ORPHAN DRUGS & RARE DISEASES

- Meeting unmet needs

WIESLAB BIOANALYTICAL SERVICES FOCUS AREA

ORPHAN DRUGS & RARE DISEASES

Orphan drugs are developed to prevent, treat or diagnose rare diseases or conditions.

An orphan drug is a pharmaceutical agent used to treat medical conditions which, since they are so rare, would not be profitable to produce without government assistance. The formal definition, in the US, is diseases affecting fewer than 200,000 people and in EU its diseases affecting fewer than 10.000 people.

Given the overall rarity of the disease/condition the incentive for developing and financing an orphan drug has historically been low. However recent legislation incentives has created a global effort in the clinical development of orphan drugs and at Wieslab, we can assist with risk assessment and assay strategies within relevant service fields. 

Let us help accelerate your orphan drug and rare disease development project!

Contact us to discuss your project with our scientists today! 

Contact Us

 

YOUR CHALLENGES 

Common challenges when developing orphan drugs;

  • Bioanalytical program design (i.e. assay design, what to validate, how to do samples analysis)
  • Understanding the disease or condition
  • Regulatory landscape
  • Clinical trial design

OUR EXPERIENCE

We have experience in orphan drug bioanalytical development/validation and sample analysis as well as general Bioanalytical program designing. Due to our collaborative approach we are adaptive to bioanalytical strategies for small sample sizes etc.

In parallell to this we can aid with understanding the regulatory landscape and assist when setting up risk analysis to meet compliances. 

WHERE WE CAN HELP 

We offer service and expert knowledge within the following application areas: