Life-cycle Project Diagram
Abu Dhabi Pharma
Executive Summary
Project Management’s relevance across industry is tested and tried. The Pharmaceutical industry has lately undergone rapid changes. It is demonstrated, however, that project management can add benefits when applied to the new product development in the pharmaceutical industry. The industry is specific for its rigorous regulatory compliance and product quality. Clinical research and drug development is not only key to managing newer infections but also staying ahead of the pack with newer and innovative molecules. Project management techniques can help the planning, scheduling, managing the project phases risks and ultimately assure quality and timely delivery. Managers and Executives have to be clear on the dual concepts of a project having beginning and an end, the understanding of which can aid the pharmaceutical industry in its projects inception, management and completion in drug research, manufacture and lauch.
It is generally, recommended, for purposes of future project success that top managements take enough time to explain to the employees the need for the correct implementation of the project’s phases to ensure the overall success. In addition they must provide the necessary resources and do constant monitoring and evaluation of the project success. Flexible work application systems and procedure will especially, aid the complete loop of project life cycle. Work teams must be decentralized in a team oriented environment. The environment must enable the successful new product development project within the overall industry principles. Project managers thus have a great task to help keep the strategic orientation of pharma projects and therefore, must be taken as so by the senior management for specific purposes of the project implementation within time lines, scope and budgets.
Introduction
In a rapidly changing world, all industries go through quick changes to either adopt or survive within the business environments. This is true of any industry, and the Pharmaceutical industry has lately undergone rapid changes as well (Jerome & Cara, 2006). Project Management’s relevance across industry is tested and tried. It is demonstrated that project management can add benefits when applied to a dimension like new product development in the pharmaceutical industry. The industry is specific for its rigorous regulatory compliance and product quality. Clinical research and drug development is not only key to managing newer infections but also staying ahead of the pack with novel and innovative molecules. The techniques of project management can help the planning, scheduling and managing the project phases’ risks and ultimately assure quality and timely delivery. For any organization in the industry to cope with industry changes, it will have to take on projects that seek to improve its competitive edge among players and geographies (Anon., 1974). Managers and Executives could put their organizations to benefit from the dual concepts of a project as having a beginning and an end (Sadler-Smith, 2006). This understanding can enable application of the project lifecycle management techniques is imperative for successful project inception, management and completion (Wideman, 2003).
The management of the project has for a long time been observed to be like taking a project from the cradle-to-the grave (Mosley, et al., 1985). This may ideally represent a concept of a diagrammatic representation of the project as kicking-off to the final stage or stages of completion and handover (Weisberg, 1986). As a project goes through initiation to completion, the standard pathway of phases is universal irrespective of the industry in question (Turner & Muller, 2003). Project phase’s activities, however, may differ in length or number of phases and the details in each phase (Mangaham & Pye, 1991). These phases ordinarily go through a relatively standard sequence of five phases including start-up, definition, planning, execution and Close-out. The start-up phase defines project objectives and details the conceptual aspects agreed upon a project, including the identification of a possible problem and suggested solutions (Institute, 2004).
Defining Goals
Defining a project involves a clear definition and appraisal of solutions with a keen interest into risks, financial commitment and benefits (Weick, 1983). The planning phase of the project involves breaking down a project into manageable areas of work assignments that involve time, cost and resources (Lindenfield, 2000). However, it is worth to note that this phase is a continuous phase whose processes often extend to the final project phase of execution (Association, 2008). The execution phase covers a project’s implemented activities, the control of the activities and the process of monitoring and evaluation of results, for possible correction of deviations. Close-out, as a final stage of the project life-cycle, may also entail demobilization for the reassignment of resources; project handing over and post-project review (Hunt, 1992).
Project objectives generally lay out targeted aims at the completion of the project, whose attainment is the fulfillment of the project desires. Generally, effective goals are to be formulated within the acronym of S.M.A.R.T in order to maintain and measure specificity, measurability, and achievability, while at the same time being realistic and time bound.
A main challenge in project management is to make sure the major constraints are obeyed. Additionally, a project must focus so strongly on optimized resource allocation to enable the realization of the objectives.
