Appendix H
Pharmaceutical Work Breakdown Structure (WBS) Example
Pharmaceutical Project WBS
The following represents an example of a WBS for a pharmaceutical development project. It is not intended to represent the only feasible WBS for this type of project. There are numerous variations and approaches that a project manager can take to develop the WBS for the project.
In this example, a WBS is presented for a new compound. A development program containing more than one compound would consist of a similar WBS structure for each compound. Some Level 2 WBS elements describe deliverables that fall within the area of expertise of specific technical specialties and occur at different points over the course of the product development lifecycle. These are structured to reflect the organizations making up the enterprise, such as Marketing, Regulatory Affairs, Pharmaceutical Development, etc. Other Level 2 elements are organized according to the product development lifecycle itself, thus: Phase 1 Clinical Program, Phase 2 Clinical Program, etc., because this organization reflects the way that the business manages the overall development program. The WBS is not intended to illustrate the sequence by which the deliverables will be created. When the Network Diagram and Schedule for this project are created they would reflect the sequence of the activities that produce the deliverables within both the functionally organized elements and those organized by product lifecycle.
Note that this WBS describes a generic product, not a project to develop a specific compound. As such, it is a “WBS Standard” that can be customized using specific terms to describe different development projects. Some elements are modular and may be repeated as often as necessary in a given project. For example, the elements listed as components of 1.7.3 would be repeated for each multiple dose safety clinical trial to be conducted. Depending on the particular project, the project manager would include some but not all of the possible elements included in the standard WBS. For example, if the objective of the project were to develop a line extension of an existing product, it is likely that the project manager would choose not to include any aspect of lead identification in the WBS. In other cases, the project manager might want to illustrate geographic components in the WBS that would necessitate a modification to that depicted here. This might be the case if some clinical trials were to be performed outside the US. Similarly, if some of deliverables are to be developed by a different organization as part of a collaborative program, the project manager might organize the WBS to show the deliverables for each organization in separate branches.
The Level 2 WBS elements are not all decomposed to the same level of detail. In part this reflects the need to provide more detail for some but not others. In practice, the level of detail would also reflect the amount of information available for certain deliverables. Thus, the specific clinical trials to be conducted in Phase 3 are not usually known until after Phase 2 has been completed. Thus, early in development, these might be described with a single high-level WBS element called “Phase 3 Clinical Trial Program,” while the Phase 1 trials would be described in much more detail. It is recommended that the project manager develop the WBS to a level of detail that is appropriate to enable management of the specific project.
1 WBS for New Compound Development Project
1.1 Project Initiation
1.1.1 Decision to Develop Business Case
1.1.2 Business Case
1.1.3 Project Initiation Decision
1.2 Marketing/Sales Support
1.2.1 Market Research Program
1.2.2 Branding Program
1.2.3 Pricing Program
1.2.4 Sales Development Program
1.2.5 Other Marketing/Sales Support
1.3 Regulatory Support
1.3.1 IND Submission
1.3.1.1 Pre-IND Meeting
1.3.1.2 IND Preparation
1.3.1.2.1 Preclinical Package
1.3.1.2.2 Clinical Package
1.3.1.2.3 Clinical Pharmacology Package
1.3.1.2.4 CM&C Package
1.3.1.3 IND Submission
1.3.2 End of Phase 2 Meeting
1.3.2.1 Pre-Meeting Package
1.3.2.2 End of Phase 2 Meeting
1.3.3 BLA/NDA Submission
1.3.3.1 Pre-BLA/NDA Meeting
1.3.3.2 BLA/NDA Preparation
1.3.3.2.1 Preclinical Package
1.3.3.2.2 Clinical Package
1.3.3.2.3 Clinical Pharmacology Package
1.3.3.2.4 CM&C Package
1.3.3.3 BLA/NDA Submission
1.3.3.4 Advisory Committee Meeting
1.3.3.5 FDA review support
1.3.3.6 Pre-Approval Inspection
1.3.3.7 Approval
1.3.4 Post-approval Regulatory Support Program
1.3.4.1 Annual Reports
1.3.4.2 Adverse Event Reporting
1.3.4.3 Post-market Commitment Administration
1.4 Lead Identification Program
1.4.1 Hypothesis Generation
1.4.2 Assay Screening
1.4.3 Lead Optimization
1.4.4 Other Discovery Support
1.5 Clinical Pharmacology Support
1.5.1 Pharmacokinetic Study(ies)
1.5.2 Drug Interaction Study(ies)
1.5.3 Renal Effect Study(ies)
1.5.4 Hepatic Effect Study(ies)
1.5.5 Bioequivalency Study(ies)
1.5.6 Other Clinical Pharmacology Study(ies)
1.6 Preclinical Program
1.6.1 Tox/ADME Support
1.6.1.1 Non-GLP Animal Studies
1.6.1.2 Bioanalytical Assay Development
1.6.1.3 ADME Evaluations
1.6.1.4 Acute Toxicological Studies
1.6.1.5 Sub-Chronic Toxicological Studies
1.6.1.6 Chronic Toxicological Studies
1.6.1.7 Other Tox/ADME Support
1.6.2 Clinical Pharmacology Support
1.6.2.1 Pharmacokinetic Study(ies)
1.6.2.2 Drug Interaction Study(ies)
1.6.2.3 Renal Effect Study(ies)
1.6.2.4 Hepatic Effect Study(ies)
1.6.2.5 Bioequivalency Study(ies)
1.6.2.6 Other Clinical Pharmacology Study(ies)
1.7 Phase I Clinical Study Program
1.7.1 Pharmacokinetic/Pharmacodynamic Study(ies)
1.7.2 Dose Ranging Study(ies)
1.7.3 Multiple Dose Safety Study(ies)
1.7.3.1 Pre-Enrollment Activities
1.7.3.2 Enrollment
1.7.3.3 Treatment
1.7.3.4 Follow-up
1.7.3.5 Data Management
1.7.3.6 Data analysis
1.7.3.7 Study Report1.10
1.8 Phase II Clinical Study Program
1.8.1 Multiple Dose Efficacy Study(ies)
1.8.2 Other Clinical Study(ies)
1.9 Phase III Clinical Study Program
1.9.1 Pivotal Registration Study(ies)
1.9.2 Other Clinical Study(ies)
1.10 Submission/Launch Phase
1.10.1 Pre-Launch preparation
1.10.2 Launch
1.10.3 Post-Launch Support
1.11 Phase IV/Commercialization Clinical Study Program
1.11.1 Investigator-Sponsored Studies
1.11.2 Registry Studies
1.12 Legal Support
1.12.1 Publications
1.12.2 Patents/Intellectual Property
1.12.3 Trademarks
1.12.4 Other Legal Support
1.13 Program Management Support
1.13.1 Program-Level Project Management
1.13.2 Preclinical Project Management
1.13.3 Clinical Project Management
1.13.4 CM&C Project Management
1.13.5 Other Project Management Support
This WBS example is illustrative only and is intended to provide guidance to the reader. No claim of completeness is made—for any specific project, the example may be complete or incomplete. All examples reflect the quality principles expressed in this Practice Standard. As expressed in the PMBOK® Guide—Third Edition “the project management team is responsible for determining what is appropriate for any given project” (Project Management Institute 2004).