Managed Access: A Solution with Benefits for Everyone

Managed access programs – also known as compassionate use, early access, and named-patient programs- have clear benefits for patients and physicians. These programs provide an alternative regulatory pathway to help patients access potentially life-altering drugs when they are ineligible for clinical trials or the drug has not been approved in their home country.   Historically, the…

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Managed Access: A Missed Opportunity for Orphan Drug Developers and Patients

Product launch planning has changed since my days of working in big pharma.  Ten years ago, pharmaceutical marketing professionals focused on ensuring patients could access therapy early, even if they didn’t meet the clinical trial criteria.   Early access to therapy, pre-launch and pre-license, offers benefits for all stakeholders.  For patients, access to therapy can slow…

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