Emergent BioSolutions Expanded Access Policy
Emergent is committed to helping to protect and enhance lives. Whenever possible, patients are encouraged to participate in clinical trials. However, we understand that in rare occasions patients may not be able to participate in existing clinical trials, have exhausted all of other available therapies and may need to seek access to investigational products before approval by a regulatory authority. This is referred to as Expanded Access.
The Expanded Access Program (sometimes referred to as “Compassionate Use”) may be a potential pathway for a patient (specific population or group) with an immediately life-threatening condition or serious disease or condition to gain access to an investigational product candidate for treatment outside of a clinical trial.
General Criteria
Emergent approaches the expanded use of our investigational products under the following considerations and criteria on a case-by-case basis:
The patient has a serious or immediately life-threatening disease or condition for which there is no comparable or satisfactory alternative therapy to treat the disease or condition
There are no available clinical trials, or the patient is ineligible for participation in available clinical trials and has exhausted all other available therapies
The potential benefit justifies the potential risk of the treatment and the potential risks are not unreasonable in the context of the disease or condition to be treated; sufficient clinical data has been evaluated to ensure the proper dose and duration is considered safe and demonstrates preliminary evidence of effectiveness
Providing the investigational product for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the Expanded Access use or otherwise compromise the potential development of the expanded access use
The treating physician is willing to open an Investigator IND with the FDA
The program must be compliant with local laws and regulations
The program will be discontinued as soon as reasonably appropriate once the product is approved by regulatory agency(ies).
Contact Information
A treating physician may contact us for questions or requests regarding our Expanded Access program as follows:
Submit questions or information to: Expandedaccess@ebsi.com
Additional information may be obtained from the U.S. Food and Drug Administration: https://www.fda.gov/downloads/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm504494.pdf
Requests should include sufficient information and details to facilitate Emergent’s evaluation of the request. Contact information must be provided to ensure Emergent is able to communicate with the treating physician, (include phone number, email address and address). The requestor, i.e., treating physician, must be willing to submit an Investigator IND, as appropriate, should the request be granted.
Receipt of all requests will be acknowledged within 3 – 5 business days or as soon as possible if the request includes emergency use for an individual patient. The decision to provide the investigational product will be communicated by Emergent based on a thorough and impartial evaluation of the request.
If you are a Healthcare Professional who would like to request compassionate use of an Emergent investigational medicine, please contact us at Expandedaccess@ebsi.com.
In order to handle your enquiry, we are required to record and maintain the personal information that you have provided to us. This may include your name and contact details. This personal information will be processed solely for the purpose of dealing with your enquiry and retained in accordance with our Privacy Policy. More detailed information on the processing of your personal information is available from our Privacy Policy available at http://emergentbiosolutions.com/privacy-policy.
Available Clinical Trials
Available Clinical Trials may be referenced through https://clinicaltrials.gov/ or other regional public registries.
This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.