Campbellsville University Methodologies into Compliance and Dossier Management Paper Paper 6 requirements: I need min of 8 pages, you will have to do 1,4 5

Campbellsville University Methodologies into Compliance and Dossier Management Paper Paper 6 requirements: I need min of 8 pages, you will have to do 1,4 5,6 and 9 portions from the attached pic under SEQUENTIAL ORDER. Literary references are required for the literature review in this paper.At least 10 literary references are required for the literature references alone. where ever it is, please include your references or citations APA style 6 or 7.

Paper 7 requirements: I need min of 10 to 12 pages and it should be rest of the contents under SEQUENTIAL ORDER.

Paper 8: This paper has to be the combination of paper 6 and 7 plus more information under each section (IN TOTAL 20 PAGES). (You can refer to the PDF paper). PLEASE DO NOT COPY PASTE ANYTHING FROM THAT PAPER BUT YOU CAN USE FEW CITATIONS FROM THAT. DIAGRAMS AND CHARTS ARE IMPORTANT

TOPIC: Inculcating Agile-Leanmethodologies into compliance and Dossier management for regulatory projects.

NOTE: CITATIONS ARE IMPORTANT

you can take some citations and references from the attachments I sent you or where ever you feel you will find peer-reviewed citations. Let me know if you have any questions.

