Cambridge Healthtech Institute’s 5th Annual

ML and Digital Integration in Biotherapeutic Analytics

Best Practices for Implementing and Optimizing Big Data Tools in the Analytical Function

May 10-11, 2027

The 2027 ML and Digital Integration in Biotherapeutic Analytics track explores how discovery- and CMC-stage laboratories are embracing automation, data science, and machine learning to transform analytical and bioanalytical development for biologics. From self-driving lab platforms and digital twins for method lifecycle management to generative AI and agentic workflows, sessions will showcase real examples of how AI and advanced analytics are improving assay design, high-throughput mass spectrometry, predictive developability modeling, and real-time release testing. Speakers will address the regulatory and compendial frameworks shaping ML/AI use in analytical and CMC data, the practical work of validating predictive models against wet-lab results, and the homegrown tools scientists are building to solve problems in their own labs. 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:

  • Advances in Lab Automation, Robotics, and Self-Driving Analytical Labs
  • AI Applications in Bioanalysis, Impurity, and Safety Analytics
  • AI-Augmented Analytical Method Development and Lifecycle Monitoring
  • Automated and High-Throughput Mass Spectrometry / MAM
  • Digital Twins, PAT, and Real-Time/Predictive Analytics
  • Generative AI, LLMs, and Agentic Workflows in Analytical Development
  • Homegrown Tools and Workflows
  • Regulatory, Compendial, and Data-Integrity Frameworks for ML/AI in Analytical/CMC Data
  • Wet Lab Validation of Predictive Developability Models

The deadline for priority consideration is October 23, 2026.

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:


For more details on the conference, please contact:
Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute
Phone: 207-329-2964
Email: ksimmons@healthtech.com

For sponsorship information, please contact:

Companies A-K
Jason Gerardi
Sr. Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Email: jgerardi@healthtech.com

Companies L-Z
Ashley Parsons
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-1340
Email: ashleyparsons@healthtech.com


Register

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