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A Time for Change?


Ten years ago, IBC (now Informa) organised the first and soon-to-be annual Partnerships in Clinical Trials (PCT) conference. This grew out of 12 years of CROs and How to Manage Them, an event organised jointly by IBC and Technomark. The 10th PCT meeting took place at the end of 2011 in the impressive Cité de Congrès in Lyon. The vast number of delegates enjoyed an interesting series of plenary presentations, theme sessions and panel discussions. There was also a large exhibition where CROs and other suppliers showed their wide range of offerings.

One of the themes running through the conference was the current economic situation – read ‘crisis’ – in the pharmaceutical industry. Several speakers highlighted the expected revenue losses for the industry due to patent expiration, as well as the escalating cost of drug development which was put at $1.3 billion per drug by Professor Kenneth Kaitlin of Tufts University. These rising costs would matter less if productivity was rising, but many speakers emphasised that productivity was not increasing and timelines remain solidly reluctant to improve.

That the industry had to change was a common opinion. Some speculated that the industry might become sales and marketing only, and simply give up R&D. Dan Perlman, CEO of RPS Inc even predicted that within 12 to 18 months all top 12 pharmaceutical companies would outsource all their drug development, having seen the requests for proposals (RFPs) himself. The delegates were, in general, somewhat sceptical of this view – but this may be set to change.

Several speakers discussed how contracts and contracting had changed (or not) in the last 10 years of the conference. One session even showed a presentation from 1998 to highlight this point (full details of this are discussed on page 28).

The pharmaceutical industry is often criticised for being too insular. Two interesting presentations were given by consultants to the construction industry (Lee Griffin of Davis Langdon) and the aircraft industry (Keith Hayward of the Royal Aeronautical Society). It was mildly consoling to hear of similar outsourcing problems in those industries.

Now is the time of ‘strategic alliances’, and in fact 22 of these have been announced in the last 18 months. Several speakers discussed their so-called strategic alliances, which on close examination were at best preferred-provider arrangements or otherwise qualified suppliers. It appeared that the true strategic alliance is still a rarity.

One of the plenary sessions included a detailed discussion by Dianne Kitka of Clintec on the state of running trials in emerging countries such as China, India, Brazil, South Africa and Egypt, who predicted that they would continue to gain an increasing share of the clinical trials market. This was interestingly mirrored in a forecast of the drug sales revenue in these countries by Christopher Gallen of Zalicus Inc.

One of the main themes of the conference was quality, allied to until the final panel discussion of the conference that quality was actually defined. Up until then it was tacitly equated with ‘freedom from errors’, while probably a truer definition of ‘fit for purpose’ was eventually promulgated.

So change was a big theme – we must change trials, how we do them, how we analyse them and how we report them. But how? Few had any real ideas. Dawn Anderson of Cognizant Life Sciences was upbeat on how existing technologies could be applied and indeed showed a rather good example using mobile phones. But generally neither speakers nor delegates had any real ideas of how to change – perhaps if they had such thoughts they kept them to themselves. Maybe public exposition of a revolution in clinical trial methodology was too much to expect.

I sensed that there were signs of polarisation of the clinical trial market with the big 10 CROs working for the top 10 or 20 pharmaceutical companies, while the rest of the CROs (perhaps 1,000 of them) fought over the remaining hundreds of small- and medium-sized clients and biotechs. One medium-sized CRO told me that business development had never been easier with mid-sized companies, since the big CROs were now concentrating their resources on the big pharmaceutical companies.

It was an interesting conference: few deep insights into how the partnership scene would change, but an event well worth attending. One thing I did learn was that personalised medicine is now dead and the new buzzword is ‘precision therapy’. It makes you wonder how we ever survived imprecise therapy up until now. Perhaps we’ll learn more in the next PCT in Hamburg in 2012. See you there?

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Graham Hughes
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