Our European Navigator Solution
European Navigator leverages a series of proprietary tools tailored for life sciences companies, enabling them to map out a clear path towards realising the full value of their assets under development. Each tool aligns with the evolution of a company as they progress through clinical development planning, prelaunch and commercial phases.
Our European Navigator provides you with a clear understanding of the paths to market available, with the end goal of building a coherent and executable plan that benefits from our local market expertise, capturing the full potential of the technology to deliver on the commercial promise over the life of the asset. At the intersection of an executable strategy and operational know-how, Navigator maximises your outcome.
Clinical Development Storyboard and Target Prioritization
We’re all aware of cases where medical and clinical teams focus on ensuring the science is sound and the technology can be approved, but carry out poorly designed trials that fail to meet the needs of the market, patient or reimbursement authorities. Understanding how to prioritize attributes and corollate end points of a clinical trial so that outcomes align with the key value messages from a regulatory, commercial or market access point of view is central to our Navigator approach, ensuring poorly designed trials don’t happen. And from trial onwards, we enable clinical development to optimize pipelines and ensure the highest probability for generating commercial success.
Prelaunch Market Assessments and Go To Market Strategic Plan
Prelaunch planning plays a critical role in understanding the commercial path forward as assets advance through registration trials. We place our clients into a commercial launch plan as early as launch minus 36 months to better understand every aspect of the project. Some of the key deliverables of the plan are
- Specific market dynamics
- KOL opinions
- Patient journey
- Pricing and reimbursement pathway
- Bottom up patient based revenue forecast
- Corporate/commercial/operational infrastructure need
- Associated operating plans/budgets.
Once the optimal path forward is understood, we begin to execute the prelaunch activities necessary to ensure launch readiness and a successful commercialisation for either our client or their licensing partner.
Our team provides end-to-end regulatory affairs services and expertise-driven product development advice from the early stages of development through to post-market support. Our complete and comprehensive expert understanding of the requirements in global regulatory affairs, coupled with a strong commercial awareness, ensures we devise an optimal regulatory strategy for the registration of your new innovative drug, medical device, borderline product, generic medicine, line extension or additional indication.
Small biotechnology companies often seek to adopt a “virtual model” to support their day-to-day commercial operations in the European market due to the significant expense and potential governance risk. Solem is well positioned to support both the design and implementation of the necessary infrastructure to both commence and then thrive in the market. Whether that is choosing the right geography for your HQ, determining the most appropriate route to market to access your end customers or consideration for the most optimal solution in revenue recognition, Solem has the answers to all those complex questions.
The pharmaceutical supply chain is complex and pharmaceutical companies must address the most common challenges in order to get patients their needed medications efficiently. Solem has vast experience in supporting organizations who are commercialising their first product and help them engage with key stakeholders in Commercial, Legal, Finance and Tax to ensure alignment within the company. Our proven operational and procurement methodologies as well as our deep understanding of the outsourced market will enable companies to benefit from best in class services from its chosen vendors, at the right price, at the right time.
A NAVIGATOR CASE STUDY The value of a proven executable path.
When a biotech organisation adopted the common thought process of believing that prelaunch work would fall to the commercial partner, they suddenly found themselves concerned about being behind. We were able to launch our proven Navigator process to help bring our client back on schedule and avoided and delayed launch timescales.
Go further Global Solutions
Solem is an international life sciences consultancy committed to developing and executing tailored client solutions that navigate complex product development and commercialisation challenges, ensuring innovative treatments find their way to market and to patients in need.
OUR EXPERTISE The Outlicencing Alternative
A compelling alternative to outlicencing, we offer a de-risked model which gives our clients a detailed and comprehensive commercialisation solution across European and International markets. One which leverages a tailored launch plan, strategic brand plan and locally refined but fully integrated execution, all fulfilled by a bold team of in-market experts.