Investigator Sponsored Studies

Investigator Sponsored Studies (ISS) Program

Investigator Sponsored Studies (ISS) can play a significant role in exploring important medical and scientific questions regarding Harmony’s products and our areas of scientific focus. Such studies often advance disease-related knowledge and may contribute toward improved patient care.

These research studies are initiated, managed, and conducted by external investigators with the necessary scientific background and experience to conduct an independent scientific investigation. Investigator Sponsored Studies may be, but are not limited to, clinical, preclinical, epidemiology, screening/diagnostic, or survey studies.

The sponsor-investigator assumes responsibility for the legal and regulatory requirements of the trial and the conduct and management of the study as defined by applicable laws and regulations (e.g. 21 CFR 312.3, 21 CFR Subpart D, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and Good Pharmacovigilance Practices (GVP)).

To qualify for sponsorship, you must be a healthcare professional or researcher qualified by training and experience to undertake the proposed research. The study proposal, outline, and protocol must be originated by the investigator, independent of Harmony Biosciences’ influence.

The Harmony Investigator Sponsored Study submission process includes two phases:

1. Phase one requires a requestor to submit their research concept on the ISS Concept Submission Form (Click here to access form) along with a CV to grants@harmonybiosciences.com. ISS concepts are reviewed by a Harmony research grants committee on a rolling basis. After the initial review has been completed, the investigator will be notified of the decision.
2. If the concept demonstrates scientific rigor and aligns with Harmony's areas of scientific interest, the requestor will be required to initiate phase two by submitting a full protocol and detailed budget. The full protocol should include a defined plan for data capture, analysis, adverse event reporting, and a plan for public dissemination of data. After committee review, the requestor will be notified of a final decision.

Areas of Scientific Interest:

• The impact of pitolisant on functional outcomes and/or quality of life in patients with narcolepsy
• The effectiveness of pitolisant in diseases within which excessive sleepiness and/or fatigue are common and debilitating symptoms
• The role of histamine, the H₃ receptor, and the impact of pitolisant on neurotransmission in the CNS, including the effect on other neurotransmitter systems
• Exploratory research regarding the effect of pitolisant in other sleep or neurological disorders
• The effectiveness of pitolisant on impairments of attention, vigilance, and/or cognition
• Methods to improve the diagnosis of narcolepsy, symptom recognition, and/or evaluation of residual symptoms

For any questions, please email grants@harmonybiosciences.com.

Harmony does not provide grants to individuals unless an individual is acting as a sponsor investigator of an Investigator Sponsored Study.

Any funding provided by Harmony will be in compliance with all applicable laws, rules, and regulations.