Cambridge Healthtech Institute’s 4th Annual
ML and Digital Integration in Biotherapeutic Analytics
Best Practices for Implementing and Optimizing Big Data Tools in the Analytical function
May 11-12, 2026
Cambridge Healthtech Institute's 4th annual ML and Digital Integration in Biotherapeutic Analytics conference explores how laboratories are embracing automation, data science, and machine learning to transform analytical development for biologics. From miniaturized, automated workflows and digital twins for method lifecycle management to cloud-integrated platforms, sessions will showcase real examples of how AI and advanced analytics are improving assay design, predictive modeling, and real-time release testing. Speakers will address the infrastructure and cultural changes needed to make data “AI ready,” ensure explainability and regulatory confidence, and deliver end-to-end digital continuity across discovery, development, and quality control. By highlighting both successes and challenges, this program provides a practical roadmap for organizations seeking to modernize their analytics and unlock the full value of digital and AI-driven innovation.
Coverage will include, but is not limited to:
Automation and Digitalization
- Automation and miniaturization in analytical workflows
- Digital twins for method lifecycle management and predictive analytics
- Integration of analytical platforms with enterprise data systems and cloud-based AI tools
Use Cases for AI in Analytics
- Agentic AI applications in analytical method development and process development
- Generative AI for assay design, predictive modeling, and data augmentation
- AI-assisted interpretation for regulatory submissions and use in validated environments
ML/AI Impacts on Development Pipelines
- Explainability and bias control in AI models for regulatory and scientific trust
- Overcoming silos: enabling end-to-end digital continuity across discovery, development, and QC
- Predictive models for process design, PAT, and real-time release testing
Data Strategy and Infrastructure
- Best practices for transitioning from manual to automated data ecosystems
- Creating “AI ready” datasets: structured data capture and harmonization standards
- Implementing ontologies and FAIR principles for cross-platform data interoperability
Challenges and Solutions
- Adapting experimental scientists to digital workflows and paradigms
- AI to support FDA Modernization 2.0 initiative (alternatives to animal testing)
- Benchmarking ROI and risk management for digital transformation initiatives
The deadline for priority consideration is October 31, 2025.
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
Opportunities for Participation: