DELIVERING VALUE TO THE PROCESS DEVELOPMENT ORGANIZATION THROUGH WORKFLOW INTEGRATION by

Process development organizations in modern pharmaceutical firms face the dual challenges of making clinical supplies under tight deadlines and developing a viable commercial manufacturing process at the same time. These two work processes are intertwined in complex ways, and often involve the work of many different teams. We propose a way to meet both requirements in a parallel and coordinated fashion, by using a carefully designed software environment to revamp the workflow. Benefits derived include: eliminating errors and rework; improving communications effectiveness and efficiency; promoting collaboration and concurrency; preserving and leveraging intellectual capital to improve the quality of the design; reducing the effort for individual tasks; and rapidly evaluating alternatives to choose the best. The flexible architecture adapts to business needs quickly and easily. 1. Principal Work Components of Drug Development Figure 1 shows a simplified process map [1] for the development of new drugs in a modern pharmaceutical firm. The solid lines in the figure show the material flow. The dashed lines represent the information (process development) flow. Drug Discovery – identifying drug substances (also called active pharmaceutical ingredients, or APIs) with therapeutic benefits. Portfolio Management – allocating precious development resources across the range of drugs under development in the company. API Process Development – developing a commercially viable process to manufacture the drug substance. Pharmaceutical Product & Process Development – developing a final dosage form to administer the drug to human patients and a commercially viable pharmaceutical (formulation) process to manufacture the dosage form. The Supply Chains – procuring raw materials (e.g. reagents, solvents, excipients and coatings), converting the reagents to the drug substance, adding the additional ingredients to make the dosage form, allocating the resources to make the drug substance and dosage form (planning and scheduling of facilities and labor), and delivering the product. There are really two distinct supply chains – one that delivers the DELIVERING VALUE TO THE PROCESS DEVELOPMENT ORGANIZATION THROUGH WORKFLOW INTEGRATION by Peter A. Clark product to clinical trials and development trials, and another that delivers the product to the market. Testing – planning, conducting and analyzing the results of toxicology studies, clinical trials and stability tests to determine the safety, efficacy and shelf life of the drug. In this paper, we will focus our attention on API Process Development, and the API segment of the Supply Chain (from raw materials through production of the drug substance). We will not discuss the other work components further. 2. Critical Performance Dimensions Each of our chosen work processes has one key output, with a number of critical performance dimensions [2]. The API Segments of the Supply Chains produce the drug substance and deliver it to Pharmaceutical R&D or Pharmaceutical Manufacturing.