Tag Archives: pharmaceutical R&D

Team Development in Project Management


By Elisabeth Goodman

Team Development chapterIt’s been an honour, whilst also slightly intimidating, to have a chapter included in this latest project management publication edited by Dennis Lock and Lindsay Scott: the Gower Handbook of People in Project Management1.

Project teams may want to get to “high performance” more rapidly than operational teams

As I say in the preamble, project teams will go through various stages of development, but they may want to get to high performance at a more accelerated rate than that usually achieved by longer-term operational teams.

In this chapter I take readers through an adapted version of Tuckman’s stages of team development2: I use forming, storming, norming, high performing and renewing in my work with teams.

I also explore how these difference stages, and the different personality types from Myers Briggs Type Indicator (MBTI), and Belbin’s team roles, can be overlaid on the project lifecycle to give team leaders real insights on how they could help their teams reach high performance more rapidly and painlessly than might otherwise be the case.

Learning techniques taken from Knowledge Management also have a key role in team development

The final part of the chapter takes readers through various Knowledge Management techniques: peer assists, after action reviews, learning retrospects and communities of practice that project teams could usefully use at various stages of their lifecycle to foster high performing teams.

My colleague John Riddell and I are currently putting the finishing touches to our own Gower publicationthat will take readers in greater depth through these and other Knowledge Management techniques.

There is a whole raft of other tools available to help teams in their development

Lock and Scott’s impressive publication runs to 865 pages.  As the title of the book implies, it contains a vast range of reflections, insights and guidance on how to address the people aspect of project management.  A focus on people will inevitably enhance the quality of the team overall, and so advance it in its development.

It’s going to take me quite a while to read through this treasure of a book, but examples of the topics that caught my attention in the first 11 of 63 chapters were:

  • Successes and failures of people in projects
  • Project sponsors and stakeholders
  • Use of contractors
  • Managing in matrix, international and virtual project organisations

Somewhere in the later chapters I spotted further themes on NeuroLinguisticProgramming (NLP) and also spirituality.  So lots to explore!

Notes

  1. Elisabeth Goodman.  Team Development, in Gower Handbook of People in Project Management. Ed Dennis Lock and Lindsay Scott.  Gower Publishing Ltd, 2013 Chapter 32, pp. 403-415
  2. Tuckman, B. and Jensen, M. Stages of small group development revisited.  Group and Organisational Studies, 1977 pp 419-427
  3. Elisabeth Goodman and John Riddell.  Knowledge Management in the Pharmaceutical Industry: enhancing Research, Development and Manufacturing performance.  In preparation.

Elisabeth Goodman’s 2012 blogs in review


The WordPress.com stats helper monkeys prepared a 2012 annual report for my blogs.

Here’s an excerpt:

4,329 films were submitted to the 2012 Cannes Film Festival. This blog (Recognising reactions to change, and responding to them) had 14,000 views in 2012. If each view were a film, this blog would power 3 Film Festivals

These were the top viewed blogs:

  1. Recognising reactions to change, and responding to them  November 2011
  2. What can Lean and Six Sigma and Dilts’ Logical Levels of Change bring to effective change management? March 2012
  3. Why is employee engagement such an important topic?  March 2012
  4. Top Tips for Motivating Teams  January 2012
  5. Lean and Six Sigma in R&D and Service Delivery – opportunities and challenges  February 2011

Click here to see the complete report.

Contributors sought for new book on Knowledge Management in the Pharmaceutical Industry


John Riddell and Elisabeth Goodman are writing a book on “Knowledge Management in the Pharmaceutical Industry: Enhancing Research, Development and Manufacturing Performance”.

Whilst the book will be focused on the Pharmaceutical Industry, our aim is to discuss and demonstrate how Knowledge Management can be applied in a variety of environments.

We hope that existing and potential KM practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from the examples of good practice and the lessons learned that will be included in the book.

Whilst we are already beginning to contact people that we believe have valuable insights, experiences and perspectives to share, we’d love to hear from anyone we already know, or don’t know, who would like to contribute.

