Investigator-Initiated Studies CSL Behring R&D Awards and Grants Investigator-Initiated Studies 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 are 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 - Immunodeficiency - Hemophilia Disorders - Immune-mediated Neuromuscular Disorders - Acquired & Oral Anticoagulant-Associated Bleeding - Hereditary Angioedema (HAE) The link below is for US physicians, researchers and institutions interested in conducting their own research. For those outside the US, contact your local CSL Behring Medical Affairs representative. We receive many requests for support and carefully evaluate each one. Priority is given to proposals that align with our interests. Disclaimer: All materials submitted as IIS application must be non-confidential. By submitting an IIS application, you acknowledge that CSL Behring is under no obligation of confidentiality with respect to materials submitted. Research Priorities and Eligibility Immunoglobulins In order to advance science and improve patient care with CSL Behring's products in the area of immunoglobulin research, we support, with provision of drug and/or total or partial funding, high-quality research that is initiated, designed, implemented, and sponsored by external investigators and is involved with the immunoglobulin products Privigen® (Immune Globulin Intravenous (Human) 10% Liquid) and/or Hizentra® (Immune Globulin Subcutaneous (Human) 20% Liquid). Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest: Primary Immunodeficiency (PID) Proposals that increase the knowledge of the efficacy and safety of the immunoglobulins in PID indications, specifically route of administration, subclinical infections in diagnosed PID patients with respiratory tract engagement, quality of life, wear-off, manual push, flexible dosing/patient preference, and undiagnosed PID. Secondary Immune Deficiency (SID) Proposals that increase the knowledge of immunoglobulins in regard to efficacy and safety, specifically the combination of immunoglobulins with products that cause drug-induced SID in conditions such as multiple myeloma and chronic lymphocytic leukemia (CLL). Peripheral Neuropathy Proposals that increase the knowledge of efficacy and safety of the and pediatric patients. Hizentra and Privigen are manufactured by CSL Behring AG and distributed by CSL Behring LLC. Hizentra® and Privigen® are registered trademarks of CSL Behring AG. Coagulation To advance science and improve patient care with CSL Behring's products, we support, through total or partial funding, external investigators who initiate, design and implement high-quality research that is focused on our recombinant products, IDELVION® (Coagulation Factor IX (Recombinant) Albumin Fusion Protein) and AFSTYLA® (Antihemophilic Factor (Recombinant) Single Chain). Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest: Hemophilia A and B - Clinical studies and experience in transitioning to AFSTYLA® or IDELVION®, including on-demand and prophylaxis - Health outcome studies, including factor consumption, quality of life data, adherence - Health economic outcome studies - Clinical studies that focus on long-term joint health and radiographic imaging to assess and monitor joint damage - Use in special populations including women - Real-world evidence of hemophilia A and B management Hemophilia A only - Role of von Willebrand Factor (VWF) in reducing inhibitor development - Clinical studies that increase knowledge of immune tolerance induction with AFSTYLA® AFSTYLA and IDELVION are manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. AFSTYLA® and IDELVION® are registered trademarks of CSL Behring Lengnau AG. Specialty Products In order to advance science and improve patient care with CSL Behring's products in the areas of oral anticoagulant-associated bleeding, acquired bleeding disorders, and hereditary angioedema we support, through the provision of drug and/or total/partial funding, high-quality research that is initiated, designed, implemented and sponsored by external investigators. 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 novel oral anticoagulants (NOACs) - Clinical studies and experience with PCCs for urgent reversal prior to emergency surgery or procedures in patients treated with VKAs or NOACs Acquired Bleeding - Clinical studies of PCCs as a hemostatic agent in perioperative bleeding and trauma-induced coagulopathy - Basic science research with PCCs in trauma-induced coagulopathy Hereditary Angioedema (HAE) - Health Outcome studies on C1 Esterase Inhibitor (C1-INH) including quality of life and adherence - Clinical studies and experience with novel treatment strategies to replace C1-INH - Use of C1-INH in special patient populations (eg pregnancy, pediatrics) Application Requirements A complete Investigator-Initiated Study application is to include the following: An online application submitted through the portal Signed and dated CV Detailed study budget Draft protocol Institutional W-9 Application Request Process Review "Areas of Focus" to identify if the grant request aligns with CSL Behring's areas of interest. To start an application click on "Apply Here" below. Log in to your account. First-time requestors must create an account. Your request will be reviewed and we will notify you via email of the decision. If your request is approved, you will be contacted regarding the agreement and disbursement process. Start Your Application Apply Here Frequently Asked Questions (FAQs) Q: Who should I contact for more information regarding Investigator-Initiated Studies? A: You can contact your regional Medical Science Liaison 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 reviewed on a monthly basis and you will be notified when the CSL Behring Review Committee has 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. Contact CSL, All Rights Reserved © 2021 Terms of Use Cookie Policy Privacy Policy Accessibility Statement Patents Sitemap By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookies Settings Reject All Accept All Cookies