(209b) Advancing the Abbott Pipeline

The Pharmaceutical industry has been facing significant challenges due to rising R&D costs, increased regulatory expectations and fewer new product approvals. In this environment, increasing probability of success and process knowledge while at the same time reducing cycle time and containing cost calls for new strategies across the entire API development timeline. In early Development our business model encompasses interfacing closely with our partners in Development (Preclinical Safety, DMPK) and Discovery to enhance both compound selection and interrogation to allow timelier and more informed decision making. As an API proceeds through development essential process understanding is achieved utilizing a Quality by Design (QbD) approach employing Process Analytical Technologies (PAT), Modeling and Design of Experiments (DOE) protocols. A key focus has been the adoption of a ?Material Science? strategy with the Drug Product group for the co-development of the final API form including the understanding and manipulation of the API physical property attributes that impact the final drug product. Brief examples will be given highlighting our QbD and Material Science efforts.