Using Project Management Information Systems (PMIS) To Improve R&D Portfolio Decisions
Using Project Management Information Systems (PMIS) To Improve R&D Portfolio Decisions
Using Project Management Information Systems (PMIS) To Improve R&D Portfolio Decisions
Agenda
I.
Introduction
II.
Capacity Management
Company Confidential
Copyright 2004 Eli Lilly and Company
I. Introduction
Company Confidential
Copyright 2004 Eli Lilly and Company
Company Confidential
Copyright 2004 Eli Lilly and Company
Years
1960s
1970s
1980s
1990s
3.8
1.9
4.4
2.4
4.3
5.2
2.1
5.6
5.6
2.8
6.7
0.0
5.0
2.0
10.0
15.0
Time (Years)
1st Pharm Testing to IND File
Company Confidential
Copyright 2004 Eli Lilly and Company
Dollars (Millions)
1990
1994
1996
2001
2002
Year
Cost
Company Confidential
Copyright 2004 Eli Lilly and Company
35
30
2003
12
2002
1999
10
2001
19
1998
16
17
2000
18
1997
13
14
18
1996
11
13
16
19
1995
1994
12
14
12
1993
15
11
1992
10
16
1991
20
30
1990
Number of Approvals
60
Years
Priority Review
Standard Review
www.FDA.gov
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
1992
1991
10
1990
Number of Approvals
60
Years
New Molecular Entities
www.FDA.gov
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
5
4
3
5
2
1
2
1
2
1
1
0
Company Confidential
Copyright 2004 Eli Lilly and Company
* As of April 2004
9
Company Confidential
Copyright 2004 Eli Lilly and Company
10
Indexed growth
(1991 = 100)
R&D Expenditure
Sales
Number of NMEs
Company Confidential
Copyright 2004 Eli Lilly and Company
11
Cumulative
%
Success Change
Rate
Historical
(1995 2000)
14%
Current
(2000 2002)
13
8%
Phase I
Phase II
Phase
III/File
Launch
Preclinical
43
Source: Windhovers In Vivo: The Business and Medicine Report, Bain Drug Economics
Model, 2003
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
12
1999
2000
2001
2002
2003
2004
Mibefradil
(1997)
Astemizole
(1988)
Alosetron*
(2000)
Cerivastatin
(1997)
Vioxx
(1999)
Bromfenac
(1997)
Grepafloxacin
(1997)
Cisapride
(1993)
Rapacuronium
(1999)
Seldane
(1985)
Troglitazone
(1997)
www.FDA.gov
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
13
Company Confidential
Copyright 2004 Eli Lilly and Company
14
Company Confidential
Copyright 2004 Eli Lilly and Company
15
Company Confidential
Copyright 2004 Eli Lilly and Company
16
Not necessary
Our industry is staffed with
bright and creative people
www.thestreet.com
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
17
Company Confidential
Copyright 2004 Eli Lilly and Company
18
Company Confidential
Copyright 2004 Eli Lilly and Company
19
Company Confidential
Copyright 2004 Eli Lilly and Company
20
Company Confidential
Copyright 2004 Eli Lilly and Company
21
Company Confidential
Copyright 2004 Eli Lilly and Company
22
Company Confidential
Copyright 2004 Eli Lilly and Company
23
Company Confidential
Copyright 2004 Eli Lilly and Company
24
Portfolio
Portfolio
Mgmt
MgmtProcess
Process
Uncertainty
Attrition
Change
What resources
Capacity
Capacity
will it take in
Mgmt
MgmtProcess
Process
both people
and dollars?
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
What
molecules
should we
work on?
Project
ProjectMgmt
Mgmt
Process
Process
What studies
will we have to
do to bring
these molecules
to market?
25
Portfolio Optimization
Tools provide the
organization with
"intelligent" options
SAP
SAP
SAP consolidates
project, resource, and
direct expense
information across the
Portfolio
MS Project
captures detail
critical path
timelines
Microsoft
Microsoft
Project
Project
26
Portfolio Tool
Portfolio
Reports
Optimizer
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
SAP
Data
Repository
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Company Confidential
Copyright 2004 Eli Lilly and Company
Capacity
Reports
27
Company Confidential
Copyright 2004 Eli Lilly and Company
28
Portfolio
Portfolio
Mgmt
MgmtProcess
Process
Uncertainty
Attrition
Change
What resources
Capacity
Capacity
will it take in
Mgmt
MgmtProcess
Process
both people and
dollars?
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
What
molecules
should we
work on?
Project
ProjectMgmt
Mgmt
Process
Process
What studies
will we have to
do to bring
these molecules
to market?
