Project Management in pharmaceutical R&D - Revision history

S172420: /* Project management processes in pharmaceutical R&D */

2019-03-03T20:24:05Z

Project management processes in pharmaceutical R&D

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	Project management team manager follows a set of interrelated actions in order to provide the desired deliverable, and a good practice and framework is given by the PMBOK guide,<ref name="PMBOK"> "Project Management Institute. ''A guide to the project management body of knowledge''. 5th edition. - Available at: http://dinus.ac.id/repository/docs/ajar/PMBOKGuide_5th_Ed.pdf" </ref> where the five categories known as Project Management Process Groups are described as follows:		Project management team manager follows a set of interrelated actions in order to provide the desired deliverable, and a good practice and framework is given by the PMBOK guide,<ref name="PMBOK"> "Project Management Institute. ''A guide to the project management body of knowledge''. 5th edition. - Available at: http://dinus.ac.id/repository/docs/ajar/PMBOKGuide_5th_Ed.pdf" </ref> where the five categories known as Project Management Process Groups are described as follows:

	[[File:5groups.PNG\|400px\|thumb\|left\|Process Groups Interact in a Phase or Project. Based on "A guide to the project management body of knowledge"<ref name="PMBOK"\>]]		[[File:5groups.PNG\|400px\|thumb\|left\|Process Groups Interact in a Phase or Project. Based on "A guide to the project management body of knowledge"<ref name="PMBOK" />]]

	'''Initiation'''		'''Initiation'''

S172420: /* Project management processes in pharmaceutical R&D */

2019-03-03T20:23:03Z

Project management processes in pharmaceutical R&D

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	Project management team manager follows a set of interrelated actions in order to provide the desired deliverable, and a good practice and framework is given by the PMBOK guide,<ref name="PMBOK"> "Project Management Institute. ''A guide to the project management body of knowledge''. 5th edition. - Available at: http://dinus.ac.id/repository/docs/ajar/PMBOKGuide_5th_Ed.pdf" </ref> where the five categories known as Project Management Process Groups are described as follows:		Project management team manager follows a set of interrelated actions in order to provide the desired deliverable, and a good practice and framework is given by the PMBOK guide,<ref name="PMBOK"> "Project Management Institute. ''A guide to the project management body of knowledge''. 5th edition. - Available at: http://dinus.ac.id/repository/docs/ajar/PMBOKGuide_5th_Ed.pdf" </ref> where the five categories known as Project Management Process Groups are described as follows:

	[[File:5groups.PNG\|400px\|thumb\|left\|Process Groups Interact in a Phase or Project. ~~Inspired~~]]		[[File:5groups.PNG\|400px\|thumb\|left\|Process Groups Interact in a Phase or Project. Based on "A guide to the project management body of knowledge"<ref name="PMBOK"\>]]

	'''Initiation'''		'''Initiation'''

S172420: /* Project management processes in pharmaceutical R&D */

2019-03-03T20:21:35Z

Project management processes in pharmaceutical R&D

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	Project management team manager follows a set of interrelated actions in order to provide the desired deliverable, and a good practice and framework is given by the PMBOK guide,<ref name="PMBOK"> "Project Management Institute. ''A guide to the project management body of knowledge''. 5th edition. - Available at: http://dinus.ac.id/repository/docs/ajar/PMBOKGuide_5th_Ed.pdf" </ref> where the five categories known as Project Management Process Groups are described as follows:		Project management team manager follows a set of interrelated actions in order to provide the desired deliverable, and a good practice and framework is given by the PMBOK guide,<ref name="PMBOK"> "Project Management Institute. ''A guide to the project management body of knowledge''. 5th edition. - Available at: http://dinus.ac.id/repository/docs/ajar/PMBOKGuide_5th_Ed.pdf" </ref> where the five categories known as Project Management Process Groups are described as follows:

	[[File:5groups.PNG\|400px\|thumb\|left\|~~alt text~~]]		[[File:5groups.PNG\|400px\|thumb\|left\|Process Groups Interact in a Phase or Project. Inspired]]

	'''Initiation'''		'''Initiation'''

S172420: /* Drug development stages */

2019-03-03T20:17:41Z

Drug development stages

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	The drug development basically consists of a sequence of phases in which each phase has a specific purpose and studies associated. It takes many years and it is therefore necessary to have a clear idea of all the steps, tasks and stakeholders involved in each of them.<ref name="drugDevelop" />		The drug development basically consists of a sequence of phases in which each phase has a specific purpose and studies associated. It takes many years and it is therefore necessary to have a clear idea of all the steps, tasks and stakeholders involved in each of them.<ref name="drugDevelop" />

