Requests for access to a Day One investigational therapy must be made by the patient’s treating physician. Requests cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver.
To make a request for expanded access, physicians should send an email to email@example.com. The following information must be included in any request:
- Requesting physician’s name, contact information, address (including country), and professional qualifications;
- Name of the requested Day One investigational therapy, the therapeutic indication and intended treatment plan;
- Medical rationale for the request, including an explanation why alternative therapies cannot be used, why the patient does not qualify for an ongoing clinical trial, why the potential benefit from the use of the investigational product outweighs the potential risks, and why those risks are not unreasonable in the context of the disease or condition being treated.
Day One is committed to evaluating all requests for expanded access in a fair and equitable manner. We will acknowledge requests from licensed physicians as soon as possible, generally within five business days of receipt. A decision will be made and communicated as soon as possible thereafter. Day One cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
Any expanded access to investigational therapies must comply with the applicable country-specific laws and regulations, including importation requirements, approvals from applicable regulatory bodies, and by an review appropriate Institutional Review Board or Ethics Committee. Day One may require agreements and/or certifications executed by the treating physician and other information to be provided prior to final approval of any request.
Patients and caregivers seeking information about access to our investigational therapies, either through a clinical trial or through expanded access, should consult with their treating physician.
Day One may revise this policy at any time in line with the 21st Century Cures Act.