EIA FAQs

Close-up of faces of laboratory researchers wearing PPE

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™ CELLEX™ Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

Cutaneous T Cell Lymphoma (CTCL)
Solid Organ Transplant Rejection (SOT) (heart, lung)

The THERAKOS™ CELLEX™ Photopheresis System is indicated in patients older than 3 years of age for the management of:

Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)

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^TMPhotopheresis 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.

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 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.

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

Consult the 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) professional leaflet or the oral 8-methoxypsoralen formulation package insert before prescribing or dispensing any medication.