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Project Management
for the Pharmaceutical Industry
Strategic Drug Development Projects
and Roles of Regulatory Affairs Teams

Study Program: CAS Regulatory Affairs in Life Sciences

Author: Dr. Johanny Pestalozzi

Evaluator: Dr. Yan Lachat

Project Sponsor: Bern University of Applied Sciences (BFH)

© Photo by Alvaro Reyes on Unsplash

Expert:
Berner Fachhochschule | Haute écoleDr. rer. nat.
spécialisée Barbara
bernoise Jentges
| Bern University of Applied Sciences

Date: 27.03.2020
Abstract
Stakeholders of the pharmaceutical industry deal with multiple complex and competing tasks
throughout the life cycle of a drug product. The application of project management procedures in
the pharmaceutical industry facilitates achieving the diverse goals of this business sector, such as
discovering safe and effective drugs, successfully complying with rigorous and diverse regulatory
requirements and maximizing the return on investment of marketed products, which ultimately
increase the business value of pharmaceutical organizations. Based on a systematic literature
review, the aim of this report is to describe key elements of project management and explain their
application to the pharmaceutical industry, together with selected project management tools. This
study emphasizes the role of regulatory affairs teams within the stages for drug generation, and
complementarily describes strategic aspects for designing drug development projects.

Zusammenfassung
Stakeholder der Pharmaindustrie befassen sich während des gesamten Lebenszyklus eines
therapeutischen Produkts mit mehreren komplexen und konkurrierenden Aufgaben. Durch Einsatz
von Projektmanagementverfahren können die vielfältigen Ziele der Arzneimittelindustrie effektiver
erreicht werden. Dazu zählen die Entdeckung sicherer und wirksamer Medikamente, die Einhaltung
strenger und vielfältiger regulatorischer Anforderungen sowie die Maximierung des Returns on
Investment vermarkteter Produkte, was letztendlich den Geschäftswert von Pharmaunternehmen
erhöht. Basierend auf einer systematischen Literaturrecherche zielt dieser Bericht darauf ab,
Schlüsselelemente des Projektmanagements zu beschreiben und die Anwendung ausgewählter
Werkzeuge im Bereich der Pharmaindustrie zu erläutern. Der Schwerpunkt dieser Studie liegt auf
der Rolle von Regulatory Affairs-Teams in einzelnen Phasen der Arzneimittelentwicklung. Darüber
hinaus werden strategische Aspekte für die Entwicklung von Pharmaprojekten erläutert.

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Table of Contents

ABSTRACT ............................................................................................................................................................ 2
ZUSAMMENFASSUNG .......................................................................................................................................... 2
TABLE OF CONTENTS ............................................................................................................................................ 3
LIST OF FIGURES AND ATTACHMENTS................................................................................................................... 4
ABBREVIATIONS ................................................................................................................................................... 5
CHAPTER 1. INTRODUCTION ............................................................................................................................. 6
CHAPTER 2. METHOD ........................................................................................................................................ 8
CHAPTER 3. RESULTS/LITERATURE REVIEW ....................................................................................................... 9
3.1 PROJECT MANAGEMENT IN PHARMACEUTICAL ORGANIZATIONS: CONCEPTS, BENEFITS, PROCESS, AND STAKEHOLDERS .................9
3.1.1 Definition of Project and Conceptualization of Project Management ..........................................................9
3.1.2 Relevance of Project Management in the Pharmaceutical Industry ...........................................................10
3.1.3 Model for a Pharmaceutical Project Management Process ........................................................................11
3.1.4 Stakeholders in Pharmaceutical Project Management ...............................................................................13
3.2 STRATEGIC CONCEPTS FOR DESIGNING DRUG DEVELOPMENT PROJECTS .............................................................................15
3.2.1 Conceptualization of Strategy and its Benefits in Pharmaceutical Project Management...........................15
3.2.2 Key Elements in the Elaboration of Strategic Pharmaceutical Projects ......................................................16
3.3 DRUG DEVELOPMENT PROJECTS AND ROLES OF REGULATORY AFFAIRS TEAMS .....................................................................18
3.3.1 Drug Development Process and Regulatory Affairs Roles ...........................................................................18
3.3.2 Teams in Regulatory Affairs Supporting Drug Development Projects ........................................................22
CHAPTER 4. DISCUSSION ................................................................................................................................. 24
CHAPTER 5. CONCLUSIONS ............................................................................................................................. 25
REFERENCES ....................................................................................................................................................... 26
ATTACHMENTS .................................................................................................................................................. 27
ABOUT THE AUTHOR .......................................................................................................................................... 38

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List of Figures and Attachments

Figures
FIGURE 1. CONTENT STRUCTURE OF THE LITERATURE REVIEW ........................................................................................................7
FIGURE 2. METHODOLOGICAL APPROACH FOLLOWED IN THIS STUDY ...............................................................................................8
FIGURE 3. CHANGING CONDITIONS IN ORGANIZATIONS BY THE INFLUENCE OF PROJECTS ......................................................................9
FIGURE 4. CASES OF CHALLENGING ASPECTS THAT LEAD TO THE CREATION OF PROJECTS ....................................................................10
FIGURE 5. MODEL FOR PHARMACEUTICAL PROJECT MANAGEMENT ...............................................................................................11
FIGURE 6. RELEVANT CONCEPTS IN PHARMACEUTICAL PROJECT MANAGEMENT ...............................................................................13
FIGURE 7. EXTERNAL STAKEHOLDERS INFLUENCING PHARMACEUTICAL PROJECT MANAGEMENT ..........................................................14
FIGURE 8. INTERNAL STAKEHOLDERS INFLUENCING PHARMACEUTICAL PROJECT MANAGEMENT ...........................................................14
FIGURE 9. PROJECT MANAGEMENT IN SPECIALIZED PROJECT TEAMS..............................................................................................14
FIGURE 10. HELICOPTER VISION IN ALLUSION TO STRATEGIC THINKING IN PHARMACEUTICAL PROJECTS ................................................15
FIGURE 11. PHASES OF DRUG DEVELOPMENT AND MAIN ROLES OF REGULATORY AFFAIRS PROJECT TEAMS ............................................18
FIGURE 12. MODEL OF A COMMON PRODUCT LIFE CYCLE............................................................................................................19
FIGURE 13. COMMON STRUCTURE OF RA PROJECT TEAMS..........................................................................................................23

Attachments
ATTACHMENT 1. OUTLINE OF THE PROJECT INTEGRATION MANAGEMENT .....................................................................................27
ATTACHMENT 2. ESSENTIAL TASKS IN DRUG DEVELOPMENT PROJECTS – CASE OF CHRONIC ORAL DRUG THERAPY....................................28
ATTACHMENT 3. OVERVIEW OF A TARGET PRODUCT PROFILE – CASE OF KNEE SURGERY PATIENTS ......................................................29
ATTACHMENT 4. OUTLINE OF AN INTEGRATED DEVELOPMENT PLAN FOR STRATEGIC PHARMACEUTICAL PROJECT MANAGEMENT ..............31
ATTACHMENT 5. DETAILS OF PHASES FOR CLINICAL TRIALS ..........................................................................................................32
ATTACHMENT 6. ROLES OF THE REGULATORY AFFAIRS TEAM IN THE SUBMISSION OF A LARGE DOSSIER .................................................33
ATTACHMENT 7. GANTT CHART TO TRACK PHASES OF PHARMACEUTICAL PROJECTS ..........................................................................34
ATTACHMENT 8. FISHBONE ANALYSIS FOR ASSESSING RECRUITMENT CHALLENGES IN CLINICAL TRIALS ..................................................35
ATTACHMENT 9. PROJECT OPTION GRID – CASE OF IN-HOUSE VERSUS OUTSOURCING CLINICAL TRIALS .................................................36
ATTACHMENT 10. RISK MATRIX ANALYSIS FOR EVALUATING PHARMACEUTICAL PROJECTS ..................................................................36
ATTACHMENT 11. UNCERTAINTY-IMPORTANCE GRID IN THE ANALYSIS OF CONDITIONS FOR LAUNCHING A NEW DRUG ............................37
ATTACHMENT 12. MEANS TO ENSURE DRUG PRODUCT OWNERSHIP .............................................................................................37

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Abbreviations

ADME Absorption, distribution, metabolism, and excretion

API Active pharmaceutical ingredient

CRO Contract Research Organizations

CTD Common Technical Document

FDA Food and Drug Administration

GCP Good Clinical Practice

GCPT Global Core Project Team

IDP Integrated development plan

IMPD Investigation Medicinal Product Dossier

IND New investigational drugs

IPT International Project Team

IRB Institutional Review Board

MAA Marketing Authorization Application

PIM Project Integration Management

PM Project management

PMI Project Management Institute

PMS Postmarketing surveillance

RA Regulatory affairs

SmPC Summary of product characteristics

SoA State of the art

TPP Target Product Profile

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Chapter 1. Introduction
The development and commercialization of pharmaceutical products entail multiple competing,
complex, and especially highly expensive tasks. Between the 2000s-2010s, pharmaceutical orga-
nizations had estimated costs of US$ 2.5 billion for the development of a new drug (DiMasi et al.,
2016). This is a significant increase in comparison to US$ 179 million that used to be spent for
the same purposes between 1970-early 1980s (DiMasi et al., 2016). From the current budget,
investment for clinical trials represents the largest share, requiring up to 50% of the drug
development capital. Phase III is continuously the most expensive activity in pharmaceutical
investments, covering up to 29.9% of the budget (EFPIA, 2019). Obtaining a functional drug also
takes 10-15 years, requiring screening over 10,000 substances (Pattanaik, 2014).
This costly, meticulous, and prolonged endeavor evidences the need for strategic planning, careful
execution, and continuous evaluation for improvement in the pharmaceutical industry, in order to
optimize performance and assure correct investment. Activities in the pharmaceutical sector also
require the intervention of diverse stakeholders. Finding a suitable drug involves dense
interactions between wide-ranging business functions, which include R&D, regulatory, financial,
supply chain, legal, sales, and marketing teams, among others (Pattanaik, 2014). Moreover,
significant coordination efforts are needed to ensure compliance of the drug product and its
development, in light of stringent regulatory requirements.
Besides the financial, regulatory, and coordination challenges in the pharmaceutical industry, there
are rising external transformations that urge this sector to swiftly find strategic management
approaches in order to remain competitive. Some of these transformations capable of impacting
the entire life cycle of a product are i) emerging novel, complex, and costly treatments, such as
combination therapies, nutrigenomics, gene editing, and digital treatments; ii) fast-paced changes
in regulatory requirements with recurrent delayed feedback and influence the strategies for drug
development, production, and regulatory submission processes; and iii) both regulators and
patients are increasingly adopting computerized & real-time data management technologies, such
as machine learning and robotic process automation (Deloitte, 2018).
In order to confront growing challenges, develop effective & safe drug products in the market and
guarantee optimal return on investment, pharmaceutical organizations require systematic and
established planning, execution, monitoring and control procedures, and tools.
Project management comprises a series of techniques to methodically address the individual tasks
of a planned endeavor (project), in order to achieve the desired outcome within given boundaries
(e.g., limited time and capital) aiming at increasing value in organizations. Drug development
projects are key processes of the pharma industry but are complex in nature and evidence the
need for establishing project management strategies to successfully perform tasks and achieve
overall business objectives in pharmaceutical organizations.
In this context, the aim of this study is to explain the essential elements of project management
techniques and their application in the pharmaceutical sector. The focus lies on the description of
the stages of drug development projects and the roles & structure of regulatory affairs teams along
this process. Complementarily, relevant aspects of strategic drug development projects are
characterized.
This study has been formulated based on the following research questions:
1. How can project management be applied to pharmaceutical business functions? What are
key benefits, processes, and actors involved?
2. What elements are of relevance for the design of strategic drug development projects?
3. What are common project activities in drug development? And what are the essential
roles of regulatory affairs teams along this process? How are these teams structured to
enable the successful development and commercialization of therapeutic products?
Figure 1 shows the structure and content of the study, guided by the research questions.
Chapter 1 covers the introduction, depicting the rationale of the subject, Chapter 2 describes
the method applied, Chapter 3 presents the details of the literature review, Chapter 4 provides a
discussion of the topics presented, and Chapter 5 contains the conclusions of the study.
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Project Management Fundamentals: Application to the
Pharmaceutical Industry

•Concept of project & project management (PM)


•Relevance of PM in the pharma industry
•Model for pharma PM processes
•Stakeholders influencing pharma PM

Strategic Aspects for Designing Drug Development Projects

•Concept of strategy
•Benefits of strategic thinking in pharmaceutical PM
•Key strategic elements for planning drug development projects

Process of Drug Development Projects and Roles of RA Teams

•Process of drug development projects & activities of regulatory affairs teams


•Structure of RA teams supporting drug development

Figure 1. Content structure of the literature review

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Chapter 2. Method
This study was performed as desk research, thoroughly and systematically identifying,
categorizing, and analyzing relevant literature (based on year of publication and legitimacy of
source) on the subjects of pharmaceutical project management and regulatory affairs tasks in drug
development projects. The content was narrowed down, based on the drafted research questions.
References on the general concept of project management were also consulted, in order to provide
a framework for the content of the investigation.
Literature identification
The following sources were consulted for the literature collection:
• Specialized books
• Google Scholar and results from Google search
• Open-access pharmaceutical regulatory affairs journals
• Publicly available regulatory intelligence reports of major consulting organizations such as
Deloitte, McKinsey, PricewaterhouseCoopers, and KPMG
Key phrases in the consultation of these sources were used, which include among others: project
management, regulatory affairs, and pharmaceutical project management strategy.
Literature categorization
Once relevant literature was collected, the author carefully revised the content and grouped the
sources within three major sub-topics that reflect the structure of the present manuscript:
(1) Concept of project management and its relevance in the pharmaceutical industry
(2) Strategic aspects for designing drug development projects
(3) Process of Drug development Projects and the role of regulatory affairs teams
Literature analysis & writing
The author meticulously read the literature and marked relevant statements that aid in answering
the research questions of the present study. Once the literature consulted was distributed within
the defined sub-topics of the investigation, the author proceeded to draft the literature review.
In the discussion section, the author assesses the literature in light of the guiding research
questions, leading the discussion on the benefits of applying concepts of project management in
the pharma sector and the activities of regulatory affairs teams along the drug development
process. Figure 2 illustrates the individual steps in writing a review manuscript as described by
Mayer (2009). This reference served as a framework for defining the methodological approach of
this investigation.

Explore the literature, Read, evaluate, and Indicate scope of each


narrow down topic classify literature paragraph
and research scope (outline headings) per section

Draft methods, body, Check citations and


Elaborate tables,
conclusions, references, edit and
figures, etc.
introduction, abstract revise layout

Figure 2. Methodological approach followed in this study


Source: Mayer (2009)

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Chapter 3. Results/Literature Review

3.1 Project Management in Pharmaceutical Organizations: Concepts, Benefits, Process, and


Stakeholders
Fundamental aspects of project management are illustrated in this section, and their relevance for
the pharmaceutical industry is clarified. A model for pharmaceutical project processes is included
in addition to a succinct identification of key stakeholders that influence pharmaceutical projects.

3.1.1 Definition of Project and Conceptualization of Project Management


The term project has been traditionally defined as a multifaceted group of operations aimed at
achieving a carefully planned outcome within a defined timeframe and budget (Brown and Grundy,
2011). Alternatively, The Project Management Institute (PMI), a globally leading organization of
project management specialists, defines the term project as “a temporary endeavor undertaken
to create a unique product, service, or result”. The PMI breaks down the key concepts embedded
in the project concept (PMI, 2017):
• Distinctive goods, services or outputs: projects are performed to accomplish specific
objectives with defined quantifiable or unquantifiable results, e.g., generating a new drug
product, getting approval for changes in a marketed drug, acquiring knowledge on
competitors on a particular therapy or geography, etc.
• Time-limited task: projects are characterized by having a well-defined start and end. The
completion of a project is achieved when, e.g., aims have been reached, capital is depleted,
or when due demand ceases.
• Steer change: in the implementation of a project, organizations move from a “current state”
to a “future” (desired) state, attaining the specified goals. Figure 3 depicts the
transformational nature of projects within organizations, increasing value with respect to
time.
• Facilitate generating business value: projects generate measurable profit to business
stakeholders, such as increased assets, improved reputation, advantageous networks, etc.

Figure 3. Changing conditions in organizations by the influence of projects


Source: PMI (2017)
Projects originate in the need for mechanisms to deal with challenging aspects that affect the
feasibility and the growth of an organization. The management of these aspects is inherently
connected with the business benefit of a project and the strategic goals of the overall business
(PMI, 2017).

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According to the PMI’s guideline on project management, the external and internal challenging
aspects that lead to the creation of projects can be grouped within four rationales (PMI, 2017): i)
compliance with regulations, or societal demands, ii) fulfillment of business partner’s expectations
or requests, iii) adoption or transformation of corporate policies or changes in operational
processes, and iv) development, upgrade, or adjustment in manufactured goods, functions, or
services. Figure 4 shows an overview of instances that lead to the generation of projects in
companies.

Figure 4. Cases of challenging aspects that lead to the creation of projects


Source: PMI (2017)
A project is composed of multiple systematically combined activities that need to be purposefully
coordinated to achieve the stated goals of the endeavor. In this regard, project management refers
to “the application of knowledge, skills, tools, and techniques to a broad range of activities in order
to meet the requirements of a particular project” (Kennedy, 2008; PMI, 2017).
In other words, project management refers to the task of systematizing means to make sure that
projects are completed within planned timeframes, budget, extent, and quality (Sara, 2012).

3.1.2 Relevance of Project Management in the Pharmaceutical Industry


Project management facilitates organizations to achieve their business goals, by executing their
activities proficiently. Project management techniques benefit pharmaceutical business processes
(Brown and Grundy, 2011):
• Identifying crucial business project goals, scope, and by specifying their
interdependencies
• Focusing on the ultimate business value
• Determining crucial intermediate actions (sub-projects)
• Keeping schedules on track and facilitating means
• Assessing challenges & incertitude, and identifying alternatives to handle them
• Coordinating stakeholders to leverage on opportunities

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These activities aid pharmaceutical companies with the following (Brown and Grundy, 2011), e.g.:
• Launching the appropriate products in the correct moment (competitive advantages)
• Boosting the probability of product success (e.g., ensuring market approval)
• Accomplishing commercial goals and fulfilling stakeholders’ financial projections
• Maximizing the benefit of resources and proficiently handling risks
In summary, project management helps organizations facing constrained resources, limited time,
reduced budgets, and fast-evolving technologies, to keep afloat, remain competitive, and continue
generating business benefits (PMI, 2017).

3.1.3 Model for a Pharmaceutical Project Management Process


Brown and Grundy (2011) have proposed a model for project management in the pharmaceutical
sector that encompasses five major steps:
(1) Project definition
(2) Establishment of the project strategy
(3) Thorough project planning
(4) Execution and monitoring
(5) Evaluation and lessons learned
Figure 5 illustrates the steps for project management in the pharmaceutical sector as proposed by
Brown and Grundy (2011). As indicated in that graph, projects need to be revised and adjusted on
a regular basis, and potential challenges require to be assessed early in the development of any
task. For executing projects, these activities a single person, a group, a specific business
department, or various departments of different organizations that may be involved (PMI, 2017).

Figure 5. Model for pharmaceutical project management


Source: Brown and Grundy (2011)
The following paragraphs give a brief description of the individual tasks in this model (Brown and
Grundy, 2011):
Project definition
This step includes:
• Assessing potential hurdles as well as chances of success that initiate the creation of the
project, e.g., need of a proper IT tool to report clinical trials
• Determining the project framework and specialization, e.g., geographies/characteristics
of patients to design the clinical trials
• Identifying areas of connectedness with other projects, phases of drug development, or
business units
• Specifying the fundamental goals of the project, e.g., what segment of the market the
drug is meant to cover?
• Distinguishing the stakeholders involved in the project and possible reactions, e.g., the
media’s response to certain clinical trials
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Definition of the project strategy
This step includes:
• Thoroughly clarifying inner and outer conditions for the development of the project
• Defining essential strategic targets of the project
• Identifying tactical alternatives in what and how to perform certain activities
• Developing an initial assessment of the project’s relevance and potential challenges in
execution
• Detailed analysis of essential roles among stakeholders and evaluating factors
determining their performance
Thorough project planning
This step includes:
• Comprehensively identifying essential tasks/subsequent actions required to fulfill the
project objectives
• Examining the interconnection of the individual tasks in a systematic manner, and
consideration of susceptible stages
• Assessment of major risks, elaboration of concepts to counteract possible undesired
events in the course of the project, and elaboration of sensitivity analyses
• Estimating the project’s budget & timeline, identifying economic worth and expenses of
the planned endeavor
Execution and monitoring
This step includes:
• Clearly stating milestones and duties within the team
• Realization of activities and application of strategies to handle challenges encountered
• Regularly evaluating project performance, schedule and use of further resources
• Continuous assessment of the project’s target and strategy, to certify the actual
completion of the project’s goals
Evaluation and lessons learned
This step includes:
• Reviewing the project to evaluate if milestones were overall fulfilled, if the work
procedure was suitable, if the project was properly communicated, etc.
• Examining areas of improvement for the overall project management – in pharma, R&D
(especially clinical trials) are rarely reviewed for lessons learned, costing a vast amount of
money to organizations
Pattanaik (2014) considers separate steps in pharmaceutical project management, namely: scope
management, schedule & cost planning and control, stakeholder & team management, regulations
vigilance and conformity tactics, ecological footprint schemes, and risk management. Pandya
(2017) includes quality assurance and global project implementation and coordination.
Some challenges emerging in the management of projects in the pharmaceutical sector include
constrained resources, complex cross-functional team coordination, bureaucratic procedures,
cultural differences, and challenges in the fulfillment of customers’ expectations (Pattanaik, 2014).
In light of growing business uncertainty, strong interdependencies, difficult allotment of assets,
and significantly complex structures, Brown and Grundy (2011) propose the integration of four
notions within project management practices in the pharmaceutical sector, as shown in Figure 6.
These relevant aspects to consider in pharmaceutical project management include (Brown and
Grundy, 2011):
• Strategic analysis: e.g., assessing conditions to access new drug markets, aspects to win
a competitive stance in a specific region to introduce a drug, opportunities for strategic
investment (e.g., R&D, training, marketing, etc.), enabling cooperation among different
corporate units., etc.

