NAMs for Rare Diseases

Patient-derived cells and disease-in-a-dish models are revolutionizing rare disease research—creating hope for the 300 million people worldwide affected by over 7,000 rare conditions

7,000+
Known rare diseases
300M
People affected worldwide
95%
Have no FDA-approved treatment
5-7 yrs
Average time to diagnosis
Why Rare Disease Drug Development Is So Difficult

Small Patient Populations

Too few patients for traditional clinical trials—some diseases affect only hundreds of people worldwide.

No Animal Models

Many rare genetic diseases have no natural animal equivalent—the mutations simply don't cause the same effects in mice.

Limited Commercial Interest

Small market size means less pharmaceutical investment, despite devastating patient impact.

Complex Genetics

80% of rare diseases are genetic, often involving multiple genes with varied mutations across patients.

The NAMs Solution: Patient-Derived Disease Models
1

Patient Sample

Collect blood or skin cells from patients with the rare disease

2

Create iPSCs

Reprogram cells into induced pluripotent stem cells

3

Differentiate

Turn iPSCs into the affected cell type (neurons, heart, liver)

4

Disease in a Dish

Cells show disease features—test drugs on the actual patient's cells

Rare Diseases Modeled with NAMs

Real conditions being studied with human-relevant approaches

Cystic Fibrosis

1 in 3,500 births

CFTR gene mutations cause thick mucus buildup. Patient-derived organoids now guide personalized treatment selection.

NAM: Patient intestinal organoids to test CFTR modulators

Huntington's Disease

1 in 10,000 people

CAG repeat expansion causes progressive neurodegeneration. iPSC-neurons show disease-specific pathology.

NAM: iPSC-derived neurons with patient HTT mutations

Duchenne Muscular Dystrophy

1 in 3,500 male births

Dystrophin gene mutations cause progressive muscle weakness. iPSC-myocytes model disease progression.

NAM: iPSC-derived muscle cells for gene therapy testing

Progeria (HGPS)

1 in 4 million births

LMNA mutation causes rapid aging. iPSC-derived cells show premature aging phenotypes for drug testing.

NAM: iPSC-derived smooth muscle and fibroblasts

Spinal Muscular Atrophy

1 in 10,000 births

SMN1 gene deficiency causes motor neuron loss. iPSC models helped develop first approved gene therapy.

NAM: iPSC-derived motor neurons for drug screening

Niemann-Pick Disease

1 in 150,000 births

Lipid metabolism disorder causing neurodegeneration. iPSC models reveal disease mechanisms in human cells.

NAM: iPSC-derived neurons and hepatocytes

Why NAMs Matter for Rare Diseases

Unique advantages for orphan drug development

Patient-Specific Models

Create disease models from actual patients when no animal model exists for the condition.

Capture Genetic Diversity

Model different mutations in the same gene that cause varying disease severity.

Reduce Trial Size Needs

In vitro screening helps identify patients most likely to respond, enabling smaller clinical trials.

Accelerate Development

Test drug candidates faster without waiting to establish animal models that may never work.

Personalized Treatment

Test which drugs work on individual patient's cells before prescribing treatment.

Biobank for Future

Create iPSC repositories that provide unlimited supply of patient cells for ongoing research.

Success Story: Cystic Fibrosis Organoids

Patient-derived intestinal organoids now guide treatment for cystic fibrosis patients. Doctors test which CFTR modulator drugs work on a patient's own organoids before prescribing. This approach has transformed CF treatment from trial-and-error to personalized precision medicine—all without animal testing and directly predicting human response.