Course Description
Covering the principles of project management as applied to the discovery and development of therapeutics within the pharmaceutical and biotechnology industries. Through an integrated approach, students will learn about the philosophy regarding and principles of project management and gain hands-on experience with project management software and collaborative platforms.
Athena Title
Project Management
Prerequisite
Acceptance into UGA Graduate School
Semester Course Offered
Offered fall
Grading System
A - F (Traditional)
Student learning Outcomes
- Students will develop a comprehensive understanding of project management principles and methodologies as applied to therapeutic discovery and development.
- Students will be equipped with practical skills to plan, execute, monitor, and close projects within the pharmaceutical and biotechnology sectors.
- Students will apply risk management, resource allocation, and budgeting strategies to real-world therapeutic discovery projects.
- Students will foster effective leadership and teamwork abilities for managing multidisciplinary project teams in a therapeutic research environment.
- Students will be equipped capabilities in stakeholder communication, reporting, and documentation essential for successful project delivery.
- Students will use tools and technologies for project tracking, data management, and collaborative work in drug discovery pipelines.
Topical Outline
- Module 1: Foundations of project management in therapeutic discovery
• Introduction to project management: Definition, key concepts, and the project lifecycle initiation, planning, execution, monitoring & control, closure).
• The therapeutic discovery pipeline: An overview of the stages from target identification to clinical trials from the perspective of management to understand the Product Development Lifecycle (PDL).
• Defining the project: Scope, goals, and success criteria for a therapeutic project.
• Stakeholder analysis: Identifying and managing the expectations of internal (researchers, management) and external (investors, regulatory bodies) stakeholders.
- Module 2: Project planning and execution
• Project scope and objectives: Defining clear project goals and deliverables.
• Work Breakdown Structure (WBS): Decomposing large therapeutic projects into manageable tasks.
• Scheduling and timelines: Creating and interpreting visual project schedules using Gantt charts. Identifying the longest sequence of tasks that determines the project's duration using the Critical Path Method (CPM).
• Data management and digital tools: Utilizing project management software, data analytics, and potentially AI/blockchain technologies to track progress, manage data silos, and improve decision-making.
• Resource allocation and budgeting: Assigning personnel and financial resources and creating a project budget: matching people and resources to project tasks.
- Module 3: Financial management
• Funding models: A comparison of funding for start-ups (venture capital) versus larger corporations.
• Project implementation, monitoring and control: Implementing the project plan. Monitoring project expenditures and controlling costs using Key Performance Indicators (KPIs) to track progress and make data-driven decisions.
• Change management: Handling changes to the project scope or plan.
• Project closure: The process of officially closing a project, documenting lessons learned, and archiving project data.
- Module 4: Risk and quality management
• Risk identification and assessment: Identifying potential risks in therapeutic projects, such as scientific failure, clinical trial setbacks including enrollment challenges, supply chain disruptions, or regulatory delays.
• Funding challenges: Evaluating and responding to changes in financial circumstances, collaborating with scientific leads to adjust plans as necessary, ensuring program continuity under revised funding conditions through clear communication, rigorous expenditure management, or, if required, program cancellation.
• Risk mitigation and contingency planning: Developing strategies to minimize or respond to project risks.
• Quality management in a regulated environment: Ensuring adherence to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and other regulatory standards.
• Problem-solving and adaptability: Thriving when faced with unexpected scientific results, regulatory changes, or market shifts by quickly adjusting plans and solutions.
• Ethical considerations: Addressing ethical dilemmas in therapeutic research and project management.
- Module 5: Leadership, team management, and communication
• Leadership in therapeutic projects: The role of the project manager as a leader. Strategies for managing and motivating a team. Fostering collaboration and communication within cross-functional teams. Grasping the relationship between individual projects and the overall company portfolio, ensuring alignment with strategic goals, and productively function within a framework of multiple interrelated projects.
• Effective communication: Developing strong communication plans for different audiences, including presentations and project status reports.
• Negotiation and conflict resolution: Handling disagreements and fostering a collaborative environment.
• Regulatory communication: Understanding the documentation and reporting requirements for regulatory bodies like the FDA.
- Methods to support students in meeting learning outcomes:
• Interactive lectures
• Case study analysis: Students will analyze a real-world therapeutic project, identifying its successes, failures, and management challenges.
• Project plan development: Students will work in teams to develop a comprehensive project plan for a hypothetical therapeutic development project (after the discovery phase) to be assigned by the instructors. This will include a WBS, Gantt chart, budget, and risk management plan.
Institutional Competencies Learning Outcomes
Leadership & Collaboration
The capacity to engage in the relational process of optimizing personal and collective strengths toward a common goal.
