PPMLD Newsletter - February 2009

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Welcome to our occasional newsletter. We would like to offer some tips, guidance and case studies which 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, a tip of the day, and an introduction to our new assessment system.

John Faulkes and Ralph White - February 2009

We specialize in improving collaboration and engagement at work – particularly in Pharmaceutical and Biotech project management. This 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. We can help with accurate diagnosis, strategic and operational team sessions, plus individual coaching.

See more below.

Picture of John Faulkes

John

Picture of Ralph White

Ralph

See us in Spring 2009!

We will be speaking at several forthcoming conferences and meetings in the coming months:

The Drug Information Association (DIA) EuroMeeting in Berlin, March 2009.
Download the programme here.

ERBI's 'Bio Project Management – Leading the Development Process' course, specific for small and medium sized companies in Pharma, Biotech, Devices and Pharma Services – March 9-10 2009.
See the details here.

The PIPMG spring meeting – 6-7 May 2009 – 'Can we talk? Project Management Communication Strategies for the Pharmaceutical Industry'. See more detail here.

Case study – fully engaging a Product Development Team

A few months ago we were asked to work with a large pharma international product development team, just formed to manage a key alliance project.

The team was in the vanguard of a new organizational approach for the company – a more empowered team, with top-performing members, selected by the project leader. Due to pressing planning discussions and short travel windows we were only able to work with them for a short time – but were able to resolve some key issues:

Firstly, although all members were highly experienced project reps, there was hesitancy about the initiative and creativity with which the new team was expected to operate. We helped the leader to generate understanding about the new approach and to raise the expectations.

Secondly, it emerged quickly in discussions that the team was in danger of becoming blocked by an issue with the alliance partner. It was a genuine 'big picture' concern, but one that could only be resolved at top management level. We helped the project leader and manager refocus commitment on current, necessary and urgent work to meet a submission deadline.

Thirdly, we helped the team to commit to maximizing their use of IT to manage their meetings. We used a model we've tried and tested, that can radically reduce the time spent in admin. – particularly by the project manager. Contact us to learn more.

Change does not necessarily stick with one short intervention! We met with the project leader during the following month, to coach on appropriate leadership style, in order to keep things moving briskly forward.

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 – Quality by Design George Santayana is famously misquoted for the aphorism 'Those who cannot remember the past, are condemned to repeat it'. And so it is with the various lenses we use to study the management of drug development projects. Techniques come and go with the fashions, but whether it is TQM or BPI, there is an underlying consistency that tells us to 'Start with the end in mind' – but it is all too easy to forget. Within manufacturing, the development of the Pharmaceutical Quality Assurance Scheme (PQAS) is rapidly moving the emphasis away from Quality by Inspection, to Quality by Design. The former has a stultifying effect and the parallel in general Pharma Development is an overdue emphasis on time and cost metrics which tell you with unnerving accuracy and precision why you are not on course, but fail to inform what needs to happen. In contrast, the emphasis of PQAS is on: Quality by Design (quality assured by well designed product & process) Knowledge rich submission, (supporting product & process design) Specifications based on product performance requirements Flexible process within design space allowing continuous improvement Focus on robustness (understanding & controlling variation) Why should this resonate so well with the Pharma Development Project Manager? Because it paraphrases all the best practices in setting up a Project and running it to success: Scope (what does the customer want, who is sponsoring it and what are the boundaries?) Time (get real: stretch targets are not a one-way bet) Cost (things happen – delay does not freeze spend) Human Resource (have we got what it takes?) Communications (no RBS's around here please) Risk (think about what to do if and when…) Procurement (make it or buy it?) Quality metrics (choose the right ones – people will concentrate on those that affect them) All this is well known but Quality by Design is a timely reminder not to forget and then repeat those all too easy to make mistakes.


In the last year we have featured on the PPMLD site and in our newsletters a fair amount of detail about our project capabilities online assessment tools. Our providers for these have recently set up a new brand, 'Agio Interactive', and the detail and demos have moved onto their site – www.agio-interactive.com. They provide bespoke services to anyone wanting to do online research, assessment or eLearning. We appreciate that not everything they offer may be of direct interest to you, but we would be delighted if you would pass this link to your HR colleagues!

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Our registered address is: PPMLD Ltd, 132 Burnt Ash Road, London, SE12 8PU, United Kingdom
Our telephone Number: +44 (0)20 8852 2758
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