The document provides a work plan for ESR10, a fellow working on the DECIDE project, which aims to develop more potent forms of Vitamin D3 that are extremely active against leukemia cells. Over three years, ESR10 will conduct chemistry to produce Vitamin D3 compounds, analyze their structures, test their binding and activity against leukemia cells, and select the most potent compound. The plan also includes training objectives for ESR10 to develop skills, participate in workshops, and receive supervision.

1. Unveiling the Unforeseen
Collaborative Risk Management of
the DECIDE Project
Martin Smith
Commercial and Legal Management Director
High Point Rendel Ltd
12/11/2013

3. EXTRACTS FROM ANNEX 1, THE FUNDING CONTRACT
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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.

4. The Scientific Method

5. What is PRINCE2?
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PRINCE2 (an acronym for PRojects IN Controlled Environments) is a de facto process-based
method for effective project management.
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Used extensively by the UK Government, PRINCE2 is also widely recognised and used in the
private sector.
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The PRINCE2 method is in the public domain, and offers non-proprietorial best practice
guidance on project management.
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Key features of PRINCE2:
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Focus on business justification
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Defined organisation structure for the project management team
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Product-based planning approach
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Emphasis on dividing the project into manageable and controllable stages
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Flexibility that can be applied at a level appropriate to the project

6. Risks in Global Scientific Research Projects in addition to all the features of
a simpler scientific research project
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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.
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7. 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

8. 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.

9. Risk Register
Identified
Risks
1.
…
n.
Comments
Probability Impact Urgency
Risk
Owner
Response
Strategy

10. ESR 10
Fellow
Host institution
Duration
Start date
ESR10
PRI
36 months
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: Y
Objectives: ● 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 D 3 sensitizing agents,
miRs
Results: ● 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)

11. Work Plan
Project Workplan
1st Year
Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14
SCIENTIFIC
ERS10
3rd Year
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
Start Date End Date Duration
To develop forms of Vitamin D3 that are extremely
active against Leukemia cells
2nd Year
Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15
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
To check compounds bind to the intended target
molecule (Vitamin D3 receptor)
To select a compound that is most active than the
ERS10-SD5
starting structure against Leukemia cells
Completion Statement: We now have a more
potent drug
ERS10-SD4
01/05/2015 31/08/2015 4 months
01/09/2016 31/08/2016 1 Year
TRAINING
Supervisory Board/Training/Lead Supervisors
Requirements
Visits to other institutions and secondments to
ERS10-LA2
transferring and acquiring technological knowledge
ERS10-LA1
Every six months
Every Year Jun-Aug 1-2 months
ERS10-LA3 ITN Training
Every Year Sept-Nov
ERS10-LA4 College/Graduate School Training
Every year in October 1 week
Completion Statement: Meet Training objectives
TO1-TO6
PERSONAL CAREER DEVELOPMENT PLAN
ERS10-CDP1 Develop and update
ERS10-CDP2 Acquire mentoring relationship
1 or 2 months only
1 week only
1 week
1 week
1 or 2 months only
1 or 2 months only
1 week only
1 week only
1 week
1 week

12. Project Workplan
Sep-13
SCIENTIFIC
Start Date
ERS10
To develop forms of Vitamin D3 that are extremely
active against Leukemia cells
01/09/2013 31/08/2016
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
ERS10-SD3
Nov-13
3 Years
To check that the chemical structures are as expected 01/01/2015 30/04/2015 4 months
To check compounds bind to the intended target
molecule (Vitamin D3 receptor)
To select a compound that is most active than the
ERS10-SD5
starting structure against Leukemia cells
Completion Statement: We now have a more
potent drug
ERS10-SD4
End Date
Oct-13
Duration
01/09/2014 31/12/2014 4 months
01/05/2015 31/08/2015 4 months
01/09/2016 31/08/2016
1 Year
TRAINING
ERS10-LA1
ERS10-LA2
Supervisory Board/Training/Lead Supervisors
Requirements
Visits to other institutions and secondments to
transferring and acquiring technological knowledge
Every six months
Every Year Jun-Aug
1-2 months
ERS10-LA3
ITN Training
Every Year Sept-Nov
1 week
ERS10-LA4
College/Graduate School Training
Every year in October
1 week
Completion Statement: Meet Training objectives
TO1-TO6
PERSONAL CAREER DEVELOPMENT PLAN
ERS10-CDP1 Develop and update
ERS10-CDP2 Acquire mentoring relationship
1 week only
1 week
Dec-13
Jan-14
F