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23 May 2019 Insight Blog

3 essential questions to answer when considering early access

  1. Are you prepared? If you have a promising oncology medicine in clinical development is your organisation already starting to plan for how and when you will handle requests for early access? Do you know which stakeholders need to be involved and do those stakeholders all understand the difference between early access and a clinical trial? Do you know what is and isn’t feasible prior to launching your medicine? Does your company have a stance on early access?

  2. Can you deliver? How are you going to enable access to your oncology medicine for patients with unmet medical needs in countries where it is not yet launched? Does your company have the capability, resource, framework and desire to manage all the complexities associated with supplying an unlicensed medicine? How will you provide access in countries where you never plan to launch?

  3. How can you drive value? If you are going to provide access to your oncology medicine in countries where it is not launched how are you going to drive the most value for your company, healthcare professionals and patients? Could the collection of 'Real World Data' support your route to market? How are you going to ensure patients get the right information about access in a compliant way? And how can you ensure you build strong and sustainable relationships with healthcare professionals wanting to access your unlicensed oncology medicine?

As the global leader in access to unlicensed oncology medicines, we can help your organisation answer all of these questions empowering you to plan for and deliver access to your oncology medicine in a way that drives maximum value for all stakeholders.

This year Clinigen will be attending the ASCO Annual Meeting, May 31 - June 4 in Chicago, Illinois.

To arrange a 20 minute consultation with our team at ASCO please click below.

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