“We do everything we can to help”

Dr Shahidi, Boehringer Ingelheim is driven by the desire to serve humankind by improving health through research and the development of innovative medicines. What role do the company’s compassionate use programs play in this regard?

Our regular way of delivering better health to patients is through our numerous clinical trials that pave the way to make innovative drugs available to patients through the various drug approval processes around the world. After years of meticulous work in the drug development process and based on information collected from patients participating in our clinical trials, we know and understand what our drugs can deliver in terms of efficacy and safety. Over many years, we gather the data necessary to get the medicines approved and make sure patients have access to them. Even though this process takes years, it is the gold standard approach: it allows for the understanding of the safety and efficacy of our medications and the regulatory approval process makes them available for the larger group of patients. However, real life is not always ideal, and situations may arise that approved drugs may not yet be available for patients and their physicians especially to treat life threatening conditions. 

And this is where compassionate use programs come into play?

Yes. We recognise that patients might be in situations where all other available treatment options have failed, and they are unable to participate in one of our studies. In these cases, access to one of our medications that is still under study might provide an opportunity for patients whose health condition does not allow them to wait many years for results of clinical trials and approvals. It is certainly an exception to the rule, and is applicable essentially for patients with life-threatening conditions.

What have Boehringer Ingelheim’s experiences with these programs been like so far?

We have been taking requests for compassionate use very seriously for many years, since this is a way for us to support patients that suffer from serious, life-threatening diseases. I am an oncologist by training, so I am very familiar with patients who are in desperate situations. For me personally, it is very important that we do everything we can to help, always ensuring that we follow strict processes.

How does Boehringer Ingelheim decide whether or not to grant access to one of its experimental drugs outside of clinical trials?

We have a clearly defined process for granting access to our drug candidates. If the patient meets certain criteria, his or her doctor can send a request for compassionate use to Boehringer Ingelheim. The form is available from Boehringer Ingelheim Medical Professionals around the world  on our website. Once it has been submitted, a committee of in-house experts then carefully reviews the request and does its best to get back to the patient’s doctor within seven days. Requests that are more complex may require additional consultation and discussion with external experts including an independent bioethics committee.

What insights can Boehringer Ingelheim gain from compassionate use programs?

Well, when we receive several requests for a certain condition, it proves that we are on the right path. That there is an unmet need. Also we will ask the treating physician to provide us with information on any observed adverse events, which can give us further insight about the treatment beyond our clinical trials.

I want to emphasize that for us at Boehringer Ingelheim, patients are at the core of everything we do. That’s why we invest heavily in research and development in our fields of expertise, as it’s the only way to provide new and promising treatment options for patients in need.

Dr Mehdi Shahidi

Mehdi Shahidi joined Boehringer Ingelheim in 2005 as a clinical development lead for oncology. Over the following years, he assumed broader responsibilities in the Oncology Therapeutic Area in clinical development and medical affairs and in 2016 became Global Head of Medicine, Oncology. Dr Shahidi is a UK qualified Clinical Oncologist, and completed his specialist oncology training at the Royal Marsden Hospital, London. Prior to joining the pharmaceutical industry, he had a successful clinical and research career in oncology.