29
FHD
To
FED
FED
To
FPD
FPD
To
FS
FS
To
Launch
MARKETED
PRODUCTS
Revenue $$
DRUG
DISCOVERY
FTD
To
FHD
2001
Company Confidential
Copyright 2004 Eli Lilly and Company
2002
2003
2004
2005
2006
2007
30
Buy-Ups
In-License
FTD
To
FHD
FHD
To
FED
FED
To
FPD
FPD
To
FS
FS
To
Launch
Consider Buy-Up
Proposals, Acceleration
Strategies, or In-License
Opportunities to fill critical
gaps
Acceleration
Trade-Offs, Park,
Out-License, Alliance
31
Market
Valuation
Probability
of Technical
Success
Portfolio
Prioritization
Resource
Intensity
Cycle
Time
Company Confidential
Copyright 2004 Eli Lilly and Company
32
Portfolio Tool
Portfolio
Reports
Optimizer
Probability
of Technical
Success
Actual
Financial
Inputs to the
Portfolio
Resource intensity
Cycle time
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
33
Portfolio Tool
Portfolio
Reports
Optimizer
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
Examples of Portfolio
Reports
8Q Rolling Forecast
8Q Forecast Plan by
Project
Project Milestones, Cost,
and Revenues
Plan vs Actual Spend
34
Portfolio
Reporting
Net
Net Present
Present
Value
Value
Portfolio Tool
Optimizer
Probability
Probabilityof
of
Technical
Technical
Success
Success
Portfolio
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
35
Net
Net Present
Present
Value
Value
Portfolio
Reporting
Portfolio Tool
Portfolio
Reports
Optimizer
Probability
Probabilityof
of
Technical
Technical
Success
Success
Cost ($$$)
Direct
People
Target
1Q03
2Q03
3Q03
4Q03
1Q04
2Q04
3Q04
4Q04
Cost ($$$)
Direct
People
Target
1Q03
2Q03
3Q03
4Q03
1Q04
2Q04
3Q04
4Q04
Company Confidential
Copyright 2004 Eli Lilly and Company
36
Supply vs Demand
115%
Compare supply vs
demand over
periods of time
105%
Used to identify
chronic bottleneck
functions
Company Confidential
Copyright 2004 Eli Lilly and Company
Project Mgmt
Regulatory
Medical Affiliates
Medical Operations
Clinical Pharm
CT Materials
Product Dev
Process Dev
pK
ADME
Toxicology
Chemistry
85%
Biology
95%
Is the bottleneck
where you want it
to be?
Trade-off
decisions, strategic
hiring
37
Company Confidential
Copyright 2004 Eli Lilly and Company
38
What resources
will it take in
both people and
dollars?
November 19, 2004
Mass. Biotech. Council, MDH, acb
Portfolio
Portfolio
Mgmt
MgmtProcess
Process
Uncertainty
Attrition
Change
Capacity
Capacity
Mgmt
MgmtProcess
Process
Company Confidential
Copyright 2004 Eli Lilly and Company
What
molecules
should we
work on?
Project
ProjectMgmt
Mgmt
Process
Process
What studies
will we have to
do to bring
these molecules
to market?
39
Target
To
Hit
Target
Milestones Target
Hit
Hit
Lead
To
PgS
Lead
Lead
Early Development
Late Development
Launch
Lead
Optimization
Pre-Clinical
Development
Phase I
Phase 2
Global
Launch
Phase 3
Registration
PgS
PgS
CS
FTD
FHD
FHD
FED
FED
PD/RD
FPD
FS
FS
FA
FA
FL
FL
GL
Planning Horizon?
Level
of
Detail?
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
40
Company Confidential
Copyright 2004 Eli Lilly and Company
41
Portfolio Tool
Portfolio
Reports
Optimizer
Probability
of Technical
Success
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project Management
Inputs
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
42
Portfolio Tool
Portfolio
Reports
Optimizer
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
Example Reports
Planning Board
Capacity
Cost
Dollars
People (Project Hours)
43
Project
Reports
Portfolio Tool
Optimizer
Actual
Financial
Time Entry
Company Confidential
Copyright 2004 Eli Lilly and Company
SAP Portfolio
Data
Repository
Project
Reports
44
V. Capacity Management
Company Confidential
Copyright 2004 Eli Lilly and Company
45
What resources
will it take in
both people and
dollars?
November 19, 2004
Mass. Biotech. Council, MDH, acb
Portfolio
Portfolio
Mgmt
MgmtProcess
Process
Uncertainty
Attrition
Change
Capacity
Capacity
Mgmt
MgmtProcess
Process
Company Confidential
Copyright 2004 Eli Lilly and Company
What
molecules
should we
work on?
Project
ProjectMgmt
Mgmt
Process
Process
What studies
will we have to
do to bring
these molecules
to market?
46
Functional Capacity
Management
There is a significant
amount of detail at
the functional level
that feeds the Project
Level information
This level of detail is
managed at the
functional level
Detailed
Activities
Roles
Skill Set
Capability
Training
Flexibility
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
Detailed
Activities
Physical
Plant
Facility
Equipment
Technology
Detailed
Activities
External
Capacity
Vendor Mgmt
Contract
Negotiation
Alliances
47
Portfolio Tool
Portfolio
Reports
Optimizer
Probability
of Technical
Success
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
48
Portfolio Tool
Portfolio
Reports
Optimizer
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
Example Reports
Plan, Actual, and Forecast
for:
each project
the portfolio of projects
function
division
49
Capacity Reports
From PMIS
Portfolio Tool
Optimizer
SAP Portfolio
Data Repository
Plan
Project Mgt.
