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Editor of Pharmaceutical Technology Europe
To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.
The contract development and manufacturing organization (CDMO) sector has progressed from its original business model to now cater to pharma companies of all sizes via multiple verticals to help deliver success. To find out more about the development of the relationship between CDMOs and the pharma industry over the past three decades, Pharmaceutical Technology Europe spoke with Cornell Stamoran, viceâpresident of Strategy and Corporate Development at Catalent.
PTE: How has the CDMO–pharma relationship developed during the past three decades?
Stamoran (Catalent): Historically, outsourcing was associated with a fee-for-service business model, but over the years, outsourcing partners have increasingly been able to provide deep expertise and access to unique, proven technologies that can make the difference between a successful product and one that struggles to demonstrate value beyond an incremental benefit in patients’ lives.
Whereas drug development was once the preserve of traditional large pharma, we have seen more recently a marked increase for outsourcing from smaller, venture capital-backed companies, to the extent that around 75% of the current pipeline is now coming from small and mid-sized companies. These companies do not have the resources of large pharma and are, therefore, looking to partner on every aspect of development from formulation expertise to clinical supplies, and on to commercial manufacturing.
CDMOs can help pharma companies improve R&D effectiveness and reduce costs by first helping better predict which will be the more viable candidates and molecule forms to develop, and then which drug delivery systems will ultimately improve outcomes and provide better treatments for patients.
A further significant change is the number of new technologies starting to impact the industry, such as new biopharma therapeutics and cell and gene therapies. CDMOs have begun to grow and invest in capabilities in these technologies of the future and broadening their offerings to meet the demands of the evolving research directions of the industry.
PTE: Presently, what are the most important facets a CDMO must offer to meet the wide-ranging pharma demands and still be considered an attractive partner?
Stamoran (Catalent): Modern CDMOs increasingly need to be adaptable and possess a deep understanding of the science that enables better treatments. This can, for example, be by offering access to proven technologies or by helping pharma companies improve R&D effectiveness and reduce cost by first helping better predict which candidates to develop, and then which drug delivery systems will yield better treatments for patients. It is essential that CDMOs can bring flexibility for pharma customers, helping them to reduce expenditure on costly infrastructure by spreading costs and achieving better overall utilization.
Recent years have seen innovator companies reaching out to service-providing CDMOs to be more than just a ‘contract company’, and as a result, some CMOs have evolved and matured into CDMOs where ‘development’ has been important in becoming collaborative partners, offering clients a broad range of experience, technologies, and tools with a focus on quality, reliability, and operational excellence.
The drive among innovators is to adopt value-based drug purchasing that focuses towards real-world outcomes, where the intentional design of drug products (formulation, dose form, device, packaging, ‘smart’-enabled features) for optimal patient usability will become critical to maximize a product’s return on investment.
Innovators are increasingly engaging in strategic partnerships with collaborators as the wealth of experience partners have in formulating, delivering, and launching new drug products brings an impartial perspective on development programmes. Therefore, from the outset of a project, targets around the design of a new drug product can be set that focus on the key goal, which is delivering the best possible treatments effectively, safely, and conveniently to patients.
PTE: In your opinion, what is on the cards for CDMOs and pharma in the future?
Stamoran (Catalent): The pharmaceutical industry can make a significant difference to patient adherence by focusing on drug product design. Once considered as only a late-phase activity, drug product design has, and should, increasingly become an early-stage commitment. There is significant evidence to show that every product design decision made can impact patient adherence and, ultimately, patient outcomes. This begins with selecting the best molecule variant given the therapeutic target, the best formulation type, finding the optimal dose form design, and goes all the way through to designing delivery devices and the medicine’s packaging.
Recent research conducted by Catalent indicated that only a quarter of R&D groups surveyed pursue a systematic approach to patient-focused drug design and that chemistry, manufacturing, and controls teams often do not have access to a target product profile-a clinical development programme summary in the context of prescribing information goals (i.e., targeted labelling claims) that can be used to facilitate product development. The biggest challenge is that the R&D teams making crucial, early decisions about design do not have enough information on the real-world challenges experienced by patients, caregivers, and providers in administering treatments.
Real-world evidence from patients, clinical trial data, claims data, and even patient groups’ views expressed on social media will increasingly influence drug product design, and will be used to demonstrate the value of an innovative treatment to payers.
Pharmaceutical Technology Europe
Vol. 31, No. 8
When referring to this article, please cite it as F. Thomas, “Partnering Up for Success,” Pharmaceutical Technology Europe 31 (8) 2019.