EIA FAQs

Advancing ECP Immunomodulation Investigator Award in Graft versus host disease:
Refining THERAKOS ECP Immunomodulation™

Frequently Asked Questions

Who is eligible for the grant award? Are applicants from all countries eligible?

Clinicians, physicians, scientists or others who are interested in ECP Immunomodulation based in the EMEA region* are encouraged to apply. We would like to encourage especially young clinicians and scientists to submit their proposals for evaluaton.

How much funding is available?

One educational grant of €75,000 will be awarded to the institution and is to be used in the specified timeframe of 18 months.

Is the grant awarded to the applicant’s institution?

Yes, this award is designed to go to an institution.

Who is on the Investigator Award Committee?

The Investigator Award Committee will consist of Medical Scientists employed by Mallinckrodt Pharmaceuticals. The Award Committee will score applications based on the criteria outlined in the submission form – specifically on scientific merit, its novelty and feasibility – to select a winner as well as a runner-up.

Once a grant is awarded, will there be any requirements for the investigator to meet certain milestones or report to Mallinckrodt Pharmaceuticals?

Yes, the awardee is required to share the outcomes of the research through a report at the completion of the project, the exact details on reporting and potential publications will be defined in a contract agreement.

What can I do if my project does not fit the above-mentioned criteria or gets rejected?

If case your project does not fit the above-mentioned criteria or has been rejected you can still apply for an investigator initiated research program following the link at: https://investigator-initiated-research.mnk.com.

*Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.

For any question not answered in our FAQs please contact: medicalaffairseu@mnk.com

Terms and Conditions

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

Indications

The THERAKOS^TM CELLEX^TM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications

THERAKOS^TM Photopheresis is contraindicated in:

Patients possessing a specific history of a light sensitive disease.
Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm³.
Patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions

THERAKOS^TM Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure. Safety in children has not been established.

Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
When prescribing and administering THERAKOS^TM Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
Treatment frequency exceeding labelling recommendations may result in anaemia.
Venous access carries a small risk of infection and pain.

Please refer to the THERAKOS^TM CELLEX^TM Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

Contraindications

Methoxsalen is contraindicated in:

Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients
Patients with co-existing melanoma, basal cell or squamous cell skin carcinoma
Patients who are pregnant, and sexually active men and women of childbearing potential unless adequate contraception is used during treatment
Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens

Warnings and Precautions

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
Safety in children has not been established.

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOS^TM CELLEX^TMPhotopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.