pharmaceutical industry project management group pipmg spring meeting... · 2015. 4. 10. ·...

Pharmaceutical Industry Project Management Group

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PHARMACEUTICAL PROJECT MANAGEMENT IN A CONSTRAINED ENVIRONMENT

How to break the chains and deliver value Chaired by: Catherine Mortlett (CMPM Ltd) Stephen Clegg (GE Healthcare, Bio-Sciences) Janette Thomas (AccentBio Ltd)


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Executive summary We live in an ever changing and demanding world in which the business environment is subject to seemingly relentless instability – and especially now with the consequences of the global economic climate. Project Managers find themselves faced with increasingly tough choices and pressures as they seek to deliver projects in often uncertain and difficult circumstances. How can a Project Manager succeed in managing these pressures, both project and personal, in an increasingly constrained environment? Using a proven mix of presentations by industry experts, the sharing of real case studies and facilitated workshops, this PIPMG meeting explored the vital contribution project management tools and techniques can make by: - • Taking a fresh look at how to balance the competing drivers of cost, quality and time when operating under constraints • Identifying the critical constraints Pharmaceutical Project Managers face and practical ways to operate within, or overcome, these constraints • Sharing practical advice and tips to help us to be more effective in our roles in areas including personal time management, and surviving reorganisation and change


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Contents PHARMACEUTICAL PROJECT MANAGEMENT IN A CONSTRAINED ENVIRONMENT....................................................................................................................... 2 How to break the chains and deliver value ............................................................................... 2 Executive summary .................................................................................................................. 3 Biographies .............................................................................................................................. 5 Project Management With the Time, Cost, Quality Triangle - Is it still the best way? .............. 6 Workshop 1: Challenges, Changes and Constraints ................................................................ 7 Navigating Uncertainty: Addressing ill-defined regulatory routes for novel biopharmaceuticals .................................................................................................................. 8 Project Management tools and techniques used to complete the Large Hadron Collider project ....................................................................................................................... 10 Workshop 2: Solutions for Success? ...................................................................................... 12 Surviving re-organisation and change? .................................................................................. 14


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Biographies Dr Martin Barnes CBE President, The Association for Project Management Martin Barnes is one of the founders of modern project management. He invented the ʻTime/Cost /Qualityʼ triangle more than thirty years ago and has been an influential figure in the emerging profession of project management ever since. He has been involved in projects in the engineering, construction, defence, media and ICT sectors as well as business projects such as mergers and acquisitions. Pharmaceutical companies he has helped with projects (using their names at the time!) are ICI, Wellcome, Glaxo, Smithkline, Beecham and Hoffman LaRoche. He is President of the Association for Project Management, the professional body for UK project managers. His current work includes a role in delivering the London 2012 Olympics projects and project management of the next generation of nuclear power plants in the UK. Tim Farish Senior Consultant, Grant Pearson Brown Consulting Ltd Tim Farish works for GPB, a leading European coaching & consulting firm who specialise in how businesses develop and grow. Timʼs background was in advertising where he worked for London Weekend Television (LWT) and Saatchi & Saatchi before changing direction and taking an Msc in Organisational Change at University of Surrey. Tim has worked with many organisations including the Metropolitan Police, Unilever and KPMG. GPBʼs pharmaceutical clients include NovoNordisk, GSK, Sanofi Aventis & Shire Pharmaceuticals. Tim typically coaches individuals and teams improving how they communicate, sell, negotiate and deal with change. He currently understands change all too well having recently opened a branch of GPB in Oslo with plans to settle down and grow the family side of his life with his Norwegian wife, Tale. In the meantime, he is managing his time between London and Oslo. Dr Chris Holloway Group Director of Regulatory Affairs, ERA Consulting Chris Holloway is Group Director of Regulatory Affairs at ERA Consulting, with overall responsibility for the companyʼs operations in Germany, London, Washington, DC, and Australia. He has worked in regulatory affairs, specializing in biotech products and other biologics, for more than 20 years, since leaving academia where he was Professor of Clinical Biochemistry at Hannover Medical School in Germany. Chris graduated in 1971 and obtained his Ph.D. in 1975, after which he held a Royal Society European Research Fellowship at the Max-Planck-Institute in Germany. He then moved into university, and was awarded the venia legendi in 1982. Chris is particularly interested in regulatory strategies for novel therapeutics/ platforms, interacting wherever possible with regulators to define expedient routes towards marketing authorizations. He has worked on more than 350 different products, contributing particularly towards approaches to manufacturing and control as well as early non-clinical and clinical development. His team has compiled dossiers, and Chris authors expert reports for European submissions. Jurgen De Jonge Software Project Management and Internal Project Management Consultant, CERN Jurgen De Jonghe holds a MSc in computer science and applied mathematics from the University of Leuven, Belgium. At CERN, he was in charge of all business processes and administrative workflow from 1992. Since 1999, he has been in charge of providing project management tools for internal use. These tools have been used to support project management in a variety of projects ranging from the ATLAS detector (the largest particle physics collaboration ever), the LHC accelerator, EGEE (the European grid project) and now for planning all strategic activities at CERN as well as future High Energy Physics projects being prepared now. Jurgen has over 15 years of experience leading a software development team for medium to large software development projects.


