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 innovative medicines that help patients fight serious disease.
Our employees are motivated by this single focus and work tirelessly to discover and develop new medicines with the hope that ours and others’ scientific insights can be translated into new medicines that truly help 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 is to help as many patients as possible.
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. Then it’s important to consider if there is any 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 what is best for the patient.
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 should be made through your physician who can reach Bristol-Myers Squibb by visiting Bristol-Myers Squibb Early Patient Access Requests. You can also access more information on our clinical trial programs at Bristol-Myers Squibb Study Connect.
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.
Francis Cuss, MB BChir, FRCP
Chief Scientific Officer