Modular 2 Day Workshop designed for Busy Executives

Background

The workshop addresses some of the latest trends that are appearing within the pharmaceutical industry and encourages the CEO’s and senior managers to begin to think about and plan their approaches to these changes. Over the two days (four modules) we will stimulate thinking and discussion about changing approaches for those who haven’t already led the change with contributions from those who may have embraced the ‘new order’.

With the shortage of ‘blockbuster’ drugs in the pipeline, pharmaceutical companies have changed their approaches to drug development from linear, vertically integrated development, to systems development, translational medicine and in-licencing from biotech companies. Other strategies utilised include the increasing trend to outsourcing many functions to control costs. However, even this broader net is not delivering the hoped-for returns and the drug that makes a billion dollars to recover the true cost of development – estimated at between 800 – 1,000M USD (Tufts CSSD).

The application of genome level science has also spawned pharmacogenomics approaches to drug development where the more likely outcome is smaller volume, targeted products which meet the needs of better defined patient populations while delivering superior outcomes in terms of disease free survival – coming to be known as ‘personalised medicine’. Cancer is a prime target as patient populations who have failed existing treatment regimes can participate in phase II clinical trials, decreasing the time to market.

A systems approach that begins with the end in mind (and incorporates Product Life Cycle Management – PLM - thinking) demonstrates the need for integration at every step of the critical path – cross functional teams containing representatives from manufacturing, quality control, quality assurance, pre-clinical, clinical, regulatory affairs, health economics, marketing, sales and project management are a part of this.

Participants will be encouraged to embrace the opportunities and lead the changes within their organisations as only the CEO can develop a true leadership culture.