Project Management Templates
Planning is a cornerstone of project management. It is a vital part of the project management process and for this reason alone it is one of the most important functions. Planning activities can vary considerably, depending on the type of project and the management environment in which the project originates and develops. They can range from a simple descriptive coverage of what needs to be done to extensive computer-generated diagrams and printouts showing details of every aspect of the project. Poor planning has often been blamed for poor project performance and management problems. Planning needs commitment and ownership, and an appropriate attention to the level of details required. Where planning is linked to future funding, proposals such as business plans need to be made as explicit as possible by incorporating factors such as markets, finance and so on.
Risk management in this long and tremendously complex process has become a major driver in drug discovery, and even more so, in drug development. Given the (largely financial) stakes, failure of drug candidates in late-stage clinical trials can have disastrous financial consequences, even for relatively large companies. Risk management is therefore the driver behind initiatives to render the drug discovery process more predictable. The target validation process and the development of molecular diagnostics and biomarkers must be considered in this context. Added to this are competitive pressures to be first in the market. This is in conflict with careful risk management thus, methods have been sought to reconcile the two demands. Generally speaking, the individual activities are optimized through rigorous quality assurance, automation, robotics, and the like. Once this is accomplished, a further reduction in timelines can only be achieved through telescoping the activities, i.e., these...
A major criterion in a biotech firm being able to trigger such funds is the quality and excellence of the research team, as previously discussed. This may be a disadvantage in pushing a research-institute based team back to a grant mentality (but where funds are subject to strict commercial-type milestones) rather than assisting in the development of a business culture within the firm. Careful management of such a process is therefore important, and here advanced project management skills come into play.
Most biotechnology innovation is a story of product development, innovation and diversification, all aimed at improving return on investment and even profitability. New product development (NPD) can be treated as a project and therefore requires project management skills, but many of the start-up companies are considered as projects and hence the management of the entire companies requires well-honed project management skills. Project management (PM) has been defined as Identified requirements (needs) and unidentified requirements (expectations). (Project Management Institute, Standards Committee 1996, p. 3) The project management triangle consists of cost, time and performance. The implication of this structure is that the three are inextricably linked. If costs are reduced, either time or performance suffers. In order to accelerate the project, more resources and a concomitant increase in cost will be required. An increase in the performance (scope) and cost or time or both must...
The level of detail required depends on how much control or accuracy is needed by the project manager, how much visibility or monitoring is required and how much risk is expected to be reduced if the additional analysis is achieved and the commensurate detail included in the planning. One of the undisputed benefits of doing explicit detailed planning using techniques such as the critical path method (CPM) is that it enforces a discipline in which all aspects of the project are defined, analysed and connected - providing an assurance that important aspects, and even seemingly unimportant elements, will not be forgotten.
Where established standard equipment is involved, the process of liaison with the supplier should be relatively simple. The manufacturer's sales or applications engineer will be able to advise on the optimum equipment for the work to be undertaken. There is a lot of precedence for deciding on isolator pressures, flow regime, transfer, sterilisation, room conditions, and the like. This would be the case, for instance, in hospital pharmacy work or in sterility testing. Even so, as we have seen, isolation technology is still to some degree in its infancy, and the project manager would be well advised to take into consideration many of the aspects discussed in this book. This would allow the manager to confirm that any system proposed by the supplier meets the requirements of the project in terms not only of the process to be carried out but also of ergonomics and safety, documentation and validation, etc.
Crisis team training should focus on organizational skills, not on medical and nursing assessment and treatment skills. Required elements in a crisis team training session include well-written, simulated resuscitation scenarios and skillful debriefing that focuses on organization. General principles to follow for crisis team training scenarios include using life-like situations, having a specific learning objective or objectives for each scenario (or more accurately, each debriefing), and incorporating team quality improvement goals. In addition, real-life errors can be replicated to train teams to avoid similar mistakes. Finally, scenarios should be focused they can be as short as 1 minute if the learning objective is to see how long it takes a person to recognize a crisis, request a MET response, and have the first responder arrive. On the other hand, if the goal is to focus on diagnosis and triage to an appropriate ICU, the scenario may require as long as 20 minutes.
Planning cannot be done successfully in an ivory tower or in a vacuum. It is the overall collective responsibility of the project manager and his team of specialists - whether they are a dedicated team or a mix of staff from functional areas. One person does not have all the specialist knowledge to adequately plan all areas of a project. Each specialist has his or her own perspective of the project and this can often be a narrow perception related to their own area of expertise. This perception has to be drawn out and developed into its correct place in the overall plan.
Internal diffusion also relates to the organizational structure and design. For example it may be easier to achieve in a company which is essentially an R&D unit than in one which has a more complex structure and functional focus. This relates to the type and main functions or purpose of the firm. Firm structure and design would relate to factors such as control and management as well as internal systems. Effective project management is an effective part of this process. This topic was covered briefly in Chapter 3.
The goal is clear, but is the opportunity available to most biotech firms to reduce their cycle times Methods used in engineering and construction to improve project management efficiencies such as the critical path method (CPM), briefly introduced in Chapter 3, are worth noting. However the most pertinent point made by Kessler and Bierly is the moderating effect uncertainty can have on project success. Unlike construction where most variables such as labour, equipment, materials, excavation rates, prefabrication rates, and so on (except of course the weather), can be calculated, biotechnology is notoriously uncertain.
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.