Good logistics are paramount for successful clinical trials. Medicines must be shipped and stored in a way that maintains their quality, often complying with a number of strict national guidelines. And this attention to detail must be carried out right through to the point of demand.
As a result, companies that are running numerous clinical trials have to conduct clinical and operational planning while tackling variables that could change at any moment. In addition, a tightening of regulatory definitions around the world has enhanced the importance of strategic decision making.
Regulations in the cold chain storage and distribution space, for example, such as Canada’s Guide 0069 and the USP <1079> Good Storage and Shipping Practices, specify protocols that have to be implemented along the supply chain to ensure compliance. Partner these requirements with increasingly complex, global and expensive clinical trials and the pressure on the industry is getting ever greater.
Testing times for clinical trials
It is not only regulatory pressure that has brought about the need for tighter logistic controls. Regarding clinical trials, many biotech firms, for example, are experiencing a ‘study explosion’, with the number of trials they are operating increasing at a much faster rate than the headcount of staff. Medimmune develops and manufactures formulations for use in immunisation programmes and has seen the number of studies it is conducting increase dramatically. Supply chain planning manager Chris Popple says effective planning in clinical trials is very hard to do but absolutely essential to the success of the study.
“Clinical demand is very uncertain, studies are very volatile and it is very difficult to plan when you have constantly moving goal posts like you do in clinical studies,” Popple says.
Unlike trials of the past, drug and pharma companies can now make the most of a range of tools that can cater specifically to a trial’s demands especially when it comes to forecasting. Popple says that using a basic sales and operations planning strategy model used in many industries – that brings together representatives from many divisions to adequately plan future supply and demand – and applying it to the clinical trials can help many firms get ahead in the clinical trial arena.
“Pharmaceutical and biotech companies in the commercial world have been doing this for many years and have been doing it very effectively. But in the clinical arena it is relatively new and although people are trying to do it, no one is having much success,” he says.
There are, however, a number of forecasting simulation tools that can help the supply planning process. Working with the variables companies do know – including their finite manufacturing capability, headcount and technology – the IT solutions that are available can prove much more useful in helping to forecast the requirements supply managers will need than the traditional Excel spreadsheet.
“Everyone was using Excel [for planning and forecasting] and they still are to some extent. It is good for retrospective data but not good for forecasting. The tools have been built depending on different business models so you have to evaluate your own business model in order to choose the right solution,” Popple says.
Getting the goods out there is one thing, keeping tabs on their progress is another. Merck & Co associate director, worldwide regulatory coordination and clinical supplies Donna McDermott says effective planning and communication is key to optimising supply operations.
Much of McDermott’s role involves overseeing the export and distribution of investigational material around the globe. One of her key priorities is tracking the national regulatory requirements for shipping and importing pharmaceutical goods to make sure they make their destination and the task is becoming ever harder because of the increasing use of automation tools by port authorities.
“Ports are getting stricter and becoming more automated, so we have to get our documentation correct as it is going to be scrutinised more [by port authorities with better processes in place],” McDermott says. A new initiative by the US Food and Drug Administration (FDA), in the form of a database that will be used to screen imported goods known as PREDICT, is also placing more emphasis on getting documentation correct.
Identifying the countries that will be part of the distribution chain as early as possible allows plans to be made. “From the very beginning you need to identify the countries as it will give you an idea of the scope of the whole project. This will impact the translation of your labels, your logistics and identifying approval timelines,” she adds.
Each country presents its own challenges but McDermott cites China and Brazil as two that have especially long approval timelines. A number of companies have become increasingly stung when importing goods into the US, where if goods are detained, the FDA is under no obligation to ensure the material is stored at a suitable temperature.
The good news for the industry though is that the storage of temperature-controlled goods is getting easier through the use of technologically advanced monitoring systems that are able to track the temperature of drugs over a long period of time and issue warnings if they deviate outside the required limits.
It seems that the number of factors influencing supply operations in the clinical arena is getting more diverse as regulation becomes much stricter. Formulating an effective strategy and clearly communicating the plan to all sectors of the supply chain is no longer a model to be admired but a technique that must be used. Going forward, in an economic climate where every penny or cent is being counted, optimising capabilities and minimising delays will be key in making a profit for pharmaceutical and drug development firms.
On 19-20 October 2009, industry experts will meet at two co-located conferences in Philadelphia in the US state of Pennsylvania to discuss the logistical challenges surrounding both clinical trials and supply management after. ViB’s Cold Chain Storage and Distribution USA and the 8th Annual Clinical Trials Supply East Coast 2009 will see pharmaceutical research firms, distributors and importers meet to discuss how best to overcome the supply chain obstacles they face in their day-to-day operations.