Expanding your orphan drug footprint internationally

 
    
International commercial opportunities for orphan drugs outside the North American and European markets. 
 
For various good reasons most emerging biopharmaceutical companies that are in the process of developing a commercial strategy for launching its late stage investigational or FDA/EMA approved orphan drug focus their introductions on the North American and European markets first.
 
Why not try to meet the unmet medical needs of patients in other countries around the world? Specifically in those countries where the regulatory authorities offer companies with an FDA and/or EMA approved drug an expedited regulatory process and/or a named patient sales program in anticipation of the local registration.
 
Bioneur conducts in-depth rare disease specific market research, find and meet with local key stakeholders involved, such as, but not limited to, treating physicians, key opinion leaders, scientists, patients, patient societies, regulatory - pricing - reimbursement subject matter experts and local officials. 
 
All information obtained will be consolidated in a written report and presented to client in a PowerPoint presentation and include: 
 
1.    Executive summary.
2.    Key milestones.
3.    SWOT analysis. 
4.    Strategic imperatives and critical success factors. 
5.    Diagnostic and treatment pathways for specific rare diseases.
6.    Orphan drug regulation, pricing and reimbursement pathways and timelines.
7.    Evaluate competitive landscape, estimate local market sizing, commercial opportunities, incl. named patient programs.          
8.    Drivers and barriers for local market entrance.
9.    Evaluate potential local logistic partner companies/distributors.
10.  Provide recommendations for a strategic market approach. 
11.  List with names of all key stakeholders.
 
With 25 years of International hands-on experience with all facets of commercial introductions, Bioneur is very well positioned and specialized in providing emerging biopharmaceutical companies with a deep understanding of market opportunities in countries in Eastern Europe, Asia Pacific, Middle East and South America that have a sustainable healthcare system in place.