	[[File:DrugDevelop.PNG\|700px\|thumb\|right\|Drug development phases. Inspired by "Drug development project management".]]		[[File:DrugDevelop.PNG\|700px\|thumb\|right\|Drug development phases. Inspired by "Drug development project management".<ref name="drugDevelop" /> ]]

	'''Discovery Research''': The process starts with the identification of a molecule that revels some potential and that meets the strategic considerations – meaning it has both commercial and medical value potential. This molecule has therefore to follow the internal and external strategical considerations mentioned before. The duration of this phase is around 2 years.		'''Discovery Research''': The process starts with the identification of a molecule that revels some potential and that meets the strategic considerations – meaning it has both commercial and medical value potential. This molecule has therefore to follow the internal and external strategical considerations mentioned before. The duration of this phase is around 2 years.

S172420: /* Body of Knowledge */

2019-03-03T20:15:44Z

Body of Knowledge

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	The BoK representing the role of the project manager is usually equally balanced between General Management, Scientific/Technical, Project Management. For what concern the pharmaceutical R&D project manager there are some different opinions, mostly based on the technical competences required to cover such a role. On the other hand, though, due to the complexity and length of the project its role requires a lot of knowledge in the project management field. Planning and breaking down the activities in a good way can determinate the success or the failure of the project.		The BoK representing the role of the project manager is usually equally balanced between General Management, Scientific/Technical, Project Management. For what concern the pharmaceutical R&D project manager there are some different opinions, mostly based on the technical competences required to cover such a role. On the other hand, though, due to the complexity and length of the project its role requires a lot of knowledge in the project management field. Planning and breaking down the activities in a good way can determinate the success or the failure of the project.

	In the first case, the supporters of this type of project manager point out the fact that it has to have more Scientific/Technical BoK – in fact it has to manage and understand the interdisciplinary scientific issue arising around the discipline of pharmacology, chemistry, toxicology, metabolism, pharmacokinetics, pharmacy, clinical research, and statistics.<ref name="PMinR&D" /> This represents one case and, obviously, the higher the two competencies are, the better it is. [[File:BodyOfKnowledge.PNG\|300px\|thumb\|right\|Different types of Body of Knowledge. Based on "The project manager in pharmaceutical R&D" ]]		In the first case, the supporters of this type of project manager point out the fact that it has to have more Scientific/Technical BoK – in fact it has to manage and understand the interdisciplinary scientific issue arising around the discipline of pharmacology, chemistry, toxicology, metabolism, pharmacokinetics, pharmacy, clinical research, and statistics.<ref name="PMinR&D" /> This represents one case and, obviously, the higher the two competencies are, the better it is. [[File:BodyOfKnowledge.PNG\|300px\|thumb\|right\|Different types of Body of Knowledge. Based on "The project manager in pharmaceutical R&D"<ref name="PMinR&D" /> ]]
	In the other hand, the project manager is purely seen as a coordinator, scheduler, and operations researcher. This brings some useful strategy in an organization because some scientist feel less threatened by non-scientists’ asking question – they appear less judgmental.		In the other hand, the project manager is purely seen as a coordinator, scheduler, and operations researcher. This brings some useful strategy in an organization because some scientist feel less threatened by non-scientists’ asking question – they appear less judgmental.

S172420: /* Annotated Bibliography */

2019-03-03T20:12:41Z

Annotated Bibliography

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	'''Dowden, S. B. - The project manager in pharmaceutical R&D'''. This article outlines the environment and context in which a project manager in research and development has to work and the tasks he has to deal with.		'''Dowden, S. B. - The project manager in pharmaceutical R&D'''. This article outlines the environment and context in which a project manager in research and development has to work and the tasks he has to deal with.

			'''Bouley, J. - Prescription for success.''' This article provides information about different approaches in research & development project management. It even provides real cases in which these approaches are implemented.

