Project Planning and ManagementRoger Tatoud, Ph.D.

Senior Programme ManagerInternational HIV Clinical Trials Research Management OfficeImperial College London

DPFS/DCS Workshop: 15 February 2013

Introduction

• Background• From Bench to Bedside• Project Management

• Why Project Management• Management Structure• Planning

• Gantt Chart• Setting Milestones

• Risk Management• Project Monitoring

• Budget and MRC T&C• Your Project Manager

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Background

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Translational Medicine as a Linear Path

Basic resear

ch

Prototype

Discovery &

Design

Pre-clinical Develop-ment

Early clinical trials (I/II)

Late clinical trials (III/IV)

Regulatory

approval

Marketing

Post market

ing compliance

Patient

DPFS/DCS

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Translational Medicine as a Mosaic

5

Systemic overview

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What to do? Where to Start?

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... Project Management is here to help!

• Poor definition of objectives• Inadequate resources

• Poor team and capacity issues• Poor communication• Lack of a cross functional team• Resistance to change

• Lack of top management commitment• Poor leadership• Poor baseline management

• Poor planning and control• Technical problems not resolved• Failure to anticipate problems• Too many uncontrolled changes• Lack of customer/user involvement

Why Projects Fail?Adapted from HANDBOOK OF PROJECT MANAGEMENT © Trevor L Young January 2003

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Leadership

Team Work

Management

• Assumed competency• Specification (scope) not specific

• What are we doing?• Who does what and when?

• Lack of individual commitment• Resistance to change

• “I’ll do it my way” (great song, poor management)• The feeling that planning is an unnatural act

• “I don’t work like that”• Over-optimism supported by our keen ability to

underestimate everything• Bérézina Complex: “We will cross that bridge when

we reach it”

Why Projects Fail? Being Human

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1. Control scope and manage change2. Deliver project results on time and on budget3. Focus the project team on the solution4. Obtain project buy-in from disparate groups5. Define the critical path to optimally complete

your project6. Provide a process for estimating project resources,

time, and costs7. Communicate project progress, risks, and changes8. Surface and explore project assumptions9. Prepare for unexpected project issues10. Document, transfer, and apply lessons learned from

your projects Source: http://www.bizmanualz.com

Why Project management?

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3D Approach to Project Management

ManageProcesses

Manage

Stakeholders

Manag

ePe

rform

ance

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Essential elements of Project Management

• Good management• Effective record keeping• Good filing practices• Budget management

• Good communication• On progress (looking backward)• On planning (looking forward)

• Good project planning• Identify critical path & rate limiting activities• Enable allocation of sufficient time and resources

• Good scenario planning / Risk management• Go/NoGo decision points• Be one step ahead of the game

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Project ManagementA dynamic action cycle

PHASE 1 PHASE 2

PHASE 4PHASE 3

CONCEPTION & DEFINITION

EXECUTING THE WORK

HAND

OVER

& C

LOSU

RE

PLANNING & SCHEDULING

DEFINEOBJECTIVES

PLAN THE WORK

COMMUNICATETHE PLAN

MONITORPROGRESS

REVIEW& EVALUATE

INSTITUTIONALLEARNING

PHASE 0 SELECTION

OpportunitiesIdentified

Adapted from HANDBOOK OF PROJECT MANAGEMENT© Trevor L Young January 2003

Redefine

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SC

eGroup

PMG

TMG

• Don’t recycle old management structures• Identify the needs of the project…• Bring together people that can contribute to issues

arising in the project through…• Groups that will meet and communicate regularly.

The Project Management Structure

Research

Stats

Regulator

Finance

Clinical

Database

Admin

Comm.

IP

Research Regulator

Clinical

Database

IP

IndustryIndustry

Contract

Contract Finance

Stats

Strategy

Comm.

Admin

Strategy

Operation

The Project Management Group

Principal InvestigatorStrategic focus

Project ManagerOperational focus

Project Management GroupExperienced team members responsible for other roles

PM+PI(PMG)

Industry

Regulators

Clinical

Researchers

Funder

University

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Choosing a Project Manager

• Appointed and involved at an early stage• Central point of contact for Project Team and

Stakeholders• Empowered to do his/her job

• Good organisation skills• Good communicator• Flexible, creative, resilient• Multitasker• Show initiative – know what (s)he knows and doesn’t• Think globally, act locally

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Project Planning • First you need a plan!

• A good project plan should monitor:• Timelines• Milestones• Budget• ResourcesProgress

• Identify critical path / rate limiting activities• Enable allocation of sufficient time and resources

• Project plans are dynamic - evolve as project develops• Level of detail will depend on target audience

• The Gantt Chart...

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• A graphical method of showing a project schedule that shows project time, dates of all activities and their relationships

• For planning• For identifying dependencies• For identifying a Critical Path• For determining Milestones• For monitoring

The Gantt Chart

Too simplist

ic

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Gantt Chart - Planning of a Phase I trial

From Idea to Phase I - Manufacturing

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Milestones - be SMART

• Specific: objectives should be specific and written in clear, concise, and understandable terms.

• Measurable: measurable outcomes allow determination of delivery. Set realistic and justifiable success criteria: Target value range and acceptable (cut-off) values.

• Achievable: objectives must be aggressive but realistic – don’t be too ambitious!

• Relevant: tasks and deliverables must focus on progressing the project along an appropriate (critical) development path.

