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By Ken Morris, Ph.D., associate head of Industrial and Physical Pharmacy, Purdue University, with Sam Venugopal, director, Life Science Business Operations, Conformia Software, Inc. and Michael Eckstut, vice president, Life Science Operations, Conformia Software, Inc.
|Data Use and Misuse
For years, drug development has included informal business processes, lots of paper, some well-known spreadsheet and database tools and the occasional homegrown system. However, the overall infrastructure required to support process development activities has failed to keep pace with the increased workload and the increasing complexity of drug products.
Nowhere has this become more apparent than within the area of drug development that FDA refers to as the “Critical Path,” between discovery and commercial launch. The survey identified the following inhibitors:
|Demographics and Process Development Growth Trends
A total of 104 organizations responded to the survey. About half had less than 100 development employees, while many had more than 1,000. Almost 40% of the participating companies had a single development site in the U.S., 25% had multiple U.S. sites and 35% multiple global sites.
Respondents had on average 18 total compounds in development, with approximately three compounds each in Phase 2 and Phase 3 trials, and roughly 15 in early-stage development. Several manufacturers had as many as 40 to 50 compounds in development.
More than half of the organizations had less than 100 staff in development, with 11% having more than 1,000. Of the 35% of respondents representing international, multi-site development operations, 40% indicated that their companies employ over 500 people in drug development.
Collaborative partnerships have helped many respondent companies grow their process development efforts. These partnerships are used to access compounds at different stages of development, access technologies for synthesis or recovery and obtain capacity at a reasonable cost. Between 40% and 50% of the respondents said that they will increase partnerships across all phases of development over the next two years.
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