Capacity Plan
Company Confidential
Copyright 2004 Eli Lilly and Company
STAR
Database
Capacity
Reports
50
Company Confidential
Copyright 2004 Eli Lilly and Company
51
Portfolio
Portfolio
Mgmt
MgmtProcess
Process
Uncertainty
Attrition
Change
What resources
Capacity
Capacity
will it take in
Mgmt
MgmtProcess
Process
both people and
dollars?
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
What
molecules
should we
work on?
Project
ProjectMgmt
Mgmt
Process
Process
What studies
will we have to
do to bring
these molecules
to market?
52
Financial Process
The corporate
budgeting process
defines the R&D budget
Fiscal process to
establish annual
budget for upcoming
year
Total Budget
R&D
R&D
Mfg
Mfg
Mrktg
Mrktg
$$$
$$$
$$$
8 quarter forecasting
process for refinement
throughout the year
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
53
Budget Reconciliation
Supply
(Budget)
Total
Project
Demand
Company Confidential
Copyright 2004 Eli Lilly and Company
54
Financial Inputs
Net Present
Value
Portfolio Tool
Portfolio
Reports
Optimizer
Probability
of Technical
Success
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
55
Portfolio Tool
Portfolio
Reports
Optimizer
Actual
Financial
LRL Global
Employees
Time Entry
SAP Portfolio
Data Repository
SAP
Business
Warehouse
Project
Reports
Web
mySAP.
com
Plan
Project
Management
Functional
Capacity
Planner
STAR
STAR
Database
Database
Capacity
Reports
Company Confidential
Copyright 2004 Eli Lilly and Company
56
Financial Reports
From PMIS
Portfolio Tool
Optimizer
Actual
Financial
SAP Portfolio
Data
Repository
Time Entry
Project
Reports
(Compound, % Total)
Drug Candidate 1
Drug Candidate 2
Drug Candidate 3
Drug Candidate 4
Drug Candidate 5
Drug Candidate 6
Drug Candidate 7
Drug Candidate 8
Drug Candidate 9
Drug Candidate 10
Top 10 ^
Drug Candidate 11
Drug Candidate 12
Drug Candidate 13
Lilly FTE $
Drug Candidate 14
Direct $
Drug Candidate 15
Drug Candidate 16
Drug Candidate 17
Drug Candidate 18
Drug Candidate 19
Drug Candidate 20
$ thousand
500
1,000
1,500
2,000
Company Confidential
Copyright 2004 Eli Lilly and Company
2,500
3,000
3,500
57
Financial Reports
From PMIS
Portfolio Tool
Optimizer
Actual
Financial
Time Entry
SAP Portfolio
Data
Repository
2004 Plan
Company Confidential
Copyright 2004 Eli Lilly and Company
2004 Actual
Project
Reports
2005 Plan
58
VII. Conclusion
Company Confidential
Copyright 2004 Eli Lilly and Company
59
Company Confidential
Copyright 2004 Eli Lilly and Company
60
Company Confidential
Copyright 2004 Eli Lilly and Company
61
Company Confidential
Copyright 2004 Eli Lilly and Company
62
Key Question
Can small companies benefit from this type
of approach?
Yes
Significant benefit is derived from
Project management tools
Business process
Company Confidential
Copyright 2004 Eli Lilly and Company
63
Company Confidential
Copyright 2004 Eli Lilly and Company
64
Company Confidential
Copyright 2004 Eli Lilly and Company
65
Business Process
Significant benefit can be derived from
Establishment of a business process for:
Project management
Portfolio management
Resource / capacity management
Project governance / gate reviews / project
charters / approvals
Establishment of a dictionary for key terms
Examples First Human Dose
Submission
Establish a common language
November 19, 2004
Mass. Biotech. Council, MDH, acb
Company Confidential
Copyright 2004 Eli Lilly and Company
66
Business Process
Significant benefit can be derived from
Making data driven decisions
Projects
Portfolio
Function
Disciplined execution
Proactive risk management
Frequent communication
Company Confidential
Copyright 2004 Eli Lilly and Company
67
Conclusion
As an industry, we need to continue to adapt
by:
Reinventing the drug development process
FDAs Critical Path initiative
Controlling drug development cost and cycle
times
Project management
Capacity management
Resource management
Company Confidential
Copyright 2004 Eli Lilly and Company
68
Thank You
Using Project Management Information Systems
(PMIS) To Improve R&D Portfolio Decisions
Martin D. Hynes III, Ph.D.
Director, Operations & Quality,
Pharmaceutical Product Research & Development
Lilly Research Laboratories
A Division of Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285 U.S.A.
www.lilly.com