Training Workshops in Project Management. The Project Charter or another look at Grant Proposals

Training Workshops in Project Management The Project Charter or another look at Grant Proposals SIRIC BRIO Bordeaux, 7 & 8 December 2015 Thomas Chattaway Life Science Consultant

The Trainer Thomas Chattaway Background and Experience Engineering Masters and PhD in Biochemical Engineering Over 25 years in Biotech Industries Last 10 years in Bio-Pharma Multiple Project Leadership Roles Many from «Bench to Factory» Current Consultancy Offer Where Technology, Development and Patient Needs meet Particular interest in Access to Treatments Life Science Industries, including Research Organisations, emphasis on BioPharma

Outline Project Management Concepts Refresher from previous sessions What is a Project Charter? Why do we need one? Group exercise: identify the ingredients The Project Charter WHY and WHAT? Defining the need WHERE? Positioning the project HOW and WHEN? Managing the project Application Proposal for a Project Charter Template Group exercise: mapping the template on Grant applications Setting up the coaching workshop

Refresher Concepts What is a Project? A temporary endeavour undertaken to create a unique product, service, or result (PMBOK Guide, the Project Management Institute, 2013) Examples in your experience. Relevance of Projects Research grants are applied for, in order to fund Projects, for example in translational medecine Almost all Academic Projects are funded by Grants Writing successful applications is a key activity

Refresher Need / Solution / Feasibility (workshop 4) A paradigm for translational research projects : Medical Need (Bedside) Technology Solution (Bench) Feasible Realisation (Translation) A successful project depends on: An accurate identification of the need An effective solution for meeting them A realistic plan of delivery A successful application depends on: A high priority medical need A competitive solution for meeting it A well managed execution A high potential for valorisation A Project Charter is a means of ensuring that these elements are well thought through and of convincing the sponsors

Refresher From idea to project (workshop 5) On Brief On Budget On Time

Project Life Cycle Link to from idea to project I D E A Project Charter Initiation frame P R O J E C T Management Plan Organising Planning define Deliverables Accepted Effecting realise OBOBOT R E S U L T transfert Closing Archived evaluate

Management of Large / Long Projects Project Structure Stage Gates Initiation Feasibility Proof of Concept Validation Implementation Close out At the end of each Stage (Phase) a Gate is Crossed : Go / Go with Mods / No Go Each gate is associated with standardised objectives Each Stage is a project in itself For large projects, each gate corresponds to a need for significant funding Research grants would normally cover only one Stage

Refresher The Framework (workshop 4)

Refresher From idea to project (workshop 5) Definition (What) Defining objectives Scope of activities Milestones and Deliverables Documents These notions will be revisited as we talk about the project charter Project Charter Work Break Down Structure Budget Planning Quality Plan Management (How) Work organisation Monitoring activities in time Delivering results Use of resources & budget Evaluation and Valorisation Meeting Objectives Relevance of objectives Use of ressource Process Efficiency Transfer of Results Growth in Know How

Project Life Cycle Implications for Project Management Staffing Level & Spend Project Charter Initiation Management Plan Organising Planning Deliverables Accepted Effecting Closing Cost of Changes Archived Uncertainty / Risk

Importance of Project Initiation Initiation Phase (also called Pre-Project ) Preparatory work prior to project sanction Open ended, exploratory, relatively unfocused Sometimes defined as a project in itself Often handled as off budget Tolerant to iterations Critical Activity Enables proper definition of needs / solutions / transfer Small spend rate Significant Risk Reduction Changes to scope cost relatively little at this stage Ends with Project Charter signed

Project Initiation What are we dealing with? Medical need (unmet) Diverse Stakeholders Competition Patient requirements Long road from bench to bedside Funding and Budget Cost effectiveness From Idea to Project R&D Strategy of Institution Science and Technology Defining work packages Various possible approaches Potential Collaborations Ressources for work Department Assets

