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Investigator-Initiated Studies

Investigator-Initiated Studies

CSL Behring is committed to 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. Through the provision of total or partial funding, CSL Behring supports high-quality research that is initiated, designed, implemented, and sponsored by external investigators. 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

  • Immunology
  • Haematology
  • Respiratory
  • Cardiovascular and Metabolic
  • Transplant

The CSL Behring IIS programme 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.

 

Research Priorities and Eligibility

Immunology

We seek to advance science and improve patient care in the field of immunology.

Primary Immunodeficiency Diseases (PID)

Proposals that increase the knowledge of the efficacy and safety of immunoglobulins in PID, 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 Immunodeficiency Diseases (SID)

Proposals that increase the knowledge of the efficacy and safety of immunoglobulins in SID 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 paediatric patients.

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 for C1-INH replacement therapy
  • Use of C1-INH in special patient populations (eg; pregnancy, pediatrics)

Haematology

Haemophilia B

  • Clinical studies and experience in transitioning to extended half-life
  • Health outcome studies, including factor consumption, quality-of-life data
  • 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 haemophilia A and B management

Von Willebrand Disease

  • Clinical studies that generate evidence of efficacy or safety in selected Von Willebrand Disease populations specifically: low vWF, type 3, type 2, menorrhagia, pregnancy, or prophylaxis for angiodysplasia, epistaxis and joint bleeds 
  • Generate data supporting efficacy and safety, and health economic benefits of high-ratio pdvWF/FVIII vs. 1:1 concentrates 
  • Generate data in vWD (including burden of disease), increase awareness of vWD and show benefit of treatment

Studies with head to head comparisons with other products are excluded

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

Acquired Bleeding

  • Clinical studies of PCCs as haemostatic agents in perioperative bleeding and trauma-induced coagulopathy
  • Basic science research with PCCs in trauma-induced coagulopathy

Fibrinogen

  • Clinical studies of fibrinogen as a haemostatic agent 
  • Basic science studies of fibrinogen as an haemostatic agent

Other areas of interest

Respiratory

Specific priorities: Alpha 1 Antitrypsin deficiency

  • Prevalence, epidemiology, natural course of disease and the development of new biomarkers to monitor disease progression
  • Burden of disease 
  • Pathophysiology of Alpha-1 Antitrypsin deficiency

Transplant

Specific Research Priorities include:

  • Graft versus Host Disease (GvHD) following Haematopoietic Cell Transplant (HCT) 
  • Ischemia/Reperfusion Injury 
  • Antibody Mediated Rejection (AMR) 
  • Tolerance

Cardiovascular and Metabolic

Our goal in cardiovascular and metabolic disease is to address areas of high, unmet medical need and we continue to explore opportunities to work with external investigators to better define and address these needs.

Application

Requirements

A complete Investigator-Initiated Study application must include the following:

  • An online application submitted through this portal
  • Signed and dated curriculum vitae
  • Detailed study budget
  • Draft protocol

Application Process

  • Review the "Areas of Focus" sections to identify if the grant request aligns with CSL Behring's areas of interest.
  • To start an IIS application click on "Apply Here".
  • Log in to your account. First time requestors will need to 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.
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

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 Organisation.

GBR-CRP-0178 July 2021