Expanded Access Policy
Gateway Institute for Brain Research (“Gateway”) is dedicated to the discovery and development of safe and effective therapeutics for Parkinson disease.
Gateway currently has several clinical product candidates in active clinical trials. These product candidates, also known as investigational new drugs, have not yet been found to be safe and effective for their specific purpose by the U.S. Food and Drug Administration (“FDA"), or other health authorities, and require additional testing in clinical trials. A clinical trial is a research program conducted with patients to evaluate an investigational new drug in which comprehensive safety and efficacy data are compiled.
What is Expanded Access?
Although the FDA does not typically permit investigational new drugs to be used outside of the context of a clinical trial, in certain circumstances it may be permissible under an expanded access program. Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Per the FDA, expanded access may be appropriate when all of the following criteria are met:
Patient has a serious disease or condition, or whose life is immediately threatened.
There is no similar or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
Enrollment in a clinical trial is not possible.
Possible patient benefit justifies the possible risks of treatment with investigational products.
Providing the investigational medical product will not affect the investigational trials.
Does Gateway Consider Expanded Access Requests?
Gateway believes that participation in our clinical trials is the most appropriate way to access our investigational drugs, consistent with FDA recommendations: “Whenever possible, an investigational medical product should be used as part of a clinical trial.” Accordingly, Gateway has decided not to provide expanded access to any of its investigational new drugs at this time.
In the future, Gateway may reassess its policy on expanded access as additional clinical trials are conducted and more safety and efficacy data becomes available.
Where can I go for additional information?
If you are a physician who is interested in learning more about our investigational products, or participating in our clinical trials, please submit a request to email@example.com.
If you are a patient who is interested in accessing our investigational drugs through our ongoing clinical trials, please speak with your physician. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Gateway Institute for Brain Research, LLC.
Posting this policy does not guarantee access to any specific investigational drug for any individual patient. Gateway reserves the right to revise this policy statement in whole or in part at any time, without notice.