ONY Biotech Products

Research & Development

Innovating with every breath.

 

ONY Biotech’s Investigator-Initiated Research program is a support platform for research projects that advance medical and scientific knowledge about our therapies or generate promising medical interventions. This global program is open to all researchers who are interested in conducting their own research.

Depending on the type of research, ONY Biotech may provide flexible funding to support development, preclinical and early clinical development activities. If approved, funding will be accessible in installments related to achievement of specific program milestones.

Requestors may seek external funding in addition to any funding provided by ONY Biotech as long as such arrangements are consistent with the parties’ agreements and do not negatively impact the overall objectives of the project.

Areas of Interest:

E

Administration of Infasurf® (calfactant) via thin catheter methods (i.e. LISA)

E

Administration of Infasurf via laryngeal or supraglottic airway devices (i.e. SALSA)

E

Administration of Infasurf in aerosolized/nebulized dose form

E

Nebulizing/Aerosolizing surfactant

E

Infasurf dose volume studies

E

Infasurf as a delivery medium for other drugs

Infasurf® (calfactant) is FDA-approved for Intratracheal administration only.

See full prescribing information.

Types of Research Eligible for Support:

Asset Focused Research

ONY Biotech supports Asset Focused Research (AFR) projects that advance medical and scientific knowledge about our therapies.

An AFR is a type of grant that supports an independent research study where the investigator or organization is the sponsor of the study and where ONY Biotech provides financial and/or non-financial support for the development or refinement of specific and defined medical knowledge relating to an ONY Biotech asset or specified area of interest. This global program is open to all researchers who are interested in conducting their own research. This grant type is used as support for development, interventional pre-clinical and clinical, or retrospective studies, that involve an ONY Biotech asset (e.g., investigational or commercial drug, device, or method).

General Research

ONY Biotech also supports general research projects focused on the development or refinement of specific and defined medical knowledge unrelated to an ONY Biotech asset, including support for an organization’s general research fund, outcomes research.

If you’re interested in discussing research questions or submitting your ideas, email us at [email protected] and tell us about the research area you are interested in pursuing.

For more information, please review the Investigator-Initiated Research Program Details below.

Project Types Eligible for Support

There are multiple project types that are eligible for funding through an Independent Medical Grant. When submitting a grant request, organizations will be asked to specify their project type.

  • Independent Research
  • Independent Medical Education

More information on these classifications can be found in the Decision Matrix below. Please note, independent research is divided into 2 categories.

 

Investigator-Initiated Research Program Details

Independent ResearchIndependent MedEd
TitleAsset Focused Research GrantGeneral Research GrantMedical Education Grant
TypeDevelopment / Preclinical / Clinical / RetrospectiveGeneral Research / Outcomes Research / FellowshipsCME (accredited and non-accredited)
Required ElementsIRB, Informed Consent, Drug / Device Supply, Adverse Event ReportingIRB and Informed Consent (not required for general support)Standards for Commercial Support; Academy for the Accreditation of CPD
RestrictionsResearch involves ONY Biotech asset; No support for ongoing researchResearch cannot involve the study of an ONY Biotech Asset
IndependenceNo ONY Biotech involvement or influence with any aspect of the study / initiative / activity supported by the grant

Definitions

Asset Focused Research (AFR)

Grant funding that supports independent research study where the investigator or organization is the sponsor of the study and where ONY Biotech provides financial and/or non-financial support for the development or refinement of specific and defined medical knowledge relating to an ONY Biotech asset. This grant type is made to an organization (e.g., universities, hospitals, clinics, etc.) to conduct independent research based upon medical and scientific merit. This grant type is used as support for development, interventional pre-clinical and clinical, or retrospective studies that involve an ONY Biotech asset (e.g. Investigational or commercial drug, device or method).

General Research

Grant funding supporting independent research where the investigator or organization is the sponsor of the research and where ONY Biotech provides financial and/or non-financial support for the development or refinement of specific and defined medical knowledge unrelated to an ONY Biotech asset. This grant type supports research that does not include the study of an ONY Biotech asset, including support for an organization’s general research fund, outcomes research unrelated to an ONY Biotech asset, and research fellowships.

Independent Medical Education (MedEd)

Grant funding for independent medical education (MedEd) activities which actively develop, enhance, or increase the knowledge, skills, and/or performance of a healthcare professional (e.g. continuing education with or without accreditation). The content of the MedEd activity can relate to an ONY Biotech asset or not and can be related to approved or unapproved uses (unless the latter is prohibited by country regulations). ONY Biotech will not be involved in review or approval of the content.