Making the Most of Drug Development Data

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References

1. AMR Research Report, Enterprise LIMS Market Research Study, 2002.
   
   
2. Raju, G.K., Components of Pharmaceutical Industry Costs, a presentation made in 2001.

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About the Authors

Ken Morris, Ph.D. – Professor and Associate Head of Industrial and Physical Pharmacy at Purdue University, Dr. Morris joined the faculty in 1997, after working for Squibb and Bristol-Myers and teaching at Rutgers and St. Johns. He is also the technical director of Purdue University’s CAMP (Consortium for the Advanced Manufacturing of Pharmaceuticals), the outgoing associate director of the Center for Pharmaceutical Processing Research, and one of the founders of the Particle Technology and Crystallization Consortium. Dr. Morris received his Ph.D. from the University of Arizona in 1987.

Sam Venugopal – Director of Conformia Software’s Life Science Operations, he has over 15 years of management consulting, market research, and technical experience with companies that include Pittiglio Rabin Todd & McGrath (PRTM). At Conformia, Mr. Venugopal currently co-investigator on a Cooperative Research and Development Agreement (CRADA) with FDA, which is examining the root causes of drug development bottlenecks.

Michael Eckstut – Vice President of Conformia Software’s Life Science Operations, he has specialized in pharmaceuticals and life sciences consulting at companies that include A.T. Kearney. Mr. Eckstut serves on Booz Allen’s Board of Directors and is co-chair of the Keiretsu Forum’s life sciences committee.

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: Limited business and information processes supporting the transition from bench to commercial-scale operations; Unstructured information collection, storage and retrieval capabilities; Lack of information visibility and missing contextual relationships; Limited coordination across multiple process development groups and sites.

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.