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Figure 6. Relevant concepts in pharmaceutical project management
Source: Brown and Grundy (2011)

• Operational analysis: e.g., enhancing performance in business functions (e.g., improve


clinical trials), addressing work restrictions (e.g., in supply, IT support, communication,
etc.), streamlining work procedures, accomplishing top-notch operational criteria,
implementing advanced processes (e.g., digitalization and automation).

• Organizational analysis: e.g., appraising existing skills to build on them or to create new
ones to improve performance, strengthening team-work (e.g., to gain from diversity),
fostering organizational accessibility and agility, streamlining procedures, etc.

• Financial analysis: e.g., increasing net present value, return on investment, on sales, or
on margins, lessening over-expenses, etc.
The combination of the different procedures, analyses, and tasks of project management, to report
to the Project Management Process Groups, is called Project Integration Management (PIM). This
serves as a means to characterize, summarize, communicate, and interconnect project activities
across various teams (PMI, 2017).
PIM assists in the assignment of assets, deciding on competing requirements, evaluating options,
adjusting procedures to fulfill business goals, and coordinating interrelations among the project
knowledge areas (PMI, 2017). Attachment 1 provides a scheme of the individual components of
the PIM.

3.1.4 Stakeholders in Pharmaceutical Project Management


In the execution of projects, multiple actors come into play, influencing the operational,
technological, and organizational business activities internally and externally. Figure 7 and Figure
8 illustrate these actors respectively (Anton et al., 2006).
A product may be owned by various companies, and health authorities determine the development
and commercialization of a product. Outsourcing of project phases in drug development
introduces a new actor in pharmaceutical project management: Contract Research Organizations
(CRO), and ultimately, physicians predominantly determine the drugs that clients (patients) use,
and health management organizations determine levels of co-payment (Anton et al., 2006).
Internally, the sponsor company is further sub-divided into various project teams, based on focus
units (see Figure 9). The overarching units manage three main functions: i) strategic approach,
project/programs/portfolio design, and performance, ii) time scope and financial impact, and iii)
effects of specific projects in the company’s overall targets and investment context (Anton et al.,
2006). When pharmaceutical organizations become large (> 10,000 employees and > 20B $),
project teams are further grouped as shown in Figure 9, coordinated by a Project Management
Office (PMO) (Anton et al., 2006).

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Figure 7. External stakeholders influencing pharmaceutical project management
Source: Anton et al. (2006)

Figure 8. Internal stakeholders influencing pharmaceutical project management


Source: Anton et al. (2006)

Figure 9. Project Management in specialized project teams


Abbr.: IPT= International Project Team. Source: Kennedy (2008)
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3.2 Strategic Concepts for Designing Drug Development Projects
Project outputs can be optimized by considering key elements and acquiring a strategic thinking
approach. The first part of this section provides a general description of these terms,
complemented by a list of benefits in project management. The second part specifies strategic
concepts to consider in drug development projects.

3.2.1 Conceptualization of Strategy and its Benefits in Pharmaceutical Project Management


In order to align project activities to the ultimate business goals in a pharmaceutical organization,
strategies are indispensable. They assist project managers in carefully identifying potential
(internal/external) risks to their products and investments, optimally assigning resources, and
critically prioritizing among competing and ever-important tasks.
Before going into details of strategic project management and its application in drug development
and success, it is essential to understand the term strategy and its core concepts. The term
strategy has been traditionally defined as “the means of getting from where you are now to where
you want to be and with competitive advantage” (Mintzberg, 1994). This notion emphasizes the
relevance of understanding the current status of an organization/product and clarifying the
improved future state. The path in between, connecting both sides is then defined aided by a
strategy (Brown and Grundy, 2011).
An alternative explanation of strategy is “the intuitive sense, not of where the business actually is
but where it ought to be, and of what needs to happen to bring about this ideal state” (Brown and
Grundy, 2011; Mintzberg, 1994). This second definition highlights clearly stating what the
improved condition should look like and figuring out mechanisms to make that happen, in other
words, it is about the plan to achieve the project goals successfully, using the least amount of
resources, time, and effort, while integrating ingenious concepts in the project execution (Brown
and Grundy, 2011).
In this context, strategic thinking is a vital competency that needs to be integrated for effective
project management in the pharmaceutical industry. Brown and Grundy (2011) defined strategic
thinking as “the creative and relentless pursuit of options for action which leverage resources and
produce shareholder value more easily and, in less time”.
This notion encompasses the following aspects: ingenuity, thorough assessment, and methodical
approach, alternatives on what and how processes/activities can be performed, specifying required
measures to undertake and indicating duties within teams, optimizing the use of resources, and
providing evidence on the project efficiency, reflected on improved financial statements (Brown
and Grundy, 2011). Strategic thinking is conventionally illustrated in the form of a “helicopter
thinking” by pharmaceutical organizations, as shown in Figure 10.

