By: Jonathan Calderwood – Director of Commercial Development – Almac Clinical Services
Small, emerging biotechnology companies are at the frontier of a revolution in human healthcare. They are also operating in an era where traditional clinical trial models are being surpassed by demand for flexible, patient-centric strategies that accurately reflect the rapidly changing trial dynamics of a time-sensitive biotechnology sector.
Yet, it is typical for such biotechnology companies to neither have the specific in-house resources needed for clinical supply nor the provision of a global framework and assets to manufacture and supply all clinical destinations. Outsourcing is therefore a prerequisite to successfully delivering supply to patients enrolled in clinical trials. To enable a successful vendor-client relationship, it’s important to partner with a CDMO that can offer a comprehensive set of outsourcing solutions and tailor-made strategies that meet biotechnology sponsors’ unique requirements, regardless of where they are in their development journey.
This begins with understanding the Emerging Biopharma and Biotech (EBP) market and development of outsourcing partnerships based on unique sponsor needs that are able to satisfy both near-term and longer-term objectives.
Tactical Outsourcing Partnerships
Many smaller biotechnology firms approach the idea of outsourcing aspects of the supply chain to larger CDMOs with caution. This is often due to a misconception that such companies aren’t able to offer the tactical-based partnerships they need to deliver task-by-task support or plug a particular resource gap. The thinking is that because of their global footprint, vast capabilities and work with ‘big pharma’, they’re too large to be a cost-effective choice for managing aspects of biotechnology trial supply.
While there was once perhaps some truth in this assumption, times are changing. In response to the rapid evolution of the clinical trials’ landscape and emergence of biologics, larger CDMOs can now represent a value for money proposition for small biotechnology sponsors in need of tactical partnerships that satisfy short-term goals.
From study planning, project management, forecasting to IRT integration, label design to comparator sourcing and temperature management tasks, a tactical outsourcing partnership can provide biotechnology firms, that may or may not be working with a CRO and/or multiple vendors to assist with other aspects of their pipelines, with the trusted oversight and integrated planning needed to align study goals with task-specific outputs.
By partnering with a CDMO, biotechnology firms can leverage global assets, niche talent, processes and technology, across a broad array of capabilities, when and how they need them on a study-by-study placement for rapid deployment to meet immediate need. They can achieve this through benefiting from expert advice on design and procedures, detailed project timelines and proactive status updates that facilitate smart and informed decision making and ensure key deliverables are met.
Outsourcing on a tactical level opens up greater choice for biotechnology sponsors and helps them to establish outsourcing partnerships that are both built around their precise needs and scalable. In addition, it helps to support patient retention, agility and promote an overall positive site and patient experience.
Opting to partner with a larger CDMO can pay dividends when it comes to building scalable supply chains and future-proofing clinical trial operations. Many biotechnology firms progress from tactical outsourcing partnerships to those that are more strategic in nature.
A strategic relationship enables longer-term integration and business alignment of both commercial and study goals. Capable outsourcing partners will achieve this for sponsors through the alignment of business models including shared governance practice and integrated
processes, leading to increased efficiencies. Often this is supported by executive endorsement and a shared vision for the operational and innovation strategy. The product knowledge, shared processes and systems and removal of job-by-job administrative burden will promote a faster deployment of study resources to meet aggressive clinical timelines. Additionally, co-development of new innovations can continue to add to the small and emerging biotechnology value chain and boost the performance for both the sponsor and its trials.
By partnering with an established and trusted CDMO with a proven track record of delivering for emerging, small and medium biotechnology firms and big pharma alike, sponsors can utilize multi-disciplinary expertise, resources, global infrastructure and capabilities to better prepare for commercial success.
Selecting the Right Outsourcing Model
While customizable outsourcing models exist for biotechnology firms looking to benefit from the expansive expertise and capability of a global CDMO partner, it’s important to remember that these models can and should be tailored to fit unique needs.
Sponsors should prioritize working with CDMOs that are able to adopt the same principles and be adaptive to the specific requirements of the biotechnology firms they partner with. Critical factors when selecting an optimal partner include service portfolio, clinical aspirations, and governance models. These aspects, when addressed within partner selection, can garner cultural alignment and value creation – vital and exciting for the rising tide of small, nimble and funded biotechnology companies.
Sponsors at different stages in their journey will naturally require various levels of support. From help with a specific packaging operation to management of supply for one clinical program, or a longer-term partner to be fully immersed in their company culture and help nurture them from a phase 1 through to full commercialization - or anything and everything in between. The point is, no two EBPs are the same so it’s up to vendors to discard the one size fits all outsourcing approach and use their expertise to consult with sponsors to build best-fit solutions.
By selecting the right partner, sponsors can ensure they are better positioned to augment and streamline a trial’s unique potential for success. This will in turn optimize supply chains to reduce risk and promote flexible, patient-centric operations that play a leading role in achieving critical milestones and regulatory approvals on time and on budget.
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