What are “3 Key Trends” shaping the CDMO industry in 2022 and beyond? Piramal Pharma Solutions’ chief commercial officer, Stuart Needleman, shares his thoughts with Contract Pharma.

Integrated offerings

One important trend we see is that pharma innovators are more routinely partnering with their CDMO on an integrated basis. In the early days of integrated programs, CDMOs were primarily geared toward early-stage development, helping clients obtain an investigational new drug (IND) application. Today, however, integrated CDMOs like Piramal Pharma Solutions (PPS) assist companies across the entire development process, including late stage and commercial programs.

This trend is driven by multiple factors. Integration has inherent benefits in speed to market and cost efficiency. Tech transfer within a single company is more seamless. Likewise, multiple elements of the project can be overseen by a single, primary point of contact for project management. Additional benefits are also seen through supply chain integration, with synchronized material handling and raw material purchasing. Cross-functional expertise also comes into play.

For example, at PPS we have core strengths in high potency APIs, conjugations and sterile fill/finish, each at a different site. We know how to put that together into fully integrated antibody-drug conjugations that combine the payload, linker, conjugation and fill/finish, all in one integrated program.

The pandemic and the supply chain

Over the past two years, everyone saw clearly how the pandemic affected global supply chains. The pharma supply chain is particularly complex—possibly the most complex of any industry. Specialization is a huge factor; our supply chain is deep, global and features materials that are in high demand. There’s a global trend built on rethinking the global supply chain, including reshoring, building redundancies in suppliers, rethinking logistics and updating systems and processes to ensure that stocks are readily available.

PPS proactively addressed the issue through its supply chain risk mitigation team. They worked to categorize and prioritize raw materials we use, grouping them based on whether they were used in new or commercial products and ranking them against certain risk criteria. The risk criteria covered details such as the commercial potential of a product, manufacturing location, whether it had a single source, current availability, reliance on China and procurement value. Based on the extent and nature of the threats linked to a raw material, the team proposed tailored risk mitigation strategies intended to deliver fast, efficient, effective and sustainable results.

Applied technology

Digitization along with the rise of artificial intelligence is another trend facing CDMOs now and in the long-term future. This is a very broad and very deep topic, with ramifications internally and externally. On the operations side, technology is embedded in supply chain management, data collection, data management, R&D, production and project management, just to name a few.

On the administrative side, we not only have to consider accounting and finance, but also communications, cybersecurity and more. External demands are also growing intensely in clinical data and with the coming wave of digitization in drug design, such as personalized medicines. To keep up, PPS is in the midst of a global tech upgrade. This is a multiyear journey, encompassing a review and enhancements of all elements of our digital footprint.

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Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle, serving customers through a globally integrated network of facilities in North America, Europe and Asia. It offers a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Piramal also offers specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug product.