Figure 10. Helicopter vision in allusion to strategic thinking in pharmaceutical projects


Source: Brown and Grundy (2011)
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In the helicopter view of strategies, the project management/organization has an objective (to
reach the customer on top of the mountain) but is surrounded by a difficult landscape. An option
is to walk all the way, but the visibility to distinguish potential threats (e.g., competitors) is
obstructed by elements on the ground. Besides, walking as an alternative (sub-optimized strategy)
has the risk of potential falls due to “rabbit-holes” (e.g., confusing situations, typical in pharma
owing to frequent complex and lengthy technicalities) on the way, that may distract from the
ultimate goal.
In this regard, strategic thinking applied to pharmaceutical project management entails multiple
benefits, as indicated by Brown and Grundy (2011):
• Assessing if a particular project/activity is the most convenient means to achieve the
defined strategic goals
• Determining alternatives for executing the planned project
• Becoming aware of potential risks and opportunities of the project both internally and
externally, and recognizing associated assets and vulnerabilities
• Matching the project with various expertise units, to evaluate its overall relevance

3.2.2 Key Elements in the Elaboration of Strategic Pharmaceutical Projects


Essential aspects guiding strategic drug development are explained in this section, together with
the procedures of interdisciplinary international teams when finding suitable product candidates
to enable reaching the overall business goals in pharmaceutical organizations.
1) Process for Developing a Strategy & Plan in Drug Development Projects
A project is “nominated” (approved) once a prospect drug fulfills the requirements set by the upper
management in a pharmaceutical organization. After approval, the project is transferred from the
preliminary research to the development phase, in which an international (and interdisciplinary)
project team (IPT) takes full responsibility (see IPT composition in Figure 9) and generates an
integrated development plan (IDP). The IDP is then briefed to a committee in charge of the project
development, which grants approval after considering timelines, budget and overall resources
needed. A decision is also taken, if developing the project in-house or if it is more convenient to
outsource it (Kennedy, 2008).
At this stage, the IPT proceeds in the following order (Kennedy, 2008):
• The scientific arguments justifying the project are evaluated together with the initial results
of the preclinical pharmacological studies that state the benefits of the drug
• A clinical strategy is defined, accounting for the benefits of the drug within a particular
segment of patients, and proving that currently marketed/in-development products do not
suffice for the therapy at hand
• The target product profile (TPP) is created in a preliminary form, listing the uniqueness of
the product in contrast to existing competing drugs and the content of the product labeling
is also defined
• An IDP is developed, portraying the extent of capital required, pursued goals along with
varying timelines, and outlines associated risks and estimated profits to generate
2) Target Product Profile
The TPP serves as a strategic tool for the IPT and the overall business units, to succinctly specify
the objectives of the drug to be developed. The TPP entails a description of the product and its
initial recommendations for use, the patients’ target group, and provides initial indications on
safety and efficacy. In addition, it entails the estimated investment necessary for the project as
well as the expected time to launch the product (Kennedy, 2008).
Details on minimum elements of the product (commercial properties), desired performance and
expected profiles are discussed, in order to assess the boundary conditions of the project
(Kennedy, 2008). Attachment 3 shows the typical content of a TPP based on the case of venous
thromboembolism (VTE) in patients that experienced knee surgery.

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In the course of product development, the TPP needs to be re-evaluated and adjusted, considering
new market conditions or findings obtained from the studies performed, since both determine
product success (Kennedy, 2008). Brown and Grundy (2011) provide an abridged list of key
elements to consider in a TPP:
(1) Code number of the drug to be potentially developed
(2) Therapeutic indications
(3) (Satisfactory) pharmacology profile
(4) Applicable manufacturing process, considering:
 Potential for up-scaling to commercialization
 (Proper & steady) clinical dose and formulation
(5) Minimum efficacy
(6) Safety/benefit ratio (no significant side effects)
(7) Dose treatment
(8) Innovation versus product in the market or in pipeline (“first-in-class”)

3) Integrated Development Plan


The IDP represents the business case for the realization of a drug development project, detailing
requirements and goals for a near and far future. The TPP is used as the basis for the elaboration
of the IDP. This document has the structure of a project plan and includes further clarifications on
the use of the product and the timeline for market introduction, the phases for drug development
and their respective timeframes, estimated budget in general and per subproject (Kennedy, 2008).
Return on investment is also appraised from global sales and estimations of costs and risks are
included with details on measures for risk management. Financial estimations are also included
that allow the comparison of the particular project with other projects in an organization’s
portfolio (Kennedy, 2008). Attachment 4 outlines the content of an IDP structured within nine
sections and indicates a typical extent on the number of pages per section.
The stakeholders reviewing and deciding on the IDP are the development committee (assessing its
feasibility), functional leaders in the discovery and marketing units, and the IPT. The IDP is then
periodically revised on each development stage, making conclusions and recommendations for
the following stages, e.g., on the need for additional investment (Kennedy, 2008).

4) Project Feasibility and Investment Decisions


A project may be closed if unacceptable issues arrive in the progress of project activities, e.g.,
above threshold toxicity in animals or during clinical tests if the IPT recommends that a drug may
not be a successful candidate on completion of the TPP, or if members of the development
committee consider from a project IDP that associated risks are intolerable or if return on
investment may not justify the product development (Kennedy, 2008).
Some pharmaceutical organizations choose to license a project, which evidence shows that those
tend to be successfully developed up to commercialization. Organizations address the following
“big 5 questions” on taking a decision of an investment via a licensing company (Kennedy, 2008):
• Does the outsourcing company own the drug?
• Do they possess a feasible drug-product form?
• Is their available drug suitable for the clinical intended use?
• Is there evidence of financial attractiveness for the drug of interest?
• Is it possible to obtain a significant return on investment by developing the drug?
Attachment 9 illustrates a useful project management tool “project option grid” useful when
deciding if developing clinical trials as part of drug development either internally or if outsourcing
the task.
As part of a review process, these questions are answered and the results of the options
assessment are evaluated, leading to decision-making within a group of experts from diverse
disciplines. The IPT compiles the key points and drafts a briefing with recommendations to the
senior management of the pharmaceutical organization (Kennedy, 2008).

17
3.3 Drug Development Projects and Roles of Regulatory Affairs Teams
In this section, the phases for drug development are described highlighting RA activities that are
accomplished in parallel. In addition, the typical structure of RA teams enabling these processes
is described, together with indications of selected project management tools that may assist in
achieving the respective goals of drug development projects.

3.3.1 Drug Development Process and Regulatory Affairs Roles


The development of a drug is composed of various carefully regulated and controlled activities,
aimed at assuring the safety and efficacy of a drug product (Kennedy, 2008). Each of these
activities, from R&D to market launch, represents a project with specific sub-tasks and milestones,
requiring thorough planning, monitoring, and evaluation. In this section, the phases for drug
development are succinctly described, followed by indications of key regulatory actions to consider
in a pharmaceutical project.
Figure 11 shows the main phases in drug development (after discovery is completed), with
indications on key regulatory project management activities.

