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AOP Orphan Contact

AOP Orphan worldwide

Wilhelminenstraße 91/IIf
1160 Vienna, Austria
office(at)aoporphan.com

Why work with us


AOP Orphan as a research partner

AOP Orphan is itself heavily involved in research and development activities and can therefore be a highly competent partner for other companies. A well-equipped research department, broad detailed knowledge and close ties to study centres are of particular value here. 

Research & Development

  • The research department in Vienna has a broad base and is highly specialised.
  • It has particular experience in the fields of cardiology and pulmonology, hemotology and oncology, and neurology and psychiatry.
  • AOP Orphan’s experts provide special know-how for small molecules and biologics.
  • An in-house regulatory affairs department implements all approvals, both centrally and decentrally.

Early inclusion in projects

  • Thanks to the exceptional medical knowledge of AOP Orphan employees, collaboration and project inclusion can occur at a very early stage.
  • Indications without satisfactory treatment approaches are specifically targeted.

Access to studies

  • Close ties to leading medical experts in the respective treatment areas enable excellent access to study centres and testing physicians in the core markets to carry out clinical trials. 

Research partnering
As a fully integrated pharmaceutical company, AOP Orphan conducts phase 1 to phase 4 clinical trials for and together with partners. A good example is the two studies PEGINVERA and PROUD-PV, in the course of which ropeginteredon α 2b is being tested as a way of treating polycythemia. In this case, AOP Orphan is already responsible for the pharmacology in phase, conducting the entire process with its own team up including central approvals in Europe and the USA. The development programme encompasses a total of around 400 patients.

AOP Orphan as a market partner

AOP Orphan knows about the intricacies of doing business in the markets of Europe and the Middle East. Mentality, culture, healthcare system and, above all, legal frameworks are so different that a superficial knowledge of the market is not enough. This is why AOP Orphan is present in each of its core markets with its own employees in order to meet these challenges properly.

Cultural understanding
In such a sensitive area as rare diseases, a deep understanding of the culture, social connections and processes in the healthcare system is absolutely essential.

Marketing know-how
Even when it comes to marketing, different rules apply in different countries – both regarding the (normally rigidly defined) legal regulations and efficiency. What may be effective in one country to position a product sustainably in the market may have no effect whatsoever in another country.

Cost and approval know-how
A thorough understanding of approval, price-setting and cost reimbursement systems is indispensable. Only if you have a detailed knowledge of local decision-making processes can you successfully commercialise a product.

Compliance
Ownership in compliance matters starts at the management level for all people to live and take responsibility for. It is for management to exemplify and colleagues to follow. AOP Orphan also expects this from its partners. The conduct guidelines (SOPs and corporate governance code) substantiate and complement the legal frameworks. Compliance should be firmly anchored in the company by means of regular training courses. Internal monitoring and audits also play a part here. At AOP Orphan, compliance means ‘work in progress.’ Improvement, not standstill, is the order of the day, as well as clarity, efficiency and effectiveness of the rules.

Health Technology Assessment
With the rapid expansion in new medical technologies, Health Technology Assessment (HTA) is increasingly being used to optimise the adoption of new interventions and make best use of finite health resources. 

Leaders in field include UKs National Institute for Health and Care Excellence (NICE) and Germany’s Institute for Quality and Efficiency in Health Care (IQWiG). These organisations are increasingly influencing and informing authorities in other markets including Central and Eastern European markets about HTA processes and methodologies. EUnetHTA, a network of national government appointed HTA organisations, is at the forefront of supporting collaboration between European HTA organisations. 

At AOP Orphan we believe understanding the HTA environment and potential impact of assessment will be become increasingly important consideration for companies seeking the best partner for their assets. AOP see this as core competence within the company, and an important point of differential advantage compared to other companies active within CEE region. During 2015 the Company made investments to further strengthen and enhance our HTA expertise and attractiveness as a potential partner.