Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development program at a time when regulatory standards are evolving, or competition is catching up with comparable products.
There is a particular source of risk, however, which deserves special attention. Currently, the pharmaceutical and biologics industry outsources approximately $25 billion dollars worth of clinical development projects. That is over a quarter of the $98 billion dollars currently devoted to clinical drug development.
This naturally raises several questions:
- What are the risks of outsourcing?
- Can outsourcing be used to reduce other forms of clinical development risks?
- What is the best way to manage all of these risks.
On May 19th, Cytel Senior Vice President Steve Herbert delivered a lecture on the idea of risk in clinical development outsourcing at the annual 5th Annual Outsourcing in Clinical Trials Conference in Dusseldorf, Germany . Click below to see the slides. You will learn:
- A coherent way to categorize risk in the context of pharmaceutical development
- How outsourcing can effect risk, cost and outcome in both good and bad ways
- Why you need to pay closer attention to your biostats & data management provider
- How to use outsourcing to reduce risk
