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Integrated service partners outperform standalone CDMOs in clinical development – Thermo Fisher
Engaging an integrated services partner could reduce risk and speed-up the process for drug sponsors.
Drug product development can be an expensive and time-consuming process, with development companies facing a range of challenges in their efforts to create a scalable, marketable formulation, ensure safety and efficacy of the drug product, and ultimately receive regulatory approval.
Partnerships between Contract Development and Manufacturing Organisations (CDMOs) and drug sponsors offer significant benefits, though collaborating with a range of different vendors incurs its own set of risks.
This was the subject of a presentation by Kevin Kane, Senior Staff Scientist, R&D at Thermo Fisher, during CPHI North America last week. Kane offered insights into the sponsor’s clinical development journey and discussed de-risking CMC (Chemistry, Manufacturing and Controls) services offered by CDMOs.
Kane noted that large pharmaceutical companies are looking for ‘specialty capabilities they might not have in-house' or ‘flex capacity because they’re busy with other things’ when engaging a CDMO partner, while smaller biotechs are ‘really looking for everything.’
Speaking about smaller companies, he said: ‘They’re focused on the disease state. They don’t have the time to build out capabilities, so they’re looking for partners that will help them move downstream and leverage the expertise that comes from working with different molecules over the years.’
Kane added that both small and large companies are seeking ‘the best return now’ from CDMO relationships.
It is common for sponsors to engage multiple vendors when attempting to bring a drug to market, which Kane refers to as ‘brute force development’. This approach requires considerable effort and resources from the sponsor, who must negotiate and oversee multiple service and quality agreements.
Vendors tend to take responsibility for their own work, not the overall success of the programme, and it can be difficult to mitigate delays when the process is so fragmented. As there is no single point of accountability on the vendor's side, the sponsor incurs almost all of the risk.
Kane advises engaging an integrated services partner to de-risk CMC programmes.
Taking an integrated services approach can have many benefits for drug sponsors, including closer alignment to clinical needs, seamless handoff between sites, and cost savings.
He said: ‘What we want is to reduce the time where the client’s sat waiting around, because their overhead costs are running. So, any time we can take weeks or months off their overall timeline where they’re having to wait for the next step, that’s the benefit of an integrated services offering.’
Kane advised evaluating everything an integrated services partner has to offer and deciding which services best suit the needs of the project. He also encouraged sponsors to share their clinical strategy with CMC partners and to view these sponsors as ‘potential collaborators’.
API development strategies
It is critical for sponsors to be able to account for the manufacturing needs and challenges of APIs and develop a sound strategy for producing drugs efficiency, consistently and cost-effectively.
Kane advises that sponsors evaluate their approach to API development, noting that early investment in development can ‘yield downstream dividends in API progression’.
This can allow companies to make smarter selections in terms of regulatory starting materials, create a process that avoids overly hazardous reagents, and make earlier decisions on final isolation solvents.
He also noted the benefits of identifying API solubility issues early in the process, saying this ‘allows us to predict and shave off weeks of potential dead-end experimental work’.
Kane then touched on Thermo Fisher’s solid-state chemistry services, continuous manufacturing programme, and Quick to Care™ solution. He advised sponsors to ‘flip the script’ to get the best returns from CMC partners and advised tackling clinical objectives and requirements early in the relationship.
‘Clients, help us understand what your clinical objectives are. Make sure we’re lined up with that. If we’re not listening, knock us on the head,’ he concluded.
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