Project Management for Drug Developers

Cover
Half Title
Series Page
Title Page
Copyright Page
Table of Contents
Foreword
Preface
Glossary of Terms and Abbreviations
Editor
Contributors
PART 1 The Role of PM in Drug Development
	Chapter 1 Overview of Drug Development
		1.1 Introduction
		1.2 Preclinical Development
			1.2.1 Pharmacodynamics (PD)
			1.2.2 Pharmacokinetics (PK)
			1.2.3 Toxicology
		1.3 Early Clinical Development
			1.3.1 Phase 1
			1.3.2 Phase 2
		1.4 Late Clinical Development
			1.4.1 Phase 3
		1.5 Innovative Clinical Development Strategies
			1.5.1 Seamless Trials
			1.5.2 Master Protocols
			1.5.3 Regulatory Flexibility
		1.6 Registration
		1.7 Lifecycle Management
		1.8 Summary
	Chapter 2 Project Management's Place in Drug Development and the Various Project Management Roles in Biopharma
		2.1 Introduction
		2.2 What Is Project Management and What Does a Project Manager Do?
		2.3 Evolution of Project Management in Biopharma
		2.4 What Do Project Managers Do in Biopharma?
			2.4.1 Research Project Manager
			2.4.2 Development Project Manager
			2.4.3 Commercial Project Manager
			2.4.4 CMC Project Manager
			2.4.5 Regulatory Project Manager
			2.4.6 Emerging Roles for Project Managers in Drug Development
		2.5 Who Becomes a Project Manager in Biopharma?
		2.6 What Makes for a Successful Development Project Manager?
			2.6.1 Collaboration of Multiple Disciplines
			2.6.2 Coordination of Business Processes
			2.6.3 Communication across Multiple Stakeholders
			2.6.4 Management of Risks and Issues in a Cross-Functional Context
		2.7 Summary
	Chapter 3 Project Teams
		3.1 Introduction
		3.2 Project Team Models
			3.2.1 Top-Down Hierarchy
			3.2.2 Hub and Spoke
			3.2.3 Latticed Network
		3.3 Components of a Hub-and-Spoke Project Team
			3.3.1 Core Team
			3.3.2 Sub-Team
			3.3.3 Task Forces and Working Groups
			3.3.4 Joint Teams
			3.3.5 Tying It All Together with a Project Team Charter
		3.4 Roles within a Project Team
			3.4.1 Executive Sponsor
			3.4.2 Project Leader
			3.4.3 Project Manager
			3.4.4 Sub-Team Lead
			3.4.5 Functional Area Representative
			3.4.6 Functional Area Head
			3.4.7 Technical Expert
		3.5 Functional Representation within a Project Team
			3.5.1 Clinical Operations
			3.5.2 Clinical Pharmacology
			3.5.3 Clinical Science
			3.5.4 Commercial
			3.5.5 Medical Affairs
			3.5.6 Research/Nonclinical Science
			3.5.7 Pharmaceutical Science/CMC/Technical Operations
			3.5.8 Regulatory Affairs
			3.5.9 Other Key Interfaces with the Project Team
		3.6 Team Culture, Dynamics, and Leadership
			3.6.1 Characteristics of a High-Performance Team
			3.6.2 Meeting Operating Norms
			3.6.3 Managing through Disruption
				3.6.3.1 Organizational Shifts in Priority
				3.6.3.2 Departmental Reorganizations
				3.6.3.3 Mergers & Acquisitions
				3.6.3.4 Team Member Turnover or Nonperforming Members
				3.6.3.5 Abrupt Handover of Responsibility to a New Project Manager
	Chapter 4 The Project Management Office
		4.1 Introduction
			4.1.1 What Types of PMO Are There?
			4.1.2 What Does a "Good" PMO Look Like?
		4.2 What Does a PMO in Biopharma Do?
			4.2.1 Support the PPM Process
			4.2.2 Support the Project Management Process
			4.2.3 Support the Annual Planning Process
