An Investigator Initiated Trial (IIT) is a clinical or non clinical research study. The investigator independently generates the research proposal and Apellis does not solicit or discuss the research with the investigator prior to its submission.
Clinical research is a research study in which one or more human subjects are assigned to one or more interventions to evaluate the effects of those interventions on health related, biomedical, or behavioral outcomes. This research category includes translational research, which involves human subjects and aims to characterize disease processes, generate novel biological hypothesis, or identifies biomarkers of response/resistance to a drug.
Non clinical research refers to in-vitro, ex-vivo, animal, or human derived bio specimens or in-vivo animal model studies per applicable regulatory guidelines. This research category includes diagnostic research, which refers to diagnosis of disease or other conditions, including a determination of the state of health.
Apellis may consider providing the following support for IITs:
- Drug: Commercial product or pure drug substance.
- Study funding: Direct costs, i.e., procedural and personnel, as well as indirect costs (e.g., overhead), publications, IRB review, CRO/vendor fees, etc. Apellis may fund reasonable and customary services rendered that are needed to achieve the research objectives and all costs are subject to fair market value assessment. Apellis does not support requests for capital equipment.
- Data and sample access: Access to Apellis datasets, e.g., banked blood/plasma samples, or images.
Please visit Our Scientific Focus to learn about our scientific areas of interest.
If you have any questions or would like to connect with the local medical contact in your country/region,please email us at MedicalResearch@apellis.com
*Note to applicants outside the US: All proposals for systemic pegcetacoplan research to be conducted outside the US should be submitted to Sobi.
Apellis reserves the right to modify, revise, or delete the terms and conditions of its Medical Research program at any time and without notice.