Commercialization advice for rare diseases

Challenge

A small, Swiss-based biotechnology company with a pre-commercial pipeline of therapeutic antibodies for rare and ultra-rare diseases was preparing to launch its first asset. This company was looking for advice on how to transition from being a research-focused organization to becoming a global, commercial company with marketed drugs.

Solution

Our rare diseases specialist was instrumental in moving his previous company, Synageva, through the commercialization transition, so he was well-placed to guide our client. Over the course of two months, our consultant provided guidance on the size and structure of the organization the client would need in key markets (USA and selected European countries). This detailed outline included headquarter size, the number of personnel required and what roles needed to be filled within the initial medical, legal, and commercial teams. He also specified how those teams might be expanded in the future. His commercial advice included suggestions to maximize taxation efficiency within Switzerland and how to efficiently adhere to the regulatory rules guiding the use of antibodies in the USA and Europe. He prepared a comprehensive budget for their first year of commercial operations [MP: 1st year correct?] including marketing, medical affairs, commercial and sales force components.

The second major challenge our consultant solved was to define the supply chain. The therapeutic will be produced in Europe but sold globally, and both the client and our consultant anticipate substantial US sales. Our consultant informed the client on interstate regulations in the USA and country-specific regulations in Europe, and provided solutions to ensure a smooth supply chain across these borders.

Our consultant contacted and collaborated with key members of his personal network to ensure that he was providing the most accurate, up-to-date advice to the client, and was therefore able to accomplish these tasks in a short time. His network of experts has been built up over his many years of experience in rare diseases, and Alacrita has consultants based in Europe and in the USA, so we are tuned in to both markets. We have consultants and associates that can step into a variety of interim positions, including general managers and chief medical officers.

We’ve received very positive feedback from this client: we exceeded their expectations largely by providing concrete examples of how the organization and the supply chains should be structured. Our advice should see them through the transition from a research-focused organization to a pharmaceutical company with global potential.

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