Transcript Project Leader Authority in Pharmaceutical Discovery

Project Leader Authority in
Pharmaceutical Discovery &
Development is Inversely Proportional to
Aggregate Project Risk
James Samanen
President
James Samanen Consulting
www. jamessamanenconsulting.com
Learning
Objectives
• The differences between Discovery and
Development Project Leadership come down to the
Level of Aggregate Project Risk
• Project Leadership is no less important in
Discovery than it is in Development
• It’s just different
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Pharmaceutical R&D
Where’s the Research?
• Its all research whether it’s the discovery of
- a new protein implicated in viral replication, or
- a side effect in patients implicating a new potential
indication.
• To investors its all research prior to Phase III.
• There is so much Research in Development, we call
it Discovery & Development
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Discovery vs.
Development
Discovery - early research leading to discovery of a biological
target, first agents (leads) which interact with the target in the
desired manner (agonist, antagonist, etc.), and clinical
candidates through optimization of properties in subsequent
analogs
Development - the focus is on a single agent.
Target Discovery
Target
Selection
Drug Discovery
Drug Development
Focus - Target
Focus – Clinical Candidate
Lead Discovery
Preclinical
Evaluation
Lead Optimization
Candidate
Selection
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POC
Full Development
Registration
& Launch
Product
Differentiation
Market
Access
Attrition =
1/Success
What Percent of Projects Move on to the Next Stage?
• ~25% Target Discovery projects reach Candidate Selection,
• 7% Candidates reach Launch
• 2% success overall
Stage:
% Success
Target
Discovery
Lead
Lead
Discovery
Optimization
63%
61%
Candidate
to Clinic
64%
Phase
1
Phase
2
Phase
3
Development
24.5%
Based on data from Brown, Drug Disc Today, 8, 23 2003 and “Can the
pharmaceutical industry reduce attrition rates?” I. Khola and J. Landis, Nature
Reviews / Drug Discovery 3, 711, 2004.
7%
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Launch
57% 56% 44% 60% 83%
1.8%
Discovery
Registration
How many projects
provide 1 Launch?
• Working backwards - 57 projects are needed for 1 launch
– 75% of pipeline in Discovery (43), 25% in Development (14)
Stage:
No. Projects
For 1 Launch
% Success
Target
Discovery
Lead
Lead
Discovery
Optimization
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22
36
63%
Candidate
to Clinic
61%
Phase
1
14
64%
57%
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Phase
2
Phase
3
4.5
2
Registration
1.2
Launch
1
56% 44% 60% 83%
1.8%
Cycle
Times
PreClin
Discovery
2 yrs
1.5 yrs
Ph 1 - III
6.5 yrs
– 10 year avg. cycle time from Target Discovery to Registration
Based on data from Brown, Drug Disc Today, 8, 23 2003 and “Can the
pharmaceutical industry reduce attrition rates?” I. Khola and J. Landis, Nature
Reviews / Drug Discovery 3, 711, 2004.
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Attrition-Based
Pipeline is not
scalable
• If 4 launches are needed due to future
patent expiration of marketed
blockbusters, the company would need
200+ projects in Target Discovery
- Does it have the capacity??
• Historically acquisitions made up the
difference,
- but reducing attrition and cost would
have dramatic impact on profitability.
- 10% improvement in attrition would
save $100 million dollars per drug (a)
“All it takes is one good drug”
a) FDA white paper “Innovation or Stagnation” , 2004
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The one sure thing
pays for the rest
• Even the one good drug
that got to launch, in the
beginning was no “sure thing”. In Discovery, every project
has the potential to be the next “blockbuster”. It’s the 10+
years of experimentation that prove it so.
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The one sure thing
pays for the rest
• Even the one good drug
that got to launch, in the
beginning was no “sure thing”. In Discovery, every project
has the potential to be the next “blockbuster”. It’s the 10+
years of experimentation that prove it so.
This drug pays for all of this
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The one sure thing
pays for the rest
• Even the one good drug
that got to launch, in the
beginning was no “sure thing”. In Discovery, every project
has the potential to be the next “blockbuster”. It’s the 10+
years of experimentation that prove it so.
This is why Discovery
Project & Portfolio
Management Is Important
This drug pays for all of this
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D&D is the
removal of Risk
• At the start of a project, the risk that any aspect of it will
succeed is unknown
• All of the potential project risk is loaded at the beginning –
Aggregate Project Risk
• Every experiment is designed to answer one question about
whether the target and related compounds will work against
a disease. There is a risk that any experiment will fail.
• If the experiment is a success, that particular risk is
eliminated and the probability of success is increased.
