Biologics trials: the ‘stretched’ global supply chain

07-Sep-2014 - Last updated on 08-Sep-2014 at 13:40 GMT

The global nature of clinical trials is adding to their complexity, says Almac

The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics even more important than for small molecule studies says Almac.

Almac’s Director of Supply Chain Strategy told Outsourcing-Pharma.com the company is experiencing increased demand for biopharmaceutical clinical trials – studies which bring special challenges for supply chain management.

“There is limited supply [of the drug candidate], there is limited experience in the industry, they require cold chain to ensure the product is not compromised and they are global, many requiring depot strategies to expedite drug to site,” said Michelle Foust.

Biosimilars: comparator trials

The company added that the increasingly global nature of clinical studies – with multiple sites in different countries – means shorter availability of complex products. Sponsor companies need to source expensive comparators and “variable patient demands,” all in “an increasingly stretched global supply chain.”

Unlike the makers of small molecule generic drugs, biosimilars makers must run comparator trials, testing their compound against originator biologics. This means obtaining their rivals’ heavily guarded product, which companies try to prevent, sometimes by shutting down supply to middle-men wholesalers.

Real-time planning

Foust told us Almac’s Supply Chain Management (SCM) service provides consulting help and supply chain technology to help with the logistical problems of running global clinical trials.

The forecasting system combines Material Resource Planning (MRP) and Interactive Response Technology (IRT) and provides real-time data to stakeholders, said Almac.

“The system is not cloud-based; the bespoke forecasting tool is fully integrated and the IRT data generated auto-adjusts the forecast on a daily basis,” Foust told us.

The technology hands control back to sponsors, drives down costs, reduces timeframes and matches clinical supply to patient demand, said Almac.

The company’s comments echo those of data services company Exco InTouch, which told BioPharma-Reporter.com shorter timelines are putting the pressure on biopharma investigators and leading to greater adoption of data capture technologies.