LUCENT
biopharma
Case Study 1
Training and development for pre-launch European Field Medical Team
Partnering with a pre-launch biotech who were establishing a brand-new European presence, LUCENT undertook detailed analysis of their European MSL capabilities, comparing those with the requirements for the impending first EU launch.
LUCENT delivered a detailed and bespoke MSL training and development program, which we delivered over the subsequent months leading-up to European product launch.
Our US client, with a product launch completed in the US, started with a simple question: ‘What do we need to think about for a European launch of our product’.
Taking the lead on the gap and needs analysis for European reimbursement, LUCENT then delivered to them a European Reimbursement Playbook, with a detailed roadmap for achieving reimbursement in each of the EU5.
Case Study 2
European reimbursement - Strategic analysis of data availability and gaps
Case Study 3
Omni-channel strategy, compliance, build and roll-out
Becoming a core part of the in-house technical and marketing team, LUCENT partnered with a newly operational EU biotech to plan, develop, test and build their omni-channel strategy.
What LUCENT delivered over the coming months was an entirely new framework for the compliant delivery of both promotional and non-promotional digital content, weaving together web-portals, online webinars and automated delivery of email marketing, all of high clinical value and entirely compliant.
As part of early-thinking in the planning for a European launch, our client partner asked for a clear, and segmented forecast and scenario plan for the European market, for their Phase 2 asset. Primarily to support in answering the question, ‘Do we out-licence or do we go-it-alone?’ it was as part of this project that the phrase ‘The Third Way’ was first used to describe LUCENT’s approach.
Case Study 4
European forecasting for a Phase 2 asset
Case Study 5
Pre-launch European strategy development and implementation
As our client-partner awaited regulatory feedback on their MAA in Europe, we were asked to develop a medico-marketing strategy for launch, including strategic pillars, medical imperatives and estimate project plans and budgets for key activities.
The final deliverable was an in-depth medico-marketing launch plan, closely aligned to global strategy with detailed timelines and costs.
Our US clients’ data needs in Europe beyond launch were far-reaching, and built around a single Phase 4 study. They asked what else they could be doing to support product strategy.
LUCENT added a sophisticated suit of RWE gathering exercises in key European countries, including a retrospective analysis of all Phase 2 and 3 databases to deliver new insights to their launch product.
Case Study 6
European RWE clinical development planning
Case Study 7
Phase 3b clinical study design, operationalisation and reporting.
Our client-partner asked LUCENT to design and implement a Phase 3b study for a new medicine – to generate new data on the product and to support its regulatory and reimbursement plans.
LUCENT designed and set-up the study, including protocol authorship, CRF design, site recruitment and SAP development, ultimately recruiting over 230 patients to treatment. We then wrote up the outcomes and successfully published the study.
The first step for our client following the initiation of the Phase 3 development program was the exploration and creation of a key-opinion leader network across Europe.
LUCENT led on over-mapping clinical development sites, scientific leadership and likely key-prescribing centres to deliver a KOL network across Europe that entirely belonged to our client.
Case Study 8
European key opinion leader and prescriber network development.
Case Study 9
Strategic advisory board creation and management.
Drawing on the KOL network that we had previously built from scratch, LUCENT developed a highly strategic framework for the gathering of insight, scientific feedback and challenges, and from that established a tiered system of Advisory Board and Scientific Steering Committees for key projects.
LUCENT partnered with its European client to develop and then execute on a range of EU scientific speaker meetings – some associated with key congresses, others stand-alone. Fifteen non-promotional scientific meetings were designed and delivered overall.
Case Study 10
Medical education scientific speaker meetings
Case Study 11
New indication strategic review regulatory application and launch.
With a medicine already in market, and an expected new indication available in the next 12 months, our client needed to understand the potential for the new indication in Europe and what would be required to get it there.
LUCENT performed this European analysis proposing a range of scenarios on which they could base their plans for this new launch.