Expanded Access Program

 

Oneness Biotech Policy on Expanded Access Program for IND 079526  

Oneness Biotech is dedicated to developing innovative treatments for serious and life-threatening conditions. Understanding that certain patients with serious or life-threatening diseases may have exhausted all available treatment options, meet the unique needs of expanded access requirements and are interested in receiving Oneness’s drug candidate through an expanded access policy, Oneness is willing to provide our investigational drug products to patients for the treatment in compliance with FDA Expanded Access (Compassionate Use) Policies.

Oneness Biotech’s Expanded Access Policy
Oneness Biotech’s policy is to be able to provide appropriate and ethical access to its investigational products to patients under certain defined circumstances outside of the planned clinical research program prior to marketing authorization. Such Expanded Access Programs, or EAPs (often called “Compassionate Use” programs), are for exceptional circumstances only.

Expanded Access

All expanded access programs must be conducted in agreement with applicable legal and regulatory requirements related to providing an investigational product under expanded access protocols. Oneness Biotech believes that participation in one of our clinical trials is the best way to access our investigational drug product. We encourage patients to speak with their physicians regarding participating in clinical trials. In exceptional cases where patients with serious diseases are unable to participate in clinical trials and have exhausted all available options, requests for EAP will be considered, on a case-by-case basis, if it meets the following criteria listed below:

Criteria for Consideration of a Request for EAP

1. A patient has a serious, life-threatening or chronically debilitating disease;
2. There is a clear understanding that the investigational product is intended to treat diabetic foot ulcers for which use is requested by the licensed physician and the patient;
3. The investigational product is regarded by the licensed physician and the patient that the available clinical data presents evidence of efficacy such that a clinically meaningful benefit may be expected;
4. There is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition;
5. The patients are ineligible for, or otherwise unable to participate in, a clinical trial for the product;
6. The treating physician must complete FDA Form 3926 and is willing to open a Treatment IND with the FDA, including file paperwork with FDA and IRB (for many expanded access request types), and is responsible for patient care and reporting;
7. The treating physician should provide the completed Form to Oneness Biotech for review prior to submission to FDA;
8. The treating physician and the patient (and the patient’s family or custodians) agree to waive claims for damages against Oneness Biotech;
9. There is adequate supply of the investigational product to meet all needs for patients enrolled in ongoing clinical studies, and that designating investigational product for an expanded access treatment use will not compromise supply or otherwise postpone providing the new treatment, once approved, to the broader patient population;
10. Providing expanded access to an investigational product shall not negatively jeopardize the initiation, conduct, or completion of clinical investigation(s) and the overall development program to support registration of the product.

Requesting Procedure

1. A licensed physician may apply for access to a Oneness Biotech’s investigational product in the pre-approval stage of development by contacting this email: EAPrequest@onenessbio.com.tw
2. The requestor may expect to receive acknowledgment of the request within 5 business days.
3. Oneness Biotech may request more detailed information from the physician or institution in order to fully evaluate a request. The decision to grant access is solely at the discretion of Oneness Biotech.
4. Any physicians or institutions participating under an EAP must agree to comply with all relevant laws, regulations and requirements, including:
  a. Any reporting requirements (such as relating to the maintenance and release of treatment records and data to Regulatory Agencies, and to Oneness Biotech, as specified/required),
  b. Supervise administration of the investigational product, obtain informed consent and/or assent, adhere to Good Clinical Practice guidelines, and other procedures as outlined by Oneness Biotech.
If Oneness decides a single-patient IND can be pursued, a Letter of Authorization (LOA) will be issued to the licensed physician to reference the existing IND under which the investigational drug is being studied. The EAP will be discontinued as soon as feasible when the drug is approved for its labeled indication.

Additional information about Oneness Biotech’s clinical trials is available on the NIH’s website by searching “Oneness Biotech” at www.clinicaltrials.gov.

Oneness Biotech shall reserve the right to revise the policy from time to time.