Francis Cuss, Chief Scientific Officer
Early Patient Access to Investigational Medicines
At Bristol-Myers Squibb patients are at the center of everything we do. Every day, we come to work committed to our mission -- to discover, develop, and deliver transformational medicines that help patients fight serious disease.
Our employees are motivated by this single focus and work tirelessly with the hope that our scientific insights can be translated into new medicines that make a meaningful difference in the lives of patients. We work with urgency, knowing that many patients around the world are waiting for new therapeutic options.
As chief scientific officer I receive many inquiries about our investigational medicines, including requests outside of our clinical trials – a practice commonly referred to as “compassionate use” (which we call “early patient access”). This is an important topic for me and for our company, as we know that many of the patients seeking access to our investigational medicines are facing a serious or life-threatening illness and often have no further treatment options or a clinical trial available to them. We welcome requests for early patient access from the physicians treating these patients and we take great care to have each individual patient case assessed by a physician on our staff. Our goal with our early patient access programs is to ensure that appropriate patients can obtain access to our investigational medicines.
Decisions about early patient access of our investigational medicines are made after considerable thought. Our first concern is that of any doctor, namely the safety and well-being of the patient. This is especially important because these medicines have not completed the normal course of studies for the indications at issue. Then consideration must be paid to the possibility of a benefit for the patient based on what we know about the investigational medicine at the time. In this regard we work closely with the patient’s physician to determine whether access to the investigational medicine is best for the patient. We also make sure that medicines are provided in a fair and equitable manner, but there is no guarantee that every request will be fulfilled.
Lastly, we must ensure that by providing an investigational medicine to an individual outside of a clinical trial it in no way compromises the scientific validity of the broader development program or delay any regulatory filings, which is aimed at making the medicine available to help many more patients through regulatory review and approval.
If you are a patient with questions concerning access to an investigational medicine -- either through a clinical trial or under compassionate use – please discuss your situation with your treating physician.
Early patient access requests must be made through your physician who can reach Bristol-Myers Squibb by visiting Bristol-Myers Squibb Early Patient Access Requests. Bristol Myers Squibb strives to respond to the request as quickly as possible, usually within 48 hours. You can also access more information on our clinical trial programs at Bristol-Myers Squibb Study Connect.
Specific eligibility criteria must be met for access outside of a clinical trial. These criteria include:
- The illness must be serious or life threatening
- There are no other viable options (including approved products or active clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
- There is a plan by Bristol-Myers Squibb to make the medicine, once approved, available commercially in the country from which the request was received
- Whether or not sufficient quantities of the investigational medicine are available
This is an unprecedented time for scientific innovation and the development of important new medicines. At Bristol-Myers Squibb, we are doing everything we can to ensure that patients with serious disease get the benefit of these innovations as quickly as possible.
Learn more about Bristol-Myers Squibb's standpoint on early patient access to investigational drugs and how to request access through your physician.
Francis Cuss, MB BChir, FRCP
Chief Scientific Officer