Joan Boren
Joan Boren works in Oncology Regulatory Science Strategy and Excellence, AstraZeneca, Cambridge, UK. He provides regulatory strategy and advice on global product development and marketing strategies, being involved in interactions with regulatory authorities worldwide to agree on a successful pathway. His area of focus is on oncology products, with expertise in ATMP and biologics. He holds a PhD in biochemistry and molecular biology.
JournalControlled substances development – past, present, and future
Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...
JournalA year of clinical trials under IVDR:
a sponsor’s perspectiveThis has led to differences in interpretation between IVD manufacturers, investigational drug sponsors, ethics committees and regulators across Europe, resulting in delays to initiation of clinical trials. A coordinated consultation process is urgently needed, alongside clear guidance on the interface between the Clinical Trial Regulation (CTR) and IVDR, to address ...
EditorialRegulatory support for drug development – maximising options for timely patient access
As medicinal innovation evolves and becomes more complex, there is a need for agencies to support this innovation by establishing additional expedited pathway routes to improve drug development and its evaluation