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Investigator Initiated Trials
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.
Submission Process
Are you ready to submit your Medical Research proposal? Medical Research proposals are submitted to Apellis through our online portal
Investigator Qualifications
The following investigator qualifications are required for Apellis to evaluate and consider supporting the proposed research.
- The investigator(s) is a physician or researcher qualified by training and experience to undertake the proposed research.
- If conducting clinical research or research that involves patients, the investigator(s) license is current and may be verified
- The investigator(s) is not excluded, debarred, suspended, or otherwise not eligible to participate in health care programs
- The investigator(s) are not an employee of Apellis or its affiliated entities
- For IITs, the research proposal is developed independent from Apellis and the study design/protocol will be authored by the investigator(s) without Apellis input. Support for Medical Research is awarded strictly based on research merit criteria.
Support of Medical Research in no way implies any obligation toward or is in any way connected to the recommendation of prescribing of Apellis products.
Apellis is committed to transparency in its interactions with healthcare professionals and health care organizations/institutions. Consistent with relevant laws and/or codes of practice applicable to the pharmaceutical industry, certain information related to the project (including but not limited to, the names of the parties and the amount of funding) may be reported to any relevant authorities/institutions and/or publicly disclosed by Apellis and/or by its affiliated companies.
Organization Eligibility
Eligible Medical Research organization types include, but are not limited to:
- Hospitals
- Academic Medical Centers
- Schools of Nursing or Pharmacy
- Professional Societies and Associations
- Other institutions specializing in specific healthcare-related disciplines (e.g., public health, quality improvement)
Review Process
Medical Research proposals are reviewed on a rolling basis and decisions typically issued quarterly. Actual review times and decisions may vary depending on several factors, including the scale and complexity of the research proposal, location of sites, and the availability of requested resources.
To contact a member of the Apellis Medical Research Team, please email MedicalResearch@apellis.com
For information about requesting drug for research that is not Investigator Initiated or Collaborative, please click here.
*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.