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