CelltrionHealthcare

Investigator-Initiated Trials (IIT), also known as Investigator-Initiated Studies (IIS), are unsolicited research studies in which the investigator (usually an individual or institution, collaborative study groups) takes the lead in designing, planning, and conducting the study, as opposed to a pharmaceutical company or sponsor. These studies play a crucial role in advancing scientific knowledge regarding Celltrion products, exploring new uses for existing treatments, and addressing clinical questions to expand patient care.

The investigator assumes a central role and are primarily responsible for the design, execution, and oversight of the study. Their responsibilities encompass scientific,legal, regulatory and ethical aspects of the trial.

Investigators bear the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study, complying with applicable laws and regulations. Such obligations associated with the conduct of the study include, but are but not limited to, the following:

• Study Design and Planning
• Ethics and Approvals
• Participant Recruitment and Consent
• Data Collection and Monitoring
• Safety Oversight
• Data Management
• Study Reports or Publications

Areas if Interest:

Celltrion US is currently accepting IIT proposals in the following areas of Interest

Areas of Interest Drug: Zymfentra (Infliximab-dyyb) Subcutaneous (SC) Injection

Real World Studies (Prospective, Retrospective, Observational) Patient Reported Outcomes Intravenous (IV) vs. Subcutaneous SC Infliximab (IFX) dosing Efficacy Therapeutic Drug Monitoring Switching patterns Different SC IFX dosing regimens

IV Vs. SC IFX dosing

Attributes of ideal candidates for IFX SC Therapy

Therapeutic Drug Monitoring

Switching from IV to SC IFX New start patients Stable patients on IV IFX Switching from optimized IV IFX dosing to SC IFX

Dose Escalation due to loss of response

SC IFX dosing in high (body mass index (BMI) Patients

SC IFX in Patients with Perianal Disease/Fistulizing Crohn’s Disease

Crohn’s Disease (CD) and Ulcerative Colitis (UC) disease modification

Cost Efficiency of SC IFX utilization

Optimal monitoring of disease, including non-invasive mucosal healing monitoring tools (e.g., ultrasound)

Assessment of biomarkers aimed at identifying various factors influencing response

Precision Therapy Strategy

Explore Dosing Strategies to enhance disease management

Treatment decisions in rural/underserved populations

Scope of Support

The IIT support provided by Celltrion USA is for US researchers only. Celltrion USA will provide support as either a research grant and/or supply of an investigational medicinal product (IMP) provided that align with the company-defined areas of strategic interest.

How to Apply

Celltrion USA accepts concept proposal submission and full studyproposalsubmissions for IITs. Investigators requesting IIT support should submit their initial concept proposalsubmission to grants_usa@celltrionhc.com

If you need assistance prior to submission and during the review process, please contact your Celltrion USA Field Based Medical Science Liaison for more information.If you do not know who your local Celltrion USA Medical representative is, pleasesend an email to medical_usa@celltrionhc.com and you will be connected with your Medical Science Liaison.

Concept Proposal Submission:

A brief concept proposal must provide sufficient information for Celltrion USA to evaluate its potential and decide whether to request full study proposal. When submitting a concept proposal please include the following (if applicable):

• Principal Investigator contact information
• Proposed (preliminary) Title of the research study
• Brief background and rationale for the study
• Primary study objectives/endpoints
• Brief Study Synopsis
• Study population including estimated number of subjects and preliminary justification
• Research Setting: Single-site or Multi-site
• Estimated total length of the study
• Estimated study timelines
• Estimated total study budget
• Curriculum vitae from the principal investigator dated within the last calendar year

Full Study Proposal

Upon request, a full study proposal submission must contain enough detail about the research study to enable the Celltrion USA to make an evaluation on support. When submitting a full study proposal, the following information will be requested (if applicable):

• Principal Investigator contact information
• Title of the proposed research study
• Study Type: non-clinical or clinical
• Grant Funding: Funding, Drug, or Both
• Study Rationale
• Objectives: Primary and Secondary
• Inclusion/Exclusion criteria
• Study Design
• Target Enrollment
• Treatment Plan/Dosing Regimen (if applicable)
• Study Duration
• Target Start and End Dates
• Efficacy Variables/measures
• Safety variables/measures
• Adverse event/Serious adverse event reporting
• Decision points/statistical methods/interim analysis
• Ethical rationale for the study
• Study Deliverables
• Applicable Scientific References
• Publication Plan
• Detailed budget

Please Note: For all research grant proposals that include monetary support the investigator should submit a completed copy of the payee IRS W-9 Form.

Review Process

The Celltrion USA IIT review process involves the following steps: