Clinigen is committed to delivering meaningful, compliant and ethical Early Access Programs (EAPs) for patient communities with unmet needs. To this aim, we work on various initiatives that support the inclusion of the right inputs and perspectives to foster successful EAP development. The patient voice is absolutely central to this. We are therefore thrilled to provide a platform for the Patient Advocate Fellowship in early access. As a company that has been operating in this space for three decades, running more than 300 Early Access Programs, we feel we are uniquely placed to bring real-life answers to some of the burning questions that patient advocates have about early access.

The scheme offers a mixture of learning provided by external speakers, workshop-based content, review of case history, selected events, and networking opportunities. Despite the restrictions caused by the continuing COVID-19 pandemic, Clinigen will be seeking to foster a human, tailored program as far as is possible.  This will proceed virtually for most of 2021, unless otherwise communicated. If restrictions allow, we will be aiming for a final face to face graduation element in early 2022 to complete the scheme.

To apply, applicants must be representatives of patient advocacy groups (either in a voluntary capacity or employed on staff), with a remit to support patient communities within disease areas with high unmet medical need.

Applicants must:

• Demonstrate a commitment to the disease community in question.
• Confirm their appointment “in post” with a patient advocacy group
• Demonstrate a foundational level of awareness of capacity building already completed within the healthcare field, an understanding of drug development and commercialisation.
• Confirm their remit to cover a number of territories (European or international level umbrella patient organisation).
• Provide information to support the relevance of Early Access to them (now or in future)
• Evidence of current interest in and investment in bettering patient group engagement in drug development
• Willingness to abide by compliance procedures relevant to this specialised area.

Full information is available in the application pack upon request.

There is no cost to joining the scheme. Clinigen will provide the educational resources and opportunities to network and access peer support at no cost to fellows. Clinigen will also cover expenses, travel and accommodation for any face-to-face elements of the scheme (as applicable under restrictions).

What we expect from each Fellow, if they are selected, is the following:

• A commitment to see the program through, presently the scheme is expected to run for 6-8 months, the total time commitment is likely to be no more than 22 hours over those 8 months. This is assuming deep-dive learning of 8 hours, two events attendance leading to 12 hours of participation, and a “graduation” event for 2 hours.
• A willingness to provide periodic feedback on their involvement to measure the scheme’s success and impact (during scheme implementation)
• A willingness to provide feedback after the scheme’s conclusion, to help improve future schemes.
• A willingness to contribute towards content developed about the 2021 scheme.
• A willingness to be part of media content summarising the scheme in support of future schemes.
• Keeping receipts for any expenses incurred through the scheme.