Wednesday, September 30, 2026

12:15 - 13:00

SPEAKERS' CORNER 1: DOROTEA BARNÉS

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Overview

Sponsor: Klinea

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Details

How early technical choices sculpt scalability, manufacturability, regulatory success and market readiness. Engineering doesn’t wait for shovels in the ground. It begins the moment a scientist chooses a route in the lab — a decision that can ripple through industrial design, regulatory strategy and the economic fate of a product. This roundtable will celebrate engineering as a continuous creative force across the entire biotech journey — from initial discovery and process development, through industrialization and GMP manufacture, to commercialization. The goal is to show engineering not as a finishing touch but as a guiding hand that helps teams make smarter choices at every turn. 1) The role of engineering throughout the product lifecycle Think of engineering as the cartographer, bridge-builder and translator of the development path. When engaged early, it helps teams to: - Anticipate technical risks before they become crises. - Design for scalability so a lab success can grow into a reliable plant process. - Reduce regulatory uncertainty by embedding compliance-minded choices into the workflow. - Smooth technology transfer so knowledge travels cleanly from bench to plant. - Shape industrialization strategies that align process design with real-world constraints. - Strengthen investor confidence by turning technical stories into credible execution plans. - Accelerate time-to-market by avoiding late-stage rework and surprises. At heart, many seemingly late-stage failures trace back to early experimental choices. When engineering is part of those choices, the pathway to market becomes clearer and more navigable. 2) Crossing the “valleys of death” The development journey is punctuated by perilous transitions — from research to process development, from process development to GMP manufacture, from manufacturing readiness to investor readiness, and from regulatory approval to commercial traction. These so-called “valleys of death” swallow promising innovations when technical, regulatory and economic realities are not anticipated. Introducing engineering thinking early is like building bridges and laying maps across those valleys: it reduces surprises, shortens detours and raises the odds that a promising technology will reach patients and markets.

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Speaker