NOTE: I NEED 3 SEPARATE PAPERS. PLEASE LET ME KNOW IN CASE OF ANY QUESTIONS Harrisburg University of Science and Technology
Digital Commons at Harrisburg University
Dissertations and Theses
Project Management (PMGT)
8-2017
The Implication of Agile & Traditional Method as a
Practice in Pharmaceutical Industry
Vishant Shah
Harrisburg University of Science and Technology
Follow this and additional works at: http://digitalcommons.harrisburgu.edu/pmgt_dandt
Part of the Management Information Systems Commons, and the Management Sciences and
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Recommended Citation
Shah, V. (2017). The Implication of Agile & Traditional Method as a Practice in Pharmaceutical Industry. Retrieved from
http://digitalcommons.harrisburgu.edu/pmgt_dandt/15
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PROGRAM: ISEM, PROJECT MANAGEMENT, LEARNING TECHNOLOGIES
PROPOSAL FOR MASTER THESIS OR APPLIED PROJECT
TITLE: THE IMPLICATION OF AGILE & TRADITIONAL METHOD AS A PRACTICE
IN PHARMACEUTICAL INDUSTRY
AUTHOR NAME: VISHANT SHAH
Date:
1
Table of Contents
Abstract …………………………………………………………………………………………………………………………. 1
keywords: ………………………………………………………………………………………………………………………. 3
1. Introduction ………………………………………………………………………………………………………………… 4
2. Problem Statement and Justification ……………………………………………………………………………….. 7
3. Literature Review — Analysis of Related Work ………………………………………………………………. 12
4. Proposed Solution Approach …………………………………………………………………………………………. 4
5. Work Plan ………………………………………………………………………………………………………………….. 5
References
Appendices
2
ABSTRACT
Traditional Project Management theory followed by Pharmaceutical industry since decades
needs to be revitalized with implication of some modern ideas and techniques. Macro economy
parameters such as government rules, regulation and economic stability is been changing the outset
of the industry from time to time. Project Management approach followed by pharmaceutical
industry needs to be revitalize, more adaptive and more agile to counter fit the changing needs.
Effective pharmaceutical project management enables new medical discoveries to reach us
sooner and, perhaps, at less cost. To that extent, researchers and practitioners of project
management art and science influence the treatment of disease and maintenance of health
worldwide. Their process, therefore, deserves our close attention
KEYWORDS:
Few Keywords: Examples — Pharmaceutical Project Management, Agile with Traditional.
3
1. INTRODUCTION (2-4 PAGES)
Pharmaceutical industry has provided many valuable break through, such that their
presence can be felt in everyday life. Life saving drug are being developed but the time to
the market has its own definition. New Drug Development is a process that goes through
various stages proper management with right direction and right resources will prove to be
more beneficial and will help to reach out to it end users more quickly and more effectively.
The adaptation in the mid-1960s of some of these “new” project management
philosophies, organizational forms, procedures and tools by some leading health-care
companies marked the beginning of the current era of pharmaceutical R&D project
management, Staples, et al., 1989.
Projects usually involve a high volume of manpower, financial and emotional
investments. According to the old business rule efficiency multiplied by effectiveness leads
to excellence. This paper will give an insight of newly adopted Agile methodology and how
it can be incorporated within pharmaceutical industry that is so versatile and diverse which
in turn can increase the productivity and minimize the cost, reduce overhead of unwanted
processes. There are many instances where pharmaceutical industry does need this agility
to be incorporated into traditional approach especially during development of new drug.
Agile method has proven its value and has contributed to the success of software
industry to roll out software projects on the fly. Fundamental concept of Agile describes the
agility of an organization and its process to adapt to changes. The aim is to encounter the
defects at early stages and to concentrate on possible areas of improvement during the
development which accelerates the product development by eliminating defects and
4
enhances product delivery time and quality to the market. Pharmaceutical industry has
always been striving to keep up the product quality.
Pharmaceutical drug development is combination of various functional sections or
groups within the pharmaceutical organization. Diagram portrays overview of high level
organizational structure of overall development team.
Figure: 1 Organizational Over view of pharmaceutical development, Christopher D.
Breder, 2012
Pattanaik Asima (2014) underlines challenges involved in project management in the
pharmaceutical industry; she identifies key players involved in project management which are
Project Manager, Functional Manager, Upper Management and Project team members. Paper
highlights challenges encountered by project manager in pharmaceutical industry which are
resource limitation, cross-functional team management, institution processes, cultural differences
and customer management. Pattanaik, Asima (2014) underlines that resource limitations are one of
the major concerns in project execution.
5
The basic process of pharmaceutical drug development is a long process that stretches
across the time of 15 years and can be visualized as under. At various stages there are various
groups of people involved and with traditional project management it becomes difficult to keep
track of all activities and areas of focus
Figure: 2 Outline of various activities and phases of New Drug Development,
The PMI Pulse of the profession capturing value of project management in their February
2015 publication have outlined that organization with agility have more success rate and have
achieved their business goal with project outcomes. Their research concluded the numbers as
shown in picture below.
6
Figure: 3 Agility and Project Outcomes, PMI Pulse, 2015
PMI Pulse publication of February 2015 indicates that Agility may also be linked to profitable
growth: Research conducted at the Massachusetts Institute of Technology suggests that agile firms
grow revenue 37 percent faster and generate 30 percent higher profits than non-agile companies
PMI Pulse, 2015. This further extends the interest of research reach area.