Please do get in touch via info@riverrhee.com if you’d be interested in discussing this further.  We look forward to hearing from you.

GSK ‘Working in Partnership’ Networking event – with One Nucleus


By Elisabeth Goodman(1)

As a member of One Nucleus, I had the opportunity to join about 200 delegates from a mixture of Biotech, CRO, Biopharm, Technology, IT, Government, Academic and Business Consulting organisations at an open evening at GlaxoSmithKline’s Stevenage site on Wednesday 8th June, 2011

After an opening address by One Nucleus’s CEO, Harriet Fear, we heard a series of presentations by Damien McDevitt on GSK’s Business Development teams, Nicki Thompson on the Alternative Discovery and Development Group (for virtual and externalized drug discovery), Declan Jones on the Centre of Excellence for External Drug Discovery (Ceedd), Adrian Pritchard on Scinovo (for collaborative drug discovery and development). We also had some closing remards from Nicki Thompson, and a very brief introduction to Martino Picardo – CEO of Stevenage BioCatalyst.

The evening was rounded-off by up to 2 hours of networking amongst delegates, speakers, and other members of GSK who were present for the event.

As Damien McDevitt explained, with 70% of its current late stage pipeline being in-licensed, GSK’s ‘working in partnership’ model is about exploring opportunities for creative deal making with external partners.

Nicki Thompson spoke about how GSK has been moving from the Pharmaceutical model of centralized control and management, heavily reliant on internal resources, to a de-centralised ‘virtualisation’ of drug discovery (and development) relying more on external resources.

Declan Jones said that GSK are looking for companies with strong management teams, a leading position in a specific technology or therapeutic area based on first class science, and more!

Adrian Pritchard explained how Scinovo provides scientific consulting and advisory support from early discovery research, through non-clinical, and clinical development. They have hubs of experts in Hertfordshire, UK, on the East Coast of North America, and in Shanghai, acting as account executives, scientific consultants, and outsourcing managers working with global CRO / CMO suppliers. Access to Scinovo can be via the Alternative Discovery and Development Group (e.g. the Ceedd within it), through the Stevenage Bioscience Catalyst group, or directly.

All in all, an excellent opportunity to hear an update on GSK’s approach to working in partnership with external organisations, and to meet and network with others looking to participate in such partnerships.

Notes

  1. Elisabeth Goodman is Owner and Principal Consultant at RiverRhee Consulting– a Business Consultancy that helps business teams to enhance team effectiveness for greater productivity and improved team morale. She is also Co-Founder and Principal Consultant at OI Pharma Partners helping the Pharmaceutical industry, academia and the public sector use Open Innovation to accelerate drug development and leverage the power of underutilised Intellectual Property.

2nd Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices (2 of 2)


Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices, The Brewery, London, April 2011 (2 of 2)

John Riddell and Elisabeth Goodman, RiverRhee Consulting1

For part 1 of this blog see: 2nd Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices (1 of 2) http://wp.me/pAUbH-40

Application to ‘other’ environments (1): biotech

Simon Orchard, Vice President Biotech Operations Europe, Pfizer, described applying Operational Excellence in a Biotech environment from facility and process design through to technology transfer and start-up.  In the design phase a key issue was to build in flow and takt, rather than gravitate to maximising volume.  The main opportunity was with simplification as the process.

In the technology transfer phase a structured process was used and efforts needed to be made to avoid a moving target.  Learning points were centred on building in the development of cleaning, taking time to plan including carrying out risk assessments to explore what could go wrong, and the difficulties of establishing a truly integrated cross-functional team from functional areas which were globally spread.

At start-up a problem was encountered with below specification results.  The team had the option of looking to increase results overall, or decrease the variation.  The latter was selected and a DMAIC approach followed, involving a key decision to suspend the plant start-up, i.e. get it right from the start and resolve it while focus and resource is there (and not moved onto the next project).

Application to ‘other’ environments (2): laboratories

Daniela Jansen and Donna Wall, Waters outlined how opportunities to lean documentation, data handling, sample preparation and QC decisions can reduce laboratory lead times.  The focus of their case study was to improve flow and eliminate non value adding steps through the introduction of data management in the interface between instruments and SAP/LIMS.  Manual data entry was addressed resulting in a major reduction in data input time and the quality of data improved as did its security and opportunity for manipulation.