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Project Management With the Time, Cost, Quality Triangle - Is it still the best way? Dr Martin Barnes President, APM Project Management is about achieving objectives. The main objectives invariably relate to ʻTimeʼ, ʻCostʼ & ʻQualityʼ, which are defined at the start of a project. However, the project plan nearly always has to be modified throughout the project, since Project Management is actually all about managing ʻuncertaintyʼ rather than certainty. Examples of one constraint being dominant Fixed time - the Olympic Games or other scheduled event Fixed cost - generally rare for cost to dominate time/quality e.g. a public memorial where the deliverable requires the best quality for a fixed price, & time is of less importance Fixed Quality - this often relates to ʻPerformanceʼ rather than quality…and ʻPerformanceʼ can actually refer to many things (slide 5) NOT just ʻQualityʼ Unless there is consensus about what the performance objectives are, the end result is unlikely to satisfy all stakeholders, and will be considered a failure. Barnesʼ First Law of Project Management (Slide 9) “In every decision, choose the best option for achieving the project objectives“ All decisions affecting tasks in a project should focus on the best option for achieving project objectives Barnesʼ Second Law of Project Management (Slide 10) “You can only manage the part of the project which is still to do” Too many project meetings are ʻprogressʼ meetings to discuss past events/performance rather than future events. Dwelling on mistakes & delays, rather than focusing on solutions, is generally not constructive. Decisions are required relating to new tasks, or amendments to the plan, throughout the duration of a project. Itʼs not always the best course of action to accept the (Project) Managerʼs decision, for example if it is uninformed, and unlikely to achieve the project objectives (Slide 19). No forecast is guaranteed to be correct, so itʼs prudent to recognize this ʻuncertaintyʼ during the decision-making. Since all Project Management is management in uncertainty, EVERY meeting should consider ʻrisk-managementʼ (Slide 23). Risk management is the most important part of the project, since modifications/corrections to the original plan for the remaining work are always required in order to deliver the objectives; and each future risk should balance Performance/Cost/Time. Float should always be included in the programme, and contingency in the budget. Conclusions

• The performance, cost, time triangle is still the best way! • The best way to complete a project on time is to have a sensible amount of ʻfloatʼ

or ʻcontingencyʼ in the program. If an expedited path is required to shorten the total time is it likely to involve significantly greater cost, yet it still requires float, otherwise it will fail.


