FAQs - Oncidium Foundation

Q: What are the roles of the other stakeholders (clinical sites, radioisotope suppliers, local radiopharmacies)?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="true" hover_type="none" min_height="" link="" background_blend_mode="overlay" first="true"][fusion_text] Clinical Sites • Selection of patients and creation of paperwork for treatment access: early access, compassionate use, expanded access, etc. • Submission of cases on online platform • Contact with local radiopharmacy for the logistics, labeling and QC. • Feedback on treatment outcomes Local Radiopharmacies • Importation process, customs clearance, inland transportation. • Labeling and QC • Delivery at clinical site Isotope suppliers • Dose donations • Definition of number of doses to be donated each year [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: Who can register on the platform?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="true" hover_type="none" min_height="" link="" background_blend_mode="overlay" first="true"][fusion_text] • Healthcare professionals working in centers that already use 177Lu and that have experience in treating patients with 177Lu radiopharmaceuticals. Thus, patients cannot register themselves to seek a dose. • Radioisotopes suppliers that wish to donate radioisotopes (including dose donation, shipment, importation taxes). [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: What is being donated?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" type="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" hover_type="none" min_height="" link=""][fusion_text] The RLT-Connect is currently donating 177LuCl (lutetium-177 (177Lu) chloride). [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: Who can benefit from the donation?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="true" hover_type="none" min_height="" link="" background_blend_mode="overlay" first="true"][fusion_text] Patients who cannot afford the therapy, mainly from low- and medium-income countries, where there is no reimbursement. Dose distribution is limited for each country and will be allocated evenly across the world. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: Who can request a treatment/dose?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" type="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" hover_type="none" min_height="" link=""][fusion_text] Healthcare professionals, in countries where the necessary infrastructure is already implemented to deliver the doses to the patients. Moreover, patients cannot register themselves to seek a dose, the request should come from the hospital that can deliver the treatment. What’s more, once the donation is approved, doses are donated by the Radioisotopes Companies and directly to the centers and will not transit through the Oncidium foundation. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: How many doses can a patient expect to receive within the donation program?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" type="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" hover_type="none" min_height="" link=""][fusion_text] Once a case is accepted and validated for donation to a patient, the foundation commits to providing the necessary doses, including a full treatment cycle personalized to the patient’s needs. Additionally, patients who have already received doses and require additional ones may also benefit from the donation in case they meet the eligibility criteria established for the program. On the other hand, if a patient does not respond to the treatment, the doses will be reallocated to another patient in need, ensuring efficient use of resources. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: Who will validate the treatment/dose donation?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" type="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" hover_type="none" min_height="" link=""][fusion_text] An Ad Hoc committee set up by the Oncidium foundation composed of field specialist. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: Who is responsible for the labelling?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" type="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" hover_type="none" min_height="" link=""][fusion_text] The labelling will be carried out by the radiopharmacy center that already works with the hospitals. It must be indicated in the registration form. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: Who is responsible for the importation and logistics process?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="true" hover_type="none" min_height="" link="" background_blend_mode="overlay" first="true"][fusion_text] The importation and logistics of the 177LuCl dose will follow the same process as already done by your center for commercial doses. The Oncidium foundation does not intermediate these processes. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: How can I request a donation?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="true" hover_type="none" min_height="" link="" background_blend_mode="overlay" first="true"][fusion_text] 1- Register your center here https://rlt-connect.oncidiumfoundation.org/registration/clinical/ ; 2- Receive the confirmation of the registration request by e-mail; 3- If your center registration is approved, you will receive by e-mail a contract and the RLT-Connect ethical charter to be signed by the physician and the hospital director; 4- An additional document will also be attached, to the local radiopharmacy your hospital is working with for signature; 5- Once the contracts are signed, you will be able to request a dose; 6- To request a dose, log into the platform: https://rlt-connect.oncidiumfoundation.org/ ; 7- Click on “Create a request”; 8- Answer the qualifying criteria form and submit it; 9- After careful consideration of the request, you will receive a response within 15 working days, indicating either a positive or negative return. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]