Project Management

The following systematic tools and processes approach available for project management [9,10] can be applied to management of biomarker programs:

Gantt charts

Contracts, scope documents Meeting minutes Communication plans RACI (responsible, accountable, consulted, informed) charts Lessons-learned tools Milestone charts

Decision trees

Risk analysis logs

PERT (performance, evaluation, review, tracking) charts Work breakdown structures Budget tracking Lean-sigma tools

Process mapping with the team is useful to ensure that all aspects of the biomarker project management are well understood. The level of detail can range from GANTT charts (Figure 2) designed principally to track time lines to program-wide integrated biomarker strategies. An example of the latter for development of an oncology candidate is illustrated in Figure 3. The development strategy has to include open discussion about the advantages and disadvantages of including the biomarker, recognizing that this often has to occur in the absence of clear and straightforward knowledge of the value of the biomarker across species and in a specific disease or subset of patients. Increasingly, project teams are expected to analyze risk associated with different activities and develop contingency plans far in advance of the actual activity occurring. Risks associated with various biomarkers (e.g., timely assay qualification, sampling logistics, patient recruitment, regulatory acceptance) have to be part of this analysis and contingency plan development.

There are also numerous stakeholders beyond the development team who influence and may guide the development of the pharmaceutical:

• Sponsor (may include different departments with diverse goals/ interests)

• Business analysts

• Investors (small companies) or shareholders

• Regulators

• CROs and/or biomarker labs

• Investigators

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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