Pharmaceutical Industry Project Management Lifecycle
As observed, above, in the project lifecycle management key elements are imperative. These include project definition, project teams and organization, planning, scheduling and control; problem solving and decision-making using proto-type, senior management review and control, proactive and real time change management. Applying the S.M.A.R.T acronym for goal setting above, in the pharmaceutical industry context, the industry objectives depend on organisational management and authority, development, legal requirements for registration, supply chain, QA, patents, market and also parallel time & cost.
This is typically, represented in the table below.
Broadly categorized, the pharma industry objectives look into product development and the launch of the product into the market. As a consequence, management and authority are charged with running the project, clinical trials come under product development, product launch must follow registration, the supply chain facilitates raw material needs, and patents secure the business, as the Quality analysis assures product quality. Finally, a ready quality and registered product is launched into the market. Project management life cycle is constrained by the triad of scope of work for performance, time to market and resources. The dependency of each leg of the triangle is absolute and none will be effective without the other.
This paper focuses on the project report of Abu Dahbi Pharma. Our project on drug development and launch phases, generally followed the paths of accepted project phases (Stewart, 1994). In addition, right staff was employed in the drug development and technology transfer phases to enable the manufacture of the right molecule which was later patented (Thamhain & Lemon, 1975). The inherent control system and structure was offered by thy top management which provided the necessary support required (Muller & Turner, 2005). Abu Dhabi pharma’s primary business structure that requires the top management and its internal employees to drabble in the management affairs of the project in all its phases at it was long and would consume time and money until clinical trials and market launch (Webber & Klimoski, 2004).
2.1 Strategic Consideration
A number of phases ideally make up the Pharmaceutical project development (Songer, et al., 2004). This also caters for transfer processes and problem solving. For smooth success of projects in the pharma industry, many if not all of these phases need to be visualized and understood (Cleland, 1999). Top in this category is the clinical development of a drug, followed by the technology transfers in manufacturing, major pharmaceutical projects milestones like US FDA stock submission and approval (Thamhain & Lemon, 1975). Also included is the use of product proto-typing cycles and their value towards solving problems, communicating progress results within cross functional teams. Design-build-test cycles is one more chance enhancer in the drug molecule roll out in the pharma industry and utilizing the cycles for feedback of progress (Hill, 1977). Design-build-test cycles can use the bulk drug vendors, formulation feasibility, complete engineering runs, clinical and stability samples, ramp-up manufacturing process and producing first lot for stocking (Merriam, 2007). Our Pharmaceutical firm, in Abu Dhabi, was meant to meet its objectives through a range of high value drug marketing services in approximately all of the major towns pursuing a combined regional business economic block (Fisher & Ury, 1991).
The Abu Dhabi pharma company narrowly viewed the drug launch process and made a blunder in blanket sales forecasts, pricing, and market roll outs, without due consideration of the philosophy of right process for right results, for conventional business practices (Bobbins, 1974). In attempting to achieve the objective of drug roll out, Abu Dhabi Pharma always tried to impress upon its people the client’s potential need for these molecules without prior check. The company then began to market its twin strategy of focusing on drug solutions to all and sundry with a singular mindset and emphasis on seamless process execution steps for strategic differentiation (Salaman & Mabey, 1995). Ideally, they were selling right medicines to the wrong market. Our pharmaceutical company’s original plans were to evolve quickly and consistently and roll out a range of patented molecules in Abu Dhabi.
Figure 1. Proposed six-phase comprehensive top level project life cycle model for Abu Dhabi Pharma.
The management and control of organizations is sponsored by the top executives. They additionally, fund, and champion the needed pharma projects for the teams. Top management absolute involvement is necessary to help link business strategy with organizational objectives. They also observe the risk issues and monitor the project flow through its life. The involvement of top management is especially key at the start of the project to help facilitate the smooth transition through project phases. P.E.R.T is especially necessary to help in tracking the project phases. But because P.E.R.T was generally found to be cumbersome a Ghantt chart was used that easily tracked the project phase activities by month and year. For coherent work applications, the tools, above, are taken to offer considerable flexibility in the application of works. This work application was carried out within a decentralized group with unifies unique skills sets. The resultant force that sprung from teams made the orientation towards the attainment of the Abu Dhabi Pharma goals more possible. The top management made the environment more conducive and enhances facilitation in the successful pharmaceutical new product development.
