Orphan Drug Development
From Orphan Designation to Market Exclusivity
In the EU, the US and several other jurisdictions, legislation has been implemented to incentivise the development of new drugs for patients suffering rare diseases often with no approved treatment options available. Prior to the legislation those patients suffering a rare disease were in a desperate situation as no drugs were developed for these small or very small patient populations with a high unmet medical need. The term “orphan disease” is used synonymously with rare disease. Rarity is, in fact, a key feature of the orphan disease´s conditions.
Applying for an orphan drug designation is the first and critical step before initiating clinical development in a rare disease. The orphan designation is the pre-condition to qualify for the incentives in the respective orphan drug legislation such as free scientific advice at the EMA. After authorisation, market exclusivity is granted for orphan drugs for 7-10 years in the US and EU, respectively.
We offer support during all stages of orphan drug development – from the initial orphan designation to final marketing authorisation.
Company Information
ConEckt Consulting, founded by Dr. med. Klaus Eckhardt, MDRA, provides expert services and advice to drug developers in academia, start-ups, global pharma and biotech industry as well as for patient organisations, investors and regulatory authorities in clinical drug development and regulatory affairs. Our focus, offering advice on evidence generation by connecting clinical insights and regulatory expertise.
Our Purpose
Expedite the provision of therapies to patients to address their unmet medical needs
Our Services
We provide independent expert services and advice in all phases of clinical drug development and regulatory affairs as well as in due diligences. We help you define innovative and robust development strategies to generate the evidence needed for your target population. We offer medical writing support when it comes to clinical documents for your marketing authorisation application.
We facilitate meetings with key stakeholders such as regulatory agencies, HTA agencies and payers support the preparation of necessary briefing packages containing a full development strategy.
Thus, we can support you throughout the entire clinical development of your projects taking care that you generate exactly the evidence that is required by key stakeholders, such as regulatory agencies, HTA, and payers.
Success of your Drug is Our Motivation – Better Treatments for Patients with Unmet Needs
* For further information see Klaus Eckhardt´s CV: Download it now!