Analysis of the project management of BIOSIMILAR AWARENESS INITIATIVE

Project Management Plan Analysis: Biosimilar Awareness Initiative
Executive Summary
In this document, the project management plan (PMP) for the Biosimilar Awareness Initiative Project is analyzed. The Australian Ministry of Health is funding this research, which aims to boost confidence in and awareness of biosimilar and biologic medicines. The Project Management Body of Knowledge (PMBOK) has been utilized as the benchmark in the analysis, comparison, and PMP of the standards structure. In the PMP adopted by the Biosimilar Awareness Initiative project, deviations from the conventional PMP are viewed as a gap. Analysis has been performed on two major issues; the overall structure and the contents. Key findings reveal that while the PMP has addressed most of the issues set out in a standard project management plan, some sections which are set out in the standard PMP have been left out in the analysed PMP. So as to make the analysed PMP more informative and hence more useful, some sections such as Integration management, governance structure, and risk management should be added and explained in details.



Introduction

A Project management plan (PMP) is a formal document that is used to guide the execution and control of projects (Hwang & Ng 2013, p.273). Ideally, a PMP Documents the decisions and planning assumptions, document the approved scope, schedules and cost baselines. Additionally, a PMP acts as a useful tool for facilitating communication between all project stakeholders. Different project managers and scholars may use different names such as project plan (PL), and project implementation Plan (PIP) to refer to PMP. However, for the purposes of this report, a PMP has been adopted. This report presents an analysis of the PMP adopted by Biosimilar Awareness Initiative. The analysis is based on the standard project management plan. The analysis is useful in highlighting some gaps which may adversely hinder timely, effective and efficient delivery of the project. What has been considered as the standard PMP is the guideline provided by the Project Management Body of Knowledge (PMBOK). Therefore, any deviations from the said guideline are considered as gaps in the analysed PMP.

The analysed PMP was prepared in June 2016 and is used to foster the execution and control of a Biosimilar Awareness Initiative in Australia (Pharmaceutical Benefits Scheme 2016, p.3). The PMP has been divided into two major sections. The first section addresses the project background, project objectives, and the project scope. The second section addresses the project plan in details. In this section, the stages adopted in the project management and the communication strategy adopted are set out. The last section of the PMP covers the project evaluation methodologies. Project evaluation is very important as it outlines the strategies adopted to determine whether the desired goals, objectives and outcomes of the project have been met.

Project Background

Over the last decade, the popularity of biologic medicines in Australia has increased significantly. These medicines are now able to treat conditions such as Arthritis. As a result, Australia’s Minister for Health announced a Pharmaceutical Benefits Scheme (PBS) Sustainability and Access package in 2015 (Pharmaceutical Benefits Scheme 2016, p.4). The reforms witnessed in the pharmaceutical sector were as a result of negotiations and consultations which were held across the entire pharmaceutical supply chain. Stakeholders in the supply chain such as consumers, doctors, pharmacists, and medicine manufacturers were engaged in the consultations.

The project is sponsored by the Ministry of Health. A funding of $20 million was committed over a period of three years, 2015-2018 (Pharmaceutical Benefits Scheme 2016, p.6). The money committed was part of the Sustainability and Access Package. These funds were specifically intended supporting the confidence in and awareness of biosimilar medicines.

In 2008, Australia established processes for regulating biosimilar medicines hence making it one of the earliest countries to do so (Pharmaceutical Benefits Scheme 2016, p.10). The conditions that can be treated using the biologic medicines are however complex and hence require most of these medicines to be prescribed in hospitals. Despite this fact, community pharmacies have shown an increasing trend to supply the medicines. There is, therefore, a need to enhance confidence and increase awareness of the biosimilar medicines. Some of the major objectives of the project include communicating the ways of overcoming barriers to the use of the medicines, improving overall awareness of biosimilar and biologic medicines in Australia, and maintaining as well as supporting patient choice. This can be achieved by an improved understanding of the biosimilar medicines consumed by the patients as well as their families.

Structure of the Pmp

The structure of a PMP plays a significant role in determining whether the plan will achieve its objectives. Ideally, a project management plan should address the specific information needed by the audience. In the Biosimilar Awareness Initiative project, the audience of the PMP is the consumers and healthcare professionals in Australia. The structure of the project plan, therefore, determines whether the consumers and the healthcare professionals gain the needed awareness of the biosimilar medicines as outlined in the project’s objectives and goals section (Kelley et al 2016, p.18). While project management plans may differ in their structure, the baseline is the structure of the PMP should ensure that the specific information that needs to be passed to the audience is passed in the most convenient and efficient manner.