The case study that Donna shared revealed how lab space had been saved.  The issue of each instrument having its own PC was addressed through the introduction of acquisition servers.  The lab team also analysed equipment utilisation over a 24 hour period and improved it through changing working practices.  When asked if there were other aspects (other than technology) Donna said that simple things need to be done and that metrics created an awareness that made things happen quicker.

Application to ‘other’ environments (3): clinical development

Nadine DeDecker, Director Strategic Business Improvement, Jansen R&D, reminded us that the second output of our industry is knowledge, and that value stream mapping can address information creation (as well as product creation).  Her case study showed how she started by addressing Phase 2 and 3 processes as the area with the most process improvement opportunities.  This led to standardisation of processes and the development of a common language, collaborative working, role-based training and, process improvement.  One of the biggest challenges though, is finding the best place to start.

Does process excellence limit innovation?

This was the title of a group discussion led by Craig Johnstone, Director Chemistry and Value Chain Leader, AstraZeneca.  An audience poll indicated that about 40% thought that Lean Sigma was pro-innovation, non-one thought that it killed innovation, and about 60% declined to vote many of them having experienced real pushback from their colleagues in R&D.  Craig’s suggestion, and the discussion that followed on the whole supported this, was that it was how Lean and Six Sigma were deployed that determined the extent of innovation.

Mitali Sharma, Senior Executive, Accenture, suggested that a combination of ‘Lean Innovation’ (simplifying and streamlining) and ‘Open Innovation’ (collaboration externally and engagement internally) were needed to change the Pharmaceutical R&D model and so enable R&D to not only “do the right projects”, but “to do them right”.

Keith Russell, Global Director Lean Six Sigma, AstraZeneca, described how ‘Design Thinking” can be applied to innovation as a process.  He discussed how this can be used to identify value for customers (internally or externally) to identify needs, in product design and programme design (through definition of requirements, features and strategy), and in programme execution (by focusing on core processes).  Keith’s approach, which is derived from QFD (Quality Function Deployment) recognises that R&D requires increased as well as decreased variation, and the exploitation of divergent thinking, in a controlled way.

The conference ended with Stephen Walker, Director, R&D Continuous Improvement Lead, Pfizer, and Charles Aubrey leading 2 respective focus groups on BPE in Drug Discovery, and in Manufacturing and Engineering.  They were useful opportunities to reflect further on points raised during the course of the 2 days.

Notes and further reading:

  1. RiverRhee Consulting enhances team effectiveness using process improvement, knowledge management and change management.  Follow the links to find out more about RiverRhee Consulting and about Elisabeth Goodman and John Riddell
  2. Ten Top Tips for Successful Lean and Six Sigma Implementation – RiverRhee Consulting – February 2011 http://wp.me/p1jPm6-D
  3. Operational Excellence and Knowledge Management in an R&D Laboratory Environment http://wp.me/pAUbH-3P

 


2nd Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices (1 of 2)


Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices, The Brewery, London, April 2011 (1 of 2)

John Riddell and Elisabeth Goodman, RiverRhee Consulting1

This was the second of IQPC’s specialist conferences on this theme, and as last time2, many of those questioned by the authors were finding it of real value for learning about the specific application of Lean and Six Sigma in their environment.

The conference extended over 2 days, with pre-conference workshops covering a range of topics3. With the conference themes including strategy, change management, relevance to non-manufacturing environments, and innovation, it was obvious from the start that deploying Business Process Excellence was going to be about more than Lean and Six Sigma tools.

Business Process Excellence is not just about the (Lean and Six Sigma) tools

Martin Conroy, Director, Global Lean Sigma at Medtronic, kicked off the conference by reflecting about the pains encountered when moving to a continuous improvement culture and what can be done about them. He argued that Lean is an apparently simple concept, but one that can be difficult to ‘nail’: it’s not enough to have the tools, but they need to be used intelligently (with know-how), together and, especially, with the right mindset.  He also emphasized that continuous improvement is neither a ‘bolt-on’ nor something to be done once (quickly) before moving onto the next initiative: it is something that requires careful planning and integration within the business.

