Alessio Maiolica | Director
Novartis

Festival of Biologics Day 3 @ 09:05

From Strategy to Delivery: Aligning Bioanalytical Innovation and Execution Across Clinical Phases

Novel therapeutic modalities in the Biologics (Bx) space are transforming biomedical research and changing how medicines are discovered and developed.As a result, deciding what , when , where to measure, and why it matters, has become both more important and more complex.

To keep pace, bioanalytical organizations must deliver fit-for-purpose assays quickly, while ensuring high-quality consistent data and methods as programs move from early studies to late-stage clinical trials. That requires BA strategy and execution be co-designed and built into development plans from the start.

At Novartis, we support the BA for Bx development through a four-pillar operating model:

- Align: governance and clear strategy-setting for bioanalytical deliverables 

- Orchestrate: portfolio visibility, prioritization, smart risks, and accountable decision-making 

- Accelerate: innovation and agility in internal laboratories to enable Phase I and II delivery 

- Scale: high-throughput, compliant external delivery to support Phase III and beyond 

In this session, we will share how the four pillars work together, with a particular focus on establishing two state-of-the-art bioanalytical facilities and how they enable modern, end-to-end bioanalytical solutions to accelerate getting medicines to patients.

Alessio Maiolica, Director, Novartis

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Alessio Maiolica / From Strategy to Delivery: Aligning Bioanalytical Innovation and Execution Across Clinical Phases

Alessio Maiolica, Director,
Novartis

Alessio Maiolica is a bioanalytical leader at Novartis, focused on shaping bioanalytical strategy and operating models that enable reliable decision-making across drug development. He works at the intersection of governance, portfolio execution, and laboratory innovation to deliver fit-for-purpose...

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