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

Comments

Probability Impact Urgency

Risk
Owner

Response
Strategy
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)
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
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

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Project management and unveiling risks

  • 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 • • • • • • • • • • 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.
  • 5. 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
  • 6. 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. • • •
  • 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.
  • 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