Figure 11. Phases of drug development and main roles of regulatory affairs project teams
Source: Kennedy (2008)
The overall drug development process is structured within six stages: i) preclinical, ii) phase 1,
iii) phase 2, iv) phase 3, v) registration, and vi) life cycle management (Kennedy, 2008). Across this
process, the following project activities are completed: a) objectives definition of the drug
development stage, b) assurance of product ownership (see Attachment 12), c) feasibility of
product form and d) assessment of risk/benefit balance (Kennedy, 2008). A common project
management tool used to track the different phases of a pharmaceutical project is the Gantt chart
(see Attachment 7).
The combination of these stages and project activities, from product inception to product
termination, is called the “ drug product life cycle” (Kennedy, 2008). Figure 12 illustrates the stages
of a product life cycle, in reference to revenues and timeframe. Attachment 2 compiles the
individual project activities along with a drug development project, taking as an example a chronic
oral drug therapy, based on evidence of Kennedy (2008). In the following paragraphs, the
individual phases for drug development are succinctly described, providing also indications of key
regulatory affairs activities in the respective stages, as described by Kennedy (2008):

18
Figure 12. Model of a common product life cycle.
Source: Kennedy (2008)
Preclinical Phase
The purpose of this phase is to obtain relevant facts about the suitability of a novel drug for the
treatment of a particular condition in humans. The processes encompassing this stage comprise
the production of the drug substance or active pharmaceutical ingredient (API), identification of
appropriate analytical methods to proof API’s purity, and its integrity in the drug product during
temporary repository state, toxicological and pharmacological studies to determine drug doses
suitable for assays in humans.
The project team in charge of the preclinical phase aims at identifying a substance that exhibits
prolonged effects, high levels of assimilation, low/high spike strength, low side effects, good
pharmacological profile, and low harmfulness. Results on drug exposure from the toxicology
studies are then correlated with scheduled clinical exposure ranges. This information will serve
specialists to assess the safety of the drug to be applied in volunteers and to track possible clinical
symptoms during pre-clinical assessments.
The completion of this phase lasts 9-15 months and costs could reach €1.8-3.6 million.
The preclinical phase includes the following studies/project activities, as described by Brown and
Grundy (2011) and Kennedy (2008):
 Acute toxicity
 Subacute toxicity (two to four weeks in two species)
 Subchronic (three months in two species)
 Chronic toxicity (e.g., six months in two species)
 Reproduction studies (incl. embryotoxicity, fertility, perinatal toxicity)
 Oncogenicity (carcinogenicity)
 Mutagenicity
 Pharmacokinetic assessments
 Absorption, distribution, metabolism, and excretion (ADME) in two species.

Regulatory activities in the discovery/preclinical phase encompass:


 The regulatory project team provides recommendations to the group performing
toxicological studies on the latest ordinances regarding the kind and amount of
species required to perform the investigation as well as the sort and timespan of
the respective assessments.
 Once the results from this phase are generated, the regulatory team makes sure all
of this information is documented in order to populate the nonclinical chapter for
the Investigation Medicinal Product Dossier (IMPD).
 The IMPD serves as the technical reference for a clinical trial application. It also
functions as a foundation for the nonclinical and summary parts for the marketing
authorization applications (e.g., NDA/MAA).

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Clinical Studies
Phase 1
In this stage, the target is to prove that the drug is not dangerous and that it can tolerable by the
participants of the study. It is also the moment, in which the pharmacokinetics of the drug is
described, based on its performance in humans. Results from this phase enable the collection of
sufficient data to suggest proceeding studies, testing the drug with patients, under careful
monitoring of drug effects on the volunteers.
The so-called “first-in-human” assessment includes a gradual dose increment in patients, following
guidelines on state of the art on phase 1 clinical trials. This study seeks to obtain a dose treatment
and a reliable drug concentration, assuring the efficacy of the drug. Also, food assessments on
pharmacokinetics are performed, in order to provide advice on ideal hours for drug ingestion with
respect to meal intervals, which will be used in tests for phase 2. Moreover, drug interaction
assessments are performed to evaluate possible contraindications in comedication in the target
patient group and evaluate possible adjustments in the new drug. Parallel to clinical studies, other
project activities in drug product development are performed, such as:
a) Drug synthesis optimization
b) Analytical development
c) Formulation studies
d) Toxicology tests
e) Evaluations of drug effects in animals and in vitro with human tissues
This phase has a duration of 10-15 months, subject to the number of studies to perform, and
requires a budget of €2.4-4.8 million.
Phase 2
On this step, the project goal is to gather preliminary information on the drug safety in patients
and appraise the dose-response correlation in them. The project team seeks to provide reasonable
arguments on the selection of a dose treatment to be evaluated in phase 3 key trials. Details of
critical proceedings in phase 2 will assist to better characterize the target patient group that will
be analyzed and to determine the clinical endpoints, which are the outcomes being assessed in
the trials to prove the functionality of the novel drug treating the target disease in a patient group.
It is common to test three to four dose routines, in reference to the data obtained from phase 1
and preclinical in vitro and in vivo records. The number of patients may vary from as little as 25
to as many as 1,500, subject to the clinical endpoint and the statistical minimum necessary to gain
robust information from the study on the dose treatments of the drugs tested.
At the end of this phase, the drug synthetic mechanism has been determined, enabling the use of
a fixed impurity profile of the API (that will be introduced into the market) for the prolonged
toxicity studies and for phase 3 clinical tests. The budget and duration for phase 2 also vary,
ranging between 12-36 months and requiring investments of €7.2-24 million.
Phase 3
The purpose of this phase is to generate full documentation with a detailed risk/benefit analysis
to validate the application of a particular drug for the treatment of a clinical condition in a
determined patient segment. In this stage, the product label scope is defined, derived from the
results of the trial protocols. This phase normally requires 18-40 months to be finalized, and the
budget can reach €18-120 million.
Overall, the clinical phase consists of the following studies/project activities, as described by
Brown and Grundy (2011):
 Phase 1 (human pharmacology): single and multiple-dose, bioequivalence studies,
interaction analyses, special populations (e.g., renal, hepatic impairment, elderly,
children)
 Phase 2 (therapeutic exploratory): dose-finding
 phase 3 (therapeutic confirmatory): efficacy studies (at least two)
 Phase 4 (therapeutic use): post-marketing surveillance (PMS)

20
Later on, the manufacturing process includes the following project activities, as described by
Brown and Grundy (2011):
 Clinical trial supply manufacturing
 Formulation (phase 1 formulation can vary from other phases)
 Full scale-up of a commercial product
 Stability testing, substance and formulation characterization
Regulatory activities along this process encompass the following (Kennedy, 2008):
 During the clinical progress, the regulatory team assists clinical specialists in the
respective country requirements and schedules for drug approval.
 In case of a drug is being matched with a product already put in the market
(comparator drug), the regulatory team informs about the available licenses in the
individual countries of interest in which the comparator drug is planned to be
implemented in the clinical tests.
 In case there is no registered comparator in a target country, the drug needs to be
treated as an exploratory product and further detailed information is necessary to
sustain the application of that drug in the clinical tests.
Attachment 5 summarizes key details of the phases in clinical trials, including the number of
patients, places to conduct the assessment, and characteristics of the test participants. Moreover,
Attachment 8 shows a common project management tool “fishbone analysis” that can assist, for
example, when assessing causes for challenging patient recruitment in clinical trials.
Drug Registration
This phase centers on the dossier submission to health authorities, to obtain drug marketing
approval. Normally, the review process takes 12 months and could be extended. In the case of
priority cases, the revision step may take 6 months only. Attachment 10 provides the project
management tool “risk matrix”, which the RA team may use to assess potential risks associated
with the registration of a drug, e.g., delays, missing regulatory intelligence, incomplete
documents, etc. While the registration is ongoing, clinical tests are maintained, aimed at providing
further evidence to assure marketing approval (phase 3b) or meant for assessing additional
indications for a particular drug. Regulatory affairs tasks include addressing the following
questions, as described by Brown and Grundy (2011):
 Can the drug fulfill the requirements for the Food and Drug Administration (FDA)
regarding new investigational drugs (IND)? / Can the drug satisfy the EU Clinical
Trial Directive submission criteria?
 Is the submission ready to fulfill specifications of the Common Technical Document
(CTD) of the International Conference of Harmonization (ICH), the specifications for
New Drug Application (FDA, USA) and the Marketing Authorization Application
(MAA, EU)?
 Are other domestic or international regulations or demands considered and can
they be met? E.g., Good Clinical Practice (GCP) or Institutional Review Board (IRB)
approval?
Further regulatory activities during submission, approval, and launch encompass the following
(Kennedy, 2008): the international regulatory affairs team guides the preparation for drug approval
application and has different roles on this stage, depending on the sub-project activity in the
compilation of the dossier, e.g., planning, reviewing, compiling, signing, and submitting.
Attachment 6 lists the different RA activities and the respective tasks of the RA team in an example
for a large submission.
Before a drug is approved by a particular health authority, the international RA team, local RA
members and representatives from marketing units generate a launch program to introduce the
product in the market, which is executed immediately once approval is obtained. Aspects
considered in this launch plan are production schedules, packaging, storage and supply from
distributors to drug stores. Labels and brochures with information for use are elaborated and the
summary of product characteristics (SmPC) and marketing documentation deems approval by the
marketing, medical affairs and the RA team (to assure regulatory compliance) before distribution.

21
Postapproval/Life Cycle Management
In this stage, additional capital is placed into the drug product, in order to obtain the highest
return on investment. Activities in this phase comprise: financing additional indications of the
drug, completion of commitment studies agreed on during the registration phase (phase 4),
performance of market analysis to evaluate competitive advantages, assessments of novel
formulations and dose plans.
The additional tests enable pharmaceutical companies to feed a database on the product that helps
increase drug safety. Capital is provided across the entire life cycle of a product until disinvestment
is decided, and patents of products expire, however, in many cases, tasks in life cycle management
(LCM) focus on patent-extension strategies. There are reports of investment done in this phase
exceeding 36 million, in order to enhance the market share of a product.
In postapproval, the RA team holds the following tasks:
 Assuring the drug remains being commercialized and facilitating the expansion of
the market segment reached by the product via:
▪ Variations
▪ Pharmacovigilance
▪ Manufacture and distribution
▪ Liaising with cross-function groups
▪ Fulfilling line extensions (e.g., new chemical/salt, new dosage form, new
delivery system, a new route of administration, new medication, or new
patient population)
 The RA also makes sure (due to experience, knowledge, team-work) that potential
challenges in the drug environment do not compromise the success of the product.
These challenges include regulatory and commercial factors of:
▪ Positive nature, such as patent and data protection, line extensions,
competitors’ failure, licensing deals, new active substances, etc.
▪ Negative nature, such as high bureaucracies, strong competition, generics,
product failures due to epidemiology, restrictions, and warnings

3.3.2 Teams in Regulatory Affairs Supporting Drug Development Projects


The diverse complex tasks and subprojects in drug development and commercialization, require
establishing functional RA teams that help to properly handle growing regulatory challenges and
constraints in the pharmaceutical industry, related with scarce resources, tight schedules, limited
budgets, and increased volume of work (Kennedy, 2008).
Besides NDA/MAA and investigational NDA/clinical trial applications, RA teams undertake the
following projects: license extensions or updates, due diligence for product ownership,
assessment of marketing documentation, regulatory intelligence, and managing situations of
product withdrawal (Kennedy, 2008). Members of RA teams commonly demonstrate the following
skills: technical understanding and familiarity in the area of work, attentive and responsive,
analytical and practical skills, crisis management, and dynamism (Kennedy, 2008). An RA team is
typically structured within three major degrees: corporate level, regional level, and at a national
level, as depicted in Figure 13. At the top rank, one finds the Global Core Project Team (GCPT),
followed by the Regional Core Project Teams, and as fundament are the affiliates/ national
business unit project teams.
Global Core Project Team
This is composed of an interdisciplinary group of experts (e.g., marketing, manufacturing, medical
affairs, clinical research, and RA) that define the strategic development of a drug/various products
in a defined treatment field. This team has the overall duty of guiding the entire drug development
process, generating global submission plans across the whole product life cycle, coordinating
actions for postapproval commitments, and tracking product performance on the market. Due to
the multifaceted nature of a product marketing plan, this is developed in a combination of
regulatory, marketing, and development strategies (Kennedy, 2008).

22
Figure 13. Common structure of RA project teams
Source: Kennedy (2008)
Attachment 11 shows the “uncertainty-importance grid” as a sample project management tool to
assess the landscape for launching a product, which can be of relevance for the GCPT when making
decisions.
A GCPT essentially provides recommendations, based on the latest content in regulations and state
of the art (SoA) in drug development processes. The work of this team is not only reliant on the
know-how and experience of its senior members, but it is also dependent on the feedback obtained
from the respective RA subteams/regional groups and the individual RA therapeutic unit specialists
(Kennedy, 2008).

Regional Core Project Teams


This subteam is led by a GCPT member of a specific functional area, and the group is composed
of the individual regional leaders, e.g., EU, USA, Japan, or thematic activities, e.g., Chemistry,
Manufacturing, and Controls (CMC), Project Management, etc.
This team oversees the peculiarities of local regulations, and structures the evidence gathered by
the national/affiliate RA groups. Once the available information is revised, the regional team finds
an agreement, which is then forwarded to the GCPT leaders. In addition, the regional team makes
sure that the respective geographical project goals are achieved and tracks the progress in liaison
with the affiliates, serving as a communication link between them and the CGPT (Kennedy, 2008).

Affiliates/National Business Unit Project Teams.


This team has similar roles as the regional project group. Affiliates handle drug projects with a
focus on the current national regulations and provide feedback to the regional RA team. In some
cases, affiliates are directly responsible for national submissions and of the communication with
the health authorities. However, electronic publishing is progressively enabling the specialization
of a submission group that sends the dug applications to the local regulatory organizations
(Kennedy, 2008).
As soon as the drug receives clearance for marketing, affiliates are responsible for the release of
the product in the market, under the leadership of the GCPT and in congruence with the global
submission plan. On some occasions, national teams, in reduced numbers, can be designated
postapproval, to generate a product or a set of products. This is then achieved in cooperation with
specialists from regulatory, marketing, medical affairs, medical information, clinical research, and
outsourced marketing agencies (Kennedy, 2008).
Additional aspects pertaining to the roles of regulatory teams are communicating requirements
on quality assurance systems to other teams, following on personnel qualifications/training, and
maintaining excellent documentation systems (Tobin and Walsh, 2008).

