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European Pharmaceutical Contractor

Letter from the Editor

All industry players know that speed is of the essence in pharma R&D. Karyn Korieth and Annick Anderson at CenterWatch report that, over the last 15 years, efforts to improve the pace and efficiency of drug development have had little success, and no significant gains have been made in reducing median clinical cycle times. The company’s recent analysis looked at over 300 approvals from 2000 to 2013, and found that the average duration between investigational new drug and new drug application status was around 5.6 years. However, these findings hide the high degree of variability when comparing the fastest and slowest developers, and also mask an inconsistency in cycle times across different therapeutic areas. As well as providing advice from standout sponsors, the authors warn that maintaining speed advantages for long periods is no mean feat.

In this edition of EPC, we have two features addressing two rather different localities. Jim Worrell at AmeriStart gives some useful guidance on how to break into the North American market, often seen as a prime opportunity for business expansion. He notes that breaking into the US can be expensive, risky and cause delays, and that a wise strategy may be to ignore the region’s prospects altogether. Nonetheless, Worrell suggests 12 steps that, with the right amount of patience, can bring European life sciences firms US success.

The Turkish market is also one that may present challenges, but can eventually yield significant benefits. Ömer Sadun Okyaltırık and Yamin Khan at Pharm-Olam outline some of the advantages of carrying out clinical trials in the country – namely, the high number of potential, treatment-naïve patients, a practical registry process and competitive cost structure. The authors conclude that the regulatory, regional and linguistic barriers are minor when weighed against the rewards on offer, and can easily be surmounted with the help of a local partner that is familiar with regional practices and restrictions.

Patient safety and the reporting thereof is a topic addressed by PSI CRO’s Maxim Kosov, John Riefler and Maxim Belotserkovskiy, who discuss the thorny issue of prompt recognition of adverse drug reactions (ADRs) and their causal relationships with study products. They highlight that ADRs can be difficult to differentiate from patients’ underlying disease symptoms, using two examples where the sponsors and investigators have disagreed in their interpretation. It is proposed that event causality may be crucial to the fate of a drug if this interpretation is incorrect.

Marc Hoffman of Theorem Clinical Research weighs in on the patient protection debate too – particularly in relation to vulnerable research subjects. Regrettably, history is full of reports on the abuse of patients’ rights, especially those in at-risk populations. But Hoffman asserts that, in recent times, protection has dramatically improved, while underlining that patient safety should be the number one priority of those working in clinical research.

The theme of protection also extends to the article by Jeannette Paulussen at WIL Research. She defines the objectives of the European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, which aims to further safeguard the general public against the effects of substances. Paulussen describes how the latest enactment of REACH is impacting companies, and recommends that pharma enlist the assistance of an experienced toxicology CRO to provide peace of mind, as well as accurate and efficient substance production.

These are just a small selection of the wealth of interesting pieces featured in EPC June. I would like to finish by thanking all our contributors – you have made for a varied and informative issue.

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