“We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

Radio Compass

2024-09-10

Impressions: 118

This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules.

🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules

Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years?

We have achieved incredible milestones over the last two years, thanks to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent CDMO by building on the 50 years of expertise that we brought with us. In addition, we expanded our capabilities and applied a more agile approach available to us as a company singularly focused on life sciences. This has allowed us to move into our second year with clear and strategic goals for generating growth in our sites, people, capabilities, and offerings.

Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some exciting growth milestones of my own. Most recently, we announced an estimated US$ 30 million investment in our Devens, Massachusetts, site. This expansion will allow us to build upon existing development and manufacturing capabilities in ADCs and HPAPIs that will address the growing demand for strong US-based capacity in these key drug modalities.

We also appointed our Advisory Board, thereby bolstering Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas.

We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024.

🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board

Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years?

The pharmaceutical pipeline is witnessing an increasing number of complex and highly potent molecules. This trend is driven by the demand for more targeted, patient-centric therapeutics and the focus on innovative modalities such as ADCs and other bioconjugates.

At Veranova, our expertise, world-class facilities, and scientific excellence enable us to provide our customers with the clarity and solutions needed to manage this development and manufacturing complexity and ultimately deliver the required treatments to customers and patients.

Our people are key to this approach. We have an expert team ready to collaborate with customers at any point, from early development through large-scale commercial production. Our services include world-leading crystallization development, process development, and specialized manufacturing expertise for complex synthetic molecules, including those requiring chromatography capabilities. In many cases, we can provide all these under one roof.

Our service offering to our customers is also based on the foundational element of strong quality and compliance systems. We operate multiple facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually focused on ways to strengthen our global quality management system.

Looking ahead, we are focused on continually investing in our facilities and team to meet growing complexity, as evidenced by our recent announcement of new investment in our Devens site. This investment signals our commitment to providing state-of-the-art capacity and capabilities to enable these next-generation therapies to reach patients. It is a key milestone as we advance Veranova’s broader growth strategy.

🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems

How is Veranova approaching the challenge of designing and manufacturing effective linker molecules for ADCs?

As a leader in complex linker-payload synthesis, Veranova is committed to unlocking the life-changing potential of ADCs without letting their complexities slow down the development of much-needed cancer therapies.

ADCs are intricate, multi-component molecules that require extensive expertise and agile collaboration to overcome unique development challenges. With over a decade of experience in ADC linker-payload systems, we have developed the ability to anticipate challenges and avoid common pitfalls.

The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic.

We prioritize getting it right the first time, minimizing change orders and ensuring high-quality results. We have developed a robust phase-appropriate strategy that is backed by state-of-the-art analytical equipment and regulatory procedures to ensure our partners can rapidly progress their ADC projects from pre-clinical to commercialization.

🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects

Can you specify how Veranova is using artificial intelligence (AI) to optimize manufacturing processes that can reduce costs and environmental footprint as well as speed up development?

In May 2024, Veranova announced a partnership with Phorum.AI to leverage AI to optimize pharmaceutical manufacturing processes. This collaboration aims to enable the rapid development of processes that can drive efficiency and reduce costs while maximizing environmental sustainability.

Our goal is to combine Veranova’s extensive empirical manufacturing dataset of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers.

At Veranova, we are constantly looking to employ innovative technologies and approaches to improve efficiency, accelerate time to market and reduce environmental footprint. We have the means to work with a variety of partners who have unique project requirements, without sacrificing time to market.

🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint

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Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years?

Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years?

How is Veranova approaching the challenge of designing and manufacturing effective linker molecules for ADCs?

Can you specify how Veranova is using artificial intelligence (AI) to optimize manufacturing processes that can reduce costs and environmental footprint as well as speed up development?