Therapeutic Experience

Our three founders combine for 50+ years of experience in the industry in a vast array of therapeutic areas that includes targeted experience in the biostatistics application of orphan drugs for the treatment of rare diseases and statistical analysis of oncology trials. Specific therapeutic areas and indications of experience include:

• Allergy/immunology (allergic rhinitis)

• Anethesia (pain management [various])

• Antiviral (HCV, HIV)

• Autoimmune (rheumatoid arthritis, Crohn’s disease, lupus, multiple sclerosis, ALS)

• Cardiovascular (cardiomyopathy)

• Central nervous system (migraine, post-herpetic neuralgia)

• Dermatology (acne rosacea, acne vulgaris, onychomycosis, skin ulcer, hypertrophic or keloid scars)

• Device (atrial fibrillation, recurrent GBM)

• Endocrine/metabolism (Cushing’s Disease, prediabetes, type 2 diabetes mellitus, hyperkalemia, chronic kidney disease)

• Gastroenterology (bowel obstruction, esophagitis, Wilson’s Disease, nonalcoholic steatohepatitis)

• Genitourinary (renal failure, renal disease, kidney transplant)

• Hematology (AL Amyloidosis, anemia, beta-thalassemia, sickle cell disease)

• Immunology (NLRC4 Mutation / XIAP Deficiency)

• Metabolic disorders (Phenylketonuria)

• Neurodegenerative Disorders (Parkinson’s Disease, Dyskinesia, Huntington’s Disease)

• Neurology (Fabry Disease)

• Oncology (solid tumors, new and recurrent glioblastoma, colon cancer, B-cell lymphoma, T-cell lymphoma, NSCLC, TNBC)

• Ophthalmology (vitreous hemorrhage, wAMD, dry eye, pediatric myopia, cataract surgery)

• Psychiatry (gambling addiction, drug addiction, major depressive disorder with psychotic features)

• Respiratory (IPF, chronic cough, asthma)

• Women’s Health (preeclampsia, healthy volunteers)

In addition, we have statistical analysis experience in Pharmacokinetics (including food effect and drug-drug-interaction studies), Pharmacodynamics, PK/PD modeling, biomarker endpoints, and adaptive design applications.