Carla Luciani

Carla Luciani

Company: Vertex Pharmaceuticals

Job title: Senior Director, Chemical Engineering


Dr. Luciani received her B.S in chemical engineer from Universidad Nacional de Mar del Plata in 2001 and PhD in Chemical Engineering from Universidad Nacional del Litoral in 2006. She spent 4 year at University of Maryland, initially as a postdoctoral fellow and then as a research professor. She joined Small Molecule Design and Development at Eli Lilly in 2011 as a process engineer. In 2014, she joined the process design and development group as the leader of the drug substance M&S group. In that role, she guided a group of chemical engineers and developed models for hybrid and continuous drug substance processes. She became an engineer advisor in 2016 and the leader of Future Manufacturing Platforms, an innovation capability group, in 2017. Future manufacturing platforms main objective was to identify, design, develop and test new manufacturing platforms and ensure that chemistry, formulation, engineering and analytical solutions can meet future manufacturing needs for both drug substance and drug product for synthetic molecules (inducing small molecules and novel modalities). In this role, she has supported innovation by identifying new technologies, helped established collaborations with academia and contract research organizations, and promoted the implementation of innovation for the manufacturing. In 2019, she lead RNA-therapeutics team at Lilly Cambridge Innovation Center. In 2020, she joined Vertex Pharmaceuticals and she is currently a Sr. Director of Chemical Engineering.


The Business Case for Drug Substance Continuous Manufacturing: A Modeling & Simulation Perspective 11:30 am

• Brief introduction to the challenges faced when building a business case for drug substance continuous manufacturing • Discussion of potential strategies pros and cons • Modeling and simulation beyond process design and development: How do support your business case? • Case studiesRead more

day: Stream 1 - Day 2

Panel Discussion: Measure Vs Model in CM Validation & Approval 9:45 am

• What measurements can be replaced with a model, whilst retaining product quality and regulatory compliance? • How can regulatory approval for CM differ across the world? • Key differences between traditional bath processing vs continuous in regulatory submission, e.g. continuous process validation • Inspection preparedness as we move into commercial spaceRead more

day: Day Two

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