Strategic Portfolio Management in Drug Development Training Course

Strategic Portfolio Management in Drug Development Training Course

Introduction

Strategic Portfolio Management in Drug Development Training Course is designed to empower leaders and professionals in the biopharmaceutical sector with the advanced skills needed to navigate the complex and high-stakes world of drug development. In an era of increasing R&D costs and intense market competition, mastering portfolio strategy is no longer a luxury, but a necessity. This comprehensive program delves into the data-driven decision-making frameworks and innovative methodologies essential for optimizing R&D pipelines, maximizing asset value, and ensuring sustainable growth. Participants will learn how to align their companyΓÇÖs drug portfolio with overarching corporate strategy, mitigate inherent risks, and accelerate the commercialization of groundbreaking therapies.

The course content is meticulously crafted to be highly SEO-friendly and rich with trending keywords to attract the right audience. We focus on real-world application, incorporating case studies from both small-cap biotech and large-scale pharma companies. This hands-on approach ensures that you will not just learn the theory but also gain practical expertise in pipeline optimization, resource allocation, and risk management. By the end of this training, you will be equipped to lead your organization's drug development efforts with a clear, strategic vision, driving R&D productivity and securing a competitive edge in the global market.

Course Duration

10 days

Course Objectives

Upon completion of this course, you will be able to:

• Implement effective R&D portfolio management strategies.
• Optimize your drug pipeline for maximum asset value and ROI.
• Apply data-driven decision-making tools in drug development.
• Master advanced risk assessment and mitigation techniques.
• Align the project portfolio with corporate strategy and business goals.
• Enhance resource allocation for improved R&D productivity.
• Lead and facilitate pipeline reviews and project governance meetings.
• Utilize financial modeling and valuation methods for projects.
• Navigate the complexities of market dynamics and competitive intelligence.
• Evaluate and prioritize drug candidates using quantitative and qualitative criteria.
• Integrate digital technologies and AI into portfolio management.
• Understand the impact of regulatory affairs and intellectual property on portfolio decisions.
• Develop robust lifecycle management strategies for marketed drugs.

Target Audience

• R&D Leadership and Management
• Portfolio and Project Managers
• Strategic Planning and Business Development Teams
• Finance and Investment Analysts in the life sciences
• Clinical Development and Operations Leaders
• Medical Affairs and Commercial Teams
• Early-Stage Researchers and Scientists seeking to understand the commercial aspects of their work
• Regulatory Affairs and Quality Assurance professionals

Course Modules

Module 1: Foundations of Strategic Portfolio Management

• Core Concepts: Understanding the principles of portfolio management.
• Industry Challenges: Addressing declining R&D productivity and rising costs.
• Strategic Alignment: Linking the portfolio to corporate vision.
• Key Stakeholders: Identifying and managing expectations.
• Case Study: The rise and fall of a major pharma company's portfolio.

Module 2: R&D Pipeline Analysis & Optimization

• Pipeline Metrics: Measuring success beyond traditional KPIs.
• Go/No-Go Decisions: Establishing clear decision criteria.
• Optimization Techniques: Balancing risk and reward.
• Pipeline Scenarios: Exploring "what-if" analyses.
• Case Study: Optimizing a late-stage oncology pipeline.

Module 3: Risk Management in Drug Development

• Identifying Risks: Technical, clinical, regulatory, and market risks.
• Quantifying Uncertainty: Using probability and statistics.
• Risk Mitigation: Developing contingency plans.
• Portfolio Diversification: Spreading risk across therapeutic areas.
• Case Study: Managing the risks of a breakthrough gene therapy project.

Module 4: Financial Modeling & Valuation

• Net Present Value (NPV): Calculating project value.
• Expected Commercial Value (ECV): Assessing potential returns.
• Valuation Methods: Comparing projects using various models.
• Cost of Capital: Understanding its impact on decisions.
• Case Study: Valuing a novel compound from Phase 1 to launch.

Module 5: Resource Allocation & Capacity Planning

• Resource Constraints: Human, financial, and time resources.
• Prioritization Frameworks: Using scoring models and matrices.
• Resource Allocation: Distributing resources strategically.
• Capacity Planning: Ensuring resource availability for future projects.
• Case Study: Re-allocating R&D budget after a major clinical setback.

