Unveiling the Unforeseen Collaborative Risk Management of

the DECIDE Project Martin Smith

Commercial and Legal Management DirectorHigh Point Rendel Ltd

12/11/2013

EXTRACTS FROM ANNEX 1, THE FUNDING CONTRACT

• B.3.1.1 Structure of the training programme and objectives at the consortium level

• We aim to develop a cohort of Europe’s best young researchers to be, first and foremost, purposeful thinkers who aspire to solve a major scientific problem who will then translate this new understanding into solutions to medical needs.

• • First, is to ensure that finished ESRs are highly skilled scientists: proficient in a

variety of technologies and able to cross scientific disciplines. • • Second, is to ensure that ESRs acquire entrepreneurial aspirations coupled to the

skills required to work across academia and industry and forge valuable links.:• • B.3.1.2 HPR-led GRSCs will train ESRs to manage timelines to deliverables and

to assess risks.

• B.3.1.6 HPR will deliver high-level management training - GRSC1: Management: Governance and GRS2: Management: Project Delivery - allowing ESRs to consider business as a career. Management training will be new at participants’ universities.

•

The Scientific Method

What is PRINCE2?

• PRINCE2 (an acronym for PRojects IN Controlled Environments) is a de facto process-based method for effective project management.

• Used extensively by the UK Government, PRINCE2 is also widely recognised and used in the private sector.

• The PRINCE2 method is in the public domain, and offers non-proprietorial best practice guidance on project management.

• Key features of PRINCE2:

• Focus on business justification

• Defined organisation structure for the project management team

• Product-based planning approach

• Emphasis on dividing the project into manageable and controllable stages

• Flexibility that can be applied at a level appropriate to the project•

Risks in Global Scientific Research Projects in addition to all the features of a simpler scientific research project

• ;-

• complexity, • geographically diverse • projects where facilitation may be uncertain, • where thinking patterns and motivation interfere with the teamwork necessary for

the project because of cultural differences– as between different nationalities– and between those working in an academic, as compared with a commercial

environment • ‘cock ups’, people and organisational failures. • Contain interdependencies between activities that affect producing results. That

means a problem in one individual research component project may cause problems in another individual research component project

• The deliverables promised by the proposer to the funder for the scientific man time in the Agreement may not be achievable because of optimism bias in the proposal.

RISK FOCUSSED MANAGEMENT PROCESS

STUDY THE PROPOSAL;

UNDERSTAND THE CONTRACT;

UNDERSTAND OUR OBLIGATIONS AND

CONSEQUENCES OF FAILURE

SET OUT METHODS

AND PROGRAMME AT HIGH LEVEL

CONDUCT A COLLABORATIVE RISK

WORSHOP TO INDENTIFY RISKS TO PERFORMANCE AND

STRATEGIES TO AVOID OR MITIGATE

IMPACT

SET OUT METHODS AND

PROGRAMME AT DETAILED LEVEL

IMPLEMENT PROJECT;

INSTALL AN INFORMATION MANAGEMENT

SYSTEM TO COMPARE ACTUAL

ACHIEVEMENTS TO PLANNED

Donald Rumsfeld, USA Secretary of Defence, on the absence of evidence for the supply of weapons of mass

destruction to terrorist groups 2002

• Reports that say that something hasn't happened are always interesting to me, because as we know,

• There are known knowns; there are things we know that we know.

• There are known unknowns; that is to say, there are things that we now know we don't know.

• But there are also unknown unknowns – there are things we do not know we don't know.

Risk Register

Identified Risks Comments Probability Impact Urgency Risk

OwnerResponse Strategy

1.

…

n.

