SOMES REFERENCES

 

Our unique position as a team experts in scientific and technical information analysis, and focused exclusively on life sciences, makes us a privileged partner for actors in the Health, Pharmaceuticals, Biotechnology and Medical Devices sectors.

We can suppor all departments

  • R&D

  • Scientific Documentation

  • Pharmacovigilance

  • IP

  • Marketing / Prospective

  • Management

CASE STUDIES

LITERATURE REVIEW

Clinical and Non Clinical

​BACKGROUND & OBJECTIVES :

A pharmaceutical company asked BIOLEDGE to undertake an overview of the clinical and non-clinical literature to identify new and significant safety findings about a marketed medicinal product.

STATE-OF-ART

Manufacturing Process

BACKGROUND & OBJECTIVES :

An injectable manufacturer faced with an industrialization process issue concerning the presence of impurities in finished products needed to improve its understanding related to the control of pharmaceutical impurities.

COMPETITIVE LANDSCAPE

Immunotherapy

BACKGROUND & OBJECTIVES :

A biotechnology company required insight into the scientific, technological, and competitive environment in ovarian cancer treatment by immunotherapy, in order to identify therapies under development and key actors in the field.

CLINICAL AND NON CLINICAL LITERATURE REVIEW

Background & Objectives

A pharmaceutical company asked BIOLEDGE to undertake an overview of the clinical and non-clinical literature to identify new and significant safety findings about a marketed medicinal product.

Approach

BIOLEDGE used a selection of bibliographic databases to conduct a wide and qualitative literature search in order to identify, in published case reports and clinical trials, new signals and safety information related to the same active substance of the product in question.

Result

The Marketing Authorization Holder was provided with a report that detailed the overall safety findings over the updated period. These clinical and non-clinical overviews have enabled the Pharmacovigilance unit to update their routine safety reports (PSUR/PBRER) and address safety related data on their medicinal product.

STATE-OF-ART RELATED TO A MANUFACTURING PROCESS

Background & Objectives

An injectable manufacturer faced with an industrialization process issue concerning the presence of impurities in finished products needed to improve its understanding related to the control of pharmaceutical impurities.

Approach

Information research has been operated both on internet sources, patent and scientific literature databases subscribed. Bioledge used a bibliometric tool to pre-analyze gathered documents and validate its conclusions with expert interviews.

Result

BIOLEDGE was able to: 

  • offer an extensive and precise overview of knowledge about sources of impurities in the academic and industrial world

  • identify international KOLs working on this field (academic and industrial players) to develop new expertise

  • map new and promising technologies relevant in controlling these specific impurities.

    IMMUNOTHERAPY COMPETITIVE LANDSCAPE

    Background & Objectives

    A biotechnology company required insight into the scientific, technological, and competitive environment in ovarian cancer treatment by immunotherapy, in order to identify therapies under development and key actors in the field.

    Approach

    BIOLEDGE‘s solution consisted in analyzing patents, scientific papers, and clinical trials. The corpus was loaded into a text-mining and data-visualization tool and enriched using specific thesauri. After global and simultaneous processing, discovery and analysis of the relevant documents allowed a pertinent description of the competitive environment and trends through interactive visualizations.

    Result

    Visualizations were used to identify different market players and therapeutic approaches. We created a comprehensive report on the entire landscape of immunotherapy in ovarian cancer.

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