Event Date/Time: Sep 21, 2004
End Date/Time: Sep 22, 2004
GLP and GCP regulated bioanalysis of drugs are a major component of the drug development process and an attractive opportunity for in-sourcing based on both cost savings and time-to-shelf advantages. Many pre-IND compounds are supported with small-sample-number studies, requiring very fast turnaround to choose between candidates, plan dose levels, and define parameters of next-step studies. Many contract laboratories see these small studies as unprofitable and unattractive and charge a "batch fee" to offset the cost of handling small studies. In addition, many drug candidates do not proceed to IND early development. As a result many small, mid-sized, and large pharmaceutical companies are re-investing, or increasing their investment in internal GLP. The growth in this area has driven a need to develop services for the industry that smooth the transition to in-sourcing.
Contract laboratories have a stake in supporting the growth of internal GLP laboratories to support small, unprofitable studies and in providing the variety of services that new GLP labs will require to begin in-sourcing. There are many examples to be found of such business opportunities. This opens up the opportunity for contract laboratories to demonstrate their expertise and build a strong partnership with pharmaceutical companies that facilitates their participation for later-stage large study support.