Module 6: Competitive Intelligence & Market Dynamics

• Competitive Landscape: Analyzing rival pipelines and market positioning.
• Unmet Medical Need: Identifying opportunities for innovation.
• Market Analysis: Forecasting market size and growth.
• First-Mover Advantage: Assessing the value of being first-to-market.
• Case Study: A comprehensive market analysis for a new rare disease drug.

Module 7: The Role of Governance & Executive Decision-Making

• Governance Structures: Setting up effective portfolio review committees.
• Decision-Making Biases: Recognizing and mitigating cognitive biases.
• Portfolio Reviews: Conducting routine and ad-hoc evaluations.
• Executive Communication: Presenting complex data clearly to leadership.
• Case Study: Overcoming sunk cost fallacy in a failing project.

Module 8: Integrating AI & Digital Tools

• AI in Drug Discovery: Accelerating target identification.
• Predictive Analytics: Forecasting clinical trial success.
• Portfolio Software: Using advanced analytics platforms.
• Real-World Evidence (RWE): Incorporating post-market data.
• Case Study: Leveraging AI to identify new therapeutic areas.

Module 9: Lifecycle Management of Marketed Assets

• Post-Launch Strategy: Maximizing a drug's commercial life.
• Line Extensions: Developing new indications.
• Patent Cliff: Planning for loss of exclusivity.
• Generic Competition: Strategies for maintaining market share.
• Case Study: Extending the lifecycle of a blockbuster drug.

Module 10: Partnerships, Licensing & M&A

• Strategic Partnerships: Collaborating to share risk and resources.
• In-Licensing vs. In-House Development: Weighing options.
• Due Diligence: Assessing a potential asset for acquisition.
• M&A Strategy: Identifying portfolio gaps to fill via acquisition.
• Case Study: The strategic rationale behind a major biotech acquisition.

Module 11: Intellectual Property & Regulatory Strategy

• Patent Protection: Securing and defending intellectual property.
• Regulatory Pathways: Navigating global submission processes.
• Regulatory Intelligence: Staying ahead of new policies.
• Adaptive Trial Design: Designing flexible clinical studies.
• Case Study: Navigating FDA and EMA regulations for a complex biologic.

Module 12: Building a High-Performing Portfolio Team

• Team Structure: Defining roles and responsibilities.
• Cross-Functional Collaboration: Fostering communication across departments.
• Change Management: Implementing new portfolio processes.
• Leadership Skills: Developing the next generation of portfolio leaders.
• Case Study: Restructuring an R&D department to improve portfolio performance.

Module 13: Special Topics in Drug Development

• Precision Medicine: Tailoring therapies to patient subsets.
• Orphan Drugs: Managing small-market, high-impact projects.
• Biologics & Cell Therapy: The unique challenges of these assets.
• Medical Devices: Portfolio considerations for a different product class.
• Case Study: The portfolio strategy for a personalized cancer vaccine.

Module 14: Practical Application: Portfolio Review Simulation

• Data Room: Analyzing a mock portfolio with real-world data.
• Scenario Planning: Responding to unexpected events.
• Decision-Making: Making and defending resource allocation decisions.
• Executive Presentation: Delivering a compelling portfolio review.
• Case Study: A full-scale simulation of a quarterly portfolio review.

Module 15: Capstone Project

• Individual Project: Applying all learned concepts to a real-world problem.
• Peer Review: Providing and receiving constructive feedback.
• Final Presentation: Presenting a comprehensive portfolio strategy.
• Expert Feedback: Getting insights from industry veterans.
• Case Study: Developing a complete portfolio strategy for a new biotech venture.

Training Methodology

This course utilizes a blended learning approach to ensure maximum engagement and retention. The methodology includes:

• Interactive Lectures: Dynamic presentations with Q&A sessions.
• Hands-on Workshops.
• Collaborative Case Studies: Group work on complex, real-world scenarios.
• Simulation Exercises: A multi-day, immersive portfolio review simulation.
• Peer-to-Peer Learning: Networking and discussion among participants.
• Expert Panels: Insights from leading industry professionals.
• Post-Course Mentorship: Optional one-on-one sessions for continued support.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.