DYNAVAX POLICY FOR EXPANDED ACCESS
Investigational Medicines and Clinical Trials
Dynavax is committed to developing safe and effective medicines and treatments for patients. Before marketing drugs to patients, Dynavax 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. Dynavax designs and conducts clinical trials to generate valid scientific evidence and to protect the rights, safety, and welfare of research participants, and encourages individuals who are interested in seeking access to an investigational drug to seek enrollment in an appropriate clinical trial. Clinical trials, including eligibility criteria are listed at www.clinicaltrials.gov.
Enrolling in a clinical trial is the most common way that persons who seek access to an investigational drug may receive that drug, and Dynavax's clinical studies should be the primary route by which patients receive access to investigational medicine. 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 Dynavax, 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. Because the patient would not qualify for the clinical study, the patient and the patient's physician may seek to obtain the investigational product outside of the clinical study through a process that is commonly referred to as "compassionate use" or "expanded access."
In circumstances, when no satisfactory alternatives are available, and in compliance with all applicable laws, Dynavax 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 Dynavax applies when considering such requests are set forth below. When Dynavax makes an investigational drug available to a patient and his/her physician who requests the drug, Dynavax 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
Guiding Principles for Expanded Access
The determination to grant or deny expanded access to an investigational drug is complex. In this process, Dynavax commits to conducting a clinical review of each request, deciding each request fairly and equitably, and using all available scientific and clinical evidence. Dynavax is committed to ensuring that patients are not exposed to unreasonable or unnecessary risks. In particular, Dynavax considers, among other factors, the following criteria:
- Whether the requesting patient has a serious or life-threatening disease or condition;
- Whether the patient is ineligible or otherwise unable to participate in any clinical study of a Dynavax investigational drug;
- Whether there are alternative treatment options available;
- Whether clinical data is available to assess the potential benefits and risks in providing the investigational drug for the treatment contemplated, and that the risks are not unreasonable;
- Whether it is reasonable and appropriate, from a clinical and scientific perspective, to use the investigational drug for a particular patient;
- Whether the use of the investigational drug will be monitored and controlled appropriately and adequately by a licensed physician who is sufficiently qualified to administer the investigational drug in a safe manner;
- Whether there is an adequate supply of the investigational drug and whether granting the request could affect or interfere with Dynavax's initiation, conduct or completion of clinical trials for the investigational drug; and
- Whether the request, and Dynavax's grant of the request, would be compliant with applicable local, state, and federal laws and regulations.
Procedure to Request Expanded Access
Requests 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
Dynavax may require up to five (5) business days to acknowledge requests either orally or in writing, and may require the requesting physician to sign certain agreements, including a confidential disclosure agreement, before Dynavax will disclose confidential and proprietary information or ship the investigational drug for the patient's use. The requesting physician also must agree to obtain all other necessary regulatory authority and ethics and institutional committee approvals, as well as comply with all applicable regulatory requirements, including monitoring, reporting, and recordkeeping obligations. In addition, if Dynavax does grant a request for expanded access, Dynavax will require that the physician provide the patient with a legally effective consent form that describes, among other information, the risks and benefits of the investigational drug, as well as alternative treatment options.
Dynavax may be required to obtain permission from one or more regulatory authorities, including the FDA, before granting a request for expanded access, which could delay or prevent an investigational drug’s availability. Dynavax may also request additional information from patients and their requesting physicians.