Martin Wing-King
Vice President & General Manager - Reading, UK
Arcinova, A Quotient Sciences Company
Eleanor Row
Vice President, Global Commercial
Arcinova, A Quotient Sciences Company
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. Time is still needed to “train” these Ai systems to perfect the outcomes and ensure that data generated can be protected.
We’re seeing a growing industry shift toward integrated development models that streamline drug substance and drug product workflows. At Arcinova, our end-to-end capabilities de-risk tech transfer transitions and accelerate speed to clinic.
Eleanor Row: Technologies like continuous manufacturing, automation, and digital twins are gradually transforming pharmaceutical development. They are enhancing efficiency, sustainability, and scalability of manufacturing processes. These innovations can streamline the transition from early development to GMP API production and contribute to reducing environmental impact.
For example, continuous processing lowers waste, energy use, and solvent consumption, while automation supports more consistent and resource-efficient operations. Digital twins offer the ability to simulate and optimize processes in real time, reducing the need for physical experimentation and its associated footprint.
We’re investigating these technologies at Arcinova, , through our Project ETERNAL platform we are able to support customers in their steps towards adopting automated reactors and digital twin technologies to develop more environmentally friendly manufacturing processes.
Martin Wing-King: Introducing these technologies early in development lets teams design more sustainable, cost-effective processes. It also encourages stronger collaboration between R&D and manufacturing.
These technology-driven approaches not only support faster timelines,but contribute to the industry’s goals of having a greener pharmaceutical supply chain, overall.
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.
Advanced analytical techniques, particularly solid-state characterization, play a critical role in understanding how changes in the synthetic process impact the physical and chemical properties of the API, which is especially important for small-molecule drugs.
In parallel, securing a reliable supply chain for starting materials and intermediates, along with implementing rigorous quality control systems, is essential to maintain consistency and meet regulatory standards.
As projects transition from candidate selection to first-in-human trials, the ability to develop a compliant, high-quality, and efficient manufacturing process becomes a key differentiator. By focusing on these areas early, companies can mitigate downstream risks, accelerate timelines, and improve the overall success of later-stage development.
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: 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.
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.
Eleanor Row: As discussed, having a proven synthetic route early in development for the API helps to avoid time-consuming changes later. Minimizing the number of steps, developing simple purification and isolation strategies, and eliminating the use of hazardous reagents are crucial for smooth API scale up, so the next steps of drug product manufacturing can progress.
What types of specialized services and partnerships are most valuable for assisting pharmaceutical companies through early drug development, especially in areas like preclinical testing, formulation, and process optimization?
Eleanor Row: Services such as salt/polymorph screening, pre-formulation, and early-phase formulation development are critical in developing proof of concept formulations. As an example, our inhalation development capabilities include device evaluation, particle engineering, real-time adaptive GMP manufacturing as well as clinical kit manufacturing. This adds a greater dimension to the development services on offer.
How have recent changes in global and regional regulatory requirements impacted early drug development, and what proactive steps can companies take to better manage regulatory risk?
Eleanor Row: Global and regional regulatory frameworks are certainly evolving and impacting early drug development. Initiatives such as ICH, Project Orbis, and the Access Consortium are helping to streamline multi-regional submissions, while regulatory agencies are increasingly exploring the use of digital tools and AI to support more efficient data review. Also, legislation such as the BIOSECURE Act in the U.S. and growing expectations around ESG globally are introducing new dimensions to compliance planning.
Martin Wing-King: Companies should look to engage early with regulators and invest in regulatory intelligence so they can adapt their strategies to comply with changing global standards. Enhancing digital readiness, integrating ESG considerations, and taking part in collaborative regulatory pathways can also support more agile and informed decision-making.
What role do emerging technologies—such as artificial intelligence, automation, or advanced analytical techniques—play in enhancing efficiency and quality during early pharmaceutical development?
Eleanor Row: Artificial intelligence (AI), automation, and advanced analytical techniques are going to be even more critical to enhance efficiency during early pharmaceutical development, while also keeping standards of quality and optimizing processes in both traditional and batch manufacturing approaches.
Martin Wing-King: In addition to the benefits for manufacturing, AI and machine learning can also be used to predict drug behavior, optimize formulations and streamline clinical trials. Automation is improving the precision and speed of laboratory processes, while advanced analytical techniques are providing deeper insights into drug properties and interactions.