The Interplay Between Structured Data and AI Technologies for CMC Workflows and Control Strategy Development

Yash Sabharwal 
QbDVision

Abstract 

The explosion of AI technologies, especially generative AI and associated language models, has led to the re-evaluation of many data and technical workflows in therapeutic development. Many organizations have moved quickly to apply these generative AI technologies to accelerate the synthesis of information and the development of agents to automate workflows.  Similarly, we have seen broader adoption of AI/ML technologies for process optimization and characterization activities as these models can be more mathematically robust than traditional DOE strategies.  

While many of these activities have worked in pilot projects, they have often struggled to scale across enterprises. A key challenge has been the absence of a structured CMC framework to provide context to data and information, creating knowledge. In this presentation, digital strategies are discussed for building and combining structured data and information to construct knowledge bases, and how high-quality knowledge bases are critical for successfully scaling AI technologies across large enterprises.  

Yash Sabharwal

Yash Sabharwal

President and CEO

Yash Sabharwal, co-founder and CEO of QbDVision, brings over 25 years of experience solving complex problems within the life sciences industry. His journey includes co-founding Xeris Pharmaceuticals, a public company with approved treatments for severe hypoglycemia and Cushing's disease, and his first venture, Optical Insights, established in 1997 to develop sophisticated digital imaging solutions for biomedical applications.  

Before founding QbDVision, Yash served as the COO and CFO for Xeris Pharmaceuticals in its early years.  During his later years at Xeris, when its lead program was being scaled for manufacturing, he identified a critical industry need for software tools to consolidate and standardize all CMC data and information generated throughout the product and process development lifecycle. In response, he launched the QbDVision project in 2017 to create a new category of software called Digital CMC.  

Today, QbDVision offers a comprehensive Digital CMC software platform to tackle operational hurdles across the drug development lifecycle from early-stage process development through commercial translation for pharmaceutical and biotech companies. The platform is currently being used by seven of the top 50 global therapeutics companies in the world as well as emerging biotech companies.  

Yash is widely recognized as a thought leader in digitally structured data management for CMC workstreams based on ICH guidelines and quality-by-design principles. He has contributed whitepapers, presentations, and recorded webinars on data governance and data integrity for prominent industry organizations, including Biophorum, PDA, the American Association of Pharmaceutical Scientists, and IFPAC.  

Yash holds a B.S. in Optics from the University of Rochester and M.S. and Ph.D. degrees in Optical Sciences from the University of Arizona.

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