Large pharmaceutical companies have the financial resources to bring almost any drug to market but they’re confined to strict guidelines for their pipeline and if a developing drug appears as though it won’t fit within those guidelines, development will often come to an end. Alternatively, small companies that focus on rare diseases are more likely to pursue any possible lead on a drug but they often lack the financial resources needed to see the process through to the end.
In his article for Clinical Leader, Ed Miseta explains “There is a common path whereby molecules in small companies make it to market. The current model typically starts with small companies coming up with new molecules. Those companies will take it to a certain point in the development process (often the completion of a Phase 2 trial) at which time it will be acquired by a larger company specializing in that therapeutic area. The larger company has the financial resources to take the drug through a large (and more expensive) Phase 3 trial, and then submit the data to FDA for approval. Unfortunately, there are problems with this model.”
Unfortunately, many smaller companies do not have the capabilities needed to complete a phase II trial and as such, “we may be losing out on many potentially life-saving medicines.” Ideally, large and small companies will begin their partnerships at the start of the drug development so that the plan can evolve in line with the needs of both companies. An earlier commitment can also reduce confusion around the hiring process of any necessary third-party vendors. For clinical data collection, consistency is key.
August 14th, 2017 By: Ed Miseta at Clinical Leader