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Investigator-Initiated Studies
CSL Behring Investigator-Initiated Studies
CSL Behring is committed to saving lives and improving the quality of life for people with rare and serious diseases worldwide. This commitment is reflected in the support for Investigator-Initiated Studies (IIS) that advance medical and scientific knowledge of CSL Behring products and the diseases they have been designed to treat. CSL Behring also supports innovative clinical and basic science studies that address important medical and scientific questions related to our therapeutic areas of focus.
Areas of Focus:
The CSL Behring IIS program is open to physicians, researchers and institutions interested in conducting their own research. We receive many requests for support and carefully evaluate each one with priority given to proposals that align with our interests. To facilitate your application, please carefully read the application requirements.
Disclaimer: Any application to participate in CSL Behring’s IIS program, including any information shared in connection with such application, will be used by CSL Behring for the sole purpose of evaluating the application, and will not be shared externally. To the extent that an application contains personal information about an individual, such information will be treated in accordance with CSL Behring’s privacy policy, located at https://www.cslbehring.com/privacy-policy/privacy-policy-row.
Research Priorities and Eligibility
Immunology
We seek to advance science and improve patient care with CSL Behring's products in the field of immunology. Through the provision of total or partial funding, CSL Behring supports high-quality immunoglobulin research that is initiated, designed, implemented, and sponsored by external investigators and involves our immunoglobulin products. Applicant proposals may request funding only or funding and C1-INH drug supply. Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest:
Primary Immunodeficiency (PI) Diseases
Proposals that increase the knowledge of the efficacy and safety of immunoglobulins in PI indications, specifically route of administration, subclinical infections in diagnosed PI patients with respiratory tract engagement, quality-of-life, wear-off, manual push, flexible dosing/patient preference, and undiagnosed PI.
Secondary Immunodeficiency (SI) Diseases
Proposals that increase the knowledge of the efficacy and safety of immunoglobulins in SI indications, specifically the combination of immunoglobulins with products that cause drug-induced SI in conditions such as multiple myeloma (MM) and chronic lymphocytic leukemia (CLL).
Peripheral Neuropathy
Proposals that increase the knowledge of efficacy and safety of immunoglobulins, specifically pharmacokinetics in chronic inflammatory demyelinating polyneuropathy (CIDP) including wear-off, dose titration, dose conversion from intravenous immunoglobulins (IVIg) to subcutaneous immunoglobulins (SCIg), loading dose and dosing by body mass index (BMI) or fat percent versus weight, quality-of-life in CIDP patients, health economics in CIDP and specific sub-populations, such as elderly and pediatric patients.
Hematology
We seek to advance science and improve patient care with CSL Behring's products in the field of hematology. Through total or partial funding, we support external investigators who initiate, design and implement high-quality hematological research that is focused on our recombinant products, Coagulation Factor IX (Recombinant) Albumin Fusion Protein and Antihemophilic Factor (Recombinant) Single Chain, and our plasma products, Human Plasma Derived von Willebrand Factor (HP-vWF/FVIII) concentrate, Fibrinogen, and Prothrombin complex concentrate [human]. Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest:
Oral Anticoagulant-Associated Bleeding
- Clinical studies and experience with prothrombin complex concentrates (PCCs) for the management of acute major bleeding in patients treated with Vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs)
- Clinical studies and experience with PCCs for urgent reversal prior to emergency surgery or procedures in patients treated with VKAs or DOACs
Respiratory
We seek to advance science and improve patient care with CSL Behring's products in respiratory diseases. Through total or partial funding only, we support external investigators who initiate, design and implement high-quality respiratory research that is focused on the disease alpha-1 antitrypsin deficiency to generate data on:
Transplant
We seek to advance science and improve patient care with CSL Behring's products in the field of transplantation. Through total or partial funding, we support high-quality transplantation research that is initiated, designed, implemented, and sponsored by external investigators to better define unmet medical needs and explore the use of products including complement inhibitors, Clazakizumab and Alpha-1 Antitrypsin in cell and organ transplantation. Applicant proposals may request funding only, or funding and Clazakizumab or C1-INH drug supply. Specific Research Priorities include: Graft versus Host Disease (GvHD) following:
Application
Frequently Asked Questions (FAQs)
Q: Who should I contact for more information regarding Investigator-Initiated Studies?
A: You can reach out to your local Medical Affairs contact by clicking here.
Q: Should I submit a conceptual outline or a full study proposal?
A: You should submit a full proposal of the study for CSL Behring to consider for review. Conceptual or high-level proposals will not be considered until they are fully developed.
Q: How long does the review process take?
A: Full submissions are submitted to the global review process. You will be notified when the CSL Behring reviewers have arrived at a decision. Decisions are based on medical and scientific value in addition to current resources and research priorities.
Q: What is CSL Behring’s role in a funded Investigator-Initiated Study?
A: CSL Behring is considered the Grant Provider for any Investigator-Initiated Study that it funds. Due to certain legal implications, the role of Sponsor needs to be assumed by either the Investigator or the Investigator’s Organization.
Rapporter un effet indésirable
BEL-CRP-0186 01/2024