23
Chapter 4. Discussion
The purpose of this study was to explore the suitability of project management concepts in the
business functions of the pharmaceutical industry, emphasizing drug development projects and
the roles of regulatory affairs teams along this process. This aim was achieved by exemplifying
some of the benefits described in the literature on the implementation of project management in
the pharmaceutical sector, describing key project activities in drug production and the influences
of regulatory affairs teams in drug development; and by illustrating the application of various
project management tools in pharmaceutical real-life problems, e.g., fishbone analysis, risk
matrix, and the project option grid. The relevance of strategies in project execution together with
the description of a proven model for project management in the pharmaceutical industry was also
provided.
Investigating these topics becomes of relevance when looking for processes and tools to optimize
work within pharmaceutical organizations. Moreover, learning about the applicability of project
management concepts in drug product development and in consideration of regulatory practices
becomes especially relevant for new professionals dealing with regulatory aspects of
pharmaceutical products. A sound understanding of project management provides a
comprehensive view of the individual activities in this industry, which translates into more effective
assessments, improved project actions, and targeted results.
The steps of the project management model of Brown and Grundy (2011) are comparable to other
approaches. The “idea phase concept” of Kuster et al. (2015) provides phases for projects that
include initialization, pre-study, concept, implementation, and introduction. This concept
considers a pre-evaluation step of the project (equivalent to planning). However, Kuster et al.
(2015) highlight that the number of steps and their scope will ultimately be subject to the type of
project/activities being handled.
Regulatory affairs and drug product development, as well as re-development projects, are relevant
examples for the application of project management in the pharmaceutical industry. Other
functions within these organizations in which project management can be adopted are technology
development, identification of new processes, variations of standardized procedures/activities,
enhancing the quality and operational methods, or for improving IT systems (Babler, 2010).
Although projects aim at enhancing the state of organizations, their implementation carries
challenges. Executing pharmaceutical projects involves difficulties, for instance, Beukers (2011)
identified missing authority in senior managers, low level of dedication to the project goals, and
regular absent training in the stakeholders. Other challenges along pharmaceutical project
management activities include elevated costs of projects, the extended time required to complete
tasks, scarce expertise among stakeholders, difficulties to comply with regulatory standards,
unproductive management among teams and fruitless results from diverse teams, missing clear
definition of project scopes and targets (Ding, 2018). This situation put in evidence that project
management can serve as a tool, but it is imperative to actively seek for means to improve the
application of its processes within organizations.
The limitation of this investigation essentially relates to its theoretical nature, since it does not
integrate an empirical data analysis. This situation is justified by the fact of a limited available
timeframe to perform the living cases in the CAS Regulatory Affairs, which is designed as a part-
time program within a single semester. Moreover, not being employed by a pharmaceutical
organization complicates accessing/gathering possible data for an experimental investigation.
In this regard, it is recommended for future studies on this topic, to examine possibilities to
perform an empirical analysis on the efficiency of project management in specific pharmaceutical
business functions and assess ways for improvement/optimization.
In summary, project management comprises a systematic approach for performing business
activities applicable to pharmaceutical business tasks such as drug development and compliance
with regulatory requirements. Nevertheless, the functionality of any project management approach
is dependent on the commitment and agility of the involved stakeholders and the strategies
integrated by the leaders guiding the respective teams.

24
Chapter 5. Conclusions
Project management comprises a series of processes and tools that can help pharmaceutical
organizations achieve their business goals, especially amidst scarce resources, short time, limited
budget, and challenging technological transformations. In the application of project management
techniques, managers should be aware of the key elements encompassed in the term project:
focusing on the creation of a novel product, service, or output, defined timeline, and resources,
and clearly specifying the target to achieve.
The model for pharmaceutical project management proposed by Brown and Grundy (2011)
represents a useful concept to perform activities within this industry. The steps described in that
model comprise determining the project purpose and milestones, defining a project strategy,
elaborating a detailed plan, systematically performing the individual activities, evaluating their
outcome, and assessing results to improve execution.
Drug product development projects are very complex and require detailed planning, monitoring,
and control. They also require multidisciplinary and international teams, in order to effectively
fulfill the diverse business objectives and the growing regulatory constraints in the pharmaceutical
industry. Throughout the development of projects in this sector, various external and internal
stakeholders come into play, influencing the strategies and decisions taken in the projects.
The systematic and rational nature of project management ensures organizations to accomplish
their goals, however, the application of these procedures requires a strategic mindset, focused on
not only performing tasks but in doing them in an optimal way. The term strategy has been
characterized as the manner of achieving a goal, by knowing the current conditions, estimating
future state, and finding ways of achieving it with the least use of resources. Strategies should be
at the center of every pharmaceutical project, in order to effectively and efficiently direct business
efforts.
Key elements of a strategic drug development plan considers evaluating the facts that suggest the
safety and efficiency of a drug, the elaboration of a clinical strategy, defining the target patient
group and geography, generating a target product profile and an integrated development plan,
which specify products properties and the business rationale for investing in a particular drug.
Drug development projects are composed of six basic phases: preclinical, phase 1, phase 2,
phase 3, registration, and life cycle management. In these individual project activities, careful
planning, execution, evaluation, and control is required. Along with the phases of drug
development, the regulatory affairs project team fulfills various roles, to ensure the feasibility of
the drug development, its approval, and its maintenance in the market.
These RA activities include advising on latest regulatory requirements, informing on details for
designing clinical studies, gathering documentation for submission to health authorities and
serving as liaison with them, making other teams aware of existing licenses and timelines for
approval, as well as performing market vigilance and ensuring the drug remains active in the
market. In order to fulfill these tasks, the RA team is commonly composed by a three-level
structure: Global Core Project Team (taking overall responsibility for global submissions,
postapproval commitments, defining RA strategies, etc.), Regional Core Project Teams (serving as
connection between the upper RA management and the local partners), and Affiliates/National
Project Teams (directly responsible for national submissions and communication with local health
authorities).
The processes and tools of project management can serve the pharmaceutical industry in its
business objectives, but their efficiency will always depend on the commitment of the direct
stakeholders and particularly the general management to reliably implement them, and
continuously learn and improve the execution of projects.

25
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Attachments
Attachment 1. Outline of the Project Integration Management

Source: PMI (2017)

27
Attachment 2. Essential tasks in drug development projects – case of chronic oral drug therapy

Source: Kennedy (2008)


28
Attachment 3. Overview of a Target Product Profile – case of knee surgery patients

29
Attachment 3 (cont.). Overview of a Target Product Profile – case of knee surgery patients

Source: Kennedy (2008)

30
Attachment 4. Outline of an Integrated Development Plan for strategic pharmaceutical project
management

Source: Kennedy (2008)


31
Attachment 5. Details of phases for clinical trials

Source: Kennedy (2008)

32
Attachment 6. Roles of the regulatory affairs team in the submission of a large dossier

Source: Kennedy (2008)


33
Attachment 7. Gantt chart to track phases of pharmaceutical projects

Source: Brown and Grundy (2011)

34
Attachment 8. Fishbone analysis for assessing recruitment challenges in clinical trials

Source: Brown and Grundy (2011)

35
Attachment 9. Project option grid – case of in-house versus outsourcing clinical trials

Source: Brown and Grundy (2011)

Attachment 10. Risk matrix analysis for evaluating pharmaceutical projects

Source: Brown and Grundy (2011)


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Attachment 11. Uncertainty-importance grid in the analysis of conditions for launching
a new drug

Source: Brown and Grundy (2011)

Attachment 12. Means to ensure drug product ownership

Source: Kennedy (2008)


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