Using NPV, Probability of Success and Time to Peak Sales to Rank Projects Using NPV, Probability of Success and Time to Peak Sales to Rank Projects The pharmaceutical industry operates under varying degrees of risk, with significant investments directed toward research and development (R&D) of new therapeutics. In this landscape, prioritizing projects effectively is essential to ensure optimal resource allocation and maximize the likelihood of commercial success. This manual serves as a comprehensive guide for pharmaceutical professionals focused on utilizing net present value (NPV), probability of success, and time to peak sales as key metrics for project evaluation, aligned with…

Integrating Regulatory Risk into Portfolio Management and Scenario Planning Integrating Regulatory Risk into Portfolio Management and Scenario Planning As the pharmaceutical industry becomes increasingly complex and competitive, the integration of regulatory risk into portfolio management and scenario planning is critical. The development and approval processes for pharmaceuticals are not only lengthy but also fraught with uncertainty. This uncertainty necessitates clear criteria for go/no-go decisions, effective communication strategies for boards of directors, and robust methodologies for assessing and managing regulatory risks. This manual will provide a thorough exploration of these elements aligned with FDA, EMA, and MHRA expectations. Understanding Go/No-Go Decision…

Case Studies Where Poor Go No-Go Decisions Led to Major Write Offs Case Studies Where Poor Go No-Go Decisions Led to Major Write Offs Introduction to Go/No-Go Decisions in Pharmaceutical Development Go/No-Go decisions represent critical junctures in the drug development process, determining whether a project should advance to the next phase or be halted. These decisions are influenced by multiple factors, including market analysis, regulatory risk signals, development timelines, and resource allocation. Poor decision-making can lead to significant financial repercussions, including wasted investments and missed opportunities for innovation. In this article, we will explore the factors that contribute to effective…

Risk management tools for pipeline prioritisation across multiple assets Risk Management Tools for Pipeline Prioritisation Across Multiple Assets The field of pharmaceutical development is characterized by high levels of uncertainty and complexity, necessitating robust frameworks for decision-making. Central to this process is the implementation of effective risk management tools aimed at prioritizing assets within a pipeline. This article outlines the critical components and methodologies employed in risk management for drug development, focusing on go/no-go decision criteria, probability of success assumptions, and the strategic integration of AI-enabled portfolio tools. Understanding Go/No-Go Decision Criteria Go/no-go decision criteria serve as pivotal checkpoints within…

How to design data driven go no go criteria from preclinical to phase 3 How to Design Data Driven Go No Go Criteria from Preclinical to Phase 3 Effective decision-making in pharmaceutical development is critical, particularly when considering the multitude of risks associated with drug development. As organizations aim to optimize their portfolios, the establishment of well-defined go no go decision criteria is paramount. This article provides a comprehensive guide on designing data-driven go no go criteria that encompasses all relevant phases of drug development, from preclinical to phase 3, while considering the regulatory landscapes in the US, UK, and…

Go No Go Decision Frameworks for Pharma R&D and Regulatory Milestones Go No Go Decision Frameworks for Pharma R&D and Regulatory Milestones Introduction to Go No Go Decision Frameworks In the pharmaceutical industry, making timely and informed decisions on which projects to advance through the research and development (R&D) pipeline is crucial. Go no go decision frameworks serve as the foundation for pharmaceutical portfolio management, guiding stakeholders to evaluate and prioritize drug development initiatives based on objective criteria. These frameworks are essential in balancing innovation with the rigors of regulatory compliance, particularly in the context of US FDA regulations, EMA…

Balancing High Risk Breakthrough Programs with Lower Risk Incremental Projects Balancing High Risk Breakthrough Programs with Lower Risk Incremental Projects The pharmaceutical industry is navigating an increasingly complex landscape characterized by rapid advancements and stringent regulatory frameworks. In this environment, effectively balancing high-risk breakthrough programs against lower-risk incremental projects is pivotal. This balancing act, when managed properly, can optimize the research and development (R&D) portfolio, ensuring that both transformational and traditional avenues are pursued simultaneously. The objective of this article is to provide a comprehensive overview of the go no go decision criteria, pharma portfolio risk management, and R&D portfolio…

Using Stage Gate Models and KPIs to Structure Portfolio Decision Points Using Stage Gate Models and KPIs to Structure Portfolio Decision Points Effective drug development hinges upon strategic decision-making at critical junctures. The stage gate model provides a systematic approach to progress through research and development (R&D) while ensuring that resources are allocated efficiently. This article will explore the role of stage gate models, key performance indicators (KPIs), and go/no-go decision criteria, as they relate to pharma portfolio risk management and prioritization. The focus will be on FDA guidelines, EMA/UK regulations, and the European Union (EU) expectations, addressing the important…

Regulatory Signals That Should Trigger Re-Evaluation of Development Programs Regulatory Signals That Should Trigger Re-Evaluation of Development Programs In the complex arena of pharmaceutical development, the ability to make timely and informed go/no-go decisions is essential for the efficient management of a drug portfolio. Regulatory signals play a critical role in these decisions. This article aims to provide comprehensive insights into the regulatory signals that should prompt a re-evaluation of development programs, integrating guidance from the FDA, EMA, and MHRA, as well as considerations for effective pharma portfolio risk management. Understanding Go/No-Go Decision Criteria The go/no-go decision process is a…

How to Incorporate Patient and Payer Perspectives into Go No-Go Decisions Incorporating Patient and Payer Perspectives in Go No-Go Decision Making The pharmaceutical industry is under increasing pressure to demonstrate not only the scientific and clinical efficacy of new drugs but also to validate their economic viability in terms of healthcare accessibility and overall cost-effectiveness. A strategic framework for effectively incorporating patient and payer perspectives into go no-go decisions is critical in the drug development process. This article delineates key factors and methodologies for pharma professionals regarding how these perspectives can inform R&D portfolio prioritization and risk management. Understanding Go…