Challenges in rare disease development
There are around 7,000 rare diseases, which from a regulatory outlook are defined as those diseases where there are less than 200,000 patients in the US or that affect no more than five in 10,000 of the general population in the EU. Orphan drugs are medicinal products envisioned for diagnosis, prevention, and treatment of life-threatening rare diseases. They are "orphans" because the pharmaceutical industry has little interest under normal market conditions in developing and marketing drugs intended for only a small number of patients suffering from very rare conditions
- Enrolling, engaging and retaining patients
- Designing and evaluating clinical trials
- Ensuring the quality of patient data
- Global regulatory requirements and payer evidence
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Challenges in rare disease development Conference Speakers
Recommended Sessions
- Allergic and immunologic disorders
- Challenges in rare disease development
- Clinical trials and treatment
- Gene therapy for rare diseases
- Infectious diseases
- Orphan Diseases and public health
- Orphan drugs potentiality
- Orphan medicinal products
- Rare diseases in blood stream
- Rare infectious diseases and immune deficiencies
- Rare mental and behavioral diseases
- Rare neurological diseases
- Rare nutritional and metabolic diseases
- Rare pediatric diseases
- Treatment and advanced therapies for rare diseases
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