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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 CSL Behring IIS program is open to 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® and/or Hizentra®. 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 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.

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 new recombinant products, IDELVION® and AFSTYLA®. 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
  • Transition to the new products
  • Health outcome studies, including factor consumption, quality of life data, adherence
  • Personalized prophylaxis
  • Joint health/target joints, including biomarkers of disease progression
  • Use in special populations
Hemophilia A only
  • Role of von Willebrand Factor (VWF) in reducing inhibitor development
  • Use of assays and pharmacokinetic (PK) data in guiding AFSTYLA® dosing
  • 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".
  • 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.