			4.2.4 Facilitate Governance
			4.2.5 Build Institutional Memory
			4.2.6 Set Common Corporate Culture
			4.2.7 Support Resource Management
		4.3 Who Are the Members of a PMO?
			4.3.1 PMO Leader
			4.3.2 Project Managers
				4.3.2.1 Strategic Role
				4.3.2.2 Tactical Role
			4.3.3 Resource Managers
			4.3.4 Process Managers
		4.4 What Is the Best Way to Establish a PMO?
			4.4.1 Understand Your Stakeholders and Build the "Why"
			4.4.2 Define the Services and Structure
			4.4.3 Get Executive Buy-In
			4.4.4 Identify the Processes and Workflows that Need Standardization
			4.4.5 Train Your Project Managers
			4.4.6 Continue to Examine and Improve Your Process
		4.5 Summary
	Chapter 5 Project Portfolio Management
		5.1 Introduction
		5.2 How Does a Portfolio Manager's Role Compare to a Project Manager?
			5.2.1 Portfolio Manager Accountability
		5.3 What Does the Portfolio Management Process Accomplish?
			5.3.1 Portfolio Management and Focused Decision-Making
				5.3.1.1 Portfolio Management Process Areas
			5.3.2 Decision-Making Approach
		5.4 How Different Portfolios Engage with Project Teams
		5.5 Typical Portfolio and Project Data Exchange
			5.5.1 Current State Metrics
			5.5.2 Future State Metrics
		5.6 Resource Demand and Capacity Management
		5.7 The Role of Finance in the Project World
			5.7.1 The Portfolio Roadmap and Associated Risks
			5.7.2 The Long-Range Plan and Fiscal Budget
			5.7.3 How Finance Engages with Project Teams
			5.7.4 Typical Finance and Project Data Exchange
		5.8 Summary
PART 2 Contemporary Topics in Drug Development
	Chapter 6 Agile Project Management and Its Application to Drug Development
		6.1 Introduction
		6.2 What Is Agile and Why Should a Project Manager Care?
			6.2.1 History of Agile
			6.2.2 What Is Agile and How Does It Compare to Waterfall?
			6.2.3 "Doing Agile" vs "Being Agile"
			6.2.4 VUCA Environments and How Agile Can Help
		6.3 Where Can Agile Be Applied in the Drug Development Process?
			6.3.1 The Challenge of Implementing Agile in Drug Development
			6.3.2 CMC Process Engineering
			6.3.3 Combination Product and Medical Device Development
			6.3.4 Early Development
			6.3.5 Lifecycle Management
			6.3.6 Regulatory Submission Development
			6.3.7 A How-To Guide on Managing SCRUM-Like Meetings
				6.3.7.1 Step 0: Create a Backlog
				6.3.7.2 Step 1: Prioritize the Work
				6.3.7.3 Step 2: Plan a Sprint Planning Session
				6.3.7.4 Step 3: Launch a Recurring SCRUM Meeting
				6.3.7.5 Step 4: After Completion of the Sprint
		6.4 Summary
	Chapter 7 Managing International Projects
		7.1 Introduction
		7.2 Why Do Companies Go International?
			7.2.1 Tangible Benefits: Faster Development Programs and Additional Revenue Streams
			7.2.2 Intangible Benefits: Broader Corporate Profile and Increased Institutional Knowledge
		7.3 How Do International Projects Affect a Development Project Manager?
			7.3.1 Logistical Challenges
				7.3.1.1 Physical Separation
				7.3.1.2 Time Zone Differences
				7.3.1.3 Holidays and Working Days
			7.3.2 Language Barriers
			7.3.3 Cultural Differences
				7.3.3.1 Working Styles
				7.3.3.2 Communication Styles
				7.3.3.3 Decision-Making Styles
