
CMC Strategy
Integrated Clinical Development & Supply: Breaking Down the Early Dev Journey of a Small Molecule
Catalent
CMC Strategy
Real-life tactical and operational decisions in an integrated approach to drug development.
This paper presents real-life decisions involved in the integrated approach to drug development, covering the early development journey of a small molecule from formulation through clinical supply.
This paper presents real-life decisions involved in the integrated approach to drug development, covering the early development journey of a small molecule from formulation through clinical supply.
From Formulation to Clinic
Connecting drug substance, drug product and supply reduces handoffs.
Operational Decisions
Examples show how trade-offs between speed, cost and risk are made in practice.
Benefits of Integration
Shared data and a single accountable partner accelerate timelines.
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