An Israeli biotech company hired the interim manager to develop the global marketing strategy for an orphan drug and launch the drug in Europe. At that time, the company's focus was still on development and approval - and not on marketing and sales. The challenge was therefore to develop a holistic marketing strategy and to implement the associated tasks in marketing, sales and the wider organization. The expert in strategy development and implementation supported the biotech company in this mandate as Interim Chief Commercial Officer (Interim COO).
Global strategy and marketing campaign developed for Europe
In the strategy process, the interim manager made sure to closely involve all stakeholders from clinical research, medicine, regulatory affairs, production and quality control as well as the start-up's founder. In doing so, he created an essential basis for the marketing strategy to be supported by the entire company.
In several workshops, the team led by the interim manager developed the global marketing strategy for the company, product and brand. The result was clear definitions of positioning, customers and communication. The advantages of the product were clearly worked out and sales arguments were derived from this. In addition, the interim manager and his team formulated the details of the intended target groups (customer segments). This positioning was tested with potential customers in initial focus groups.
Based on the global strategy, the team initially developed a European marketing campaign and created marketing and sales materials. This ranged from sales folders, advertisements and sales articles to the complete design of a trade fair stand.
Sales structure set up for Europe and first managers recruited
In the next sub-project, the interim manager developed the sales strategy. The company decided to set up its own marketing and sales team in Europe and to identify potential sales partners for the non-European region.
The orphan drug was approved for all EU member states. However, the market analyses as part of the strategy development had shown that there was great potential for the drug in 8 regions (EU countries) in particular. The interim manager and his team therefore concentrated on setting up a marketing and sales structure for these regions. To this end, the interim COO developed detailed job descriptions for the first management level for each region and the support functions. Following a pre-selection of potential candidates, he organized an assessment for the management positions. Together with managers from Israel, the new marketing and medical director and HR specialists, all sales management positions were then filled.
Organizational and legal requirements for market entry created
The interim CCO's tasks also included creating the organizational and legal requirements for the launch of the orphan drug. These were primarily the establishment of a German subsidiary, the rental of office space, the import of the drug, storage, physical distribution, the wholesale license and, above all, pharmacovigilance.
The interim manager prepared the establishment of a GmbH in close cooperation with the Israeli parent company and lawyers from Israel and Germany. He identified several possible locations in the Rhine-Main area and organized site visits together with the CFO, which led to the selection of a location.
Logistics chain established and pharmaceutical law requirements fulfilled
Since the drug is subject to cold chain requirements, special requirements for transport and storage had to be taken into account. The interim manager contacted several providers and, together with production and quality control staff from Israel, selected a logistics partner based in Germany and supported the drafting of the contract.
In order to be able to sell the medicine directly to customers, a wholesale license had to be applied for and obtained for the German company. The interim manager obtained the permit with a team from Israel and the help of a German service provider.
Last but not least, the German subsidiary also had to fulfill the legal requirements for pharmacovigilance: To this end, the interim manager established both the 24/7 service and a European hotline.
Sales and marketing successfully set up for market launch
Based on the initially developed strategy, the interim manager implemented all the necessary tasks and created the basis for a successful launch. In addition to the successful implementation of the many sub-projects, the introduction of the orphan drug also made it possible to develop the "clinical-stage" biotech company into a "commercial- or fully-integrated-stage" biotech company