Project Charter Definition (PMBOK Guide, PMI) A document initiated by the project initiator or sponsor that formally authorises the existence of a project and provides the project manager with the authority to apply organisational resources to project activities. It documents the business needs, assumptions, constraints, the understanding of the customer s needs and high level requirements and the new product / service / result that it is intended to satisfy. Authored by project sponsor with input from project manager

Project Charter Why do we need one? Benefit Provides a framework for the initiation phase deliverables Ensures essential background information has been incorporated Well defined starting point Well defined project boundaries (in scope / out of scope) Communcation document between stakeholders Function Formal record of the project and means of authorising Contract between Steering Committee / Project Team or Sponsor / Leader or Payor / Executor Provides Project Manager with the authority to plan and execute the project

Project Charter Group Exercise (15 20 min) Based on your own experience and what has been said up to now, list down all the items you believe should go in a charter Use post it notes, one per item Arrange them on the flip chart under the headings : Needs, Objectives, Valorisation Context in Which the Project is Carried out Execution and Management

Why and What? Doing the right project Defining a medical need How to identify such a need Expert clinician opinions Epidemiology and Statistics Patient Groups Literature. The medical need may not coincide with the patient need, or the societal one How to qualify the need Badly met or Unmet? Cost effectiveness? Side effects? Seriousness : life saving or simply quality of life Unit and aggregate value of providing a solution Constraints Economic, legal, ethical, political Practical: how to implement at bedside Pragmatic: does the solution have to fit in a care pathway

Why and What? Doing the right project Meeting a medical need Defining your solution What does it consist of (the basic idea and high level components) In what way does it meet the identified need Product scope: what specifications will you work to What are the deliverables of the project Why is the project worth doing? Impact on patient, care pathway, public health : what do the deliverables mean? Valorisation, including translation to bedside (see later slide) Cost effectiness of the solution once developed (difficult to estimate) Return on project investment (very difficult to estimate) Meeting the Objectives of the Call / Grant Giver Assumptions Identify the assumptions made in defining the solution or its implementation

Why and What? Doing the right project Mapping out the Stakeholders Stakeholder: An individual, group, or organisation who may affect, be affected by or perceive itself to be affected by a decision, activity or outcome of a project Who are the stakeholders of your projects? Why are they important Influencers (+ & -), sometimes control resources Source of inputs during the whole project, including for valorisation Identifying stakeholders, canvassing their views and obtaining their buy in is critical for project definition Communicating with stakeholders and managing their expectations is one of the key roles of the project manager.

Why and What? Doing the right project Valorisation Implementation Translate the deliverables into measurable health impact The most important, especially for Translational research If part of the project: specific work package(s) If not part of project: must take future requirements into account (assumptions / constraints / practicalities / risks) Industrial Valorisation and Intellectual Property Potential for taking / consolidating a patent position Essential if commercial partners needed to finalise development Scientific Benefit Publication and communication Strengthening R&D or clinical capability

Why and What? Doing the right project Valorisation Translational Research Defining the medical need Unmet or poorly met, for well identified reasons Seek input from field, KOLs, clinicians Define how the innovation would fit in the current (/disrupted) care pathway Quantify the benefits : epidemiology, costs Implementation Practicalities Reliability, robustness and simplicity of technology / intervention Patient acceptance and compliance Appeals to physicians / medical centers/ hospitals Cost and Re-imbursement issues (clinical efficacy is no longer enough!) (Pre)-Clinical Validation Plan your deliverables as the requirements for the next clinical phase Seek active input from clinicians and statisticians asap Privilege use of bio-banks and existing CT data (if possible!) Realistic view of powering tests and recruiting patients Watch out for alternative / competitive approaches Excellence of results and of project management!

