The mission of the Halozyme Investigator Sponsor Trial (IST) Program is to:
The Halozyme IST Program is open to qualified researchers worldwide who are interested in conducting their own research. Applications to the program are reviewed on a quarterly-basis by a committee of Halozyme medical and scientific staff. Support is provided based on the scientific merit and rigor of the proposal as well as whether it is in alignment with the Halozyme published areas of interest. Information related to areas of interest and requirements for submission can be found below.
Proposed research must address an appropriate medical or scientific question. Halozyme evaluates IST proposals on a quarterly basis on their clinical value, scientific validity and rigor of the proposed research, benefits and risks to human subjects, confirmation that the study design meets ethical guidelines concerning human subjects in research, intellectual property considerations, amount of funding and drug requested, experience of the investigator and research site, and alignment with Halozyme values and clinical areas of interest.
Clinical investigations must be conceived and executed by external investigators. All responsibility for the conduct of the study resides with the investigator and their institution, including ensuring that the study is conducted under the appropriate ethical, legal, and regulatory guidelines including ICH GCP Guidelines. Financial and/or product support is contingent upon full execution by both parties of an IST research agreement.
Current areas of interest for PEGPH20 include targeting malignancies with high hyaluronan (HA) in the tumor stroma including:
Other areas of interest include the use of PEGPH20 in combination with traditional chemotherapeutics, such as tyrosine kinase inhibitors (TKIs) and immunotherapy agents including:
All IST submissions must be submitted by the applicant via this website. To be considered for review, applicants must complete the Concept Proposal Form in its entirety. If funding is being requested, a top-line budget must be provided.
Submission of an IST proposal does not ensure approval. All proposals are carefully reviewed and funding decisions are based on criteria mentioned above. Applicant will be notified of funding decisions within 5 business days of IST Committee meetings.
To initiate the submission process, please click to download the Halozyme Concept Proposal Form. To submit a completed Concept Proposal, please click on the Submission link. For more information on the IST Submission and Review Process, please click to download the Halozyme Instructions for Submission of Investigator-Sponsored Trials and General Guidance.
Funding may be independent of institutional grant or private sources. Requests for funding may be made for partial support from Halozyme and may be provided as study drug and/or financial support.
If you wish to discuss your research questions or ideas, please contact your Halozyme Medical Science Liaison. If you do not know who to contact, please email us at email@example.com with your area of therapeutic interest and we will provide you with an appropriate contact.
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