The paper describes how the use of agile project management (APM) in accordance with
traditional project management enables enhancement the new drug development in pharmaceutical
industry. Tools and practices from APM such as iterative development; the use of artifacts such as
boards, panels and sticky-notes, (Highsmith, 2004; Chin, 2004; Augustine, 2005, Boehm &
Turner, 2004) in conjunction with traditional approach proves to reduce the time and enables to
concentrate on focus area.
2. PROBLEM STATEMENT AND JUSTIFICATION (1-3 PAGES)
2.1 Clear statement of the problem
Project management methodology that has been vastly followed through decades by many
industries along with pharmaceuticals industry has been traditional approach. Since traditional
7
methodology has proven its success in the past its essence are been found in modern day project
management as well. But rapid and drastic changes in the surrounding does call for revamp of the
ancient methodology by introduction of modern day philosophy of successful mantra. It has been
said that old experience with new thinking is always a right mantra for success; hence modern day
winning team combines people with vast old school experience people with modern day computer
savvy less experienced people. Hence to reflect this mantra in pharmaceutical project management
current thesis will enlighten our thought process on revamping of traditional methodology by
introduction of modern day agile project methodology.
2.2 Why it should be solved (justification)
Pharmaceutical project management is quite challenging. There is a vital uncertainty that
prevails internally and externally, at macro level and at micro level. Every pharmaceutical company
either big or small, brand or generic are striving hard to bring new drug to the market which are
beneficial to patient and can prove profitable to the drug manufacturing company. Delivering
Quality product safely, quickly and cheaply is mantra for pharmaceutical firm to be successful.
The drug manufacturing processes involves lot of complexes from laboratory to market
shelf. Process involves technical development team using quality by design, drug evaluation and
regulatory process team, clinical studies team and supply chain team. Project proves to be
successful if all these teams communicate and coordinated among themselves during drug
manufacturing process. Normally it takes more than 5 – 10 years for successful manufacturing of
new drug, during this time frame inherent uncertainty during drug evolution and many
circumstantial factors change the course of the project which may lead to failure if not tackled in an
appropriate timely manner. Coordination between many internal functional group such as R&D,
8
regulatory, legal, finance, supply chain, sales, and marketing, as well as external partners. The
efficiency in coordination between different functional groups is crucial.
Uncertainty in pharmaceutical industry has been vital key player that contributes to the fact
and increase the gap since most of the new invention are based on the assumption, it requires a
continuously evolving, knowledge-based ecosystem utilizing user feedback to improve.
Assumption changes as and when information becomes available which changes the course of the
project and the management of that project as new hurdles are been encountered. Hence to have
prevailing team that compromises of expert from various streams under single roof becomes more
relevant. AGILE philosophy enables the team to act together on any obstacle or hurdle during their
small sprint and resolve it much quicker obsoleting the condition of project or product failure.
Project management becomes challenging due to known and unknown risks. Traditional
project management technique where Program Evaluation and Review Technique (PERT), Gantt
chart techniques help in identifying risk and develop plan for mitigating of known risks. Unknown
risk which can staggered your entire project can be crucial at time; it can be handled through
formation of proper team of right members, addressing it at each and every stage and building it
into the product. This is possible through inclusion of AGILE methodology along with traditional
methodology.
According to a survey of the Standish Group, $80 -145 billion per year is spent on failed
and cancelled projects
[1]
. Forrester Research indicates a 66% project failure, costing U.S.
businesses at least $30 billion every year
[1].
According to the Meta Group, 60% – 80% of project
failures can be attributed directly to poor requirements gathering, analysis, and management
[1]
.
Improving these performance records is essential for any organization. However, if traditional
9
project management is ineffective, it is necessary to research other methods of managing and
delivering projects. This is where agile methods come into play [2].
2.3 What will be the deliverables?
The purpose of this thesis is to show that agile project methodology when used in
conjunction with traditional project management can prove to be more effective in accomplishment
of the new drug development in pharmaceutical industry.
Thesis will mainly focus on using agile tool to revamp traditional project management practices
that is been followed by pharmaceutical industry to avoid any project failure in development of new
drug.
Our research objectives are
•
To understand the new product development cycle/stages in pharmaceutical industry and
important area of project management.
•
To understand main characteristic and differences between Traditional and Agile project
management Methodologies
•
To understand WBS involved during the new product development and club agile tools
during various stages of traditional project management.
•
Thesis will also discuss the success of HYBRID project management in various industry
along with pharmaceutical industry.
•
Thesis will also conclude some observation from daily life pharmaceutical industry.
2.3 Type of work: behavioral research, building an artifact, applied study
Thesis will present Qualitative research on agile methodology being implemented with
traditional project management often called as hybrid. It will include literature review, interviews,
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Case study analysis followed by evaluation and conclusion. The outlay of the research foundation
will be:
Problem Statement
Explanation of Various Methodology
Literature Review
Research Question
Interviews and Analysis
Case Study Analysis
