Maria Batalha on How Digital Tools Transform Drug Substance Lifecycle Management

Access Part 1 of this interview on how Batalha’s team assited a comapny in centralizing drug substance data, standardize processes, and unlock powerful AI-driven insights.

In Part 2 of a two-part interview at INTERPHEX 2026, Maria Batalha, senior project lead, Delivery, Valgenesis, discusses a real-world case study in pharmaceutical digital transformation, examining how a centralized digital platform can manage the full lifecycle of a drug substance, from early R&D through to commercial manufacturing, in alignment with Industry 4.0 principles. Batalha’s team unified disparate sets of legacy data across multiple mediums into a single, FAIR-compliant repository, making critical process knowledge findable, accessible, interoperable, and reusable across all three stages of a product's lifecycle. The session highlights how AI-enabled analytics and visualization tools can surface hidden patterns and support data-driven decision-making.

Batalha reflects on how the digital platform showcased in the presentation was applied to a genuine product journey spanning research and development through to commercial manufacturing. The case study draws on actual data from each phase of that product's lifecycle, illustrating how the platform serves as more than a theoretical tool.

Batalha explains that the specific project involved a client already operating commercially in other markets who was working toward FDA approval to enter the US. "We could log in the platform data from the R&D, data from stage two validation, and then data from commercial manufacturing already," she notes, underscoring how the solution brought together previously fragmented information into one cohesive system.

A key theme of the conversation is the platform's versatility. Batalha emphasizes that its application extends well beyond the single case study presented, spanning drug substances, drug products, analytical method monitoring, and even medical devices.

"Our platform gives you the flexibility of building your project there," she explains, pointing to how different product types, from small molecules to highly complex biologics and cell and gene therapies, can be accommodated within the same framework.

When asked about handling more complex modalities, Batalha is clear that the underlying approach remains consistent regardless of complexity. The system simply scales to accommodate more variables, more configurations, and more monitoring parameters. Whether a team is working with a straightforward small molecule or a multi-parameter biologic, the platform adapts without requiring a fundamentally different methodology, making it a flexible, future-ready solution for organizations at any stage of their manufacturing journey.