Marker is committed to developing T cell immunotherapies for patients with rare, life-threatening diseases. At Marker our values to maintain the highest ethical standards in our scientific research methods and programs, guide our decision-making. We also comply with regulatory and industry guidelines as we seek to make advances in science and technology.
Clinical trials, which form the foundation of our development programs, are designed to assess the safety and efficacy of investigational medicines. Participation in a clinical trial represents the best way, in a controlled setting, to gain access to an investigational medication. Information about ongoing Marker sponsored clinical trials can be accessed either at Marker website www.markertherapeutics.com or at National Institutes of Health (NIH) site for clinical trials being conducted in the US www.clinicaltrials.gov. In some circumstances, a patient with a serious or life-threatening disease may not be able to participate in a clinical trial. Seeking use of an investigational medication under these circumstances (early access) is permitted by the US Food and Drug Administration (FDA) and the US government under Expanded Access Programs (EAP) and Right to Try (RTT), respectively.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected for marketing authorization. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy. Our policy is intended to comply with FDA requirements for any such use or access.
A number of factors consistent with the US FDA and other regulatory agencies’ guidelines should be taken into account when considering EAP and RTT, which include the following:
- The illness must be serious or immediately life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials).
- The patient must have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
- The patient is ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
- There is an ability to provide the product in a fair and equitable manner and there is adequate manufacturing capacity for ongoing programs.
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.
Our policy for considering early access to investigational medicines is grounded in the following key ethical principles:
- All requests for early access are considered in a fair and just manner.
- Sufficient understanding of the potential benefits and risks of the investigational medicine has been established through the conduct of a rigorously designed, scientifically and medically sound, development program.
- Patients are not put at risk of unnecessary harm by the use of the investigational medicine.
- Fulfillment of early access will not jeopardize the development program that may lead to broader public access through marketing authorization.
- Fulfillment of pre-approval access fully complies with applicable laws and regulations.
All requests must be submitted by the appropriately licensed treating physician caring for the patient to better understand the benefit-risk of the therapy for the patient’s condition. Physicians in the United States wishing to discuss an early access request should submit the request via email using the email@example.com address. The treating physician should include in the email communication the following:
- A brief history of the patient.
- Medications administered to control the underlying disease condition.
- List of available alternative treatments.
- A description why the treating physician believes the patient would benefit from receiving the investigational medicine.
Marker believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies at the current stage of the development programs. Marker is in the opinion that until there is sufficient safety and efficacy data gathered from the clinical trials, patients should not be put at risk of unnecessary harm by the use of the investigational medicine outside of a well-controlled clinical trial. If you have additional questions, please speak with your physician and have your treating physician contact Marker at firstname.lastname@example.org email address. Marker does not accept requests directly from patients or family members. We anticipate acknowledging receipt of requests sent to this email within approximately seven business days.