A key component of project success is project review with senior management. The review constitutes a key element in the new product process. The project manager must institute ability to constantly engage or be engaged by the senior management. This interface has to be created for the smooth flow of information, instructions and feedbacks. The hierarchy reviews are important in so far as they assure timely and continual project status and issues. This enables quick correction of deviations. Also important in the industry is the stage-gate reviews that consider, possibly, an outsiders opinion on the progress, after each stage. Stage-gates are fairly popular reviews for clarifying project planning; objectives and they help in evaluating the case for the implementation of each project phase. It is also during the gate-reviews that technical issues that emanate from the implementation phases can be ironed. The gate-reviews are a pointer to the direction of the overall project implementation. It is very vital that the senior management get deeply involved in them, for final accountability, yes lies with the project teams, but ultimate responsibility is the top echelons. Failure or success of an implemented project, as is observed severally in this paper, remains the single most test of the viability and long-term success of a company’s objectives.
Management involvement can be assured by defining the long-term objectives and the direction to help achieve the demand of new product development. The higher management must also define new product project portfolio and the overall set of products required, while actively assigning tasks and providing support for project reviews and resources.
The project structure had all the chances of original success. It had been properly planned, and operationalised in the lower phases of the product development, including clinical trials. The drug molecule was legally registered in the Abu Dhabi market, but not without first seeking the US FDA approval. The drug molecules were also patented as per the requirements of the originator molecules. The gaps were, however, quickly identified, and appropriate decisions made, when in the final phase, drug launch into the market appeared bungled. The company did not, follow Abu Dhabi pharma project through from inception from the practical steps of feasibility studies, starting the project, defining and organizing the project to completion (Mullins, 2001). The all important latter phase, of the product launch, was the missing phase. We then embarked on the initial rigorous execution steps looking into our project phases, finally closed out and conducted a post evaluation with a written report (Schutz, 1958). The structure proposed was to review the stakeholders to include a resident Project Team Leader (PTL), while all ignored the inclusion of the interest of personnel from Abu Dhabi where the marketing of the products would be rolled out. This would cultivate ownership and collegiate practices at the project (Womack, 1988). While the project team continued to have overall directions from the pharma top management, it had kept a lean team of departmental heads under the new project team leader. It was not lost on the company that the original objectives of conquering the pharma market in Abu Dhabi did not succeed. The lack of success was immediately attributable to inadequate involvement of the team to understand that Abu Dhabi site was part of an emerging economy where pricing and specific molecules were necessary. To assume that the drug molecule would sell in any market was the primary mistake.
2.3 How Planning Implementation will be approached
It is essential to ensure that the project life cycle used on the project is appropriate to the work being carried out and split into distinct and manageable phases. Therefore, the process of a formal strategy and TQM practices at the Abu Dhabi pharmaceuticals will be jointly conducted with the involvement of departmental heads and seconded officers previously used in the gate procedure.
The planning process for the new phase of the project was significantly changed. The project team with the managers agreed to have formal planning meetings specific for the project implementation with everybody constantly informed of the agenda and items serially disused and documented (Mintzberg, 1973). The project team, under the project team leader raw out the new project planning schedules that included the phases of fresh feasibility studies, starting the project, defined and organized the project. The project then embarked on the initial rigorous execution steps looking into our project phases, finally closed out and conducted a post evaluation with a written report. The project team workers embarked on fresh identification of stakeholders, and the new stakeholder analysis was planned to include the pharmaceutical manufacturing business legal requirements and the new products’ development and launch phases.
2.4 The Change Process
Organizations go through rapid changes. Changes make transitions to be both prepared for any eventuality and/or to capitalize on emerging strategies to help them stay competitive in their markets (Watson, 2002b). Our change process considered the implementation of a change program that sought the combined change approaches of Strategic Planning (SP) and Total Quality Management (TQM) (Whetton & Cameron, 2002). The overall change process encompassed the diagnosis of the possible causes of the failure of the objectives originally intended (Raelin, 2004).
