How are biological entities developed?

Course Date:  Monday 15 June 2009                        Venue: Window Conference Venue, London UK

Cost:  £260.00 + VAT £39.00  (Total £299.00)

Early-bird rate if booked and paid by Friday 10 April 2009 £234.00 + VAT £35.10 (Total £267.10)

Course details:

The aim of this 1-day workshop is to address the question: 'How are biological entities developed?'

(Including a general understanding of different types of biological product/biopharmaceutical e.g. gene therapy, monoclonals but with a particular emphasis on vaccines)

This will encompass the full range of development stages, at an introductory level only, from discovery research through to post-launch activities, with a main focus on the development phases.  There will be a particular emphasis on the key differences which exist in biological drug development (e.g. in vaccine development) as opposed to developing chemical entities.  These aspects will be covered from the points of view of the Quality (CMC), Pre-clinical and Clinical development disciplines (including a general introductory summary of the key manufacturing issues and challenges, particularly in CMC)

The course will benefit:

Those working in roles across the drug development disciplines who wish to gain a basic grounding in developing biological entities.  This would include toxicologists, pre-clinical development scientists, clinical operations, regulatory, pharmaceutical development, and project management personnel.

Those involved in R & D functions will be exposed to an introduction to the CMC aspects of developing biological entities, and those in pharmaceutical development roles will receive an outline of R & D disciplines.

Course Leader:

Dr Steve Rees