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Talecris links
Timelines
| Task | Date |
|---|---|
| LOIs accepted (starting from) | TBC |
| Deadline for LOI acceptance | TBC |
| Proposals evaluated and scored by Evaluation Committee | TBC |
| Deadline for full proposals | TBC |
| Meeting of review committee | TBC |
| Funding decisions made | TBC |
| Funding available | TBC |
The table above summarizes the application timelines for 2010.
Letters of Itent (LOIs) will be reviewed by members of the Talents Evaluation Committee, and those applicants whose LOIs are approved by the committee will be emailed a blank full proposal form for completion.
The results of the review process and funding decisions will be communicated to applicants by the end of October each year. Funded applicants must send a letter of acceptance and enter into a contract with Talecris; which outlines both parties' responsibilities and obligations prior to the disbursement of funds.
Generally the responsibilities of the investigator and major milestones include the following: agreeing to sign a Material Transfer Agreement for basic research projects that include product. If the project is a clinical research project involving human research subjects, IRB approval and informed consent from each subject must be obtained. If IGIV is to be used in human studies for off-label areas, an investigator-initiated IND application must be filed with the FDA and approved. A detailed timeline highlighting these milestones will enable both investigator and Talecris to manage expectations. Once these milestones have been met, the first disbursement of funds can be made. Following receipt of a midterm report, the second disbursement of funds is made; and the final disbursement is made after receipt of a final report. Talecris also encourages investigators to publish their work and will provide assistance with that effort if requested.
Talecris' Medical Affairs representatives will visit the study site quarterly to help the investigator ensure that all milestones are met on a timely basis. It is essential that investigators agree to meet with their respective Medical Science Liaison when requested. Talecris may withdraw research funding if milestones are not met, and the study does not progress in a timely fashion.
© 2010 Talecris Biotherapeutics