Developing Risk-Reduction Approaches to Outsourcing

Pharma Tech Outlook: Pharma Tech Magazine

Developing Risk-Reduction Approaches to Outsourcing

Pharma Tech Outlook | Monday, January 03, 2022

A trial's unique potential for success can be bolstered and streamlined by partnering with the right company.

FREMONT, CA: Small, emerging biotechnology companies are on the cusp of a healthcare revolution. Additionally, they operate in an era in which traditional clinical trial models are being supplanted by demand for adaptable, patient-centric strategies that accurately reflect the rapidly changing trial dynamics inherent in the time-sensitive biotechnology sector.

However, it is common for such biotechnology companies to lack the specialized in-house resources required for clinical supply and a global framework and assets capable of manufacturing and supplying to all clinical destinations. Therefore, outsourcing is necessary for delivering supplies to patients enrolled in clinical trials to be successful. To ensure a successful vendor-client relationship, it's critical to partner with a CDMO that can provide a comprehensive set of outsourcing solutions and tailor-made strategies to meet the unique requirements of biotechnology sponsors, regardless of their stage of development.

This begins with an understanding of the Emerging Biopharmaceutical and Biotechnology (EBP) market and the formation of outsourcing partnerships tailored to sponsors' specific needs and capable of meeting both near- and long-term objectives.

Partnerships for Tactical Outsourcing

Many smaller biotechnology companies are hesitant to outsource supply chain functions to larger CDMOs. This is frequently due to the misconception that such businesses cannot provide the tactical-based partnerships required to provide task-by-task support or fill a particular resource gap. The argument is that, due to their global footprint, extensive capabilities, and collaboration with 'big pharma,' they are too large to be a cost-effective choice for managing aspects of biotechnology trial supply.

While there may have been some truth to this assumption in the past, times have changed. As a result of the rapid evolution of the clinical trial landscape and the emergence of biologics, larger CDMOs can now represent a cost-effective option for small biotechnology sponsors seeking tactical partnerships to accomplish short-term objectives.

From study planning and project management to IRT integration, label design, comparator sourcing, and temperature management tasks, a tactical outsourcing partnership can provide biotechnology firms that may or may not be collaborating with a CRO and multiple vendors to assist with other aspects of their pipelines with the trusted oversight and integrated planning necessary to align study objectives with task-specific outputs.

By partnering with a CDMO, biotechnology companies can leverage global assets, niche talent, processes, and technology across a broad range of capabilities on a study-by-study basis for rapid deployment to meet an immediate need. They can accomplish this by leveraging expert advice on design and procedures, detailed project timelines, and proactive status updates that enable intelligent and informed decision-making and ensure key deliverables are met.

Outsourcing on a tactical level provides biotechnology sponsors with more options and enables them to establish outsourcing relationships tailored to their specific needs and scalable. Additionally, it contributes to patient retention, agility, and an overall positive site and patient experience.

Strategic Alliances

Selecting a larger CDMO as a partner can pay dividends in scaling supply chains and future-proofing clinical trial operations. Numerous biotechnology companies have evolved from tactical outsourcing relationships to more strategic ones.

A strategic relationship enables the integration and alignment of commercial and study objectives over the long term. Capable outsourcing partners will accomplish this for sponsors by aligning business models, including shared governance practices and integrated supply chain management processes, which results in increased efficiency. This is frequently backed up by executive endorsement and a shared vision for the operational and innovation strategies. The combined product knowledge shared processes and systems and eliminating job-specific administrative burden will enable more rapid deployment of study resources to meet aggressive clinical timelines. Additionally, the co-development of innovations can contribute to the growth of the small and emerging biotechnology value chain, enhancing both the sponsor's and its trials' performance.

By partnering with a reputable and established CDMO with a track record of delivering for emerging, small, and medium-sized biotechnology companies and large pharma, sponsors can leverage multidisciplinary expertise, resources, global infrastructure, and capabilities to better position their commercial product success.

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