Why and What? Doing the right project Valorisation Intellectual Property Why protect your innovation Guarantee exclusive use Asset : potential sale or licensing Costs: especially at extension stage Criteria for patentability Innovative >> also a criterion for grants Original >> also a criterion for grants Applicable (industrially) Publish or Protect? Not mutually exclusive Patent first, publish after

Where? The project in context Playing on your strengths Why are you well positioned to succeed? Departmental record in this clinical / translational area Scientific Excellence / Expertise / Publications Synergies with other (running) projects Leveraging strengths Access to resources: data bases, biobanks, equipment Collaborations: departmental, institutional, industrial How will these be managed if part of proposal Ability to recruit patients

Where? The project in context Is your project aligned? BRIO Strategic Matrix 6 Research programmes 7 Strategic axes

Where? The project in context Meeting Evaluation Criteria (EC Framework Call) Scientific and/or Technological excellence and its relevance to the topics addressed by the call Ambition and quality of the S/T objectives, and soundness of concept; Excellence of the research and major progress beyond the state of the art; Quality and effectiveness of the S/T methodology and the associated work plan. Quality of the participants and the consortium, and efficiency of the implementation Excellence/quality and (where appropriate) relevant track record of the individual participants (persons and teams); Excellence/quality of the consortium as a whole (including complementarity and balance); Appropriateness of the management structures and procedures; Appropriateness of the allocation and justification of the resources to be committed (budget, personnel, equipment). Potential impact on science, technology and application Contribution at the European and/or international level to the expected impacts listed in the work programme under the relevant topic/activity; Appropriateness of measures for the development, exploitation and/or dissemination of project results, and the management of intellectual property rights. 28

Where? The project in context Competition must be considered Who are your competitors? Competitive Threat Others working in the same clinical area Others working in the same technology area Others trying to access the same resources Not only about first to publish! Freedom to Operate (FTO) Patents that cover an element of technology / application foreseen to be used Can be filed (unpublished), published or granted patents Perform a Search, then keep it current Seek input from Tech Transfer Office and Patent Attorney Show Stopper for Commercial Valorisation In principle, use for non commercial application is not infringement

Where? The project in context Alternative Approaches Alternatives must be considered Almost always exist, part of the (future) clinical landscape Think beyond the box May or may not be a competive threat Position your approach wrt to these SWOT (Strenghs, Weaknesses, Opportunities, Threats) Influence on project objectives

How and When? Doing the project right. The Logical Framework Methodology Risques Sources vérification Indicateurs 32

How and When? Doing the project right. Logical Framework Applied (Euromedicat) Collection of Observations Work Break-Down Structure (WBS) A hierarchical decomposition of the total scope of work to be carried out by the project team to accomplish the project objectives and create the required deliverables.

How and When? Doing the project right. Terminology d e l i v e r y Goal / Mission Objective(s) / Outcome(s) Deliverables / Outputs Work Package / Activities The specific problem the project is aiming to solve Something toward which is to be directed, a strategic position to be attained, a purpose to be achieved, a result to be obtained, a product to be produced, or a service to be performed. Any unique and verifiable product, result, or capability to perform a service that is required to be produced to complete a process, phase, or project. The work defined at the lowest level of the work breakdown structure, for which cost and duration can be estimated and managed. p l a n n i n g Milestone A significant point or event in a project, progam or portfolio. A progress marker, can coincide with delivery of work package, deliverable or fulfilling objective. Benefit An advantage conferred by executing the project. Not part of formal project vocubulary, useful to designate a spin off of the project, rather than an objective / deliverable Definitions are from PMBOK Guide, except Goal and Benefit

How and When? Doing the project right. Project Mission In Scope of Project Charter Objectives Deliverables Main Work Packages For Project Execution Detailed Work Packages

How and When? Doing the project right. Building the Project Plan What is required in the charter Identifying key objectives and deliverables Specifying the main work packages to meet these Providing some milestones (project monitoring) Logic of articulation must be made transparent What could go wrong: Constraints / Assumptions / Risks Still a lot of uncertainty for execution Avoid overspecification Use judgement for estimating resource & duration Detail will come during execution Only very simplified GANTT chart

How and When? Doing the project right. Resources Normal running resources People s time (FTEs) Equipment and Consumables Hired Services Competences Internal >> Project positioning External : Collaborations >> Management thereof Resources for Clinical Validation Special case: samples, trial data, patients Privacy protection, Consent, Ethical Committee Powering test sets or clinical trials appropriately May identify new stakeholders / collaborators Identify the most critical resources or relations for the project

