Use case #1 : Efficacy & Valorization

New efficacy data and enhancement of a marketed product

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Objectives

Revitalize the medical-scientific communication of an existing product and strengthen the product's efficacy evidence without conducting a clinical study

Environment

  • Status: Drug
  • Phase: Marketed Product - Enhancement / Efficacy Demonstration

Project Requirments 

  • Identify an innovative approach related to the pathophysiology of the disease, the properties of the product, and international guidelines recommendations.
  • Develop a translational in vitro model to humans.
  • Provide robust and impactful evidence of efficacy.
  • Differentiate from competing products.
  • Publish the results in an international specialized journal.

Project Structuring

Analysis

  • Review of scientific literature focusing on pathophysiology and new treatment perspectives.
  • Comparative analysis of the mechanisms of action of different market players.
  • Evaluation of available experimental models.
  • Identification of innovative, coherent, and differentiating approaches.

Proposal to evaluate the product's activity on a new emerging mechanism of action in the scientific literature. This approach should be coherent with the pathophysiology and mechanism of action, as well as innovative and differentiating compared to competitors.

Design

  • Design of an in vitro study as translational as possible to the human situation:
  • Use of primary cells (not previously described for this cell type).
  • Testing performed with finished products (medications) rather than active ingredients to be as close as possible to the clinical situation.
  • Dosage aligned with clinical conditions for all tested products.
  • Identification of robust, visual, and impactful study parameters to integrate the requirements of medical-marketing teams and sales forces from the project’s inception.
  • Validation of the study proposal by international Key Opinion Leaders (KOLs) to assess the alignment of the approach with international guidelines.
  • Identification of CROs for conducting the study

Realization

  • Contractualization with the CRO on behalf of the client.
  • Supervision of the study (scientific, budgetary, and scheduling coherence) on behalf of the client.
  • Management of risks and deviations.
  • Analysis of results and consistency with objectives and scientific hypotheses.

Valorization

  • Identification of the best value-enhancement levers.
  • Creation of a scientific presentation for sales teams.
  • Identification of target journals and drafting of a scientific publication (link to the publication).
  • Organization of a Q&A session with sales teams to present key points and messages from the publication and facilitate the assimilation of the scientific discourse.
  • Identification of relevant conferences, drafting, and submission of abstracts.
  • Creation of a presentation and talk at a major conference in the field (link to the conference).

This project, conducted according to the budget, schedule, and specifications, enabled immediate value enhancement by the medical-marketing teams and sales forces of the laboratory

The commercial success was clearly driven by the scientific dimension and is closely linked to:

  • The consideration of medical-marketing communication from the inception of the project enabled the construction of a robust scientific study with impactful messaging for the sales teams.
  • The use of human material and experimental conditions closely aligned with clinical reality facilitated a translational approach to humans without the need for a clinical study.
  • The study design highlighted an original and innovative mechanism of action, improved understanding of the disease pathophysiology, and fully aligned with international guidelines.
  • The publication of results in a specialized journal and communication at a major conference established the scientific credibility of the results and provided valuable elements for enhancement and comparison for the sales teams.

Overall, the costs and timelines associated with this project were minimal compared to those of a clinical study. Similarly, the risk was contained. However, the economic value of the experimental results was high due to the originality, translational nature, and robustness of the study, as well as the clarity and impact of the key messages.

The return on investment was therefore very positive for the client

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