Pharmaceutical Executive Europe - April 2008 - (Page 14)

14 Technology: Supply Chain April 2008 Pharmaceutical Executive Europe Designing Tomorrow’s Supply Chain As companies become ‘globally agile’ enterprises, Rebecca Drinkwater and R.S. Kumar look at how the supply chain can be developed to keep up with the change. t is no secret that clinical development represents the longest and most cumbersome aspect of launching new drugs into the global market place. Product development challenges have increased due to increased regulatory requirements, new technologies and the complexity of studies being conducted. One important factor in successfully conducting clinical studies is the efficient management of clinical trial supplies, particularly for those complex studies requiring detailed monitoring, precise planning and co-ordination between many players. BearingPoint and AMR recently conducted a benchmarking study of the clinical supply chain. This highlighted the increasingly complex environment in which life science companies are working. To thrive in this environment, companies need to become globally agile enterprises, and this requires a more effective and efficient supply chain than currently exists. The focus, however, needs to expand from the commercial supply chain to also include the clinical supply chain. Only then will companies achieve their goals of reducing time to market, shortening study timelines and reducing R&D costs. I A new focus In the past, companies have focused primarily on innovation and new product development. Few are running their clinical supply chains based on leading practices, resulting in lacklustre performance in this key operational area. Our research showed that the number of trials is increasing (nearly 50% of companies will have more than 20 studies per year by 2010), more adaptive trials are planned (39% of these companies said six or more of their trials will be adaptive) and that trials are becoming longer (33% of our respondents planned longer trials). Inefficient clinical supply chains will increasingly put these complex global trials at risk. The success of these studies is heavily dependant on providing study supplies to often large numbers of sites so that the drugs can be administered at the correct times throughout the study. Issues such as supply stock-outs can result in patients being disqualified, potentially jeopardising the entire study. However, forecasting of trial stock requirements is difficult. Patient recruitment occurs at different speeds and patients sometimes drop out of trials before study completion. Patient recruitment is one reason why companies are looking further afield to perform studies where this is easier and often cheaper (only 38% of our respondents’ trials will be administered within North America and Europe), but global trade regulations are a particular challenge for the clinical supply chain. These can prevent movement of product between sites, delay delivery of supplies to sites (a particular issue when there are short expiration dates) and even potentially un-blind trial supplies. Repeat infringement of trade regulations can also result in substantial fines and penalties, and potentially more significant regulatory sanctions. These and other regulatory requirements keep regulatory compliance as a top two concern for over half of our EU respondents. Manufacturing of the clinical supplies has additional complexities to that of commercial drug manufacture. These include short supply of the active pharmaceutical ingredients (API), requirements to produce small batches of the drug product, and complexity in the product portfolio with numerous dosage strengths, comparators and placebos all being required (looking alike but operating as unique entities). On the packaging and distribution side, companies have traditionally tried to outsource the function to third parties to reduce costs and ensure on-time delivery of supplies to sites. But the lack of inventory visibility across organisations and regulatory constraints on movement between sites has resulted in increased inventory levels often more than offsetting the benefits of outsourcing. Building an efficient and effective clinical supply chain is critical to the future success of drug development programmes. But although all supply chain optimisation strategies have the common goals of trimming costs, reducing risk and enhancing service levels, no single strategy works for all organisations. In addition, different strategies may be applicable depending on where a product is in the pipeline. For example, one strategy may work well in a Phase I trial but not be appropriate in Phase III. The globally agile enterprise Even relatively small changes in the supply chain can reduce costs, better manage risk and reduce time to market. Companies which leverage expertise around core supply chain functions like planning, forecasting, logistics and global trade will develop faster and more efficient clinical supply chains, thus reducing cost, time to market and regulatory risk. Chain image: Influx Productions/Getty Images

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - April 2008

Pharmaceutical Executive Europe - April 2008
From the Editor
News and Analysis
Brussels Report
Designing Tomorrow's Supply Chain
Look After Your eHealth
Why CIOs Need the X Factor
Doing It Right
Online and On-Message
Reward: Better Business
The Only True Advertising 'Reward'

Pharmaceutical Executive Europe - April 2008