Investigator Sponsored Studies

Investigator Sponsored Studies

Investigator sponsored studies play an important role in answering meaningful medical and scientific questions regarding medicines and related diseases. Sobi North America embraces new and innovative disease-related research that will assist in advancing science and improving patient care. One avenue through which we support enhancing such knowledge is the Investigator Sponsored Study program. Investigator Sponsored Studies are pre-clinical or clinical studies initiated and managed by the investigator or institution, who, as the sponsor, is responsible for the conduct and management of the study as defined by applicable laws and regulations. We meticulously consider all synopses submitted in the context of our medical objectives and based upon scientific merit and availability of resources. If approved by Sobi’s Medical Affairs Committee, support of Investigator Sponsored Studies may include supplying medicines, funding, materials, or a combination of such, as allowed under applicable laws and regulations. Support of a research study in no way implies any obligation toward, or is any way connected to, the recommendation or prescribing of Sobi’s medicines.

Access to investigational medicines through compassionate use or expanded access are not considered Investigator Sponsored Studies.

Prior to Sobi being able to provide any support, the following documents should be in place:

  • Detailed Study Protocol, that Sobi and the sponsor have aligned on
  • Fully executed Investigator Sponsored Study Agreement between the sponsor and Sobi
  • Fully executed Investigator Sponsored Safety Data Exchange Agreement between Sponsor and Sobi along with Ethics Committee/Institutional Review Board approval

Current Primary Areas of Interest for Sobi North America (all proposals will be considered, regardless of whether they align to a primary area of interest)

  • Thrombocytopenia: Diseases associated with low platelet counts, where platelet enhancing interventions may provide clinical value
  • IFN-γ Inflammatory Disorders: Diseases where IFN- γ, or related up/down stream cytokines play a crucial role in the pathogenesis of disease
  • IL-1 Inflammatory Disorders: Diseases where IL-1, or related up/down stream cytokines play a crucial role in the pathogenesis of disease

Visit the global Sobi website for more information about ISS here »

 

Grants

At Sobi North America, we strive to advance healthcare and to improve patient outcomes. We consider all eligible educational grant requests we receive. While we make every effort to review these applications in a timely manner, we ask that requests be submitted at least 60 days before the program date to allow sufficient time for review and processing. Please review the following criteria to make sure your submission is in line with our additional application guidelines. Sobi only considers grants that are aligned with our current approved products, approved therapeutic areas, and/or pipeline.

The following types of entities may be eligible to receive a grant:

  • Academic Institutions
  • Professional Associations
  • Patient Advocacy Organizations
  • Hospitals
  • Medical Societies
  • Third-party Meeting Organizers

Education Grants are not:

  • Provided to induce, reward, or influence the purchasing, prescribing, formulary placement, or use of Sobi products;
  • For support of entertainment, social events, or any activity prohibited by the PhRMA Code;
  • For support of political organizations or lobbying activities;
  • For support of an organization’s general operational, ordinary overhead costs, or routine business expenses
  • Provided to support the costs of honoraria, travel, lodging or other personal expenses of non-faculty patients or HCPs attending or participating in the activity.
  • Used to compensate non-faculty patients or HCPs for time spent at an educational activity

Also note that while we receive many submissions, as an emerging company with finite resources, we are limited in the number of grant submissions we can fund.

To complete a grant application, please visit our submission portal here.

For questions or for more information, please contact us at grants.us@sobi.com.

 

Find an MSL

Use this tool to locate and contact your local Sobi Medical Science Liaison in the United States

Get in touch with a Sobi Medical Science Liaison here.

 

Medical Affairs Portal

Do you have a Medical Information question? Please feel free to use this self-directed automated tool and potentially receive an immediate answer, or if preferred you may also call 866-773-5274 or email Sobi Medical Information mailbox: medinfo.us@sobi.com