Linking continuous improvement to organisational strategy

Many of the speakers referred to the importance of taking a holistic approach to implementing Lean and Six Sigma and of linking this to organisational goals.  See for example Elisabeth Goodman’s4 presentation that included case studies on this.  Tom Cochrane, Head of Security Operations and Process Development, Napp, described how their charter supports a continuous improvement culture although Lean and Six Sigma are never explicitly mentioned.  Instead, they take a systems approach to the whole production process, and use statistical process control as an intrinsic continuous improvement tool across all disciplines, with cross-functional teams operating from the QA department.

Damian Morgan, Senior Executive, Accenture described how industry pressures and the Pharmaceutical Industry’s own responses were resulting in slowing growth and margin pressures.  He suggested a consequential increased reliance on Operational Excellence (in the sense of Process Excellence) for winning.  Pharmaceutical companies need to be agile, to be operationally excellent, and have differentiated capability.  Indeed a cross sector study has shown that those who ‘win’ make investments in people and processes and, although they may look worse than their competitors who make draconian cuts in the short term, they recover more quickly and their recovery lasts longer (for more than 5 years).

Sauman Chakraborty, President and Global Head of Quality, HR & IT, described “Dr Reddy’s Way” which is a 4 strand strategic framework combining versions of EFQM’s Business Excellence Model, the Balanced Scorecard, Policy Deployment, and a Strategy and Tactics Logical Tree and underpinning everything that they do.

Top-down, middle-out or bottom-up implementation

Elisabeth Goodman also explored the pros and cons of taking a top-down, middle-out, or bottom-up approach.

This was a theme that came up in the first panel discussion.  Responses centred on “Yes, leadership can be sceptical” or “just don’t get it”, but can be brought round if they understand, or more importantly, tangibly see the benefits.  The bottom-up approach can be used to generate examples that demonstrate value and approaches.  Middle-out must not be forgotten, and here champions and change agents provide a key influence.

The theme also came up in the second panel discussion, when Karsten Benzing, Boehringer Ingelheim said that their most successful project were those driven top-down by leaders.  A further thought was that a bottom-up approach only has a finite life as “you can only do something for so long without your boss’s approval”.

Engaging leadership: senior management need to be involved

It was suggested in the second panel discussion of Day 1 that there are two levels of leadership support – passive – “I’ll let you do this”, and active – getting involved and showing commitment.

Celia Banks’ (R&D and Medical BT CI Lead, Pfizer) initial work in Pfizer was as a contractor engaged to prove the benefit of a Continuous Improvement programme to a sceptical leadership (they were unsure how a “manufacturing programme” could be applied in R&D).  Some pilot projects were carried out, ensuring that they tied in to a strategic imperative, and the necessity of top-down support identified.  Celia also recommended the use of Nemawashi with senior management i.e. introduce ideas step-by-step (and involving them in developing), and not going to them with a packaged solution.

Engaging staff: it’s about improving people’s lives at work

The first panel discussion on day 1 included the theme of engagement of staff.  Delegates and panellists discussed the importance of using simple language, giving recognition, and ensuring that people’s lives improve.  The word “humility” was used in the context of recognising that managers “are non-value-adding” and that their role should be to ask questions and facilitate and look for their people to provide answers.

Chris Christodoulou, Head, Laboratory Compliance, MedImmune came back to this theme in his presentation when he described how Operational Excellence is introduced to new employees during induction, and yellow belt training is available to everyone, with a target of >80% take-up.  There is an emphasis on communicating successes to show measurable result, and showcase projects including small yellow belt projects.  All projects are expected to deliver tangible benefits.

The underlying message of his various case studies (management of consumables in the lab, analytical process simplification, 5S of the fridge, templates for writing up, and eliminating duplicate HPLC testing ) was to “do simple projects to make peoples’ lives easier and happier, and make things work better.”

