ONY Biotech has an active pipeline of research and development therapies. We are committed to providing access to therapies that are not yet approved for use, when permissible, to patients who are suffering from a serious condition and who might potentially benefit from these therapies.
ONY Biotech’s Expanded Access Policy includes how we evaluate when a doctor requests the use of investigational therapies for a patient with a serious or life-threatening illness or condition. The primary option for patients to get access to investigational therapies is to participate in a clinical trial. Patients and physicians can learn more about clinical trials at clinicaltrials.gov
There may be circumstances where access to investigational therapies outside of a clinical trial is appropriate, and a patient’s doctor can request consideration for access if (1) the patient suffers from a serious or life-threatening illness or condition, (2) there are no other suitable treatment options, and (3) the patient does not qualify for ongoing clinical trials. We need to ensure that the potential benefits of the investigational therapy outweigh the risks to the individual patient, that providing access under this policy doesn’t have a negative impact on clinical trials, and that enough supplies of the therapeutic materials are available.
Requests for access to investigational therapies under development and prior to approval, under this policy, must be made by Treating Physicians, who should contact ONY Biotech at firstname.lastname@example.org with a detailed description of the request and provide full contact information. A representative from ONY Biotech will respond to the physician with care to gather information to allow for a carefully considered and fair decision. Each case is unique and will be considered individually.