ALLOVIR POLICY ON PROVIDING EXPANDED ACCESS TO INVESTIGATIONAL DRUGS
AlloVir is committed to developing safe and effective medicines and treatments for patients worldwide. Before marketing drugs to patients, AlloVir is responsible for conducting clinical trials involving research participants to determine whether investigational drugs are safe and effective for treating a specific disease or condition. AlloVir designs and conducts clinical trials to generate valid scientific evidence, while protecting the rights and welfare of research participants. To the extent required or allowed by applicable law, regulations and, as applicable, patient consent, AlloVir intends to use the clinical data gathered from the Expanded Access Program for internal purposes, regulatory submission purposes, or reimbursement purposes.
Enrolling in a clinical trial is the most common way that persons who seek access to an investigational drug may receive that drug, and AlloVir’s clinical studies should be the primary route by which patients receive access to AlloVir’s investigational drug(s). In certain cases, however, a patient with a serious or life-threatening disease or condition may not be eligible to enroll in a clinical study sponsored by AlloVir, or an AlloVir clinical study may not be available or the patient may lack feasible access to a clinical study, but the patient and the patient's physician believe the patient could potentially benefit from access to the investigational drug before it is approved by a regulatory agency. In this case, the patient and the patient's physician may seek to obtain the investigational product outside of a clinical study, by using a process commonly referred to as “expanded access” or “compassionate use.” In those circumstances, when no satisfactory alternatives are available and to the extent compliant with all applicable laws, AlloVir may provide a physician with access to an investigational drug outside of a clinical trial to treat a particular patient or a group of patients with that investigational drug. The decision criteria AlloVir applies when considering such requests are set forth below. When AlloVir makes an investigational drug available to a patient and his/her physician who requests the drug, AlloVir is not representing or promising that the investigational drug is safe or efficacious to treat, diagnose, or monitor the patient's illness or medical condition.
In general, AlloVir will consider making investigational drug(s) available, for expanded access use for individual patients, only in response to a request from a licensed physician (a "Program Request"). The determination to grant or deny a Program Request is in the sole discretion of AlloVir. It is important for patients and physicians to understand that AlloVir does not guarantee that it can or will approve any Program Requests for investigational drugs. If a Program Request is granted, to the extent allowed by applicable law, regulations and, as applicable, patient consent, AlloVir will require the physician to ensure that AlloVir receives clinical data that are obtained as a result of the physician’s administration of the investigational product. AlloVir's decision to grant or deny a Program Request may be modified or reversed by AlloVir at any time, and is subject to AlloVir's continuing evaluation of safety and effectiveness data about the investigational drug, as well as other considerations related to inventory, manufacturing, and clinical development programs. AlloVir may revise this Policy at any time.
Decision Criteria. In general, AlloVir will consider whether:
Program Requests directed to AlloVir must be in writing, must be signed and submitted by a licensed physician who is in a treatment relationship with the patient for whom the investigational drug is being requested, and must be sent to firstname.lastname@example.org. AlloVir may require up to 5 business days to acknowledge receipt of the Program Request. While AlloVir intends to provide a written response to all Program Requests in a timely manner, certain factors which may affect the length of the review period include, but are not limited to, obtaining permission from regulatory authorities, the need for additional information from the requestor, or other factors beyond AlloVir’s control. AlloVir recognizes that the decision to grant or deny a Program Request is complex. AlloVir commits to: (i) conducting a clinical review of all requests, (ii) deciding each request in an equitable and fair manner, and (iii) using the available scientific and clinical evidence in making each decision.