The PMP set out by the Biosimilar Awareness Initiative project is quite short and summarized. Although the plan has set out some of the major items that a standard PMP should outline, there is an alternative PMP that could have been adopted to make the project plan more comprehensive and hence more informative. The reason behind this thinking is based on principles set out by the theoretical framework that is needed to foster the effective and efficient delivery of a project. Basically, the underlying assumption in the project management theoretical framework is that a project can be thought of as a process that seeks to transform inputs into outputs (Flyvbjerg 2013, p.11). Therefore, the process of transformation can be broken down into some well-thought and well-understood tasks. So as to achieve optimal results of a project, each task should be optimized. The process of determining whether a project is a success must, therefore, begin by analysing whether the project has been divided into tasks and whether these sub-transformational activities have been conducted in an optimal manner` (Too & Weaver 2014, p.1382). The underlying theoretical framework assumes that tasks are independent of each other except in situations where there exist sequential relationships. Additionally, all tasks are seen as bounded and discrete. When developing a PMP, the uncertainty as to the sub transformational tasks and the corresponding requirements to fulfil the tasks is considered to very low.

An alternative to the PMP adopted by Biosimilar Awareness Initiative project starts by outlining the executive summary of the project. In this section, the key issues which drive the project should be addressed. Further, the problem or the opportunity should be identified clearly (Kerzner 2013, p.87). In a nutshell, the overall summary of the PMP should be set out in this section. The PMP adopted for the implementation and control of the Biosimilar Awareness Initiative project does not contain an executive summary hence lacking all the items which should be captured in this section.

After the executive summary, the next section should discuss integration management according to the alternative PMP structure. Unifying and integrating all these tasks is very crucial in ensuring that the overall goals and objectives of the project are met (Snyder 2014, p.19). The steps to be taken by the project management to eliminate any cases of goal incongruence in the sub-transformational tasks should be set out. Sub categories in the interaction management section include the project team structure and project governance, their roles and responsibilities, change management and project close out.

The decision to include the project team and governance structure in the PMP has been informed by the theory of management in project management. Essentially, this theory is sub-divided into three major theories which include the theories of planning, execution control (Darnall & Russell 2015, p.15). According to the theory of planning, management is taken as an important facet of project organization and planning. Setting out the project governance team, therefore, helps the organization in outlining the specific roles of the management in both the planning and organization roles pertaining to the project. Any successful project must be planned and organized in a smooth manner. A PMP should set out how the activities of the project have been planned and how they have been organized (Snyder 2014, p.19). The PMP adopted for the implementation and control of the Biosimilar Awareness Initiative project does not set out the project the project team and the governance team and structure for the project. Identifying who will be responsible for a given task is therefore very hard. As a result, the audience may fail to obtain very crucial information hence reducing the chances of the project success.

The scope management set out in the Biosimilar Awareness Initiative project PMP is quite shallow. Ideally, the PMP has just set out the things which are outside the scope of the project. I would have expected to see a more comprehensive and detailed scope management in the PMP. Some of the areas which should be captured in the PMP include the statement of the scope, management of key requires, and project deliverables (Svejvig & Andersen 2015, p.281). Ideally, some of the items to capture in the project deliverables include work activities, assumptions, stakeholders and requirements control. All these have not been set out in the PMP of Biosimilar Awareness Initiative project.

The alternative project management plan also provides that the PMP should have included sections of schedule, cost, quality, human resource, risk, procurement, and communication management (Flyvbjerg 2013, p.13). The inclusion of the schedule, quality and cost management in the plan has been informed by the control theory, which is the idea that in a project management, there is always a process to be controlled. Further, the theory opines that there is always a possibility of variation in the expected outcomes and the real outcomes. Quality and cost management will, therefore, ensure that everything is kept under control hence minimizing the chances of a significant deviation from the expectations (Flyvbjerg 2013, p.18). Procurement management and human resource management inclusion are generally informed by the execution theory of project management. The execution theory opines that execution is generally the process of dispatching and distributing tasks to the relevant workstations. The Biosimilar Awareness Initiative project has only detailed the communication management plan. The PMP has not, however, explained the risk management plan, quality management, and cost control management.