• Timely (deadlines not durations): objectives should have a realistic timeframe with an end date assigned to them.

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Be SMARTObjectives (ex: Detection of virus sequences in blood using new qPCR plateform)

• 1. qPCR primer sets capable of amplifying 15 of 16 diverse blood samples tested with a combination of the assays targeting 3 virus genes using the fluorescent detection system

• 2. The positive assays will yield a Ct of <10 and the negative control a Ct >38

• 3. The clinical isolates tested will yield Ct below background (sensitivity) and the correct positive call (specificity) on the Q-PCR platform

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Success Criteria

1. qPCR primer sets amplifies 15 of 16 diverse blood samples tested with a combination of the assays targeting 3 virus genes using the fluorescent detection system.

2. The positive assays yields a Ct <10 and the negative control a Ct >38

3. The clinical isolates tested yields a Ct below background and the correct positive call on the Q-PCR platform

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• Example: development of an ultra low viral load assay• What?• How?• Results?• Variance• Go/No Go• What’s next?

Identifying and writing milestones

M StartDate

EndDate

Month What ismeasured?

How is it measured?

What are the possible results?

(Go/No go)

Acceptablevariance

What happens then?

Worded Milestone

1 01/10/12 31/03/13 6 Sensitivity of UL VL assay

Lab assays <0.2 RNA copy/mL

10%

Proceed to Stage 2An UL VL assay with a sensitivity below 0.2 RNA copy/mL has been developed by Milestone End date>0.2 RNA copy/mL Contract Assay to

Company X.

Risk and its management

Project Schedule

Issues

RISKS

Contains inherent…

Which if theyOccur become…

Which if unresolvedimpact on…

• Identify & evaluate risks• Identify risk ownership• Mitigation• Prepare a response &

contingency plans• Continuous process• Identify early & resolve

promptly• Constraints # Risks

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• Strategic risks concern long-term strategic objectives of the project. This type of project risks affects such areas as initial project financing, technology, reputation, changes in the physical environment, etc.

• Operational risks concern issues and problems that project participants are confronted with from day to day. Mitigation of operational risks contributes to reducing of strategic risks.

• Compliance risks concern issues associated with the need to comply the project course with documented statements and regulations. Managing compliance risks lets ensure that current project activities are undertaken in the manner which project stakeholders and customers expect.

• Financial risks are associated with existing financial structure of the project and with all the transactions made to carry out the project. Identification of financial risks involves examining daily operations. Financial risks are an indicator that shows whether current project has serious implications for viability.

• Knowledge risks are associated with effective management and control of knowledge resources, communication mechanisms, and protection systems. Project knowledge risks may include abuse of intellectual property, loss of the key project staff, system malfunction, etc.

Type of risk and their estimation

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Quantifying risk – Assessing impact

• Probability of occurrence• Impact on the project• Decided by team consensus• Identified at the start• Added as required• Reviewed regularly

Impact on the project (conservative matrix)

Low Medium High

Probability

0.65 - 1.00 Medium High Not acceptable

0.30 – 0.64 Low High Not acceptable

0.0 – 0.29 Low Medium High

• HIGH: Major Impact, serious consequences. Likely to affect a Milestone, must be monitored regularly and closely

• MEDIUM: Significant impact, not expected to affect a Milestone, monitor regularly

• LOW: Not expected to have a serious impact. Review regularly for ranking

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• Progress• Risks• Finance

• Monthly PMG meeting (TMG, SC, eGroup)• Ad hoc meetings (milestones, finance)• Quarterly Reports• Milestones Reports• End of grant report

• Publications• Capacity building• Commercialisation

Project Monitoring & Evaluation

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Good Meeting Management practice• Schedule regular meetings – with reminders (use Outlook!)• Request status report (provide template!)

• Circulate agenda in advance – seek input from team members• Circulate status report and relevant papers (early enough)

• Chair meeting – keep to time (park what needs to be parked)• Start by reviewing previous Action Points– close completed APs• Identify issues requiring a decision by whom and when• Identify Action Points, their owner(s) and a due date

• Circulate minutes/actions for comment within 2-3 days• Sooner if some actions require immediate action• Finalise sign-off minutes at next meeting

• Follow up 10 days later

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• When setting budgets consider cost beyond basic research and clinics• Travel, publications, samples shipment• Regulatory support (consultants)• Regulatory meetings in response to data• Storage cost IMP (GMP)• Storage cost samples (short and long term)• Labelling, packaging, shipping• Pharmacy (equipment), set up fees (clinical site)

• Ensure grant is set up in your system and that your finance and admin people know about it

Budget and resources

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Conclusion

• Diversity• Complexity• Relationships• Dependencies• Stakeholders

Managing a Project……is managing change

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• Trevor L. YoungYoung is an expert project management practitioner and his book provides everything needed to manage a project from start to finish in a clear, concise and to the point style. Many of the templates I use are based on his work.• The Handbook of Project Management: A Practical Guide to Effective

Policies, Techniques and Processes

• Scott BerkunBerkun’s books are an everyday reminder that tools are as good as those who use them and that however good they may be, they are no magic bullet for successful project management. Berkun also debunk a number of myths about project management and challenges many management clichés (such as “thinking outside of the box”).

• Julie Warneck Protogenia Consulting Ltd

• Loic Lhuillier Translational Research Portfolio Manager King’s College London/NIHR BRC

Acknowledgement