			7.3.4 Differences in Development Pathways and Regulatory Requirements
		7.4 Recommended Practices for Managing International Projects
			7.4.1 Form Geography-Based Team Structures
				7.4.1.1 Global Subteam Leads
				7.4.1.2 Regional Project Teams
			7.4.2 Be Culturally Sensitive
			7.4.3 Enhance Communications
				7.4.3.1 Organized Information Sharing
				7.4.3.2 Regular Interactions
				7.4.3.3 Active Listening
		7.5 Summary
	Chapter 8 Managing Combination Drug–Device Projects
		8.1 Introduction
		8.2 History of Device Regulation
		8.3 Determining the Regulatory Path
			8.3.1 Establishing the Primary Mode of Action
			8.3.2 Strategic Considerations When Picking the PMOA
		8.4 Developing the Project Plan
			8.4.1 Project Planning for Drug PMOA
			8.4.2 Project Planning for Device PMOA
		8.5 Developing Combination Products
			8.5.1 Development Path in Drug vs. Device
			8.5.2 Considerations for Development of Companion Diagnostics (CDx)
			8.5.3 Lifecycle Management (LCM)
		8.6 Difference in Project Management between Drug Development and Device Development
			8.6.1 Quality and Risk Management Systems
			8.6.2 Use of Agile Methodologies
			8.6.3 Team Structure
		8.7 Summary
	Chapter 9 How Technology Can Assist Project Managers Now and in the Future
		9.1 Introduction
		9.2 Project Management Tools
			9.2.1 Task Management Software
			9.2.2 Project Management Software
			9.2.3 PPM Software
		9.3 Resource Management Tools
		9.4 Budgeting Tools
		9.5 Tools to Maintain Project Information
		9.6 Tools to Communicate with Team Members
			9.6.1 Meetings and Videoconferences
			9.6.2 Email and Chat
			9.6.3 Reports and Dashboards
		9.7 How Advanced Technologies Will Benefit Project Managers
			9.7.1 Artificial Intelligence
				9.7.1.1 Predictive Estimation
				9.7.1.2 Risk Identification
			9.7.2 Robotic Process Automation
				9.7.2.1 Automated Reports
				9.7.2.2 Chatbots
				9.7.2.3 Algorithms
				9.7.2.4 Monte Carlo
		9.8 Summary
	Chapter 10 Assessing, Selecting, and Implementing a Project Management Information System
		10.1 Introduction
		10.2 Needs Assessment When Considering a Project Management Solution
			10.2.1 Team Member Visibility
			10.2.2 Pipeline Complexity Requires Integrated Planning
			10.2.3 Operational Portfolio Management
			10.2.4 Finance Scrutinizes Project Forecasts
			10.2.5 Resource Bottlenecks Causing Unnecessary Delays
			10.2.6 Connected Strategy with Execution
		10.3 Project Plan Considerations Unique to Life Sciences
			10.3.1 "What Is a Project?"
				10.3.1.1 Project Structure
				10.3.1.2 Functional Plans
			10.3.2 Use Templates
				10.3.2.1 Success Factors
				10.3.2.2 Template Level of Detail
				10.3.2.3 Template Resistance
		10.4 Resource Management Integration within Project Management Tools
			10.4.1 What Level of WBS to Assign Resources?
			10.4.2 What Level of RBS to Assign Resources?
			10.4.3 What Is the Definition of an FTE?
			10.4.4 How to Distribute Resources across an Assignment
			10.4.5 What Calendar to Use?
		10.5 The Broader Ecosystem: IT Data Flow
			10.5.1 CTMS Integrations
			10.5.2 ERP Systems
			10.5.3 Reporting . Output and Access
			10.5.4 CROs
		10.6 Tips for Successful Change Management
			10.6.1 Executive Stakeholders
			10.6.2 "What's in It for Me?"
