Contents Cover story
6 News & numbers The headlines and figures impacting the sector.
Regulatory
8 A harmony of interests Data sets obtained through collaboration across multiple countries are an important way to strengthen research findings, and in some cases can be necessary to study rare diseases due to the limited number of cases. But there’s no overarching governance on conducting trials, and in many cases organisers must navigate a complex web of regulation that spans both countries and regions within them before research can begin. Mae Losasso speaks to Mic McGoldrick, associate director, global chemistry, manufacturing and controls (CMC) policy at Merck, and Akira Yamaguchi, CTO at LORENZ Life Sciences Group, to better understand the complexity of global clinical trials regulation, and what’s being done to achieve greater harmonisation of the rules.
11 Flex and adapt: the new onsite model Trilogy Writing & Consulting
Clinical supply & logistics
14 Backwards about moving forwards
Clinical trials have long been famous for their sophistication and lengthy
4 14 Clinical Trials Insight /
www.worldpharmaceuticals.net In this issue 17
management systems into a strategy with other elements of interactive response technology (IRT) can be an effective way to mitigate it. Monica Karpinski speaks to Jan Pieter Kappelle, senior supply chain strategist and advisor to the Bio Supply Management Alliance, Tom Schiavon, senior analyst for UAT and validation and clinical IRT, and clinical supply chain consultant Henk Dieteren, to better understand what is at stake, and how the combined approach can help trial organisers avoid pitfalls.
21 Product return and destruction PCI
timespans. But traditionally, organisers have paid less attention to what happens once the research is done and medications have to be disposed of. Yet, with so-called reverse logistics offering a range of financial and other efficiencies, this is changing fast. Andrea Valentino talks to Kimberly Finn at Marken and Edward Groleau at PCI Pharma Services to learn more.
17 The right temperature Temperature control can be the difference between a supply of usable products and a shortfall that delays a trial and increases the overall cost for sponsors. This level of risk demands greater supply chain visibility, and integrating temperature excursion
23 How to optimise your supply strategy Clinigen
24 Outsourcing a comparator RxSource
26 Seeking value in serialisation
The concept of serialisation was primarily a response to the counterfeit drug challenge of the early 2000s. Though technological advances and regulatory development never fully resolved this problem, the tools pharmaceutical companies employed have delivered value in other areas, and serialisation can do more than simply appease the regulators. Jim Banks speaks to
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