How and When? Doing the project right. Budget Budget is required in order to Demonstrate the project is realistic Make a decision on funding Monitor the project during execution Requirements and constraints vary by type of grant application Building the budget From the resource requirements Special attention to additional and external spend Pay attention to budget profile Time lines are built at the same time as they can depend on budget profile WBS and Time lines for each package leads to a simple GANTT chart

How and When? Doing the project right. Risk Management R& D is inherently risky Result is by definition only known after the work is done Yet experience and judgement allows risk levels to be ascribed Other risks can also affect a project Dependency on external factors (collaborations, patient recruitment, access to equipment) Risk Management: Risk identification Risk quantification : Likelihood and Impact Risk mitigation: predefined actions should event occur Mitigation plan is advisable if Likelihood or Impact is High

How and When? Doing the project right. Roles and Responsibilities Roles Sponsor / Champion Steering Committee Project Leader / Manager Core Team Supporting Team Stakeholder Responsibilities Identifies the need and defends the project in the institution Ensures that the project is adequately resourced Supports the project leader and indirectly the project team Can also be the end customer and financer ; this is not usual for academic projects Represents the interests of the institution / of stakeholders Approves significant changes to project scope or execution Responsible for managing a portfolio of projects; as such balances resource allocation Ensures project execution is conform to expectations and intervenes if not Most members are stakeholders in the project Leads the team responsible for the project execution Accountable to the project sponsor for time, cost, quality of project Reports progress and issues to the Steering committee Ensures the different elements of the project are integrated Communication towards the stakeholders Defining, managing and executing the main workpackages Report in a project sense to the project leader The extended team includes all those involved in at least one workpackage Provide indirect or functional support to the project Eg : analytical lab management, IT, Quality, other services In general stakeholders have interests in the project, not necessarily responsibilities Many of the other roles listed are stakeholders and as such have responsibilities

Project Charter Template 1 Statement, Background, Definition Project name: Project Champion: Project Mission Statement Charter issued xx /yy/ 2016 One or two line description of project & goal(s). Project Background 1. Background: to the problem and to the solution proposed Description of the medical need, its context and why the proposed approach would address it 1. Background: literature and competitive landscape Focus on the literature to support the approach, discuss direct competition and alternative approaches to the same problem. Relevant patents may also be included here. Project Definition 1. Objectives and Deliverables The main purpose(s) of the project and the main outputs that can be expected The important specifications the output has to meet The strategic alignment of the project (especially to the objectives of the general call) can be included here 1. Project set up and Components The outline structure of the project (especially relevant in case of collaborations) and the main elements that need to come together for success. Their articulation should be explained 1. Competitive Advantage Why are the involved teams well placed to succeed in this area and approach

Project Charter Template 2 Valorisation, Work Packages Project Valorisation 1. Impact What is the predicted patient benefit How is it proposed to make that effective (during or after project) Cost effectiveness to be included here, if possible 1. Intellectual Property / Industrial Valorisation Potential for patentability ; existing relevant patents (owned or not); Freedom to Operate, must be covered 1. Publication and Communication Internal and external channels foreseen Project Work Packages 1. List work-packages and explain how they are articulated together, if necessary. Milestones are listed below (key milestones). These may or may not coincide with work-package completion 2. 3. In Scope: Make explicit the elements included in project (especially if not obvious) Out of Scope: Clarify the elements not included in the project

Project Charter Template 3 Evaluation and Milestones How success will be measured: KPI Current Goal What will be measured Key Performance Indicator Value at start of project Value by end of project Benefits of success This recapitulates both how the project will be valorised, other key deliverables and additional indirect benefits (list the items as bullets) Key Milestones Target Dates for completion Actual Status Comments:

Project Charter Template 4 Risk Management Constraints identified Assumptions Impact on Project or Outcomes Resulting risk to the project Challenges/Risks Impact Occurrence Risk level Identify the main risks to the project s execution H / M / L H / M / L H / M / L Risk Mitigation Approach: (one paragraph at least for each medium / high risk item)

