Early Patient Access to Investigational Medicine

Tom Lynch, CSO Bristol-Myers Squibb

Tom Lynch, Chief Scientific Officer, Bristol-Myers Squibb

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.

We 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 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 to 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 are 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.

For further information or to request access to a Bristol-Myers Squibb investigational product, please discuss with your physician.

Tom Lynch, M.D.
Chief Scientific Officer

Tom Lynch Signature

Right to Try Act

In May 2018, the President of the United States signed into law the Right to Try Act.

Bristol-Myers Squibb supports efforts to improve the safe and timely access to investigational medicines for patients facing a serious or life-threating illness and who have no further treatment options or a clinical trial available to them. We believe our current approach to early patient access, as outlined above, is consistent with the objectives of the Right to Try Act. Requests for early patient access to Bristol-Myers Squibb investigational medicines should continue to be made through the treating physician and by visiting Bristol-Myers Squibb Early Patient Access Requests Portal


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