Analysis of the Contents of the Pmp

The PMP adopted for the execution and control of the Biosimilar Awareness Initiative project has been subdivided into two major sections; the project definition section and project plan. The PMP is rather short and summarized. In the project definition section, the project brief has been set out. Ideally, this section explains the overview of the project, its sponsor and the funds set out for the project. The inclusion of the project is important in the sense that it enables the PMP audience to gain an overview of why the project was initiated (Conforto et al. 2016, p.61). Considering that this is a government-sponsored project, the procedures behind the arrival at the reforms in PBS and Biologics medicine had to be outlined. The PMP sets out that negotiations and consultations were held between all stakeholders in the pharmaceutical supply chain. By outlining that the necessary consultations were held, the project is able to obtain buy-in from all the stakeholders. This buy-in is very crucial in enabling the project to gain acceptability among the doctors, wholesalers, consumers and medicine manufacturers. Considering the fact that the project targets the consumers and hospital practitioners, their involvement in the decision process is crucial for the project success.

The project background has also been set out in the project definition section of the project management plan. Ideally, this section has set out what the project is intended for. Further, the project background section has also set out the rationale for the project. Through the background section, the audience for the PMP is, therefore, able to understand why the Ministry of Health has decided to embark on this project. The project outcomes and objectives have also been detailed under the project definition. The importance of outlining the objectives and goals of the project cannot be underestimated. Ideally, objectives and goals show that the project has been planned well (Mir & Pinnington 2014, p.210). Further, the presence of goals and objectives gives a room for evaluating the success of a project. The baseline of determining the success of a project is evaluating whether the goals and objectives of the project have been met. This conforms to the planning theory of project management.

According to the planning theory of project management, there is always a managerial aspect as well as an effector in any project. The theory opines that planning is the primary function of the managerial aspect of a project. On the other hand, an effector is tasked with the responsibility of transforming the plans into actions. The major principle behind the planning theory in project management is that project managers must always give grips of the current state of things. Afterwards, the managers then define the desired state. This occurs through the setting of goals and objectives. So as to move from the current state of affairs to the desired state, there is always a need to take some actions (Svejvig & Andersen 2015, p.290). The effector coordinates these actions hence resulting in a common goal. The PMP adopted by the Biosimilar Awareness Initiative project recognizes the need to establish a desired state. The goals are a major strength of the PMP.

The PMP for Biosimilar Awareness Initiative project does however set a definite scope on the issues it will address. Rather, the ‘out of scope’ addresses the areas that will not be addressed by the project (Pharmaceutical Benefits Scheme 2016, p.4). The failure to explain the main scope of the project may leave the audience confused on to the extent to which the project will contribute to the fulfilment of their needs. Although outlining the out of scope activities is a good idea, the PMP should have been more educative and informative if it explained the project scope in details. Setting out the scope of a project in the PMP is an important step of the planning process. Ideally, scope assists managers in knowing the areas they should concentrate on. Without the scope, the managers may exert efforts and direct resources to activities which are not part and parcel of the project (Blomquist et al. 2010, p.5). As outlined in the Four Stages Theory of PM, effective and efficient management of a project entails the following key activities; start-up, planning, execution and close down. Setting out the scope of the PMP conforms to this theory.

Under the section titled ‘project plan’, the project management stages, as well as the communication strategy adopted in the management of the project, have been set out. The lifespan of the project has been set out as 3 years (Pharmaceutical Benefits Scheme 2016, p.7). According to the PMP, the first stage will entail initial awareness research plan. This will be followed by implementation, monitoring, review and project refining. The last stage of the plan is evaluation, finalization and recommendation stage. By breaking down the project execution into stages, the PMP recognizes that the project is an interrelation of different tasks and activities which work together towards the achievement of the set goals and objectives (Todorović at al. 2015, p.775). The plan has set out that a steering committee will be responsible for the oversight of the implementation stages. One of the major strengths of the project implementation stages is that the timeline for each stage is set out. Although timelines for the second and third stages have not been explicitly stated in the plan, the PMP has outlined that the first stage is expected to be completed by the end of the current year. The other two stages are therefore expected to be completed over the last two years of the project life.

The PMP has left out the issue of governance and team structure in the project implementation plans. According to the project management theory, the managing aspect of a project cannot be ignored. Outlining the specific team members as well as the governance team that will be responsible for the project delivery enhances accountability and responsibility hence helping the team members to better work towards the realization of the project goals (Papke-Shields & Boyer-Wright 2017, p.170). The reporting structure has not been set out clearly in the PMP. Although the PMP has indicated that the steering committee will oversee the implementation of each of the three stages, there ought to have been a more elaborate reporting structure. The importance of a reporting structure is based on the theory of control and execution. The theory of control recognizes that the control process in project management consists of the evaluation of the rate of realizing the goals and objectives of a project. Further, the theory opines that control should address the causes for non-realization of the set goals and objectives. After the causes for non-realization of goals and objectives have been identified, the project manager should now seek ways of eliminating them.