The change process started by changing awareness created by flop of the marketing entry into the emerging economy. The company had not prioritized what would work in these economies and did not also check carefully into the appropriate pricing. Personnel were hired included as a resident project team advisor to make clear recommendations for a productive market entry. Literature has guide that change programs need to be accompanied by culture transformation programs (Mumford & Gold, 2004). The pharma project team needs to undergo organization transformation workshops that sought to shift the older order of thoughts and decision making patterns (Pedler, et al., 1994, 2001, 2007 editions).
A method of identifying risks is proactive project installation procedure. The real problem must be identified, with relevant facts and several alternative solutions with analysis to review impact alternatives. The best alternative is adopted and effectively communicated to all stakeholders with an audit outcome followed for cost/ benefit of time improvements and assessment of financial impacts to reduce costs. In reality risks due to uncertainties is a global feature of all project managements and the pharmaceutical industry is no isolation.
The original disorder in the project’s implementation was as a result of the possibility of secondary resistance from the middle level managers at the firm stemming from lack of clear marketing information about the emerging economies where new drug molecules would be launched. Planning sessions then zeroed in on the complete assurance and ground involvement to help bring all on board (Gosling & Mintzberg, 2004). The reverse psychology of the impact of the original loss of the project objectives was also played into openly and honestly without any recrimination to help reinforce the need for change. This time round new product laucnch was taken up as a project, in itself.
2.5 Cultural Considerations and Impacts
On their own, change management approaches yield just so much or altogether fail in the face of company objectives. Change management programs are reported in the literature to have either met or achieved less than desired results or failed altogether if implemented without attacking the underlying corporate culture networks, positively (Cover & Schwenk, 1990). Maintaining patterns of decision making and communication networks often sabotage corporate change programs (Starke & Sexty, 1992). The re-introduction of the project objectives was re-communicated in change management workshops unlike previously where no workshops were ran. Although an external consultant was engaged to impress professionally, upon the staff, the need for reaching out to the company objectives which would create a platform for competitive advantage versus the competition, this was only temporary guide to help steer the formal planning process (Muller & Turner, 2005). The structured workshops ran on company working hours to help emphasize the need for understanding the necessity of the program (Hales, 1986).
Individual countries have individual governing laws and perhaps country specific behavior by culture, language, dressing, etc. The same laws govern the launch and marketing of pharmaceutical products. Our planning session delved into the demographic orientation of each of the individual countries of interest (Leavitt & Bahrani, 1988). The possible limitations were anticipated, and solutions drawn. Advance delegations were made to the local embassies of these nations, and as much documentation about their individual histories, politics, economics and all, were collected, analyzed and compiled (Songer, et al., 2004). It was widely expected that some of these nations perhaps still were not very development to take on the full impact of an originator pharmaceutical brand molecule let alone getting the pricing policy right in these countries (Songer, et al., 2004). However, it was necessary to keep this fact on paper and find out the possibility of a more programmed market entry into the emerging economies, wher we failed to initiate successful marketing system. Further, delegations went to these individual countries to visit their key towns and reveal, for the project team, the true picture of things regarding pharma business (Hassard & Parker, 1994).
2.6 Management
2.6.1 Various Roles of Management
Management roles have been examined in the literature. The diversity of these includes roles that look into the manger’s ability in putting together the resources including, available to him or her for the success of an organization. These roles have been largely categorized into interpersonal, informational and decisional (Mintzberg, 2004). In the seminal works of Mintzberg, interpersonal roles encompass the general component of emotional skills, as they are popularly used. These are interactive person to person skills that enhance relationships and general levels of interactions. These interpersonal skills may include a far range of skill sets that can be studied including communication and leadership (Mosley, et al., 1985). They are morale boosters, innovative ways of capturing moments for the better (Heller, 1985). On the contrary, informational skills constitute the programs of skill sets that enable the planning sequence of an organization.
The management must at all times scheme through the sheaf of available information to leverage on the decision of the company procedure (Stogdill, 1975). Once the information is collected and adequately analyzed, the complete planning process can be made as the decisions will be based often on some solid ground that involves prior information (Wheatley, et al., 2007). This later consideration constitutes the skill sets of a manager based on the decision making process skills. Senior management must define the projects’ strategic direction, as observed, and follow through for success within the constraints of time, resources and money.
