaker
Dana Immerso Director of Strategic Partnerships - Avrok Biosciences
Developing Digital Biomarkers: Using Wearables, Apps, and Machine Learning for Validated Digital Endpoints
Speaker
Hao Zhang Director, Digital Healthcare Innovation - Mitsubishi Tanabe Pharma America
Executing Decentralized Clinical Trials: Theory vs Reality
Speaker
Bob Bois Innovation Program Director - Novartis
Key Considerations for Organizations Stepping Into Digital Transformation and Developing their Technology Roadmap
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
Bob Bois Innovation Program Director - Novartis
Martina Endzhova Global Category Lead for Clinical Trial Technologies - Bayer
Closing Presentation by Mushroom Solutions Inc.
Sponsor
Srinivas Kommalapati CEO - Mushroom Solutions
Close of Conference

Drinks Reception Hosted by Mushroom Solutions
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