Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Project-, Drug-, and Business Development in a Biotech SME ***

Christian Hanke (Abschlußjahr: 2012)

This thesis highlights the Project-, Drug-, and Business Development process of a hypothetical biopharmaceutical company advancing an anticancer platform based on a new antibody design.

The objective is to present some decisive steps and gate controlled decisions in setting the course for development and to put it in the context of the existing regulatory framework. The rational why and how specific decisions are made is presented.

The topics are embedded in a story line and illustrated as case studies with an emphasis on the management of risks as the recurring theme throughout the entire drug development.
A failure in product development of small enterprises could lead to a discontinuation of development and might be detrimental for the whole company. Due do their limited resources the perception of risks in SMEs lead to a more proactive and formal approach towards decision-making and risk mitigation.

However, some systemic risks cannot be moderated such as the uncertainty whether the anticipated business case of the drug ever becomes a reality.

Others are inherent to the development process and the drug itself but these risks often can be mitigated.

Ways to shorten this risky and costly development are legitimate objectives of the pharmaceutical industry and especially SMEs can profit from expedited approval pathways, which are also presented.

Pages: 48, Annexes: pages 17: Figures & Tables