The Biotherapy Development Association, an international group focused on developing targeted cancer therapies using biological agents held a conference late last year, the results of which have just been published in the March issue of Annals of Oncology. The aim was to air challenging issues related to market and patient access to new anticancer agents. It provided a forum for representatives of drugmakers and academia to interact with European regulatory and post-regulatory agencies.
Among the outcomes of the meeting were a greater understanding of the barriers facing drug developers in an evolving post-regulatory world, clarity about what regulatory bodies expect to see in dossiers of new anticancer agents as they contemplate licensure and reimbursement, as well as several sets of recommendations to optimize patient access to innovative, safe, effective and fairly priced cancer treatments.
New paradigm for drugmakers
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