Project Charter Template 5 - Organisation Communication (include main stakeholders in to whom and add lines if needed) What To whom When Who How Project updates Task updates (for each task) Reviews, incl interim report Project team Name(s) Utilization Start End Project leader Project (optional) facilitator Team members (can be restricted to core team members) Other support needed Approval Name Signature Date ( Project Sponsor) (Project Lead) (Steering co members)

Project Charter Template 6 - Appendices Appendix 1: Details of Work Plans / WBS Appendix 2 : GANNT Chart Appendix 3 : Budget

Charter Template Group Exercise From Charter to Grant Application (30 min) Assume that you have a completed Charter for a given project Consider the Grant Application template assigned to you Map the Project Charter onto the Grant Application For each section of the grant application, identify where the information resides in the project charter Are any sections missing (cannot fill the grant template)? Is any information not used (not required in the grant template)? The Project Charter is a Universal Grant Application: Discuss Prepare to share your findings with the group

Grant Application Workshop Each participant to come with: A grant application you need to complete (ideal) A project you are working on, to use as a case study An idea for a possible future grant application Sharing a topic between 2 (3) people is OK Apply learning to develop a charter / proposal, focus on Translation: Addressing the medical need Competitive landscape and FTO Defining the Work Packages (WBS) Other topics you require help on (optional) Prepare to share your results on one of these points (5 min) Prepare an action plan for making use of the learning

Additional Material

Glossary / Definitions from Project Management Body of Knowledge, PMBOK Guide, 5th edition, PMI (2013) Benefit: An advantage that something gives you; a helpful and useful effect that something has (Oxford dictionnary on-line) Critical Path: The sequence of activities that represents the longest path through a project; it determines its shortest possible duration. Deliverable: Any unique and verifiable product, result, or capability to perform a service that is required to be produced to complete a process, phase, or project. GANTT Chart: A bar chart of schedule information, where activities are listed on the vertical axis, dates on the horizontal one and activity durations are shown as horizontal bars placed according to start and finish dates. Milestone: A significant point or event in a project, progam or portfolio.

Glossary / Definitions from Project Management Body of Knowledge, PMBOK Guide, 5th edition, PMI (2013) Objective: Something toward which is to be directed, a strategic position to be attained, a purpose to be achieved, a result to be obtained, a product to be produced, or a service to be performed. Phase (stage) Gate: A review at the end of a phase, in which a decision is made to continue to the next phase, to continue with modification or to end a project or program. Project (def): A temporary endeavour undertaken to create a unique product, service, or result. Project Charter: A document initiated by the project initiator or sponsor that formally authorises the existence of a project and provides the project manager with the authority to apply organisational resources to project activities. It documents the business needs, assumptions, constraints, the understanding of the customer s needs and high level requirements and the new product / service / result that it is intended to satisfy.

Glossary / Definitions from Project Management Body of Knowledge, PMBOK Guide, 5th edition, PMI (2013) Project Phase: A collection of logically related project activities that culminates in the completion of one or more deliverables. Sponsor: A person or group who provides resouces and support for the project, program, or porftfolio and is accountable for enabling success Stakeholder: An individual, group, or organisation who may affect, be affected by or perceive itself to be affected by a decision, activity or outcome of a project. Work Break-Down Structure (WBS): A hierarchical decomposition of the total scope of work to be carried out by the project team to accomplish the project objectives and create the required deliverables. Work package: The work defined at the lowest level of the work breakdown structure, for which cost and duration can be estimated and managed.

13 Knoledge Areas Project Management Tools (adapted from PMBOK Guide, PMI) Initiating Planning Executing Monitoring & Controlling Closing Integration P. Charter X X X X Scope X X Time X X Cost X X Quality X X X Human Ressources Communications X 5 Process Groups X X X X Risk X X Procurement X X X X Stake-Holders X X X X X denotes specific processes for each knowledge area