The theory of Execution opines that there should a procedure for undertaking the tasks necessary for the achievement of the project goals and objectives. Both the execution and control theories play an important role in ensuring that the project team members tasked with the responsibility of delivering given sub-transformational tasks do so in the most effective and efficient manner (Kerzner 2017, p.79). The presence of a more elaborate reporting structure should have placed the PMP in a better chance to effectively describing the monitoring strategies which have been set out by the Biosimilar Awareness Initiative project managers to ensure that every team member is performing his or her tasks as required. The PMP has mentioned that the Biosimilar Awareness Initiative project has put in place methodologies for ensuring and maintaining the quality of the project. However, the specific methodologies have not been set out in the PMP.

The PMP is quite elaborate in setting out the communications strategy of the project. In any project, communication is a vital tool for enhancing coordination. The communication objectives for the Biosimilar Awareness Initiative project have been set out in the PMP (Pharmaceutical Benefits Scheme 2016, p.12). Further, the PMP has also described the purpose of the communication strategy. The Project plan has also set out the core themes which the project team believes are important in helping the project to achieve its set goals and objectives. Importantly, the communication channels have also been set out in the PMP. However, the PMP has just mentioned the channels to be used without explaining how it intends to use them. For instance, it would have been better if the PMP for the Biosimilar Awareness Initiative project explained how it would mix the communication channels and the frequency of communication for the chosen channels. The language action perspective proposes a two-way communication model for fostering project communication.

Lastly, the PMP has outlined how the project will be evaluated. Project evaluation is essential in determining whether the objectives and goals of the project have been met. The use of Key Performance Indicators (KPIs) is specifically very useful in Biosimilar Awareness Initiative project as it helps the stakeholders in measuring the extent to which the objectives and goals of the projects have been realized(Kerzner 2017, p.79). Project evaluation is based on the control theory of project management where deviations from the set outcomes should be established.

Conclusions

Although the PMP set out for the execution and control of Biosimilar Awareness Initiative project captures some of the major items that are set out in the standard project management plan, some key items have been left out or loosely described. For the purposes of analysis, a standard PMP has been defined as the one set out by Project Management Body of Knowledge (PMBOK). The Biosimilar Awareness Initiative project was as a result of the increase in the popularity of Biologics medicine in Australia. The goal of the project is to increase awareness of and confidence in the biosimilar medicine. The project targets the consumers and healthcare professionals.

The PMP analysed is divided into two major sections; the project definition and the project plan. The project definition set out the project overview, background, objectives, and scope. The scope is however loosely explained as the PMP has only discussed the ‘out of scope’ areas. The project objectives, background, and overview, however, conform to the planning theory in project management. The PMP also sets out the ‘project plan’ section which explains in detail the stages of the project implementation. One of the major strengths of this section is that it has set out the timeline for the first stage of the implementation process. The timeline for the whole project is also clearly outlined in this section. Another strength of the PMP is that it has extensively outlined the communication and evaluation strategy for the project. However, some weaknesses of the PMP arise from the fact that the PMP does not outline the risk management, integration management and the governance team and structure for the project.

Recommendations

Based on the weaknesses noticed from the analysis of the PMP adopted for the execution and control of Biosimilar Awareness Initiative perfect, the following recommendations have been developed.

The PMP should set out an integration management plan. Essentially, integration management will specify the project processes which need to be unified so as to effectively run the project and make it a success. This section is heavily informed by the project theory which recognizes a project as a collection of sub-transformational tasks which together transform inputs to outputs. By creating an integrated management plan, all the tasks involved in the project delivery will be integrated effectively hence contributing to the achievement of universal project goals (Snyder 2014, p.19). Through integration management, tasks whose goals are incongruent to the overall objective of the project will be identified and eliminated or corrected depending on the best way forward.

The PMP should also set out the project management teams and governance structure that will be adopted in the project. By linking project tasks to a specific team member (s), the project fosters responsibility and accountability. All these are very crucial in helping a project to realize its set goals and objectives. A clear governance structure fosters quality as it the project managers closely monitor the performance of the project teams.

