Supporting patient advocates to help improve early access

Patient group leaders can play a pivotal role during the design and roll out of Early Access Programs (EAPs). They can ensure the voices and needs of their community are considered by industry. They can help explain the complexities of EAPs and access to investigational treatments to families who are desperate for treatments.

Early access – also known as compassionate use, or pre-approval access, amongst other names - is a complex and heavily regulated space. Delivering an EAP is a delicate balancing act that requires understanding of the regulations, processes and drivers on all sides.

Patient groups are often stretched for time and resources, and so are not always in a position to get to grips with early access before it becomes relevant to them. And yet, their timely input could make all the difference in developing an EAP that better serves both patients and company.

That’s why Clinigen has founded an innovative fellowship scheme to reduce barriers to entry for patient advocates in early access. The Patient Advocate Fellowship in early access was developed to give patient advocates across oncology, rare disease, and other areas of unmet medical need the best opportunity to understand the nuances of early access, and represent the real needs of their community in developing more successful EAPs.

Designed with patient advocates, for patient advocates, the fellowship aims to equip patient group leaders with the skills and experience they need through tailored learning, networking and peer support.

The fellowship’s four key goals:

To find out more, visit:

• the fellowship webpages here, for more information on the scheme, application process, content and time commitment
• this article summarising the patient expert and patient group input we received which shaped the fellowship scheme, from across oncology and rare diseases
• this article from Nicole Gusset, President of SMA Europe, about her experience of driving success in Early Access Programs through patient engagement
• this article for some pharma company and patient advocacy group perspectives about engagement in early access

If you are a patient advocate who a) represents a community with high unmet medical need and b) is aware that early access might be a relevant topic, read more and apply here.

The Patient Advocate Fellowship in early access is a Clinigen initiative. Clinigen has remunerated the patient advocates involved in shaping this scheme.

If you have any questions, please get in touch with Patient Advocacy Lead Holly Lumgair on holly.lumgair@clinigengroup.com.

_{Job number: UK-CPL-0-004 Date of production: May 2021}