Creating a New Way: Putting Scientific Excellence and Digitalization at the Heart of CMC Medicine Acceleration

By Mark Barrett, Group CEO, APC & VLE Therapeutics

What's the Next Wave of Innovation?

APC was formed at the lab bench in 2011, born out of a passion for great science and a curiosity to understand the impact of this science on biopharma R&D, manufacturing, and patients. I remember so well the application of our early innovations in developing and optimizing processes for large and small molecules so that medicines could be manufactured more easily and at lower cost. Transforming the cost to manufacture a new breakthrough for a neurological disorder being a key milestone in that early founder journey. This significant achievement brought our chemical engineering breakthroughs to real life, it felt like the start of our life's work!

As APC’s ambition grew, our team expanded. We did more science, more innovation, more experiments and worked on more medicines. This scaling journey meant welcoming more great people to our dynamic team. We added new buildings, new labs and new capabilities, and we worked on more magical medicines, from synthetic molecules to cell and gene therapies, with vaccines and highly potent compounds in between. This felt like a collective journey – starting from a founder-led business, progressing to an executive-led one with more amazing colleagues, more smiles, exceptional leaders and even greater ambition and scale. This amalgamation of talents, powered by the amazing APC and VLE teams, brought the possibilities for The Medicine Accelerator mission to life!

The depth and breadth of the collaborative work combined with the unique partnerships we have forged with the world’s most innovative biopharma companies, have led us to a significant epiphany. This is the realization that our next wave of innovation will rely not only on our scientific foundations but will revolve around connecting our team’s scientific endeavors, and The Medicine Accelerator ecosystem, directly with the medicine. This presents us with interesting questions to answer e.g. “How can we redefine the possibilities for medicine acceleration?” or “How can we go faster?”

‘’The CMC function will need to ensure data findability, accessibility, interoperability, and reusability; oversee the effective sharing of data between different departments through appropriate data governance models; work at a pace that meets the needs of counterparts in the manufacturing and R&D functions; and work out how to use this wealth of data for the benefit of patients and the business.." Bader et al. "Out of the shadows: A bright future for pharma technical development". McKinsey & Co report 2023.

Redefining how the development & manufacture of medicines can be accelerated

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The Complex CMC Journey - Managing a balancing act: The Old Way

A medicine’s CMC journey is complex and is ultimately a balancing act. Scientific and manufacturing risk needs to be balanced against clinical need, while timelines and budgets need to become more aggressive to satisfy patient and shareholder needs. Underinvesting in the CMC journey can make timelines and budgets smaller, but increases manufacturing risk - often delaying clinical trials, to the ultimate detriment of the patient. Overinvestment means resources and effort that could have been deployed to other medicines went towards one of the many candidates that is poised to fail in our high-risk industry.

Leaders in our field face this balancing act daily.  This is the field on which The Medicine Accelerator plays to win. At the bench it can be difficult to understand the true context of a single experiment, or the required breakthrough needed for the medicine, one of many in the development cycle. This necessitates the design of a cohesive CMC strategy that satisfies all stakeholders, whilst consistently delivering the most innovative and valuable scientific experiments within acceptable timelines and costs. And it can be difficult to adapt to new information, perhaps from a patient or manufacturing site - meaning the scientific approach need to change and a fork in the CMC road must be navigated. This is the shared challenge that we call the medicine development tightrope. To tackle this, we must imagine, innovate and define a new winning-formula that combines breakthrough science with industry-first digitalization of CMC and ultimately a science-led approach to GMP manufacture and patient delivery.

A New CMC World: The New Way

To empower our scientists to get closer to patients and to actively influence the journey across this tightrope – our next wave of innovation will focus on three pillars:

1. The Scientific Frontier

2. The Digital Connection

3. Radical collaboration

By focusing on these areas, we believe we can redefine the possibilities of medicine acceleration to patients because the following will be true:

• Every person’s intellectual contribution, every data point, experiment, insight, regulatory decision, social context and collaborative interaction, CMC strategy and deliverable will be digitized. Not just in our ecosystem but the global one - digitally connected forever. This eliminates the document burden and information conundrum defined by the old way of people aggregation for development, characterization, tech transfers and life cycle management of medicines.

• Like the processes for the medicines we develop, the information that underpin them, will live on forever. The information must become a living, breathing entity that mirrors the patient impact we all aspire to deliver. AI and Natural Language Processing will be the hand of wisdom that will elevate our data and information.

• Our team’s collective creativity will shine, because their focus will always be on the patient and medicine.

This new winning formula is not just a technological upgrade; it is a fundamental change in our collaborative approach to the fight against diseases. It will create a new way for the acceleration of medicines’ development and manufacture.

As we look ahead to the future of The Medicine Accelerator, I am excited about the possibilities of what we aspire to do. So much good news to share in the months ahead. Lots of smiles, lots of hard work and lots of potential to impact people's lives. That fuel will take us to a special place !