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Workshop 1: Challenges, Changes and Constraints Working in facilitated small groups, delegates identified the foremost issues they faced in delivering projects successfully, identifying common themes and root causes. Table 1 - Lack of clear objectives & priorities (poor understanding)

• Poor budgeting & planning • Insufficient training & lack of PM culture within an organization & the role of

the individuals & governing bodies • Poor (slow) decision making by senior management having a lack of

understanding of the issues • Insufficient empowerment of project team • Insufficient resources / unrealistic expectations (especially timelines) • Insufficient risk management • External considerations - changes in regulations / competitor environment

Table 3 - Resources

• Insufficient or incorrect resources to deliver project successfully e.g. (trained) staff, financial investment into facility/equipment

• External factors Table 4 - Change

• Root causes of change due to external inputs (to project) o Organisational changes / Company structure o Change of industry environment o Process changes o Regulatory changes

• Budget constraints • Changing (sponsor) priorities • Changing (unclear) objectives

Table 5 - Decision Making – involved in all aspects

• Lack of clarity/transparency on who makes the decisions? • Criteria & structure not prepared in advance • Lack of trust (by project team) • Procrastination making decisions & lack of clarity in decisions that are made • Objective setting & constraints - unclear / changing objectives

Table 6 - Over-optimism during planning phase

• Unrealistic timelines leading to distrust between management & project team (& possibly lack of commitment)

• Identifying associated risks & (undocumented) assumptions • Changing project teams • External pressures e.g. competitor announcements • Peer pressure introduced by (other) Project Leaders with (false) promises


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Navigating Uncertainty: Addressing ill-defined regulatory routes for novel biopharmaceuticals Dr Elliot Lawrence, Associate Director of Regulatory Affairs, ERA Consulting Using TGN 14121 as an example, it was highlighted how preclinical findings for novel biopharmaceuticals may not always be relevant to First-in-Man (FIM) studies, and how the mode of action needs to be considered more carefully. EMEA published guidelines following the adverse drug reactions elicited by TGN 14122 ʻBiosimilarsʼ Due to their complexity, ʻbiosimilarsʼ3, particularly monoclonal antibodies, are considered to pose a greater risk than small molecules during clinical development. The EMA published guidelines relating to such products in 2005 (Slide 15) and a concept paper was released in 2009 on the development of biosimilars containing monoclonal antibodies (Slide 17). Other ʻProduct-specificʼ guidance is also available (Slide 16). There is still yet to be any biosimilar monoclonal antibody-containing product approved in the main territories (EU, US, Japan). There are a number of technical issues to consider,

• Deamidation • Oxidation • Glycosylation - altered antibody glycosylation during scale-up (Slide 22) • Truncation • Aggregation • Acetylation

Biosimilarity for all monoclonal antibody products may not be possible. In Europe, besides immunogenicity data being essential, extrapolation (of clinical data) between indications may not be relevant. Advanced Therapy Medicinal Products (ATMP) There is currently a regulatory gap in defining ATMPs; legislation has recently been updated to include tissue engineering products along with cell therapy & gene therapy products (Slides 26-27). One of the most common mistakes that companies make is poor planning, particularly with respect to the timing of scientific advice. Presenting limited data can result in inappropriate advice and a decision to follow the wrong development path. Therefore good project management, risk management and scenario planning is essential.

1 Also known as CD28-SuperMAB, in its first human clinical trials in March 2006, it caused catastrophic systemic organ failure in the subjects, despite being administered at a supposed sub-clinical dose of 0.1 mg per kg; some 500 times lower than the dose found safe in animals. Six volunteers were hospitalized on 13 March 2006, at least four of these suffering from multiple organ dysfunction. 2 EMEA/CHMP/SWP/28367/07 Guideline on strategies to identify and mitigate risks for first-in-man human clinical trials with investigational medicinal products 3 Generic follow-on biological products made by a different sponsor following patent and exclusivity expiry on the innovator product


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National scientific advice can vary from agency to agency (Slide 35) and the advice is not necessarily binding. Some agencies offer specific product expertise (Slide 37). Within the EMA there is an Innovation Task force (Slide 40), which offers free, but informal, interaction & feedback. The pharmaceutical industry has been moving away from more traditional small molecules to biological product development. However, it remains to be seen whether biosimilar development continues to be pursued or whether, due to the bespoke pre-clinical/clinical requirements & their related costs, they become less desirable.


