Support Services & the Holistic Approach to the RFP Decision-Making Process – A Consultative Approach to Pharmaceutical Outsourcing

The provision of non-core support services is what differentiates the good from the great, and sponsors should consider the impact of such services when developing their RFPs.

In the current pharmaceutical landscape, CDMOs are ubiquitous. But until the CDMO boom in the 1990s this wasn’t the case. What began in the 1980s as an industrial stopgap to fulfil capacity needs is now conservatively projected to become a $170+ billion dollar market in 20321. Naturally, when an industry grows so quickly, so does the evolution of service offerings, such as the ability to handle multiple dosage forms, scalability from early clinical supply to commercial launch, and the continued investment in, and expansion of, industry leading technology and facilities.

However, whereas reports estimate that over 500 CDMOs are currently operating around the globe2, only a small percentage are able to serve in a consultative capacity and perform non-core, value-added functions alongside the core functions of development and manufacture, clinical trial supply and commercial packaging. The provision of non-core support services is what differentiates the good from the great, and sponsors should consider the impact of such services when developing their RFPs.

Package Design for Manufacturability (DFM)

Whereas the core services of D&M, clinical supply and commercial packaging remain the core drivers of On Time, In Full (OTIF) delivery, there are a range of support services that a CDMO may offer that can help streamline the overall drug product journey. Package design is one example.

Traditionally, these services have been outsourced to third-party agencies who produce a design based on the dosage form and the sponsor’s branding requirements. On paper, this process can produce a slick, branded package that is suitable for the selected dosage form; however, when package design is not performed with manufacturability in mind, it can cause significant challenges that may add both cost and time when it comes to manufacturing the commercial pack at the selected CDMO.

For example, if the design specifications do not fit the CDMOs packaging equipment, it has to either be re-designed or the sponsor would have to consider purchasing suitable equipment for the required specifications. Combine this with the fact that package design is often regarded as an afterthought, only to be considered at the very latest stages of drug development, and the result is a significant cost- and time-loss implication at a crucial stage of the drug development journey.

The solutions here are twofold:

  1. Sponsors should consider package design much earlier in the drug development process. Whereas not all drug products will reach the market, good preparation is strongly advisable to avoid costly launch delays.
  2. Sponsors can partner with a CDMO that is able to offer package development and design services in-house. By doing so, sponsors avoid complicating their supply chain by outsourcing additional services, are able to review sample commercial packs during the clinical stages, and save time and money in the process.

Taking a meticulous approach to package design therefore ensures a much smoother road to commercial launch, particularly where the CDMO is able to provide in-house expertise, support and design services from an earlier stage in the drug development journey.

The same is true for artwork services, identifying a CDMO able to offer a full suite of services relating to packaging services including in-house artwork services can again, reduce vendor management complexity and drive efficiencies.

Supply Chain Management Solutions

Not all sponsor organizations have the resource or expertise to manage every aspect of their supply chain. Without dedicating internal resources, or recruiting additional staff, it becomes operationally complex and often unachievable within the clinical and commercial timelines, especially when unforeseen difficulties emerge which threaten said timelines.

Imagine, for example, that a clinical trial has started, but it is discovered that the quantity of drug product packaged and supplied to trial sites is not sufficient to support ongoing site re-supplies to the end of the treatment period. Or that, during the planning of a complex global clinical trial involving multiple dosage forms and inventory items, that the sponsor’s internal Clinical Supply Manager resigns, creating a gap in support. In these situations, project delivery can depend on the ability of the CDMO to support their sponsors with immediate resource and expertise in the form of embedded personnel.

Releasing a drug product within the US requires a single stock keeping unit (SKU), but not all markets allow this level of simplicity. For example, releasing a drug into Europe involves producing artwork in many different languages, and potentially holding stock within each individual market awaiting commercial orders. The potential waste involved with pre-printing artwork for multiple SKUs is yet another negative in what used to be the normal way of doing things. However, some CDMOs have moved towards HAPA digital printing as a way to achieve Late Stage Customization (LSC), which revolutionizes the way drug products are commercially supplied across complex markets.

By producing commercial drug product in bulk and storing as brite stock, various markets can be supplied via a Just in Time model by utilizing HAPA digital printers and shipping the required order quantity without overstocking or wasting resources on excess materials and shipping fees. The ultimate benefit is a greater speed to market, whilst maximizing the use of product with short expiry dates and the reduction of line clearance activities.

Figure 1 below shows a visualization of the ‘Trumpet Effect’, wherein a single drug product requires packaging into multiple SKUs for a multi-market destination such as EU and RoW countries. Using LSC as a commercial packaging strategy reduces the overall complexity of the drug manufacturing and packaging process, resulting in shorter lead times and a quicker route to market for your drug product.

Partnering with a CDMO that is able to provide robust and varied supply chain management solutions is hugely beneficial. It ensures a lower-risk and more efficient supply chain, access to established expertise in a range of essential non-core services, and ultimately achieves greater speed to study and market for your drug product.

CDMO Selection

Due diligence is essential when selecting a CDMO partner. The RFP process often focuses on the core services and processes alone, and whereas many CDMOs can fulfil these requirements, the RFP may not involve a wider consideration of the full scope of what the CDMO is able to offer along the way to deliver a seamless solution and reduce vendor management complexity.

References:

  1. https://www.marwoodgroup.com/wp-content/uploads/2022/02/2022.02.14-Pharma-CDMO-Whitepaper.pdf
  2. https://www.globenewswire.com/en/news-release/2023/06/07/2683991/0/en/Pharmaceutical-CDMO-Market-Size-Will-Expand-to-USD-172-02-BN-by-2032.html#:~:text=The%20global%20pharmaceutical%20CDMO%20market,6.21%25%20from%202023%20to%202032.

Support Services – A Consultative Approach to Pharmaceutical Outsourcing with Justin Schroeder, PCI Pharma Services. | As seen in a custom ebook presented in partnership with Pharmaceutical Technology.


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