November 11th 2008
£995 / $1740 / €1245
Greedy companies being economical with the truth?
Overzealous regulators pursuing political agendas?
Poorly designed or inconclusive clinical trials?
Whatever your view, the failure of a drug late in its development or, worse still, post-launch hurts. It hurts the developer commercially, it hurts the credibility of the regulator, it hurts those patients who are able to benefit from it and it undermines confidence in the industry as a whole.
Statistics may indicate that the rate of drug approval failure hasn’t increased, but there has been a succession of failures and withdrawals, some of them very high profile, which have knocked profits, investment and confidence.
What can be learnt from these events and what action can the industry and regulators take to improve their performance in this critical area?
The rate of drug failure – be it at the approval stage or post-launch – may have increased only slightly, but that rate has to be seen in the context of a long term decline in new products being brought to the market.
Over the last 10 years, the regulatory demand and commercial imperatives facing the industry have been growing. Safety has become a key issue, allied to the need not only to prove efficacy, but efficacy that is superior to currently available products.
Some will argue that these trends are both desirable and necessary for the provision of safe medicines in a cost constrained world. Others argue that unless reformed, the current regulatory path will effectively eliminate the widespread development of new drugs and deny effective medicines to the mass of the treatable patient population who can take them safely.
The impact on the industry’s profitability and ability to invest in new research and development is being felt. With a number of significant products losing patent protection over the coming period, there are clear holes appearing in many companies’ portfolios.
About the Author
Dr Cheryl Barton is a highly regarded independent consultant with over 16 years research and business analysis experience. Following her senior research positions in academia and seven years with Merck, in which she was responsible for research projects ranging from Alzheimer’s disease to schizophrenia, Dr Barton joined Dutch investment bank ABN Amro NV as a senior equity analyst. At ABN Amro NV she was lead analyst on major pharmaceutical companies such as Roche and Sanofi-Synthélabo, and assessed the potential impact of new drug development on European Stocks.
In 2002, Dr Barton founded a consulting business (www.Pharmavision.co.uk) to provide independent, tailor-made, pharmaceutical thematic research to investment houses and pharmaceutical companies. The research reports combine independent scientific analysis with patient-based models to forecast the potential sales growth of key drugs in clinical development.