ESR 10Fellow

ESR10

Host institution

PRI

Duration

36 months

Start date

M1 Project title: Vitamin D3 analogs with more Potent Anti-Cancer Potential WP2

Supervisors names: Kutner and Marcinkowska (UWroc), with Studzinski (UMDNJ) or someone with similar expertise

PhD enrolment: YObjectives: ● search for 1,25-(OH)2D3 analogs which have sufficient anti-cancer potential if used alone ● use the convergent synthesis strategy to prepare analogs in quantity (link to work by ESR11) ● confirm identity by analytical chemistry ● screen for affinity for vitamin D receptor (an indicator of clinical applicability) ● activity against a panel of leukaemia cell lines.Tasks and methodology: Medicinal chemistry of 1,25-(OH)2D3 analogs, analytical chemistry to confirm identity and homogeneity, measurement of activity of analogs against VDR, leukaemic cell differentiation, TF technologies, use of D3 sensitizing agents, miRsResults: ● Synthesis of more potent/less calcemic 1,25-(OH)2D3s (M @ month 24) ● New analogs of 1,25-(OH)2D3s for differentiation therapy of AML (D @ month 36)

Work PlanSep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16

SCIENTIFIC Start Date End Date Duration

ERS10To develop forms of Vitamin D3 that are extremely active against Leukemia cells

01/09/2013 31/08/2016 3 Years

ERS10-SD1 Chemistry to produce a range of Vitamin D3 compouds 01/09/2014 31/08/2014 1 Year

ERS10-SD2 To produce compounds for analysis 01/09/2014 31/12/2014 4 months

ERS10-SD3 To check that the chemical structures are as expected 01/01/2015 30/04/2015 4 months

ERS10-SD4To check compounds bind to the intended target molecule (Vitamin D3 receptor)

01/05/2015 31/08/2015 4 months

ERS10-SD5To select a compound that is most active than the starting structure against Leukemia cells

01/09/2016 31/08/2016 1 Year

Completion Statement: We now have a more potent drug

TRAINING

ERS10-LA1Supervisory Board/Training/Lead Supervisors Requirements

ERS10-LA2Visits to other institutions and secondments to transferring and acquiring technological knowledge

1-2 months

ERS10-LA3 ITN Training 1 week

ERS10-LA4 College/Graduate School Training 1 week 1 week 1 week 1 week

Completion Statement: Meet Training objectives TO1-TO6

PERSONAL CAREER DEVELOPMENT PLAN

ERS10-CDP1 Develop and update

ERS10-CDP2 Acquire mentoring relationship

Project Workplan

Every year in October

Every six months

Every Year Jun-Aug 1 or 2 months only

Every Year Sept-Nov 1 week only 1 week only1 week only

1st Year 2nd Year 3rd Year

1 or 2 months only 1 or 2 months only

Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14SCIENTIFIC Start Date End Date Duration

ERS10To develop forms of Vitamin D3 that are extremely active against Leukemia cells

01/09/2013 31/08/2016 3 Years

ERS10-SD1 Chemistry to produce a range of Vitamin D3 compouds 01/09/2014 31/08/2014 1 Year

ERS10-SD2 To produce compounds for analysis 01/09/2014 31/12/2014 4 months

ERS10-SD3 To check that the chemical structures are as expected 01/01/2015 30/04/2015 4 months

ERS10-SD4To check compounds bind to the intended target molecule (Vitamin D3 receptor)

01/05/2015 31/08/2015 4 months

ERS10-SD5To select a compound that is most active than the starting structure against Leukemia cells

01/09/2016 31/08/2016 1 Year

Completion Statement: We now have a more potent drug

TRAINING

ERS10-LA1Supervisory Board/Training/Lead Supervisors Requirements

ERS10-LA2Visits to other institutions and secondments to transferring and acquiring technological knowledge

1-2 months

ERS10-LA3 ITN Training 1 week

ERS10-LA4 College/Graduate School Training 1 week 1 week

Completion Statement: Meet Training objectives TO1-TO6

PERSONAL CAREER DEVELOPMENT PLAN

ERS10-CDP1 Develop and update

ERS10-CDP2 Acquire mentoring relationship

Project Workplan

Every year in October

Every six months

Every Year Jun-Aug

Every Year Sept-Nov 1 week only

1st Year