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. What emerged was a detailed and bespoke MSL training and development program, which we delivered over the subsequent months leading up to product launch

European reimbursement - Strategic analysis of data availability and gaps

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

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 emerged over the coming months was an entirely new framework for the compliant delivery of digital content, weaving together web-portals, online webinars and automated delivery of email marketing, all of high clinical value and entirely compliant

European forecasting for a Phase 2 asset

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

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

European RWE clinical development planning

Our US clients’ data needs in Europe beyond launch were far-reaching, and built around a single Phase 4 study. 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

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 for their key product – to generate new data on the product and to support it’s 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

European key opinion leader and prescriber network development

The first step for our client following development was the exploration and creation of a key-opinion leader network across Europe. Over-mapping clinical development sites, scientific leadership and likely key-prescribing centres led to the delivery of a KOL network across Europe that entirely belonged to our client

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

Medical education scientific speaker meetings

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

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 and proposed a range of scenarios on which they could base their plans for this new launch