	==References==		==References==
	<references/>		<references/>

S172420: /* Project Manager: role and activities */

2019-03-03T20:06:20Z

Project Manager: role and activities

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	== Project Manager: role and activities ==		== Project Manager: role and activities ==

	The role of the project manager in pharmaceutical R&D is a critical role that requires both technical and soft skills. It must be able to cope with projects that range in duration from six months to ten years or more. And while focusing on making the project successful, it also needs to be aware of the organization’s strategical goals.<ref name="PMinR&D" /> ''Dowden, S. B. (1995). The project manager in pharmaceutical R&D. PM Network, 9(5), 15–22. - Available at: https://www.pmi.org/learning/library/project-manager-pharmaceutical-research-development-4975</ref>		The role of the project manager in pharmaceutical R&D is a critical role that requires both technical and soft skills. It must be able to cope with projects that range in duration from six months to ten years or more. And while focusing on making the project successful, it also needs to be aware of the organization’s strategical goals.<ref name="PMinR&D"> "Dowden, S. B. (1995). ''The project manager in pharmaceutical R&D.'' PM Network, 9(5), 15–22. - Available at: https://www.pmi.org/learning/library/project-manager-pharmaceutical-research-development-4975</ref>

	In the following section the level of technical and management skills and the day to day activities are analysed.		In the following section the level of technical and management skills and the day to day activities are analysed.

S172420: /* Project Manager: role and activities */

2019-03-03T20:01:04Z

Project Manager: role and activities

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	== Project Manager: role and activities ==		== Project Manager: role and activities ==

	The role of the project manager in pharmaceutical R&D is a critical role that requires both technical and soft skills. It must be able to cope with projects that range in duration from six months to ten years or more. And while focusing on making the project successful, it also needs to be aware of the organization’s strategical goals.<ref name="PMinR&D" /> Dowden, S. B. (1995). The project manager in pharmaceutical R&D. PM Network, 9(5), 15–22. - Available at: https://www.pmi.org/learning/library/project-manager-pharmaceutical-research-development-4975</ref>		The role of the project manager in pharmaceutical R&D is a critical role that requires both technical and soft skills. It must be able to cope with projects that range in duration from six months to ten years or more. And while focusing on making the project successful, it also needs to be aware of the organization’s strategical goals.<ref name="PMinR&D" /> ''Dowden, S. B. (1995). The project manager in pharmaceutical R&D. PM Network, 9(5), 15–22. - Available at: https://www.pmi.org/learning/library/project-manager-pharmaceutical-research-development-4975</ref>



	In the following section the level of technical and management skills and the day to day activities are analysed.		In the following section the level of technical and management skills and the day to day activities are analysed.

S172420: /* Project Manager: role and activities */

2019-03-03T19:59:27Z

Project Manager: role and activities

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	== Project Manager: role and activities ==		== Project Manager: role and activities ==

	The role of the project manager in pharmaceutical R&D is a critical role that requires both technical and soft skills. It must be able to cope with projects that range in duration from six months to ten years or more. And while focusing on making the project successful, it also needs to be aware of the organization’s strategical goals.<ref name="PMinR&D" />		The role of the project manager in pharmaceutical R&D is a critical role that requires both technical and soft skills. It must be able to cope with projects that range in duration from six months to ten years or more. And while focusing on making the project successful, it also needs to be aware of the organization’s strategical goals.<ref name="PMinR&D" /> Dowden, S. B. (1995). The project manager in pharmaceutical R&D. PM Network, 9(5), 15–22. - Available at: https://www.pmi.org/learning/library/project-manager-pharmaceutical-research-development-4975</ref>



	In the following section the level of technical and management skills and the day to day activities are analysed.		In the following section the level of technical and management skills and the day to day activities are analysed.

S172420: /* Approaches in R&D project management */

2019-03-03T19:53:00Z

Approaches in R&D project management

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	=== Approaches in R&D project management ===		=== Approaches in R&D project management ===

	Project management provides necessary best practice, but different companies can choose among varied approaches. The three that are going to be analysed are:<ref name="~~PMinR&D~~"> ''~~Dowden~~, ~~S. B~~. (~~1995~~). ~~''The project manager in pharmaceutical R&D~~.'' PM Network, 9(5), ~~15–22~~. - Available at: https://www.pmi.org/learning/library/project-~~manager~~-pharmaceutical-~~research~~-~~development-4975''~~ </ref>		Project management provides necessary best practice, but different companies can choose among varied approaches. The three that are going to be analysed are:<ref name="Prescription"> ''Bouley, J. (2005). Prescription for success. PM Network, 19(1), 24–30. - Available at: https://www.pmi.org/learning/library/project-management-develop-pharmaceutical-products-4684</ref>

	* Many working as One – distributed project management system;		* Many working as One – distributed project management system;