Investigator Sponsored Studies (ISS)
United Therapeutics provides support for both interventional and non-interventional research in our therapeutic and strategic areas of interest:
- Personalized medicine
- Pharmacogenomics, “-omics”, biomarkers, individualized drug therapy, diagnostic strategies for pulmonary diseases
- Novel indications and study endpoints
- Hemodynamics, cardiopulmonary function/structure and imaging, biomarkers
- Group 1 (pulmonary arterial hypertension [PAH]) and Group 3 (pulmonary hypertension due to lung diseases and/or hypoxia) pulmonary hypertension (PH)
- Real-world data analyses and other health outcomes research in PH
- Claims database analyses, electronic health record analyses, health economic studies
- Respiratory diseases and disorders
- Novel treatment approaches to acute and chronic respiratory diseases (e.g., acute lung injury [ALI], COVID-19, interstitial lung disease [ILD])
- Congenital heart and/or lung defects
- Lung transplantation
- Preclinical prostacyclin pharmacology and mechanism of action (across WHO PH groups) – synergistic treatment pathway approaches, prostacyclin receptor pharmacology
- New treatment approaches and adverse event management strategies associated with prostacyclin class therapies for PH – multimodal therapy, synergistic treatment pathway approaches, transitions, treprostinil adverse events
- GD2 positive pediatric tumors
- Biomarker research for GD2 positive pediatric tumors
- Preclinical GD2 antibody mechanism of action and synergies in pediatric GD2 positive tumors
- Novel treatment approaches, delivery methods and indications for use of antibody therapy in GD2 positive pediatric tumors
The research must be intended to contribute knowledge to the medical community, and the budget must be reasonable and appropriate for the proposed work. In considering applications for support, United Therapeutics will also consider the expertise of the proposed principal investigator and any sub-investigators, including their experience in the relevant therapeutic area, demonstrated ability to successfully conduct research, and available resources.
Available ISS materials:
- Treprostinil, active pharmaceutical ingredient
- Tyvaso® (treprostinil) Inhalation Solution (0.6 mg/mL ampules)
- Orenitram® (treprostinil) extended-release tablets
- Remodulin® (treprostinil) Injection (1, 2.5, 5, 10 mg/mL concentration vials)
- Next generation infusion pumps to administer Remodulin®
- Unituxin® (dinutuximab) injection (17.5 mg/5mL concentration vials)
- Ralinepag, subject to supply constraints*
- Unexisome™ (bone marrow mesenchymal stem cell-derived exosomes), subject to supply constraints*§
*Development-stage product, not approved in any jurisdiction
§Unexisome is a composition of complex biologic vesicles containing cytokines, enzymes, and ribonucleic acid in development for the treatment of bronchopulmonary dysplasia.
Data Query Program
The purpose of the Data Query program is to allow investigators to propose independent post-hoc analyses of United Therapeutics clinical data sets.
Submit a study concept or data query concept:
Proposals are considered on a rolling basis. To apply, please visit www.utcrequests.com.
For assistance, please email ISS@unither.com.