Evaluation & Conclusion
Figur: 4 Research Over view Chart.
Limitation of Research
The research paper will be limited to defining various agile methodology tools that can be
included within traditional project management to improve the current traditional project
management practices. Projects will not emphasis on adoption of AGILE methodology by a
pharmaceutical organization or implementation of AGILE methodology to replace current
traditional methodology. Thesis will be limited to define some methodologies from Agile that can
be easily implemented into traditional format for better project management within pharmaceutical
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3. LITERATURE REVIEW — ANALYSIS OF RELATED WORK (4-5 PAGES)
3.1 Conducting further Literature review
Literature review will help us to understand the existing area of research. Literature review
will emphasis on some of the work and ideas that has been conducted by experts in the field of
pharmaceutical project management. The literature review will be focused on the following aspect:
•
Pharmaceutical Project management.
•
Traditional and existing Pharmaceutical project management and its approach in new drug
development
•
Challenges of traditional project management methodology during new product
development in pharmaceutical industry, this will help us to understand some of the major
setback that are been encountered and calls in for solution.
•
Success & failures of agile product management methodology in pharmaceutical new drug
development.
•
Prospects of hybrid methodology in pharmaceutical new drug development.
3.2 Pharmaceutical Project Management
New drug development is a process which involves multiple resources. As per,
Pharmaceutical Manufacturers Association (PMA) estimates that current cost to develop a drug in
US is between 97-125 million dollars, Murphy, P. L. (1989). Traditional Project management has
flourished in highly regulated environment of pharmaceutical industry where predominantly black
and white documentation has been a key feature. Regulated environment refers to the law and
regulation that has been developed by various countries federal, state and local government body in
12
order to control and protect business trades and practices to protect people. It also establish certain
norms that should be followed in best interest to keep quality of the product intact and establish a
standard procedure called as GxP (Good manufacturing practices) which is trade secret of being
best in pharmaceutical industry.
Pharmaceutical new drug development project team consists of four major group Clinical,
Non-Clinical, Regulatory, Chemistry Manufacturing and Controls.
Figure: 5 Pharmaceutical Project Team, Christopher D. Brede 2011
Each of these groups is further divided into diversified sub-groups which are focused on
individual functionality areas of new drug developmental studies. Figure: 6 explain functionality of
these individual groups in area of new drug development.
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Figure: 6 Team at First Level, Christopher D. Breder, 2011
Each of these subgroups are further divided into individual functional teams which work on
day to day project activities for new drug development project, activity of one of such functional
team is highlighted below.
Figure: 7 Clinical Development Project Team, Christopher D. Breder, 2011
Research paper by Tanzeena Sara(2012), explains that Pharmaceutical project management
emphasizes on six elements of project management, Project definition, Project team and
organization, Project planning, scheduling and control, Problem solving and decision making using
proto-type, Senior management review and control, Proactive and real time change management.
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Paper further explains core objective of pharmaceutical project management are
management/authority, development, registration, supply chain, QA, patent, market. Figure:8 is
visualization of pharmaceutical project management core objective.
Figure: 8 Objects of a Pharmaceutical Project Management, Tanzeena Sara2012
Tanzeena Sara (2012) in her work described role of each above objects Management/
Authority will run the project, development department develop the product through galenical,
analytical, clinical study etc, registration is required for the launching of the product which will do
the respective department, supply chain department will provide raw material necessary for the
development through active and excipient sourcing, QA will assure the quality of the product
according to marketing authorization and marketing department will deal with the market to launch
the product. To make product successful all objects of management have to be performed within
time frame & budget.
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3.3) Comparing existing methods that address the general area of thesis problem statement:
Traditional, water fall methodology has been followed since the evolution of project
management methodology. The term Waterfall refers to the sequential nature of project phases,
with each phase starting as another ends. There are supporters and critics of this approach to
Project Management. PMBOK [4] defines the traditional project management as ‘a set of
techniques and tools that can be applied to an activity that seeks an end product, outcomes or a
service’.
Pharmaceutical industry had adopted project management since early 1960s but scope of
its practice extended during mid of 1960s. One of the classic example of traditional project
management explained in article by Staples, et al., 1989 was breakthrough of VAS-OTEC
hypertension drug in 1979 by one of the leading drug manufacturing company MERCK, was
remarkable. The history of this drug dictates that it was first marketed in United States six years
after drug initiation of the development cycle. The article by Staples, et al., 1989 further describes
how MERCK laid emphasis on waterfall methodology with more comprehensive approach to
project management with which it was able to meet and at time surpass its project goal.
Article by Staples, et al., 1989 further explains that the massive development effort that
transformed the active new chemical entity into a FDA-approvable New Drug Application (NDA)
was accomplished in just over four years, about 20-40% faster than the indus…
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