医学事务

案例展示

在高度竞争的环境中为扩大药品上市许可范围提供长期支持

The vision was to expand a product’s marketing license into a new and challenging patient subpopulation facing a high degree of unmet need, spanning multiple indications and specialties.

We comprehensively supported a spectrum of medical activities over a 2-year period around the label change. Consistent support from a core team ensured clinical insights and technical knowledge gained at each stage were built upon as the overall strategy evolved and tactics delivered. Furthermore, our collaborative in-house approach brought in technical expertise from other specialist teams across Costello Medical to optimise related projects, offering joined-up support to achieve the long-term goal.

Targeted literature reviews performed in collaboration with our evidence development team identified existing gaps in treatment management and evidence for the current unmet need for this specific patient subpopulation. These findings informed the overall strategic objectives and laid the foundations for the communication plan.

Engaged international experts through advisory board meetings to closely examine and interrogate the supporting clinical data. Resulting insights fed into the development and testing of a scientifically robust and compelling narrative for the value of the product in this patient group.

Comprehensive and engaging internal training programmes were designed, developed and deployed in close partnership with our in-house design team. Engaging eLearning modules, interactive slide kits, training events and assessments equipped medical field teams with the technical knowledge required to speak with accuracy and consistency around the science behind the label change.

Targeted multichannel medical and educational activities, events and tools deployed to engage external stakeholders around the license expansion. These spanned educational webinars and symposia, standard-response documents and interactive slide kits. Close collaboration with our publications team enabled us to fast-track communications based on pivotal publications. All activities involved a critical attention to compliance.

Post regulatory change, the collaboration deepened to include scientific, training and technical support of the commercial and market access teams and activities driving global product re-positioning. Our effective long-term partnership with multilevel medical support helped achieve the expansion of a product’s license to serve more patients.

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Explore our process

Targeted literature reviews performed in collaboration with our evidence development team identified existing gaps in treatment management and evidence for the current unmet need for this specific patient subpopulation. These findings informed the overall strategic objectives and laid the foundations for the communication plan.

Engaged international experts through advisory board meetings to closely examine and interrogate the supporting clinical data. Resulting insights fed into the development and testing of a scientifically robust and compelling narrative for the value of the product in this patient group.

Comprehensive and engaging internal training programmes were designed, developed and deployed in close partnership with our in-house design team. Engaging eLearning modules, interactive slide kits, training events and assessments equipped medical field teams with the technical knowledge required to speak with accuracy and consistency around the science behind the label change.

Targeted multichannel medical and educational activities, events and tools deployed to engage external stakeholders around the license expansion. These spanned educational webinars and symposia, standard-response documents and interactive slide kits. Close collaboration with our publications team enabled us to fast-track communications based on pivotal publications. All activities involved a critical attention to compliance.

Post regulatory change, the collaboration deepened to include scientific, training and technical support of the commercial and market access teams and activities driving global product re-positioning. Our effective long-term partnership with multilevel medical support helped achieve the expansion of a product’s license to serve more patients.