We have a long history of integrating cutting-edge science and innovative technology to develop products and devices that meet the needs of patients living with difficult-to-treat diseases. Our long-standing legacy of making a difference to patients and their loved ones fuels our passion to invest further. In fact, we dedicate more than 20% of our global revenues to continued research and development (R&D) investment in oncology, immuno-oncology and immunology.
In recent years, we radically redesigned our R&D operating model, advancing our development and regulatory capabilities while refocusing resources on high-priority programs.
projects in clinical development
of global revenues
dedicated to continued R&D
We are committed to developing new medicines for patients impacted by difficult-to-treat diseases, whether collaborating with the scientific community to bring clinical studies to life, or encouraging patients to enroll.
As part of that, EMD Serono provides grants for Investigator Sponsored Studies. These requests are handled via separate websites. For information about the submission process for the therapeutic area of Neurology & Immunology, please visit www.emdserono.com/neurology-immunology-iss.com. For all other therapeutics areas, please visit www.ist.emdserono.com.
At the same time, in an effort to secure approval of new, safe, effective medicines, we encourage patients to participate in clinical studies in an effort to secure approval of new, safe, effective medicines for broad patient groups. To learn more about available clinical studies visit www.clinicaltrials.gov.
Some patients may not be eligible or able to participate in a clinical study and may want access to the experimental medicine being tested in the clinical study. In certain circumstances, EMD Serono may provide patients with access to unapproved or investigational medicines outside the clinical studies process via Early Access. For more information from the FDA about early access to experimental medicine in the U.S., click here. To search for all available expanded (“early”) access programs in the U.S., click here and scroll down to select “Expanded Access: Available”. Additional search criteria may also be entered.
If a treating physician determines a patient is not eligible or able to participate in a clinical study and the patient has exhausted all available treatment options, the physician may contact EMD Serono to make a formal request for experimental (i.e., investigational) medicine on behalf of the patient. This will allow the physician to work with EMD Serono physicians to evaluate the request.
Physicians seeking experimental medicine on behalf of their patients may contact EMD Serono at firstname.lastname@example.org. Once EMD Serono has received the request, we will respond within five business days. If the request is approved by EMD Serono, the FDA will need to grant final approval before EMD Serono can ship the experimental medicine to the requesting physician.
For more information on EMD Serono’s External Position Statement on Early Access to Experimental Medicine, download the PDF here.