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Project Management tools and techniques used to complete the Large Hadron Collider project Jurgen De Jonghe, Software Project Manager and Internal PM Consultant, CERN CERNʼs Large Hadron Collider was funded by and built in collaboration with over 10,000 scientists and engineers from over 100 countries as well as hundreds of universities and laboratories. http://public.web.cern.ch/public/en/lhc/lhc-en.html It has received a lot of attention (a subtle mix of fact and fiction) over the past 18 months since the proton beams were successfully circulated in the main ring of the LHC for the first time (10 September 2008) but nine days later, operations were halted due to a serious fault between two superconducting bending magnets. Repairing the resulting damage and installing additional safety features took over a year. On 20 November 2009, the proton beams were successfully circulated again, with the first proton–proton collisions being recorded three days later at the injection energy of 450 GeV per beam. The LHC became the world's highest-energy particle accelerator on 30 November 2009, achieving a world record 1.18 TeV per beam and surpassing the record previously held by the Tevatron at Fermilab in Batavia, Illinois. After the 2009 winter shutdown, the LHC was restarted and the beam was ramped up to 3.5 TeV per beam, half its designed energy, which is planned for after its 2012 shutdown. On 30 March 2010, the first planned collisions took place between two 3.5 TeV beams, which set a new world record for the highest-energy man-made particle collisions. Stable beam mode has been achieved for 30 hours and around half a billion collisions to date. Some of the challenges constructing the LHC were described (Slide 33). An EVM (Earned Value Management)-based project control system was used (Slide 7), based on planned value PV), earned value (EV) and actual cost (AC), producing a cost variance (CV). EVM doesnʼt consider critical path, so it shouldnʼt be used as a stand-alone for project control. However, it does allow up-front predicting as well as ad hoc reporting, and typically identify problems of (cost)-overrun early. It took 4 months to upload data for EVM (first baseline) & had to be re-worked after 12 months. Nevertheless, the use of EVM significantly contributed to the credibility of the PM team when discussing the project, which was deliverable-orientated, based on physical progress reporting. Note: Payment milestones of result-oriented contracts refer to effective deliveries (and finish dates of activities are always known!). Key Learnings (Slides 13-14) The LHC project was introduced at CHF 1 billion

• Initial implementation & maintenance was a challenge, and planning a nightmare, but the EVM system helped manage a large number of activities (>12,000), which would otherwise have been extremely difficult, if not impossible

• Use of EVM provided a credible basis for the project • Weak integration with schedule networks • Project engineers planned too optimistically


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• Deliverable-orientated approach revealed to be efficient • Strong Project Leader support essential

Linear & Repetitive Scheduling Methods

• Excellent companions to EVM If repetitive activities have different production rates, a production rate imbalance will negatively impact on the project, causing,

• Inefficient utilization of resources (PERFORMANCE)/ excessive costs (COST) & work stoppages (TIME)


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Workshop 2: Solutions for Success? The objective of this workshop was to generate and share practical solutions to the problems identified in workshop 1 (above). Each table was given 2 of the foremost problem statements from the 1st workshop, with delegates asked to identify possible solutions e.g. tools and techniques, ways of working. Table 1 Projects can seem to be victims of their circumstances, senior management decisions, budget changes etc. For project teams to be effective what is the balance between being given empowerment and taking charge themselves? What can teams do to be more empowered?

• Good governance, Project Charter • Clarify expectations • Clarity of roles, responsibilities • Clear systems/process to communicate to management – what is the

impact/action/solution? • Transparent culture

Table 4 There can be a lack of clarity over who can make what decision & when. What are the secrets to ensuring good decision-making by senior management? How can teams get a clear understanding of relative priority & what does that mean to the team?

• Prepare! Circulate sufficient information on time & ensure it is accurate & contains appropriate substance

• Clear communication; define ʻpriorityʼ in relation to resources/funding etc. • Transparency - ensure process is clear & changes conveyed promptly & clearly

Tables 1 and 4 Project teams can lack control of resources and funding to deliver projects due to internal competition between projects, functional allocation of resources, changes in budget being imposed. How can teams proactively manage the uncertainty in resources and budget in order to deliver the project? Reflect on T C P triangle.