			10.6.3 Begin with the End (Report) in Mind
			10.6.4 Set an Implementation Up for Success
			10.6.5 Training Never Ends
			10.6.6 Tying It All Together
		10.7 Summary
	Chapter 11 Creating an Asset Development Plan
		11.1 Introduction
		11.2 What Is an Asset Development Plan and Why Should a Project Manager Care?
		11.3 What Is in an Asset Development Plan?
			11.3.1 What Is a Clinical Development Plan?
			11.3.2 What Is a Regulatory Plan?
			11.3.3 What Is the Nonclinical Development Plan?
			11.3.4 What Is a CMC Plan?
			11.3.5 Medical Affairs Plan
			11.3.6 What Is a Commercialization Plan?
			11.3.7 What Is a Product Protection Plan?
		11.4 Summary
	Chapter 12 Creating a Clinical Development Plan
		12.1 Introduction
		12.2 What Is in a CDP?
		12.3 How Does a Project Manager Go about Creating a CDP?
			12.3.1 The Target Product Profile
				12.3.1.1 What Is a dTPP and Why Should a Project Manager Care?
				12.3.1.2 How Does a Project Manager Go about Creating a dTPP?
			12.3.2 Investigational Plan and Trial Designs
			12.3.3 Regulatory Plan
			12.3.4 Operating Assumptions and Resource Requirements
			12.3.5 Risk Assessment (Probability of Technical and Regulatory Success)
				12.3.5.1 Why Should a Project Manager Care about the PTRS?
				12.3.5.2 How Is PTS Estimated?
				12.3.5.3 How Is PRS Estimated?
				12.3.5.4 What Other Risks Should Be Considered in the CDP?
			12.3.6 Valuation
			12.3.7 Governance Summary
		12.4 Summary
	Chapter 13 Creating a Market Application Submission
		13.1 Introduction
		13.2 What Is a MAS Plan and Why Should a Project Manager Care?
		13.3 Best Practices for Creating a MAS Plan
			13.3.1 Before TLR
				13.3.1.1 Team Structure
				13.3.1.2 Author/Reviewer Assignment Matrix
				13.3.1.3 Defining the Content Creation Process
				13.3.1.4 Submission Content Plan
				13.3.1.5 Project Roadmap
				13.3.1.6 Lexicon
				13.3.1.7 Preliminary Key Messaging
			13.3.2 After TLR
				13.3.2.1 Final Messaging
				13.3.2.2 Draft Label
				13.3.2.3 CSRs and Narratives
				13.3.2.4 Administrative Documents
		13.4 Summary
PART 3 GRIDALL: A Comprehensive Framework for Managing Projects
	Chapter 14 Introduction to GRIDALL
		14.1 Introducing the GRIDALL Framework
		14.2 GRIDALL as a Framework for Building Your Project Management Methodology
		14.3 GRIDALL as a Tool to Assess Your Organization's Project Management Methodology
		14.4 GRIDALL as a Project Communications Model
		14.5 How GRIDALL Applies to Biopharma Projects
		14.6 Best Practices for Implementing GRIDALL in Your Organization
		14.7 Summary
	Chapter 15 Goals
		15.1 What Are Goals and Why Should a Project Manager Care?
		15.2 Some History and Theory of Goal-Driven Activities
			15.2.1 Publications on Goal Theory That Every Project Manager Should Know About
			15.2.2 What Is the Difference between Goals, Objectives, and Requirements?
			15.2.3 What Are Cascading and Aligning, and Why Are Those Important?
			15.2.4 What Are Committed, Stretch, and Moonshot Goals?
			15.2.5 Why Should We Use a Goal-Setting Framework, and What Options Do We Have?
		15.3 A Three-Step Process for Setting Project Goals
			15.3.1 Identify
			15.3.2 Refine and Align
			15.3.3 Finalize and Socialize
			15.3.4 Next Steps for the Project Manager
		15.4 Pros and Cons of Annual Goals
		15.5 Summary
	Chapter 16 Risks
		16.1 Introduction
			16.1.1 General Risks of Doing Business in Drug Development
			16.1.2 The Unmanageable "Design" Risks
			16.1.3 The Manageable "Implementation" Risks
		16.2 A Four-Step Process for Managing Risks
			16.2.1 Identify the Risk
			16.2.2 Assess the Severity
				16.2.2.1 Scoring the Probability
				16.2.2.2 Scoring the Impact
			16.2.3 Form a Response
			16.2.4 Monitor Until Resolution
		16.3 Best Practices for Keeping the Risk Management Process Finely Tuned
		16.4 Summary
	Chapter 17 Issues
		17.1 Introduction
		17.2 A Three-Step Process for Managing Issues
			17.2.1 Detect the Issue
				17.2.1.1 Detecting an Issue That Was Previously Identified as a Risk
				17.2.1.2 Detecting an Issue That Was Not Previously Identified as a Risk
				17.2.1.3 Recording the Issue
			17.2.2 Assess the Impact
			17.2.3 Resolve the Issue
				17.2.3.1 Decide at Project Team
				17.2.3.2 Escalate to Higher Level of the Organization
		17.3 Framing the Issue
		17.4 Summary
	Chapter 18 Decisions
		18.1 Introduction
		18.2 Principles of Decision-Making
		18.3 Governance Structures
		18.4 A Five-Step Process for Efficient Decision-Making
			18.4.1 Set the Context
			18.4.2 Define the Roles
			18.4.3 Gather Information
			18.4.4 Make the Decision
			18.4.5 Document and Implement
		18.5 Summary
	Chapter 19 Actions
		19.1 Introduction
		19.2 Principles of Managing Actions
		19.3 A Four-Step Process for Managing Action Items
			19.3.1 Identify
			19.3.2 Define
			19.3.3 Record
			19.3.4 Monitor
		19.4 Impossible Missions
		19.5 Summary
	Chapter 20 Lessons Learned
		20.1 Introduction
		20.2 Types of Lessons Learned
		20.3 A Five-Step Process for Gathering Lessons Learned
			20.3.1 Collect Initial Feedback from Stakeholders
			20.3.2 Narrow Down the Scope of Topics to Discuss
			20.3.3 Hold a Live Session with All Stakeholders
			20.3.4 Convert Key Findings into Action Plans
			20.3.5 Report Outcomes and Record Lessons Learned
		20.4 How to Implement Lessons Learned and Best Practices
		20.5 Summary
Appendix I: Team Performance Survey
Appendix II: List of Common Agile Practices
Appendix III: New PM Onboarding Checklist
Appendix IV: Transition Plan
Appendix V: Resource Management Definitions
Appendix VI: Generic Job Description for a Director-Level Development Project Manager
Index