Project Leader Authority in Pharmaceutical Discovery &
Development is Inversely Proportional to Aggregate Project Risk
James SamanenPresidentJames Samanen Consulting
www. jamessamanenconsulting.com
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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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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
Pharmaceuti-cal R&D
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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.
Discovery vs. Development
Registration & Launch
TargetSelection
CandidateSelection
MarketAccess
ProductDifferentiation
Full DevelopmentPOCPreclinicalEvaluation
Lead OptimizationLead DiscoveryTarget Discovery
Drug Discovery Drug Development
Focus - Target Focus – Clinical Candidate
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What Percent of Projects Move on to the Next Stage?• ~25% Target Discovery projects reach Candidate Selection, • 7% Candidates reach Launch• 2% success overall
Attrition = 1/Success
Phase1
Candidateto Clinic
Lead Optimization
Lead Discovery
Target Discovery
Phase2
Phase3
Stage: Regis-tration
Launch
61%63% 57%64% 44%56% 83%60%% Success
1.8%
24.5% 7%
Discovery Development
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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• Working backwards - 57 projects are needed for 1 launch
– 75% of pipeline in Discovery (43), 25% in Development (14)
– 10 year avg. cycle time from Target Discovery to Registration
Phase1
Candidateto Clinic
Lead Optimization
Lead Discovery
Target Discovery
Phase2
Phase3
Stage:
3657 1422 4.58
Regis-tration
Launch
1.22 1No. Projects
For 1 Launch
61%63% 57%64% 44%56% 83%60%% Success
1.8%
2 yrs 6.5 yrs1.5 yrs
CycleTimes
Discovery Ph 1 - IIIPre-Clin
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.
How many projects provide 1 Launch?
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• 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)
Attrition-Based Pipeline is not scalable
a) FDA white paper “Innovation or Stagnation” , 2004
“All it takes is one good drug”
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• 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.
The one sure thing pays for the rest
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• 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.
The one sure thing pays for the rest
This drug pays for all of this
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• 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
This is why Discovery Project & Portfolio Management Is Important
The one sure thing pays for the rest
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• 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.
D&D is the removal of Risk
POSRisk
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• “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+)
Project Risk Mgmt – Increase POS
POSRisk
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• As the project team works to reduce Aggregate Project Risk, • The project POS increases, and• The total project Cost increases,
Project Risk vs. POS, Cost
Cost
POSRisk
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• 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,
Project Risk vs. POS, Cost, Value
Cost
Value
POSRisk
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• 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.
Project Risk vs. POS, Cost, Value and Commitment
Cost
Value
POSRisk
Commitment
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• At each stage of Discovery and Development, work is performed to reduce aggregate project risk and increase “potential” value.
Goal to Reduce Risk & Increase Value
Registration & Launch
TargetSelection
CandidateSelection
MarketAccess
ProductDifferentiation
Drug Discovery Drug Development
Full DevelopmentPOC
PreclinicalEvaluation
Lead Optimization
Lead Discovery
Target Discovery
Cost
Value
POSRisk
Commitment
• Project leader authority is influenced by line managers
Influence of Line Managers
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, 4 th Edition, 2008.
Functional Weak Matrix Strong Matrix Projectized
Autono-mousTeam
ProjectMgmtOffice
Full-TimeProjectLeader
Full-timeCoordinator
Part- timeCoordinator
NoCoordinator
Managementof
Projects
High
Med.
None
Infl
ue
nc
e o
f L
ine
Ma
na
ge
rs o
n P
roje
ct
Project Leader Authority High
Low
None
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Influence of Line Managers
• Project leader authority can vary dramatically according to the impact of the project on the corporation
Functional Weak Matrix Strong Matrix Projectized
Autono-mousTeam
ProjectMgmtOffice
Full-TimeProjectLeader
Full-timeCoordinator
Part- timeCoordinator
NoCoordinator
Managementof
Projects
High
Med.
None
Infl
ue
nc
e o
f L
ine
Ma
na
ge
rs o
n P
roje
ct
Project Leader Authority High
Low
Cost
Value
POSRisk
Commitment
None
• In Pharma, Project Leader authority and effectiveness tends to increase from early Discovery to final Drug Development
Influence of Line Managers
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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
LineFunctions
ProjectTeam
ProjectLeader
PortfolioManagement
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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 Line D Line E Line F Project 1 Project 2 Project 3 Project 4 Project 5 Project 6 Project 7 Project 8 Project 9 Project 10
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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
LineFunctions
ProjectTeams
ProjectLeaders
PortfolioManagement
Some Differences Between Discovery & Development
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Discovery 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
Development Project Leader• 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.comwww.portfoliomanagementsolutions.com
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ContactInformation
James Samanen Consulting610-983-9602
www.jamessamanenconsulting.com