Managing HPAPI programmes under accelerated timelines
Rabiaâ Berkous, project manager – development programmes at Carbogen Amcis, presents some of the challenges linked to accelerated timelines for managing HPAPI programmes
The use of highly potency APIs( HPAPIs) has increased significantly over recent decades, particularly in oncology and rare diseases. Between 1998 and the end of 2024, the US Food & Drug Administration( FDA) approved 217 new molecular entities( NMEs) for cancer indications and oncology accounted for about 35 % of the novel drugs the agency approved in 2025.1
To support the development of innovative therapies for serious diseases and unmet medical needs, the FDA has established several expedited review pathways over the past four decades. They include orphan drug designation, accelerated approval, fast track designation, breakthrough therapy designation and priority review.
These are intended to accelerate development timelines and patient access to new therapies. Breakthrough therapy designation can lead to the fastest overall development, with studies showing a median development time over 30 % shorter than the standard pathway. 2 Priority Review reduces the standard review time from ten to six months.
In 2025, among the 46 novel drugs approved by the FDA, 23 received orphan drug designation, 18 received fast track designation and 15 received breakthrough therapy designation. Overall, approximately 72 % of approved drugs were subject to an expedited review pathway.
Many oncology drugs also received orphan drug designation. While these pathways can significantly shorten
Figure 1- Compound categorisation at Carbogen Amcis
development timelines compared with standard approval processes, they also increase operational pressure across development and manufacturing programmes.
The development and manufacture of high potency compounds require specialist containment technologies and safety considerations, as well as a strong understanding of development phases and regulatory expectations, and close collaboration between sponsors and CDMOs. This article examines the operational and project management considerations involved in developing HPAPI programmes from early development through to commercialisation in Carbogen Amcis’ experience.
Early project evaluation
Before development activities for a new HPAPI programme begin, preliminary discussions typically take place between the customer and the commercial teams. The objective is to establish a clear understanding of expectations regarding projected volumes, quality requirements, timelines and the overall strategy, enabling a more accurate evaluation of the programme from the outset.
Once a Request for Proposal( RfP) is received, it is reviewed internally by a dedicated evaluation team, known as the‘ gatekeepers’. This team assesses the programme’ s overall feasibility within the organisation, including chemistry requirements, specific technologies, equipment availability and manufacturing capacity, and identifies the most suitable sites.
Depending on programme requirements, development and manufacturing activities may be coordinated across sites in Switzerland, France, China and India, taking into account containment
22 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981