A looming challenge facing the pharmaceutical industry is the management and integration of the vast amount of data, information and knowledge generated during drug product development [1]. Documentation for a new drug application to the FDA includes over 500,000 pages [2] and is expected to double every 5 years [3]. Information is stored in hundreds to thousands of repositories [4], making integration and efficient use a significant problem.

While there had been multiple efforts to identify the scope of the challenge, there is little work done in quantifying the costs associated with the lack of information interoperability. In addition few attempts have been made to quantify the indirect effects of lack of efficient information processing. These issues are addressed in this work. The cost of information interoperability is computed by adaptation of an approach used in the US Capital Facilities Industry [5]. In addition, the indirect effects of more efficient information processing on the industry's revenue, through improvement of the likelihood of drug substances to get to market, is discussed. Solutions being developed in our group at Purdue to address these challenges are described.

References

1. Venkatasubramanian V., C. Zhao, G. Joglekar, A. Jain, L. Hailemariam, P. Suresh, V. Akkisetty, K. Morris and G.V. Reklaitis (2006) Ontological Informatics Infrastructure for chemical product design and process development. Computers and Chemical Engineering. CPC 7 Special Issue, 30(10-12) 1482-1496

2. Fitzmartin R. (1998) The challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry Drug Information Journal 32 745–756, 1998

3. Morris K, Venugopal S and Eckstut M (2005) Making the most of drug development data Pharmaceutical Engineering 11 399-402

4. Kataria A. (2007) Information Management: Challenges and Opportunities in Achieving Qbd. Presentation at the AIChE Annual Conference, Salt Lake City UT

5. Gallaher M.P., O'Connor A.C., Dettbarn J.L and Gilday L.T. (2004) Cost Analysis of Inadequate Interoperability in the U.S. Capital Facilities Industry. NIST GCR 04-867