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Maximizing Drug Development Success: The Strategic Role of Target Product Profiles (TPPs)
Enhancing drug development efficiency through strategic planning
Ian Fisher, Senior Director, Design Analytics, Regulatory Affairs and Drug Development Solutions, IQVIA
Jin Chen, Therapeutic and Regulatory Strategy Vice President, Regulatory Affairs and Drug Development Solutions
Manesh Bedder, Senior Director, Drug Development Team Lead, Regulatory Affairs and Drug Development Solutions
May 14, 2025
  • Blogs
  • Maximizing Drug Development Success: The Strategic Role of Target Product Profiles (TPPs)

Introduction

In the competitive and complex landscape of drug development, early-stage planning strategies, particularly the use of Target Product Profiles (TPPs), are essential for optimizing drug development and ensuring commercial success. TPPs are dynamic frameworks that encapsulate the desired attributes of a drug; aligning clinical, regulatory, and commercial objectives. They serve as a roadmap, ensuring that every step taken in the development process is purposeful and directed towards a clear goal.

The importance of TPPs has grown significantly as the number of distinct drugs in development has nearly doubled over the past decade, driven by the emergence of novel modalities and a deeper understanding of disease biology. By providing a structured approach to drug development, TPPs help teams anticipate and address potential obstacles, optimize resource allocation, and ultimately increase the likelihood of success.

Drawing from recent industry insights and supported by data from the Citeline research report, "How Early-Stage Planning Strategies Are Optimizing Drug Development," there’s clear evidence how TPPs can optimize early-stage planning, enhance stakeholder engagement, and integrate advanced technologies like AI.

Understanding TPPs is crucial for drug development

TPPs are strategic tools that outline the desired attributes of a drug, guiding its development from early stages through to approval and commercialization. They help align clinical, regulatory, and commercial objectives, ensuring that all stakeholders are working towards a common goal. The importance of TPPs has grown as drug development has become more competitive. According to the research report, the vast majority of biopharma companies now use TPPs, reflecting a broader recognition of their value. However, the approach to TPP deployment varies, with many companies focusing primarily on regulatory and feasibility considerations.

Key industry research findings

A significant majority of respondents, 83%, have a TPP for their assets, with regulatory reviews and feasibility studies being the primary methods of testing these profiles. However, only 68% of companies explore multiple TPPs for each asset, indicating room for improvement in strategic planning. Regulatory compliance, commercial viability, and technical feasibility are the top priorities when developing a drug development plan. The research supports this, showing that regulatory compliance is the most critical factor for both emerging and mega pharma companies. External expertise is crucial for strategic planning, with 75% of respondents seeking external partners for regulatory operations, clinical strategy, and TPP identification. This trend underscores the value of diverse perspectives in optimizing drug development strategies.

The role of AI in commercial success

TPPs serve as a roadmap for drug development, ensuring that all efforts are aligned with the ultimate goal of regulatory approval and market success. The research report highlights the need for a well-defined TPP to navigate the complexities of modern R&D. Several challenges were identified, including the need for better stakeholder engagement and the integration of patient needs into TPPs. Companies must also navigate regulatory complexities and ensure that their development plans are commercially viable. The role of AI and other advanced technologies in drug development is growing. These tools can help optimize trial designs, analyze large datasets, and predict commercial success, making them invaluable for modern R&D.

Early biopharma versus mega pharma

Smaller companies often face resource constraints, making it essential to leverage external expertise and advanced technologies. The research report provides examples of how emerging pharma companies prioritize commercial viability and technical feasibility in their development plans. Larger companies focus on managing costs and risks, with a strong emphasis on regulatory compliance. The research report shows that mega pharma companies are more likely to invest in advanced technologies and external partnerships to optimize their development strategies.

Strategic partner collaboration

Companies should create detailed TPPs that consider multiple scenarios and include input from all stakeholders. This approach ensures that development plans are robust and adaptable. Early and continuous engagement with regulators, payers, and patient advocacy groups is crucial for aligning development efforts with market needs. Investing in AI and other advanced technologies to optimize trial designs, analyze data, and predict commercial success is essential. Collaborating with external partners to gain diverse perspectives and enhance strategic planning is highly recommended.

Ready to learn more?

The use of TPPs in drug development is essential for navigating the complexities of modern R&D. By adopting comprehensive TPPs, engaging stakeholders, leveraging advanced technologies, and utilizing external expertise, companies can optimize their development strategies and increase the likelihood of commercial success. The insights from recent industry discussions and the supporting research report underscore the transformative potential of TPPs in modern drug development.

For personalized guidance and expert support in developing and implementing TPPs, contact IQVIA today. Our team of seasoned professionals is ready to help you navigate the complexities of drug development and achieve your strategic goals.

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