How Sciensus supported the launch and distribution of a breakthrough therapy in Europe and beyond

Sciensus has more than 30 years’ experience supporting pharmaceutical companies with the launch and distribution of orphan drugs outside the US, providing a customisable, fully managed service.

The client, a leading US biotech, has developed a pioneering therapy for an ultra-rare disorder. Using our expertise we designed and implemented a turn-key solution tailor-made to meet the company’s needs, from early access to patients in Europe through market authorisation.

The objective

Reaching patients globally with a first-to-market therapy. With no other treatment available in Europe, the client’s breakthrough therapy has the power to transform the lives of young people. The company required our support to license and obtain approval for the distribution of its life-extending drug in Europe.

The solution

Partnering with Sciensus enabled the company to extend the reach of its pioneering treatment.

Sciensus supported the client to:

• Import the product into EU using its wholesale distribution authorisation (WDA) and manufacturing and import license (MIA).
• Navigate through the complexity of setting up an early access programme in France. This allowed people to benefit from the unlicensed medication.
• Establish a new EU-based entity and successfully obtaining EU marketing authorisation.
• Facilitate the first official licenced launch of the drug in Germany in as little as 4 months following EMA approval.

To enable the client to continue to deliver the highest level of service to patients, Sciensus provided:

• A complete tailor-made European infrastructure package – effectively a ‘one stop shop’, adapting to any challenges and obstacles that were encountered.
• A dedicated rare disease account director who implemented tried and tested governance approach which consists of:
  • Quarterly business reviews, face to face with senior teams, operations, commercial, finance, quality and legal when required.
  • Monthly team KPI review sessions.
  • Bi-weekly quality, operational, and customer service meetings with appropriate individuals.

Here are some examples of how our partnership achieved and exceeded expectations:

• Our multilingual customer service team is fluent in most European languages. This additional level of expertise was highly valued by our client, as it helped facilitate the early access programme in France and the licensed launch in Germany.
• Sciensus designed a patient support programme comprising face-to-face and remote nurse interventions. This provides patients and their caregivers with the knowledge and skills to help them manage their condition and treatment autonomously and more effectively. Our European programme is customised to comply with the clinical and information governance regulation which may vary from one country to another.
• The client entrusted Sciensus with responsibility for key issues such as processing orders and returns management, as well as customer credit checks and contracts.
• Thanks to our knowledge and expertise we were able to take care of tender management in different countries, as well as auditing, and managing all the legal and regulatory requirements.
• We offer a range of shipping solutions via our well-established GDP-approved international delivery network. This provides validated routes for both European and international distribution. Orders are shipped using our special goods communication delivery service. This ensures that we overwhelmingly meet our targets for on-time delivery, which, in turn, helps to minimise stock loss.
• In addition, we offer a full order to cash service. Once our dedicated team has received an order, we take control of the complete supply process across warehousing, customer communications, delivery and cash collection.