PPMLD Newsletter - November 2009

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Welcome to our occasional newsletter – for November 2009. We would like to offer some tips, guidance and case studies that may help you improve the effectiveness of your work. In this edition, there's a reminder of who we are and what we do, an example of something we've done recently for a client, an introduction to our assessment system and a 'tip of the day'.

John Faulkes and Ralph White - November 2009

We can help you by:

Making projects work better in your company
Building trust and enhancing collaboration across partnerships and alliances
Finding the keys to unlocking motivation and engagement of your people
Coaching people who have to lead in complex situations
Assessing the companies you invest in and measuring their potential to run projects efficiently

Picture of John Faulkes

John

Picture of Ralph White

Ralph

Improving collaboration and engagement at work is one of the most cost-effective things you can do! It can make a dramatic difference at a time when you can't make major investments or hire staff freely.

See us next week!

Meet us at the Pharmaceutical Industry Project Management Group (PIPMG) Meeting on November 24–25th
See more information here

Case study – rapid improvement to CRO partnering

Earlier this year we were asked to help with CRO partnering at a major European Pharma Company. They were looking to increase the scope of outsourcing, and were keen to ensure that they managed relationships with suppliers in the most effective way.

They asked us to focus on some specific global studies for which the contract had been assigned to one CRO. In the setup period there had already been some potentially worrying communication problems. However,in talking to the internal operations team and several other stakeholders, we were able to ascertain that at the root of this was insufficient understanding between the internal players, of the objectives.

The stated objectives of the studies were clear, agreed at top management level and published internally. But these were complex trials, involving opinion leaders in many countries as well as company affiliates. In effect this meant a subtle mix of different 'drivers' for these objectives.

How can you make your operation as effective as possible?

We can assess your strengths and the barriers to effective project working, using brief meetings, and, where relevant, our quick online tools.

For small and medium sized companies – we can help you take action exactly where you need to – and not waste money on things that will not make a real difference. See more details here.

For VC investors and companies acquiring assets – Due Diligence may have been performed, but in our experience this is all about the asset and not about how it is to be developed. Too often the asset is turned over to a Project team ill–prepared to take it on and that's where the trouble starts. We can help you avoid this trap and identify improvements that will ensure that development is successful. See more details here.

Key Tip – to Profile or not to Profile? It was the White Queen from Alice in Wonderland who said she could imagine six impossible things before breakfast ... the Project Manager may not be so challenged but may be asked to balance two opposite approaches in early stage medicines development: planning with the expectation of success and the cheapest route to failure. At its simplest, the former carries the at-risk costs of formulation, manufacture, and conduct of clinical trials, whilst the latter will mean delay to market because essential parallel tasks have not been commenced. At face value, the management challenge this presents is from the Dirty Harry manual of decision science i.e. 'do you feel lucky?' But this blunt choice can be softened somewhat by ensuring that you align to the objectives of your organisation. Large pharma, despite cash constraints, may commit to at-risk studies and not be distracted by, for instance Phase 0. At the opposite extreme, an early-stage company may focus just on First time in Humans (FTIH), or even progress to Proof of Concept (PoC) with a minimum package because success at either stage will increase the value of the asset prior to selling on. But there is a real danger that FTIH or PoC becomes an end in itself and this is dangerous. Potential customers will use the lens of a Product Profile to evaluate the commercial value of the asset and it is essential that early stage companies do the same: a candidate for a chronic therapy that works in primary pharmacology ... but has a half life of 30 mins in FTIH? ... or works in PoC but only when given by IV infusion? Think with the commercial end in mind: understand the Product Profile.

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