The value of training everyone: organise training so that it is utilised immediately

The second panel were asked about the value of training everyone.  Chris Christodoulou said that this would result in everyone talking the same language and plant seeds [i.e. it’s part of the culture change].  David Hampton, Rath & Strong, “controversially” pointed out that training itself is non-value adding and that green and black belt training needs to be integrated with a project and support.

Celia Banks described how specific training was devised for Continuous Improvement leads – on-demand, on-line, rather than as a block in a classroom.

Charles Aubrey, Vice President Performance Excellence, Anderson Pharmaceutical Packaging, echoed the approach of integrating training into application. Their programme was initiated through 4 days of training with the Leadership Team (to create understanding) then a pilot project was carried out in order to get buy-in.  From there a comprehensive programme developed with the aim of everyone in the organisation having a role e.g. Yellow belts objective was to improve the way they work (they defined the 8th of Ohno’s wastes as that of the human mind).

The role of black belts

Martin Conroy was the first to raise the role of black belts in organisations.  He referred to them as experts parachuted in “behind enemy lines” and described the challenges that they face the biggest one being the need for people to recognise that continuous improvement is not about these experts “doing things to or for you”.

A panel discussion later in the day came back to the role of black belts.  It was generally thought that they should be full-time so they are more practised in the basics and have a wider set of tools, but there were mixed views on where their expertise should be applied.  One panellist’s view was that black belts can be a “nuisance” e.g. in causing processes to be reworked unnecessarily e.g. Kanbans, to achieve standardisation across an organisation.

Using consultants: bring in someone to help kick-start programmes

There was agreement in the first panel discussion, that building internal capability is essential, but external involvement by consultants can bring in lessons learnt and play a role in mentoring senior management.

Panellists in the second discussion suggested that consultants were useful for transformational projects, although a further guarantee of the success of such projects was that they would necessarily involve senior leadership commitment.

Notes and further reading:

  1. RiverRhee Consulting enhances team effectiveness using process improvement, knowledge management and change management.  Follow the links to find out more about RiverRhee Consulting and about Elisabeth Goodman and John Riddell
  2. Business Process Excellence for Pharmaceuticals, Biotech & Medical Devices – April 2010 – Key Themes http://wp.me/pAUbH-2u
  3. John Riddell and Elisabeth Goodman ran a workshop entitled: “Communities of practice and other knowledge management techniques to implement and sustain continuous improvement”.  Please contact us if you would be interested in arranging a version of this workshop for you. http://slidesha.re/eoqKH5
  4. Elisabeth Goodman.  “Sustaining Effective Continuous Improvement In An Organisation: A Holistic View”. Presented at Business Process Excellence for Pharmaceuticals, Biotech and Medical Devices, The Brewery, London, April 2011 http://slidesha.re/h2vVhN

Operational Excellence and Knowledge Management in an R&D Laboratory Environment


Reflections from IQPC’s 6th Annual Smartlab Exchange, Berlin, February 2011

ELNs, LIMS, and LESs

IQPC kindly invited me to speak on Operational Excellence and Knowledge Management at this year’s Smartlab Exchange conference in Berlin.  Although I have been responsible for Biological Data Management and Laboratory Notebooks in an R&D environment during the course of my career, that was some time ago now, and the concept of electronic laboratory notebooks or ‘ELN’s was in its infancy, and so it was good to catch-up.

LIMS or Laboratory Information Management Systems on the other hand have been around somewhat longer so I was more familiar with these.  The application of ELNs and Laboratory Exchange Systems (LESs) in the GxP regulated Development environment is the newest of all, and both John Leonard (AstraZeneca) and Ken Rapp (VelQuest) helped give us a very good understanding of how this could (and does) work.

Getting comfortable with business language in an R&D Laboratory environment

The conference delegates were at various stages in their adoption of Knowledge Management and process improvement techniques (or Lean and Six Sigma), but had some good insights on effective change management, and so this was an interesting perspective during the course of the two and a half day programme.