The PMP should also set out the risk management, cost management, schedule management and resource management. Through this, the project quality can be controlled better hence reducing the deviation from the set goals and objectives.

 



References

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APPENDIX

APPENDIX 1: PMP FOR BIOSIMILAR AWARENESS INITIATIVE

BIOSIMILAR AWARENESS INITIATIVEPROJECT MANAGEMENT PLAN

Date: June 2016

1 Project Definition

Project Brief

In May 2015 the Minister for Health, Sussan Ley announced the government’s Pharmaceutical Benefits Scheme (PBS) Access and Sustainability Package. The reforms followed consultations and negotiations across the pharmaceutical supply chain including consumers, pharmacists, medicine manufacturers, wholesalers and doctors.

As part of the package, funding of $20 million has been committed over three years (2015-16 to 2017-18) to undertake awareness and education activities. These are intended to support awareness of, and confidence in, biosimilar medicines.

Background

Biologic and Biosimilar Medicines in Australia

Biologic medicines have become increasingly popular in the last decade to treat conditions like arthritis. This is reflected in the PBS, where biologic medicines have grown from about 4 per cent of the PBS budget 10 years ago, to about 25 per cent today.

Australia was one of the earliest countries to establish processes for the regulation of biosimilar medicines, in 2008. Aczicrit® and Grandicrit® (epoetin lambda) were the first products approved in Australia as biosimilars in 2010.

The complexity of the conditions that can be treated with biologic medicines and the specialist nature of the condition treated means that the bulk of these medicines are currently prescribed in a hospital setting. However, community pharmacies are increasingly becoming involved in supply of these medicines.

Increasing numbers of submissions for these medicines are seeking listing on the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) considered applications for biosimilar medicines at its March 2015, July 2015, March 2016 and July 2016 meetings, and this trend is expected to continue.

The availability of biosimilar medicines creates choice and competition. With multiple brands available, the prescriber, patient and pharmacist have options and the competition can lead to lower prices.

Project Objectives & Outcomes

The aim of the Biosimilar Awareness Initiative (the Initiative) is to improve awareness of, and confidence in the use of biosimilar medicines for healthcare professionals and consumers.

The Projects Key Objectives are to:

improve the overall awareness of the PBS and the future potential of biologic and biosimilar medicines across the community;

communicate to stakeholders the benefits and information required to overcome barriers to the use of biosimilar medicines;

supporting and maintaining patient choice, by improving understanding of the medicines used by patients and their families;

providing education and/or refreshing previous education to support healthcare professionals to meet the clinical and information needs of their patients with regard to both prescribing and dispensing the medicines; and

supporting the specific communication and information needs of stakeholders, including the PBAC, at times when a particular medicine is being considered and or recommended for listing on the PBS, especially where brand substitution may apply.

Out of Scope

The following are outside the scope of the project:

the process for determining whether a medicine is a biosimilar;

the regulatory and/or assessment processes used by the Therapeutic Goods Administration (TGA) to consider the registration of medicines, including biosimilar medicines;

the assessment processes used by the PBAC to assess medicines, including biosimilar medicines, for recommended listing on the PBS; or

any approaches to attract manufacturers of biologic and biosimilar medicines to Australia.

Project plan

Project Management Stages

This project has a life span of 3 years ending in June 2018 with Stage 1 due to be completed in 2016. The following diagram provides an overview of the current Project Stages.





The Initiative has in place robust project management methodologies to maintain and ensure the quality of this project.

Communications Strategy

Purpose

The Communication Strategy contains the description of the means and frequency of communication to stakeholders internal and external to the project. It facilitates engagement with stakeholders through the establishment of a controlled and bi-directional flow of information.

Communication Objectives

The objectives of the communication strategy are:

To raise awareness and understanding of biosimilar medicines.

To increase the confidence of healthcare professionals and patients to consider and use biosimilars.

To raise awareness and understanding about the PBS and the role of the PBAC in evaluating and listing biosimilar medicines.

To engage with key stakeholders and harness support for the project.

Stakeholder Identification and Engagement Plan

Effective stakeholder identification and engagement is an iterative process critical to the success of the Initiative. For a detailed update of this plan refer to attachment A.

Core Themes

Having undertaken extensive research and consulted with experts, the following key information needs have been identified.

Definition: Some medicines are made from biological sources. Once the patent on the first brand of the biologic medicine expires, copies can be made. These are called biosimilar medicines.

Biologic and biosimilar medicines are subject to rigorous checks and balances before approval: Biologic medicines are made in a ste...