All research concepts must be received through our online portal for review by the Apellis Medical Research committee.  All proposals will be evaluated in accordance with Apellis polices and applicable laws and regulations.  Decisions are based on scientific merit as well as alignment with research areas of interest and availability of resources.  Submission of a proposal does not guarantee approval by the committee.  Prior to entering your concept, please consider the following:

• Medical Research Category. The online concept submission form will prompt you to indicate a Medical Research category. Please read the definitions below prior to making a selection.

  An Investigator Initiated Trial (IIT) is a clinical, non clinical, diagnostic, or translational research study. Apellis does not solicit or discuss the research with the investigator prior to its submission online. The investigator independently generates the research proposal and Apellis may only provide support in the form of funding, commercial product, pure drug substance, or Apellis-owned data.

  A Collaborative Research Project (CRP) is a collaboration between Apellis and an investigator on a research proposal. Apellis and the investigator contribute to the design and the interpretation of the results. Apellis may support the research beyond funding, commercial, pure drug substance, or Apellis-owned data (see “support type” below). Publication and authorship will adhere to the International Committee of Medical Journal Editors (ICMJE) criteria. Please contact an Apellis Medical Director (MedicalResearch@apellis.com) if you have questions about project planning and submission.

  For US-based research, the investigator and/or institution is the study regulatory sponsor or accountable party for IITs and CRPs. This means that the investigator assumes responsibility for initiating and conducting the study, directing the administration of study drug (if applicable), and ensuring compliance with all local laws and regulatory requirements.

• Research Type. The online concept submission form will prompt you to indicate the type of study you are submitting to Apellis. Please read the definitions below prior to making a selection.

  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.

  Non clinical research refers to in-vitro, animal, or human derived bio specimens or in-vivo animal model studies per applicable regulatory guidelines.

  Diagnostic research refers to diagnosis of disease or other conditions, including a determination of the state of health.

  Translational research involves human subjects and aims to characterize disease processes, generate novel biological hypothesis, or identifies biomarkers of response/resistance to a drug.

• Support Type. Based on the study type, Apellis may consider providing the following support:

  Investigator Initiated Trials

  • 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.
  
  

  Collaborative Research Projects

  • Drug (see definition above)
  • Study funding (see definition above)
  • Data and sample access (see definition above)
  • Medical writing: Assistance with writing manuscripts, posters, etc.
  • Data management: Assistance with data storage, review, handling, and cleaning.
  • Statistical analysis: Assistance with development of the sample size justification calculation and/or the statistical analysis plan.
  • Project/vendor management: Assistance with selecting, contracting, and managing vendors required to complete your project.

Support for an IIT or CRP is awarded strictly based on research merit criteria. Support of a study in no way implies any obligation toward or is in any way connected to the recommendation of prescribing of Apellis products.

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 concept was developed independent from Apellis and the study design/protocol will be authored by the investigator(s), without Apellis input.

Medical research concepts are reviewed on a rolling basis and full proposals are reviewed at minimum quarterly.  

1. Concept
   A succinct description of the research concept.  If in scope, the concept will move to the full proposal stage.  Apellis will provide a response within 10 business days.
   
   
2. Full Proposal
   If your concept is of interest, you will be asked to provide a detailed research proposal, budget and/or resource request(s).  
   
   
3. Protocol/research plan
   If the full proposal is accepted, provide final study details.
   
   
4. Readiness
   Contracting and other activities, as applicable, e.g., IC/IRB ethics review, drug shipments.
   
   
5. Approved Research
   The research is executed according to contract and protocol/research plan.