Niche CDMOs in the biopharmaceutical industry; is this the right choice?
14 June 2024
Interview with Dr. Mattia Cassanelli from Biopharma Group
Introduction:In an industry dominated by big service providers, niche CDMOs are carving out a specific sector with their agile approaches and tailored solutions. We sat down with a key representative from Biopharma Group, Dr Mattia Cassanelli, to discuss how their personalised service is transforming pharmaceutical development.
Interviewer:
Thank you for joining us. Could you start by explaining what sets niche CDMOs apart in today’s pharmaceutical landscape?
Dr Mattia Cassanelli:
It’s a pleasure to be here. I believe the core difference lies in how we handle communication and project management. While larger entities often face challenges with communication and a slower decision-making process, we ensure that our clients have clear visibility and direct lines to the team. This approach not only accelerates project timelines but also enhances trust and collaboration. For example, at Biopharma Group, we provide a dedicated project manager and ensure accessibility to key technical and commercial figures, ensuring our clients always feel supported and valued.
Interviewer:
What are the main differences in collaboration with a niche CDMO between small and large pharmaceutical companies?
Dr Mattia Cassanelli:
The collaboration dynamics differ significantly. Small companies often engage with us for proof-of-concept studies and development support to swiftly navigate the regulatory landscape. Their goal is typically to advance from early development stages to readiness for clinical trials efficiently. In contrast, large companies usually approach us seeking a reliable backup and specific expertise to troubleshoot complex issues in their existing projects. Both types of companies value our ability to provide in-depth technical support and rapid problem-solving capabilities to maintain project continuity and quality.
Interviewer:
What are the top three challenges you hear from CEOs in the pharmaceutical industry when approach you?
Dr Mattia Cassanelli:
Firstly, handing the financial risk and high costs of drug development are always the main challenges at the forefront of a CEOs mind. We are advocates of “better to invest now than work retrospectively”, since this could lead to significant improvements, such as increased batch acceptance rates and more efficient logistics and operations from the outset. For example, we have taken a few projects and calculated an average of 80% reduction in cost of storage, by eliminating the cold chain.
Secondly, regulatory hurdles are a major concern. Our use of Quality by Design (QbD) and Design of Experiments (DoE) streamlines compliance and simplifies the approval processes.
Lastly, the long development times required for market approval can be daunting; our expert team and efficient methodologies help shorten these timelines, ensuring quicker market entry.
Interviewer:
It’s impressive how Biopharma Group addresses these industry-wide challenges. Could you expand on how these solutions directly benefit your clients?
Dr Mattia Cassanelli:
Certainly. First, we often analyse the commercial aspects of projects with clients. We can predict and project the number of batches that are needed to fully recover the R&D investments. We lay down the benefits in terms of increased productivity and logistics, which gives extra reassurance to our clients. In general, investing in our efficient and optimised services means that clients see quicker turnaround times, higher batch acceptance rates, and more cost-effective outcomes. Our approach doesn’t just meet immediate project needs, it also sets a foundation for sustainable success, supporting clients through regulatory approval and beyond.
Interviewer:
How do you ensure that projects remain flexible and responsive to client needs?
Dr Mattia Cassanelli:
Flexibility is integral to our operations. We’re structured to adapt quickly to changes, whether they’re client requests or unexpected scientific developments. Our decision-making processes are streamlined, allowing us to respond promptly and keep our projects moving forward without the typical bureaucratic delays. This agility is crucial both at the onset, such as during discussions on master service agreements, and during the project, should there be a need to adjust due to evolving R&D decisions. Interestingly, from some internal analyses, a full development programme conducted at Biopharma Group would take just around 4-6 months, from full formulation development to lyo cycle optimisation.
Interviewer:
And when it comes to scaling up from laboratory to production, how do you manage this transition?
Dr Mattia Cassanelli:
That’s an excellent question. Scalability is indeed a critical concern. From the outset, we design our processes with scalability in mind, considering both process and equipment specifications to ensure smooth scale-up. Some niche CDMOs might need to form strategic partnerships with larger CDMOs for expanded capacity to support seamless growth while providing excellent niche expertise.
Interviewer:
Shifting the focus a bit, intellectual property (IP) ownership is another hot topic. How does Biopharma Group handle generated IP in collaborations?
Dr Mattia Cassanelli:
We are fully transparent with the intellectual property that emerges from our projects. The IP, particularly the foreground IP specific to the product, is always owned by our clients. This aspect is crucial, because CDMOs often retain some sort of ownership, whether it is on the developed formulation or process. It is fundamental to be aware of this when appointing a CDMO. This clarity ensures that the clients can continue to innovate and commercialise their discoveries without constraint.
Interviewer:
Thank you for these insights. It’s clear that specialist CDMOs like Biopharma Group play a pivotal role in the evolving pharmaceutical industry.
Dr Mattia Cassanelli:
Thank you for having me. We're committed to pushing the boundaries of what’s possible in pharmaceutical development, ensuring our clients can bring their innovations to market swiftly and successfully.
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