In:
Clinical Pharmacology & Therapeutics, Wiley, Vol. 114, No. 5 ( 2023-11), p. 1043-1049
Abstract:
The European Medicines Agency (EMA) offers guidance and support to pharmaceutical companies through bilateral discussions called business pipeline meetings (BPMs). An analysis of BPMs in oncology over a 5‐year period was conducted to identify common topics and recurring queries. The documents of all BPMs available at the EMA regarding the field of oncology from January 1, 2018, to Decemer 31, 2022, were reviewed. For every query, a main category was assigned, and in case of multiple relevant topics, a secondary category was appointed too. For all queries, the follow‐up offered by the EMA was documented, and whether the requested information was available. Subsequently, all queries were scanned for overlapping topics between meetings. From 2018 to 2022, 31 BPMs were held between the EMA and pharmaceutical companies to discuss oncology‐related questions, for a total of 397 queries raised. They were classified into 24 topics, of which 15 were common topics ( n ≥ 10 queries) with regulatory pathways/guidelines and trial design having the most queries. Post‐BPM actions were taken or recommended by the EMA for 41.3% of queries, such as referrals to scientific advice or published guidelines. Forty‐three queries were raised at more than one BPM. Targeted therapy, companion diagnostics, institutional collaboration, trial design, and regulatory pathways/guidelines were the most discussed topics in oncology BPMs, with molecular developments being the common denominator. Creating Q & A documents, publishing new guidelines, providing a framework for discussions, and questionnaire‐based follow‐up research can improve the quality of BPMs, and the accessibility of the information requested during the BPMs.
Type of Medium:
Online Resource
ISSN:
0009-9236
,
1532-6535
Language:
English
Publisher:
Wiley
Publication Date:
2023
detail.hit.zdb_id:
2040184-X
SSG:
15,3
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