By Lori Ball
In biopharmaceutical development, ancillary business operations such as shipping logistics are frequently perceived as secondary to the ultimate goal of discovering novel treatments and cures for the world’s most devastating diseases. This is especially true today as big pharma is coping with expiring drug patents and dwindling product pipelines. However, in the hypercompetitive world that is drug development, forward-thinking companies have found that optimizing their clinical trial supply chain operations can provide a strategic advantage to accelerating current and future drug discovery.
With the advent of molecular and other analytical technologies, properly preserved biospecimens such as plasma, tissue, and blood serve as the foundation for breakthrough therapeutic treatments. As such, these invaluable materials represent assets that can bring significant long-term value to an organization from a commercial, scientific, and medico-legal perspective. However, to capitalize on the potential benefits provided by properly preserved biospecimens, drug developers must consider a comprehensive strategy for the transportation and distribution of these temperature-sensitive critical science assets.
Cold chain management defines how temperature-sensitive products and biomaterials are packaged, transported, and stored throughout research and development. It is projected that 7 of the top 10 global pharma products in 2014 will be biopharmaceuticals that require cold chain handling. Despite this, companies often overlook the critical step of outlining cold chain strategies for upstream processes at the outset of the drug development. This misstep can be detrimental to a company’s bottom line, as the cost to ship these materials has increased exponentially for various reasons. In fact, recent industry estimates indicate that logistics can account for as much as 30% of a study budget. In addition, miscalculations for global transportation can have a trickle down effect that can decelerate future research initiatives.
Regulatory agencies also are requiring increasingly detailed information for the approval of new pharmaceuticals. Without a complete audit trail detailing a specimen’s history from collection to destruction, drug developers risk setbacks that could postpone product launch. In an industry marked by huge operation cost, even a momentary downtime can have a far-reaching impact. Add to this burgeoning environmental responsibilities, revolving regulatory guidelines, and stringent protocols for advancing technology, and the equation becomes extremely complex. However, by developing a strategic sample management plan that takes into account best practices for temperature-controlled storage and logistics, regulatory guidelines, and audit trails, organizations can protect financial investments while streamlining the clinical research processes.
Fundamental Changes In Methodology And Operating Procedures
Like most elements of drug development, managing the global cold chain requires meticulous and exact application of best practices to maximize its potential. The challenge not only requires the implementation of novel technologies, but also fundamental changes in methodology and operating procedures to manage the increasingly complex demands of maintaining visibility throughout a global supply chain.
With this in mind, biopharmaceutical firms are increasingly turning to specialized outsourced providers to manage their cold chain distribution. Outsourcing this multifaceted function to cold chain experts helps biopharmaceutical firms mitigate risks of degradation and allows them to allocate capital and resources to developing novel pharmaceuticals and therapeutics. Many companies have found that with the right expertise, an organization can increase its ability to fully leverage supply chain efficiency and incorporate cold chain strategies into their existing business models.
As global clinical trials become more prevalent, cold-chain management is now recognized as a critical component of optimizing clinical trials. This presents pharma with decisions they have not faced in the past. Do we outsource, insource, or use the partnercentric approach? Do we implement ambient or temperature-controlled transportation? What effect does our global transportation have on our corporate environmental policies?
While logistics was once considered a means to an end, it has become clear that life sciences organizations that recognize the intrinsic value of a highly visible and efficient cold chain will be the companies setting the pace for proficient drug development in the 21st century.