Early Access Programmes Blog
Early and Managed Access Programmes can prolong the life of patients who have a life-threatening illness or a chronic or rare condition, by providing them access to investigational drugs currently going through the Clinical Development stages. The investigative nature of these drugs does mean that ethical challenges often arise during the process of these programmes. Ahead of the annual Early and Managed Access Programmes Forum we have worked with industry and compiled three 'top tips' to ensure an ethical and sustainable Early Access Programme.
Pharma IQ spoke exclusively to Martin Naley, US General Manager and Global Head of Business Development at myTomorrows about the challenges of increasing patient access to therapies through early access programmes. We also discussed the work that myTomrorows is doing to assist patient access through real world therapeutic testing and the key elements in building a framework for expanded access.
One of the key benefits of Early Access Programmes is that they allow companies to collect real world data from patients within the programme, which can help inform a product’s effectiveness and value proposition.
With insights from Tom Watson, Executive Vice President, Early Access Programmes, Bionical, in this article you will learn:
- The benefits of gathering RWD during the testing phase
- The preferred methods for RWD collection in patients with rare conditions
- The insights that RWD can provide to support expanded indication