David Pole

Department Lead for Respiratory Drug Product Development. Responsible for delivering CMC aspects of a diverse respiratory portfolio, including drugs delivered by DPI, pMDI, and nebulisation. Track record of ensuring successful development and regulatory programs from concept to market. Provides CMC technical leadership and project management for all elements of product development. Team defines elements of Formulation and Process and works with Manufacturing to transfer processes into a cGMP environment. Preparation of content for Global regulatory submissions. Budget and forecast management.

Devices Centre of Emphasis. Drug Product team leader for Phase 2&3 dry powder inhaler drug product development. Lead team of formulation, process, and analytical scientists to deliver clinical supplies for Ph2b and develop formulation and process for Ph3. Responsible for partnering with manufacturing colleagues to support technology transfer. Maximize efficiency of experimental work to deliver knowledge and de-risk process. Responsible for development of drug product in keeping with the principals of Quality by Design; Defining process understanding related to micronisation and blending unit operations

Research Formulations -- Dermatology and CNS Lead an organization responsible for innovation in drug delivery and early formulation. Created Dermatology formulation group to support emerging business needs from research. Played key role with other Therapeutic Area leaders to define Pharmaceutical Sciences role in what started as a new business area. Lead the Pharmaceutical Sciences matrix Team for Ph1 clinical dermatology candidates. Fostered an innovative culture with tangible goals towards the development of the science and technology of topical drug delivery to local (dermatological) targets in the skin. Departmental Lead on the implementation of efficient business practices designed to streamline the preparation of simple dosage forms for FIH. Responsible for development of an expert system (DELPHI) for the prediction and publishing of drug degradation information. Computer programming in Visual Basic and Prolog.