Expanded Access Policy to Investigational Products
Updated: February 5, 2020
Emalex Biosciences, Inc. (Emalex) is a biopharmaceutical company developing innovative therapies for patients with neurological and psychiatric conditions. The company’s clinical development resources are focused on conducting clinical studies required by the US FDA and other regulatory authorities to establish the potential risks and benefits of our investigational products, and to obtain regulatory approval. As a result, participation in clinical trials should be the primary route by which patients get access to investigational products.
Emalex is also committed to making investigational products available to seriously ill patients who have exhausted other treatment options under appropriate conditions. The purpose of this policy is to describe the requirements for Expanded Access to Emalex investigational products to patients outside of a clinical study, in accordance with the 21st Century Cures Act.
This policy applies to provision of access to an Emalex investigational product that is not approved for any purpose in the country from which the requested investigational product is intended to be used.
Any use of an Emalex investigational product outside of a clinical study must be in accordance with local laws and regulations governing such programs, including Emalex policies and procedures.
In general, where permitted by local regulation, the Emalex investigational product supplied via Expanded Access will no longer be provided by Emalex when it becomes available via the local healthcare system.
Emalex does not intend to provide an investigational product under this policy if the Company does not intend to market the product in the country.
A. Patient Eligibility Criteria
To be eligible for access to an Emalex investigational product, patients must meet the following criteria:
- Suffer from a serious or immediately life-threatening disease or condition.
- Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
- Have attempted to access other investigational products with more completely understood or better benefit-risk profiles.
- Are ineligible for participation in any ongoing clinical study of the investigational product.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
- There is adequate information to support appropriate dosing for a special population patient such as pediatric, elderly, renal or hepatic disease, etc.
- Any other pertinent medical criteria for access to the investigational product, as established by the Emalex Senior Vice President for Drug Development or designee.
B. Investigational Product Criteria
In addition to the patient eligibility requirements, the Emalex investigational product must meet the following criteria:
- The product is under investigation in an Emalex development program in one or more clinical studies for the same indication(s), disease type and stage that the investigational product is being requested for.
- There are adequate data from clinical studies supporting the use of the investigational product for the patient requesting compassionate use.
- The provision of the investigational product will not interfere with or compromise the clinical development of the product.
- There are adequate supplies of the investigational product.
- Emalex has the financial ability to provide the investigational product for expanded access equitably to all potential eligible patients.
C. Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving an Emalex investigational product through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:
- Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
- The instructions for storage and administration of the investigational product, and the Investigator’s Brochure.
- Any Emalex requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.
- A treating physician may submit questions or requests regarding expanded access to the group email email@example.com for review by the Expanded Access Review Team.