• Portfolio planning • Prioritisation • Sub-contracting

Table 3 There can be a lack of trust and relationship between senior management and project teams. How can you build, & re-build, trust? Consider stakeholder management, getting credibility in the plan etc.

• Know the stakeholders - who they are, their character & influence • Build confidence, and relationships, early & nurture them by getting to know

individual interests, concerns & expectations


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Your project team is not working effectively; how do you fix a dysfunctional team?

• Team facilitation & effectiveness events • Re-confirm roles & expected contributions to the project • Communication - building trust requires accurate information

Table 5 Teams often consider project plans to be imposed rather than realistic. How do you obtain mutual trust between senior management and teams in order to achieve credible and realistic project plans? Discuss defining the plan - good practice and the opportunity to manage change.

• Clarity of Governance - Committee to meet at set times in project lifetime • Functional Team representative • Regular interaction between Management & Project Team (transparency) • Clear scope of project – timelines, budget, performance

Establishing a project culture can be a large change; it can involve implementing new tools, techniques and ways of working. What is critical to success to make the change from the line structure to a project structure? What will be you priorities?

• Communicate the value of a ʻProject-basedʼ approach • Identify roles & responsibilities • Strong sponsor/mentoring input required from senior management

o Clarify business needs o Communication

Table 6 Unclear & changing objectives make it difficult for the project team to understand what is expected of them. In a changing environment how can you establish & maintain clear & consistent objectives?

• Ensure a strong/clear business case & develop into a project charter • Challenge the business case to ensure understanding • Kick-off meeting, defining roles/responsibilities • Manage change • Empowerment of PM important • Communication • Process for change control • Courage to reject change • Risk management • ʻOpenʼ culture to allow team members to share information & make suggestions • Recognise which method of communication different individuals prefer – email,

phone, mail Change is inevitable in Pharma projects. However the nature of the change may not be predictable. What are the characteristics of a project team that are good at anticipating and reacting to change. What are the tools and techniques that can be used?


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Surviving re-organisation and change? Tim Farish, Grant Pearson Brown How do organizations manage change? (Slide 2) What tools are available to companies to avoid defaulting to a less elegant approach because of time and cost constraints?

• Education & Communication • Participation & Involvement • Facilitation & support • Negotiation & agreement • Manipulation & Co-option (Key opinion leaders) • Explicit & implicit coercion

The most effective organizations try to carry out all 6 but in reality they often resort to just 5 & 6 because they donʼt have time to do 1-4. What is change?

• Often defined as ʻThings we donʼt likeʼ; things we ʻdoʼ like are considered progress, or improvement

How do we respond to change? • Things we donʼt anticipate are a challenge • Things we predict (& manage) are less of a challenge

How do employees react to change? Employees at all levels should understand the phases of change and human reactions/emotions associated with each phase (Slide 4). Scott and Jaffe (1988) identified four phases of response to change: Denial Resistance Exploration Commitment Each manifests specific behaviours and emotions of those facing change The mindset (Slide 7) Rather than being too focused on any particular, one, there needs to be a balance between ʻselfʼ, ʻothersʼ & ʻcontextʼ e.g. consider in the context of a current project, how are/were energies focused? What have been the learnings / what needs to be changed moving forward? The most ʻableʼ people can usually shift their attention/purpose. We commonly become too task-focused, particularly when under stress, when we should probably treat work issues more like ʻlifeʼ issues. Tips4 1. Find a buddy/mentor 2. Create a list 3. Familiarise quickly 4. Consider others 5. Focus on one thing at a time - too much multi-tasking can be a bad thing 6. Exercise patience with yourself 7. Ask productive questions –ʻ how?ʼ Rather than ʻwhy?ʼ 8. Take control – Action 9. Donʼt get too comfortable 4 http://www.pwc.com/gx/en/pharma-life-sciences/index.jhtml

pharmaceutical industry project management group pipmg spring meeting... · 2015. 4. 10. ·...

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