Alan Foreman (Accenture) encouraged people to ‘get comfortable with business language’ such as business cases and productivity, ways to reduce cost and review operating models.  Patrick Jeufraux (Areva) gave us an interesting overview of how his organisation is bringing the support groups for process management, quality and business improvement closer together and integrating them into the business units for the various forms of renewable energy as an illustration of this.

The challenges of integration and data explosion

John Trigg (phaseFour Informatics) who chaired the conference and led one of the Think Tank sessions highlighted these 2 challenges for practitioners in the ELN and LIMS space.  We debated whether the lack of standards in Research in particular may have been a handicap in the development of IT applications, and whether increased outsourcing in the Pharmaceutical Industry e.g. through CROs (Contract Research Organisations) and Open Innovation might drive or accelerate the development of standards.

Cameron Neylon (Science and Technology Facilities Council) challenged us to ‘think like the web’.  Rather than trying to force diverse data and information into relatively inflexible databases, we should consider adopting Facebook, Amazon or Google Reader type models to aggregate the information, assuming that each item has its own unique URL.  He suggested that we could then build databases on the fly to manage questions, rather than the data.  He based his suggestions on Jon Udell’s blog Seven ways to think like the web

Workflow, process excellence and productivity in R&D Laboratories

Ken Rapp’s (VelQuest) and John Leonard’s (AstraZeneca) case studies beautifully illustrated how an understanding of processes and workflows in the lab, and an exploration of how they can be improved provide an excellent foundation for effective implementation of IT systems.  Working with lab scientists and QA they achieved increases in productivity, reductions in cycle time and lowering of compliance risks.

Chris Christodoulou (Medimmune) described how the R&D organisation in the UK and the US have adopted Operational Excellence as an enabler and a mindset for achieving Medimmune’s goals, and how Lean and Six Sigma tools such as 5S are helping them to ‘do things right first time’ and generally save time and money.

Change Management or effective implementation of ELN and LIMS

John Leonards’ case study of implementing electronic laboratory notebooks to facilitate technology transfer from Research scientists to Development Manufacturing illustrated how involving end-users to understand their issues and requirements, and then to pilot the proposed solution in an iterative way, together with engaging QA in solution development achieved 100% user acceptance as well as significant business benefits.  In a conversation with me afterwards he also described how starting with enthusiastic champions, peer influence and senior management support, together with a committed and flexible supplier also contributed to the original 100% user acceptance from Research scientists.

Gary Bouwman’s (Dow Chemical) Think Tank also drew out the many factors for success in implementation such as having clear business goals, measurable benefits, being aware of other factors that may affect implementation and the importance of having people on the team who really know the process.

Knowledge Management in the context of the R&D Laboratory

My fellow speaker, Mary Jensen (Baker Hughes), and Andrew Barendrecht (Innovation and Knowledge Consultant), between them expertly reviewed the key components for an effective KM ‘ecosystem’: people, process, content or information, technology and business or strategy (as well as compliance).  Mary Jensen gave a case study of how this applies in the oil and gas industry, whilst Andrew Barendrecht described how intelligent ‘cloud’ collaborations can operate using people in an Open Innovation and web 2.0 / web style framework.  Andrew indicated Steve Flynn’s ‘The Learning Layer’ as a good source of information for this approach.

Putting Operational Excellence, Knowledge Management and Change Management together in an R&D Laboratory context

My presentation “Applying knowledge management to operational excellence in a laboratory environment” discussed how Lean and Six Sigma could be applied to processes and the physical environment in the laboratory.  I picked up Mary Jensen’s knowledge ecosystem themes to show how Knowledge Management can contribute to the success of Operational Excellence, and also conclude with the Change Management related critical success factors for implementation.

 

Notes

  1. Elisabeth Goodman is Owner and Principal Consultant at RiverRhee Consulting: enhancing team effectiveness using process improvement, knowledge management and change management.  Follow the links to find out more about RiverRhee Consulting, and about Elisabeth Goodman
  2. For an overview of electronic laboratory notebooks and how to implement them see John Trigg’s “Getting started with an Electronic Laboratory Notebook”, Scientific Computing World and phaseFour Informatics, 2011