What does a pharmaceutical integrated services programme entail?

Published: 20-Jul-2021

Here Kevin Duffield, Head of Client Services North America/United Kingdom discusses key attributes to look for in an integrated services provider

As drug development gets ever more competitive, complex and costly, innovator and generic pharma companies are increasingly choosing contract development and manufacturing organisations (CDMOs) to streamline and significantly accelerate their pipelines. While there was a time when firms used to do all their R&D, manufacturing and commercial filing in-house, now they’re looking to outsource those operations and leverage the proficiencies of CDMOs which provide end-to-end solutions.

How can an integrated services programme help your company achieve success?

Depending on a company’s needs, a full-service CDMO can assist firms from start to finish in the drug development life cycle. CDMOs offer various services across the drug development pipeline from vital discovery research, supplying APIs, developing formulations to manufacturing and packaging. They can also help with technology transfers and regulatory clearances. Importantly, customers get access to the CDMO’s specialist range of expertise. This, crucially, helps de-risk drug development, especially in the game-changing and scientifically challenging biotech area where the price of failure can be huge. CDMOs also offer customers the major convenience of having a one-person point-of-contact overseeing the entire project. In short, by putting many steps under one roof, CDMOs enable the process of bringing products to market more efficiently, safely and cost-effectively while meeting ever- tighter timelines.

What to seek in a CDMO?

The CDMO segment is still highly fragmented, so choosing the best partner involves legwork. In scouting for the right fit, you want a CDMO which boasts of a project management team that can manage and execute all stages of the drug development and manufacturing process seamlessly. Such a set-up allows the customer to manage work not just sequentially but also in parallel across multiple sites to deliver quickly and efficiently. You also want your CDMO to have a scientifically and technically experienced team who have the expertise to come up with solutions to difficult problems and the ability to devise improved processes. In addition, vital to any successful corporate relationship is knowing that you’ll be able to collaborate closely and communicate well with the CDMO throughout the entire project cycle.

Got specialty needs for your molecules? Your CDMO must be able to address them

Companies want a CDMO that can meet speciality needs such as high-potency active pharmaceutical ingredients (APIs), highly-targeted Antibody Drug Conjugates (ADCs) and other complex molecules. It generally requires capital- intensive investments to have such capabilities in-house. To prevent delays, a CDMO should have a flexible supply chain with backward integration of APIs, Key Starting Materials and/or intermediates. For instance, when the Covid-19 pandemic erupted in Wuhan, it caused supply-chain issues related to raw materials sourced from China. (CDMOs have been reporting an up-tick in Covid-19-related outsourcing inquiries ever since the pandemic began).

Global presence is a must

Another CDMO attribute to check for is its global depth of offerings -- especially valuable in the current Covid-19 business climate. If there’s an additional wave of the virus or if similar issues crop up in one area of the world, having multiple sites allows the CDMO to conduct its work elsewhere in its network. This is a critical benefit, since the work CDMOs do for their sponsors has a direct impact on reducing the burden of disease on patients.

A successful track record speaks volumes

Before committing to a partner, you’ll want to rigorously examine the CDMO’s track record to confirm that they’ve got the latest technology and are nimble and flexible in executing projects when circumstances suddenly change. Does the CDMO finish projects on time? Above all, you need a CDMO which has a robust regulatory compliance track record so your product does not get stuck anywhere along the ever more challenging journey to market. And ultimately, once a company finds the right CDMO to take ownership of their project, it has much more time to start bringing its next life-saving drug to market.

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