Twittering from the ICR conference next week

Next week will see the Institute of Clinical Research 30th Anniversary Conference & Exhibition, taking place on March 17th & 18th at the ICC in Birmingham. Of course, I will be there to:

• Cover the meeting for CRfocus (along with a team of roving reporters!)
• Help with the organisation and operation of the meeting (ICR is the parent organisation of CRfocus)
• Chairing a session on the tension between pricing and patient value, and how you can accurately assess either

I also plan to Twitter live from the conference (I’ll be too busy to live-blog like I normally do from such meetings). You can see my most recent “tweets” on the main CRfocus webpage, or follow me on Twitter itself. I’m also hoping to have time to do some other neat things, such as one or two audio interviews with delegates or speakers, and post some photos live from the meeting…

This is going to be a great conference, and I’m looking forward to it immensely. If you haven’t registered yet, take a look at the conference programme, and come along (we have passes available from a half day up to the entire meeting).

I’d love to see you there…

A message from our sponsor…

The CRfocus blog is pleased to be sponsored by the Institute of Clinical Research 2009 Annual Conference & Exhibition.

ESSENTIAL UPDATES

AND LIVELY DEBATES

ICR understands the importance of maintaining your competitive edge in the current environment. Therefore, this year’s conference is packed with opportunities to hone your professional skills, stay abreast of the latest regulatory developments and keep up to date with the hottest innovations in the clinical research industry.

There will also be plenty of opportunity for you to make new contacts and network with influential figures from across the industry.

Programme highlights include:

• Essential regulatory updates, plus “GCP Question Time”
• Intensive half-day sessions on oncology, organ transplants & cardiovascular medicine
• Lively discussions on EDC, off-shoring and global contracts
• New Professional Development stream with certificates & CPD points
• Debates on controversial questions with the chance to vote

For details of how to register and to view the full conference programme click here

Unthinkable!?

If you dig past the current economic doom and gloom spread throughout the media, you’ll come across the idea that a recession can actually be a great time to be innovative and entrepreneurial. If this can (and does) happen in the wider sphere of business, I would argue it can (and should) also happen in the development of new medicines.

Despite the instinct to stop training, stop advertising and stop investing in R&D, this is the very last thing we should be doing. Some will survive the next couple of years by simply cutting costs, but they will emerge into a world where the old models no longer apply. The rules will have been changed by maverick organisations who kept looking for the next big thing, and individuals who could ‘think the unthinkable’.

This ‘unthinkable’ might be a genuinely new idea. But, like stories, there are only so many, and once we start constraining ourselves into a specific sector, genuinely new ideas are rare. A far more approachable category of unthinkables is those ideas that pop into our heads from time to time but are swiftly forced out again because we can’t see a way to make them feasible, beneficial or politically acceptable. If we can set aside the voices of criticism and negativity (whether internal or corporate) and try to view these unthinkable ideas in a different way, we might be able to do something with them.

This generally requires someone to look from a different perspective, to change how we interpret an idea or situation, perhaps as radical as taking a view diametrically opposite the ‘conventional wisdom’ to see whether the boundaries we imagine simply disappear. (As an exercise, try to think of ways to interpret the current recession in a positive way.) This, in turn, requires a dynamic kind of optimism or, to borrow the vocabulary of an American politician who is likely to define the next few years, “hope, for change”.

Of course, the problems facing us in clinical research are exacerbated, but not created, by the current economic turmoil. Patent expiries on blockbusters reduce the revenue we can plough back into R&D; regulators raise the bar for the size of patient safety databases; governments base reimbursement decisions on evidence for patient value; and drug discovery hands us candidates that we can’t find enough patients to test, let alone enough professionals to conduct the studies… It would be easy to get depressed by this ‘perfect storm’, even before the recession hit!

But, for a moment, try to look at this situation from a hopeful, positive perspective. If the current recession can be viewed as an opportunity for the next generation of innovators to change the way business will be done for the next decade, can’t the same be true for clinical research? If this is what it takes for us to change the way we evaluate new medicines, creating a model that is a step-change more effective and efficient than at present, then would it be unthinkable for me to say that we can view our situation in a positive way?

PPRS: Achievable Compromise or Missed Opportunity?

In 1867, Otto von Bismarck described politics as “the art of the possible”; it’s easy for commentators (myself included) to pontificate without the responsibility to implement those suggestions in the ‘real world’. With this in mind, I’m cautious of being too critical of the recent announcement of a deal¹ between the UK Department of Health and the ABPI on parts of the voluntary scheme to replace the Pharmaceutical Pricing Regulation Scheme (PPRS). This was accompanied by a consultation² from the Department of Health on a statutory alternative.

This is important in an international context, as pricing systems in many countries are benchmarked against the UK. Healthcare payers around the world will be watching with interest, to see how far prices can be squeezed in return for investment in research infrastructure, and how deeply economic models of patient value can be built into reimbursement negotiations.

Last year, I wrote³ about the beginnings of this process, as an Office of Fair Trading report recommended that the current arrangements be overhauled. I was broadly optimistic, because the OFT proposed changing the system from a complex network of controls on profits and post-launch price changes to one based more on the value of individual medicines, based on economic evaluation of their benefit to patients. However, the settlement is based on an across-the-board price cut… While it gives stability and predictability for the next 5 years (the statutory scheme will be reviewed annually), the settlement appears to be a polishing of the same ‘blunt instrument’, sweetened by a commitment to speed the uptake of newly-registered medicines.

This is certainly not the value-based pricing many had hoped for. In the days following its announcement, Jim Furniss of Bridgehead Consulting told me that he thought “the opportunity provided by the OFT report for a much-needed reform to reflect the realities of the modern pharmaceutical industry has been squandered.” Were Jim and I being too hopeful? In the short term, perhaps, but not in the longer timeframe. Implementing a value-based model across the whole range of pharmaceuticals so quickly was probably impractical, but there have been pilot schemes (such as Velcade, where the NHS will be able to recoup the costs of treatment of any patient who shows no or minimal response) and these need to be applauded, nurtured and expanded.

So, is this re-negotiation of the PPRS an equitable balance to the large investment that government has made into NHS R&D over the past few years, a ‘quick fix’ to shore up public finances while ignoring the opportunity to put patient value at its heart, or a practical compromise to help the NHS’ depleted coffers while a more sophisticated, value-based model is being developed? I’d certainly like to think that it’s the last of these, but to be confident I’ll need to see strong signals from government that a more sophisticated pricing model is indeed the intended way forward.

References

1. Association of the British Pharmaceutical Industry (ABPI) press release (18^th June 2008): “Big Progress In Government And Industry Drug Price Deal”, available via www.abpi.org.uk/press/press_releases_08/180608.asp [accessed 25th June 2008]
2. UK Department of Health (18^th June 2008): “Consultation on a statutory scheme to control the prices of branded NHS medicines”, available via www.dh.gov.uk/en/Consultations/Liveconsultations/DH_085523 [accessed 25th June 2008] This consultation closes on July 15^th 2008 (part) and September 25^th 2008.
3. Smith A (2007): “Who Wins From Value-Based Pricing? Everybody!”, CRfocus 18(3) p4