At Genzyme, we've always taken an outward-looking approach to science, recognizing that important medical research has many sources and paths to success. In this spirit, we've established an Investigator-Sponsored Studies (ISS) program to support researchers not affiliated with Genzyme who are studying our products or disease areas of interest to us.
Genzyme's ISS program supports research that can advance scientific, medical, health economic, and other knowledge about our existing marketed products and diseases we study. Results of such studies may lead to greater understanding of our therapies and their potential applications, may improve patient care, and spark new ideas for further disease-related research.
Researchers may propose the following types of studies for evaluation:
- Prospective and retrospective clinical studies with approved Genzyme drugs or devices
- Observational studies, such as epidemiological research on diseases we treat
- Health outcomes research, especially related to diseases we treat
- In vitro and animal studies with Genzyme drugs or devices
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Several forms of support may be approved, in whole or in part, by Genzyme's ISS Scientific Review Committee, including:
- Funding to pay for expenses based on fair market value that are directly associated with research protocol-related study activities
- Free clinical trial material for in-vitro and animal studies or human clinical trial research
- A combination of the above
Researchers interested in Genzyme's ISS program should first contact their local Genzyme Medical Science Liaison or Genzyme Country Affiliate Medical Director for a preliminary discussion of their research proposal. The Genzyme representative will also provide an explanation of the ISS application, review, and approval process.
After this preliminary communication, a researcher may decide to submit an application outlining the research proposal and request for support, to be evaluated by Genzyme's ISS Scientific Review Committee. The submission occurs entirely online through our web-based tool, in a two-part process:
- Submit a preliminary concept proposal
- Upon Genzyme Scientific Review Committee approval of the concept proposal, submit a full protocol
An applicant will be kept updated of the proposal status throughout the process. Upon approval of the full protocol and study budget by the Scientific Review Committee, Genzyme will send the researcher a research support agreement to be agreed upon by the researcher, his or her institution, and Genzyme. Institutional review board or ethics committee approval of the protocol is also required.
If you don't know your local Genzyme representative, use the links below to contact the Genzyme Medical Information department in your region, and they will put you in touch with the appropriate person. Be sure to include the following information in your inquiry:
- Your contact details and preferred method of contact (phone, email, etc.)
- Your country or jurisdiction of practice
- The Genzyme product and/or therapeutic area relevant to your research
- A very brief description of your idea
Medical Information: Regional Contacts
Genzyme is committed to maintaining integrity in all our professional relationships. To that end, we have established the following code of conduct around data privacy, financial disclosure, transparency, and ethics for our ISS program
- Genzyme will process the personal data of ISS applicants solely for the purpose of evaluating their applications and administering the research support relationship
- We may disclose to authorities and the public our ISS support or other financial relationship with researchers and their institutions
- Participating researchers and their institutions and employees are under no obligation to solicit or refer patients for any Genzyme business or to promote Genzyme or our products before, during, or after the research project
- In order to provide reasonable compensation or reimbursement, we expect the charges or values for items, procedures, and tasks in an ISS budget to reflect current market prices/fair market value (FMV) for the study's geographic region. Genzyme may not pay or compensate for costs that exceed FMV or are unrelated to protocol-required research.