In this Pharmaceutical Outsourcing Q&A, Martin Wing-King, Vice President & General Manager – Reading, and Eleanor Row, Vice President, Global Commercial, share insights on key trends, challenges, and specialised services shaping early drug development.
This article highlights the latest trends transforming early-stage drug development, from AI-driven strategies and integrated workflows to sustainable manufacturing technologies. Learn how these innovations tackle key challenges, streamline drug substance to drug product product, and accelerate speed to clinic.
What are the most significant trends currently shaping early-stage pharmaceutical drug development, and how are they influencing project strategies?
Martin Wing-King: Companies are increasingly using AI and machine learning to help streamline early-stage development. This also has extended to investigating AI-guided formulation development to replace traditional development strategies.
When considering drug substance development, what are the key scientific and technical challenges pharma companies frequently encounter, and how can these be effectively addressed?
Eleanor Row: One of the primary challenges in drug substance development is selecting safe, sustainable, and scalable synthetic pathways for the active pharmaceutical ingredient (API). This requires early investment in route design and solid-state analysis to ensure the process is not only efficient and cost-effective but also robust enough for scale-up.
What important factors should be considered during the transition from drug substance to drug product development, and how can companies ensure a seamless progression between these phases?
Martin Wing-King: To integrate drug substance and drug product development activities, there needs to be close collaboration between teams to ensure that the drug substance is compatible with the intended drug product formulation. Aligning these activities lets companies avoid not only supply chain and vendor management issues, but compatibility issues that may arise during scale-up and commercialization at even later stages of development.
Using multiple CDMO partners adds risk in development, creating handovers between providers. It may be possible to leverage one partner, such as Arcinova, for both drug substance and drug product manufacturing, in an integrated way.
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