1st Quarter 2008

Lifecycle Management - What is your Value Proposition?

By Marc Ginsky

The statistics do not tell a happy story:

• The number of new molecular entities approved by the FDA in 2007 (18) was the same as that in 1983.
• The research and development spend in 1983 was $5 billion, and by 2007 that number had ballooned to $65 billion.
• Only one out of every three drugs brought to market recoups its development costs.

The hard reality is that this is simply not a sustainable business model. What is a manufacturer to do when under attack for both price and safety at the same time? It is more important than ever that pharmaceutical and biotechnology manufacturers start demonstrating their value proposition against their competition sooner in the development process, and that every possible commercial advantage is gained for existing marketed products throughout the entire lifecycle. It is absolutely vital that the right drug is delivered to the right patient in the right dose and at the right cost.

Below are some steps that can be taken to address these and other pressures facing manufacturers:

• Identify key biomarkers early in the development cycle to allow for quicker go/no go decisions during development.
• Identify key safety signals throughout the drug lifecycle.
• Adopt a truly global strategy for the launch and pricing of your drug and then couple that with comprehensive pull-through programs to drive favorable access policies.
• Recognize the impact of the trend in the United States toward information democracy, cost shifting to the patient, and the increasing importance of ex-US precedents.
• Use clinical trial data together with meaningful data gathered in real world observational studies to (a) identify trends and safety signals, (b) demonstrate real-world effectiveness in heterogeneous patient populations that reflect enrollment bases of major players, and (c) be better prepared in the event of government and payer scrutiny of safety or efficacy.
• Adopt innovative persistency and adherence programs to ensure that once you take all of the steps to deliver the right drug to the right patient at the right cost at the right time, the patient stays on therapy for the entire course of treatment.

Please contact Covance for our ideas on how you can get maximum value out of your brands over their entire lifecycle.