Meet the Authors

Jay Jackson

Partner, Market Access Practice Lead

Evidence Generation Strategy for a New Drug Formulation

Client Overview

A global pharmaceutical company worked with us to plan their European Union (EU) access strategy for a novel oncolytic drug based on a new formulation. The goal was to identify strategic value drivers for compound development and ensure optimal market access upon product launch.

Client Profile

Our client, a prominent global pharmaceutical company, aimed to develop a new formulation for a mature brand, with a specific focus on the oncolytic drug segment. To achieve this, they needed to define a market-relevant value proposition and establish an early target value hypothesis to guide their compound development strategy effectively.


  1. Developing a new formulation for a mature brand: The client aimed to revitalize a mature brand by introducing a novel formulation. This endeavor required a robust value proposition and a thorough understanding of the market dynamics.

  2. Identifying underserved patient populations: To succeed in the competitive pharmaceutical landscape, the client needed to pinpoint underserved patient populations within their target disease area.

  3. Determining payers’ willingness to pay: Understanding the willingness of payers to invest in solutions for unmet medical needs and the key requirements for market access was vital for the success of the new formulation.

  4. Early target value hypothesis: The client required an early target value hypothesis that would guide their compound to become a first-in-class therapy and provide a superior value alternative for disease treatment.

Our Solution

To address these challenges, our team implemented a comprehensive evidence-generation strategy:

  1. Assessment of epidemiologic and clinical literature: We conducted an in-depth assessment of the epidemiologic and clinical literature to identify underserved patient populations in the client’s target disease area. This step provided critical insights into the unmet medical needs.

  2. Secondary analysis of payers’ decisions and expert interviews: We performed a secondary analysis of payers’ decisions related to analogs in the market and conducted interviews with advisors to Health Technology Assessment (HTA) and payer bodies. This helped us determine payers’ willingness to pay for solutions to unmet needs and the key requirements for market access.

  3. Testing the proposed value proposition: Our team conducted final testing of the proposed value proposition, which identified key differentiating product attributes and clinical trial endpoints in the early phases of product development. This also helped in identifying likely access barriers that the client’s access strategy would need to address.

Herspiegel case study evidence generation for market access strategy


Value Delivered

The early target value hypothesis provided by our team guided the client’s compound to become a first-in-class therapy. This allowed the client to establish a superior value alternative for disease treatment in a highly competitive market.

This demonstrates the successful application of an evidence generation strategy to plan the EU access strategy for a new drug formulation. By conducting a thorough assessment of patient populations, understanding payers’ willingness to invest, and defining a compelling value proposition, the client was able to achieve a superior market position and create a first-in-class therapy.


Meet the Authors

Jay Jackson

Partner, Market Access Practice Lead

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Herspiegel is a leading professional services firm helping biotech start-ups and the world’s largest pharmaceutical companies navigate the path from science to brand performance and change patients’ lives. We are committed to using strategic insights from medical to commercial to market access to solve critical problems.