2.6.2 Functions of Management
Common management functions follow the basics of planning to allow the smooth running of the organization (Mintzberg, 1995). Organization functions match people skills and their jobs while staffing involves the processes of recruitment and selection (Dinsmore, 1990). Coordination duties of the management are closely related to ensuring the roles of employees are in tandem as controls ensure the outcomes are the intended ones in the company objectives.
On a considered note, the planning functions are widely correlated to the complete application of the management roles, discussed above, to enable the optimization of the human and other resources at the disposal of a manager to achieve the desired company objectives. It involves taking decisions from available options (Polyani, 1966). Looked at further, the organizing function involves a manager’s role to match people skills and tasks for optimum performance, while directing enables constant vigilance over efforts and procedure towards the attainment of the company goal or goals (Pye, 2005). All important management function of staffing is perhaps, the managers’ single tool to help in the overall success of the project implementation (kotter, 1982). It is from recruitment and selection that managers draw human resource plans to help fill company vacancies. Properly, aligned for skill, capabilities and performance, the objectives of any organization are nearly sure to be met once the right staffing is looked into. The final corollary function of the manager being an organization’s activities controller empowers a sequence of behavior and monitoring trends for onward looking indicators of success. If deviations are noticed, then, corrections can be promptly installed.
2.7 Description of the Company Management
The double use of the company accountant to deal with the project was a major split personality that ran into quick conflict and made the accountant to get into lies and substandard accounting reporting procedure (Beardwell & Holden, 2001). The new resident project monitoring officer settled to work internally allowing for a quick catch up with the daily occurrences, and reporting to the office of the Managing Director, fulfilling the immediate need of change of tact by the company (Hofstede, 1993).
2.8 Overview of Ethical Issues
This process of starting up the last phase of the Abudhabi pharmaceutical product market launches suddenly possibility of internal difficulties by the project market launch managers and secondary managers drawn from regular operations. These managers failed to appreciate the rigorous pursuit of the manufacturing firm’s major objectives for growth and expansion, Choosing even to lie to external auditors through lack of accountability and commitment (Grint, 2001), it bacame obvioues the markting of the US FDA approved molecule was on disruption. The company had, however, failed to appreciate the importance of all-inclusive participation right at inception of the program (Raelin, 2003). It did no factor in the feasibility components of entry strategies and pricing for the Abu Dhabi emerging economy.
3.0 Conclusion
Projects are, perhaps, single and occasional ventures organizations embark on for a specific purpose and clamped down when either purpose is achieved, or time is expired. As already observed in the introduction of this project program report, we re-emphasize the complete need of the projects to be demarcated in phases for effective implementation. Noteworthy in this process is the absolute necessity to keep within the triad of costs, time and resources (Arnold & Robertson, 1995). Any in-ordinate fluctuations in the forgoing doubtless result into serious implications to the organization. While it’s observed up here that projects go through phases for a possible successful completion, it is not entirely enough to assume that an ordinary project structure will always yield the desired results (Watson, 2001).
This paper has been making attempts to view project management with specific reference to the pharma industry. Our focus has looked into the full cycle of project planning, evaluation to project closure. Project management era has its beginnings in very early times where work breakdown structure and Gantt chart were applied. This paper, in the characteristic pursuit of the early project management decisions, has been studied using knowledge of PERT, Gantt Chart Yellow sticky method and work breakdown structure (Cleland, 1999).
The introduction of the strategic elements in the pharma industry is meant to have the results that mitigate disaster where cooperation for proper work achievement becomes less and less dangerous (Russell, 1962).
3.1 Recommendation
It is generally, recommended, for purposes of future project success that top managements take enough time to explain to the employees the need for the correct implementation of the project’s phases to ensure the overall success (Upward, 1997). In addition they must provide the necessary resources and do constant monitoring and evaluation of the project success. Flexible work application systems and procedure will especially, aid the complete loop of project life cycle. Work teams must be decentralized in a team oriented environment. The environment must enable the successful new product development project within the overall industry.
Project management will promote good team work, cross-functional solutions and the provision of scientific and technical perspective for the most optimized results. Integrations. Project managers thus have a great task to help keep the strategic orientation of pharma projects and therefore, must be taken as so by the senior management for specific purposes of the project implementation within time and budgets (Higgins, 2007).
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