Investigator Sponsored Studies

Investigator Sponsored Studies (ISS) Program

Harmony Biosciences supports Investigator Sponsored Studies (ISS) aimed at furthering the understanding of our products and that align with our areas of scientific interest. Such studies may advance disease-related knowledge, improve patient care, or explore unmet clinical needs.

These research studies are initiated and conducted by external investigators with the appropriate (or relevant) scientific background and experience to conduct an independent scientific investigation. Investigator Sponsored Studies may be, but are not limited to, interventional (clinical and non-clinical), observational (epidemiological or outcomes) or survey studies.

The external 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, regulations, and guidance documents (e.g. 21 CFR Part 312, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and Good Pharmacovigilance Practices (GVP)).

The study proposal, outline, and protocol must be designed and written 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 create an account and submit their research concept through the Harmony ISS Portal. ISS concepts are then reviewed by the Harmony research grants committee. After a 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 rationale, comprehensive study design, defined plan for data capture and 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 which excessive daytime sleepiness (EDS) and/or fatigue are common and debilitating symptoms
  • The role of histamine, the H3 receptor, and the impact of pitolisant on histaminergic neurotransmission, including the effect on other neurotransmitter systems
  • Exploratory research regarding the effect of pitolisant in other central disorders of hypersomnolence
  • The effectiveness of pitolisant on impairments of attention, vigilance, and/or cognition
  • Improvements in recognition of EDS, the diagnosis of narcolepsy, or evaluation of sleepiness as a comorbid symptom in other disease states

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.