Policy on expanded access for investigational medicines
Orca Bio is a company focused on developing innovative therapies for patients with serious, life-threatening disease. In our mission to bring these treatments to patients as quickly as possible, we conduct clinical trials to establish the safety and efficacy of an investigational product, which is a medicine in active clinical development but one that has not yet received marketing approval by the relevant health authorities, such as the FDA.
For this reason, we prioritize access to an investigational medicine through clinical trials and encourage patients to enroll in such studies. More information can be found at: www.clinicaltrials.gov.
We recognize that there are circumstances where patients with serious or life-threatening diseases may not be eligible for, or are unable to participate in, one of our trials. In such circumstances, subject to the criteria set forth below and country specific regulations, patients may be eligible to access Orca Bio’s investigational therapies through our Expanded Access Policy.
A request for expanded access must meet all the following requirements:
- Use of any investigational medicine must be overseen by a licensed and appropriately qualified physician, in accordance with local laws and regulations governing such programs, as well as all Orca Bio policies and procedures.
- Competent healthcare facilities must be available that are appropriate to administer the therapy, manage potential side effects, and monitor the patient with appropriate follow-up.
- The risk-benefit of receiving the therapy must be assessed and confirmed by the requesting physician and will be by further assessed Orca Bio.
- Orca Bio has determined that sufficient preliminary efficacy and safety data have been generated to identify an appropriate dose and that potential benefits from treatment are likely to outweigh any associated risks to the patient.
- The patient does not qualify for participation in ongoing or pending clinical trials and all necessary regulatory and institutional approvals have been obtained to allow administration of the investigational product.
- The disease or condition is life-threatening and is commensurate with the indication for which the investigational therapy is likely to be approved.
- There are no other satisfactory treatment options available, including approved medicinal products, or open clinical trials available.
- Supply logistics for the treatment can be achieved such that the therapy can be provided in a timely and effective manner.
- Treatment will not adversely impact, impede, or compromise ongoing clinical development programs and/or regulatory interactions.
- The patient will receive treatment in a country or jurisdiction where Orca Bio’s plan is to seek regulatory approval to market the product.
Instructions for making a request
A request for expanded access must be submitted in writing by the patient’s treating physician. Please make sure that no patient identifying information is included. The request can be sent to email@example.com.
Orca Bio will acknowledge receipt of all requests within three business days and will consider and determine whether to offer investigational product under this expanded access program. There is no guarantee that therapy will be available to a patient at any given time.
Orca Bio reserves the right to modify or terminate this expanded access policy at any time.