Risk
POS
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Project Risk Mgmt –
Increase POS
• “Risk Management is the systematic process of identifying,
analyzing, and responding to project risk. It includes maximizing
the probability and consequences of positive events and
minimizing the probability and consequences of adverse events to
project objectives.”
– Project Management Book of Knowledge (2000+)
Risk
POS
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Project Risk vs.
POS, Cost
• As the project team works to reduce Aggregate Project Risk,
• The project POS increases, and
• The total project Cost increases,
Cost
Risk
POS
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Project Risk vs.
POS, Cost, Value
•
•
•
•
As the project team works to reduce Aggregate Project Risk,
The project POS increases, and
The total project Cost increases, but
Because the POS increases, the “anticipated” value of the
project increases,
Value
Cost
Risk
POS
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Project Risk vs.
POS, Cost, Value
and Commitment
•
•
•
•
As the project team works to reduce Aggregate Project Risk,
The project POS increases, and
The total project Cost increases, but
Because the POS increases, the “potential” value of the
project increases, and
• Corporate commitment increases.
Commitment
Value
Cost
Risk
POS
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Goal to Reduce
Risk & Increase
Value
• At each stage of Discovery and Development, work is
performed to reduce aggregate project risk and increase
“potential” value.
Commitment
Value
Cost
Risk
POS
Drug Discovery
Target
Discovery
Target
Selection
Lead
Discovery
Drug Development
Lead
Optimization
Preclinical
Evaluation
Candidate
Selection
POC
Full
Development
Product
Differentiation
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Registration
& Launch
Market
Access
Influence of
Line Managers
• Project leader authority is influenced by line managers
Influence of Line
Managers on Project
Functional
Weak Matrix
Strong Matrix Projectized
High
Med.
Low
None
Management
of
Projects
No
Part- time
Full-time
Coordinator Coordinator Coordinator
None
Full-Time
Project
Leader
Project Leader Authority
Project
Mgmt
Office
Autonomous
Team
High
Section 1.9.1 in The Standard for Portfolio Management, 2nd Ed. P. 17, Project Management Institute, 2008. See also Section 2.4.2
“Organizational Structure”, p. 28-32, in A Guide to the Project Management Body of Knowledge, Project Management Institute, 4th
Edition, 2008.
Influence of
Line Managers
• Project leader authority can vary dramatically according to
the impact of the project on the corporation
Commitment
Value
Cost
Risk
POS
Influence of Line
Managers on Project
Functional Weak Matrix
Strong Matrix Projectized
High
Med.
Low
None
Management
of
Projects
No
Part- time
Full-time
Coordinator Coordinator Coordinator
None
Full-Time
Project
Leader
Project Leader Authority
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Project
Mgmt
Office
Autonomous
Team
High
Influence of
Line Managers
• In Pharma, Project Leader authority and effectiveness tends
to increase from early Discovery to final Drug Development
Influence of
Line Managers
• The lines tend to control resource in Discovery and early
Development. In late Development the projects control
resource
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The Triangular
Relationship
• There is a triangular relationship between line departments,
the project leader and portfolio management, focused on the
project team
Line
Functions
Project
Leader
Project
Team
Portfolio
Management
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Project Leaders as
Matrix Managers
• When there are many projects, each competes for resource
from the various line departments
Line A
Line B
Line C
Project 1
Project 2
Project 3
Project 4
Project 5
Project 6
Project 7
Project 8
Project 9
Project 10
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Line D
Line E
Line F
The Triangular
Relationship
• Line managers not only impact project teams through the
contribution of resource to the teams,
• They also pick the project leaders and
• They control much of the valuable project data needed by
portfolio management
Line
Functions
Project
Teams
Portfolio
Management
Project
Leaders
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Some Differences
Between Discovery
& Development
Discovery Project Leader
Development Project Leader
• Volunteer* from line departments
• Averse to detailed project tracking &
reporting – keep it simple (Gantt
charts a tough sell)
• Line managers needs to value this
work
• The PL will be beholden to the line
managers for resource and delivery
dates
• Professional project leader
• Appreciates the value of project
tracking & reporting (Gantt
charts a minimal necessity)
• Line managers will be influential
in early Development.
• Project more important than line
*
The consequences of a volunteer scientist project leaders may include less training,
less visibility and accountability (not sure of their role), more interest in exploring
science than meeting timelines.
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Presentation
Summary
• The differences between Discovery and
Development Project Leadership come down to the
Level of Aggregate Project Risk
• Project Leadership is no less important in Discovery
than it is in Development
• It’s just different
– These differences are further elaborated at
www.projectleadersolutions.com
www.portfoliomanagementsolutions.com
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Contact
Information
James Samanen Consulting
610-983-9602
www.jamessamanenconsulting.com
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